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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Lantern
Pharma Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-39318 |
|
46-3973463 |
(State
or Other Jurisdiction |
|
(Commission |
|
(IRS
Employer |
of
Incorporation) |
|
File
Number) |
|
Identification
No.) |
1920
McKinney Avenue, 7th Floor Dallas, Texas |
|
75201 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(972)
277-1136
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act: Common Stock
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value |
|
LTRN |
|
The
Nasdaq Stock Market |
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 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. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange 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 ☒
As
of August 5, 2024 the registrant had 10,764,725 shares of common stock, $0.0001 par value per share outstanding.
Table
of Contents
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking
statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities
Exchange Act of 1934, as amended, and other federal securities laws. All statements, other than statements of historical fact, contained
in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future preclinical studies and clinical trials, future
expectations for existing preclinical studies and clinical trials, future financial position, projected costs, prospects, plans and objectives
of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,”
“could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,”
“plan,” “potential,” “predict,” “project,” “target,” “model”,
“objective”, “aim,” “upcoming”, “should,” ‘will” “would,” or
the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these words. Forward-looking statements reflect our current views with respect to future events and are based on assumptions
and subject to risks and uncertainties.
The
forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements relating to:
|
● |
the
potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely
to respond to a drug candidate; |
|
|
|
|
● |
our
strategic plans to advance the development of any of our drug candidates; |
|
|
|
|
● |
our
strategic plans to expand the number of data points that our RADR® platform can access and analyze; |
|
|
|
|
● |
our
research and development efforts of our internal drug discovery and development programs and antibody drug conjugate (ADC) development
program and the utilization of our RADR® platform to streamline the drug development process; |
|
|
|
|
● |
the
initiation, timing, progress, and results of our preclinical studies or clinical trials for any of our drug candidates; |
|
|
|
|
● |
our
intention to leverage artificial intelligence, machine learning and biomarker data to streamline the drug development process and
to identify patient populations that would likely respond to a drug candidate; |
|
|
|
|
● |
our
plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves
or in collaboration with others; |
|
|
|
|
● |
our
expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our existing cash and
cash equivalents; |
|
|
|
|
● |
our
ability to secure sufficient funding and alternative sources of funding to support our existing and proposed preclinical studies
and clinical trials; |
|
|
|
|
● |
our
estimates regarding the potential market opportunity for our drug candidates we or any of our collaborators may in the future develop; |
|
|
|
|
● |
our
anticipated growth strategies and our ability to manage the expansion of our business operations effectively; |
|
|
|
|
● |
our
expectations related to future expenses and expenditures; |
|
|
|
|
● |
our
ability to keep up with rapidly changing technologies and evolving industry standards, including our ability to achieve technological
advances; |
|
● |
our
ability to source our needs for skilled labor in the fields of artificial intelligence, genomics, biology, oncology and drug development;
and |
|
|
|
|
● |
the
impact of government laws and regulations on the development and commercialization of our drug candidates and ADC development program. |
We
may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations
disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this
Quarterly Report on Form 10-Q and in the Risk Factors section of our Annual Report on Form 10-K (“2023 Form 10-K”), for the
year ended December 31, 2023 filed with the Securities and Exchange Commission, or the SEC, on March 18, 2024, and have identified other
factors such as the results of our clinical trials, and the impact of competition, that we believe could cause actual results or events
to differ materially from the forward-statements that we make. Furthermore, we operate in a competitive and rapidly changing environment.
New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could
have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q.
You
should read this Quarterly Report on Form 10-Q and the documents that we file with the SEC with the understanding that our actual future
results may be materially different from what we expect. These forward-looking statements are based on management’s current expectations.
These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors
that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Factors that may cause actual results to differ materially from current expectations
include, among other things, those listed elsewhere in this Quarterly Report on Form 10-Q and those listed under the Risk Factors section
of our 2023 Form 10-K. You may access our 2023 Form 10-K under the investor SEC filings tab of our website at www.lanternpharma.com or
on the SEC’s website at www.sec.gov. Given these uncertainties, you should not rely on these forward-looking statements as predictions
of future events. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly
Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future
events or otherwise, except as required by applicable law.
In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such
information forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be
read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These
statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Unless
the context requires otherwise, references to the “Company,” “Lantern,” “we,” “us,” and
“our” in this Quarterly Report on Form 10-Q refer to Lantern Pharma Inc., a Delaware corporation, and, where appropriate,
its wholly-owned subsidiaries.
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
CURRENT ASSETS | |
| | | |
| | |
Cash and cash equivalents | |
$ | 12,976,565 | | |
$ | 21,937,749 | |
Marketable securities | |
| 20,285,554 | | |
| 19,364,923 | |
Prepaid expenses & other current assets | |
| 2,029,458 | | |
| 2,038,653 | |
Total current assets | |
| 35,291,577 | | |
| 43,341,325 | |
| |
| | | |
| | |
Property and equipment, net | |
| 50,292 | | |
| 52,127 | |
Operating lease right-of-use assets | |
| 213,045 | | |
| 228,295 | |
Other assets | |
| 32,015 | | |
| 25,869 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 35,586,929 | | |
$ | 43,647,616 | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 4,436,796 | | |
$ | 2,505,211 | |
Operating lease liabilities, current | |
| 164,002 | | |
| 172,975 | |
Total current liabilities | |
| 4,600,798 | | |
| 2,678,186 | |
| |
| | | |
| | |
Operating lease liabilities, net of current portion | |
| 54,694 | | |
| 61,496 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 4,655,492 | | |
| 2,739,682 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES (NOTE 4) | |
| - | | |
| - | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred Stock (1,000,000 authorized at June 30, 2024 and December 31, 2023; $.0001 par value) (Zero shares issued and outstanding at June 30, 2024 and December 31, 2023) | |
| - | | |
| - | |
Common Stock (25,000,000 authorized at June 30, 2024 and December 31, 2023; $.0001 par value) (10,758,805 shares and 10,721,192 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively) | |
| 1,076 | | |
| 1,072 | |
Additional paid-in capital | |
| 96,581,666 | | |
| 96,258,726 | |
Accumulated other comprehensive loss | |
| (6,585 | ) | |
| (107,460 | ) |
Accumulated deficit | |
| (65,644,720 | ) | |
| (55,244,404 | ) |
Total stockholders’ equity | |
| 30,931,437 | | |
| 40,907,934 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 35,586,929 | | |
$ | 43,647,616 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations (Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 1,519,724 | | |
$ | 1,632,080 | | |
$ | 3,000,939 | | |
$ | 3,365,401 | |
Research and development | |
| 3,888,737 | | |
| 3,558,217 | | |
| 8,139,523 | | |
| 6,111,164 | |
Total operating expenses | |
| 5,408,461 | | |
| 5,190,297 | | |
| 11,140,462 | | |
| 9,476,565 | |
Loss from operations | |
| (5,408,461 | ) | |
| (5,190,297 | ) | |
| (11,140,462 | ) | |
| (9,476,565 | ) |
Interest income | |
| 188,660 | | |
| 117,823 | | |
| 389,610 | | |
| 251,605 | |
Other income, net | |
| 260,295 | | |
| 326,076 | | |
| 350,536 | | |
| 610,797 | |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (4,959,506 | ) | |
$ | (4,746,398 | ) | |
$ | (10,400,316 | ) | |
$ | (8,614,163 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share of common shares, basic and diluted | |
$ | (0.46 | ) | |
$ | (0.44 | ) | |
$ | (0.97 | ) | |
$ | (0.79 | ) |
Weighted-average number of common shares outstanding, basic and diluted | |
| 10,758,805 | | |
| 10,857,040 | | |
| 10,750,801 | | |
| 10,857,040 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Comprehensive Loss (Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
NET LOSS | |
$ | (4,959,506 | ) | |
$ | (4,746,398 | ) | |
$ | (10,400,316 | ) | |
$ | (8,614,163 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive (loss) income | |
| | | |
| | | |
| | | |
| | |
Unrealized gain on available-for-sale securities | |
| 26,483 | | |
| 33,763 | | |
| 70,429 | | |
| 84,536 | |
Unrealized (loss) gain on foreign currency translation | |
| (34,928 | ) | |
| 4,077 | | |
| 30,446 | | |
| 25,013 | |
Other comprehensive (loss) income | |
| (8,445 | ) | |
| 37,840 | | |
| 100,875 | | |
| 109,549 | |
Comprehensive loss | |
$ | (4,967,951 | ) | |
$ | (4,708,558 | ) | |
$ | (10,299,441 | ) | |
$ | (8,504,614 | ) |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity (Unaudited)
| |
Preferred Stock Number | | |
Preferred Stock | | |
Common Stock Number of | | |
Common Stock | | |
Additional Paid-in- | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
of Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
Three and Six Months Ended June 30, 2023 |
Balance, December 31, 2022 | |
| - | | |
$ | - | | |
| 10,857,040 | | |
$ | 1,086 | | |
$ | 95,691,194 | | |
$ | (371,386 | ) | |
$ | (39,282,870 | ) | |
$ | 56,038,024 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 333,530 | | |
| - | | |
| - | | |
| 333,530 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,867,765 | ) | |
| (3,867,765 | ) |
Other comprehensive income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 71,709 | | |
| - | | |
| 71,709 | |
Balance, March 31, 2023 | |
| - | | |
| - | | |
| 10,857,040 | | |
| 1,086 | | |
| 96,024,724 | | |
| (299,677 | ) | |
| (43,150,635 | ) | |
| 52,575,498 | |
Balance | |
| - | | |
| - | | |
| 10,857,040 | | |
| 1,086 | | |
| 96,024,724 | | |
| (299,677 | ) | |
| (43,150,635 | ) | |
| 52,575,498 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 392,390 | | |
| - | | |
| - | | |
| 392,390 | |
Issuance of restricted common stock awards | |
| - | | |
| - | | |
| 12,000 | | |
| 1 | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,746,398 | ) | |
| (4,746,398 | ) |
Other comprehensive income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 37,840 | | |
| - | | |
| 37,840 | |
Balance, June 30, 2023 | |
| - | | |
$ | - | | |
| 10,869,040 | | |
$ | 1,087 | | |
$ | 96,417,113 | | |
$ | (261,837 | ) | |
$ | (47,897,033 | ) | |
$ | 48,259,330 | |
Balance | |
| - | | |
$ | - | | |
| 10,869,040 | | |
$ | 1,087 | | |
$ | 96,417,113 | | |
$ | (261,837 | ) | |
$ | (47,897,033 | ) | |
$ | 48,259,330 | |
| |
Preferred Stock Number | | |
Preferred Stock | | |
Common Stock Number of | | |
Common Stock | | |
Additional Paid-in- | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
of Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income (Loss) | | |
Deficit | | |
Equity | |
Three and Six Months Ended June 30, 2024 |
Balance, December 31, 2023 | |
| - | | |
$ | - | | |
| 10,721,192 | | |
$ | 1,072 | | |
$ | 96,258,726 | | |
$ | (107,460 | ) | |
$ | (55,244,404 | ) | |
$ | 40,907,934 | |
Common stock issued from warrant exercises | |
| - | | |
| - | | |
| 37,613 | | |
| 4 | | |
| 54,712 | | |
| - | | |
| - | | |
| 54,716 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| | | |
| 134,057 | | |
| - | | |
| - | | |
| 134,057 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| (5,440,810 | ) | |
| (5,440,810 | ) |
Other comprehensive income | |
| - | | |
| - | | |
| - | | |
| | | |
| - | | |
| 109,320 | | |
| - | | |
| 109,320 | |
Balance, March 31, 2024 | |
| - | | |
| - | | |
| 10,758,805 | | |
| 1,076 | | |
| 96,447,495 | | |
| 1,860 | | |
| (60,685,214 | ) | |
| 35,765,217 | |
Balance | |
| - | | |
| - | | |
| 10,758,805 | | |
| 1,076 | | |
| 96,447,495 | | |
| 1,860 | | |
| (60,685,214 | ) | |
| 35,765,217 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 134,171 | | |
| - | | |
| - | | |
| 134,171 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,959,506 | ) | |
| (4,959,506 | ) |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,445 | ) | |
| - | | |
| (8,445 | ) |
Other comprehensive income (loss) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,445 | ) | |
| - | | |
| (8,445 | ) |
Balance, June 30, 2024 | |
| - | | |
$ | - | | |
| 10,758,805 | | |
$ | 1,076 | | |
$ | 96,581,666 | | |
$ | (6,585 | ) | |
$ | (65,644,720 | ) | |
$ | 30,931,437 | |
Balance | |
| - | | |
$ | - | | |
| 10,758,805 | | |
$ | 1,076 | | |
$ | 96,581,666 | | |
$ | (6,585 | ) | |
$ | (65,644,720 | ) | |
$ | 30,931,437 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows (Unaudited)
| |
2024 | | |
2023 | |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (10,400,316 | ) | |
$ | (8,614,163 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 8,319 | | |
| 6,929 | |
Non-cash lease adjustments | |
| 83,092 | | |
| 80,272 | |
Stock-based compensation | |
| 268,228 | | |
| 725,920 | |
Accretion of discounts on available for sale debt securities, net | |
| (93,166 | ) | |
| (86,578 | ) |
Foreign currency remeasurement loss | |
| 50,778 | | |
| 50,633 | |
Realized (gain) loss on redemptions of available for sale debt securities | |
| (7,088 | ) | |
| 60,909 | |
Unrealized loss (gain) on equity securities | |
| 1,799 | | |
| (12,050 | ) |
Changes in assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (12,932 | ) | |
| 415,114 | |
Accounts payable and accrued expenses | |
| 1,931,888 | | |
| 111,774 | |
Operating lease liabilities | |
| (83,617 | ) | |
| (79,867 | ) |
Other assets | |
| (6,146 | ) | |
| (7,980 | ) |
Net cash flows used in operating activities | |
| (8,259,161 | ) | |
| (7,349,087 | ) |
| |
| | | |
| | |
INVESTING ACTIVITIES | |
| | | |
| | |
Purchase of property and equipment | |
| (6,484 | ) | |
| (8,876 | ) |
Redemptions of marketable securities | |
| 13,608,333 | | |
| 4,500,000 | |
Net cash flows used in investing activities | |
| (758,231 | ) | |
| (1,418,120 | ) |
| |
| | | |
| | |
FINANCING ACTIVITIES | |
| | | |
| | |
Proceeds from warrant exercises | |
| 54,716 | | |
| - | |
Net cash flows provided by financing activities | |
| 54,716 | | |
| - | |
| |
| | | |
| | |
Effect of foreign exchange rates on cash | |
| 1,492 | | |
| (11,409 | ) |
| |
| | | |
| | |
CHANGE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH FOR THE PERIOD | |
| (8,961,184 | ) | |
| (8,778,616 | ) |
| |
| | | |
| | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | |
| 21,937,749 | | |
| 37,742,966 | |
| |
| | | |
| | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | |
$ | 12,976,565 | | |
$ | 28,964,350 | |
| |
| | | |
| | |
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 12,976,565 | | |
$ | 28,423,170 | |
Restricted cash | |
| - | | |
| 541,180 | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |
$ | 12,976,565 | | |
$ | 28,964,350 | |
| |
| | | |
| | |
Non-cash investing and financing activities | |
| | | |
| | |
Operating lease right-of-use asset acquired through operating lease liability | |
$ | 198,405 | | |
$ | 141,989 | |
Remeasurement of operating lease right-of-use asset and operating lease liability | |
| - | | |
| 198,847 | |
Unrealized gain on available-for-sale debt securities | |
| 70,429 | | |
| 84,536 | |
Removal of operating lease right-of-use assets and related operating lease liabilities upon early termination of leases | |
| 130,563 | | |
| - | |
See
accompanying Notes to Condensed Consolidated Financial Statements
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note
1. Organization, Principal Activities, and Basis of Presentation
Lantern
Pharma Inc., and Subsidiaries (the “Company”) is a clinical stage biopharmaceutical company, focused on leveraging artificial
intelligence (“A.I.”), machine learning and biomarker data to streamline the drug development process and to identify the
patients that will benefit from its targeted oncology therapies. The Company’s portfolio of therapies consists of small molecule
drug candidates that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that it
is developing with the assistance of its A.I. platform and its biomarker driven approach. The Company’s A.I. platform, known as
RADR®, uses big data analytics (combining molecular data, drug efficacy data, data from historical studies, data from
scientific literature, phenotypic data from trials and publications, and mechanistic pathway data) and machine learning. The Company’s
data-driven, genomically-targeted and biomarker-driven approach allows it to pursue a transformational drug development strategy that
identifies, rescues or develops, and advances potential small molecule drug candidates.
Lantern
Pharma Inc. was incorporated under the laws of the state of Texas on November 7, 2013, and thereafter reincorporated in the state of
Delaware on January 15, 2020. The Company’s principal operations are located in Texas. The Company formed a wholly owned subsidiary,
Lantern Pharma Limited, in the United Kingdom in July 2017 and a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia
in September 2021. In January 2023, the Company formed a wholly owned subsidiary, Starlight Therapeutics Inc. (“Starlight”),
to continue with advancing the development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications.
Since
inception, the Company has devoted substantially all its activity to advancing research and development, including efforts in connection
with preclinical studies, clinical trials and development of its RADR® platform. This now includes three lead drug candidates
and an Antibody Drug Conjugate (ADC) program directed towards 11 disclosed therapeutic targets:
|
● |
LP-300
(Tavocept), which we are advancing in a Phase 2 clinical trial, the Harmonic™ trial, focused on never smokers with
advanced non-small cell lung cancer; |
|
|
|
|
● |
LP-184,
which we are advancing in a Phase 1 clinical trial and has potential for treatment of solid tumors including pancreatic, breast,
bladder, and lung cancers, and glioblastoma and other CNS cancers. Following the formation of Starlight, the Company may now also
refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”; |
|
|
|
|
● |
LP-284,
the stereoisomer (enantiomer) of LP-184, is advancing in a Phase 1 clinical trial, and has shown promising in-vitro and in
vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184; and |
|
|
|
|
● |
Our
ADC program is focused on developing highly specific ADCs with highly potent drug payloads. |
The
Company’s fiscal year ends on December 31 of each calendar year. The accompanying interim condensed consolidated financial statements
are unaudited and have been prepared on substantially the same basis as the Company’s annual consolidated financial statements
for the fiscal year ended December 31, 2023. In the opinion of the Company’s management, these interim condensed consolidated financial
statements reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the
Company’s financial position, results of operations and cash flows for the periods presented. The preparation of financial statements
in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
periods. Actual results could differ from these estimates.
The
December 31, 2023 year-end condensed consolidated balance sheet data in the accompanying interim condensed consolidated financial statements
was derived from audited consolidated financial statements. These condensed consolidated financial statements and notes do not include
all disclosures required by U.S. generally accepted accounting principles and should be read in conjunction with the Company’s
audited consolidated financial statements as of and for the year ended December 31, 2023 and the notes thereto included in the Company’s
Annual Report on Form 10-K, dated March 18, 2024, on file with the Securities and Exchange Commission.
The
results of operations and cash flows for the interim periods included in these condensed consolidated financial statements are not necessarily
indicative of the results to be expected for any future period or the entire fiscal year.
Any
reference in these notes to applicable guidance refers to Accounting Standards Codification (“ASC”) and Accounting Standards
Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). To date, the Company has operated its business
as one segment. The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries, Lantern Pharma Limited, Lantern Pharma Australia Pty Ltd. and Starlight Therapeutics Inc. All intercompany balances and
transactions have been eliminated in consolidation.
Note
2. Liquidity
The
Company incurred a net loss of approximately $10,400,000 and $8,614,000 during the six months ended June 30, 2024 and 2023, respectively.
As of June 30, 2024, the Company had working capital of approximately $30,691,000. The Company plans to continue to explore periodic
capital raises and also plans to apply for grant funding in the future to assist in supporting its capital needs. We may also explore
the possibility of entering into commercial credit facilities as an additional source of liquidity. We believe that our existing cash,
cash equivalents, and marketable securities as of June 30, 2024, and our anticipated expenditures and capital commitments, will enable
us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date this quarterly report is
filed.
Note
3. Summary of Significant Accounting Policies
Use
of Estimates and Assumptions
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research
and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining
present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.
Risks
and Uncertainties
The
Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations
are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including
the potential risk of business failure.
Our
marketable securities have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of
cash and cash equivalents at one or more financial institutions that are federally insured. Interest bearing and non-interest bearing
accounts we hold at these banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to
$250,000 per depositor, per FDIC-insured bank, per ownership category. Substantially all of our cash balances held at banking institutions
at June 30, 2024 are in excess of FDIC coverage.
Research
and Development
Research
and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses,
costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure
on the cloud for the purposes of developing the Company’s RADR® platform, and other costs for identifying, developing,
and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
Cash
and Cash Equivalents
The
Company considers money market funds and other highly liquid instruments with a short-term maturity of 3 months or less to be cash equivalents.
Cash equivalents at June 30, 2024 and December 31, 2023 were approximately $11,508,000 and $20,881,000, respectively, and are included
along with cash under the caption cash and cash equivalents on the Company’s condensed consolidated balance sheets.
Leases
The
Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use
(“ROU”) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities
on our condensed consolidated balance sheets. Lease ROU assets represent the Company’s right to use an underlying asset for the
lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities
are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s
leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement
date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless
it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a
straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease
term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.
Marketable
Securities
The
Company’s marketable securities consist of government and agency securities, corporate bonds, and mutual funds. We classify our
marketable debt securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance sheet
date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result,
we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying condensed
consolidated balance sheets. Available-for-sale debt securities and equity securities are recorded at fair value each reporting period.
Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and recorded as a separate component within
“Accumulated other comprehensive income” or “Accumulated other comprehensive loss” on the condensed consolidated
balance sheets and condensed consolidated statements of comprehensive loss until realized. Unrealized gains and losses on equity securities
are reported within “Other income, net” on the condensed consolidated statements of operations. Interest is reported within
“Interest income” and dividend income is reported within “Other income, net” on the condensed consolidated statements
of operations. We evaluate our investments to assess whether the amortized cost basis is in excess of estimated fair value and determine
what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in
“Other income, net” on the condensed consolidated statements of operations, and any remaining unrealized losses are included
in “Accumulated other comprehensive income (loss)” on the condensed consolidated balance sheets and condensed consolidated
statements of comprehensive loss. There were no credit losses recorded during the three and six months ended June 30, 2024 and 2023,
and there is no allowance for credit losses reported on the condensed consolidated balance sheets as of June 30, 2024 and December 31,
2023. We determine realized gains and losses on the sale of marketable securities based on the specific identification method and record
such gains and losses in “Other income, net” on the condensed consolidated statements of operations.
Recent
Accounting Pronouncements
The
Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial
position or results of operations upon adoption.
Note
4. Commitments and Contingencies
General
The
Company has entered into, and expects to enter into from time to time in the future, license agreements, strategic alliance agreements,
assignment agreements, research service agreements, and similar agreements related to the advancement of its product candidates and research
and development efforts. Significant agreements (collectively, the “License, Strategic Alliance, and Research Agreements”)
are described in detail in the Company’s 2023 Form 10-K. While specific amounts will fluctuate from quarter to quarter based on
clinical trials progress, advancement and completion of research studies and manufacturing projects, and other factors, the Company believes
its overall activities regarding License, Strategic Alliance, and Research Agreements are materially consistent with those described
in the 2023 Form 10-K, as supplemented by the discussion in the following paragraph.
As
described in the 2023 Form 10-K, the Company has previously entered into agreements with Fortrea Inc. (“Fortrea”) to provide
contract research organization (CRO) services in connection with the Company’s Phase 2 clinical trial for LP-300 and the Company’s
Phase 1 clinical trial for LP-184. In addition, the Company previously entered into a start-up work order with Fortrea regarding start-up
assistance services to be provided by Fortrea relating to the LP-284 Phase 1 trial, which start-up work order terminated in the first
quarter of 2024. In addition, in May 2024 the Company entered into an amendment to the work order with Fortrea relating to the LP-184
Phase 1 trial in order to reflect additional services to be provided by Fortrea relating to this clinical trial. The Company is currently discussing with Fortrea a potential amendment to make certain adjustments to the work order
with Fortrea relating to the LP-300 Phase 2 clinical trial. The Company expects to finalize and enter into the amendment to the LP-300
work order in the third quarter of 2024.
In
addition to the specific agreements described in the 2023 Form 10-K and the Fortrea work order amendment and potential amendment
described above, the Company has entered into, and will in the future enter into, other research and service provider agreements for
the advancement of its product candidates and research and development efforts. The Company expects to pay additional amounts in
future periods in connection with existing and future research and service provider agreements.
Set
forth below are the approximate amounts expensed for License, Strategic Alliance, and Research Agreements during the three and six months
ended June 30, 2024 and 2023, respectively. These expensed amounts are included under research and development expenses in the accompanying
condensed consolidated statements of operations.
Schedule
of Research and Development
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amount Expensed for License, Strategic Alliance, and Research Agreements | |
$ | 1,639,000 | | |
$ | 2,100,000 | | |
$ | 3,741,000 | | |
$ | 3,348,000 | |
Set
forth below at June 30, 2024 and December 31, 2023, respectively, are (1) the approximate amounts accrued and payable under License,
Strategic Alliance, and Research Agreements, and (2) the approximate amount of prepaid expenses and other current assets under License,
Strategic Alliance, and Research Agreements. These amounts are included in the accompanying condensed consolidated balance sheets.
Schedule
of Accounts Payable and Accrued Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Amount accrued and payable under License, Strategic Alliance, and Research Agreements | |
$ | 2,016,000 | | |
$ | 1,563,000 | |
| |
| | | |
| | |
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements | |
$ | 935,000 | | |
$ | 511,000 | |
Actuate
Therapeutics
In
May 2021, the Company entered into a Collaboration Agreement with Actuate Therapeutics, Inc. (“Actuate”), a clinical stage
private biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases
leading to fibrosis. Pursuant to the agreement, the Company and Actuate are collaborating on utilization of the Company’s RADR®
platform to develop novel biomarker derived signatures for use with one of Actuate’s product candidates. As part of the collaboration,
the Company received 25,000 restricted shares of Actuate stock, subject to meeting certain conditions of the collaboration, as well as
the potential to receive additional Actuate stock if results from the collaboration are utilized in future development efforts. In 2023,
the term of the Collaboration Agreement was extended to continue until March 31, 2024. We are currently in discussions with Actuate to
extend the Collaboration Agreement. Certain affiliates of Bios Partners beneficially own greater than 10% of the Company’s common
stock and also hold substantial beneficial ownership interests in Actuate. Through June 30, 2024, no revenues have been recognized under
the Collaboration Agreement.
The
restricted shares of Actuate stock had a nominal value when acquired and, therefore, were recorded at a cost of $0. These shares did
not have a readily determinable fair value at June 30, 2024, but will be adjusted for observable price changes, if any, in future periods.
There were no adjustments to the carrying amount through June 30, 2024.
Note
5. Leases
The
following provides balance sheet information related to leases as of June 30, 2024 and December 31, 2023:
Schedule
of Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 213,045 | | |
$ | 228,295 | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 164,002 | | |
$ | 172,975 | |
Operating lease liabilities, net of current portion | |
| 54,694 | | |
| 61,496 | |
Total operating lease liabilities | |
$ | 218,696 | | |
$ | 234,471 | |
At
June 30, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases
| |
| | |
2024 (remaining six months) | |
$ | 92,725 | |
2025 | |
| 140,216 | |
Total minimum lease payments | |
| 232,941 | |
Less amount representing interest | |
| 14,245 | |
Present value of future minimum lease payments | |
| 218,696 | |
Less current portion of operating lease liabilities | |
| 164,002 | |
Operating lease liabilities, net of current portion | |
$ | 54,694 | |
In
April 2021, the Company entered into two operating leases for office space that commenced in May 2021. The lease terms were set to expire
in April 2023, subject to automatic renewal on a month-to-month basis unless the Company provided three-months written notice to the
landlord prior to initial expiration. In January 2023, the Company renewed one of the operating leases for an additional two years and
notified the landlord of its intent not to renew the other lease. In January 2023, the Company also entered into two new leases that
commenced in March 2023 and May 2023, respectively, and continued through April 2025 (“Legacy West Leases”).
Effective
April 30, 2024, the Legacy West Leases were terminated in conjunction with a new lease with the same landlord. The new lease began May
1, 2024 for a period of 19 months, requires payments of approximately $11,200 per month, and is subject to automatic renewal on a month-to-month
basis unless the Company provides three-months written notice to the landlord. The exercise of lease renewal options is at the Company’s
sole discretion and is assessed as to whether to include any renewals in the lease term at inception
The
following table provides a reconciliation for our operating right-of-use assets and operating lease liabilities:
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities
| |
Operating | | |
Operating | |
| |
Right-of- Use | | |
Lease | |
| |
Assets | | |
Liabilities | |
Balance at December 31, 2023 | |
$ | 228,295 | | |
$ | 234,471 | |
Operating right-of-use asset acquired through operating lease liability | |
| 198,405 | | |
| 198,405 | |
Early termination of Legacy West Leases | |
| (130,563 | ) | |
| (130,563 | ) |
Amortizations and reductions | |
| (83,092 | ) | |
| (83,617 | ) |
Balance at June 30, 2024 | |
$ | 213,045 | | |
$ | 218,696 | |
Other
supplemental information related to operating leases is as follows:
Schedule of Other Supplemental Information Related to Operating Leases
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Weighted average remaining term of operating leases (in years) | |
| 1.31 | | |
| 1.81 | |
Weighted average discount rate of operating leases | |
| 9.03 | % | |
| 7.36 | % |
The
Company also leased office space in Dallas, Texas under month-to-month lease arrangements during the six months ended June 30, 2024 and
2023. In April 2023, the Company entered into a two-year lease for material storage and handling. The lease is cancellable with 45-days’
written notice. Under these short-term leases, the Company elected the short-term lease measurement and recognition exemption under ASC
842 and recorded rent expense as incurred.
The
components of lease expense were approximately as follows for the three and six months ended June 30, 2024 and 2023:
Schedule of Lease Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease cost | |
$ | 45,000 | | |
$ | 67,000 | | |
$ | 90,000 | | |
$ | 109,000 | |
Short-term lease cost | |
| 4,800 | | |
| 5,000 | | |
| 9,300 | | |
| 5,000 | |
Lease expense | |
$ | 49,800 | | |
$ | 72,000 | | |
$ | 99,300 | | |
$ | 114,000 | |
During
the six months ended June 30, 2024 and 2023, cash used in operating activities associated with operating leases was approximately $91,000
and $111,000, respectively.
Note
6. Stockholders’ Equity
Common
Stock
During
the three and six months ended June 30, 2023, the Company issued 12,000 shares of restricted common stock to consultants with a grant
date fair value of approximately $63,000, of which 9,500 shares vested and 2,500 shares were cancelled.
As
of June 30, 2024 and December 31, 2023, the Company had 25,000,000 authorized shares of Common Stock, of which 10,758,805 shares and
10,721,192 shares were issued and outstanding as of June 30, 2024 and December 31, 2023, respectively.
Warrants
During
the six months ended June 30, 2024, the Company issued 20,132 shares of common stock relating to the cashless exercise of 79,021 warrants
that were expiring. The Company also issued 17,481 shares of common stock for aggregate proceeds of $54,716, relating to the exercise
of warrants that were expiring during the six months ended June 30, 2024. There were no warrant exercises during the three months ended
June 30, 2024 and 2023, or during the six months ended June 30, 2023. The Company had warrants to purchase 81,496 shares of common stock
outstanding and exercisable as of June 30, 2024 at a weighted average exercise price of $16.55 per share, and with expiration dates ranging
from July 25, 2024 to June 10, 2025.
Options
The number of shares available under the Lantern Pharma Inc. 2018 Equity
Incentive Plan, as amended and restated (the “Plan”), was increased by 125,000 shares at the Company’s Annual Meeting of Stockholders on June 13, 2024. A
summary of stock option activity under the Plan during the six months ended June 30, 2024 is presented below:
Schedule
of Stock option Activity
| |
Options Outstanding | |
| |
Number of Shares | | |
Weighted- Average Exercise Price Per Share | |
Outstanding December 31, 2023 | |
| 1,091,196 | | |
$ | 6.11 | |
Granted | |
| 20,000 | | |
| 7.70 | |
Cancelled or expired | |
| (47,648 | ) | |
| 5.99 | |
Outstanding June 30, 2024 | |
| 1,063,548 | | |
$ | 6.14 | |
Options
were exercisable for 916,670 shares of common stock at June 30, 2024 at a weighted average exercise price of $6.23 per share.
Stock-based
compensation was as follows for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 56,051 | | |
$ | 237,459 | | |
$ | 112,296 | | |
$ | 445,071 | |
Research and development | |
| 78,120 | | |
| 154,931 | | |
| 155,932 | | |
| 280,849 | |
Total stock-based compensation | |
$ | 134,171 | | |
$ | 392,390 | | |
$ | 268,228 | | |
$ | 725,920 | |
Note
7. Marketable Securities
At
June 30, 2024, marketable securities consisted of the following:
Schedule
of Marketable of Securities
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
Aggregate | |
| |
Cost | | |
Gains | | |
Losses | | |
Fair Value | |
Government & Agency Securities | |
$ | 10,078,916 | | |
$ | 882 | | |
$ | (25,530 | ) | |
$ | 10,054,268 | |
Corporate Bonds | |
| 4,672,628 | | |
| 97 | | |
| (12,089 | ) | |
| 4,660,636 | |
Marketable Securities – Debt | |
| 14,751,544 | | |
| 979 | | |
| (37,619 | ) | |
| 14,714,904 | |
| |
| | | |
| | | |
| | | |
| | |
Mutual Funds – Fixed Income | |
| 4,002,704 | | |
| - | | |
| (257,254 | ) | |
| 3,745,450 | |
Mutual Funds – Alternative Investments | |
| 2,015,467 | | |
| - | | |
| (190,267 | ) | |
| 1,825,200 | |
Marketable Securities – Equity | |
| 6,018,171 | | |
| - | | |
| (447,521 | ) | |
| 5,570,650 | |
| |
$ | 20,769,715 | | |
$ | 979 | | |
$ | (485,140 | ) | |
$ | 20,285,554 | |
The
contractual maturities of the investments classified as Government & Agency Securities and Corporate Bonds are as follows:
Schedule
of Contractual Investments of Marketable Securities
| |
As of | |
| |
June 30, 2024 | |
Due within one year | |
$ | 14,714,904 | |
The
following table presents gross unrealized losses and fair values for those marketable securities that were in an unrealized loss position
as of June 30, 2024, aggregated by investment category and the length of time that individual securities have been in a continuous loss
position:
Schedule
of Gross Unrealized Losses and Fair Values for Marketable Securities
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
| |
As of June 30, 2024 | |
| |
Less than 12 months | | |
More than 12 months | |
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
Government & Agency Securities | |
$ | 4,908,989 | | |
$ | (5,411 | ) | |
$ | 1,272,182 | | |
$ | (20,119 | ) |
Corporate Bonds | |
| 2,977,500 | | |
| (3,279 | ) | |
| 1,387,409 | | |
| (8,810 | ) |
Mutual Funds – Fixed Income | |
| - | | |
| - | | |
| 3,745,450 | | |
| (257,254 | ) |
Mutual Funds – Alternative Investments | |
| - | | |
| - | | |
| 1,825,200 | | |
| (190,267 | ) |
| |
$ | 7,886,489 | | |
$ | (8,690 | ) | |
$ | 8,230,241 | | |
$ | (476,450 | ) |
We
do not believe the unrealized losses represent credit losses based on our evaluation of available evidence as of June 30, 2024, which
includes an assessment of whether it is more likely than not we will be required to sell the investment before recovery of the investment’s
amortized cost basis.
Note
8. Fair Value Measurements
We
determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous
market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions
that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the
hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes
the inputs into three levels that may be used to measure fair value:
Level
1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level
2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability,
either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level
3 - Inputs are unobservable inputs based on our assumptions.
Financial
Assets
When
available, our marketable securities are valued using quoted prices for identical instruments in active markets. If we are unable to
value our marketable securities using quoted prices for identical instruments in active markets, we value our investments using broker
reports that utilize quoted market prices for comparable instruments. As of June 30, 2024 our available-for-sale debt securities were
valued through use of quoted prices for comparable instruments in active markets and are classified as Level 2, and our money market
accounts and mutual funds were valued using quoted prices in active markets for identical assets and are classified as Level 1.
Based
on our valuation of our marketable securities, we concluded that they are classified in either Level 1 or Level 2, and we have no financial
assets measured using Level 3 inputs. The following table presents information about our assets that are measured at fair value on a
recurring basis using the above input categories.
Schedule
of Assets are Measured at Fair Value on Recurring Basis
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
Fair Value Measurements as of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Government & Agency Securities | |
$ | 10,054,268 | | |
$ | - | | |
$ | 10,054,268 | | |
$ | - | |
Corporate Bonds | |
| 4,660,636 | | |
| - | | |
| 4,660,636 | | |
| - | |
Money Markets | |
| 10,521,208 | | |
| 10,521,208 | | |
| - | | |
| - | |
Mutual Funds – Fixed Income | |
| 3,745,450 | | |
| 3,745,450 | | |
| - | | |
| - | |
Mutual Funds – Alternative Investments | |
| 1,825,200 | | |
| 1,825,200 | | |
| - | | |
| - | |
Fair value recurring
basis | |
$ | 30,806,762 | | |
$ | 16,091,858 | | |
$ | 14,714,904 | | |
$ | - | |
Note
9. Loss Per Share of Common Shares
Basic
loss per share is derived by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock
outstanding during each period (excluding unvested shares of restricted common stock). Diluted loss per share includes the effect, if
any, from the potential exercise or conversion of securities, such as warrants and stock options, which would result in the issuance
of incremental shares of common stock unless such effect is anti-dilutive. In calculating the basic and diluted net loss per share applicable
to common stockholders, the weighted average number of shares remained the same for both calculations due to the fact that when a net
loss exists, dilutive shares are not included in the calculation. Potentially dilutive securities outstanding that have been excluded
from diluted loss per share due to being anti-dilutive include the following:
Schedule
of Anti-dilutive Securities Outstanding Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
Outstanding at June 30, | |
| |
2024 | | |
2023 | |
Warrants to purchase common stock | |
| 81,496 | | |
| 177,998 | |
Unvested restricted shares of common stock | |
| - | | |
| 12,000 | |
Stock options | |
| 1,063,548 | | |
| 1,078,468 | |
Anti-dilutive securities | |
| 1,145,044 | | |
| 1,268,466 | |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read the following discussion and analysis of our financial condition and plan of operations together with our condensed consolidated
financial statements and the related notes appearing elsewhere in this Quarterly Report. In addition to historical information, this
discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may
differ materially from the plans, intentions, expectations and other forward-looking statements included in the discussion below. Factors
that could cause or contribute to such differences include, but are not limited to, those identified below, and those factors discussed
in the Risk Factors section of our 2023 Form 10-K on file with the SEC.
Overview
We
are a clinical stage biotechnology company, focused on leveraging artificial intelligence (“A.I.”), machine learning and
genomic data to streamline the drug development process and to identify the patients that will benefit from our targeted oncology therapies.
Our portfolio of therapies consists of small molecules that others have tried, but failed, to develop into an approved commercialized
drug, as well as new compounds that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach.
Our A.I. platform, known as RADR®, currently includes more than 100 billion data points, and uses big data analytics
(combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials
and publications, and mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated
to drug response, and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted
and biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops,
and advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional
cancer drug development.
We
now have active clinical programs for our three lead small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused
on multiple important cancer indications, including both solid tumors and blood cancers. We have established a wholly-owned subsidiary,
Starlight Therapeutics, to focus exclusively on the clinical development of our promising opportunities for central nervous system (“CNS”)
and brain cancers, many of which have no effective treatment options. We are also advancing an antibody-drug conjugate (“ADC”)
program focused on developing highly specific ADCs with highly potent drug-payloads.
Our
strategy is to both develop new drug candidates using our RADR® platform, and other machine learning driven methodologies,
and to pursue the development of drug candidates that have undergone previous clinical trial testing or that may have been halted in
development or deprioritized because of insufficient clinical trial efficacy (i.e., a meaningful treatment benefit relevant for the disease
or condition under study as measured against the comparator treatment used in the relevant clinical testing) or for strategic reasons
by the owner or development team responsible for the compound. Importantly, these historical drug candidates appear to have been well-tolerated
in many instances, and often have considerable data from previous toxicity, tolerability and ADME (absorption, distribution, metabolism,
and excretion) studies that have been completed. Additionally, these drug candidates may also have a body of existing data supporting
the potential mechanism(s) by which they achieve their intended biologic effect, but often require more targeted trials in a stratified
group of patients to demonstrate statistically meaningful results. Our dual approach to both develop de-novo, biomarker-guided drug candidates
and “rescue” historical drug-candidates by leveraging A.I., recent advances in genomics, computational biology and cloud
computing is emblematic of a new era in drug development that is being driven by data-intensive approaches meant to de-risk development
and accelerate the clinical trial process. In this context, we intend to create a diverse portfolio of oncology drug candidates for further
development towards regulatory and marketing approval with the objective of establishing a leading A.I.-driven methodology for treating
the right patient with the right oncology therapy.
A
key component of our strategy is to target specific cancer patient populations and treatment indications identified by leveraging our
RADR® platform, a proprietary A.I. enabled engine created and owned by us. We believe the combination of our therapeutic
area expertise, our A.I. expertise, and our ability to identify and develop promising drug candidates through our collaborative relationships
with research institutions in selected areas of oncology gives us a significant competitive advantage. Our RADR® platform
has been developed and refined over the last five years and integrates billions of data points immediately relevant for oncology drug
development and patient response prediction using artificial intelligence and proprietary machine learning algorithms. By identifying
clinical candidates, together with relevant genomic and phenotypic data, we believe our approach will help us design more efficient pre-clinical
studies, and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market.
Although we have not yet applied for or received regulatory or marketing approval for any of our drug candidates, we believe our RADR®
platform has the ability to reduce the cost and time to bring drug candidates to specifically targeted patient groups. We believe
we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that
leverages artificial intelligence along with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic
areas to address today’s treatment needs.
Our
current portfolio consists of three lead drug candidates that are in clinical phases (known as LP-300, LP-184 and LP-284) and an Antibody
Drug Conjugate (ADC) program that is in preclinical research optimization. In January 2023, we formed a wholly owned subsidiary, Starlight
Therapeutics Inc. (“Starlight”), to develop drug candidate LP-184’s central nervous system (CNS) and brain cancer indications
– including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Following the formation
of Starlight, we may also refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”. All of these
drug candidates and our ADC program are leveraging precision oncology, A.I. and genomic driven approaches to accelerate and direct development
efforts.
We
are currently conducting a targeted phase 2 trial (the Harmonic™ trial) for LP-300 in never smoking patients with advanced non-small cell lung cancer (“NSCLC”) in combination
with chemotherapy, under an existing investigational new drug application. Our candidate LP-184 has shown promising in-vitro and
in vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma and triple negative breast
cancer), and it is advancing in a Phase 1A clinical trial that commenced in mid-2023. Our candidate LP-284 has shown promising in-vitro
and in vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184.
LP-284 is advancing in a Phase 1A clinical trial that commenced in the fourth quarter of 2023.
Our
ADC program has also continued to advance. In 2023, we entered into a research collaboration with Bielefeld University in Germany focused
on development of ADCs utilizing cryptophycin as the ADC drug-payload. Cryptophycins are promising antitumor molecules that have demonstrated
potency at ultra-low, picomolar, concentrations. In a broad range of preclinical studies, the cryptophycin-ADC synthesized as part of
the Bielefeld collaboration demonstrated promising picomolar level potency and anti-tumor activity in multiple solid tumor cell lines,
including breast, bladder, colorectal, gastric, pancreatic and ovarian.
In
addition to our lead drug candidates and ADC program, we also have an additional drug candidate, LP-100, that we believe has potential
for future development in combination with the class of anticancer agents known as PARP inhibitors (PARPi). For LP-100, as well as our
lead drug candidate LP-300, we are leveraging data from prior preclinical studies and clinical trials, along with insights generated
from our A.I. platform, to target the types of tumors and patient groups we believe will be most responsive to the drug. Both LP-100
and LP-300 showed promise in important patient subgroups, but failed pivotal Phase 3 trials when the overall results did not meet the
predefined clinical endpoints. We believe that this was due to a lack of biomarker-driven patient stratification.
LP-300
has been studied in multiple randomized, controlled, multi-center non-small cell lung cancer, or NSCLC, trials that included administration
of either paclitaxel and cisplatin and/or docetaxel and cisplatin. LP-100 has previously been in a genomic signature guided phase 2 clinical
trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment
of 27) were treated in the trial. The median overall survival (OS) for the initial group of 9 patients was approximately 12.5 months,
which is an improvement over other similar fourth-line treatment regimens for mCRPC. Based on our evaluation of the synergies of LP-100
with PARP inhibitors, the decision was made in the first quarter of 2023 to close the phase 2 clinical trial in Denmark, to allow the
focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market
opportunities. LP-100 was previously out-licensed by us to Allarity Therapeutics A/S. In July 2021, we entered into an Asset Purchase
Agreement to reacquire global development and commercialization rights for LP-100 from Allarity.
Our
development strategy is to pursue an increasing number of oncology focused, molecularly targeted therapies where artificial intelligence
and genomic data can help us provide biological insights, reduce the risk associated with development efforts and help clarify potential
patient response. We plan on strategically evaluating these on a program-by-program basis as they advance into clinical development,
either to be done entirely by us, or with licensing partners, to maximize the commercial opportunity and reduce the time it takes to
bring the right drug to the right patient.
To
date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been
financed primarily by sales of our equity securities. Our net losses were approximately $10,400,000 and $8,614,000 for the six months
ended June 30, 2024 and 2023, respectively.
Our
net losses have primarily resulted from costs incurred in licensing and developing the drug candidates in our pipeline, planning, preparing
and conducting preclinical studies and clinical testing, and general and administrative activities associated with our operations. We
expect to continue to incur significant expenses and corresponding increased operating losses for the foreseeable future as we continue
to develop our pipeline. Our costs may further increase as we conduct additional preclinical studies and clinical trials and potentially
seek regulatory clearance for and prepare to commercialize our drug candidates. We expect to incur significant expenses to continue to
build the infrastructure necessary to support our expanded operations, preclinical studies, clinical trials, and commercialization, including
manufacturing, marketing, sales and distribution functions. We have experienced and will continue to experience substantial costs associated
with operating as a public company.
Components
of Our Results of Operations
Revenues
We
did not recognize revenues for the three and six-month periods ended June 30, 2024 and 2023.
Expenses
Our
research and development expenses by project category for the three and six months ended June 30, 2024 are as follows:
| |
Three Months | | |
Six Months | |
| |
Ended June 30, 2024 | | |
Ended June 30, 2024 | |
LP-300 | |
$ | 1,011,392 | | |
$ | 2,063,296 | |
LP-184 | |
| 1,770,227 | | |
| 4,002,829 | |
LP-284 | |
| 545,618 | | |
| 1,008,040 | |
LP-100 | |
| 17,105 | | |
| 30,400 | |
ADC Program | |
| 44,058 | | |
| 78,422 | |
RADR® Platform | |
| 310,864 | | |
| 587,790 | |
Other | |
| 189,473 | | |
| 368,746 | |
Total research and development expenses | |
$ | 3,888,737 | | |
$ | 8,139,523 | |
We
expect that our research and development expenses will continue to increase as we progress our clinical trials for LP-300, LP-184, and
LP-284, and advance our other drug candidates and programs. We expect this increase to include additional expenses associated with research
and service provider agreements for the advancement of our drug candidates and research and development efforts.
Because
of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion
costs of these or other current or future clinical trials of LP-300, LP-184, LP-284 or our other drug candidates. We may never succeed
in achieving regulatory approval for LP-300, LP-184, LP-284, LP-100, or any of our other drug candidates. The duration, costs and timing
of clinical trials and development of our drug candidates will depend on a variety of factors, including the uncertainties of future
clinical and preclinical studies, uncertainties in clinical trial enrollment rates and significant and changing government regulation.
In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing
capability and commercial viability.
General
and Administrative
General
and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, corporate
development and administrative support functions, including stock-based compensation expenses and benefits. Other significant general
and administrative expenses include accounting and legal services, insurance, the cost of various consultants, occupancy costs, investor
relations and information systems costs.
We
expect increased administrative costs resulting from our existing and anticipated clinical trials and the potential commercialization
of our drug candidates. We believe that these increases will likely include increased costs for hiring additional administrative personnel
to support future market research and future product commercialization efforts and increased fees for outside consultants and other administrative
service providers.
Summary
Results of Operations for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 1,519,724 | | |
$ | 1,632,080 | | |
$ | 3,000,939 | | |
$ | 3,365,401 | |
Research and development | |
| 3,888,737 | | |
| 3,558,217 | | |
| 8,139,523 | | |
| 6,111,164 | |
Total operating expenses | |
| 5,408,461 | | |
| 5,190,297 | | |
| 11,140,462 | | |
| 9,476,565 | |
Loss from operations | |
| (5,408,461 | ) | |
| (5,190,297 | ) | |
| (11,140,462 | ) | |
| (9,476,565 | ) |
Interest income | |
| 188,660 | | |
| 117,823 | | |
| 389,610 | | |
| 251,605 | |
Other income, net | |
| 260,295 | | |
| 326,076 | | |
| 350,536 | | |
| 610,797 | |
NET LOSS | |
$ | (4,959,506 | ) | |
$ | (4,746,398 | ) | |
$ | (10,400,316 | ) | |
$ | (8,614,163 | ) |
Comparison
of the Three Months Ended June 30, 2024 and 2023
General
and Administrative Expenses
General
and administrative expenses decreased approximately $112,000, or 7%, from approximately $1,632,000 for the three months ended June
30, 2023 to approximately $1,520,000 for the three months ended June 30, 2024. The decrease was primarily attributable to decreases
in payroll and compensation expenses of approximately $139,000, decreases in insurance expenses of approximately $97,000, decreases
in business development expenses of approximately $27,000, and decreases in office and administrative fees of approximately $22,000.
This was partially offset by increases in other professional fees of approximately $106,000 and increases in patent and legal fees
of approximately $69,000. General and administrative expenses for the three months ended June 30, 2024 and 2023 included
administrative expenses relating to our wholly-owned subsidiaries, including Starlight Therapeutics Inc., which was formed in
January 2023.
Research
and Development Expenses
Research
and development expenses increased approximately $331,000, or 9%, from approximately $3,558,000 for the three months ended June 30, 2023
to approximately $3,889,000 for the three months ended June 30, 2024. The increase was attributable to increases in research studies
of approximately $724,000, increases in consulting expenses of approximately $187,000 and increases in payroll and compensation expenses
of approximately $122,000. This was partially offset by decreases in manufacturing expenses of approximately $702,000.
Interest
and Other Income, Net
Interest
income increased approximately $71,000, or 60%, from approximately $118,000 for the three months ended June 30, 2023 to approximately
$189,000 for the three months ended June 30, 2024. Other income, net decreased approximately $66,000 from a gain of approximately $326,000
for the three months ended June 30, 2023 to a gain of approximately $260,000 for the three months ended June 30, 2024. This decrease
was primarily attributable to decreases of approximately $187,000 in research and development tax incentives related to our Australia
subsidiary, offset in part by increases in unrealized gains on investments of approximately $55,000 and reductions in foreign currency
losses of approximately $61,000.
Comparison
of the Six Months Ended June 30, 2024 and 2023
General
and Administrative Expenses
General
and administrative expenses decreased approximately $364,000, or 11%, from approximately $3,365,000 for the six months ended June 30,
2023 to approximately $3,001,000 for the six months ended June 30, 2024. The decrease was primarily attributable to decreases in payroll
and compensation expenses of approximately $269,000, decreases in corporate insurance expense of approximately $218,000 and decreases
in office and administrative expenses of approximately $88,000. This was partially offset by increases in patent and legal expenses of
approximately $117,000, increases in other professional fees of approximately $35,000, increases in travel expenses of approximately
$32,000, and increases in business development expenses of approximately $30,000. General and administrative expenses for the six months
ended June 30, 2024 and 2023 included administrative expenses relating to our wholly-owned subsidiaries, including Starlight Therapeutics
Inc., which was formed in January 2023.
Research
and Development Expenses
Research
and development expenses increased approximately $2,028,000, or 33%, from approximately $6,111,000 for the six months ended June 30,
2023 to approximately $8,140,000 for the six months ended June 30, 2024. The increase was primarily attributable to increases in research
studies of approximately $2,268,000, increases in payroll and compensation expenses of approximately $411,000 and increases in consulting
expenses of approximately $256,000. This was partially offset by decreases in manufacturing expenses of approximately $906,000.
Interest
and Other Income, Net
Interest
income increased approximately $138,000 from approximately $252,000 for the six months ended June 30, 2023 to approximately $390,000
for the six months ended June 30, 2024. Other income, net decreased approximately $260,000 from a gain of approximately $611,000 for
the six months ended June 30, 2023 to a gain of approximately $351,000 for the six months ended June 30, 2024. This decrease was primarily
attributable to decreases of approximately $399,000 in research and development tax incentives related to our Australia subsidiary, which
were partially offset by increases in dividend income of approximately $84,000 and increases in unrealized gains on investments of approximately
$54,000.
Cash
Flows
The
following table summarizes our cash flow for the periods indicated:
| |
For the Six Months ended June 30, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | |
Net cash flows used in operating activities | |
$ | (8,259,161 | ) | |
$ | (7,349,087 | ) |
Net cash flows used in investing activities | |
| (758,231 | ) | |
| (1,418,120 | ) |
Net cash flows provided by financing activities | |
| 54,716 | | |
| - | |
Effect of foreign exchange rates on cash | |
| 1,492 | | |
| (11,409 | ) |
Net decrease in cash, cash equivalents and restricted cash | |
$ | (8,961,184 | ) | |
$ | (8,778,616 | ) |
Operating
Activities
For
the six months ended June 30, 2024, net cash used in operating activities was approximately $8,259,000 compared to approximately $7,349,000
for the six months ended June 30, 2023. The increase in net cash used in operating activities was primarily due to the increase in the
net loss for the six months ended June 30, 2024, offset in part by increases in accounts payable and accrued expenses during the six
months ended June 30, 2024, which reduced the use of cash.
Investing
Activities
For
the six months ended June 30, 2024, net cash used in investing activities was approximately $758,000 compared to $1,418,000 of net cash
used in investing activities for the six months ended June 30, 2023. The decrease in cash used in investing activities is primarily related
to a reduced level of net investments in marketable securities during the six months ended June 30, 2024, as compared to the six months
ended June 30, 2023.
Financing
Activities
Net
cash provided by financing activities was approximately $55,000 during the six months ended June 30, 2024, which is attributable to proceeds
from warrant exercises. No cash was provided by or used in financing activities during the six months ended June 30, 2023.
Operating
Capital and Capital Expenditure Requirements
As
of June 30, 2024, we had total assets of approximately $35.6 million and working capital of approximately $30.7 million. As of June 30,
2024, our liquidity included approximately $33.3 million of cash, cash equivalents and marketable securities. We believe that our existing
cash, cash equivalents, and marketable securities as of June 30, 2024, and our anticipated expenditures and capital commitments, will
enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date this quarterly report
is filed. We expect to continue to incur significant and increasing operating losses at least for the next several years as we continue
our clinical trials for LP-300, LP-184 and LP-284, advance our other drug candidates and programs, and seek potential future marketing
approval for our drug candidates, which could be several years in the future, if at all. We do not expect to generate revenue, other
than possible license and grant revenue, unless and until we successfully complete development and obtain regulatory approval for our
therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing
of our existing and planned clinical trials and our expenditures on other research and development activities.
We
have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our
available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development
and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. We
anticipate that our expenses will increase substantially as we:
|
● |
continue
the development, including preclinical studies and clinical trials, of our drug candidates; |
|
|
|
|
● |
initiate
preclinical studies and clinical trials for any additional indications for our current drug candidates and any future drug candidates
that we may pursue; |
|
|
|
|
● |
continue
to build our portfolio of drug candidates through the acquisition or in-license of additional drug candidates or technologies; |
|
|
|
|
● |
continue
to develop, maintain, expand and protect our intellectual property portfolio; |
|
|
|
|
● |
pursue
regulatory approvals for those of our current and future drug candidates that successfully complete clinical trials; |
|
|
|
|
● |
ultimately
establish a sales, marketing, distribution and other commercial infrastructure to commercialize any drug candidate for which we may
obtain marketing approval; |
|
|
|
|
● |
hire
additional clinical, regulatory, scientific and accounting personnel; |
|
|
|
|
● |
incur
additional legal, accounting and other expenses in operating as a public company; and |
|
|
|
|
● |
continue
to develop, maintain, and expand our RADR® platform. |
We
expect that we will need to obtain substantial additional funding in order to complete our clinical trials. To the extent that we raise
additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interests of our
existing stockholders may be materially diluted and the terms of these securities could include liquidation or other preferences that
could adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased
fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions,
such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct
our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to significantly delay, scale
back or discontinue the development or commercialization of LP-300, LP-184, LP-284, and/or our other drug candidates and programs, seek
collaborators at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available,
and relinquish or license, potentially on unfavorable terms, our rights to LP-300, LP-184, LP-284, and/or other drug candidates and programs
that we otherwise would seek to develop or commercialize ourselves.
Critical
Accounting Estimates
There
have been no changes to our critical accounting estimates during the six months ended June 30, 2024.
Quantitative
and Qualitative Disclosure About Market Risk
Our
primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.
Fixed rate securities may have their market value adversely affected due to a rise in interest rates. Accordingly, our future investment
income may fluctuate as a result of changes in interest rates, or we may suffer losses in principal if we are forced to sell securities
that decline in market value as a result of changes in interest rates.
Historically,
we have raised capital through the issuance of equity securities. We had no long-term debt outstanding as of June 30, 2024 and December
31, 2023.
We
do not believe that our cash and cash equivalents have significant risk of default or illiquidity. Our cash and cash equivalents consist
primarily of cash and money market funds. Our exposure to market risk relating to cash and cash equivalents due to changes in interest
rates is limited because our cash and cash equivalents have a short-term maturity and are used primarily for working capital purposes.
Our marketable securities have had and may in the future have their market value adversely affected due to rises in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of
cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits. Interest bearing and
non-interest bearing accounts we hold at banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”)
up to $250,000. Substantially all of our cash balances held at banking institutions are in excess of FDIC coverage. We consider this
to be a normal business risk.
We
formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency losses
of approximately $51,000 for each of the six months ended June 30, 2024 and 2023 in connection with this subsidiary. We will remain subject
to the risk of foreign currency losses in future periods, although we do not expect the impact of any foreign currency losses to be material.
We do not participate in any foreign currency hedging activities, and we do not have any other derivative financial instruments.
Inflation
generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect
on our results of operations during the periods presented. Inflation has increased substantially in recent periods and could have a greater
impact on our future results of operations if it remains at current levels or increases further.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As
a Smaller Reporting Company we are exempt from the requirements of Item 3.
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 (our principal executive officer and principal
financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2024. The term
“disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934,
as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported,
within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based
on the evaluation of our disclosure controls and procedures as of June 30, 2024, our Chief Executive Officer and Chief Financial Officer
have concluded that, as of such date, our disclosure controls and procedures, as defined above, are effective.
Changes
in Internal Control Over Financial Reporting.
There
were no changes in our internal control over financial reporting that occurred during the three months ended June 30, 2024 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent
Limitations on Effectiveness of Controls.
Our
management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or
our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design
of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative
to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments
in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any
system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART
II – OTHER INFORMATION
Item
1A. Risk Factors.
As
a Smaller Reporting Company we are exempted from the requirements of Item 1A.
Item
6. Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
Lantern
Pharma Inc., |
|
|
|
A
Delaware Corporation |
|
|
|
Dated:
August 8, 2024 |
By:
|
/s/
Panna Sharma |
|
|
Panna
Sharma, Chief Executive Officer |
|
|
|
Dated:
August 8, 2024 |
By: |
/s/
David R. Margrave |
|
|
David
R. Margrave, Chief Financial Officer |
EXHIBIT
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES
EXCHANGE
ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Panna Sharma, certify that:
| 1. | I
have reviewed this Quarterly Report on Form 10-Q of Lantern Pharma Inc. |
| 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 registrant as of, and for, the periods presented in this report; |
| 4. | The
registrant’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 registrant 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
registrant, 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 registrant’s disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed
in this report any change in the registrant’s internal control over financial reporting
that occurred during the registrant’s most recent fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial
reporting; and |
| 5. | The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’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 registrant’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 registrant’s internal control over financial reporting. |
Date:
August 8, 2024 |
|
|
|
/s/
Panna Sharma |
|
Chief
Executive Officer (Principal Executive Officer) |
|
EXHIBIT
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES
EXCHANGE
ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
David R. Margrave, certify that:
| 1. | I
have reviewed this Quarterly Report on Form 10-Q of Lantern Pharma Inc. |
| 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 registrant as of, and for, the periods presented in this report; |
| 4. | The
registrant’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 registrant 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
registrant, 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 registrant’s disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed
in this report any change in the registrant’s internal control over financial reporting
that occurred during the registrant’s most recent fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial
reporting; and |
| 5. | The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’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 registrant’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 registrant’s internal control over financial reporting. |
Date:
August 8, 2024 |
|
|
|
/s/
David R. Margrave |
|
Chief
Financial Officer (Principal Financial Officer) |
|
EXHIBIT
32.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
18
U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Lantern Pharma
Inc. (the “Company”) hereby certifies, to his knowledge, that:
| (1) | the
accompanying Quarterly Report on Form 10-Q of the Company for the fiscal quarter ended June
30, 2024 (the “Report”) fully complies with the requirements of Section 13(a)
or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and |
| (2) | the
information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company. |
Date:
August 8, 2024 |
|
|
|
/s/
Panna Sharma |
|
Chief
Executive Officer (Principal Executive Officer) |
|
EXHIBIT 32.2
CERTIFICATION OF PRINCIPAL
FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY
ACT OF 2002
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002, the undersigned officer of Lantern Pharma Inc. (the “Company”) hereby certifies, to his
knowledge, that:
| (1) | the accompanying Quarterly Report on Form 10-Q of the Company for the fiscal quarter ended June 30, 2024 (the “Report”)
fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended;
and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date: August 8, 2024 |
|
|
|
/s/ David R. Margrave |
|
Chief Financial Officer (Principal Financial Officer) |
|
v3.24.2.u1
Cover - $ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 05, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-39318
|
|
Entity Registrant Name |
Lantern
Pharma Inc.
|
|
Entity Central Index Key |
0001763950
|
|
Entity Tax Identification Number |
46-3973463
|
|
Entity Incorporation, State or Country Code |
DE
|
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Entity Address, Address Line One |
1920
McKinney Avenue
|
|
Entity Address, Address Line Two |
7th Floor
|
|
Entity Address, City or Town |
Dallas
|
|
Entity Address, State or Province |
TX
|
|
Entity Address, Postal Zip Code |
75201
|
|
City Area Code |
(972)
|
|
Local Phone Number |
277-1136
|
|
Title of 12(b) Security |
Common
Stock, $0.0001 par value
|
|
Trading Symbol |
LTRN
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
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Yes
|
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Entity Filer Category |
Non-accelerated Filer
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|
Entity Small Business |
true
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true
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Elected Not To Use the Extended Transition Period |
true
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Entity Shell Company |
false
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|
10,764,725
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
CURRENT ASSETS |
|
|
Cash and cash equivalents |
$ 12,976,565
|
$ 21,937,749
|
Marketable securities |
20,285,554
|
19,364,923
|
Prepaid expenses & other current assets |
2,029,458
|
2,038,653
|
Total current assets |
35,291,577
|
43,341,325
|
Property and equipment, net |
50,292
|
52,127
|
Operating lease right-of-use assets |
213,045
|
228,295
|
Other assets |
32,015
|
25,869
|
TOTAL ASSETS |
35,586,929
|
43,647,616
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued expenses |
4,436,796
|
2,505,211
|
Operating lease liabilities, current |
164,002
|
172,975
|
Total current liabilities |
4,600,798
|
2,678,186
|
Operating lease liabilities, net of current portion |
54,694
|
61,496
|
TOTAL LIABILITIES |
4,655,492
|
2,739,682
|
COMMITMENTS AND CONTINGENCIES (NOTE 4) |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred Stock (1,000,000 authorized at June 30, 2024 and December 31, 2023; $.0001 par value) (Zero shares issued and outstanding at June 30, 2024 and December 31, 2023) |
|
|
Common Stock (25,000,000 authorized at June 30, 2024 and December 31, 2023; $.0001 par value) (10,758,805 shares and 10,721,192 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively) |
1,076
|
1,072
|
Additional paid-in capital |
96,581,666
|
96,258,726
|
Accumulated other comprehensive loss |
(6,585)
|
(107,460)
|
Accumulated deficit |
(65,644,720)
|
(55,244,404)
|
Total stockholders’ equity |
30,931,437
|
40,907,934
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 35,586,929
|
$ 43,647,616
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, shares authorized |
1,000,000
|
1,000,000
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, shares authorized |
25,000,000
|
25,000,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares issued |
10,758,805
|
10,721,192
|
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10,758,805
|
10,721,192
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating expenses: |
|
|
|
|
General and administrative |
$ 1,519,724
|
$ 1,632,080
|
$ 3,000,939
|
$ 3,365,401
|
Research and development |
3,888,737
|
3,558,217
|
8,139,523
|
6,111,164
|
Total operating expenses |
5,408,461
|
5,190,297
|
11,140,462
|
9,476,565
|
Loss from operations |
(5,408,461)
|
(5,190,297)
|
(11,140,462)
|
(9,476,565)
|
Interest income |
188,660
|
117,823
|
389,610
|
251,605
|
Other income, net |
260,295
|
326,076
|
350,536
|
610,797
|
NET LOSS |
$ (4,959,506)
|
$ (4,746,398)
|
$ (10,400,316)
|
$ (8,614,163)
|
Net loss per share of common shares, basic |
$ (0.46)
|
$ (0.44)
|
$ (0.97)
|
$ (0.79)
|
Net loss per share of common shares, diluted |
$ (0.46)
|
$ (0.44)
|
$ (0.97)
|
$ (0.79)
|
Weighted-average number of common shares outstanding, basic |
10,758,805
|
10,857,040
|
10,750,801
|
10,857,040
|
Weighted-average number of common shares outstanding, diluted |
10,758,805
|
10,857,040
|
10,750,801
|
10,857,040
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.2.u1
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
NET LOSS |
$ (4,959,506)
|
$ (4,746,398)
|
$ (10,400,316)
|
$ (8,614,163)
|
Other comprehensive (loss) income |
|
|
|
|
Unrealized gain on available-for-sale securities |
26,483
|
33,763
|
70,429
|
84,536
|
Unrealized (loss) gain on foreign currency translation |
(34,928)
|
4,077
|
30,446
|
25,013
|
Other comprehensive (loss) income |
(8,445)
|
37,840
|
100,875
|
109,549
|
Comprehensive loss |
$ (4,967,951)
|
$ (4,708,558)
|
$ (10,299,441)
|
$ (8,504,614)
|
X |
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v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
|
$ 1,086
|
$ 95,691,194
|
$ (371,386)
|
$ (39,282,870)
|
$ 56,038,024
|
Balance, shares at Dec. 31, 2022 |
|
10,857,040
|
|
|
|
|
Stock-based compensation |
|
|
333,530
|
|
|
333,530
|
Net loss |
|
|
|
|
(3,867,765)
|
(3,867,765)
|
Other comprehensive income (loss) |
|
|
|
71,709
|
|
71,709
|
Balance at Mar. 31, 2023 |
|
$ 1,086
|
96,024,724
|
(299,677)
|
(43,150,635)
|
52,575,498
|
Balance, shares at Mar. 31, 2023 |
|
10,857,040
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 1,086
|
95,691,194
|
(371,386)
|
(39,282,870)
|
56,038,024
|
Balance, shares at Dec. 31, 2022 |
|
10,857,040
|
|
|
|
|
Net loss |
|
|
|
|
|
(8,614,163)
|
Other comprehensive income (loss) |
|
|
|
|
|
$ 109,549
|
Issuance of restricted common stock awards, shares |
|
|
|
|
|
12,000
|
Balance at Jun. 30, 2023 |
|
$ 1,087
|
96,417,113
|
(261,837)
|
(47,897,033)
|
$ 48,259,330
|
Balance, shares at Jun. 30, 2023 |
|
10,869,040
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 1,086
|
96,024,724
|
(299,677)
|
(43,150,635)
|
52,575,498
|
Balance, shares at Mar. 31, 2023 |
|
10,857,040
|
|
|
|
|
Stock-based compensation |
|
|
392,390
|
|
|
392,390
|
Net loss |
|
|
|
|
(4,746,398)
|
(4,746,398)
|
Other comprehensive income (loss) |
|
|
|
37,840
|
|
37,840
|
Issuance of restricted common stock awards |
|
$ 1
|
(1)
|
|
|
|
Issuance of restricted common stock awards, shares |
|
12,000
|
|
|
|
|
Balance at Jun. 30, 2023 |
|
$ 1,087
|
96,417,113
|
(261,837)
|
(47,897,033)
|
48,259,330
|
Balance, shares at Jun. 30, 2023 |
|
10,869,040
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 1,072
|
96,258,726
|
(107,460)
|
(55,244,404)
|
40,907,934
|
Balance, shares at Dec. 31, 2023 |
|
10,721,192
|
|
|
|
|
Stock-based compensation |
|
|
134,057
|
|
|
134,057
|
Net loss |
|
|
|
|
(5,440,810)
|
(5,440,810)
|
Other comprehensive income (loss) |
|
|
|
109,320
|
|
109,320
|
Common stock issued from warrant exercises |
|
$ 4
|
54,712
|
|
|
54,716
|
Common stock issued from warrant exercise, shares |
|
37,613
|
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 1,076
|
96,447,495
|
1,860
|
(60,685,214)
|
35,765,217
|
Balance, shares at Mar. 31, 2024 |
|
10,758,805
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 1,072
|
96,258,726
|
(107,460)
|
(55,244,404)
|
40,907,934
|
Balance, shares at Dec. 31, 2023 |
|
10,721,192
|
|
|
|
|
Net loss |
|
|
|
|
|
(10,400,316)
|
Other comprehensive income (loss) |
|
|
|
|
|
100,875
|
Balance at Jun. 30, 2024 |
|
$ 1,076
|
96,581,666
|
(6,585)
|
(65,644,720)
|
30,931,437
|
Balance, shares at Jun. 30, 2024 |
|
10,758,805
|
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 1,076
|
96,447,495
|
1,860
|
(60,685,214)
|
35,765,217
|
Balance, shares at Mar. 31, 2024 |
|
10,758,805
|
|
|
|
|
Stock-based compensation |
|
|
134,171
|
|
|
134,171
|
Net loss |
|
|
|
|
(4,959,506)
|
(4,959,506)
|
Other comprehensive income (loss) |
|
|
|
(8,445)
|
|
(8,445)
|
Balance at Jun. 30, 2024 |
|
$ 1,076
|
$ 96,581,666
|
$ (6,585)
|
$ (65,644,720)
|
$ 30,931,437
|
Balance, shares at Jun. 30, 2024 |
|
10,758,805
|
|
|
|
|
X |
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net loss |
$ (10,400,316)
|
$ (8,614,163)
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
Depreciation and amortization |
8,319
|
6,929
|
Non-cash lease adjustments |
83,092
|
80,272
|
Stock-based compensation |
268,228
|
725,920
|
Accretion of discounts on available for sale debt securities, net |
(93,166)
|
(86,578)
|
Foreign currency remeasurement loss |
50,778
|
50,633
|
Realized (gain) loss on redemptions of available for sale debt securities |
(7,088)
|
60,909
|
Unrealized loss (gain) on equity securities |
1,799
|
(12,050)
|
Changes in assets and liabilities: |
|
|
Prepaid expenses and other current assets |
(12,932)
|
415,114
|
Accounts payable and accrued expenses |
1,931,888
|
111,774
|
Operating lease liabilities |
(83,617)
|
(79,867)
|
Other assets |
(6,146)
|
(7,980)
|
Net cash flows used in operating activities |
(8,259,161)
|
(7,349,087)
|
INVESTING ACTIVITIES |
|
|
Purchase of property and equipment |
(6,484)
|
(8,876)
|
Purchases of marketable securities |
(14,360,080)
|
(5,909,244)
|
Redemptions of marketable securities |
13,608,333
|
4,500,000
|
Net cash flows used in investing activities |
(758,231)
|
(1,418,120)
|
FINANCING ACTIVITIES |
|
|
Proceeds from warrant exercises |
54,716
|
|
Net cash flows provided by financing activities |
54,716
|
|
Effect of foreign exchange rates on cash |
1,492
|
(11,409)
|
CHANGE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH FOR THE PERIOD |
(8,961,184)
|
(8,778,616)
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD |
21,937,749
|
37,742,966
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
12,976,565
|
28,964,350
|
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: |
|
|
Cash and cash equivalents |
12,976,565
|
28,423,170
|
Restricted cash |
|
541,180
|
Non-cash investing and financing activities |
|
|
Operating lease right-of-use asset acquired through operating lease liability |
198,405
|
141,989
|
Remeasurement of operating lease right-of-use asset and operating lease liability |
|
198,847
|
Unrealized gain on available-for-sale debt securities |
70,429
|
84,536
|
Removal of operating lease right-of-use assets and related operating lease liabilities upon early termination of leases |
$ 130,563
|
|
X |
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v3.24.2.u1
Organization, Principal Activities, and Basis of Presentation
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization, Principal Activities, and Basis of Presentation |
Note
1. Organization, Principal Activities, and Basis of Presentation
Lantern
Pharma Inc., and Subsidiaries (the “Company”) is a clinical stage biopharmaceutical company, focused on leveraging artificial
intelligence (“A.I.”), machine learning and biomarker data to streamline the drug development process and to identify the
patients that will benefit from its targeted oncology therapies. The Company’s portfolio of therapies consists of small molecule
drug candidates that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that it
is developing with the assistance of its A.I. platform and its biomarker driven approach. The Company’s A.I. platform, known as
RADR®, uses big data analytics (combining molecular data, drug efficacy data, data from historical studies, data from
scientific literature, phenotypic data from trials and publications, and mechanistic pathway data) and machine learning. The Company’s
data-driven, genomically-targeted and biomarker-driven approach allows it to pursue a transformational drug development strategy that
identifies, rescues or develops, and advances potential small molecule drug candidates.
Lantern
Pharma Inc. was incorporated under the laws of the state of Texas on November 7, 2013, and thereafter reincorporated in the state of
Delaware on January 15, 2020. The Company’s principal operations are located in Texas. The Company formed a wholly owned subsidiary,
Lantern Pharma Limited, in the United Kingdom in July 2017 and a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia
in September 2021. In January 2023, the Company formed a wholly owned subsidiary, Starlight Therapeutics Inc. (“Starlight”),
to continue with advancing the development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications.
Since
inception, the Company has devoted substantially all its activity to advancing research and development, including efforts in connection
with preclinical studies, clinical trials and development of its RADR® platform. This now includes three lead drug candidates
and an Antibody Drug Conjugate (ADC) program directed towards 11 disclosed therapeutic targets:
|
● |
LP-300
(Tavocept), which we are advancing in a Phase 2 clinical trial, the Harmonic™ trial, focused on never smokers with
advanced non-small cell lung cancer; |
|
|
|
|
● |
LP-184,
which we are advancing in a Phase 1 clinical trial and has potential for treatment of solid tumors including pancreatic, breast,
bladder, and lung cancers, and glioblastoma and other CNS cancers. Following the formation of Starlight, the Company may now also
refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”; |
|
|
|
|
● |
LP-284,
the stereoisomer (enantiomer) of LP-184, is advancing in a Phase 1 clinical trial, and has shown promising in-vitro and in
vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184; and |
|
|
|
|
● |
Our
ADC program is focused on developing highly specific ADCs with highly potent drug payloads. |
The
Company’s fiscal year ends on December 31 of each calendar year. The accompanying interim condensed consolidated financial statements
are unaudited and have been prepared on substantially the same basis as the Company’s annual consolidated financial statements
for the fiscal year ended December 31, 2023. In the opinion of the Company’s management, these interim condensed consolidated financial
statements reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the
Company’s financial position, results of operations and cash flows for the periods presented. The preparation of financial statements
in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
periods. Actual results could differ from these estimates.
The
December 31, 2023 year-end condensed consolidated balance sheet data in the accompanying interim condensed consolidated financial statements
was derived from audited consolidated financial statements. These condensed consolidated financial statements and notes do not include
all disclosures required by U.S. generally accepted accounting principles and should be read in conjunction with the Company’s
audited consolidated financial statements as of and for the year ended December 31, 2023 and the notes thereto included in the Company’s
Annual Report on Form 10-K, dated March 18, 2024, on file with the Securities and Exchange Commission.
The
results of operations and cash flows for the interim periods included in these condensed consolidated financial statements are not necessarily
indicative of the results to be expected for any future period or the entire fiscal year.
Any
reference in these notes to applicable guidance refers to Accounting Standards Codification (“ASC”) and Accounting Standards
Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). To date, the Company has operated its business
as one segment. The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries, Lantern Pharma Limited, Lantern Pharma Australia Pty Ltd. and Starlight Therapeutics Inc. All intercompany balances and
transactions have been eliminated in consolidation.
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v3.24.2.u1
Liquidity
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity |
Note
2. Liquidity
The
Company incurred a net loss of approximately $10,400,000 and $8,614,000 during the six months ended June 30, 2024 and 2023, respectively.
As of June 30, 2024, the Company had working capital of approximately $30,691,000. The Company plans to continue to explore periodic
capital raises and also plans to apply for grant funding in the future to assist in supporting its capital needs. We may also explore
the possibility of entering into commercial credit facilities as an additional source of liquidity. We believe that our existing cash,
cash equivalents, and marketable securities as of June 30, 2024, and our anticipated expenditures and capital commitments, will enable
us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date this quarterly report is
filed.
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
3. Summary of Significant Accounting Policies
Use
of Estimates and Assumptions
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research
and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining
present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.
Risks
and Uncertainties
The
Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations
are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including
the potential risk of business failure.
Our
marketable securities have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of
cash and cash equivalents at one or more financial institutions that are federally insured. Interest bearing and non-interest bearing
accounts we hold at these banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to
$250,000 per depositor, per FDIC-insured bank, per ownership category. Substantially all of our cash balances held at banking institutions
at June 30, 2024 are in excess of FDIC coverage.
Research
and Development
Research
and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses,
costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure
on the cloud for the purposes of developing the Company’s RADR® platform, and other costs for identifying, developing,
and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
Cash
and Cash Equivalents
The
Company considers money market funds and other highly liquid instruments with a short-term maturity of 3 months or less to be cash equivalents.
Cash equivalents at June 30, 2024 and December 31, 2023 were approximately $11,508,000 and $20,881,000, respectively, and are included
along with cash under the caption cash and cash equivalents on the Company’s condensed consolidated balance sheets.
Leases
The
Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use
(“ROU”) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities
on our condensed consolidated balance sheets. Lease ROU assets represent the Company’s right to use an underlying asset for the
lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities
are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s
leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement
date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless
it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a
straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease
term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.
Marketable
Securities
The
Company’s marketable securities consist of government and agency securities, corporate bonds, and mutual funds. We classify our
marketable debt securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance sheet
date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result,
we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying condensed
consolidated balance sheets. Available-for-sale debt securities and equity securities are recorded at fair value each reporting period.
Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and recorded as a separate component within
“Accumulated other comprehensive income” or “Accumulated other comprehensive loss” on the condensed consolidated
balance sheets and condensed consolidated statements of comprehensive loss until realized. Unrealized gains and losses on equity securities
are reported within “Other income, net” on the condensed consolidated statements of operations. Interest is reported within
“Interest income” and dividend income is reported within “Other income, net” on the condensed consolidated statements
of operations. We evaluate our investments to assess whether the amortized cost basis is in excess of estimated fair value and determine
what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in
“Other income, net” on the condensed consolidated statements of operations, and any remaining unrealized losses are included
in “Accumulated other comprehensive income (loss)” on the condensed consolidated balance sheets and condensed consolidated
statements of comprehensive loss. There were no credit losses recorded during the three and six months ended June 30, 2024 and 2023,
and there is no allowance for credit losses reported on the condensed consolidated balance sheets as of June 30, 2024 and December 31,
2023. We determine realized gains and losses on the sale of marketable securities based on the specific identification method and record
such gains and losses in “Other income, net” on the condensed consolidated statements of operations.
Recent
Accounting Pronouncements
The
Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial
position or results of operations upon adoption.
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note
4. Commitments and Contingencies
General
The
Company has entered into, and expects to enter into from time to time in the future, license agreements, strategic alliance agreements,
assignment agreements, research service agreements, and similar agreements related to the advancement of its product candidates and research
and development efforts. Significant agreements (collectively, the “License, Strategic Alliance, and Research Agreements”)
are described in detail in the Company’s 2023 Form 10-K. While specific amounts will fluctuate from quarter to quarter based on
clinical trials progress, advancement and completion of research studies and manufacturing projects, and other factors, the Company believes
its overall activities regarding License, Strategic Alliance, and Research Agreements are materially consistent with those described
in the 2023 Form 10-K, as supplemented by the discussion in the following paragraph.
As
described in the 2023 Form 10-K, the Company has previously entered into agreements with Fortrea Inc. (“Fortrea”) to provide
contract research organization (CRO) services in connection with the Company’s Phase 2 clinical trial for LP-300 and the Company’s
Phase 1 clinical trial for LP-184. In addition, the Company previously entered into a start-up work order with Fortrea regarding start-up
assistance services to be provided by Fortrea relating to the LP-284 Phase 1 trial, which start-up work order terminated in the first
quarter of 2024. In addition, in May 2024 the Company entered into an amendment to the work order with Fortrea relating to the LP-184
Phase 1 trial in order to reflect additional services to be provided by Fortrea relating to this clinical trial. The Company is currently discussing with Fortrea a potential amendment to make certain adjustments to the work order
with Fortrea relating to the LP-300 Phase 2 clinical trial. The Company expects to finalize and enter into the amendment to the LP-300
work order in the third quarter of 2024.
In
addition to the specific agreements described in the 2023 Form 10-K and the Fortrea work order amendment and potential amendment
described above, the Company has entered into, and will in the future enter into, other research and service provider agreements for
the advancement of its product candidates and research and development efforts. The Company expects to pay additional amounts in
future periods in connection with existing and future research and service provider agreements.
Set
forth below are the approximate amounts expensed for License, Strategic Alliance, and Research Agreements during the three and six months
ended June 30, 2024 and 2023, respectively. These expensed amounts are included under research and development expenses in the accompanying
condensed consolidated statements of operations.
Schedule
of Research and Development
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amount Expensed for License, Strategic Alliance, and Research Agreements | |
$ | 1,639,000 | | |
$ | 2,100,000 | | |
$ | 3,741,000 | | |
$ | 3,348,000 | |
Set
forth below at June 30, 2024 and December 31, 2023, respectively, are (1) the approximate amounts accrued and payable under License,
Strategic Alliance, and Research Agreements, and (2) the approximate amount of prepaid expenses and other current assets under License,
Strategic Alliance, and Research Agreements. These amounts are included in the accompanying condensed consolidated balance sheets.
Schedule
of Accounts Payable and Accrued Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Amount accrued and payable under License, Strategic Alliance, and Research Agreements | |
$ | 2,016,000 | | |
$ | 1,563,000 | |
| |
| | | |
| | |
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements | |
$ | 935,000 | | |
$ | 511,000 | |
Actuate
Therapeutics
In
May 2021, the Company entered into a Collaboration Agreement with Actuate Therapeutics, Inc. (“Actuate”), a clinical stage
private biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases
leading to fibrosis. Pursuant to the agreement, the Company and Actuate are collaborating on utilization of the Company’s RADR®
platform to develop novel biomarker derived signatures for use with one of Actuate’s product candidates. As part of the collaboration,
the Company received 25,000 restricted shares of Actuate stock, subject to meeting certain conditions of the collaboration, as well as
the potential to receive additional Actuate stock if results from the collaboration are utilized in future development efforts. In 2023,
the term of the Collaboration Agreement was extended to continue until March 31, 2024. We are currently in discussions with Actuate to
extend the Collaboration Agreement. Certain affiliates of Bios Partners beneficially own greater than 10% of the Company’s common
stock and also hold substantial beneficial ownership interests in Actuate. Through June 30, 2024, no revenues have been recognized under
the Collaboration Agreement.
The
restricted shares of Actuate stock had a nominal value when acquired and, therefore, were recorded at a cost of $0. These shares did
not have a readily determinable fair value at June 30, 2024, but will be adjusted for observable price changes, if any, in future periods.
There were no adjustments to the carrying amount through June 30, 2024.
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v3.24.2.u1
Leases
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
Leases |
Note
5. Leases
The
following provides balance sheet information related to leases as of June 30, 2024 and December 31, 2023:
Schedule
of Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 213,045 | | |
$ | 228,295 | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 164,002 | | |
$ | 172,975 | |
Operating lease liabilities, net of current portion | |
| 54,694 | | |
| 61,496 | |
Total operating lease liabilities | |
$ | 218,696 | | |
$ | 234,471 | |
At
June 30, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases
| |
| | |
2024 (remaining six months) | |
$ | 92,725 | |
2025 | |
| 140,216 | |
Total minimum lease payments | |
| 232,941 | |
Less amount representing interest | |
| 14,245 | |
Present value of future minimum lease payments | |
| 218,696 | |
Less current portion of operating lease liabilities | |
| 164,002 | |
Operating lease liabilities, net of current portion | |
$ | 54,694 | |
In
April 2021, the Company entered into two operating leases for office space that commenced in May 2021. The lease terms were set to expire
in April 2023, subject to automatic renewal on a month-to-month basis unless the Company provided three-months written notice to the
landlord prior to initial expiration. In January 2023, the Company renewed one of the operating leases for an additional two years and
notified the landlord of its intent not to renew the other lease. In January 2023, the Company also entered into two new leases that
commenced in March 2023 and May 2023, respectively, and continued through April 2025 (“Legacy West Leases”).
Effective
April 30, 2024, the Legacy West Leases were terminated in conjunction with a new lease with the same landlord. The new lease began May
1, 2024 for a period of 19 months, requires payments of approximately $11,200 per month, and is subject to automatic renewal on a month-to-month
basis unless the Company provides three-months written notice to the landlord. The exercise of lease renewal options is at the Company’s
sole discretion and is assessed as to whether to include any renewals in the lease term at inception
The
following table provides a reconciliation for our operating right-of-use assets and operating lease liabilities:
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities
| |
Operating | | |
Operating | |
| |
Right-of- Use | | |
Lease | |
| |
Assets | | |
Liabilities | |
Balance at December 31, 2023 | |
$ | 228,295 | | |
$ | 234,471 | |
Operating right-of-use asset acquired through operating lease liability | |
| 198,405 | | |
| 198,405 | |
Early termination of Legacy West Leases | |
| (130,563 | ) | |
| (130,563 | ) |
Amortizations and reductions | |
| (83,092 | ) | |
| (83,617 | ) |
Balance at June 30, 2024 | |
$ | 213,045 | | |
$ | 218,696 | |
Other
supplemental information related to operating leases is as follows:
Schedule of Other Supplemental Information Related to Operating Leases
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Weighted average remaining term of operating leases (in years) | |
| 1.31 | | |
| 1.81 | |
Weighted average discount rate of operating leases | |
| 9.03 | % | |
| 7.36 | % |
The
Company also leased office space in Dallas, Texas under month-to-month lease arrangements during the six months ended June 30, 2024 and
2023. In April 2023, the Company entered into a two-year lease for material storage and handling. The lease is cancellable with 45-days’
written notice. Under these short-term leases, the Company elected the short-term lease measurement and recognition exemption under ASC
842 and recorded rent expense as incurred.
The
components of lease expense were approximately as follows for the three and six months ended June 30, 2024 and 2023:
Schedule of Lease Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease cost | |
$ | 45,000 | | |
$ | 67,000 | | |
$ | 90,000 | | |
$ | 109,000 | |
Short-term lease cost | |
| 4,800 | | |
| 5,000 | | |
| 9,300 | | |
| 5,000 | |
Lease expense | |
$ | 49,800 | | |
$ | 72,000 | | |
$ | 99,300 | | |
$ | 114,000 | |
During
the six months ended June 30, 2024 and 2023, cash used in operating activities associated with operating leases was approximately $91,000
and $111,000, respectively.
|
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v3.24.2.u1
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
6. Stockholders’ Equity
Common
Stock
During
the three and six months ended June 30, 2023, the Company issued 12,000 shares of restricted common stock to consultants with a grant
date fair value of approximately $63,000, of which 9,500 shares vested and 2,500 shares were cancelled.
As
of June 30, 2024 and December 31, 2023, the Company had 25,000,000 authorized shares of Common Stock, of which 10,758,805 shares and
10,721,192 shares were issued and outstanding as of June 30, 2024 and December 31, 2023, respectively.
Warrants
During
the six months ended June 30, 2024, the Company issued 20,132 shares of common stock relating to the cashless exercise of 79,021 warrants
that were expiring. The Company also issued 17,481 shares of common stock for aggregate proceeds of $54,716, relating to the exercise
of warrants that were expiring during the six months ended June 30, 2024. There were no warrant exercises during the three months ended
June 30, 2024 and 2023, or during the six months ended June 30, 2023. The Company had warrants to purchase 81,496 shares of common stock
outstanding and exercisable as of June 30, 2024 at a weighted average exercise price of $16.55 per share, and with expiration dates ranging
from July 25, 2024 to June 10, 2025.
Options
The number of shares available under the Lantern Pharma Inc. 2018 Equity
Incentive Plan, as amended and restated (the “Plan”), was increased by 125,000 shares at the Company’s Annual Meeting of Stockholders on June 13, 2024. A
summary of stock option activity under the Plan during the six months ended June 30, 2024 is presented below:
Schedule
of Stock option Activity
| |
Options Outstanding | |
| |
Number of Shares | | |
Weighted- Average Exercise Price Per Share | |
Outstanding December 31, 2023 | |
| 1,091,196 | | |
$ | 6.11 | |
Granted | |
| 20,000 | | |
| 7.70 | |
Cancelled or expired | |
| (47,648 | ) | |
| 5.99 | |
Outstanding June 30, 2024 | |
| 1,063,548 | | |
$ | 6.14 | |
Options
were exercisable for 916,670 shares of common stock at June 30, 2024 at a weighted average exercise price of $6.23 per share.
Stock-based
compensation was as follows for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 56,051 | | |
$ | 237,459 | | |
$ | 112,296 | | |
$ | 445,071 | |
Research and development | |
| 78,120 | | |
| 154,931 | | |
| 155,932 | | |
| 280,849 | |
Total stock-based compensation | |
$ | 134,171 | | |
$ | 392,390 | | |
$ | 268,228 | | |
$ | 725,920 | |
|
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v3.24.2.u1
Marketable Securities
|
6 Months Ended |
Jun. 30, 2024 |
Cash and Cash Equivalents [Abstract] |
|
Marketable Securities |
Note
7. Marketable Securities
At
June 30, 2024, marketable securities consisted of the following:
Schedule
of Marketable of Securities
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
Aggregate | |
| |
Cost | | |
Gains | | |
Losses | | |
Fair Value | |
Government & Agency Securities | |
$ | 10,078,916 | | |
$ | 882 | | |
$ | (25,530 | ) | |
$ | 10,054,268 | |
Corporate Bonds | |
| 4,672,628 | | |
| 97 | | |
| (12,089 | ) | |
| 4,660,636 | |
Marketable Securities – Debt | |
| 14,751,544 | | |
| 979 | | |
| (37,619 | ) | |
| 14,714,904 | |
| |
| | | |
| | | |
| | | |
| | |
Mutual Funds – Fixed Income | |
| 4,002,704 | | |
| - | | |
| (257,254 | ) | |
| 3,745,450 | |
Mutual Funds – Alternative Investments | |
| 2,015,467 | | |
| - | | |
| (190,267 | ) | |
| 1,825,200 | |
Marketable Securities – Equity | |
| 6,018,171 | | |
| - | | |
| (447,521 | ) | |
| 5,570,650 | |
| |
$ | 20,769,715 | | |
$ | 979 | | |
$ | (485,140 | ) | |
$ | 20,285,554 | |
The
contractual maturities of the investments classified as Government & Agency Securities and Corporate Bonds are as follows:
Schedule
of Contractual Investments of Marketable Securities
| |
As of | |
| |
June 30, 2024 | |
Due within one year | |
$ | 14,714,904 | |
The
following table presents gross unrealized losses and fair values for those marketable securities that were in an unrealized loss position
as of June 30, 2024, aggregated by investment category and the length of time that individual securities have been in a continuous loss
position:
Schedule
of Gross Unrealized Losses and Fair Values for Marketable Securities
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
| |
As of June 30, 2024 | |
| |
Less than 12 months | | |
More than 12 months | |
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
Government & Agency Securities | |
$ | 4,908,989 | | |
$ | (5,411 | ) | |
$ | 1,272,182 | | |
$ | (20,119 | ) |
Corporate Bonds | |
| 2,977,500 | | |
| (3,279 | ) | |
| 1,387,409 | | |
| (8,810 | ) |
Mutual Funds – Fixed Income | |
| - | | |
| - | | |
| 3,745,450 | | |
| (257,254 | ) |
Mutual Funds – Alternative Investments | |
| - | | |
| - | | |
| 1,825,200 | | |
| (190,267 | ) |
| |
$ | 7,886,489 | | |
$ | (8,690 | ) | |
$ | 8,230,241 | | |
$ | (476,450 | ) |
We
do not believe the unrealized losses represent credit losses based on our evaluation of available evidence as of June 30, 2024, which
includes an assessment of whether it is more likely than not we will be required to sell the investment before recovery of the investment’s
amortized cost basis.
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v3.24.2.u1
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
Note
8. Fair Value Measurements
We
determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous
market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions
that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the
hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes
the inputs into three levels that may be used to measure fair value:
Level
1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level
2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability,
either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level
3 - Inputs are unobservable inputs based on our assumptions.
Financial
Assets
When
available, our marketable securities are valued using quoted prices for identical instruments in active markets. If we are unable to
value our marketable securities using quoted prices for identical instruments in active markets, we value our investments using broker
reports that utilize quoted market prices for comparable instruments. As of June 30, 2024 our available-for-sale debt securities were
valued through use of quoted prices for comparable instruments in active markets and are classified as Level 2, and our money market
accounts and mutual funds were valued using quoted prices in active markets for identical assets and are classified as Level 1.
Based
on our valuation of our marketable securities, we concluded that they are classified in either Level 1 or Level 2, and we have no financial
assets measured using Level 3 inputs. The following table presents information about our assets that are measured at fair value on a
recurring basis using the above input categories.
Schedule
of Assets are Measured at Fair Value on Recurring Basis
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
Fair Value Measurements as of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Government & Agency Securities | |
$ | 10,054,268 | | |
$ | - | | |
$ | 10,054,268 | | |
$ | - | |
Corporate Bonds | |
| 4,660,636 | | |
| - | | |
| 4,660,636 | | |
| - | |
Money Markets | |
| 10,521,208 | | |
| 10,521,208 | | |
| - | | |
| - | |
Mutual Funds – Fixed Income | |
| 3,745,450 | | |
| 3,745,450 | | |
| - | | |
| - | |
Mutual Funds – Alternative Investments | |
| 1,825,200 | | |
| 1,825,200 | | |
| - | | |
| - | |
Fair value recurring
basis | |
$ | 30,806,762 | | |
$ | 16,091,858 | | |
$ | 14,714,904 | | |
$ | - | |
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v3.24.2.u1
Loss Per Share of Common Shares
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Loss Per Share of Common Shares |
Note
9. Loss Per Share of Common Shares
Basic
loss per share is derived by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock
outstanding during each period (excluding unvested shares of restricted common stock). Diluted loss per share includes the effect, if
any, from the potential exercise or conversion of securities, such as warrants and stock options, which would result in the issuance
of incremental shares of common stock unless such effect is anti-dilutive. In calculating the basic and diluted net loss per share applicable
to common stockholders, the weighted average number of shares remained the same for both calculations due to the fact that when a net
loss exists, dilutive shares are not included in the calculation. Potentially dilutive securities outstanding that have been excluded
from diluted loss per share due to being anti-dilutive include the following:
Schedule
of Anti-dilutive Securities Outstanding Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
Outstanding at June 30, | |
| |
2024 | | |
2023 | |
Warrants to purchase common stock | |
| 81,496 | | |
| 177,998 | |
Unvested restricted shares of common stock | |
| - | | |
| 12,000 | |
Stock options | |
| 1,063,548 | | |
| 1,078,468 | |
Anti-dilutive securities | |
| 1,145,044 | | |
| 1,268,466 | |
|
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Use of Estimates and Assumptions |
Use
of Estimates and Assumptions
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research
and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining
present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.
|
Risks and Uncertainties |
Risks
and Uncertainties
The
Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations
are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including
the potential risk of business failure.
Our
marketable securities have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of
cash and cash equivalents at one or more financial institutions that are federally insured. Interest bearing and non-interest bearing
accounts we hold at these banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to
$250,000 per depositor, per FDIC-insured bank, per ownership category. Substantially all of our cash balances held at banking institutions
at June 30, 2024 are in excess of FDIC coverage.
|
Research and Development |
Research
and Development
Research
and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses,
costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure
on the cloud for the purposes of developing the Company’s RADR® platform, and other costs for identifying, developing,
and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers money market funds and other highly liquid instruments with a short-term maturity of 3 months or less to be cash equivalents.
Cash equivalents at June 30, 2024 and December 31, 2023 were approximately $11,508,000 and $20,881,000, respectively, and are included
along with cash under the caption cash and cash equivalents on the Company’s condensed consolidated balance sheets.
|
Leases |
Leases
The
Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use
(“ROU”) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities
on our condensed consolidated balance sheets. Lease ROU assets represent the Company’s right to use an underlying asset for the
lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities
are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s
leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement
date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless
it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a
straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease
term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.
|
Marketable Securities |
Marketable
Securities
The
Company’s marketable securities consist of government and agency securities, corporate bonds, and mutual funds. We classify our
marketable debt securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance sheet
date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result,
we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying condensed
consolidated balance sheets. Available-for-sale debt securities and equity securities are recorded at fair value each reporting period.
Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and recorded as a separate component within
“Accumulated other comprehensive income” or “Accumulated other comprehensive loss” on the condensed consolidated
balance sheets and condensed consolidated statements of comprehensive loss until realized. Unrealized gains and losses on equity securities
are reported within “Other income, net” on the condensed consolidated statements of operations. Interest is reported within
“Interest income” and dividend income is reported within “Other income, net” on the condensed consolidated statements
of operations. We evaluate our investments to assess whether the amortized cost basis is in excess of estimated fair value and determine
what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in
“Other income, net” on the condensed consolidated statements of operations, and any remaining unrealized losses are included
in “Accumulated other comprehensive income (loss)” on the condensed consolidated balance sheets and condensed consolidated
statements of comprehensive loss. There were no credit losses recorded during the three and six months ended June 30, 2024 and 2023,
and there is no allowance for credit losses reported on the condensed consolidated balance sheets as of June 30, 2024 and December 31,
2023. We determine realized gains and losses on the sale of marketable securities based on the specific identification method and record
such gains and losses in “Other income, net” on the condensed consolidated statements of operations.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
The
Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial
position or results of operations upon adoption.
|
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v3.24.2.u1
Commitments and Contingencies (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Research and Development |
Schedule
of Research and Development
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amount Expensed for License, Strategic Alliance, and Research Agreements | |
$ | 1,639,000 | | |
$ | 2,100,000 | | |
$ | 3,741,000 | | |
$ | 3,348,000 | |
|
Schedule of Accounts Payable and Accrued Liabilities |
Schedule
of Accounts Payable and Accrued Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Amount accrued and payable under License, Strategic Alliance, and Research Agreements | |
$ | 2,016,000 | | |
$ | 1,563,000 | |
| |
| | | |
| | |
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements | |
$ | 935,000 | | |
$ | 511,000 | |
|
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Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
Schedule of Balance Sheet Information Related to Leases |
The
following provides balance sheet information related to leases as of June 30, 2024 and December 31, 2023:
Schedule
of Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 213,045 | | |
$ | 228,295 | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 164,002 | | |
$ | 172,975 | |
Operating lease liabilities, net of current portion | |
| 54,694 | | |
| 61,496 | |
Total operating lease liabilities | |
$ | 218,696 | | |
$ | 234,471 | |
|
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases |
At
June 30, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases
| |
| | |
2024 (remaining six months) | |
$ | 92,725 | |
2025 | |
| 140,216 | |
Total minimum lease payments | |
| 232,941 | |
Less amount representing interest | |
| 14,245 | |
Present value of future minimum lease payments | |
| 218,696 | |
Less current portion of operating lease liabilities | |
| 164,002 | |
Operating lease liabilities, net of current portion | |
$ | 54,694 | |
|
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities |
The
following table provides a reconciliation for our operating right-of-use assets and operating lease liabilities:
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities
| |
Operating | | |
Operating | |
| |
Right-of- Use | | |
Lease | |
| |
Assets | | |
Liabilities | |
Balance at December 31, 2023 | |
$ | 228,295 | | |
$ | 234,471 | |
Operating right-of-use asset acquired through operating lease liability | |
| 198,405 | | |
| 198,405 | |
Early termination of Legacy West Leases | |
| (130,563 | ) | |
| (130,563 | ) |
Amortizations and reductions | |
| (83,092 | ) | |
| (83,617 | ) |
Balance at June 30, 2024 | |
$ | 213,045 | | |
$ | 218,696 | |
|
Schedule of Other Supplemental Information Related to Operating Leases |
Other
supplemental information related to operating leases is as follows:
Schedule of Other Supplemental Information Related to Operating Leases
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Weighted average remaining term of operating leases (in years) | |
| 1.31 | | |
| 1.81 | |
Weighted average discount rate of operating leases | |
| 9.03 | % | |
| 7.36 | % |
|
Schedule of Lease Expense |
The
components of lease expense were approximately as follows for the three and six months ended June 30, 2024 and 2023:
Schedule of Lease Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease cost | |
$ | 45,000 | | |
$ | 67,000 | | |
$ | 90,000 | | |
$ | 109,000 | |
Short-term lease cost | |
| 4,800 | | |
| 5,000 | | |
| 9,300 | | |
| 5,000 | |
Lease expense | |
$ | 49,800 | | |
$ | 72,000 | | |
$ | 99,300 | | |
$ | 114,000 | |
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v3.24.2.u1
Stockholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Schedule of Stock option Activity |
The number of shares available under the Lantern Pharma Inc. 2018 Equity
Incentive Plan, as amended and restated (the “Plan”), was increased by 125,000 shares at the Company’s Annual Meeting of Stockholders on June 13, 2024. A
summary of stock option activity under the Plan during the six months ended June 30, 2024 is presented below:
Schedule
of Stock option Activity
| |
Options Outstanding | |
| |
Number of Shares | | |
Weighted- Average Exercise Price Per Share | |
Outstanding December 31, 2023 | |
| 1,091,196 | | |
$ | 6.11 | |
Granted | |
| 20,000 | | |
| 7.70 | |
Cancelled or expired | |
| (47,648 | ) | |
| 5.99 | |
Outstanding June 30, 2024 | |
| 1,063,548 | | |
$ | 6.14 | |
|
Schedule of Stock-based Compensation |
Stock-based
compensation was as follows for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 56,051 | | |
$ | 237,459 | | |
$ | 112,296 | | |
$ | 445,071 | |
Research and development | |
| 78,120 | | |
| 154,931 | | |
| 155,932 | | |
| 280,849 | |
Total stock-based compensation | |
$ | 134,171 | | |
$ | 392,390 | | |
$ | 268,228 | | |
$ | 725,920 | |
|
X |
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v3.24.2.u1
Marketable Securities (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Marketable of Securities |
At
June 30, 2024, marketable securities consisted of the following:
Schedule
of Marketable of Securities
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
Aggregate | |
| |
Cost | | |
Gains | | |
Losses | | |
Fair Value | |
Government & Agency Securities | |
$ | 10,078,916 | | |
$ | 882 | | |
$ | (25,530 | ) | |
$ | 10,054,268 | |
Corporate Bonds | |
| 4,672,628 | | |
| 97 | | |
| (12,089 | ) | |
| 4,660,636 | |
Marketable Securities – Debt | |
| 14,751,544 | | |
| 979 | | |
| (37,619 | ) | |
| 14,714,904 | |
| |
| | | |
| | | |
| | | |
| | |
Mutual Funds – Fixed Income | |
| 4,002,704 | | |
| - | | |
| (257,254 | ) | |
| 3,745,450 | |
Mutual Funds – Alternative Investments | |
| 2,015,467 | | |
| - | | |
| (190,267 | ) | |
| 1,825,200 | |
Marketable Securities – Equity | |
| 6,018,171 | | |
| - | | |
| (447,521 | ) | |
| 5,570,650 | |
| |
$ | 20,769,715 | | |
$ | 979 | | |
$ | (485,140 | ) | |
$ | 20,285,554 | |
|
Schedule of Contractual Investments of Marketable Securities |
The
contractual maturities of the investments classified as Government & Agency Securities and Corporate Bonds are as follows:
Schedule
of Contractual Investments of Marketable Securities
| |
As of | |
| |
June 30, 2024 | |
Due within one year | |
$ | 14,714,904 | |
|
Schedule of Gross Unrealized Losses and Fair Values for Marketable Securities |
The
following table presents gross unrealized losses and fair values for those marketable securities that were in an unrealized loss position
as of June 30, 2024, aggregated by investment category and the length of time that individual securities have been in a continuous loss
position:
Schedule
of Gross Unrealized Losses and Fair Values for Marketable Securities
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
| |
As of June 30, 2024 | |
| |
Less than 12 months | | |
More than 12 months | |
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
Government & Agency Securities | |
$ | 4,908,989 | | |
$ | (5,411 | ) | |
$ | 1,272,182 | | |
$ | (20,119 | ) |
Corporate Bonds | |
| 2,977,500 | | |
| (3,279 | ) | |
| 1,387,409 | | |
| (8,810 | ) |
Mutual Funds – Fixed Income | |
| - | | |
| - | | |
| 3,745,450 | | |
| (257,254 | ) |
Mutual Funds – Alternative Investments | |
| - | | |
| - | | |
| 1,825,200 | | |
| (190,267 | ) |
| |
$ | 7,886,489 | | |
$ | (8,690 | ) | |
$ | 8,230,241 | | |
$ | (476,450 | ) |
|
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v3.24.2.u1
Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Schedule of Assets are Measured at Fair Value on Recurring Basis |
Schedule
of Assets are Measured at Fair Value on Recurring Basis
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
Fair Value Measurements as of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Government & Agency Securities | |
$ | 10,054,268 | | |
$ | - | | |
$ | 10,054,268 | | |
$ | - | |
Corporate Bonds | |
| 4,660,636 | | |
| - | | |
| 4,660,636 | | |
| - | |
Money Markets | |
| 10,521,208 | | |
| 10,521,208 | | |
| - | | |
| - | |
Mutual Funds – Fixed Income | |
| 3,745,450 | | |
| 3,745,450 | | |
| - | | |
| - | |
Mutual Funds – Alternative Investments | |
| 1,825,200 | | |
| 1,825,200 | | |
| - | | |
| - | |
Fair value recurring
basis | |
$ | 30,806,762 | | |
$ | 16,091,858 | | |
$ | 14,714,904 | | |
$ | - | |
|
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Loss Per Share of Common Shares (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Anti-dilutive Securities Outstanding Diluted Loss Per Share |
Schedule
of Anti-dilutive Securities Outstanding Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
Outstanding at June 30, | |
| |
2024 | | |
2023 | |
Warrants to purchase common stock | |
| 81,496 | | |
| 177,998 | |
Unvested restricted shares of common stock | |
| - | | |
| 12,000 | |
Stock options | |
| 1,063,548 | | |
| 1,078,468 | |
Anti-dilutive securities | |
| 1,145,044 | | |
| 1,268,466 | |
|
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v3.24.2.u1
Liquidity (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
|
Net loss |
$ 4,959,506
|
$ 5,440,810
|
$ 4,746,398
|
$ 3,867,765
|
$ 10,400,316
|
$ 8,614,163
|
Working capital |
$ 30,691,000
|
|
|
|
$ 30,691,000
|
|
X |
- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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Schedule of Research and Development (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
License Strategic Alliance and Research Agreements [Member] | Research and Development Expense [Member] |
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
Amount Expensed for License, Strategic Alliance, and Research Agreements |
$ 1,639,000
|
$ 2,100,000
|
$ 3,741,000
|
$ 3,348,000
|
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v3.24.2.u1
Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements |
$ 2,029,458
|
$ 2,038,653
|
License Strategic Alliance and Research Agreements [Member] |
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Amount accrued and payable under License, Strategic Alliance, and Research Agreements |
2,016,000
|
1,563,000
|
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements |
$ 935,000
|
$ 511,000
|
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- DefinitionAmount of liabilities incurred and payable to vendors for goods and services received, and accrued liabilities classified as other.
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v3.24.2.u1
Schedule of Balance Sheet Information Related to Leases (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases [Abstract] |
|
|
Operating lease, right-of-use asset, net |
$ 213,045
|
$ 228,295
|
Current portion of operating lease liabilities |
164,002
|
172,975
|
Operating lease liabilities, net of current portion |
54,694
|
61,496
|
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$ 218,696
|
$ 234,471
|
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v3.24.2.u1
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases [Abstract] |
|
|
2024 (remaining six months) |
$ 92,725
|
|
2025 |
140,216
|
|
Total minimum lease payments |
232,941
|
|
Less amount representing interest |
14,245
|
|
Present value of future minimum lease payments |
218,696
|
$ 234,471
|
Less current portion of operating lease liabilities |
164,002
|
172,975
|
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$ 54,694
|
$ 61,496
|
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v3.24.2.u1
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities (Details)
|
6 Months Ended |
Jun. 30, 2024
USD ($)
|
Leases [Abstract] |
|
Operating Right-of-Use Assets, Beginning Balance |
$ 228,295
|
Operating Lease Liabilities, Beginning Balance |
234,471
|
Operating Right-of-Use Assets, Operating right-of-use asset acquired through operating lease liability |
198,405
|
Operating Lease Liabilities, Operating right-of-use asset acquired through operating lease liability |
198,405
|
Operating Right-of-Use Assets, Early termination of Legacy West Leases |
(130,563)
|
Operating Right-of-Use Assets, Early termination of Legacy West Leases |
(130,563)
|
Operating Right-of-Use Assets, Amortizations and reductions |
(83,092)
|
Operating Lease Liabilities, Amortizations and reductions |
(83,617)
|
Operating Right-of-Use Assets, Ending Balance |
213,045
|
Operating Lease Liabilities, Ending Balance |
$ 218,696
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Leases [Abstract] |
|
|
|
|
Operating lease cost |
$ 45,000
|
$ 67,000
|
$ 90,000
|
$ 109,000
|
Short-term lease cost |
4,800
|
5,000
|
9,300
|
5,000
|
Lease expense |
$ 49,800
|
$ 72,000
|
$ 99,300
|
$ 114,000
|
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v3.24.2.u1
Schedule of Stock option Activity (Details) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
Jun. 13, 2024 |
Mar. 31, 2024 |
Jun. 30, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares issued |
|
$ 54,716
|
|
Number of options outstanding, balance |
|
1,091,196
|
1,091,196
|
Weighted average exercise price per share, outstanding balance |
|
$ 6.11
|
$ 6.11
|
Number of shares, granted |
|
|
20,000
|
Weighted average exercise price per share, granted |
|
|
$ 7.70
|
Number of shares, cancelled or expired |
|
|
(47,648)
|
Weighted average exercise price per share, cancelled or expired |
|
|
$ 5.99
|
Number of options outstanding, balance |
|
|
1,063,548
|
Weighted average exercise price per share, outstanding balance |
|
|
$ 6.14
|
2018 Incentive Plan [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares issued |
$ 125,000
|
|
|
X |
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v3.24.2.u1
Schedule of Stock-based Compensation (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Total stock-based compensation |
$ 134,171
|
$ 392,390
|
$ 268,228
|
$ 725,920
|
General and Administrative Expense [Member] |
|
|
|
|
Total stock-based compensation |
56,051
|
237,459
|
112,296
|
445,071
|
Research and Development Expense [Member] |
|
|
|
|
Total stock-based compensation |
$ 78,120
|
$ 154,931
|
$ 155,932
|
$ 280,849
|
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of restricted shares |
|
|
|
12,000
|
|
Fair value of restricted shares |
|
|
|
$ 63,000
|
|
Restricted stock vested, shares |
|
|
|
9,500
|
|
Restricted stock forfeited |
|
|
|
2,500
|
|
Common stock, shares authorized |
25,000,000
|
|
25,000,000
|
|
25,000,000
|
Common stock, shares issued |
10,758,805
|
|
10,758,805
|
|
10,721,192
|
Common stock, shares outstanding |
10,758,805
|
|
10,758,805
|
|
10,721,192
|
Exercise of warrants |
|
|
$ 54,716
|
|
|
Weighted average exercise price |
$ 6.14
|
|
$ 6.14
|
|
$ 6.11
|
Options were exercisable |
916,670
|
|
916,670
|
|
|
Weighted average exercise price, exercisable |
$ 6.23
|
|
$ 6.23
|
|
|
Warrant [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares issued |
|
|
20,132
|
|
|
Cashless exercise of warrants |
|
|
79,021
|
|
|
Number of shares issued |
|
|
17,481
|
|
|
Exercise of warrants |
|
|
$ 54,716
|
|
|
Warrants to purchase shares of common stock |
81,496
|
|
81,496
|
|
|
Weighted average exercise price |
$ 16.55
|
|
$ 16.55
|
|
|
Warrant [Member] | Minimum [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Expiration date of warrants |
|
|
Jul. 25, 2024
|
|
|
Warrant [Member] | Maximum [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Expiration date of warrants |
|
|
Jun. 10, 2025
|
|
|
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v3.24.2.u1
Schedule of Marketable of Securities (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
$ 20,769,715
|
|
Unrealized gains |
979
|
|
Unrealized losses |
(485,140)
|
|
Aggregate fair value |
20,285,554
|
$ 19,364,923
|
US Government Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
10,078,916
|
|
Unrealized gains |
882
|
|
Unrealized losses |
(25,530)
|
|
Aggregate fair value |
10,054,268
|
|
Corporate Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
4,672,628
|
|
Unrealized gains |
97
|
|
Unrealized losses |
(12,089)
|
|
Aggregate fair value |
4,660,636
|
|
Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
14,751,544
|
|
Unrealized gains |
979
|
|
Unrealized losses |
(37,619)
|
|
Aggregate fair value |
14,714,904
|
|
Mutual Funds - Fixed Income [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
4,002,704
|
|
Unrealized gains |
|
|
Unrealized losses |
(257,254)
|
|
Aggregate fair value |
3,745,450
|
|
Mutual Funds - Alternative Investments [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
2,015,467
|
|
Unrealized gains |
|
|
Unrealized losses |
(190,267)
|
|
Aggregate fair value |
1,825,200
|
|
Equity Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized cost |
6,018,171
|
|
Unrealized gains |
|
|
Unrealized losses |
(447,521)
|
|
Aggregate fair value |
$ 5,570,650
|
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v3.24.2.u1
Schedule of Gross Unrealized Losses and Fair Values for Marketable Securities (Details)
|
Jun. 30, 2024
USD ($)
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Fair Value Less than 12 months |
$ 7,886,489
|
Unrealized Loss Less than 12 months |
(8,690)
|
Fair Value More than 12 months |
8,230,241
|
Unrealized Loss More than 12 months |
(476,450)
|
US Government Debt Securities [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Fair Value Less than 12 months |
4,908,989
|
Unrealized Loss Less than 12 months |
(5,411)
|
Fair Value More than 12 months |
1,272,182
|
Unrealized Loss More than 12 months |
(20,119)
|
Corporate Debt Securities [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Fair Value Less than 12 months |
2,977,500
|
Unrealized Loss Less than 12 months |
(3,279)
|
Fair Value More than 12 months |
1,387,409
|
Unrealized Loss More than 12 months |
(8,810)
|
Mutual Funds - Fixed Income [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Fair Value Less than 12 months |
|
Unrealized Loss Less than 12 months |
|
Fair Value More than 12 months |
3,745,450
|
Unrealized Loss More than 12 months |
(257,254)
|
Mutual Funds - Alternative Investments [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Fair Value Less than 12 months |
|
Unrealized Loss Less than 12 months |
|
Fair Value More than 12 months |
1,825,200
|
Unrealized Loss More than 12 months |
$ (190,267)
|
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v3.24.2.u1
Schedule of Assets are Measured at Fair Value on Recurring Basis (Details)
|
6 Months Ended |
Jun. 30, 2024
USD ($)
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
$ 30,806,762
|
Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
16,091,858
|
Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
14,714,904
|
Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
US Government Agencies Short-Term Debt Securities [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
10,054,268
|
US Government Agencies Short-Term Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
US Government Agencies Short-Term Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
10,054,268
|
US Government Agencies Short-Term Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Corporate Bond Securities [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
4,660,636
|
Corporate Bond Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Corporate Bond Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
4,660,636
|
Corporate Bond Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Money Market Funds [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
10,521,208
|
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
10,521,208
|
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Mutual Funds - Fixed Income [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
3,745,450
|
Mutual Funds - Fixed Income [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
3,745,450
|
Mutual Funds - Fixed Income [Member] | Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
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|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
|
Mutual Funds - Alternative Investments [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
1,825,200
|
Mutual Funds - Alternative Investments [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value recurring basis |
1,825,200
|
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|
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|
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|
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|
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|
Fair value recurring basis |
|
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v3.24.2.u1
Schedule of Anti-dilutive Securities Outstanding Diluted Loss Per Share (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
1,145,044
|
1,268,466
|
Warrants to Purchase Common Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
81,496
|
177,998
|
Unvested Restricted Shares of Common Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
|
12,000
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
1,063,548
|
1,078,468
|
X |
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