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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the Quarterly Period Ended June 30, 2023
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from to .
Commission
file number: 001-41705
Azitra,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
46-4478536 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
no.) |
21
Business Park Drive
Branford,
CT 06405
(Address
of principal executive offices, including zip code)
(203)
646-6446
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock: Par value $0.0001 |
|
AZTR |
|
NYSE
American |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company (as defined in Rule 12b-2 of the Act):
|
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
|
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
|
|
|
Emerging growth company |
☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the registrant’s common stock outstanding as of August 14, 2023 was 12,097,643.
AZITRA,
INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
AZITRA,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,290,355 | | |
$ | 3,492,656 | |
Accounts receivable | |
| 445,120 | | |
| 182,820 | |
Tax credits receivable | |
| 42,446 | | |
| 69,666 | |
Income tax receivable | |
| 13,722 | | |
| 13,722 | |
Deferred offering costs | |
| - | | |
| 216,886 | |
Prepaid expenses | |
| 48,523 | | |
| 160,133 | |
Total current assets | |
| 6,840,166 | | |
| 4,135,883 | |
| |
| | | |
| | |
Property and equipment, net | |
| 803,107 | | |
| 846,958 | |
| |
| | | |
| | |
Other assets | |
| | | |
| | |
Other assets | |
| 47,744 | | |
| 47,507 | |
Operating lease right-of-use asset | |
| 976,959 | | |
| 1,116,697 | |
Intangible assets, net | |
| 241,580 | | |
| 219,567 | |
Deferred patent costs | |
| 920,001 | | |
| 800,831 | |
Total other assets | |
| 2,186,284 | | |
| 2,184,602 | |
| |
| | | |
| | |
Total assets | |
$ | 9,829,557 | | |
$ | 7,167,443 | |
| |
| | | |
| | |
LIABILITIES, PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 364,183 | | |
$ | 784,687 | |
Current operating lease liability | |
| 298,047 | | |
| 287,384 | |
Accrued expenses | |
| 767,721 | | |
| 993,961 | |
Contract liabilities | |
| 310,700 | | |
| 156,000 | |
Total current liabilities | |
| 1,740,651 | | |
| 2,222,032 | |
| |
| | | |
| | |
Long-term operating lease liability | |
| 693,609 | | |
| 840,896 | |
Warrant liability | |
| 158,994 | | |
| 70,283 | |
Convertible notes payable, net | |
| - | | |
| 6,600,000 | |
Total liabilities | |
| 2,593,254 | | |
| 9,733,211 | |
| |
| | | |
| | |
Preferred stock: | |
| | | |
| | |
Series A convertible preferred stock; $0.0001 par value; 205,385 shares authorized at June 30, 2023 and December 31, 2022; 0 and 205,385 shares issued and outstanding at June 30, 2023 and December 31, 2022 respectively; liquidation value of $0 and $3,337,506 at June 30, 2023 and December 31, 2022 respectively | |
| - | | |
| 3,272,944 | |
Series A-1 convertible preferred stock; $0.0001 par value; 380,657 shares authorized at June 30, 2023 and December 31, 2022; 0 and 380,657 shares issued and outstanding at June 30, 2023 and December 31, 2022 respectively; liquidation value of $0 and $14,274,638 as of June 30, 2023 and December 31, 2022, respectively | |
| - | | |
| 14,100,533 | |
Series B convertible preferred stock; $0.0001 par value; 851,108 shares authorized at June 30, 2023 and December 31, 2022; 0 and 391,303 shares issued and outstanding at June 30, 3023 and December 31, 2022, respectively; liquidation value of $0 and $17,000,159 as of June 30, 2023 December 31, 2022 respectively | |
| - | | |
| 16,321,065 | |
Preferred stock value | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity (deficit) | |
| | | |
| | |
Common stock; $0.0001 par value, 100,000,000 shares authorized at June 30, 2023 and December 31, 2022, 12,097,643 and 1,043,988 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | |
| 1,210 | | |
| 104 | |
Additional paid-in capital | |
| 51,436,352 | | |
| 1,054,138 | |
Accumulated deficit | |
| (44,201,259 | ) | |
| (37,314,552 | ) |
Total stockholders’ equity (deficit) | |
| 7,236,303 | | |
| (36,260,310 | ) |
Total liabilities, preferred stock and stockholders’ equity (deficit) | |
$ | 9,829,557 | | |
$ | 7,167,443 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
AZITRA,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
| |
Three Months Ended June
30, 2023 | | |
Three Months Ended June
30, 2022 | | |
Six Months Ended June
30, 2023 | | |
Six Months Ended June
30, 2022 | |
Service revenue – related party | |
$ | 172,000 | | |
$ | 85,000 | | |
$ | 285,300 | | |
$ | 205,000 | |
Total revenue | |
| 172,000 | | |
| 85,000 | | |
| 285,300 | | |
| 205,000 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
| 844,640 | | |
| 667,940 | | |
| 1,687,651 | | |
| 1,529,248 | |
Research and development | |
| 812,836 | | |
| 1,505,447 | | |
| 1,643,017 | | |
| 3,060,815 | |
Total operating expenses | |
| 1,657,476 | | |
| 2,173,387 | | |
| 3,330,668 | | |
| 4,590,063 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,485,476 | ) | |
| (2,088,387 | ) | |
| (3,045,368 | ) | |
| (4,385,063 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 265 | | |
| 335 | | |
| 550 | | |
| 855 | |
Interest expense | |
| (76,187 | ) | |
| (17,811 | ) | |
| (166,019 | ) | |
| (35,448 | ) |
Employee retention credit | |
| - | | |
| 229,813 | | |
| - | | |
| 229,813 | |
Other income | |
| 1,600 | | |
| - | | |
| 2,746 | | |
| - | |
Forgiveness of accounts payable | |
| 56,285 | | |
| - | | |
| 56,285 | | |
| - | |
Change in fair value of convertible note | |
| (2,830,100 | ) | |
| - | | |
| (3,630,100 | ) | |
| - | |
Other expense | |
| (95,915 | ) | |
| (14,103 | ) | |
| (104,801 | ) | |
| (26,327 | ) |
Total other income (expense) | |
| (2,944,052 | ) | |
| 198,234 | | |
| (3,841,339 | ) | |
| 168,893 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax benefit (expense) | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (4,429,528 | ) | |
| (1,890,153 | ) | |
| (6,886,707 | ) | |
| (4,216,170 | ) |
Dividends on preferred stock | |
| (643,267 | ) | |
| (692,246 | ) | |
| (1,355,347 | ) | |
| (1,384,492 | ) |
Net loss attributable to common shareholders | |
$ | (5,072,795 | ) | |
| (2,582,399 | ) | |
$ | (8,242,054 | ) | |
| (5,600,662 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (2.36 | ) | |
$ | (2.45 | ) | |
$ | (5.14 | ) | |
$ | (5.31 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common stock outstanding, basic and diluted | |
| 2,147,526 | | |
| 1,055,454 | | |
| 1,604,510 | | |
| 1,055,336 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Azitra,
Inc.
Statements
of Preferred Stock and Stockholders’ Equity (Deficit)
For
the Three and Six Months Ended June 30, 2023 and 2022
Unaudited
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Deficit) | |
| |
Series
A Convertible Preferred Stock | | |
Series
A-1 Convertible Preferred Stock | | |
Series
B Convertible Preferred Stock | | |
Common
Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total Stockholders’
Equity | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Deficit) | |
Balance, December 31, 2021 | |
| 205,385 | | |
$ | 3,272,944 | | |
| 380,657 | | |
$ | 14,100,533 | | |
| 391,303 | | |
$ | 16,321,065 | | |
| 1,043,100 | | |
$ | 104 | | |
$ | 868,163 | | |
$ | (26,634,186 | ) | |
$ | (25,765,919 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 56,983 | | |
| - | | |
| 56,983 | |
Exercise of stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 888 | | |
| - | | |
| 1,510 | | |
| - | | |
| 1,510 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,326,017 | ) | |
| (2,326,017 | ) |
Balance, March 31, 2022 | |
| 205,385 | | |
| 3,272,944 | | |
| 380,657 | | |
| 14,100,533 | | |
| 391,303 | | |
| 16,321,065 | | |
| 1,043,988 | | |
| 104 | | |
| 926,656 | | |
| (28,960,203 | ) | |
| (28,033,443 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 53,826 | | |
| - | | |
| 53,826 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,890,153 | ) | |
| (1,890,153 | ) |
Balance, June 30, 2022 | |
| 205,385 | | |
| 3,272,944 | | |
| 380,657 | | |
| 14,100,533 | | |
| 391,303 | | |
| 16,321,065 | | |
| 1,043,988 | | |
| 104 | | |
| 980,482 | | |
| (30,850,356 | ) | |
| (29,869,770 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2022 | |
| 205,385 | | |
| 3,272,944 | | |
| 380,657 | | |
| 14,100,533 | | |
| 391,303 | | |
| 16,321,065 | | |
| 1,043,988 | | |
| 104 | | |
| 1,054,138 | | |
| (37,314,552 | ) | |
| (36,260,310 | ) |
Beginning balance | |
| 205,385 | | |
| 3,272,944 | | |
| 380,657 | | |
| 14,100,533 | | |
| 391,303 | | |
| 16,321,065 | | |
| 1,043,988 | | |
| 104 | | |
| 1,054,138 | | |
| (37,314,552 | ) | |
| (36,260,310 | ) |
Issuance of Series B Convertible Preferred Stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| 23,432 | | |
| 1,124,759 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,124,759 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 38,794 | | |
| - | | |
| 38,794 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,457,179 | ) | |
| (2,457,179 | ) |
Balance, March 31, 2023 | |
| 205,385 | | |
| 3,272,944 | | |
| 380,657 | | |
| 14,100,533 | | |
| 414,735 | | |
| 17,445,824 | | |
| 1,043,988 | | |
| 104 | | |
| 1,092,932 | | |
| (39,771,731 | ) | |
| (38,678,695 | ) |
Conversion of convertible notes payable | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,846,020 | | |
| 185 | | |
| 9,494,887 | | |
| - | | |
| 9,495,072 | |
Conversion of preferred stock | |
| (205,385 | ) | |
| (3,272,944 | ) | |
| (380,657 | ) | |
| (14,100,533 | ) | |
| (414,735 | ) | |
| (17,445,824 | ) | |
| 7,707,635 | | |
| 771 | | |
| 34,818,530 | | |
| - | | |
| 34,819,301 | |
Initial public offering, net of issuance costs of $1,508,791 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,500,000 | | |
| 150 | | |
| 5,991,209 | | |
| - | | |
| 5,991,359 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 38,794 | | |
| - | | |
| 38,794 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,429,528 | ) | |
| (4,429,528 | ) |
Balance, June 30, 2023 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 12,097,643 | | |
$ | 1,210 | | |
$ | 51,436,352 | | |
$ | (44,201,259 | ) | |
$ | 7,236,303 | |
Beginning balance | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 12,097,643 | | |
$ | 1,210 | | |
$ | 51,436,352 | | |
$ | (44,201,259 | ) | |
$ | 7,236,303 | |
AZITRA,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| |
For the Six Months Ended June
30, 2023 | | |
For the Six Months Ended June
30, 2022 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (6,886,707 | ) | |
$ | (4,216,170 | ) |
Adjustment to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 64,806 | | |
| 61,417 | |
Amortization of debt discount | |
| - | | |
| 3,936 | |
Amortization of right-of-use assets | |
| 139,738 | | |
| 140,921 | |
Accrued interest on convertible notes | |
| 165,939 | | |
| 31,512 | |
Stock based compensation | |
| 77,588 | | |
| 110,809 | |
Change in fair value of warrant liability | |
| 88,711 | | |
| (35 | ) |
Change in fair value of convertible notes | |
| 3,630,100 | | |
| - | |
Forgiveness of accounts payable | |
| (56,285 | ) | |
| - | |
Loss on disposal of property and equipment | |
| - | | |
| 7,923 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts Receivable | |
| (262,300 | ) | |
| 134,800 | |
Prepaid expenses | |
| 111,610 | | |
| (124,465 | ) |
Other assets | |
| (237 | ) | |
| 165 | |
Tax credits receivable | |
| 27,220 | | |
| (227,955 | ) |
Accounts payable and accrued expenses | |
| (149,781 | ) | |
| 134,028 | |
Operating lease liability | |
| (136,624 | ) | |
| (133,491 | ) |
Contract liabilities | |
| 154,700 | | |
| (15,000 | ) |
Net cash used by operating activities | |
| (3,031,522 | ) | |
| (4,091,605 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (17,578 | ) | |
| (31,453 | ) |
Proceeds from sale of property and equipment | |
| - | | |
| 4,250 | |
Capitalization of deferred patent costs | |
| (119,170 | ) | |
| (117,673 | ) |
Capitalization of licenses | |
| (15,263 | ) | |
| (57,372 | ) |
Capitalization of patent and trademark costs | |
| (10,127 | ) | |
| (585 | ) |
Net cash used in investing activities | |
| (162,138 | ) | |
| (202,833 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
| |
| | | |
| | |
Proceeds from initial public offering, net | |
| 5,991,359 | | |
| - | |
Proceeds from exercise of stock options | |
| - | | |
| 1,510 | |
Net cash provided by financing activities | |
| 5,991,359 | | |
| 1,510 | |
| |
| | | |
| | |
Net change in cash and cash equivalents | |
| 2,797,699 | | |
| (4,292,928 | ) |
| |
| | | |
| | |
Cash and cash equivalents at beginning of the period | |
| 3,492,656 | | |
| 8,044,262 | |
Cash and cash equivalents at end of the period | |
$ | 6,290,355 | | |
$ | 3,751,334 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
| |
| | | |
| | |
Non-cash transactions: | |
| | | |
| | |
Obtaining a right-of-use asset in exchange for lease liability | |
| - | | |
| 1,418,502 | |
Conversion of note to common stock | |
| 9,495,152 | | |
| - | |
Conversion of note to Series B Convertible Preferred Stock | |
$ | 1,124,759 | | |
$ | - | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
1. Organization and Nature of Operations
Azitra
Inc was founded on January 2, 2014. It is a synthetic biology company focused on screening and genetically engineering microbes of the
skin. The mission is to discover and develop novel therapeutics to create a new paradigm for treating skin disease. The Company’s
discovery platform is screened for naturally occurring bacterial cells with beneficial effects. These microbes are then genomically sequenced
and engineered to make cellular therapies, recombinant therapeutic proteins, peptides and small molecules for precision treatment of
dermatology diseases. On May 17, 2023, the Company changed its name to from “Azitra Inc” to “Azitra, Inc.”
The
Company maintains a location in Montreal, Canada for certain research activities. This location and operations completed there remained
consistent throughout 2022 and into 2023. The Company also opened a manufacturing and laboratory space in Groton, Connecticut during
2021.
Forward
Stock Split, Change in Par Value, and Initial Public Offering
In
June 2023, the Company completed its initial public offering (IPO) in which it issued and sold 1,500,000 shares of its common stock at
a price to the public of $5.00 per share. The shares began trading on the NYSE American on June 16, 2023 under the symbol “AZTR”.
The net proceeds received by the Company from the offering were $6.0 million, after deducting underwriting discounts, commissions and
other offering expenses.
Immediately
prior to the effectiveness of the Company’s registration statement, the Company effected a 7.1-for-1 forward stock split of its
issued and outstanding shares of common stock (the Forward Stock Split). On May 17, 2023, the Company changed the par value of its capital
stock from $0.01 to $0.0001. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited consolidated
financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the effect of the Forward Stock
Split. Refer to Note 8 for additional details relating to the Forward Stock Split.
Going
Concern Matters
The
unaudited condensed financial statements have been prepared on the going concern basis, which assumes that the Company will continue
in operation for the foreseeable future and which contemplates the realization of assets and liquidation of liabilities in the normal
course of business. However, management has identified the following conditions and events that created an uncertainty about the ability
of the Company to continue as a going concern. As of and for the six months ended June 30, 2023, the Company has an accumulated deficit
of $44.2 million, a loss from operations of $3.0 million and used $3.0 million to fund operations. These factors among others raise substantial
doubt about the Company’s ability to continue as a going concern.
Management
plans to continue to raise funds through equity and debt financing to fund operating and working capital needs; however, the Company
will require a significant amount of additional funds to complete the development of its product and to fund additional losses which
the Company expects to incur over the next few years. The Company is still in their pre-clinical phase and therefore does not yet have
product revenue. There can be no assurance that the Company will be successful in securing additional financing, if needed, to meet its
operating needs.
These
conditions and events create an uncertainty about the ability of the Company to continue as a going concern for twelve months from the
date that the financial statements are available to be issued. The financial statements do not include any adjustments that might be
necessary should the Company be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis
of Accounting
The
financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S.
GAAP”).
Unaudited
Interim Financial Information
The
unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information,
within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information
and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted
pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the
audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments,
necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of
the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements
related to the three and six month periods are unaudited. Unaudited interim results are not necessarily indicative of the results for
the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the
Company for the year ended December 31, 2022 and notes thereto that are included in the Company’s Registration Statement filed
with the SEC on June 5, 2023.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Use
of Estimates
The
preparation of the financial statement in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet.
While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results
could differ from those estimates.
Cash
and Cash Equivalents
For
purposes of the balance sheets and statements of cash flows, the Company considers all cash on hand, demand deposits and all highly liquid
investments with original maturities of three months or less to be cash equivalents.
Property
and Equipment
Property
and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives, which range
from 3 to 10 years. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are
charged to operations as incurred. Gains or losses on disposal of property and equipment are reflected in the statements of operations
in the period of disposal.
Accounts
Receivable
The
Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its
accounts receivable and establishes an allowance for doubtful accounts based on a history of past write-offs, collections and current
conditions. There was no allowance for doubtful accounts at June 30, 2023 and December 31, 2022. Accounts receivable are written off
when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received.
Deferred
Offering Costs
The
Company capitalized deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other
third-party fees relating to the Company’s initial public offering. In June 2023, the Company consummated its IPO and recorded
such amounts against the gross proceeds of its IPO within the statements of stockholders’ equity during the three and six months
ended June 30, 2023.
Right
of Use Assets
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (“Topic 842”).
ASU 2016-02 requires lessees to present right-of-use (“ROU”) assets and lease liabilities on the balance sheet for all leases
with terms longer than 12 months. See Note 2 – Recently Adopted Accounting Pronouncements.
In
calculating the effect of ASU 2016-02, the Company elected the transition method thereby not restating comparable periods. The Company
elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant
judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance,
the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months.
The
Company has operating leases for buildings. Currently, the Company has 3 operating leases with a ROU asset and lease liability totaling
$1,418,502 as of January 1, 2022. The basis, terms and conditions of the leases are determined by the individual agreements. The Company’s
option to extend certain leases ranges from 36 – 52 months. All options to extend have been included in the calculation of the
ROU asset and lease liability. The leases do not contain residual value guarantees, restrictions, or covenants that could incur additional
financial obligations to the Company. There are no subleases, sale-leaseback, or related party transactions.
At
June 30, 2023, the Company had operating right-of-use assets with a net value of $976,959 and current and long-term operating lease liabilities
of $298,047 and $693,609, respectively.
Intangible
Assets
Intangible
assets consist of trademarks and patents. All costs directly related to the filing and prosecution of patent and trademark applications
are capitalized. Patents are amortized over their respective remaining useful lives upon formal approval. Trademarks have an indefinite
life.
The
Company accounts for other indefinite life intangible assets in accordance ASC Topic 350, Goodwill and Other Intangible Assets
(ASC 350). ASC 350 requires that intangible assets that have indefinite lives are required to be tested at least annually for impairment
or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Intangible assets that have
finite lives will continue to be amortized over their useful lives. No impairment losses relating to intangible assets were recorded
during the three and six months ended June 30, 2023 or 2022.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Deferred
Patent Costs
Deferred
patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval.
These deferred costs will begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent
is not approved, the costs associated with the patent will be expensed in the year the patent was rejected. No impairment losses relating
to deferred patent costs were recorded in the three and six months ended June 30, 2023 or 2022.
Impairment
of Long-Lived Assets
In
accordance with ASC Topic 360-10, Accounting for the Impairment or Disposal of Long-Lived Assets (ASC 360-10), the Company’s
policy is to review its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount
of an asset may not be recoverable. In connection with this review, the Company also reevaluates the periods of depreciation for these
assets. The Company recognizes an impairment loss when the sum of the undiscounted expected future cash flows from the use and eventual
disposition of the asset is less than its carrying amount. If an asset is considered to be impaired, the impairment to be recognized
is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset, which is determined using the
present value of the net future operating cash flows generated by the asset.
Convertible
Debt and Warrant Accounting
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”)
and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial
instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other
conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant
issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For
issued warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional
paid-in capital at the time of issuance. For issued warrants that do not meet all the criteria for equity classification, the warrants
are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the
estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations under Other Income/loss.
Convertible
debt
When
the Company issues debt with a conversion feature, it first assesses whether the debt should be accounted for in accordance with ASC
480 – Distinguishing Liabilities from Equity. If the debt does not meet the criteria of an ASC 480 liability, the note’s
conversion features require bifurcation in accordance with ASC 815 – Derivatives and Hedging. If the Company determines the embedded
conversion feature requires bifurcation in accordance with ASC 815, the Company also considers if it can elect the fair value option.
If the fair value option is elected, the Company records the note at its initial fair value with any subsequent changes in fair value
recorded in earnings. As noted in Note 7, the Company has elected the fair value option for the 2022 Convertible Notes and will record
the notes at their initial fair values with any subsequent changes in fair value recorded in earnings. The Convertible Notes were converted
into the Company’s common stock on the Closing Date of the Company’s IPO.
Convertible
Preferred Stock
As
the Convertible Preferred stockholders have liquidation rights in the event of a deemed liquidation event that, in certain situations,
are not solely within the control of the Company and would require the redemption of the then-outstanding Convertible Preferred Stock,
the Company classifies the Convertible Preferred Stock in mezzanine equity on the balance sheet. Due to the fact that the occurrence
of a deemed liquidation event is not currently probable, the carrying value of the Convertible Preferred Stock is not being accreted
to its redemption value. Subsequent adjustments to the carrying value of the Convertible Preferred Stock would be made only when a deemed
liquidation event becomes probable.
As
noted in Note 8, at the Closing Date of the Company’s IPO, the Convertible Preferred stock converted into shares of the Company’s
common stock.
Revenue
The
Company follows the five steps to recognize revenue from contracts with customers under ASC 606, Revenue from Contracts
with Customers (“ASC 606”), which are:
|
● |
Step
1: Identify the contract(s) with a customer |
|
|
|
|
● |
Step
2: Identify the performance obligations in the contract |
|
|
|
|
● |
Step
3: Determine the transaction price |
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
● |
Step
4: Allocate the transaction price to the performance obligations in the contract |
|
|
|
|
● |
Step
5: Recognize revenue when (or as) a performance obligation is satisfied |
The
Company generates service revenue through a joint development agreement with a research partner. The Company recognizes revenue related
to the research and development aspects of the agreement over time using the input method as work is performed on the contract.
The
Company also generates grant revenue, which represents monies received on contracts with various federal agencies and nonprofit research
institutions for general research conducted by the Company to further their product development and are therefore considered contributions
to the Company. The contracts are generally for periods of one year or more and can be cancelled by either party. The Company concluded
that the grant arrangements do not meet the criteria to be treated as a collaborative arrangement under FASB ASC Topic 808 as the Company
is the only active participant in the arrangement. The grant arrangements also do not meet the criteria for revenue recognition under
Topic 606, as the U.S. Government would not meet the definition of a customer.
Amounts
earned under these grant contracts are recorded as a reduction to research and development expense when eligible expenses are incurred
and the right to payment is realizable or realized and earned. The Company believes this policy is consistent with Topic 606, to ensure
that recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that the
Company expects to be entitled to in exchange for those goods or services, even though there is no exchange as defined in Topic 606.
Additionally, the Company has determined that the recognition of amounts received as costs are incurred and amounts become realizable
is analogous to the concept of transfer of control of a service over time under Topic 606.
Receipts
of grant awards in advance, which are payable back to the funding agency if not used in accordance with conditions in the grants related
to allowable costs or receipt of funding from research partners related to service revenue arrangements before work is performed on the
contract, are classified as contract liabilities in the accompanying balance sheets.
Research
and Development
The
Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research
and Development. Accordingly, internal research and development costs are expensed as incurred. Research and development costs consist
of costs related to labor, materials and supplies. Research and development costs incurred were $812,836 and $1,643,017 during the three
and six month period ended June 30, 2023, respectively. Research and development costs incurred were $1,505,447 and $3,060,815 during
the three and six month period ended June 30, 2022, respectively.
At
June 30, 2023 and December 31, 2022, the Company has a state tax credit receivable of $32,459 for pending refunds related to the selling
of research and development tax credits back to the State of Connecticut. At June 30, 2023 and December 31, 2022, the Company has $0
and $28,925, respectively for pending refunds related to Canadian Scientific Research and Experimental Development (SRED) credits. At
June 30, 2023 and December 31, 2022, the Company has also recorded $9,987 and $8,282, respectively, related to refunds of Canadian Goods
and Services Tax (GST) and Quebec Sales Tax (QST). Receipts of refunds are recorded in other income on the statements of operations.
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation (ASC 718). ASC 718 requires
employee stock options and rights to purchase shares under stock participation plans to be accounted for at fair value. ASC 718 requires
that compensation costs related to share-based payment transactions be recognized as operating expenses in the financial statements.
Under this method, compensation costs for all awards granted or modified are measured at estimated fair value at date of grant and are
included as compensation expense over the vesting period during which an employee provides service in exchange for the award. For awards
with a performance condition that affects vesting, the Company recognizes compensation expense when it is determined probable that the
performance condition will be achieved.
The
Company uses a Black-Scholes option pricing model to determine fair value of its stock options. The Black-Scholes model includes various
assumptions, including the value of the underlying common stock, the expected life of stock options, the expected volatility and the
expected risk-free interest rate. These assumptions reflect the Company’s best estimates, but they involve inherent uncertainties
based on market conditions generally outside of the control of the Company. As a result, if other assumptions had been used, stock-based
compensation cost could have been materially impacted. Furthermore, if the Company uses different assumptions for future grants, stock-based
compensation cost could be materially impacted in future periods.
The
Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC 718 as updated by Accounting
Standards Update (ASU) No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of ASC
718 to include share-based payment transactions to non-employees.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
The
following assumptions are used in valuing options issued using the Black-Scholes option pricing model:
Expected
Volatility. The expected volatility of the Company’s shares is estimated based on the Company’s external valuation.
Expected
Term. The expected term of options is estimated using the simplified method which is based on the vesting period and contractual
term for each grant, or for each vesting-tranche for awards with graded vesting.
Underlying
Common Stock Value. The underlying common stock value of the Company’s shares is estimated by a third-party valuation expert.
Risk-free
Interest Rate. The Company bases the risk-free interest rate on the implied yield available on a U.S. Treasury note with terms equal
to the expected term of the underlying grant.
Dividend
Yield. The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company has not paid dividends
on Common stock in the past nor does it expect to pay dividends on Common stock in the near future. As such, the Company uses a dividend
yield percentage of zero
Income
Taxes
The
Company uses the liability method of accounting for income taxes, as set forth in ASC 740, Accounting for Income Taxes. Under
this method, deferred tax assets and liabilities are recognized for the expected future tax consequence of temporary differences between
the carrying amounts and the tax basis of assets and liabilities and net operating loss carry forwards, all calculated using presently
enacted tax rates.
Management
has evaluated the effect of ASC guidance related to uncertain income tax positions and concluded that the Company has no significant
financial statement exposure to uncertain income tax positions at June 30, 2023 and December 31, 2022. The Company’s income tax
returns have not been examined by tax authorities through December 31, 2022.
Fair
Value Measurements
The
Company carries certain liabilities at fair value on a recurring basis. A fair value hierarchy that consists of three levels is used
to prioritize the inputs to fair value valuation techniques:
|
● |
Level
1 – Inputs are based upon observable or quoted prices for identical instruments traded in active markets. |
|
|
|
|
● |
Level
2 – Inputs are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments
in markets that are not active, and model-based valuation techniques for which all significant assumptions are observable in the
market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
|
|
|
|
● |
Level
3 – Inputs are generally unobservable and typically reflect management’s estimates of assumptions that market participants
would use in pricing the asset or liability. The fair values are therefore determined using model-based techniques that include option
pricing models, discounted cash flow models, and similar techniques. |
In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Recent
Accounting Pronouncements
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02,
Leases (Topic 842). This ASU requires a lessee to recognize a right-of-use asset and a lease liability under most operating leases in
its balance sheet. The ASU is effective for annual and interim periods beginning after December 15, 2021. The Company adopted ASU 2016-02
on January 1, 2022. See Note 13 – Operating Leases.
In
December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard
simplifies the accounting for income taxes through the removal of various exceptions previously provided, as well as providing additional
reporting requirements for income taxes. The ASU is effective for the Company on January 1, 2022. The Company has adopted this standard
effective January 1, 2022, which did not have a material impact to the financial statements.
In
August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40), which simplifies the accounting for certain financial
instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own
equity. This standard will be effective for the Company on January 1, 2024, with early adoption permitted (but no earlier than fiscal
years beginning after December 15, 2020). The Company has adopted this standard effective January 1, 2021, which did not have a material
impact to the financial statements.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Management
does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying
financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.
Financial
Instruments
The
Company’s financial instruments are primarily comprised of accounts receivable, accounts payable, accrued liabilities, and long-term
debt. For accounts receivable, accounts payable and accrued liabilities, the carrying amount approximates fair value due to the short-term
maturities of such instruments. The estimated fair value of the Company’s long-term debt approximates carrying value.
3. Employee Retention Credit
The
CARES Act provides an employee retention credit (“CARES Employee Retention credit”), which is a refundable tax credit against
certain employment taxes of up to $5,000 per employee for eligible employers. The tax credit is equal to 50% of qualified wages paid
to employees during a quarter, capped at $10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions
were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through September
30, 2021. Based on these additional provisions, the tax credit is now equal to 70% of qualified wages paid to employees during a quarter,
and the limit on qualified wages per employee has been increased to $10,000 of qualified wages per quarter. In April 2022, the Company
determined it qualified for the tax credit under the CARES Act and recorded a receivable for $229,813 and recognized the amounts as other
income on the statement of operations. The Company received full payment for the amount in September 2022.
4. Property and Equipment
Property
and equipment consisted of the following at June 30, 2023 and December 31, 2022:
Schedule of Property And Equipment
| |
June 30,2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 1,053,710 | | |
$ | 1,034,579 | |
Computer equipment | |
| 30,825 | | |
| 30,825 | |
Furniture and fixtures | |
| 24,316 | | |
| 24,316 | |
Leasehold improvements | |
| 28,855 | | |
| 28,855 | |
Building equipment | |
| 14,932 | | |
| 14,932 | |
Property and equipment gross | |
| 1,152,638 | | |
| 1,133,507 | |
Less: accumulated depreciation | |
| (349,531 | ) | |
| (286,549 | ) |
Net property and equipment | |
$ | 803,107 | | |
$ | 846,958 | |
Depreciation
expense was $30,877 and $61,429 for the three and six months ended June 30, 2023, respectively. Depreciation expense was $30,148 and
$59,957 for the three and six months ended June 30, 2022, respectively.
5. Intangible Assets
Intangible
assets consisted of the following at:
Schedule of Intangible Assets
June
30, 2023:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 56,248 | | |
$ | - | | |
$ | 56,248 | |
Patents | |
17 years | |
| 116,076 | | |
| 11,517 | | |
| 104,559 | |
License agreement | |
17 years | |
| 80,773 | | |
| - | | |
| 80,773 | |
Intangible Assets | |
| |
$ | 253,097 | | |
$ | 11,517 | | |
$ | 241,580 | |
December
31, 2022:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 53,999 | | |
$ | - | | |
$ | 53,999 | |
Patents | |
17 years | |
| 108,198 | | |
| 8,140 | | |
| 100,058 | |
License agreement | |
17 years | |
| 65,510 | | |
| - | | |
| 65,510 | |
Intangible Assets | |
| |
$ | 227,707 | | |
$ | 8,140 | | |
$ | 219,567 | |
During
the three and six months ended June 30, 2023, amortization expense related to intangible assets was $1,780 and $3,377, respectively.
During the three and six months ended June 30, 2022, amortization expense related to intangible assets was $730 and $1,460, respectively.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
6. Accrued Expenses
Accrued
expenses consisted of the following at:
Schedule of Accrued Expenses
| |
June 30, 2023 | | |
December 31, 2022 | |
Employee payroll and bonuses | |
$ | 481,383 | | |
$ | 371,010 | |
Vacation | |
| 60,911 | | |
| 27,082 | |
Research and development projects | |
| 164,036 | | |
| 316,389 | |
Interest | |
| - | | |
| 223,792 | |
Professional fees | |
| 57,133 | | |
| 24,502 | |
Other | |
| 4,258 | | |
| 31,186 | |
Total accrued expenses | |
$ | 767,721 | | |
$ | 993,961 | |
The
Company accrues expenses related to development activities performed by third parties based on an evaluation of services received and
efforts expended pursuant to the terms of the contractual arrangements. Payments under some of these contracts depend on research and
non-clinical trial milestones. There may be instances in which payments made to the Company’s vendors will exceed the level of
services provided and result in a prepayment of expense. In accruing service fees, the Company estimates the period over which services
will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level
of effort varies from the estimate, the Company will adjust the accrual or prepaid expense accordingly. The Company has not experienced
any material differences between accrued costs and actual costs incurred since its inception.
7. Convertible Debt
In
September 2022, the Company entered into a Convertible Note Purchase Agreement (the Agreement) to issue up to $4,500,000 convertible
promissory notes. On the same day, the Company entered into convertible promissory notes (2022 Convertible Notes) with three investors
totaling $4,350,000. The 2022 Convertible Notes mature on January 13, 2023 or the occurrence of an Event of Default (as defined) and
bear interest at a rate of 8% per annum which shall accrue but is not due and payable until conversion or full repayment of outstanding
principal. The principal and interest outstanding under the 2022 Convertible Notes is automatically converted a) upon the closing of
a Qualified Financing resulting in gross proceeds to the Company of at least $20 million into securities issued in connection with the
Qualified Financing, at a discount of 30% per share; b) upon the closing of a Change of Control event into shares of capital stock of
the Company or Series B preferred stock; and c) upon the closing of a Public Company Event, into shares of capital stock being issued
to investors equal to two-times (2x) the amount of the outstanding principal and accrued interest then outstanding divided by the public
offering price per share. The principal and interest outstanding under the 2022 Convertible Notes is convertible, at the option of the
holders, at the maturity date into a new class of Company’s Preferred Stock (Series C Preferred) equal to the quotient of the outstanding
principal amount plus interest divided by the Capped Price, which is defined as the price per share equal to the Valuation Cap of $30
million divided by the Company Capitalization, as defined in the Agreement.
In
February 2023, the 2022 Convertible Notes were amended to extend the maturity date to March 31, 2023 and to change the conversion price
upon a Qualified Financing or Change in Control event to $30 million divided by the number of shares of the Company’s common stock
issued and outstanding, on a fully diluted basis, immediately prior to the close of the Qualified Financing or Change in Control event.
During
April and June 2023, the 2022 Convertible Notes were further amended to extend the maturity date to June 30, 2023 and allow for the sale
of additional notes of $500,000 for a total aggregate principal of $4,850,000.
Effective
June 21, 2023, the 2022 Convertible Notes were converted to 1,846,020 shares of the Company’s common stock equal to $9,494,887.
Upon conversion, the Company recorded a change in fair value of $2,830,100 for the three and six months ended June 30, 2023 which was
recognized as a non-cash change in fair value in Other Income (Expense) on the statement of operations.
The
Company accounts for the 2022 Convertible Notes under ASC 815. Under 815-15-25, the election can be at the inception of a financial instrument
to account for the instrument under the fair value option under ASC 825. The Company has made such election for the 2022 Convertible
Notes. Using the fair value option, the convertible promissory note is to be recorded at its initial fair value on the date of issuance,
and each balance sheet date thereafter. The Company evaluates the change based on the conversion price at the current market value. When
recognized, changes in the estimated fair value of the notes are recognized as a non-cash gain or loss in Other Income (Expense) on the
statements of operations.
Effective
January 5, 2021, the Company entered into a Note Purchase Agreement to issue up to $2,000,000 of convertible promissory notes. On the
same date, the Company entered into a convertible promissory note (2021 Convertible Note) with one investor for $1,000,000. The 2021
Convertible Note bears interest at a rate of 6% per annum and is due and payable in full on January 5, 2023. The 2021 Convertible Note
automatically converts upon a qualified equity financing, as defined in the note agreement to the number of shares equal to all principal
and accrued interest divided by the conversion price of $48.00, which is subject to adjustment as defined in the note agreement. The
2021 Convertible Note is also optionally convertible as defined in the note agreement for certain non-qualified financing, a change in
control, or upon the maturity date of the 2021 Convertible Note. The Company incurred issuance costs of $15,613 related to the 2021 Convertible
Note, which has been recorded as a debt discount and will be amortized over the term of the 2021 Convertible Note.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
In
January 2023, the Company elected to convert the 2021 Convertible Note, including interest accrued but not yet paid of $124,759 at a
conversion price of $48.00 into 23,432 shares of its Series B Preferred Stock in accordance with the terms outlined in the Note Purchase
Agreement.
The
Company evaluated the terms and conditions of the Note Purchase Agreement related to the 2021 Convertible Note in order to assess the
accounting considerations under ASC 480 – Distinguishing Liabilities from Equity, and ASC 815 – Derivatives and Hedging.
The Company determined the Convertible Note does not meet any of the criteria to be accounted pursuant to an ASC 480 liability. The Company
also assessed the embedded features pursuant to the guidance in ASC 815 and determined the embedded features do not meet any of the criteria
for bifurcation.
Convertible
notes payable consisted of the following at:
Schedule of Convertible
Notes Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
2021 Convertible Note | |
$ | - | | |
$ | 1,000,000 | |
2022 Convertible Notes | |
| - | | |
| 5,600,000 | |
| |
$ | - | | |
$ | 6,600,000 | |
There
was $0 amortized related to the debt issuance costs during the three and six months ended June 30, 2023, respectively. There was $1,968
and $3,936 amortized related to the debt issuance costs during the three and six months ended June 30, 2022, respectively. Interest accrued
on the convertible notes was $0 and $223,792 at June 30, 2023 and December 31, 2022, respectively.
8. Stockholders’ Equity
On
May 17, 2023, the Company effected a 7.1-for-1 forward stock split (the “Forward Stock Split”) of its issued and outstanding
shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s preferred
stock. The par value of the common stock was adjusted as a result of the Forward Stock Split from $0.01 to $0.0001 and the authorized
shares were increased to 100,000,0000 shares of common stock in connection with the Forward Stock Split. Fractional shares resulting
from the Forward Stock Split were rounded down to the next whole share and in lieu of any fractional shares the Company will pay a cash
amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive
effect to the Forward Stock Split for all periods presented. Shares of common stock underlying outstanding stock-based awards and other
equity instruments were proportionately increased and the respective per share value and exercise prices, if applicable, were proportionately
decreased in accordance with the terms of the agreements governing such securities.
Common
Stock
At
June 30, 2023 and December 31, 2022, per the Company’s amended and restated Certificate of Incorporation, the Company was authorized
to issue 100,000,000 shares of $0.0001 par value common stock.
The
Company had 12,097,643 and 1,043,988 shares of common stock issued and outstanding as of June 30, 2023 and December 31, 2022, respectively.
Each
share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders and the
holders of the Common Stock are entitled to elect one director of the Corporation.
The
Company currently has 1,584,414 shares of common stock reserved for future issuance for the potential exercise of stock options and warrants
outstanding at June 30, 2023.
Preferred
Stock
At
June 30, 2023 and December 31, 2022, per the Company’s amended and restated Certificate of Incorporation, the Company has authorized
1,437,150 shares of $0.0001 par value preferred stock.
In
January 2023, the Company issued 23,432 shares of its Series B Preferred Stock related to conversion of the 2021 Convertible Note at
a conversion price of $48.00 per share (see Note 7).
The
Series A, Series A-1, and Series B Preferred Stock have the following rights, preferences and privileges:
Conversion
The
preferred stock is convertible, at the option of the holder, into common shares based upon a predefined formula. A holder of preferred
stock may convert such shares into common shares at any time. For purpose of conversion, the initial conversion price is $16.25 per share
(original issue price) for Series A Preferred Stock, $37.50 per share (original issue price) for Series A-1 Preferred Stock, and $43.45
per share (original issue price) for Series B Preferred Stock, and is subject to adjustment as described in the Certificate of Incorporation.
Preferred stock will automatically convert into common shares upon the earlier of (a) an initial public offering with gross proceeds
in excess of $100,000,000 or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the required
preferred stock shareholders, all outstanding Series A, Series A-1, and Series B Preferred Stock shall automatically convert into common
shares, at the then effective conversion rate.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Upon
the Company’s IPO in June 2023, all of the outstanding preferred stock converted to common stock, resulting in the issuance of
1,458,233, 2,964,849, and 3,284,553 shares of common stock in exchange for outstanding Series A, Series A-1, and Series B Preferred Stock,
respectively. There was no gain or loss upon conversion.
Voting
Rights
The
holders of the Series A, Series A-1, and Series B Preferred Stock are entitled to vote on any matter presented to the stockholders of
the Corporation for their action or consideration at any meeting of stockholders of the Corporation (or by written consent of stockholders
in lieu of meeting), each holder of outstanding shares of preferred stock shall be entitled to cast the number of votes equal to the
number of whole shares of Common Stock into which the shares of preferred stock held by such holder are convertible as of the record
date for determining stockholders entitled to vote on such matter. The holders of the Series A and Series A-1 Preferred Stock are each
entitled to elect one director of the Corporation. The holders of the Series B Stock are entitled to elect two members of the Board.
Each class of preferred stock can remove from office such directors and to fill any vacancy caused by the resignation, death or removal
of such directors under certain circumstances as described in the Certificate of Incorporation.
Dividends
The
holders of Series A Preferred Stock are entitled to receive dividends at a rate of 8% per annum of the Series A original issue price
of $16.25 per share on each outstanding share of Series A Preferred Stock (subject to appropriate adjustment in the event of any stock
dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock). Dividends accumulate
from the original date of issuance of the Series A Preferred Stock, are cumulative and are payable upon declaration of the Board of Directors
or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series A Preferred Stock as there was no longer
any Series A Preferred Stock outstanding.
The
holders of Series A-1 Stock are entitled to receive dividends at a rate of 8% per annum of the Series A-1 original issue price of $37.50
per share on each outstanding share of Series A-1 (subject to appropriate adjustment in the event of any stock dividend, stock split,
combination or other similar recapitalization with respect to the Series A-1 Preferred Stock). Dividends are cumulative and are payable
upon declaration of the Board of Directors or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series
A-1 Preferred Stock as there was no longer any Series A-1 Preferred Stock outstanding.
The
holders of Series B Stock are entitled to receive dividends at a rate of 8% per annum of the Series B original issue price of $43.45
per share on each outstanding share of Series B (subject to appropriate adjustment in the event of any stock dividend, stock split, combination
or other similar recapitalization with respect to the Series B Preferred Stock). Dividends are cumulative and are payable upon declaration
of the Board of Directors or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series B Preferred Stock
as there was no longer any Series B Preferred Stock outstanding.
Liquidation
In
the event of any liquidation, dissolution or winding up of the Company, the holders of the preferred stock are entitled to receive, prior
to and in preference to the holders of the common shares, an amount equal to the Series A, Series A-1, or Series B Preferred Stock original
issue price, plus declared and/or accrued but unpaid dividends. In the event of any such liquidation event, after the payment of all
preferential amounts required to be paid to the holders of shares of preferred stock, the remaining assets of the Corporation available
for distribution to its stockholders shall be distributed among the holders of the shares of preferred stock and Common Stock, pro rata
based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted into
Common Stock pursuant to the terms of the Certificate of Incorporation immediately prior to such liquidation event.
9. Warrants
The
Company issued warrants to purchase 6,745 shares of common stock in 2018 in conjunction with convertible debt financing that have a redemption
provision providing the holder the right to have the Company redeem all or any portion of the warrant (or shares it has converted into)
at a purchase price equal to the fair market value of the shares as determined by the board of directors or an independent appraiser.
As a result of this redemption provision, the warrants have been classified as a liability in the financial statements based on ASC 480
– Distinguishing Liabilities from Equity. These warrants have an exercise price of $0.48 per share and a term of 10 years. The
warrants are marked to market each reporting period. The fair value is $158,994 and $70,283 at June 30, 2023 and December 31, 2022, respectively.
At June 30, 2023, the Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following
assumptions: Underlying common stock value of $3.64; Expected term of 4.8 years; Expected Volatility of 82.5%; Risk Free Interest Rate
of 3.01%; and Dividend Yield of 0%. At December 31, 2022, the Company estimated the fair value of the warrants using the Black-Scholes
option pricing model with the following assumptions: Underlying common stock value of $12.09; Expected term of 5 years; Expected Volatility
of 86.0%; Risk Free Interest Rate of 3.01%; and Dividend Yield of 0%.
The
Company also issued warrants in 2016 and 2019 which did not meet the criteria under ASC 480 to be classified as a liability, and instead
meet equity classification criteria. The 11,466 warrants issued in 2016 expired upon the initial public offering in June 2023.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
The
following table summarizes information about warrants outstanding at June 30, 2023:
Schedule
of Information about Warrants Outstanding
| |
| | |
Warrants Outstanding | | |
Warrants Exercisable | |
Year Granted | |
Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| |
| | |
| | |
| |
| | |
| | |
| |
| |
2018 | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | |
2019 | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | |
2023 | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | |
| |
| | | |
| 323,733 | | |
| |
$ | 4.75 | | |
| 323,733 | | |
| |
$ | 4.75 | |
10. Stock Options
In
March 2023, the Company’s Board of Directors and stockholders approved the 2023 Stock Incentive Plan (“2023 Plan”).The
2023 Plan allows the Committee to grant up to 2,000,000 shares of Common Stock in the form of incentive and non-statutory stock options,
restricted stock awards, restricted stock units, and other stock-based awards to employees, directors, and non-employees. As of June
30, 2023, there were no awards issued under the 2023 Plan.
During
2016, the Company established the Azitra Inc. 2016 Stock Incentive Plan (the Plan) which provides for the granting of stock options and
restricted shares to the Company’s employees, officers, directors, advisors and consultants. There were 1,490,595 shares available
for granting under the Plan at December 31, 2022. Options vest over varying time frames.
During
the three and months ended June 30, 2023 and 2022, the Company did not grant any stock options to acquire shares of common stock. During
the three and six months ended June 30, 2023, the Company recognized stock compensation expense of $38,974 and $77,588, respectively,
relating to the issuance of service-based stock options. During the three and six months ended June 30, 2022, the Company recognized
stock compensation expense of $53,826 and $110,809, respectively, relating to the issuance of service-based stock options. At June 30,
2023, there was $350,197 of unamortized compensation expense that will be amortized over the remaining vesting period. At June 30, 2023
and 2022, there were 13,120 performance-based options outstanding with a fair value of $109,551. During the three and six months ended
June 30, 2023 and 2022, the Company did not recognize any compensation expense for performance-based options. The Company determined
the options qualified as plain vanilla under the provisions of SAB 107 and the simplified method was used to estimate the expected option
life.
The
following table summarizes information about options outstanding and exercisable at June 30, 2023:
Schedule of Information about Options Outstanding and Exercisable
| | |
Options Outstanding | | |
Options Exercisable | |
Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| | |
| | |
| |
| | |
| | |
| |
| |
$ | 0.48 | | |
| 246,137 | | |
2.5 years | |
$ | 0.48 | | |
| 246,137 | | |
2.6 years | |
$ | 0.48 | |
$ | 0.93 | | |
| 202,040 | | |
2.5 years | |
$ | 0.93 | | |
| 198,290 | | |
2.5 years | |
$ | 0.93 | |
$ | 1.70 | | |
| 812,504 | | |
7.8 years | |
$ | 1.70 | | |
| 518,227 | | |
7.6 years | |
$ | 1.70 | |
| | | |
| 1,260,681 | | |
| |
| | | |
| 962,654 | | |
| |
| | |
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Total
stock option activity for the six months ended June 30, 2023 is summarized as follows:
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | |
Outstanding at December 31, 2022 | |
| 1,290,325 | | |
$ | 1.27 | |
Granted | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Forfeited | |
| (29,644 | ) | |
| 0.93 | |
Outstanding at June 30, 2023 | |
| 1,260,681 | | |
$ | 1.28 | |
There
are 229,914 shares available for future grant under the Plan at June 30, 2023.
11. Fair Value Measurements
The
following tables summarize the fair values and levels within the fair value hierarchy in which the fair value measurements fall for assets
and liabilities measured on a recurring basis as of:
Schedule of Fair Value Measurements for Assets and Liabilities
June 30, 2023 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
Total | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
December 31, 2022 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 70,283 | | |
$ | 70,283 | |
2022 Convertible Notes | |
| - | | |
| - | | |
| 5,600,000 | | |
| 5,600,000 | |
Total | |
$ | - | | |
$ | - | | |
$ | 5,670,283 | | |
$ | 5,670,283 | |
The
following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended June 30, 2023:
Schedule
of Changes in Level 3 Instruments Measured on a Recurring Basis
| |
| | |
Balance at December 31, 2022 | |
$ | 5,670,283 | |
Change in fair value of warrants | |
| (5,621 | ) |
Change in fair value of 2022 Convertible Notes | |
| 800,000 | |
Balance at March 31, 2023 | |
$ | 6,464,662 | |
Change in fair value of warrants | |
| 94,036 | |
Change in fair value of 2022 Convertible Notes | |
| 2,830,100 | |
Conversion of 2022 Convertible Notes | |
| (9,230,100 | ) |
Balance at June 30, 2023 | |
$ | 158,698 | |
Fluctuation
in the fair value of the Company’s Common stock is the primary driver for the change in the Common Stock Warrant liability valuation
during each year. As the fair value of the Common stock increases the value to the holder of the instrument generally increases.
Fluctuations
in the various inputs, including the enterprise value, time to liquidity, volatility, and discount rate are the primary drivers for the
changes in valuation of the 2022 Convertible Notes each reporting period. As the fair value of the enterprise value, estimated time to
liquidity, volatility, and discount rate increase, the value to the holder of the 2022 Convertible Notes generally increases.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
12. Net Loss Per Share
Basic
and diluted net loss per share were calculated as follows:
The
numerator for basic and diluted net loss per share is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss | |
$ | (4,429,528 | ) | |
$ | (1,890,153 | ) | |
$ | (6,886,707 | ) | |
$ | (4,216,170 | ) |
Dividends on preferred stock | |
| (643,267 | ) | |
| (692,246 | ) | |
| (1,355,347 | ) | |
| (1,384,492 | ) |
Net loss attributable to common shareholders | |
$ | (5,072,795 | ) | |
$ | (2,582,399 | ) | |
$ | (8,242,054 | ) | |
$ | (5,600,662 | ) |
The
denominator is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Weighted Average Common Stock Outstanding
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Weighted average common stock outstanding, basic and diluted | |
| 2,137,207 | | |
| 1,043,988 | | |
| 1,593,617 | | |
| 1,043,870 | |
$0.01 warrants | |
| 10,319 | | |
| 11,466 | | |
| 10,893 | | |
| 11,466 | |
Total | |
| 2,147,526 | | |
| 1,055,454 | | |
| 1,604,510 | | |
| 1,055,336 | |
Net
loss per share, basic and diluted is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Net Loss Per Share, Basic and Diluted
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss per share, basic and diluted | |
$ | (2.36 | ) | |
$ | (2.45 | ) | |
$ | (5.14 | ) | |
$ | (5.31 | ) |
The
following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation
of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
Schedule of Calculation of Diluted Net Loss Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Options to purchase shares of common stock | |
| 1,260,681 | | |
| 1,290,318 | |
Warrants outstanding | |
| 323,733 | | |
| 263,743 | |
Common stock reserved for future issuance | |
| 1,584,414 | | |
| 1,554,061 | |
13. Commitments and Contingencies
Legal
The
Company is subject to legal proceedings or claims which arise in the ordinary course of its business. Although occasional adverse decisions
or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on
its financial position, results of operations or liquidity.
License
Agreement
Effective
January 26, 2022, the Company entered into an Exclusive License Agreement (the Agreement) with an unrelated third party. Under the Agreement,
the Company is granted an exclusive license for certain patents and a non-exclusive license for certain know-how. The Agreement continues
until the later of the expiration of the last to expire licensed patent or ten years after the first commercial sale of the first licensed
therapeutic or non-therapeutic product. The Company may terminate the Agreement at any time by providing at least 30 days written notice
to the third party. The Agreement is also terminated upon breach of a material obligation under the agreement or bankruptcy. Upon any
termination of the agreement, neither party is relieved of obligations incurred prior to the termination.
During
the three and six months ended June 30, 2023 and 2022, the Company capitalized payments made under this license agreement in the amount
of $11,405 and $15,263, respectively. These capitalized costs will be amortized over the life of the licensed patents, once issued.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Operating
Leases
The
Company leases office and lab space in Branford, CT; Groton, CT; and Laval, Quebec. The Company’s leases expire at various dates
through May 31, 2027. Most leases are for a fixed term and for a fixed amount. The Company is not a party to any leases that have step
rent provisions, escalation clauses, capital improvement funding or payment increases based on any index or rate.
During
2020, the Company entered into a new lease agreement for the Company’s primary office and laboratory space in Branford, CT. The
Branford lease requires monthly payments of $13,033 for the first year of the lease, which increases approximately 2% in each of the
following years. The Branford lease also requires the Company to pay a pro-rata share of common area maintenance.
During
May 2021, the Company entered into a new lease for office and laboratory space in Groton, CT. The Groton lease required monthly payments
of $4,234, which was increased to $6,824 in September 2021 upon leasing additional space. The Groton lease is initially for a one-year
term, with up to three additional years renewal available.
Future
minimum payments under non-cancelable operating leases with initial or remaining terms in excess of one year during each of the next
five years follow:
Schedule of Future Minimum Payments Under Non-cancelable Operating Leases
| |
| | |
2023 | |
$ | 334,661 | |
2024 | |
| 319,211 | |
2025 | |
| 246,051 | |
2026 | |
| 164,469 | |
2027 | |
| - | |
Total future undiscounted lease payments | |
| 1,064,392 | |
Less: interest | |
| (72,736 | ) |
Present value of lease liabilities | |
$ | 991,656 | |
Rent
expense for all operating leases was $84,716 and $169,432 for the three and six months ended June 30, 2023. The weighted average lease
term for all operating leases is 3.4 years. The weighted average discount rate for all operating leases is 4.25%.
14. Retirement Plan
Effective
January 1, 2019, the Company sponsors a 401(k) plan that covers substantially all employees. In order to be eligible to participate,
an employee must complete two consecutive months of service and work a minimum of two hundred and fifty hours or work 1,000 hours in
their first year of service. Employees may make pre-tax deferrals upon meeting the Plan eligibility requirements. Effective January 1,
2020, the Plan was transitioned to a safe harbor plan in which highly compensated employees are not eligible for matching contributions
and non-highly compensated employees earn 100% match on first 3% contributed and 50% on the next 2% contributed. Total employer matching
contributions were $2,633 and $4,824 for the three and six months ended June 30, 2023, respectively. Total employer matching contributions
were $2,632 and $14,603 for the three and six months ended June 30, 2022, respectively.
15. Concentration of Credit Risk
Financial
instruments that potentially subject the Company to credit risk consist principally of cash and accounts receivable.
For
the three and six month periods ended June 30, 2023 and 2022, all service revenue was from one customer. For the three and six month
period ended June 30, 2023, there was no grant revenue and for the three and six month period ended June 30, 2022, all grant revenue
was from one grantor.
The
cash balance identified in the balance sheet is held in an account with a financial institution and insured by the Federal Deposit Insurance
Corporation (FDIC) up to $250,000. At times, cash maintained on deposit may be in excess of FDIC limits.
In
early March 2020, there was a global outbreak of COVID-19 that has resulted in significant changes in the global economy. While the Company
has not experienced any disruptions to its business operations to date, these changes, including a potential economic downturn, and any
potential resulting direct or indirect negative impact to the Company cannot be determined, however they could have a prospective material
impact to the Company’s business, cash flows and liquidity.
16. Related Parties
Total
related party revenue was $172,000 and $285,300 for the three and six months ended June 30, 2023. Total related party revenue was $85,000
and $205,000 for the three and six months ended June 30, 2022. Accounts receivable due from the related party was $440,000 and $175,000
at June 30, 2023 and December 31, 2022, respectively. Contract liabilities from the related party was $310,700 and $156,000 at June 30,
2023 and December 31, 2022, respectively.
In
September 2022 the Company entered into a convertible promissory note totaling $4,350,000 of which $4,000,000 was attributable to an
entity who was also an investor in the Company’s Series A, A-1, and B Preferred Stock financing (See Note 7). This entity received
1,697,490 shares of common stock up on conversion of the promissory notes for principal and interest of $4,243,726.
17. Subsequent Events
The
Company has evaluated events subsequent to the balance sheet date through August 14, 2023, the date these condensed financial statements
were available to be issued.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary
Statement
The
following discussion and analysis should be read in conjunction with our unaudited condensed consolidated financial statements and the
related notes thereto contained elsewhere in this report. The information contained in this quarterly report on Form 10-Q is not a complete
description of our business or the risks associated with an investment in our common stock. We urge you to carefully review and consider
the various disclosures made by us in this report and in our other filings with the Securities and Exchange Commission, or SEC, including
our Prospectus dated June 15, 2023 and filed with the SEC on June 21, 2023.
In
this report we make, and from time to time we otherwise make written and oral statements regarding our business and prospects, such as
projections of future performance, statements of management’s plans and objectives, forecasts of market trends, and other matters
that are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements containing the words or phrases “will likely result,” “are expected to,” “will
continue,” “is anticipated,” “estimates,” “projects,” “believes,” “expects,”
“anticipates,” “intends,” “target,” “goal,” “plans,” “objective,”
“should” or similar expressions identify forward-looking statements, which may appear in our documents, reports, filings
with the SEC, and news releases, and in written or oral presentations made by officers or other representatives to analysts, stockholders,
investors, news organizations and others, and in discussions with management and other of our representatives.
Our
future results, including results related to forward-looking statements, involve a number of risks and uncertainties, including those
risks included in the “Risk Factors” section in our Prospectus dated June 15, 2023 and filed with the SEC on June 21, 2023.
No assurance can be given that the results reflected in any forward-looking statements will be achieved. Any forward-looking statement
speaks only as of the date on which such statement is made. Our forward-looking statements are based upon assumptions that are sometimes
based upon estimates, data, communications and other information from suppliers, government agencies and other sources that may be subject
to revision. Except as required by law, we do not undertake any obligation to update or keep current either (i) any forward-looking statement
to reflect events or circumstances arising after the date of such statement or (ii) the important factors that could cause our future
results to differ materially from historical results or trends, results anticipated or planned by us, or which are reflected from time
to time in any forward-looking statement.
General
We
were formed in January 2014 as a biopharmaceutical company focused on developing innovative therapies for precision dermatology using
engineered proteins and live biotherapeutic products. We are an early-stage clinical biopharmaceutical company and have not commenced
commercial operations.
To
date, we have capitalized our operations primarily through a series of private placements of our convertible preferred stock and convertible
promissory notes and our initial public offering, IPO, of common stock which closed on June 21, 2023. In connection with our IPO, we
issued 1.5 million shares of our common stock at a public offering price of $5 per share. Concurrent with the close of our IPO, all of
our outstanding shares of convertible preferred stock and convertible promissory notes converted into a total of 8,951,526 shares of
our common stock. As of August 14, 2023, we had 12,097,643 shares of our common stock issued and outstanding. Except as otherwise indicated,
all share and share price this report gives effect to a forward stock split effected on May 17, 2023 at a ratio of 7.1-for-1.
Overview
We
focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products.
We have built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that
can be screened for unique therapeutic characteristics. The platform is augmented by an artificial intelligence and machine learning
technology that analyzes, predicts and helps screen our library of strains for drug like molecules. The platform also utilizes a licensed
genetic engineering technology, which can enable the transformation of previously genetically intractable strains. Our initial focus
is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which we consider to
be an optimal therapeutic candidate species for engineering of dermatologic therapies. The particular species demonstrates a number of
well-described properties in the skin. As of the date of this prospectus, we have identified among our microbial library over 60 distinct
bacterial species that we believe are capable of being engineered to create living organisms or engineered proteins with significant
therapeutic effect.
We
are a pioneer in genetically engineered bacteria for therapeutic use in dermatology. Our goal is to leverage our platforms and internal
microbial library bacterial strains to create new therapeutics that are either engineered living organisms or engineered proteins or
peptides to treat skin diseases. Our initial focus is on the development of our current product candidates, including:
|
● |
ATR-12,
a genetically modified strain of S. epidermidis for treating the orphan disease, Netherton syndrome, a chronic and sometimes
fatal disease of the skin estimated to affect approximately one in every 100,000, but its prevalence may be underestimated due to
misdiagnosis caused by similarities to other skin diseases. We received Pediatric Rare Disease Designation for ATR-12 by the United
States Food and Drug Administration, or FDA, in 2019. In December 2022, we submitted an investigational new drug application,
or IND, for a Phase 1b clinical trial of ATR-12 in Netherton syndrome patients, and on January 27, 2023 we received notification
from the FDA that the “study may proceed” with respect to the proposed Phase 1b clinical trial. We expect to commence
our Phase 1b clinical trial in the second half of 2023 and report initial results in the first half of 2024. |
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|
|
|
● |
ATR-04,
a genetically modified strain of S. epidermidis for treating the papulopustular rash experienced by cancer patients undergoing
epidermal growth factor receptor inhibitor, or EGFRi, targeted therapy. We intend to submit an IND for a Phase 1b clinical trial
in certain cancer patients undergoing EGFRi targeted therapy by the end of 2023. Subject to FDA approval of our IND, we expect to
commence our Phase 1b clinical trial in the first-half of 2024 with initial results expected as early as late 2024. |
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|
|
|
● |
ATR-01,
an engineered recombinant human filaggrin protein for treating ichthyosis vulgaris, a chronic, xerotic (abnormally dry), scaly skin
disease with an estimated incidence and prevalence of 1 in 250, which suggests a total patient population of 1.3 million in the United
States. We are planning to complete lead optimization and IND-enabling studies in 2023 to support an IND filing in late 2024. |
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|
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● |
Two
separate strains of bacterial microbes being investigated and developed by us and Bayer Consumer Care AG, the consumer products division
of Bayer AG, or Bayer, the international life science company. We entered into a Joint Development Agreement, or JDA, with Bayer
in December 2019. Under the terms of the JDA, we are responsible for testing our library of bacterial strains and their natural products
for key preclinical properties. After screening through hundreds of strains, we and Bayer have selected two particular strains to
move forward. Bayer holds the exclusive option to license the patent rights to these strains. In December 2020, Bayer purchased $8
million of our Series B preferred stock, which converted into 1,446,447 shares of our common stock, representing approximately 10.6%,
of our outstanding common shares. |
We
also have established partnerships with teams from Carnegie Mellon University and the Fred Hutchinson Cancer Center, or Fred Hutch, two
of the premier academic centers in the United States. Our collaboration with the Carnegie Mellon based team also takes advantage of the
power of whole genome sequencing. This partnership is mining our proprietary library of bacterial strains for novel, drug like peptides
and proteins. The artificial intelligence/machine learning technology developed by this team predicts the molecules made by microbes
from their genetic sequences. The system then compares the predictions to the products actually made through tandem mass spectroscopy
and/or nuclear magnetic resonance imaging to refine future predictions. The predictions can be compared to publicly available 2D and
3D protein databases to select drug like structures.
We
hold an exclusive, worldwide license from Fred Hutch regarding the use of its patented SyngenicDNA Minicircle Plasmid, or SyMPL, technologies
for all fields of genetic engineering, including to discover, develop and commercialize engineered microbial therapies and microbial-derived
peptides and proteins for skin diseases. We are utilizing our licensed patent rights to build plasmids in order to make genetic transformations
that have never been previously achieved. To date, our team has successfully engineered our lead therapeutic candidates without the SyMPL
technology. However, we believe that SyMPL will open up the ability to make genetic transformations of an expanded universe of microbial
species, and we expect that some or all of our future product candidates will incorporate the SyMPL technology. Our collaboration with
Fred Hutch is led by Dr. Christopher Johnston, an expert in microbial engineering, and the innovator behind the SyMPL technology.
Our
Strategy
Beyond
our three lead product candidates and collaboration with Bayer, our goal is to develop a broad portfolio of product candidates focused
on expanding the application of our platforms for precision dermatology. We believe that we have established a unique position in advancing
the development of biologics for precision dermatology.
We
intend to create a broad portfolio of product candidates for precision dermatology through our development of genetically engineered
proteins selected from our proprietary microbial library of approximately 1,500 unique bacterial strains. Our strategy is as follows:
|
● |
Build
a sustainable precision dermatology company. Our goal is to build a leading precision dermatology company with a sustainable
pipeline of product candidates. To that end, we are focused on rapidly advancing our current pipeline of live biotherapeutic candidates
while actively developing additional product candidates. Each of our current product candidates are proprietary and subject to pending
patent applications. We expect that most, if not all, genetically engineered product candidates we develop will be eligible for patent
protection. |
|
|
|
|
● |
Advance our lead
product candidates, ATR-12 and ATR-04, through clinical trials. In Netherton syndrome patients in 2022, we obtained pre-IND
correspondence with the FDA for purposes of discussing our proposed regulatory pathway for ATR-12 and obtaining guidance from the
FDA on the pre-clinical plan leading to the filing and acceptance of an IND for ATR-12. In December 2022, we filed an IND for
a first-in-human trial of ATR-12 in Netherton syndrome patients. Our IND proposes a Phase 1b clinical study of ATR-12 in patients
with Netherton syndrome. On January 27, 2023, we received notification from the FDA that the “study may proceed” with
respect to the proposed Phase 1b clinical trial, and we expect to commence our Phase 1b clinical trial in the first half of 2023,
with initial results expected in the first half of 2024. We also plan to conduct a Phase 1b trial of our ATR-04 in certain
cancer patients undergoing EGFRi therapy, and expect to file an IND for ATR-04 by the end of 2023. |
|
|
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● |
Broaden our platform
by selectively exploring strategic partnerships that maximize the potential of our precision dermatology programs. We intend
to maintain significant rights to all of our core technologies and product candidates. However, we will continue to evaluate partnering
opportunities in which a strategic partner could help us to accelerate development of our technologies and product candidates, provide
access to synergistic combinations, or provide expertise that could allow us to expand into the treatment of different types of skin
diseases. We may also broaden the reach of our platform by selectively in-licensing technologies or product candidates. In addition,
we will consider potentially out-licensing certain of our proprietary technologies for indications and industries that we are not
ourselves pursuing. We believe our genetic engineering techniques and technologies have applicability outside of the field of medicine,
including cosmetics and in the generation of clean fuels and bioremediation. |
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Leverage our academic
partnerships. We currently have partnerships with investigators at the Fred Hutchinson Cancer Center, Yale University, Jackson
Laboratory for Genomic Medicine, and Carnegie Mellon University. We expect to leverage these partnerships and potentially expand
them or form other academic partnerships to bolster our engineering platforms and expand our research and development pipeline. |
|
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● |
Expand on our other
potential product candidates. Beyond our three lead product candidates, our goal is to develop a broad portfolio of product
candidates focused on expanding the application of our platforms for precision dermatology. We have a proprietary platform for discovering
and developing therapeutic products for precision dermatology. Our platform is built around a microbial library comprised of approximately
1,500 unique bacterial strains to allow screening for unique therapeutic characteristics and utilizes a microbial genetic technology
that analyzes, predicts and engineers the proteins, peptides and molecules made by skin microbes. Our ability to genetically engineer
intractable microbial species is uniquely leveraged by our exclusive license to the SyMPL technology. |
Results
of Operations
We
are an early-stage clinical biopharmaceutical company, formed in January 2014, and have limited operating history. We have not commenced
revenue-producing operations apart from limited service revenue derived through our JDA with Bayer. Under the terms of the JDA, we are
responsible for testing our library of microbial strains and their natural products for key preclinical properties and Bayer reimburses
us for our development costs. To date, our operations have consisted of the development of our proprietary microbial library, the identification,
characterization and testing of certain bacterial species from our microbial library that we believe are capable of being engineered
to provide significant therapeutic effect and the development of our initial product candidates.
Three
Months Ended June 30, 2023 Compared to Three Months Ended June 30, 2022
The
following table summarizes our results of operations with respect to the items set forth below for the three months ended June 30, 2023
and 2022 together with the percentage change for those items.
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Service revenue - related party | |
$ | 172,000 | | |
$ | 85,000 | | |
$ | 87,000 | | |
| 102 | % |
Total revenue | |
| 172,000 | | |
| 85,000 | | |
| 87,000 | | |
| 102 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
| 844,640 | | |
| 667,940 | | |
| 176,700 | | |
| 26 | % |
Research and development | |
| 812,836 | | |
| 1,505,447 | | |
| (692,611 | ) | |
| (46 | )% |
Total operating expenses | |
| 1,657,476 | | |
| 2,173,387 | | |
| (515,911 | ) | |
| (24 | )% |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,485,476 | ) | |
| (2,088,387 | ) | |
| 602,911 | | |
| (29 | )% |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 265 | | |
| 335 | | |
| (70 | ) | |
| (21 | )% |
Interest expense | |
| (76,187 | ) | |
| (17,811 | ) | |
| (58,376 | ) | |
| 328 | % |
Employee retention credit | |
| - | | |
| 229,813 | | |
| (229,813 | ) | |
| (100 | )% |
Other income | |
| 1,600 | | |
| - | | |
| 1,600 | | |
| N/A | |
Forgiveness of accounts payable | |
| 56,285 | | |
| - | | |
| 56,285 | | |
| N/A | |
Change in fair value of convertible note | |
| (2,830,100 | ) | |
| - | | |
| (2,830,100 | ) | |
| N/A | |
Other expense | |
| (95,915 | ) | |
| (14,103 | ) | |
| (81,812 | ) | |
| 580 | % |
Total other income (expense) | |
| (2,944,052 | ) | |
| 198,234 | | |
| (3,142,286 | ) | |
| (1585 | )% |
| |
| | | |
| | | |
| | | |
| | |
Net loss before income taxes | |
| (4,429,528 | ) | |
| (1,890,153 | ) | |
| (2,539,375 | ) | |
| 134 | % |
| |
| | | |
| | | |
| | | |
| | |
Income tax benefit (expense) | |
| - | | |
| - | | |
| - | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (4,429,528 | ) | |
| (1,890,153 | ) | |
| (2,539,375 | ) | |
| 134 | % |
Dividends on preferred stock | |
| (643,267 | ) | |
| (692,246 | ) | |
| 48,979 | | |
| (7 | )% |
Net loss attributable to common shareholders | |
$ | (5,072,795 | ) | |
| (2,582,399 | ) | |
| (2,490,396 | ) | |
| 96 | % |
Service
Revenue - Related Party
We
generated $172,000 of service revenue under the Bayer JDA during the second quarter of fiscal 2023 compared to service revenue of $85,000
under the JDA for the comparable period in fiscal 2022. The increase of $87,000 in service revenue is attributable to an increase in
the amount of reimbursable development costs incurred in 2023.
General
and Administrative
General
and administrative costs during the second quarter of fiscal 2023 increased by $176,700 or 26%, to $844,640 from the prior year period.
The increase was primarily related to an increase of $259,000 in accounting, legal, hiring, and insurance costs offset by a decrease
of $80,000 in payroll and related costs attributable to the discontinuation of separation benefits paid to our former chief operating
officer, and $2,300 net decrease of other overhead expenses.
Research
and Development
Research
and development expenses include salaries and benefits of all research personnel, payments to contract research organizations, payments
to research consultants, and the purchase of lab supplies. These expenses are offset by income earned from government grant payments.
We generate grant revenue on contracts with various federal agencies and nonprofit research institutions for general research conducted
by us. These grant arrangements also do not meet the criteria for revenue recognition and amounts earned under these grant contracts
are recorded as a negative research and development expense.
During
the second quarter of fiscal 2023, research and development expenses decreased by $692,611, or 46%, to $812,836 from the prior year period.
The decrease was primarily related to a decrease of $575,000 in research and development related costs attributable to our efforts in
moving our Netherton program forward and a net decrease in payroll and related costs of $120,000 attributable to a reduction in staff
offset by a net increase in other costs of $2,389. There was no government and nonprofit grant revenue received by us during the second
quarter of fiscal 2023 or 2022.
We
expect our research and development expenses to significantly increase in the future due primarily
to our planned clinical trial activity and continued development of product candidates.
Other
Income (Expense)
Our
other income (expense) consists of refundable research and development credits, valuation of warrants, amortization of debt issuance
costs, forgiveness of accounts payable, employee retention credit, change in fair value of the convertible note and interest expense.
During the second quarter of fiscal 2023, other income (expense) increased by $3,142,286, or 1,585%, compared to the comparable period
in fiscal 2022. The increase was primarily related to an increase of $2,830,100 attributable to the change in fair value of the convertible
note, an increase of $58,376 attributable to interest expense, an increase of $229,813 attributable to the employee retention credit
and by a net increase of $23,997 attributable to other income and expense.
Six
Months Ended June 30, 2023 Compared to Six Months Ended June 30, 2022
The
following table summarizes our results of operations with respect to the items set forth below for the six months ended June 30, 2023
and 2022 together with the percentage change for those items.
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Service revenue - related party | |
$ | 285,300 | | |
$ | 205,000 | | |
$ | 80,300 | | |
| 39 | % |
Total revenue | |
| 285,300 | | |
| 205,000 | | |
| 80,300 | | |
| 39 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
| 1,687,651 | | |
| 1,529,248 | | |
| 158,403 | | |
| 10 | % |
Research and development | |
| 1,643,017 | | |
| 3,060,815 | | |
| (1,417,798 | ) | |
| (6 | )% |
Total operating expenses | |
| 3,330,668 | | |
| 4,590,063 | | |
| (1,259,395 | ) | |
| (27 | )% |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (3,045,368 | ) | |
| (4,385,063 | ) | |
| 1,339,695 | | |
| (31 | )% |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 550 | | |
| 855 | | |
| (305 | ) | |
| (36 | )% |
Interest expense | |
| (166,019 | ) | |
| (35,448 | ) | |
| (130,571 | ) | |
| 368 | % |
Employee retention credit | |
| - | | |
| 229,813 | | |
| (229,813 | ) | |
| (100 | )% |
Other income | |
| 2,746 | | |
| - | | |
| 2,746 | | |
| N/A | |
Forgiveness of accounts payable | |
| 56,285 | | |
| - | | |
| 56,285 | | |
| N/A | |
Change in fair value of convertible note | |
| (3,630,100 | ) | |
| - | | |
| (3,630,100 | ) | |
| N/A | |
Other expense | |
| (104,801 | ) | |
| (26,327 | ) | |
| (78,474 | ) | |
| 298 | % |
Total other income (expense) | |
| (3,841,339 | ) | |
| 168,893 | | |
| (4,010,232 | ) | |
| (2,374 | )% |
| |
| | | |
| | | |
| | | |
| | |
Net loss before income taxes | |
| (6,886,707 | ) | |
| (4,216,170 | ) | |
| (2,670,537 | ) | |
| 63 | % |
| |
| | | |
| | | |
| | | |
| | |
Income tax benefit (expense) | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (6,886,707 | ) | |
$ | (4,216,170 | ) | |
$ | (2,670,537 | ) | |
| 63 | % |
Dividends on preferred stock | |
| (1,355,347 | ) | |
| (1,384,492 | ) | |
| 29,145 | | |
| (2 | )% |
Net loss attributable to common shareholders | |
$ | (8,242,054 | ) | |
$ | (5,600,662 | ) | |
$ | (2,641,392 | ) | |
| 47 | % |
Service
Revenue - Related Party
We
generated $285,300 of service revenue under the Bayer JDA during the first six months of fiscal 2023 compared to service revenue of $205,000
under the JDA for the comparable period in fiscal 2022. The increase of $80,300 in service revenue is attributable to an increase in
the amount of reimbursable development costs in 2023.
General
and Administrative
General
and administrative costs during the first six months of fiscal 2023 increased by $158,403 or 10%, to $1,687,651 from the prior year period.
The increase was primarily related to an increase of $379,000 in accounting, hiring, and insurance costs offset by a decrease of $229,000
in payroll and related costs attributable to the discontinuation of separation benefits paid to our former chief operating officer, a
$26,000 reduction in legal expenses and a $34,403 net increase of other overhead expenses.
Research
and Development
Research
and development expenses include salaries and benefits of all research personnel, payments to contract research organizations, payments
to research consultants, and the purchase of lab supplies. These expenses are offset by income earned from government grant payments.
We generate grant revenue on contracts with various federal agencies and nonprofit research institutions for general research conducted
by us. These grant arrangements also do not meet the criteria for revenue recognition and amounts earned under these grant contracts
are recorded as a negative research and development expense.
During
the first six months of fiscal 2023, research and development expenses decreased by $1,417,798, or 46%, to $1,643,017 from the prior
year period. The decrease was primarily related to a decrease of $952,848 in research and development related costs attributable to our
efforts in moving our Netherton program forward, a net decrease in payroll and related costs of $420,000 attributable to a reduction
in staff and a net decrease of $44,950 of other costs. There was no government and nonprofit grant revenue received by us during the
first six months of fiscal 2023 or 2022.
We
expect our research and development expenses to significantly increase in the future due primarily
to our planned clinical trial activity and continued development of product candidates.
Other
Income (Expense)
Our
other income (expense) consists of refundable research and development credits, valuation of warrants, amortization of debt issuance
costs, forgiveness of accounts payable, employee retention credit, change in fair value of the convertible note and interest expense.
During the first six months of fiscal 2023, other income (expense) increased by $4,010,232, or 2,374%, compared to the comparable period
in fiscal 2022. The increase was primarily related to an increase of $3,630,100 attributable to the change in fair value of the convertible
note, an increase of $130,571 attributable to interest expense, an increase of $229,813 attributable to the employee retention credit
and a net increase of $19,748 attributable to other income and expense.
Financial
Condition
As of June 30, 2023, we had total
assets of approximately $9.8 million and working capital of approximately $5.1 million. As of June 30, 2023, our liquidity included approximately
$6.3 million of cash and cash equivalents. We believe that our cash on-hand will be sufficient to cover our proposed plan of operations
through, at least, the first half of 2014, including dosing in the proposed Phase 1b clinical trial for ATR-12 and the initial enrollment
in the proposed Phase 1b clinical trial for ATR-04. However, as of the date of this report, we believe that we will need additional capital
in the second half of 2014, and there can be no assurance we will not need additional capital sooner. In addition, we believe that we
will need additional capital to obtain marketing approval for ATR-12 and ATR-04, assuming such approval can be obtained at all. We intend
to seek additional funds through various financing sources, including the sale of our equity and debt securities, licensing fees for our
technology and joint ventures with industry partners. In addition, we will consider alternatives to our current business plan that may
enable us to achieve revenue producing operations and meaningful commercial success with a smaller amount of capital. However, there can
be no guarantees that such funds will be available on commercially reasonable terms, if at all. If such financing is not available on
satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations.
To the extent that we raise additional
capital through the sale of equity or convertible debt securities, our common stockholders’ ownership interests will be diluted,
and the terms of these securities may include liquidation or other preferences that adversely affect rights as a common stockholder. Debt
financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability
to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we
raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,
we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant
licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other
arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization
efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
The
report of our independent registered public accounting firm for the six months ended June 30, 2023 states that due to our accumulated
deficit, recurring and negative cash flow from operations there is substantial doubt about our ability to continue as a going concern.
Our financial statements, in Note 1, include disclosure with respect to a substantial doubt about our ability to continue as a going
concern and the report of our independent auditor includes an explanatory paragraph with respect to that substantial doubt.
Cash
Flows
The
following table shows a summary of our cash flows for the periods indicated:
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash Used in Operating Activities | |
$ | (3,031,522 | ) | |
$ | (4,091,605 | ) |
| |
| | | |
| | |
Cash Used in Investing Activities | |
$ | (162,138 | ) | |
$ | (202,833 | ) |
| |
| | | |
| | |
Cash provided by Financing Activities | |
$ | 5,991,359 | | |
$ | 1,510 | |
| |
| | | |
| | |
Net Increase (Decrease) in Cash and Cash Equivalents | |
$ | 2,797,699 | | |
$ | (4,292,928 | ) |
Operating
Activities
During
the first six months of fiscal 2023, operating activities used $3.0 million of cash primarily driven by our net loss of $6.9 million
offset by non-cash items of $3.9 million. During the comparable period of fiscal 2022, operating activities used $4.1 million of cash
primarily driven by our net loss of $4.2 million offset by non-cash items of $100 thousand.
Investing
Activities
During
the first six months of fiscal 2023, investing activities used $162 thousand of cash primarily driven by $144 thousand of trademark and
patent costs and $18 thousand for the purchase of furniture and equipment. During the comparable period of fiscal 2022, investing activities
used $203 thousand of cash primarily driven by $176 thousand of trademark and patent costs and $27 thousand for the purchase of furniture
and equipment.
Financing
Activities
During
the first six months of fiscal 2023, financing activities provided $6.0 million in cash driven by proceeds from our initial public offering.
During the comparable period of fiscal 2022, financing activities provided $2 thousand in cash primarily driven by the proceeds from
the exercise of stock options.
Critical
Accounting Policies
During
the six months ended June 30, 2023, there were no material changes to our critical accounting policies previously disclosed in our Prospectus
dated June 15, 2023 and filed with the SEC on June 21, 2023.
Critical
Accounting Estimates
Our
management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial
statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated
financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, and expenses
and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical
experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results
may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates
in light of changes in circumstances, facts and experience. The effects of material revisions in estimates, if any, will be reflected
in the consolidated financial statements prospectively from the date of change in estimates. There were no material changes to our critical
accounting estimates as reported in our Prospectus dated June 15, 2023 and filed with the SEC on June 21, 2023.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not
applicable.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of the design
and operation of our disclosure controls and procedures, pursuant to Rule 13a-15 of the Securities Exchange Act of 1934, as of June 30,
2023. In the course of that evaluation, we identified a material weakness as it relates to a lack of adequate segregation of accounting
functions. We are in the process of implementing measures designed to improve our disclosure controls and procedures and remediate this
material weakness. We intend to increase staffing within our accounting infrastructure sufficient to facilitate proper segregation of
accounting functions and to enable appropriate review of our internally prepared financial statements. Based upon the foregoing, our
chief executive officer and chief financial officer concluded that our disclosure controls and procedures were not effective as of June
30, 2023.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the six-month period ended June 30, 2023 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1A. Risk Factors
This
Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those forward-looking statements include our expectations,
beliefs, intentions and strategies regarding the future. You should carefully consider the risk factors discussed in the “Risk
Factors” section in our Prospectus dated June 15, 2023 and filed with the SEC on June 21, 2023. as, in light of those risks, the
forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely
from those anticipated or implied in our forward-looking statements. There have been no material changes in the risk factors included
in our Prospectus dated June 15, 2023. The risk factors described in our Prospectus dated June 15, 2023 are not the only risks facing
our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially
adversely affect our business, financial condition or future results.
Item
6. Exhibits
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
AZITRA, INC. |
|
|
|
Date: August 14, 2023 |
By: |
/s/
Francisco D. Salva |
|
|
Francisco D. Salva, |
|
|
President
and Chief Executive Officer
(Principal
Executive Officer) |
|
|
|
Date: August 14, 2023 |
By: |
/s/
Norman Staskey |
|
|
Norman Staskey, |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
Exhibit
31.1
CERTIFICATIONS
I,
Francisco D. Salva, certify that:
(1) I
have reviewed this Form 10-Q of Azitra, Inc. (the “Company”);
(2) Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
(3) Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
(4) The
Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d- 15(f)) for the company and have:
(a) designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) evaluated
the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the period covered by this report based on such evaluation; and
(d) disclosed
in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most
recent quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over
financial reporting; And
(5) The
Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the
equivalent functions):
(a) all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and
(b) any
fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal
control over financial reporting.
|
AZITRA, INC. |
|
|
|
Date: August 14, 2023 |
By: |
/s/ Francisco
D. Salva |
|
|
Francisco D. Salva, Chief Executive Officer |
Exhibit
31.2
CERTIFICATIONS
I,
Norman Staskey, certify that:
(1) I
have reviewed this Form 10-Q of Azitra, Inc. (the “Company”);
(2) Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
(3) Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
(4) The
Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d- 15(f)) for the company and have:
(a) designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) evaluated
the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the period covered by this report based on such evaluation; and
(d) disclosed
in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most
recent quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over
financial reporting; And
(5) The
Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the
equivalent functions):
(a) all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and
(b) any
fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal
control over financial reporting.
|
AZITRA, INC. |
|
|
|
Date: August 14, 2023 |
By: |
/s/ Norman
Staskey |
|
|
Norman
Staskey, Chief Financial Officer
(Principal
Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18
U.S.C.
1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Azitra, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023 as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), I, Francisco D. Salva, the Chief Executive
Officer, and Norman Staskey, the Chief Financial Officer, of the Company, respectively, certify, pursuant to 18 U.S.C. §1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
|
1. |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
2. |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
By:
|
/s/
Francisco D. Salva |
|
Dated:
August 14, 2023 |
|
Francisco
D. Salva, |
|
|
Title: |
President
and Chief Executive Officer |
|
|
|
|
|
|
By: |
/s/
Norman Staskey |
|
Dated:
August 14, 2023 |
|
Norman
Staskey, |
|
|
Title: |
Chief
Financial Officer |
|
|
This
certification is made solely for the purposes of 18 U.S.C. Section 1350, subject to the knowledge standard contained therein, and not
for any other purpose.
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 14, 2023 |
Cover [Abstract] |
|
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|
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|
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|
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|
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Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41705
|
|
Entity Registrant Name |
Azitra,
Inc.
|
|
Entity Central Index Key |
0001701478
|
|
Entity Tax Identification Number |
46-4478536
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
21
Business Park Drive
|
|
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Branford
|
|
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CT
|
|
Entity Address, Postal Zip Code |
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|
|
City Area Code |
(203)
|
|
Local Phone Number |
646-6446
|
|
Title of 12(b) Security |
Common
stock: Par value $0.0001
|
|
Trading Symbol |
AZTR
|
|
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NYSEAMER
|
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 6,290,355
|
$ 3,492,656
|
Accounts receivable |
445,120
|
182,820
|
Tax credits receivable |
42,446
|
69,666
|
Income tax receivable |
13,722
|
13,722
|
Deferred offering costs |
|
216,886
|
Prepaid expenses |
48,523
|
160,133
|
Total current assets |
6,840,166
|
4,135,883
|
Property and equipment, net |
803,107
|
846,958
|
Other assets |
|
|
Other assets |
47,744
|
47,507
|
Operating lease right-of-use asset |
976,959
|
1,116,697
|
Intangible assets, net |
241,580
|
219,567
|
Deferred patent costs |
920,001
|
800,831
|
Total other assets |
2,186,284
|
2,184,602
|
Total assets |
9,829,557
|
7,167,443
|
Current liabilities: |
|
|
Accounts payable |
364,183
|
784,687
|
Current operating lease liability |
298,047
|
287,384
|
Accrued expenses |
767,721
|
993,961
|
Contract liabilities |
310,700
|
156,000
|
Total current liabilities |
1,740,651
|
2,222,032
|
Long-term operating lease liability |
693,609
|
840,896
|
Warrant liability |
158,994
|
70,283
|
Convertible notes payable, net |
|
6,600,000
|
Total liabilities |
2,593,254
|
9,733,211
|
Stockholders’ equity (deficit) |
|
|
Common stock; $0.0001 par value, 100,000,000 shares authorized at June 30, 2023 and December 31, 2022, 12,097,643 and 1,043,988 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively |
1,210
|
104
|
Additional paid-in capital |
51,436,352
|
1,054,138
|
Accumulated deficit |
(44,201,259)
|
(37,314,552)
|
Total stockholders’ equity (deficit) |
7,236,303
|
(36,260,310)
|
Total liabilities, preferred stock and stockholders’ equity (deficit) |
9,829,557
|
7,167,443
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock: |
|
|
Preferred stock value |
|
3,272,944
|
Series A-1 Convertible Preferred Stock [Member] |
|
|
Preferred stock: |
|
|
Preferred stock value |
|
14,100,533
|
Series B Convertible Preferred Stock [Member] |
|
|
Preferred stock: |
|
|
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|
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v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares outstanding |
12,097,643
|
1,043,988
|
Common stock, shares issued |
12,097,643
|
1,043,988
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
205,385
|
205,385
|
Preferred stock, shares issued |
0
|
205,385
|
Preferred stock, shares outstanding |
0
|
205,385
|
Preferred stock, liquidation value |
$ 0
|
$ 3,337,506
|
Series A-1 Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
380,657
|
380,657
|
Preferred stock, shares issued |
0
|
380,657
|
Preferred stock, shares outstanding |
0
|
380,657
|
Preferred stock, liquidation value |
$ 0
|
$ 14,274,638
|
Series B Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
851,108
|
851,108
|
Preferred stock, shares issued |
0
|
391,303
|
Preferred stock, shares outstanding |
0
|
391,303
|
Preferred stock, liquidation value |
$ 0
|
$ 17,000,159
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Service revenue – related party |
$ 172,000
|
$ 85,000
|
$ 285,300
|
$ 205,000
|
Revenue, Related Party, Type [Extensible Enumeration] |
Related Party [Member]
|
Related Party [Member]
|
Related Party [Member]
|
Related Party [Member]
|
Total revenue |
$ 172,000
|
$ 85,000
|
$ 285,300
|
$ 205,000
|
Operating expenses: |
|
|
|
|
General and administrative |
844,640
|
667,940
|
1,687,651
|
1,529,248
|
Research and development |
812,836
|
1,505,447
|
1,643,017
|
3,060,815
|
Total operating expenses |
1,657,476
|
2,173,387
|
3,330,668
|
4,590,063
|
Loss from operations |
(1,485,476)
|
(2,088,387)
|
(3,045,368)
|
(4,385,063)
|
Other income (expense): |
|
|
|
|
Interest income |
265
|
335
|
550
|
855
|
Interest expense |
(76,187)
|
(17,811)
|
(166,019)
|
(35,448)
|
Employee retention credit |
|
229,813
|
|
229,813
|
Other income |
1,600
|
|
2,746
|
|
Forgiveness of accounts payable |
56,285
|
|
56,285
|
|
Change in fair value of convertible note |
(2,830,100)
|
|
(3,630,100)
|
|
Other expense |
(95,915)
|
(14,103)
|
(104,801)
|
(26,327)
|
Total other income (expense) |
(2,944,052)
|
198,234
|
(3,841,339)
|
168,893
|
Net loss before income taxes |
(4,429,528)
|
(1,890,153)
|
(6,886,707)
|
(4,216,170)
|
Income tax benefit (expense) |
|
|
|
|
Net loss |
(4,429,528)
|
(1,890,153)
|
(6,886,707)
|
(4,216,170)
|
Dividends on preferred stock |
(643,267)
|
(692,246)
|
(1,355,347)
|
(1,384,492)
|
Net loss attributable to common shareholders |
$ (5,072,795)
|
$ (2,582,399)
|
$ (8,242,054)
|
$ (5,600,662)
|
Net loss per share, basic |
$ (2.36)
|
$ (2.45)
|
$ (5.14)
|
$ (5.31)
|
Net loss per share, diluted |
$ (2.36)
|
$ (2.45)
|
$ (5.14)
|
$ (5.31)
|
Weighted average common stock outstanding, basic |
2,147,526
|
1,055,454
|
1,604,510
|
1,055,336
|
Weighted average common stock outstanding, diluted |
2,147,526
|
1,055,454
|
1,604,510
|
1,055,336
|
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v3.23.2
Statements of Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Series A Convertible Preferred Stock [Member]
Preferred Stock [Member]
|
Series A-1 Convertible Preferred Stock [Member]
Preferred Stock [Member]
|
Series B Convertible Preferred Stock [Member]
Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
$ 868,163
|
$ (26,634,186)
|
$ (25,765,919)
|
Beginning balance, shares at Dec. 31, 2021 |
205,385
|
380,657
|
391,303
|
1,043,100
|
|
|
|
Stock-based compensation |
|
|
|
|
56,983
|
|
56,983
|
Exercise of stock options |
|
|
|
|
1,510
|
|
1,510
|
Net loss |
|
|
|
|
|
(2,326,017)
|
(2,326,017)
|
Beginning balance at Mar. 31, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
926,656
|
(28,960,203)
|
(28,033,443)
|
Ending balance, shares at Mar. 31, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
868,163
|
(26,634,186)
|
(25,765,919)
|
Beginning balance, shares at Dec. 31, 2021 |
205,385
|
380,657
|
391,303
|
1,043,100
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,216,170)
|
Beginning balance at Jun. 30, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
980,482
|
(30,850,356)
|
(29,869,770)
|
Ending balance, shares at Jun. 30, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
926,656
|
(28,960,203)
|
(28,033,443)
|
Beginning balance, shares at Mar. 31, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Stock-based compensation |
|
|
|
|
53,826
|
|
53,826
|
Net loss |
|
|
|
|
|
(1,890,153)
|
(1,890,153)
|
Beginning balance at Jun. 30, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
980,482
|
(30,850,356)
|
(29,869,770)
|
Ending balance, shares at Jun. 30, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
1,054,138
|
(37,314,552)
|
(36,260,310)
|
Beginning balance, shares at Dec. 31, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Stock-based compensation |
|
|
|
|
38,794
|
|
38,794
|
Exercise of stock options, shares |
|
|
|
888
|
|
|
|
Net loss |
|
|
|
|
|
(2,457,179)
|
(2,457,179)
|
Issuance of Series B Convertible Preferred Stock |
|
|
$ 1,124,759
|
|
|
|
1,124,759
|
Issuance of Series B Convertible Preferred Stock, shares |
|
|
23,432
|
|
|
|
|
Beginning balance at Mar. 31, 2023 |
$ 3,272,944
|
$ 14,100,533
|
$ 17,445,824
|
$ 104
|
1,092,932
|
(39,771,731)
|
(38,678,695)
|
Ending balance, shares at Mar. 31, 2023 |
205,385
|
380,657
|
414,735
|
1,043,988
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 3,272,944
|
$ 14,100,533
|
$ 16,321,065
|
$ 104
|
1,054,138
|
(37,314,552)
|
$ (36,260,310)
|
Beginning balance, shares at Dec. 31, 2022 |
205,385
|
380,657
|
391,303
|
1,043,988
|
|
|
|
Exercise of stock options, shares |
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
$ (6,886,707)
|
Beginning balance at Jun. 30, 2023 |
|
|
|
$ 1,210
|
51,436,352
|
(44,201,259)
|
7,236,303
|
Ending balance, shares at Jun. 30, 2023 |
|
|
|
12,097,643
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 3,272,944
|
$ 14,100,533
|
$ 17,445,824
|
$ 104
|
1,092,932
|
(39,771,731)
|
(38,678,695)
|
Beginning balance, shares at Mar. 31, 2023 |
205,385
|
380,657
|
414,735
|
1,043,988
|
|
|
|
Stock-based compensation |
|
|
|
|
38,794
|
|
38,794
|
Net loss |
|
|
|
|
|
(4,429,528)
|
(4,429,528)
|
Conversion of convertible notes payable |
|
|
|
$ 185
|
9,494,887
|
|
9,495,072
|
Conversion of convertible notes payable, shares |
|
|
|
1,846,020
|
|
|
|
Conversion of preferred stock |
$ (3,272,944)
|
$ (14,100,533)
|
$ (17,445,824)
|
$ 771
|
34,818,530
|
|
34,819,301
|
Conversion of preferred stock, shares |
(205,385)
|
(380,657)
|
(414,735)
|
7,707,635
|
|
|
|
Initial public offering, net of issuance costs of $1,508,791 |
|
|
|
$ 150
|
5,991,209
|
|
5,991,359
|
Initial public offering, net of issuance costs of $1,508,791, shares |
|
|
|
1,500,000
|
|
|
|
Beginning balance at Jun. 30, 2023 |
|
|
|
$ 1,210
|
$ 51,436,352
|
$ (44,201,259)
|
$ 7,236,303
|
Ending balance, shares at Jun. 30, 2023 |
|
|
|
12,097,643
|
|
|
|
X |
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (6,886,707)
|
$ (4,216,170)
|
Adjustment to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
64,806
|
61,417
|
Amortization of debt discount |
|
3,936
|
Amortization of right-of-use assets |
139,738
|
140,921
|
Accrued interest on convertible notes |
165,939
|
31,512
|
Stock based compensation |
77,588
|
110,809
|
Change in fair value of warrant liability |
88,711
|
(35)
|
Change in fair value of convertible notes |
3,630,100
|
|
Forgiveness of accounts payable |
(56,285)
|
|
Loss on disposal of property and equipment |
|
7,923
|
Changes in operating assets and liabilities: |
|
|
Accounts Receivable |
(262,300)
|
134,800
|
Prepaid expenses |
111,610
|
(124,465)
|
Other assets |
(237)
|
165
|
Tax credits receivable |
27,220
|
(227,955)
|
Accounts payable and accrued expenses |
(149,781)
|
134,028
|
Operating lease liability |
(136,624)
|
(133,491)
|
Contract liabilities |
154,700
|
(15,000)
|
Net cash used by operating activities |
(3,031,522)
|
(4,091,605)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(17,578)
|
(31,453)
|
Proceeds from sale of property and equipment |
|
4,250
|
Capitalization of deferred patent costs |
(119,170)
|
(117,673)
|
Capitalization of licenses |
(15,263)
|
(57,372)
|
Capitalization of patent and trademark costs |
(10,127)
|
(585)
|
Net cash used in investing activities |
(162,138)
|
(202,833)
|
Cash flows from financing activities: |
|
|
Proceeds from initial public offering, net |
5,991,359
|
|
Proceeds from exercise of stock options |
|
1,510
|
Net cash provided by financing activities |
5,991,359
|
1,510
|
Net change in cash and cash equivalents |
2,797,699
|
(4,292,928)
|
Cash and cash equivalents at beginning of the period |
3,492,656
|
8,044,262
|
Cash and cash equivalents at end of the period |
6,290,355
|
3,751,334
|
Non-cash transactions: |
|
|
Obtaining a right-of-use asset in exchange for lease liability |
|
1,418,502
|
Conversion of note to common stock |
9,495,152
|
|
Conversion of note to Series B Convertible Preferred Stock |
$ 1,124,759
|
|
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v3.23.2
Organization and Nature of Operations
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Organization and Nature of Operations |
1. Organization and Nature of Operations
Azitra
Inc was founded on January 2, 2014. It is a synthetic biology company focused on screening and genetically engineering microbes of the
skin. The mission is to discover and develop novel therapeutics to create a new paradigm for treating skin disease. The Company’s
discovery platform is screened for naturally occurring bacterial cells with beneficial effects. These microbes are then genomically sequenced
and engineered to make cellular therapies, recombinant therapeutic proteins, peptides and small molecules for precision treatment of
dermatology diseases. On May 17, 2023, the Company changed its name to from “Azitra Inc” to “Azitra, Inc.”
The
Company maintains a location in Montreal, Canada for certain research activities. This location and operations completed there remained
consistent throughout 2022 and into 2023. The Company also opened a manufacturing and laboratory space in Groton, Connecticut during
2021.
Forward
Stock Split, Change in Par Value, and Initial Public Offering
In
June 2023, the Company completed its initial public offering (IPO) in which it issued and sold 1,500,000 shares of its common stock at
a price to the public of $5.00 per share. The shares began trading on the NYSE American on June 16, 2023 under the symbol “AZTR”.
The net proceeds received by the Company from the offering were $6.0 million, after deducting underwriting discounts, commissions and
other offering expenses.
Immediately
prior to the effectiveness of the Company’s registration statement, the Company effected a 7.1-for-1 forward stock split of its
issued and outstanding shares of common stock (the Forward Stock Split). On May 17, 2023, the Company changed the par value of its capital
stock from $0.01 to $0.0001. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited consolidated
financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the effect of the Forward Stock
Split. Refer to Note 8 for additional details relating to the Forward Stock Split.
Going
Concern Matters
The
unaudited condensed financial statements have been prepared on the going concern basis, which assumes that the Company will continue
in operation for the foreseeable future and which contemplates the realization of assets and liquidation of liabilities in the normal
course of business. However, management has identified the following conditions and events that created an uncertainty about the ability
of the Company to continue as a going concern. As of and for the six months ended June 30, 2023, the Company has an accumulated deficit
of $44.2 million, a loss from operations of $3.0 million and used $3.0 million to fund operations. These factors among others raise substantial
doubt about the Company’s ability to continue as a going concern.
Management
plans to continue to raise funds through equity and debt financing to fund operating and working capital needs; however, the Company
will require a significant amount of additional funds to complete the development of its product and to fund additional losses which
the Company expects to incur over the next few years. The Company is still in their pre-clinical phase and therefore does not yet have
product revenue. There can be no assurance that the Company will be successful in securing additional financing, if needed, to meet its
operating needs.
These
conditions and events create an uncertainty about the ability of the Company to continue as a going concern for twelve months from the
date that the financial statements are available to be issued. The financial statements do not include any adjustments that might be
necessary should the Company be unable to continue as a going concern.
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v3.23.2
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies
Basis
of Accounting
The
financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S.
GAAP”).
Unaudited
Interim Financial Information
The
unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information,
within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information
and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted
pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the
audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments,
necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of
the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements
related to the three and six month periods are unaudited. Unaudited interim results are not necessarily indicative of the results for
the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the
Company for the year ended December 31, 2022 and notes thereto that are included in the Company’s Registration Statement filed
with the SEC on June 5, 2023.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Use
of Estimates
The
preparation of the financial statement in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet.
While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results
could differ from those estimates.
Cash
and Cash Equivalents
For
purposes of the balance sheets and statements of cash flows, the Company considers all cash on hand, demand deposits and all highly liquid
investments with original maturities of three months or less to be cash equivalents.
Property
and Equipment
Property
and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives, which range
from 3 to 10 years. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are
charged to operations as incurred. Gains or losses on disposal of property and equipment are reflected in the statements of operations
in the period of disposal.
Accounts
Receivable
The
Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its
accounts receivable and establishes an allowance for doubtful accounts based on a history of past write-offs, collections and current
conditions. There was no allowance for doubtful accounts at June 30, 2023 and December 31, 2022. Accounts receivable are written off
when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received.
Deferred
Offering Costs
The
Company capitalized deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other
third-party fees relating to the Company’s initial public offering. In June 2023, the Company consummated its IPO and recorded
such amounts against the gross proceeds of its IPO within the statements of stockholders’ equity during the three and six months
ended June 30, 2023.
Right
of Use Assets
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (“Topic 842”).
ASU 2016-02 requires lessees to present right-of-use (“ROU”) assets and lease liabilities on the balance sheet for all leases
with terms longer than 12 months. See Note 2 – Recently Adopted Accounting Pronouncements.
In
calculating the effect of ASU 2016-02, the Company elected the transition method thereby not restating comparable periods. The Company
elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant
judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance,
the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months.
The
Company has operating leases for buildings. Currently, the Company has 3 operating leases with a ROU asset and lease liability totaling
$1,418,502 as of January 1, 2022. The basis, terms and conditions of the leases are determined by the individual agreements. The Company’s
option to extend certain leases ranges from 36 – 52 months. All options to extend have been included in the calculation of the
ROU asset and lease liability. The leases do not contain residual value guarantees, restrictions, or covenants that could incur additional
financial obligations to the Company. There are no subleases, sale-leaseback, or related party transactions.
At
June 30, 2023, the Company had operating right-of-use assets with a net value of $976,959 and current and long-term operating lease liabilities
of $298,047 and $693,609, respectively.
Intangible
Assets
Intangible
assets consist of trademarks and patents. All costs directly related to the filing and prosecution of patent and trademark applications
are capitalized. Patents are amortized over their respective remaining useful lives upon formal approval. Trademarks have an indefinite
life.
The
Company accounts for other indefinite life intangible assets in accordance ASC Topic 350, Goodwill and Other Intangible Assets
(ASC 350). ASC 350 requires that intangible assets that have indefinite lives are required to be tested at least annually for impairment
or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Intangible assets that have
finite lives will continue to be amortized over their useful lives. No impairment losses relating to intangible assets were recorded
during the three and six months ended June 30, 2023 or 2022.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Deferred
Patent Costs
Deferred
patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval.
These deferred costs will begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent
is not approved, the costs associated with the patent will be expensed in the year the patent was rejected. No impairment losses relating
to deferred patent costs were recorded in the three and six months ended June 30, 2023 or 2022.
Impairment
of Long-Lived Assets
In
accordance with ASC Topic 360-10, Accounting for the Impairment or Disposal of Long-Lived Assets (ASC 360-10), the Company’s
policy is to review its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount
of an asset may not be recoverable. In connection with this review, the Company also reevaluates the periods of depreciation for these
assets. The Company recognizes an impairment loss when the sum of the undiscounted expected future cash flows from the use and eventual
disposition of the asset is less than its carrying amount. If an asset is considered to be impaired, the impairment to be recognized
is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset, which is determined using the
present value of the net future operating cash flows generated by the asset.
Convertible
Debt and Warrant Accounting
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”)
and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial
instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other
conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant
issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For
issued warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional
paid-in capital at the time of issuance. For issued warrants that do not meet all the criteria for equity classification, the warrants
are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the
estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations under Other Income/loss.
Convertible
debt
When
the Company issues debt with a conversion feature, it first assesses whether the debt should be accounted for in accordance with ASC
480 – Distinguishing Liabilities from Equity. If the debt does not meet the criteria of an ASC 480 liability, the note’s
conversion features require bifurcation in accordance with ASC 815 – Derivatives and Hedging. If the Company determines the embedded
conversion feature requires bifurcation in accordance with ASC 815, the Company also considers if it can elect the fair value option.
If the fair value option is elected, the Company records the note at its initial fair value with any subsequent changes in fair value
recorded in earnings. As noted in Note 7, the Company has elected the fair value option for the 2022 Convertible Notes and will record
the notes at their initial fair values with any subsequent changes in fair value recorded in earnings. The Convertible Notes were converted
into the Company’s common stock on the Closing Date of the Company’s IPO.
Convertible
Preferred Stock
As
the Convertible Preferred stockholders have liquidation rights in the event of a deemed liquidation event that, in certain situations,
are not solely within the control of the Company and would require the redemption of the then-outstanding Convertible Preferred Stock,
the Company classifies the Convertible Preferred Stock in mezzanine equity on the balance sheet. Due to the fact that the occurrence
of a deemed liquidation event is not currently probable, the carrying value of the Convertible Preferred Stock is not being accreted
to its redemption value. Subsequent adjustments to the carrying value of the Convertible Preferred Stock would be made only when a deemed
liquidation event becomes probable.
As
noted in Note 8, at the Closing Date of the Company’s IPO, the Convertible Preferred stock converted into shares of the Company’s
common stock.
Revenue
The
Company follows the five steps to recognize revenue from contracts with customers under ASC 606, Revenue from Contracts
with Customers (“ASC 606”), which are:
|
● |
Step
1: Identify the contract(s) with a customer |
|
|
|
|
● |
Step
2: Identify the performance obligations in the contract |
|
|
|
|
● |
Step
3: Determine the transaction price |
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
● |
Step
4: Allocate the transaction price to the performance obligations in the contract |
|
|
|
|
● |
Step
5: Recognize revenue when (or as) a performance obligation is satisfied |
The
Company generates service revenue through a joint development agreement with a research partner. The Company recognizes revenue related
to the research and development aspects of the agreement over time using the input method as work is performed on the contract.
The
Company also generates grant revenue, which represents monies received on contracts with various federal agencies and nonprofit research
institutions for general research conducted by the Company to further their product development and are therefore considered contributions
to the Company. The contracts are generally for periods of one year or more and can be cancelled by either party. The Company concluded
that the grant arrangements do not meet the criteria to be treated as a collaborative arrangement under FASB ASC Topic 808 as the Company
is the only active participant in the arrangement. The grant arrangements also do not meet the criteria for revenue recognition under
Topic 606, as the U.S. Government would not meet the definition of a customer.
Amounts
earned under these grant contracts are recorded as a reduction to research and development expense when eligible expenses are incurred
and the right to payment is realizable or realized and earned. The Company believes this policy is consistent with Topic 606, to ensure
that recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that the
Company expects to be entitled to in exchange for those goods or services, even though there is no exchange as defined in Topic 606.
Additionally, the Company has determined that the recognition of amounts received as costs are incurred and amounts become realizable
is analogous to the concept of transfer of control of a service over time under Topic 606.
Receipts
of grant awards in advance, which are payable back to the funding agency if not used in accordance with conditions in the grants related
to allowable costs or receipt of funding from research partners related to service revenue arrangements before work is performed on the
contract, are classified as contract liabilities in the accompanying balance sheets.
Research
and Development
The
Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research
and Development. Accordingly, internal research and development costs are expensed as incurred. Research and development costs consist
of costs related to labor, materials and supplies. Research and development costs incurred were $812,836 and $1,643,017 during the three
and six month period ended June 30, 2023, respectively. Research and development costs incurred were $1,505,447 and $3,060,815 during
the three and six month period ended June 30, 2022, respectively.
At
June 30, 2023 and December 31, 2022, the Company has a state tax credit receivable of $32,459 for pending refunds related to the selling
of research and development tax credits back to the State of Connecticut. At June 30, 2023 and December 31, 2022, the Company has $0
and $28,925, respectively for pending refunds related to Canadian Scientific Research and Experimental Development (SRED) credits. At
June 30, 2023 and December 31, 2022, the Company has also recorded $9,987 and $8,282, respectively, related to refunds of Canadian Goods
and Services Tax (GST) and Quebec Sales Tax (QST). Receipts of refunds are recorded in other income on the statements of operations.
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation (ASC 718). ASC 718 requires
employee stock options and rights to purchase shares under stock participation plans to be accounted for at fair value. ASC 718 requires
that compensation costs related to share-based payment transactions be recognized as operating expenses in the financial statements.
Under this method, compensation costs for all awards granted or modified are measured at estimated fair value at date of grant and are
included as compensation expense over the vesting period during which an employee provides service in exchange for the award. For awards
with a performance condition that affects vesting, the Company recognizes compensation expense when it is determined probable that the
performance condition will be achieved.
The
Company uses a Black-Scholes option pricing model to determine fair value of its stock options. The Black-Scholes model includes various
assumptions, including the value of the underlying common stock, the expected life of stock options, the expected volatility and the
expected risk-free interest rate. These assumptions reflect the Company’s best estimates, but they involve inherent uncertainties
based on market conditions generally outside of the control of the Company. As a result, if other assumptions had been used, stock-based
compensation cost could have been materially impacted. Furthermore, if the Company uses different assumptions for future grants, stock-based
compensation cost could be materially impacted in future periods.
The
Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC 718 as updated by Accounting
Standards Update (ASU) No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of ASC
718 to include share-based payment transactions to non-employees.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
The
following assumptions are used in valuing options issued using the Black-Scholes option pricing model:
Expected
Volatility. The expected volatility of the Company’s shares is estimated based on the Company’s external valuation.
Expected
Term. The expected term of options is estimated using the simplified method which is based on the vesting period and contractual
term for each grant, or for each vesting-tranche for awards with graded vesting.
Underlying
Common Stock Value. The underlying common stock value of the Company’s shares is estimated by a third-party valuation expert.
Risk-free
Interest Rate. The Company bases the risk-free interest rate on the implied yield available on a U.S. Treasury note with terms equal
to the expected term of the underlying grant.
Dividend
Yield. The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company has not paid dividends
on Common stock in the past nor does it expect to pay dividends on Common stock in the near future. As such, the Company uses a dividend
yield percentage of zero
Income
Taxes
The
Company uses the liability method of accounting for income taxes, as set forth in ASC 740, Accounting for Income Taxes. Under
this method, deferred tax assets and liabilities are recognized for the expected future tax consequence of temporary differences between
the carrying amounts and the tax basis of assets and liabilities and net operating loss carry forwards, all calculated using presently
enacted tax rates.
Management
has evaluated the effect of ASC guidance related to uncertain income tax positions and concluded that the Company has no significant
financial statement exposure to uncertain income tax positions at June 30, 2023 and December 31, 2022. The Company’s income tax
returns have not been examined by tax authorities through December 31, 2022.
Fair
Value Measurements
The
Company carries certain liabilities at fair value on a recurring basis. A fair value hierarchy that consists of three levels is used
to prioritize the inputs to fair value valuation techniques:
|
● |
Level
1 – Inputs are based upon observable or quoted prices for identical instruments traded in active markets. |
|
|
|
|
● |
Level
2 – Inputs are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments
in markets that are not active, and model-based valuation techniques for which all significant assumptions are observable in the
market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
|
|
|
|
● |
Level
3 – Inputs are generally unobservable and typically reflect management’s estimates of assumptions that market participants
would use in pricing the asset or liability. The fair values are therefore determined using model-based techniques that include option
pricing models, discounted cash flow models, and similar techniques. |
In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Recent
Accounting Pronouncements
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02,
Leases (Topic 842). This ASU requires a lessee to recognize a right-of-use asset and a lease liability under most operating leases in
its balance sheet. The ASU is effective for annual and interim periods beginning after December 15, 2021. The Company adopted ASU 2016-02
on January 1, 2022. See Note 13 – Operating Leases.
In
December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard
simplifies the accounting for income taxes through the removal of various exceptions previously provided, as well as providing additional
reporting requirements for income taxes. The ASU is effective for the Company on January 1, 2022. The Company has adopted this standard
effective January 1, 2022, which did not have a material impact to the financial statements.
In
August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40), which simplifies the accounting for certain financial
instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own
equity. This standard will be effective for the Company on January 1, 2024, with early adoption permitted (but no earlier than fiscal
years beginning after December 15, 2020). The Company has adopted this standard effective January 1, 2021, which did not have a material
impact to the financial statements.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Management
does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying
financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.
Financial
Instruments
The
Company’s financial instruments are primarily comprised of accounts receivable, accounts payable, accrued liabilities, and long-term
debt. For accounts receivable, accounts payable and accrued liabilities, the carrying amount approximates fair value due to the short-term
maturities of such instruments. The estimated fair value of the Company’s long-term debt approximates carrying value.
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v3.23.2
Employee Retention Credit
|
6 Months Ended |
Jun. 30, 2023 |
Retirement Benefits [Abstract] |
|
Employee Retention Credit |
3. Employee Retention Credit
The
CARES Act provides an employee retention credit (“CARES Employee Retention credit”), which is a refundable tax credit against
certain employment taxes of up to $5,000 per employee for eligible employers. The tax credit is equal to 50% of qualified wages paid
to employees during a quarter, capped at $10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions
were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through September
30, 2021. Based on these additional provisions, the tax credit is now equal to 70% of qualified wages paid to employees during a quarter,
and the limit on qualified wages per employee has been increased to $10,000 of qualified wages per quarter. In April 2022, the Company
determined it qualified for the tax credit under the CARES Act and recorded a receivable for $229,813 and recognized the amounts as other
income on the statement of operations. The Company received full payment for the amount in September 2022.
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v3.23.2
Property and Equipment
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
4. Property and Equipment
Property
and equipment consisted of the following at June 30, 2023 and December 31, 2022:
Schedule of Property And Equipment
| |
June 30,2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 1,053,710 | | |
$ | 1,034,579 | |
Computer equipment | |
| 30,825 | | |
| 30,825 | |
Furniture and fixtures | |
| 24,316 | | |
| 24,316 | |
Leasehold improvements | |
| 28,855 | | |
| 28,855 | |
Building equipment | |
| 14,932 | | |
| 14,932 | |
Property and equipment gross | |
| 1,152,638 | | |
| 1,133,507 | |
Less: accumulated depreciation | |
| (349,531 | ) | |
| (286,549 | ) |
Net property and equipment | |
$ | 803,107 | | |
$ | 846,958 | |
Depreciation
expense was $30,877 and $61,429 for the three and six months ended June 30, 2023, respectively. Depreciation expense was $30,148 and
$59,957 for the three and six months ended June 30, 2022, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.2
Intangible Assets
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
5. Intangible Assets
Intangible
assets consisted of the following at:
Schedule of Intangible Assets
June
30, 2023:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 56,248 | | |
$ | - | | |
$ | 56,248 | |
Patents | |
17 years | |
| 116,076 | | |
| 11,517 | | |
| 104,559 | |
License agreement | |
17 years | |
| 80,773 | | |
| - | | |
| 80,773 | |
Intangible Assets | |
| |
$ | 253,097 | | |
$ | 11,517 | | |
$ | 241,580 | |
December
31, 2022:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 53,999 | | |
$ | - | | |
$ | 53,999 | |
Patents | |
17 years | |
| 108,198 | | |
| 8,140 | | |
| 100,058 | |
License agreement | |
17 years | |
| 65,510 | | |
| - | | |
| 65,510 | |
Intangible Assets | |
| |
$ | 227,707 | | |
$ | 8,140 | | |
$ | 219,567 | |
During
the three and six months ended June 30, 2023, amortization expense related to intangible assets was $1,780 and $3,377, respectively.
During the three and six months ended June 30, 2022, amortization expense related to intangible assets was $730 and $1,460, respectively.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
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v3.23.2
Accrued Expenses
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
6. Accrued Expenses
Accrued
expenses consisted of the following at:
Schedule of Accrued Expenses
| |
June 30, 2023 | | |
December 31, 2022 | |
Employee payroll and bonuses | |
$ | 481,383 | | |
$ | 371,010 | |
Vacation | |
| 60,911 | | |
| 27,082 | |
Research and development projects | |
| 164,036 | | |
| 316,389 | |
Interest | |
| - | | |
| 223,792 | |
Professional fees | |
| 57,133 | | |
| 24,502 | |
Other | |
| 4,258 | | |
| 31,186 | |
Total accrued expenses | |
$ | 767,721 | | |
$ | 993,961 | |
The
Company accrues expenses related to development activities performed by third parties based on an evaluation of services received and
efforts expended pursuant to the terms of the contractual arrangements. Payments under some of these contracts depend on research and
non-clinical trial milestones. There may be instances in which payments made to the Company’s vendors will exceed the level of
services provided and result in a prepayment of expense. In accruing service fees, the Company estimates the period over which services
will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level
of effort varies from the estimate, the Company will adjust the accrual or prepaid expense accordingly. The Company has not experienced
any material differences between accrued costs and actual costs incurred since its inception.
|
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v3.23.2
Convertible Debt
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Convertible Debt |
7. Convertible Debt
In
September 2022, the Company entered into a Convertible Note Purchase Agreement (the Agreement) to issue up to $4,500,000 convertible
promissory notes. On the same day, the Company entered into convertible promissory notes (2022 Convertible Notes) with three investors
totaling $4,350,000. The 2022 Convertible Notes mature on January 13, 2023 or the occurrence of an Event of Default (as defined) and
bear interest at a rate of 8% per annum which shall accrue but is not due and payable until conversion or full repayment of outstanding
principal. The principal and interest outstanding under the 2022 Convertible Notes is automatically converted a) upon the closing of
a Qualified Financing resulting in gross proceeds to the Company of at least $20 million into securities issued in connection with the
Qualified Financing, at a discount of 30% per share; b) upon the closing of a Change of Control event into shares of capital stock of
the Company or Series B preferred stock; and c) upon the closing of a Public Company Event, into shares of capital stock being issued
to investors equal to two-times (2x) the amount of the outstanding principal and accrued interest then outstanding divided by the public
offering price per share. The principal and interest outstanding under the 2022 Convertible Notes is convertible, at the option of the
holders, at the maturity date into a new class of Company’s Preferred Stock (Series C Preferred) equal to the quotient of the outstanding
principal amount plus interest divided by the Capped Price, which is defined as the price per share equal to the Valuation Cap of $30
million divided by the Company Capitalization, as defined in the Agreement.
In
February 2023, the 2022 Convertible Notes were amended to extend the maturity date to March 31, 2023 and to change the conversion price
upon a Qualified Financing or Change in Control event to $30 million divided by the number of shares of the Company’s common stock
issued and outstanding, on a fully diluted basis, immediately prior to the close of the Qualified Financing or Change in Control event.
During
April and June 2023, the 2022 Convertible Notes were further amended to extend the maturity date to June 30, 2023 and allow for the sale
of additional notes of $500,000 for a total aggregate principal of $4,850,000.
Effective
June 21, 2023, the 2022 Convertible Notes were converted to 1,846,020 shares of the Company’s common stock equal to $9,494,887.
Upon conversion, the Company recorded a change in fair value of $2,830,100 for the three and six months ended June 30, 2023 which was
recognized as a non-cash change in fair value in Other Income (Expense) on the statement of operations.
The
Company accounts for the 2022 Convertible Notes under ASC 815. Under 815-15-25, the election can be at the inception of a financial instrument
to account for the instrument under the fair value option under ASC 825. The Company has made such election for the 2022 Convertible
Notes. Using the fair value option, the convertible promissory note is to be recorded at its initial fair value on the date of issuance,
and each balance sheet date thereafter. The Company evaluates the change based on the conversion price at the current market value. When
recognized, changes in the estimated fair value of the notes are recognized as a non-cash gain or loss in Other Income (Expense) on the
statements of operations.
Effective
January 5, 2021, the Company entered into a Note Purchase Agreement to issue up to $2,000,000 of convertible promissory notes. On the
same date, the Company entered into a convertible promissory note (2021 Convertible Note) with one investor for $1,000,000. The 2021
Convertible Note bears interest at a rate of 6% per annum and is due and payable in full on January 5, 2023. The 2021 Convertible Note
automatically converts upon a qualified equity financing, as defined in the note agreement to the number of shares equal to all principal
and accrued interest divided by the conversion price of $48.00, which is subject to adjustment as defined in the note agreement. The
2021 Convertible Note is also optionally convertible as defined in the note agreement for certain non-qualified financing, a change in
control, or upon the maturity date of the 2021 Convertible Note. The Company incurred issuance costs of $15,613 related to the 2021 Convertible
Note, which has been recorded as a debt discount and will be amortized over the term of the 2021 Convertible Note.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
In
January 2023, the Company elected to convert the 2021 Convertible Note, including interest accrued but not yet paid of $124,759 at a
conversion price of $48.00 into 23,432 shares of its Series B Preferred Stock in accordance with the terms outlined in the Note Purchase
Agreement.
The
Company evaluated the terms and conditions of the Note Purchase Agreement related to the 2021 Convertible Note in order to assess the
accounting considerations under ASC 480 – Distinguishing Liabilities from Equity, and ASC 815 – Derivatives and Hedging.
The Company determined the Convertible Note does not meet any of the criteria to be accounted pursuant to an ASC 480 liability. The Company
also assessed the embedded features pursuant to the guidance in ASC 815 and determined the embedded features do not meet any of the criteria
for bifurcation.
Convertible
notes payable consisted of the following at:
Schedule of Convertible
Notes Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
2021 Convertible Note | |
$ | - | | |
$ | 1,000,000 | |
2022 Convertible Notes | |
| - | | |
| 5,600,000 | |
| |
$ | - | | |
$ | 6,600,000 | |
There
was $0 amortized related to the debt issuance costs during the three and six months ended June 30, 2023, respectively. There was $1,968
and $3,936 amortized related to the debt issuance costs during the three and six months ended June 30, 2022, respectively. Interest accrued
on the convertible notes was $0 and $223,792 at June 30, 2023 and December 31, 2022, respectively.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
8. Stockholders’ Equity
On
May 17, 2023, the Company effected a 7.1-for-1 forward stock split (the “Forward Stock Split”) of its issued and outstanding
shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s preferred
stock. The par value of the common stock was adjusted as a result of the Forward Stock Split from $0.01 to $0.0001 and the authorized
shares were increased to 100,000,0000 shares of common stock in connection with the Forward Stock Split. Fractional shares resulting
from the Forward Stock Split were rounded down to the next whole share and in lieu of any fractional shares the Company will pay a cash
amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive
effect to the Forward Stock Split for all periods presented. Shares of common stock underlying outstanding stock-based awards and other
equity instruments were proportionately increased and the respective per share value and exercise prices, if applicable, were proportionately
decreased in accordance with the terms of the agreements governing such securities.
Common
Stock
At
June 30, 2023 and December 31, 2022, per the Company’s amended and restated Certificate of Incorporation, the Company was authorized
to issue 100,000,000 shares of $0.0001 par value common stock.
The
Company had 12,097,643 and 1,043,988 shares of common stock issued and outstanding as of June 30, 2023 and December 31, 2022, respectively.
Each
share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders and the
holders of the Common Stock are entitled to elect one director of the Corporation.
The
Company currently has 1,584,414 shares of common stock reserved for future issuance for the potential exercise of stock options and warrants
outstanding at June 30, 2023.
Preferred
Stock
At
June 30, 2023 and December 31, 2022, per the Company’s amended and restated Certificate of Incorporation, the Company has authorized
1,437,150 shares of $0.0001 par value preferred stock.
In
January 2023, the Company issued 23,432 shares of its Series B Preferred Stock related to conversion of the 2021 Convertible Note at
a conversion price of $48.00 per share (see Note 7).
The
Series A, Series A-1, and Series B Preferred Stock have the following rights, preferences and privileges:
Conversion
The
preferred stock is convertible, at the option of the holder, into common shares based upon a predefined formula. A holder of preferred
stock may convert such shares into common shares at any time. For purpose of conversion, the initial conversion price is $16.25 per share
(original issue price) for Series A Preferred Stock, $37.50 per share (original issue price) for Series A-1 Preferred Stock, and $43.45
per share (original issue price) for Series B Preferred Stock, and is subject to adjustment as described in the Certificate of Incorporation.
Preferred stock will automatically convert into common shares upon the earlier of (a) an initial public offering with gross proceeds
in excess of $100,000,000 or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the required
preferred stock shareholders, all outstanding Series A, Series A-1, and Series B Preferred Stock shall automatically convert into common
shares, at the then effective conversion rate.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Upon
the Company’s IPO in June 2023, all of the outstanding preferred stock converted to common stock, resulting in the issuance of
1,458,233, 2,964,849, and 3,284,553 shares of common stock in exchange for outstanding Series A, Series A-1, and Series B Preferred Stock,
respectively. There was no gain or loss upon conversion.
Voting
Rights
The
holders of the Series A, Series A-1, and Series B Preferred Stock are entitled to vote on any matter presented to the stockholders of
the Corporation for their action or consideration at any meeting of stockholders of the Corporation (or by written consent of stockholders
in lieu of meeting), each holder of outstanding shares of preferred stock shall be entitled to cast the number of votes equal to the
number of whole shares of Common Stock into which the shares of preferred stock held by such holder are convertible as of the record
date for determining stockholders entitled to vote on such matter. The holders of the Series A and Series A-1 Preferred Stock are each
entitled to elect one director of the Corporation. The holders of the Series B Stock are entitled to elect two members of the Board.
Each class of preferred stock can remove from office such directors and to fill any vacancy caused by the resignation, death or removal
of such directors under certain circumstances as described in the Certificate of Incorporation.
Dividends
The
holders of Series A Preferred Stock are entitled to receive dividends at a rate of 8% per annum of the Series A original issue price
of $16.25 per share on each outstanding share of Series A Preferred Stock (subject to appropriate adjustment in the event of any stock
dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock). Dividends accumulate
from the original date of issuance of the Series A Preferred Stock, are cumulative and are payable upon declaration of the Board of Directors
or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series A Preferred Stock as there was no longer
any Series A Preferred Stock outstanding.
The
holders of Series A-1 Stock are entitled to receive dividends at a rate of 8% per annum of the Series A-1 original issue price of $37.50
per share on each outstanding share of Series A-1 (subject to appropriate adjustment in the event of any stock dividend, stock split,
combination or other similar recapitalization with respect to the Series A-1 Preferred Stock). Dividends are cumulative and are payable
upon declaration of the Board of Directors or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series
A-1 Preferred Stock as there was no longer any Series A-1 Preferred Stock outstanding.
The
holders of Series B Stock are entitled to receive dividends at a rate of 8% per annum of the Series B original issue price of $43.45
per share on each outstanding share of Series B (subject to appropriate adjustment in the event of any stock dividend, stock split, combination
or other similar recapitalization with respect to the Series B Preferred Stock). Dividends are cumulative and are payable upon declaration
of the Board of Directors or liquidation of the Company. At June 30, 2023, there were no cumulative dividends on Series B Preferred Stock
as there was no longer any Series B Preferred Stock outstanding.
Liquidation
In
the event of any liquidation, dissolution or winding up of the Company, the holders of the preferred stock are entitled to receive, prior
to and in preference to the holders of the common shares, an amount equal to the Series A, Series A-1, or Series B Preferred Stock original
issue price, plus declared and/or accrued but unpaid dividends. In the event of any such liquidation event, after the payment of all
preferential amounts required to be paid to the holders of shares of preferred stock, the remaining assets of the Corporation available
for distribution to its stockholders shall be distributed among the holders of the shares of preferred stock and Common Stock, pro rata
based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted into
Common Stock pursuant to the terms of the Certificate of Incorporation immediately prior to such liquidation event.
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v3.23.2
Warrants
|
6 Months Ended |
Jun. 30, 2023 |
Warrants |
|
Warrants |
9. Warrants
The
Company issued warrants to purchase 6,745 shares of common stock in 2018 in conjunction with convertible debt financing that have a redemption
provision providing the holder the right to have the Company redeem all or any portion of the warrant (or shares it has converted into)
at a purchase price equal to the fair market value of the shares as determined by the board of directors or an independent appraiser.
As a result of this redemption provision, the warrants have been classified as a liability in the financial statements based on ASC 480
– Distinguishing Liabilities from Equity. These warrants have an exercise price of $0.48 per share and a term of 10 years. The
warrants are marked to market each reporting period. The fair value is $158,994 and $70,283 at June 30, 2023 and December 31, 2022, respectively.
At June 30, 2023, the Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following
assumptions: Underlying common stock value of $3.64; Expected term of 4.8 years; Expected Volatility of 82.5%; Risk Free Interest Rate
of 3.01%; and Dividend Yield of 0%. At December 31, 2022, the Company estimated the fair value of the warrants using the Black-Scholes
option pricing model with the following assumptions: Underlying common stock value of $12.09; Expected term of 5 years; Expected Volatility
of 86.0%; Risk Free Interest Rate of 3.01%; and Dividend Yield of 0%.
The
Company also issued warrants in 2016 and 2019 which did not meet the criteria under ASC 480 to be classified as a liability, and instead
meet equity classification criteria. The 11,466 warrants issued in 2016 expired upon the initial public offering in June 2023.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
The
following table summarizes information about warrants outstanding at June 30, 2023:
Schedule
of Information about Warrants Outstanding
| |
| | |
Warrants Outstanding | | |
Warrants Exercisable | |
Year Granted | |
Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| |
| | |
| | |
| |
| | |
| | |
| |
| |
2018 | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | |
2019 | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | |
2023 | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | |
| |
| | | |
| 323,733 | | |
| |
$ | 4.75 | | |
| 323,733 | | |
| |
$ | 4.75 | |
|
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v3.23.2
Stock Options
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Stock Options |
10. Stock Options
In
March 2023, the Company’s Board of Directors and stockholders approved the 2023 Stock Incentive Plan (“2023 Plan”).The
2023 Plan allows the Committee to grant up to 2,000,000 shares of Common Stock in the form of incentive and non-statutory stock options,
restricted stock awards, restricted stock units, and other stock-based awards to employees, directors, and non-employees. As of June
30, 2023, there were no awards issued under the 2023 Plan.
During
2016, the Company established the Azitra Inc. 2016 Stock Incentive Plan (the Plan) which provides for the granting of stock options and
restricted shares to the Company’s employees, officers, directors, advisors and consultants. There were 1,490,595 shares available
for granting under the Plan at December 31, 2022. Options vest over varying time frames.
During
the three and months ended June 30, 2023 and 2022, the Company did not grant any stock options to acquire shares of common stock. During
the three and six months ended June 30, 2023, the Company recognized stock compensation expense of $38,974 and $77,588, respectively,
relating to the issuance of service-based stock options. During the three and six months ended June 30, 2022, the Company recognized
stock compensation expense of $53,826 and $110,809, respectively, relating to the issuance of service-based stock options. At June 30,
2023, there was $350,197 of unamortized compensation expense that will be amortized over the remaining vesting period. At June 30, 2023
and 2022, there were 13,120 performance-based options outstanding with a fair value of $109,551. During the three and six months ended
June 30, 2023 and 2022, the Company did not recognize any compensation expense for performance-based options. The Company determined
the options qualified as plain vanilla under the provisions of SAB 107 and the simplified method was used to estimate the expected option
life.
The
following table summarizes information about options outstanding and exercisable at June 30, 2023:
Schedule of Information about Options Outstanding and Exercisable
| | |
Options Outstanding | | |
Options Exercisable | |
Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| | |
| | |
| |
| | |
| | |
| |
| |
$ | 0.48 | | |
| 246,137 | | |
2.5 years | |
$ | 0.48 | | |
| 246,137 | | |
2.6 years | |
$ | 0.48 | |
$ | 0.93 | | |
| 202,040 | | |
2.5 years | |
$ | 0.93 | | |
| 198,290 | | |
2.5 years | |
$ | 0.93 | |
$ | 1.70 | | |
| 812,504 | | |
7.8 years | |
$ | 1.70 | | |
| 518,227 | | |
7.6 years | |
$ | 1.70 | |
| | | |
| 1,260,681 | | |
| |
| | | |
| 962,654 | | |
| |
| | |
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Total
stock option activity for the six months ended June 30, 2023 is summarized as follows:
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | |
Outstanding at December 31, 2022 | |
| 1,290,325 | | |
$ | 1.27 | |
Granted | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Forfeited | |
| (29,644 | ) | |
| 0.93 | |
Outstanding at June 30, 2023 | |
| 1,260,681 | | |
$ | 1.28 | |
There
are 229,914 shares available for future grant under the Plan at June 30, 2023.
|
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- DefinitionThe entire disclosure for a company's election to apply the fair value option for measurement and reporting of eligible financial assets and liabilities (as defined), as well as certain other eligible items (as defined) included in the statement of financial position, whether such option is elected for a single eligible item or a group of similar eligible items and is in addition to other disclosures concerning fair value which the company may be required to provide. Such disclosure might be expected to include: (1) for items included in the statement of financial position: (a) the reasons for electing a fair value option for each eligible item or group of similar eligible items; (b) if the fair value option is elected for some but not all eligible items within a group of similar eligible items: (i) a description of those similar items and the reasons for partial election and (ii) information of how the group of similar items relates to individual balance sheet line items; (c) for each line item in the statement of financial position that includes an item or items for which the fair value option has been elected: (i) information of how each line item in the statement of financial position relates to major categories of assets and liabilities presented in accordance with other fair value disclosures and (ii) the aggregate carrying amount of ineligible items included in each line item in the balance sheet, if any; (d) the difference between the aggregate fair value and the aggregate unpaid principal balance (assuming contractual principal amounts and fair value option elected) of: (i) loans and long-term receivables (other than securities otherwise reported at fair value) and (ii) long-term debt instruments; (e) for loans held as assets for which the fair value option has been elected: (i) the aggregate fair value of loans that are 90 days or more past due, (ii) if the policy is to recognize interest income separately from other changes in fair value, the aggregate fair value of loans in nonaccrual status, and (iii) the difference between the aggregate fair value and the aggregate unpaid principal balance for loans that are 90 days or more past due, in nonaccrual status, or both; (f) for investments that would have been accounted for under the equity method if the entity had not chosen to apply the fair value option, the information required for such investments, if material either individually or in the aggregate; (2) for items included in the income statement: (a) the amounts of gains and losses from fair value changes included in earnings and in which line in the income statement those gains and losses are reported whether or not combined with gains and losses from items required to be accounted for at fair value; (b) a description of how interest and dividends are measured and where they are reported in the income statement; (c) for loans and other receivables held as assets: (i) the estimated amount of gains or losses included in earnings attributable to changes in instrument-specific credit risk and (ii) how the gains or losses attributable to changes in instrument-specific credit risk were determined; (d) for liabilities with fair values that have been significantly affected during the reporting period by changes in the instrument-specific credit risk: (i) the estimated amount of gains and losses from fair value changes included in earnings that are attributable to changes in the instrument-specific credit risk, (ii) qualitative information about the reasons for those changes, and (iii) how the gains and losses attributable to changes in instrument-specific credit risk were determined; and (3) certain other disclosures as required or determined to be provided.
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v3.23.2
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
11. Fair Value Measurements
The
following tables summarize the fair values and levels within the fair value hierarchy in which the fair value measurements fall for assets
and liabilities measured on a recurring basis as of:
Schedule of Fair Value Measurements for Assets and Liabilities
June 30, 2023 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
Total | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
December 31, 2022 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 70,283 | | |
$ | 70,283 | |
2022 Convertible Notes | |
| - | | |
| - | | |
| 5,600,000 | | |
| 5,600,000 | |
Total | |
$ | - | | |
$ | - | | |
$ | 5,670,283 | | |
$ | 5,670,283 | |
The
following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended June 30, 2023:
Schedule
of Changes in Level 3 Instruments Measured on a Recurring Basis
| |
| | |
Balance at December 31, 2022 | |
$ | 5,670,283 | |
Change in fair value of warrants | |
| (5,621 | ) |
Change in fair value of 2022 Convertible Notes | |
| 800,000 | |
Balance at March 31, 2023 | |
$ | 6,464,662 | |
Change in fair value of warrants | |
| 94,036 | |
Change in fair value of 2022 Convertible Notes | |
| 2,830,100 | |
Conversion of 2022 Convertible Notes | |
| (9,230,100 | ) |
Balance at June 30, 2023 | |
$ | 158,698 | |
Fluctuation
in the fair value of the Company’s Common stock is the primary driver for the change in the Common Stock Warrant liability valuation
during each year. As the fair value of the Common stock increases the value to the holder of the instrument generally increases.
Fluctuations
in the various inputs, including the enterprise value, time to liquidity, volatility, and discount rate are the primary drivers for the
changes in valuation of the 2022 Convertible Notes each reporting period. As the fair value of the enterprise value, estimated time to
liquidity, volatility, and discount rate increase, the value to the holder of the 2022 Convertible Notes generally increases.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
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v3.23.2
Net Loss Per Share
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
12. Net Loss Per Share
Basic
and diluted net loss per share were calculated as follows:
The
numerator for basic and diluted net loss per share is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss | |
$ | (4,429,528 | ) | |
$ | (1,890,153 | ) | |
$ | (6,886,707 | ) | |
$ | (4,216,170 | ) |
Dividends on preferred stock | |
| (643,267 | ) | |
| (692,246 | ) | |
| (1,355,347 | ) | |
| (1,384,492 | ) |
Net loss attributable to common shareholders | |
$ | (5,072,795 | ) | |
$ | (2,582,399 | ) | |
$ | (8,242,054 | ) | |
$ | (5,600,662 | ) |
The
denominator is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Weighted Average Common Stock Outstanding
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Weighted average common stock outstanding, basic and diluted | |
| 2,137,207 | | |
| 1,043,988 | | |
| 1,593,617 | | |
| 1,043,870 | |
$0.01 warrants | |
| 10,319 | | |
| 11,466 | | |
| 10,893 | | |
| 11,466 | |
Total | |
| 2,147,526 | | |
| 1,055,454 | | |
| 1,604,510 | | |
| 1,055,336 | |
Net
loss per share, basic and diluted is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Net Loss Per Share, Basic and Diluted
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss per share, basic and diluted | |
$ | (2.36 | ) | |
$ | (2.45 | ) | |
$ | (5.14 | ) | |
$ | (5.31 | ) |
The
following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation
of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
Schedule of Calculation of Diluted Net Loss Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Options to purchase shares of common stock | |
| 1,260,681 | | |
| 1,290,318 | |
Warrants outstanding | |
| 323,733 | | |
| 263,743 | |
Common stock reserved for future issuance | |
| 1,584,414 | | |
| 1,554,061 | |
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
13. Commitments and Contingencies
Legal
The
Company is subject to legal proceedings or claims which arise in the ordinary course of its business. Although occasional adverse decisions
or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on
its financial position, results of operations or liquidity.
License
Agreement
Effective
January 26, 2022, the Company entered into an Exclusive License Agreement (the Agreement) with an unrelated third party. Under the Agreement,
the Company is granted an exclusive license for certain patents and a non-exclusive license for certain know-how. The Agreement continues
until the later of the expiration of the last to expire licensed patent or ten years after the first commercial sale of the first licensed
therapeutic or non-therapeutic product. The Company may terminate the Agreement at any time by providing at least 30 days written notice
to the third party. The Agreement is also terminated upon breach of a material obligation under the agreement or bankruptcy. Upon any
termination of the agreement, neither party is relieved of obligations incurred prior to the termination.
During
the three and six months ended June 30, 2023 and 2022, the Company capitalized payments made under this license agreement in the amount
of $11,405 and $15,263, respectively. These capitalized costs will be amortized over the life of the licensed patents, once issued.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Operating
Leases
The
Company leases office and lab space in Branford, CT; Groton, CT; and Laval, Quebec. The Company’s leases expire at various dates
through May 31, 2027. Most leases are for a fixed term and for a fixed amount. The Company is not a party to any leases that have step
rent provisions, escalation clauses, capital improvement funding or payment increases based on any index or rate.
During
2020, the Company entered into a new lease agreement for the Company’s primary office and laboratory space in Branford, CT. The
Branford lease requires monthly payments of $13,033 for the first year of the lease, which increases approximately 2% in each of the
following years. The Branford lease also requires the Company to pay a pro-rata share of common area maintenance.
During
May 2021, the Company entered into a new lease for office and laboratory space in Groton, CT. The Groton lease required monthly payments
of $4,234, which was increased to $6,824 in September 2021 upon leasing additional space. The Groton lease is initially for a one-year
term, with up to three additional years renewal available.
Future
minimum payments under non-cancelable operating leases with initial or remaining terms in excess of one year during each of the next
five years follow:
Schedule of Future Minimum Payments Under Non-cancelable Operating Leases
| |
| | |
2023 | |
$ | 334,661 | |
2024 | |
| 319,211 | |
2025 | |
| 246,051 | |
2026 | |
| 164,469 | |
2027 | |
| - | |
Total future undiscounted lease payments | |
| 1,064,392 | |
Less: interest | |
| (72,736 | ) |
Present value of lease liabilities | |
$ | 991,656 | |
Rent
expense for all operating leases was $84,716 and $169,432 for the three and six months ended June 30, 2023. The weighted average lease
term for all operating leases is 3.4 years. The weighted average discount rate for all operating leases is 4.25%.
|
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v3.23.2
Retirement Plan
|
6 Months Ended |
Jun. 30, 2023 |
Retirement Benefits [Abstract] |
|
Retirement Plan |
14. Retirement Plan
Effective
January 1, 2019, the Company sponsors a 401(k) plan that covers substantially all employees. In order to be eligible to participate,
an employee must complete two consecutive months of service and work a minimum of two hundred and fifty hours or work 1,000 hours in
their first year of service. Employees may make pre-tax deferrals upon meeting the Plan eligibility requirements. Effective January 1,
2020, the Plan was transitioned to a safe harbor plan in which highly compensated employees are not eligible for matching contributions
and non-highly compensated employees earn 100% match on first 3% contributed and 50% on the next 2% contributed. Total employer matching
contributions were $2,633 and $4,824 for the three and six months ended June 30, 2023, respectively. Total employer matching contributions
were $2,632 and $14,603 for the three and six months ended June 30, 2022, respectively.
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v3.23.2
Concentration of Credit Risk
|
6 Months Ended |
Jun. 30, 2023 |
Risks and Uncertainties [Abstract] |
|
Concentration of Credit Risk |
15. Concentration of Credit Risk
Financial
instruments that potentially subject the Company to credit risk consist principally of cash and accounts receivable.
For
the three and six month periods ended June 30, 2023 and 2022, all service revenue was from one customer. For the three and six month
period ended June 30, 2023, there was no grant revenue and for the three and six month period ended June 30, 2022, all grant revenue
was from one grantor.
The
cash balance identified in the balance sheet is held in an account with a financial institution and insured by the Federal Deposit Insurance
Corporation (FDIC) up to $250,000. At times, cash maintained on deposit may be in excess of FDIC limits.
In
early March 2020, there was a global outbreak of COVID-19 that has resulted in significant changes in the global economy. While the Company
has not experienced any disruptions to its business operations to date, these changes, including a potential economic downturn, and any
potential resulting direct or indirect negative impact to the Company cannot be determined, however they could have a prospective material
impact to the Company’s business, cash flows and liquidity.
|
X |
- DefinitionThe entire disclosure for any concentrations existing at the date of the financial statements that make an entity vulnerable to a reasonably possible, near-term, severe impact. This disclosure informs financial statement users about the general nature of the risk associated with the concentration, and may indicate the percentage of concentration risk as of the balance sheet date.
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v3.23.2
Related Parties
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Parties |
16. Related Parties
Total
related party revenue was $172,000 and $285,300 for the three and six months ended June 30, 2023. Total related party revenue was $85,000
and $205,000 for the three and six months ended June 30, 2022. Accounts receivable due from the related party was $440,000 and $175,000
at June 30, 2023 and December 31, 2022, respectively. Contract liabilities from the related party was $310,700 and $156,000 at June 30,
2023 and December 31, 2022, respectively.
In
September 2022 the Company entered into a convertible promissory note totaling $4,350,000 of which $4,000,000 was attributable to an
entity who was also an investor in the Company’s Series A, A-1, and B Preferred Stock financing (See Note 7). This entity received
1,697,490 shares of common stock up on conversion of the promissory notes for principal and interest of $4,243,726.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
17. Subsequent Events
The
Company has evaluated events subsequent to the balance sheet date through August 14, 2023, the date these condensed financial statements
were available to be issued.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Accounting |
Basis
of Accounting
The
financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S.
GAAP”).
|
Unaudited Interim Financial Information |
Unaudited
Interim Financial Information
The
unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information,
within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information
and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted
pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the
audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments,
necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of
the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements
related to the three and six month periods are unaudited. Unaudited interim results are not necessarily indicative of the results for
the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the
Company for the year ended December 31, 2022 and notes thereto that are included in the Company’s Registration Statement filed
with the SEC on June 5, 2023.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
Use of Estimates |
Use
of Estimates
The
preparation of the financial statement in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet.
While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results
could differ from those estimates.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
For
purposes of the balance sheets and statements of cash flows, the Company considers all cash on hand, demand deposits and all highly liquid
investments with original maturities of three months or less to be cash equivalents.
|
Property and Equipment |
Property
and Equipment
Property
and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives, which range
from 3 to 10 years. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are
charged to operations as incurred. Gains or losses on disposal of property and equipment are reflected in the statements of operations
in the period of disposal.
|
Accounts Receivable |
Accounts
Receivable
The
Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its
accounts receivable and establishes an allowance for doubtful accounts based on a history of past write-offs, collections and current
conditions. There was no allowance for doubtful accounts at June 30, 2023 and December 31, 2022. Accounts receivable are written off
when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received.
|
Deferred Offering Costs |
Deferred
Offering Costs
The
Company capitalized deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other
third-party fees relating to the Company’s initial public offering. In June 2023, the Company consummated its IPO and recorded
such amounts against the gross proceeds of its IPO within the statements of stockholders’ equity during the three and six months
ended June 30, 2023.
|
Right of Use Assets |
Right
of Use Assets
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (“Topic 842”).
ASU 2016-02 requires lessees to present right-of-use (“ROU”) assets and lease liabilities on the balance sheet for all leases
with terms longer than 12 months. See Note 2 – Recently Adopted Accounting Pronouncements.
In
calculating the effect of ASU 2016-02, the Company elected the transition method thereby not restating comparable periods. The Company
elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant
judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance,
the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months.
The
Company has operating leases for buildings. Currently, the Company has 3 operating leases with a ROU asset and lease liability totaling
$1,418,502 as of January 1, 2022. The basis, terms and conditions of the leases are determined by the individual agreements. The Company’s
option to extend certain leases ranges from 36 – 52 months. All options to extend have been included in the calculation of the
ROU asset and lease liability. The leases do not contain residual value guarantees, restrictions, or covenants that could incur additional
financial obligations to the Company. There are no subleases, sale-leaseback, or related party transactions.
At
June 30, 2023, the Company had operating right-of-use assets with a net value of $976,959 and current and long-term operating lease liabilities
of $298,047 and $693,609, respectively.
|
Intangible Assets |
Intangible
Assets
Intangible
assets consist of trademarks and patents. All costs directly related to the filing and prosecution of patent and trademark applications
are capitalized. Patents are amortized over their respective remaining useful lives upon formal approval. Trademarks have an indefinite
life.
The
Company accounts for other indefinite life intangible assets in accordance ASC Topic 350, Goodwill and Other Intangible Assets
(ASC 350). ASC 350 requires that intangible assets that have indefinite lives are required to be tested at least annually for impairment
or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Intangible assets that have
finite lives will continue to be amortized over their useful lives. No impairment losses relating to intangible assets were recorded
during the three and six months ended June 30, 2023 or 2022.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
Deferred Patent Costs |
Deferred
Patent Costs
Deferred
patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval.
These deferred costs will begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent
is not approved, the costs associated with the patent will be expensed in the year the patent was rejected. No impairment losses relating
to deferred patent costs were recorded in the three and six months ended June 30, 2023 or 2022.
|
Impairment of Long-Lived Assets |
Impairment
of Long-Lived Assets
In
accordance with ASC Topic 360-10, Accounting for the Impairment or Disposal of Long-Lived Assets (ASC 360-10), the Company’s
policy is to review its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount
of an asset may not be recoverable. In connection with this review, the Company also reevaluates the periods of depreciation for these
assets. The Company recognizes an impairment loss when the sum of the undiscounted expected future cash flows from the use and eventual
disposition of the asset is less than its carrying amount. If an asset is considered to be impaired, the impairment to be recognized
is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset, which is determined using the
present value of the net future operating cash flows generated by the asset.
|
Convertible Debt and Warrant Accounting |
Convertible
Debt and Warrant Accounting
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”)
and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial
instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other
conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant
issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For
issued warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional
paid-in capital at the time of issuance. For issued warrants that do not meet all the criteria for equity classification, the warrants
are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the
estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations under Other Income/loss.
Convertible
debt
When
the Company issues debt with a conversion feature, it first assesses whether the debt should be accounted for in accordance with ASC
480 – Distinguishing Liabilities from Equity. If the debt does not meet the criteria of an ASC 480 liability, the note’s
conversion features require bifurcation in accordance with ASC 815 – Derivatives and Hedging. If the Company determines the embedded
conversion feature requires bifurcation in accordance with ASC 815, the Company also considers if it can elect the fair value option.
If the fair value option is elected, the Company records the note at its initial fair value with any subsequent changes in fair value
recorded in earnings. As noted in Note 7, the Company has elected the fair value option for the 2022 Convertible Notes and will record
the notes at their initial fair values with any subsequent changes in fair value recorded in earnings. The Convertible Notes were converted
into the Company’s common stock on the Closing Date of the Company’s IPO.
|
Convertible Preferred Stock |
Convertible
Preferred Stock
As
the Convertible Preferred stockholders have liquidation rights in the event of a deemed liquidation event that, in certain situations,
are not solely within the control of the Company and would require the redemption of the then-outstanding Convertible Preferred Stock,
the Company classifies the Convertible Preferred Stock in mezzanine equity on the balance sheet. Due to the fact that the occurrence
of a deemed liquidation event is not currently probable, the carrying value of the Convertible Preferred Stock is not being accreted
to its redemption value. Subsequent adjustments to the carrying value of the Convertible Preferred Stock would be made only when a deemed
liquidation event becomes probable.
As
noted in Note 8, at the Closing Date of the Company’s IPO, the Convertible Preferred stock converted into shares of the Company’s
common stock.
|
Revenue |
Revenue
The
Company follows the five steps to recognize revenue from contracts with customers under ASC 606, Revenue from Contracts
with Customers (“ASC 606”), which are:
|
● |
Step
1: Identify the contract(s) with a customer |
|
|
|
|
● |
Step
2: Identify the performance obligations in the contract |
|
|
|
|
● |
Step
3: Determine the transaction price |
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
|
● |
Step
4: Allocate the transaction price to the performance obligations in the contract |
|
|
|
|
● |
Step
5: Recognize revenue when (or as) a performance obligation is satisfied |
The
Company generates service revenue through a joint development agreement with a research partner. The Company recognizes revenue related
to the research and development aspects of the agreement over time using the input method as work is performed on the contract.
The
Company also generates grant revenue, which represents monies received on contracts with various federal agencies and nonprofit research
institutions for general research conducted by the Company to further their product development and are therefore considered contributions
to the Company. The contracts are generally for periods of one year or more and can be cancelled by either party. The Company concluded
that the grant arrangements do not meet the criteria to be treated as a collaborative arrangement under FASB ASC Topic 808 as the Company
is the only active participant in the arrangement. The grant arrangements also do not meet the criteria for revenue recognition under
Topic 606, as the U.S. Government would not meet the definition of a customer.
Amounts
earned under these grant contracts are recorded as a reduction to research and development expense when eligible expenses are incurred
and the right to payment is realizable or realized and earned. The Company believes this policy is consistent with Topic 606, to ensure
that recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that the
Company expects to be entitled to in exchange for those goods or services, even though there is no exchange as defined in Topic 606.
Additionally, the Company has determined that the recognition of amounts received as costs are incurred and amounts become realizable
is analogous to the concept of transfer of control of a service over time under Topic 606.
Receipts
of grant awards in advance, which are payable back to the funding agency if not used in accordance with conditions in the grants related
to allowable costs or receipt of funding from research partners related to service revenue arrangements before work is performed on the
contract, are classified as contract liabilities in the accompanying balance sheets.
|
Research and Development |
Research
and Development
The
Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research
and Development. Accordingly, internal research and development costs are expensed as incurred. Research and development costs consist
of costs related to labor, materials and supplies. Research and development costs incurred were $812,836 and $1,643,017 during the three
and six month period ended June 30, 2023, respectively. Research and development costs incurred were $1,505,447 and $3,060,815 during
the three and six month period ended June 30, 2022, respectively.
At
June 30, 2023 and December 31, 2022, the Company has a state tax credit receivable of $32,459 for pending refunds related to the selling
of research and development tax credits back to the State of Connecticut. At June 30, 2023 and December 31, 2022, the Company has $0
and $28,925, respectively for pending refunds related to Canadian Scientific Research and Experimental Development (SRED) credits. At
June 30, 2023 and December 31, 2022, the Company has also recorded $9,987 and $8,282, respectively, related to refunds of Canadian Goods
and Services Tax (GST) and Quebec Sales Tax (QST). Receipts of refunds are recorded in other income on the statements of operations.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation (ASC 718). ASC 718 requires
employee stock options and rights to purchase shares under stock participation plans to be accounted for at fair value. ASC 718 requires
that compensation costs related to share-based payment transactions be recognized as operating expenses in the financial statements.
Under this method, compensation costs for all awards granted or modified are measured at estimated fair value at date of grant and are
included as compensation expense over the vesting period during which an employee provides service in exchange for the award. For awards
with a performance condition that affects vesting, the Company recognizes compensation expense when it is determined probable that the
performance condition will be achieved.
The
Company uses a Black-Scholes option pricing model to determine fair value of its stock options. The Black-Scholes model includes various
assumptions, including the value of the underlying common stock, the expected life of stock options, the expected volatility and the
expected risk-free interest rate. These assumptions reflect the Company’s best estimates, but they involve inherent uncertainties
based on market conditions generally outside of the control of the Company. As a result, if other assumptions had been used, stock-based
compensation cost could have been materially impacted. Furthermore, if the Company uses different assumptions for future grants, stock-based
compensation cost could be materially impacted in future periods.
The
Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC 718 as updated by Accounting
Standards Update (ASU) No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of ASC
718 to include share-based payment transactions to non-employees.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
The
following assumptions are used in valuing options issued using the Black-Scholes option pricing model:
Expected
Volatility. The expected volatility of the Company’s shares is estimated based on the Company’s external valuation.
Expected
Term. The expected term of options is estimated using the simplified method which is based on the vesting period and contractual
term for each grant, or for each vesting-tranche for awards with graded vesting.
Underlying
Common Stock Value. The underlying common stock value of the Company’s shares is estimated by a third-party valuation expert.
Risk-free
Interest Rate. The Company bases the risk-free interest rate on the implied yield available on a U.S. Treasury note with terms equal
to the expected term of the underlying grant.
Dividend
Yield. The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company has not paid dividends
on Common stock in the past nor does it expect to pay dividends on Common stock in the near future. As such, the Company uses a dividend
yield percentage of zero
|
Income Taxes |
Income
Taxes
The
Company uses the liability method of accounting for income taxes, as set forth in ASC 740, Accounting for Income Taxes. Under
this method, deferred tax assets and liabilities are recognized for the expected future tax consequence of temporary differences between
the carrying amounts and the tax basis of assets and liabilities and net operating loss carry forwards, all calculated using presently
enacted tax rates.
Management
has evaluated the effect of ASC guidance related to uncertain income tax positions and concluded that the Company has no significant
financial statement exposure to uncertain income tax positions at June 30, 2023 and December 31, 2022. The Company’s income tax
returns have not been examined by tax authorities through December 31, 2022.
|
Fair Value Measurements |
Fair
Value Measurements
The
Company carries certain liabilities at fair value on a recurring basis. A fair value hierarchy that consists of three levels is used
to prioritize the inputs to fair value valuation techniques:
|
● |
Level
1 – Inputs are based upon observable or quoted prices for identical instruments traded in active markets. |
|
|
|
|
● |
Level
2 – Inputs are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments
in markets that are not active, and model-based valuation techniques for which all significant assumptions are observable in the
market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
|
|
|
|
● |
Level
3 – Inputs are generally unobservable and typically reflect management’s estimates of assumptions that market participants
would use in pricing the asset or liability. The fair values are therefore determined using model-based techniques that include option
pricing models, discounted cash flow models, and similar techniques. |
In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02,
Leases (Topic 842). This ASU requires a lessee to recognize a right-of-use asset and a lease liability under most operating leases in
its balance sheet. The ASU is effective for annual and interim periods beginning after December 15, 2021. The Company adopted ASU 2016-02
on January 1, 2022. See Note 13 – Operating Leases.
In
December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard
simplifies the accounting for income taxes through the removal of various exceptions previously provided, as well as providing additional
reporting requirements for income taxes. The ASU is effective for the Company on January 1, 2022. The Company has adopted this standard
effective January 1, 2022, which did not have a material impact to the financial statements.
In
August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40), which simplifies the accounting for certain financial
instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own
equity. This standard will be effective for the Company on January 1, 2024, with early adoption permitted (but no earlier than fiscal
years beginning after December 15, 2020). The Company has adopted this standard effective January 1, 2021, which did not have a material
impact to the financial statements.
AZITRA,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
The Three and Six Months Ended June 30, 2023 and 2022
Management
does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying
financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.
|
Financial Instruments |
Financial
Instruments
The
Company’s financial instruments are primarily comprised of accounts receivable, accounts payable, accrued liabilities, and long-term
debt. For accounts receivable, accounts payable and accrued liabilities, the carrying amount approximates fair value due to the short-term
maturities of such instruments. The estimated fair value of the Company’s long-term debt approximates carrying value.
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v3.23.2
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property And Equipment |
Property
and equipment consisted of the following at June 30, 2023 and December 31, 2022:
Schedule of Property And Equipment
| |
June 30,2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 1,053,710 | | |
$ | 1,034,579 | |
Computer equipment | |
| 30,825 | | |
| 30,825 | |
Furniture and fixtures | |
| 24,316 | | |
| 24,316 | |
Leasehold improvements | |
| 28,855 | | |
| 28,855 | |
Building equipment | |
| 14,932 | | |
| 14,932 | |
Property and equipment gross | |
| 1,152,638 | | |
| 1,133,507 | |
Less: accumulated depreciation | |
| (349,531 | ) | |
| (286,549 | ) |
Net property and equipment | |
$ | 803,107 | | |
$ | 846,958 | |
|
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v3.23.2
Intangible Assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Assets |
Intangible
assets consisted of the following at:
Schedule of Intangible Assets
June
30, 2023:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 56,248 | | |
$ | - | | |
$ | 56,248 | |
Patents | |
17 years | |
| 116,076 | | |
| 11,517 | | |
| 104,559 | |
License agreement | |
17 years | |
| 80,773 | | |
| - | | |
| 80,773 | |
Intangible Assets | |
| |
$ | 253,097 | | |
$ | 11,517 | | |
$ | 241,580 | |
December
31, 2022:
| |
Estimated Useful Life | |
Gross Amount | | |
Accumulated Amortization | | |
Net Amount | |
Trademarks | |
Indefinite | |
$ | 53,999 | | |
$ | - | | |
$ | 53,999 | |
Patents | |
17 years | |
| 108,198 | | |
| 8,140 | | |
| 100,058 | |
License agreement | |
17 years | |
| 65,510 | | |
| - | | |
| 65,510 | |
Intangible Assets | |
| |
$ | 227,707 | | |
$ | 8,140 | | |
$ | 219,567 | |
|
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v3.23.2
Accrued Expenses (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses |
Accrued
expenses consisted of the following at:
Schedule of Accrued Expenses
| |
June 30, 2023 | | |
December 31, 2022 | |
Employee payroll and bonuses | |
$ | 481,383 | | |
$ | 371,010 | |
Vacation | |
| 60,911 | | |
| 27,082 | |
Research and development projects | |
| 164,036 | | |
| 316,389 | |
Interest | |
| - | | |
| 223,792 | |
Professional fees | |
| 57,133 | | |
| 24,502 | |
Other | |
| 4,258 | | |
| 31,186 | |
Total accrued expenses | |
$ | 767,721 | | |
$ | 993,961 | |
|
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v3.23.2
Convertible Debt (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Convertible Notes Payable |
Convertible
notes payable consisted of the following at:
Schedule of Convertible
Notes Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
2021 Convertible Note | |
$ | - | | |
$ | 1,000,000 | |
2022 Convertible Notes | |
| - | | |
| 5,600,000 | |
| |
$ | - | | |
$ | 6,600,000 | |
|
X |
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v3.23.2
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Warrants |
|
Schedule of Information about Warrants Outstanding |
The
following table summarizes information about warrants outstanding at June 30, 2023:
Schedule
of Information about Warrants Outstanding
| |
| | |
Warrants Outstanding | | |
Warrants Exercisable | |
Year Granted | |
Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Warrants at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| |
| | |
| | |
| |
| | |
| | |
| |
| |
2018 | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | | |
| 47,887 | | |
4.8 years | |
$ | 0.48 | |
2019 | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | | |
| 215,846 | | |
2.6 years | |
$ | 5.28 | |
2023 | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | | |
| 60,000 | | |
5.0 years | |
$ | 6.25 | |
| |
| | | |
| 323,733 | | |
| |
$ | 4.75 | | |
| 323,733 | | |
| |
$ | 4.75 | |
|
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v3.23.2
Stock Options (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Information about Options Outstanding and Exercisable |
The
following table summarizes information about options outstanding and exercisable at June 30, 2023:
Schedule of Information about Options Outstanding and Exercisable
| | |
Options Outstanding | | |
Options Exercisable | |
Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | | |
Number of Options at 6/30/2023 | | |
Weighted Average Remaining Contractual Life | |
Weighted Average Exercise Price | |
| | |
| | |
| |
| | |
| | |
| |
| |
$ | 0.48 | | |
| 246,137 | | |
2.5 years | |
$ | 0.48 | | |
| 246,137 | | |
2.6 years | |
$ | 0.48 | |
$ | 0.93 | | |
| 202,040 | | |
2.5 years | |
$ | 0.93 | | |
| 198,290 | | |
2.5 years | |
$ | 0.93 | |
$ | 1.70 | | |
| 812,504 | | |
7.8 years | |
$ | 1.70 | | |
| 518,227 | | |
7.6 years | |
$ | 1.70 | |
| | | |
| 1,260,681 | | |
| |
| | | |
| 962,654 | | |
| |
| | |
|
Schedule of Stock Option Activity |
Total
stock option activity for the six months ended June 30, 2023 is summarized as follows:
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | |
Outstanding at December 31, 2022 | |
| 1,290,325 | | |
$ | 1.27 | |
Granted | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Forfeited | |
| (29,644 | ) | |
| 0.93 | |
Outstanding at June 30, 2023 | |
| 1,260,681 | | |
$ | 1.28 | |
|
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v3.23.2
Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Measurements for Assets and Liabilities |
Schedule of Fair Value Measurements for Assets and Liabilities
June 30, 2023 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
Total | |
$ | - | | |
$ | - | | |
$ | 158,698 | | |
$ | 158,698 | |
December 31, 2022 | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Description | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
$ | - | | |
$ | - | | |
$ | 70,283 | | |
$ | 70,283 | |
2022 Convertible Notes | |
| - | | |
| - | | |
| 5,600,000 | | |
| 5,600,000 | |
Total | |
$ | - | | |
$ | - | | |
$ | 5,670,283 | | |
$ | 5,670,283 | |
|
Schedule of Changes in Level 3 Instruments Measured on a Recurring Basis |
The
following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended June 30, 2023:
Schedule
of Changes in Level 3 Instruments Measured on a Recurring Basis
| |
| | |
Balance at December 31, 2022 | |
$ | 5,670,283 | |
Change in fair value of warrants | |
| (5,621 | ) |
Change in fair value of 2022 Convertible Notes | |
| 800,000 | |
Balance at March 31, 2023 | |
$ | 6,464,662 | |
Change in fair value of warrants | |
| 94,036 | |
Change in fair value of 2022 Convertible Notes | |
| 2,830,100 | |
Conversion of 2022 Convertible Notes | |
| (9,230,100 | ) |
Balance at June 30, 2023 | |
$ | 158,698 | |
|
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v3.23.2
Net Loss Per Share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Numerator for Basic and Diluted Net Loss Per Share |
The
numerator for basic and diluted net loss per share is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss | |
$ | (4,429,528 | ) | |
$ | (1,890,153 | ) | |
$ | (6,886,707 | ) | |
$ | (4,216,170 | ) |
Dividends on preferred stock | |
| (643,267 | ) | |
| (692,246 | ) | |
| (1,355,347 | ) | |
| (1,384,492 | ) |
Net loss attributable to common shareholders | |
$ | (5,072,795 | ) | |
$ | (2,582,399 | ) | |
$ | (8,242,054 | ) | |
$ | (5,600,662 | ) |
|
Schedule of Numerator for Basic and Diluted Weighted Average Common Stock Outstanding |
The
denominator is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Numerator for Basic and Diluted Weighted Average Common Stock Outstanding
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Weighted average common stock outstanding, basic and diluted | |
| 2,137,207 | | |
| 1,043,988 | | |
| 1,593,617 | | |
| 1,043,870 | |
$0.01 warrants | |
| 10,319 | | |
| 11,466 | | |
| 10,893 | | |
| 11,466 | |
Total | |
| 2,147,526 | | |
| 1,055,454 | | |
| 1,604,510 | | |
| 1,055,336 | |
|
Schedule of Net Loss Per Share, Basic and Diluted |
Net
loss per share, basic and diluted is as follows for the three and six months ended June 30, 2023 and 2022:
Schedule of Net Loss Per Share, Basic and Diluted
| |
Three Months Ended | | |
Six Months Ended | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss per share, basic and diluted | |
$ | (2.36 | ) | |
$ | (2.45 | ) | |
$ | (5.14 | ) | |
$ | (5.31 | ) |
|
Schedule of Calculation of Diluted Net Loss Per Share |
The
following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation
of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
Schedule of Calculation of Diluted Net Loss Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Options to purchase shares of common stock | |
| 1,260,681 | | |
| 1,290,318 | |
Warrants outstanding | |
| 323,733 | | |
| 263,743 | |
Common stock reserved for future issuance | |
| 1,584,414 | | |
| 1,554,061 | |
|
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v3.23.2
Organization and Nature of Operations (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
May 17, 2023 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Proceeds from initial public offering |
|
|
|
|
$ 5,991,359
|
|
|
Forward stock split |
7.1-for-1 forward stock split
|
|
|
|
7.1-for-1 forward stock split
|
|
|
Accumulated deficit |
|
$ 44,201,259
|
$ 44,201,259
|
|
$ 44,201,259
|
|
$ 37,314,552
|
Loss from operations |
|
|
$ 1,485,476
|
$ 2,088,387
|
3,045,368
|
4,385,063
|
|
Net cash used in operating activities |
|
|
|
|
$ 3,031,522
|
$ 4,091,605
|
|
Maximum [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Sale of stock price per share |
$ 0.01
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Sale of stock price per share |
$ 0.0001
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Shares of common stock |
|
1,500,000
|
|
|
|
|
|
Sale of stock price per share |
|
$ 5.00
|
$ 5.00
|
|
$ 5.00
|
|
|
Proceeds from initial public offering |
|
|
|
|
$ 6.0
|
|
|
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v3.23.2
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
Jan. 01, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
Right-of-use asset and lease liability |
$ 1,418,502
|
|
|
|
|
|
Operating lease right-of-use asset |
|
$ 976,959
|
|
$ 976,959
|
|
$ 1,116,697
|
Current operating lease liability |
|
298,047
|
|
298,047
|
|
287,384
|
Long-term operating lease liability |
|
693,609
|
|
693,609
|
|
840,896
|
Research and development |
|
812,836
|
$ 1,505,447
|
1,643,017
|
$ 3,060,815
|
|
State tax credit receivable |
|
32,459
|
|
32,459
|
|
32,459
|
Pending refunds related to research and experimental development |
|
0
|
|
0
|
|
28,925
|
Refunds tax amount |
|
9,987
|
|
9,987
|
|
$ 8,282
|
Patents [Member] |
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
Impairment of intangible assets |
|
$ 0
|
|
$ 0
|
|
|
Minimum [Member] |
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
Property, plant and equipment, useful life |
|
3 years
|
|
3 years
|
|
|
Lease term |
|
36 months
|
|
36 months
|
|
|
Maximum [Member] |
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
Property, plant and equipment, useful life |
|
10 years
|
|
10 years
|
|
|
Lease term |
|
52 months
|
|
52 months
|
|
|
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v3.23.2
Employee Retention Credit (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Apr. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Employee retention credit |
$ 229,813
|
|
$ 229,813
|
|
$ 229,813
|
CARES Employee Retention credit [Member] |
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Refundable tax credit |
|
$ 5,000
|
|
5,000
|
|
Payments to employees wages |
|
|
|
$ 10,000
|
|
CARES Employee Retention credit [Member] | Minimum [Member] |
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Tax credit percent |
|
|
|
50.00%
|
|
CARES Employee Retention credit [Member] | Maximum [Member] |
|
|
|
|
|
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|
|
|
|
|
Tax credit percent |
|
|
|
70.00%
|
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v3.23.2
Schedule of Property And Equipment (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
$ 1,152,638
|
$ 1,133,507
|
Less: accumulated depreciation |
(349,531)
|
(286,549)
|
Net property and equipment |
803,107
|
846,958
|
Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
1,053,710
|
1,034,579
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
30,825
|
30,825
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
24,316
|
24,316
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
28,855
|
28,855
|
Building Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
$ 14,932
|
$ 14,932
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.23.2
Schedule of Intangible Assets (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Amount |
$ 253,097
|
$ 227,707
|
Accumulated Amortization |
11,517
|
8,140
|
Net Amount |
$ 241,580
|
$ 219,567
|
Trademarks [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Estimated Useful Life |
Indefinite
|
Indefinite
|
Gross Amount |
$ 56,248
|
$ 53,999
|
Accumulated Amortization |
|
|
Net Amount |
56,248
|
53,999
|
Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Amount |
116,076
|
108,198
|
Accumulated Amortization |
11,517
|
8,140
|
Net Amount |
$ 104,559
|
$ 100,058
|
Estimated Useful Life |
17 years
|
17 years
|
Licensing Agreements [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Amount |
$ 80,773
|
$ 65,510
|
Accumulated Amortization |
|
|
Net Amount |
$ 80,773
|
$ 65,510
|
Estimated Useful Life |
17 years
|
17 years
|
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v3.23.2
Schedule of Accrued Expenses (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Employee payroll and bonuses |
$ 481,383
|
$ 371,010
|
Vacation |
60,911
|
27,082
|
Research and development projects |
164,036
|
316,389
|
Interest |
|
223,792
|
Professional fees |
57,133
|
24,502
|
Other |
4,258
|
31,186
|
Total accrued expenses |
$ 767,721
|
$ 993,961
|
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v3.23.2
Schedule of Convertible Notes Payable (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Debt Instrument [Line Items] |
|
|
Convertible notes payable, net |
|
$ 6,600,000
|
2021 Convertible Note [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible notes payable, net |
|
1,000,000
|
2022 Convertible Note [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible notes payable, net |
|
$ 5,600,000
|
X |
- DefinitionCarrying value as of the balance sheet date of long-term debt (with maturities initially due after one year or beyond the operating cycle if longer) identified as Convertible Notes Payable, excluding current portion. Convertible Notes Payable is a written promise to pay a note which can be exchanged for a specified amount of another, related security, at the option of the issuer and the holder.
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v3.23.2
Convertible Debt (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Jun. 21, 2023 |
Sep. 30, 2022 |
Jan. 05, 2021 |
Jun. 30, 2023 |
Apr. 30, 2023 |
Feb. 28, 2023 |
Jan. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes payable |
|
|
|
|
|
|
|
$ 9,495,072
|
|
|
|
|
Change in fair value of convertible note |
|
|
|
|
|
|
|
(2,830,100)
|
|
$ (3,630,100)
|
|
|
Amortized debt issuance costs |
|
|
|
|
|
|
|
0
|
$ 1,968
|
0
|
$ 3,936
|
|
Interest accrued |
|
|
|
|
|
|
|
|
|
|
|
$ 223,792
|
2022 Convertible Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Maturity date |
|
|
|
Jun. 30, 2023
|
Jun. 30, 2023
|
Mar. 31, 2023
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
$ 30,000,000
|
|
|
|
|
|
|
Sale of additional notes |
|
|
|
$ 500,000
|
$ 500,000
|
|
|
|
|
|
|
|
Aggregate principal |
|
|
|
$ 4,850,000
|
$ 4,850,000
|
|
|
4,850,000
|
|
4,850,000
|
|
|
Converted shares |
1,846,020
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes payable |
$ 9,494,887
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of convertible note |
|
|
|
|
|
|
|
$ 2,830,100
|
|
$ 2,830,100
|
|
|
2021 Convertible Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
$ 48.00
|
|
|
|
|
|
|
|
|
|
Debt issuance costs |
|
|
$ 15,613
|
|
|
|
|
|
|
|
|
|
2021 Convertible Note [Member] | Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
|
|
|
|
$ 48.00
|
|
|
|
|
|
Interest accrued |
|
|
|
|
|
|
$ 124,759
|
|
|
|
|
|
Issuance of conversion shares |
|
|
|
|
|
|
23,432
|
|
|
|
|
|
Convertible Note Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note |
|
$ 4,500,000
|
2,000,000
|
|
|
|
|
|
|
|
|
|
Convertible Note Purchase Agreement [Member] | 2022 Convertible Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note |
|
$ 4,350,000
|
|
|
|
|
|
|
|
|
|
|
Maturity date |
|
Jan. 13, 2023
|
|
|
|
|
|
|
|
|
|
|
Bearing interest, percentage |
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
Gross proceeds |
|
$ 20,000,000
|
|
|
|
|
|
|
|
|
|
|
Debt discount, percentage |
|
30.00%
|
|
|
|
|
|
|
|
|
|
|
Capitalization amount |
|
$ 30,000,000
|
|
|
|
|
|
|
|
|
|
|
Convertible Note Purchase Agreement [Member] | 2021 Convertible Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note |
|
|
$ 1,000,000
|
|
|
|
|
|
|
|
|
|
Bearing interest, percentage |
|
|
6.00%
|
|
|
|
|
|
|
|
|
|
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
6 Months Ended |
|
|
May 17, 2023 |
Jan. 31, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
Forward stock split |
7.1-for-1 forward stock split
|
|
7.1-for-1 forward stock split
|
|
|
Common stock, par value per share |
|
|
$ 0.0001
|
$ 0.0001
|
|
Common stock shares authorized |
|
|
100,000,000
|
100,000,000
|
|
Common stock shares issued |
|
|
12,097,643
|
1,043,988
|
|
Common stock shares outstanding |
|
|
12,097,643
|
1,043,988
|
|
Common stock voting rights description |
|
|
Each
share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders and the
holders of the Common Stock are entitled to elect one director of the Corporation.
|
|
|
Common stock shares reserved for future issuance |
|
|
1,584,414
|
|
1,554,061
|
Preferred stock shares authorized |
|
|
1,437,150
|
1,437,150
|
|
Preferred stock, par value per share |
|
|
$ 0.0001
|
$ 0.0001
|
|
IPO [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Gross proceeds from convertible preferred stock |
|
$ 100,000,000
|
|
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Original issue price per share of series B preferred stock |
|
$ 43.45
|
|
|
|
Dividend percentage on series B preferred stock |
|
|
8.00%
|
|
|
Original issue price per share of series B preferred stock |
|
|
$ 43.45
|
|
|
Series B Preferred Stock [Member] | IPO [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Convertible series B preferred stock shares issued |
|
|
3,284,553
|
|
|
Series B Preferred Stock [Member] | 2021 Convertible Note [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Convertible series B preferred stock shares issued |
|
23,432
|
|
|
|
Original issue price per share of series B preferred stock |
|
$ 48.00
|
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Original issue price per share of series B preferred stock |
|
16.25
|
|
|
|
Dividend percentage on series B preferred stock |
|
|
8.00%
|
|
|
Original issue price per share of series B preferred stock |
|
|
$ 16.25
|
|
|
Series A Preferred Stock [Member] | IPO [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Convertible series B preferred stock shares issued |
|
|
1,458,233
|
|
|
Series A-1 convertible preferred stock |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Original issue price per share of series B preferred stock |
|
$ 37.50
|
|
|
|
Dividend percentage on series B preferred stock |
|
|
8.00%
|
|
|
Original issue price per share of series B preferred stock |
|
|
$ 37.50
|
|
|
Series A-1 convertible preferred stock | IPO [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Convertible series B preferred stock shares issued |
|
|
2,964,849
|
|
|
Forward Stock Split [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Common stock, par value per share |
$ 0.01
|
|
$ 0.0001
|
|
|
Common stock shares authorized |
|
|
1,000,000,000
|
|
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.2
Schedule of Information about Warrants Outstanding (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price of warrants |
$ 0.48
|
Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of warrants outstanding | shares |
323,733
|
Weighted Average Exercise Price, Outstanding |
$ 4.75
|
Number of warrants exercisable | shares |
323,733
|
Weighted Average Exercise Price, Exercisable |
$ 4.75
|
Year 2018 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price of warrants |
$ 0.48
|
Year 2018 [Member] | Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of warrants outstanding | shares |
47,887
|
Weighted Average Remaining Contractual Life, Outstanding |
4 years 9 months 18 days
|
Weighted Average Exercise Price, Outstanding |
$ 0.48
|
Number of warrants exercisable | shares |
47,887
|
Weighted Average Remaining Contractual Life, Exercisable |
4 years 9 months 18 days
|
Weighted Average Exercise Price, Exercisable |
$ 0.48
|
Year 2019 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price of warrants |
$ 5.28
|
Year 2019 [Member] | Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of warrants outstanding | shares |
215,846
|
Weighted Average Remaining Contractual Life, Outstanding |
2 years 7 months 6 days
|
Weighted Average Exercise Price, Outstanding |
$ 5.28
|
Number of warrants exercisable | shares |
215,846
|
Weighted Average Remaining Contractual Life, Exercisable |
2 years 7 months 6 days
|
Weighted Average Exercise Price, Exercisable |
$ 5.28
|
Year 2023 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price of warrants |
$ 6.25
|
Year 2023 [Member] | Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of warrants outstanding | shares |
60,000
|
Weighted Average Remaining Contractual Life, Outstanding |
5 years
|
Weighted Average Exercise Price, Outstanding |
$ 6.25
|
Number of warrants exercisable | shares |
60,000
|
Weighted Average Remaining Contractual Life, Exercisable |
5 years
|
Weighted Average Exercise Price, Exercisable |
$ 6.25
|
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v3.23.2
Warrants (Details Narrative)
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Dec. 31, 2022
USD ($)
$ / shares
|
Exercise price of warrants per share | $ / shares |
$ 0.48
|
$ 0.48
|
|
Maturity term |
10 years
|
10 years
|
|
IPO [Member] |
|
|
|
Number of warrants expired | shares |
11,466
|
|
|
Measurement Input, Share Price [Member] |
|
|
|
Expected dividend yield | $ / shares |
3.64
|
3.64
|
12.09
|
Measurement Input, Expected Term [Member] |
|
|
|
Expected term |
|
4 years 9 months 18 days
|
5 years
|
Measurement Input, Price Volatility [Member] |
|
|
|
Expected dividend yield |
82.05
|
82.05
|
86.00
|
Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
Expected dividend yield |
3.01
|
3.01
|
3.01
|
Measurement Input, Expected Dividend Rate [Member] |
|
|
|
Expected dividend yield |
0
|
0
|
0
|
Common Stock [Member] |
|
|
|
Number of warrants issued to purchase common stock | shares |
|
6,745
|
|
Warrant [Member] |
|
|
|
Fair value of warrants | $ |
$ 158,994
|
$ 158,994
|
$ 70,283
|
X |
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v3.23.2
Schedule of Information about Options Outstanding and Exercisable (Details) - $ / shares
|
6 Months Ended |
|
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Number of options exercise price |
$ 0.48
|
|
|
Number of options outstanding |
1,260,681
|
1,290,325
|
|
Stock Option One [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Weighted Average Remaining Contractual Life, Options outstanding |
2 years 6 months
|
|
|
Weighted Average Remaining Contractual Life, Options exercisable |
2 years 7 months 6 days
|
|
|
Stock Option Two [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Weighted Average Remaining Contractual Life, Options outstanding |
2 years 6 months
|
|
|
Weighted Average Remaining Contractual Life, Options exercisable |
2 years 6 months
|
|
|
Stock Option Three [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Weighted Average Remaining Contractual Life, Options outstanding |
7 years 9 months 18 days
|
|
|
Weighted Average Remaining Contractual Life, Options exercisable |
7 years 7 months 6 days
|
|
|
Stock Option One [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Number of options exercise price |
$ 0.48
|
|
|
Number of options outstanding |
246,137
|
|
|
Weighted Average Exercise Price, Options outstanding |
$ 0.48
|
|
|
Number of options exercisable |
246,137
|
|
|
Weighted Average Exercise Price, Options exercisable |
$ 0.48
|
|
|
Stock Option Two [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Number of options exercise price |
$ 0.93
|
|
|
Number of options outstanding |
202,040
|
|
|
Weighted Average Exercise Price, Options outstanding |
$ 0.93
|
|
|
Number of options exercisable |
198,290
|
|
|
Weighted Average Exercise Price, Options exercisable |
$ 0.93
|
|
|
Stock Option Three [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Number of options exercise price |
$ 1.70
|
|
|
Number of options outstanding |
812,504
|
|
|
Weighted Average Exercise Price, Options outstanding |
$ 1.70
|
|
|
Number of options exercisable |
518,227
|
|
|
Weighted Average Exercise Price, Options exercisable |
$ 1.70
|
|
|
Equity Option [Member] |
|
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
|
Number of options outstanding |
1,260,681
|
|
1,290,318
|
Number of options exercisable |
962,654
|
|
|
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v3.23.2
Schedule of Stock Option Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Fair Value Disclosures [Abstract] |
|
Number of Options, Outstanding Beginning | shares |
1,290,325
|
Weighted Average Exercise Price, Outstanding | $ / shares |
$ 1.27
|
Number of Options, Granted | shares |
|
Weighted Average Exercise Price, Granted | $ / shares |
|
Number of Options, Exercised | shares |
|
Weighted Average Exercise Price, Exercised | $ / shares |
|
Number of Options, Forfeited | shares |
(29,644)
|
Weighted Average Exercise Price, Forfeited | $ / shares |
$ 0.93
|
Number of Options, Outstanding Ending | shares |
1,260,681
|
Weighted Average Exercise Price, Outstanding | $ / shares |
$ 1.28
|
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v3.23.2
Schedule of Fair Value Measurements for Assets and Liabilities (Details) - Fair Value, Recurring [Member] - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
$ 158,698
|
$ 5,670,283
|
Common Stock Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
158,698
|
70,283
|
2022 Convertible Note [Member |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
5,600,000
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 1 [Member] | Common Stock Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 1 [Member] | 2022 Convertible Note [Member |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] | Common Stock Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] | 2022 Convertible Note [Member |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
158,698
|
5,670,283
|
Fair Value, Inputs, Level 3 [Member] | Common Stock Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
$ 158,698
|
70,283
|
Fair Value, Inputs, Level 3 [Member] | 2022 Convertible Note [Member |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
$ 5,600,000
|
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v3.23.2
Schedule of Changes in Level 3 Instruments Measured on a Recurring Basis (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Change in fair value of warrants |
|
|
$ 88,711
|
$ (35)
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Balance at March 31, 2023 |
$ 6,464,662
|
$ 5,670,283
|
5,670,283
|
|
Change in fair value of warrants |
|
(5,621)
|
|
|
Change in fair value of 2022 Convertible Notes |
2,830,100
|
800,000
|
|
|
Change in fair value of warrants |
94,036
|
|
|
|
Conversion of 2022 Convertible Notes |
(9,230,100)
|
|
|
|
Balance at June 30, 2023 |
$ 158,698
|
$ 6,464,662
|
$ 158,698
|
|
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v3.23.2
Stock Options (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Mar. 31, 2023 |
Dec. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
|
|
|
|
|
|
Stock options plan expense |
|
|
$ 38,974
|
$ 53,826
|
$ 77,588
|
$ 110,809
|
Performance Shares [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Performance stock options shares |
|
|
350,197
|
|
350,197
|
|
Fair value of stock options |
|
|
|
|
13,120
|
|
Fair value of stock options |
|
|
|
|
$ 109,551
|
|
2023 Stock Incentive Plan [Member] | Common Stock [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
2,000,000
|
|
|
|
|
|
2016 Stock Incentive Plan [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
|
1,490,595
|
|
|
|
|
2016 Stock Incentive Plan [Member] | Equity Option [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Shares available for future grant |
|
|
229,914
|
|
229,914
|
|
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v3.23.2
Schedule of Numerator for Basic and Diluted Net Loss Per Share (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
|
|
Net loss |
$ (4,429,528)
|
$ (2,457,179)
|
$ (1,890,153)
|
$ (2,326,017)
|
$ (6,886,707)
|
$ (4,216,170)
|
Dividends on preferred stock |
(643,267)
|
|
(692,246)
|
|
(1,355,347)
|
(1,384,492)
|
Net loss attributable to common shareholders |
$ (5,072,795)
|
|
$ (2,582,399)
|
|
$ (8,242,054)
|
$ (5,600,662)
|
X |
- DefinitionAmount of paid and unpaid preferred stock dividends declared with the form of settlement in stock.
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v3.23.2
Schedule of Numerator for Basic and Diluted Weighted Average Common Stock Outstanding (Details) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Total, basic |
2,147,526
|
1,055,454
|
1,604,510
|
1,055,336
|
Total, diluted |
2,147,526
|
1,055,454
|
1,604,510
|
1,055,336
|
Common Stock [Member] |
|
|
|
|
Total, basic |
2,137,207
|
1,043,988
|
1,593,617
|
1,043,870
|
Total, diluted |
2,137,207
|
1,043,988
|
1,593,617
|
1,043,870
|
Warrant [Member] |
|
|
|
|
Total, basic |
10,319
|
11,466
|
10,893
|
11,466
|
Total, diluted |
10,319
|
11,466
|
10,893
|
11,466
|
X |
- DefinitionThe average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period.
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v3.23.2
Schedule of Calculation of Diluted Net Loss Per Share (Details) - shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Options to purchase shares of common stock |
1,260,681
|
1,290,325
|
|
Common stock reserved for future issuance |
1,584,414
|
|
1,554,061
|
Warrant [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Warrants outstanding |
323,733
|
|
263,743
|
Equity Option [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Options to purchase shares of common stock |
1,260,681
|
|
1,290,318
|
Warrants outstanding |
962,654
|
|
|
X |
- DefinitionAggregate number of common shares reserved for future issuance.
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v3.23.2
Commitments and Contingencies (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Sep. 30, 2021 |
May 31, 2021 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Operating lease rental expense |
|
|
$ 84,716
|
$ 169,432
|
|
|
Operating lease term |
|
|
3 years 4 months 24 days
|
3 years 4 months 24 days
|
|
|
Operating lease discount rate |
|
|
4.25%
|
4.25%
|
|
|
Branford. CT [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Lease payments |
|
|
|
|
|
$ 13,033
|
Groton. CT [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Lease payments |
$ 6,824
|
$ 4,234
|
|
|
|
|
Exclusive License Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Capitalized License agreement amount |
|
|
|
$ 11,405
|
$ 15,263
|
|
X |
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Retirement Plan (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
Jan. 01, 2019 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Retirement Benefits [Abstract] |
|
|
|
|
|
Retirement plan general information |
the Company sponsors a 401(k) plan that covers substantially all employees. In order to be eligible to participate,
an employee must complete two consecutive months of service and work a minimum of two hundred and fifty hours or work 1,000 hours in
their first year of service. Employees may make pre-tax deferrals upon meeting the Plan eligibility requirements. Effective January 1,
2020, the Plan was transitioned to a safe harbor plan in which highly compensated employees are not eligible for matching contributions
and non-highly compensated employees earn 100% match on first 3% contributed and 50% on the next 2% contributed.
|
|
|
|
|
Employer contribution |
|
$ 2,633
|
$ 2,632
|
$ 4,824
|
$ 14,603
|
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v3.23.2
Related Parties (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
Jun. 21, 2023 |
Sep. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Jan. 05, 2021 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Revenues from related party |
|
|
$ 172,000
|
$ 85,000
|
$ 285,300
|
$ 205,000
|
|
|
Stock issued during conversion |
|
|
$ 9,495,072
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Stock issued during conversion |
|
|
1,846,020
|
|
|
|
|
|
Stock issued during conversion |
|
|
$ 185
|
|
|
|
|
|
2022 Convertible Note [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Stock issued during conversion |
$ 9,494,887
|
|
|
|
|
|
|
|
Convertible Note Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Convertible promissory note |
|
$ 4,500,000
|
|
|
|
|
|
$ 2,000,000
|
Convertible Note Purchase Agreement [Member] | 2022 Convertible Note [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Convertible promissory note |
|
$ 4,350,000
|
|
|
|
|
|
|
2022 Convertible Note [Member] | Common Stock [Member] | Investor [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Stock issued during conversion |
|
1,697,490
|
|
|
|
|
|
|
Stock issued during conversion |
|
$ 4,243,726
|
|
|
|
|
|
|
Related Party [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Revenues from related party |
|
|
172,000
|
$ 85,000
|
285,300
|
$ 205,000
|
|
|
Contract liabilities due from related party |
|
|
310,700
|
|
310,700
|
|
$ 156,000
|
|
Related Party [Member] | Accounts Receivable [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Accounts receivable due from related party |
|
|
$ 440,000
|
|
$ 440,000
|
|
$ 175,000
|
|
Investor [Member] | Convertible Note Purchase Agreement [Member] | 2022 Convertible Note [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Convertible promissory note |
|
$ 4,000,000
|
|
|
|
|
|
|
X |
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Azitra (AMEX:AZTR)
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From May 2024 to Jun 2024
Azitra (AMEX:AZTR)
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From Jun 2023 to Jun 2024