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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 September 30, 2023
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ___________ to __________
Commission
file number: 001-36199
PULMATRIX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
46-1821392 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
36
Crosby Drive, Suite 100
Bedford,
MA |
|
01730 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(781)
357-2333
Registrant’s
telephone number, including area code
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 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. (Check one):
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 ☒
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
PULM |
|
The
NASDAQ Stock Market LLC |
As
of November 6, 2023, the registrant had 3,652,285 shares of common stock outstanding.
PULMATRIX,
INC.
FORM
10-Q
FOR
THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023
TABLE
OF CONTENTS
PART
I—FINANCIAL INFORMATION
Item
1. Condensed Consolidated Financial Statements.
PULMATRIX,
INC.
Consolidated
Balance Sheets
(in
thousands, except share and per share data)
| |
September
30, 2023 | | |
December
31, 2022 | |
| |
| (unaudited) | | |
| | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 21,336 | | |
$ | 35,628 | |
Restricted cash | |
| 153 | | |
| 153 | |
Accounts receivable | |
| 841 | | |
| 1,298 | |
Prepaid expenses and other current assets | |
| 899 | | |
| 1,068 | |
Total current assets | |
| 23,229 | | |
| 38,147 | |
Property and equipment, net | |
| 1,166 | | |
| 235 | |
Operating lease right-of-use asset | |
| 10,686 | | |
| 710 | |
Long-term restricted cash | |
| 1,472 | | |
| 1,472 | |
Other long-term assets | |
| 217 | | |
| 389 | |
Total assets | |
$ | 36,770 | | |
$ | 40,953 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 707 | | |
$ | 1,188 | |
Accrued expenses and other current liabilities | |
| 2,535 | | |
| 1,638 | |
Operating lease liability | |
| 199 | | |
| 857 | |
Deferred revenue | |
| 988 | | |
| 1,339 | |
Total current liabilities | |
| 4,429 | | |
| 5,022 | |
Deferred revenue, net of current portion | |
| 4,038 | | |
| 4,822 | |
Operating lease liability, net of current portion | |
| 8,422 | | |
| - | |
Total liabilities | |
| 16,889 | | |
| 9,844 | |
Commitments and contingencies (Note 11) | |
| - | | |
| - | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 and 3,639,185 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | |
| - | | |
| - | |
Additional paid-in capital | |
| 305,395 | | |
| 304,585 | |
Accumulated deficit | |
| (285,514 | ) | |
| (273,476 | ) |
Total stockholders’ equity | |
| 19,881 | | |
| 31,109 | |
Total liabilities and stockholders’ equity | |
$ | 36,770 | | |
$ | 40,953 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
(unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | 1,753 | | |
$ | 1,872 | | |
$ | 5,096 | | |
$ | 4,363 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 3,963 | | |
| 5,287 | | |
| 12,002 | | |
| 13,773 | |
General and administrative | |
| 1,729 | | |
| 1,685 | | |
| 5,609 | | |
| 5,212 | |
Total operating expenses | |
| 5,692 | | |
| 6,972 | | |
| 17,611 | | |
| 18,985 | |
Loss from operations | |
| (3,939 | ) | |
| (5,100 | ) | |
| (12,515 | ) | |
| (14,622 | ) |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 217 | | |
| 102 | | |
| 675 | | |
| 118 | |
Other expense, net | |
| (52 | ) | |
| (54 | ) | |
| (198 | ) | |
| (116 | ) |
Total other income, net | |
| 165 | | |
| 48 | | |
| 477 | | |
| 2 | |
Net loss | |
$ | (3,774 | ) | |
$ | (5,052 | ) | |
$ | (12,038 | ) | |
$ | (14,620 | ) |
Net loss per share attributable to common stockholders – basic and diluted | |
$ | (1.03 | ) | |
$ | (1.45 | ) | |
$ | (3.30 | ) | |
$ | (4.32 | ) |
Weighted average common shares outstanding – basic and diluted | |
| 3,652,285 | | |
| 3,478,157 | | |
| 3,651,785 | | |
| 3,383,171 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Stockholders’ Equity
(in
thousands, except share data)
(unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance — January 1, 2023 | |
| - | | |
$ | - | | |
| 3,639,185 | | |
$ | - | | |
$ | 304,585 | | |
$ | (273,476 | ) | |
$ | 31,109 | |
Issuance of common stock, net of issuance costs | |
| - | | |
| - | | |
| 13,100 | | |
| - | | |
| 53 | | |
| - | | |
| 53 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 296 | | |
| - | | |
| 296 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,448 | ) | |
| (4,448 | ) |
Balance — March 31, 2023 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 304,934 | | |
$ | (277,924 | ) | |
$ | 27,010 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 255 | | |
| - | | |
| 255 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,816 | ) | |
| (3,816 | ) |
Balance — June 30, 2023 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,189 | | |
$ | (281,740 | ) | |
$ | 23,449 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 206 | | |
| - | | |
| 206 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,774 | ) | |
| (3,774 | ) |
Balance — September 30, 2023 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,395 | | |
$ | (285,514 | ) | |
$ | 19,881 | |
| |
Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance — January 1, 2022 | |
| 1,830 | | |
$ | 1,081 | | |
| 3,222,037 | | |
$ | - | | |
$ | 301,008 | | |
$ | (254,640 | ) | |
$ | 47,449 | |
Conversion of preferred stock to common stock | |
| (915 | ) | |
| (541 | ) | |
| 76,250 | | |
| - | | |
| 541 | | |
| - | | |
| - | |
Adjustment due to reverse stock split | |
| - | | |
| - | | |
| 12,635 | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 281 | | |
| - | | |
| 281 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,973 | ) | |
| (4,973 | ) |
Balance — March 31, 2022 | |
| 915 | | |
$ | 540 | | |
| 3,310,922 | | |
$ | - | | |
$ | 301,830 | | |
$ | (259,613 | ) | |
$ | 42,757 | |
Conversion of preferred stock to common stock | |
| (915 | ) | |
| (540 | ) | |
| 76,250 | | |
| - | | |
| 540 | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 277 | | |
| - | | |
| 277 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,595 | ) | |
| (4,595 | ) |
Balance — June 30, 2022 | |
| - | | |
$ | - | | |
| 3,387,172 | | |
$ | - | | |
$ | 302,647 | | |
$ | (264,208 | ) | |
$ | 38,439 | |
Balance | |
| - | | |
$ | - | | |
| 3,387,172 | | |
$ | - | | |
$ | 302,647 | | |
$ | (264,208 | ) | |
$ | 38,439 | |
Issuance of common stock, net of issuance costs | |
| - | | |
| - | | |
| 252,013 | | |
| - | | |
| 1,382 | | |
| - | | |
| 1,382 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 277 | | |
| - | | |
| 277 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,052 | ) | |
| (5,052 | ) |
Balance — September 30, 2022 | |
| - | | |
$ | - | | |
| 3,639,185 | | |
$ | - | | |
$ | 304,306 | | |
$ | (269,260 | ) | |
$ | 35,046 | |
Balance | |
| - | | |
$ | - | | |
| 3,639,185 | | |
$ | - | | |
$ | 304,306 | | |
$ | (269,260 | ) | |
$ | 35,046 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Cash Flows
(in
thousands)
(unaudited)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (12,038 | ) | |
$ | (14,620 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 96 | | |
| 123 | |
Amortization of operating lease right-of-use asset | |
| 1,171 | | |
| 1,033 | |
Stock-based compensation | |
| 757 | | |
| 835 | |
Loss on disposal of property and equipment | |
| 8 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 457 | | |
| (409 | ) |
Prepaid expenses and other current assets | |
| 169 | | |
| (1,042 | ) |
Other long-term assets | |
| 172 | | |
| (428 | ) |
Accounts payable | |
| (481 | ) | |
| 478 | |
Accrued expenses and other current liabilities | |
| 233 | | |
| 1,515 | |
Operating lease liability | |
| (3,383 | ) | |
| (1,007 | ) |
Deferred revenue | |
| (1,135 | ) | |
| (788 | ) |
Net cash used in operating activities | |
| (13,974 | ) | |
| (14,310 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (371 | ) | |
| (77 | ) |
Net cash used in investing activities | |
| (371 | ) | |
| (77 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from issuance of common stock, net of issuance costs | |
| 53 | | |
| 1,382 | |
Preferred stock issuance costs | |
| - | | |
| (152 | ) |
Net cash provided by financing activities | |
| 53 | | |
| 1,230 | |
Net decrease in cash, cash equivalents and restricted cash | |
| (14,292 | ) | |
| (13,157 | ) |
Cash, cash equivalents and restricted cash — beginning of period | |
| 37,253 | | |
| 55,465 | |
Cash, cash equivalents and restricted cash — end of period | |
$ | 22,961 | | |
$ | 42,308 | |
| |
| | | |
| | |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 21,336 | | |
$ | 40,683 | |
Restricted cash | |
| 153 | | |
| 153 | |
Long-term restricted cash | |
| 1,472 | | |
| 1,472 | |
Total cash, cash equivalents and restricted cash | |
$ | 22,961 | | |
$ | 42,308 | |
| |
| | | |
| | |
Supplemental disclosures of non-cash investing and financing information: | |
| | | |
| | |
Operating lease right-of-use asset obtained in exchange for operating lease liability | |
$ | 9,323 | | |
$ | - | |
Purchases of property and equipment not yet paid | |
$ | 664 | | |
$ | - | |
Conversion of preferred stock to common stock | |
$ | - | | |
$ | 1,081 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited)
(in
thousands, except share and per share data)
1.
Organization
Pulmatrix,
Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical-stage biopharmaceutical
company focused on the development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery
platform, iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense
particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies
and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE™-based
therapeutic candidates targeted at prevention and treatment of a range of respiratory and other diseases with significant unmet medical
needs.
2.
Summary of Significant Accounting Policies and Recent Accounting Standards
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “Annual Report”).
The
financial information as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, is unaudited. In
the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation
of the interim financial information have been included. The balance sheet data as of December 31, 2022 was derived from audited consolidated
financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results
that may be expected for any other interim period or for a full fiscal year.
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required 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, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive and recognize revenue, estimates related
to clinical trial accruals and upfront deposits, incremental borrowing rate, and accounting for income taxes and the related valuation
allowance.
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and nine months ended September 30, 2023, revenue from one customer accounted for 100% of revenue recognized in the accompanying
condensed consolidated financial statements. For the three and nine months ended September 30, 2022, revenue from one customer accounted
for approximately 99% of revenue recognized in the accompanying condensed consolidated financial statements. As of September 30, 2023
and December 31, 2022, one customer accounted for 100% of accounts receivable.
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the nine months ended September 30, 2023, the Company did not make any changes to its significant
accounting policies, except as described below with respect to recent accounting pronouncements.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt
any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its condensed consolidated
financial statements.
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) ASU 2016-13, Financial Instruments—Credit Losses
(Topic 326)—Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which has been subsequently
amended. The provisions of ASU 2016-13 modify the impairment model for financial instruments to utilize an expected loss methodology
in place of the currently used incurred loss methodology and require consideration of a broader range of reasonable and supportable information
to inform credit loss estimates. The Company adopted the standard as of January 1, 2023. The adoption of this standard did not have a
material effect on the Company’s condensed consolidated financial statements.
As
of September 30, 2023, there are no new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
3.
Fair Value of Financial Instruments
As
of September 30, 2023 and December 31, 2022, the Company did not hold any financial assets or liabilities that were measured at fair
value on a recurring or nonrecurring basis. During the nine months ended September 30, 2023, there were no transfers between Level 1,
Level 2 and Level 3.
4.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
September 30, 2023 | | |
December 31, 2022 | |
Insurance | |
$ | 361 | | |
$ | 286 | |
Software and hosting costs | |
| 83 | | |
| 99 | |
Clinical and consulting | |
| 50 | | |
| 517 | |
Other | |
| 405 | | |
| 166 | |
Total prepaid expenses and other current assets | |
$ | 899 | | |
$ | 1,068 | |
5.
Property and Equipment, Net
Property
and equipment, net consisted of the following:
Schedule of Property and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Laboratory equipment | |
$ | 1,639 | | |
$ | 1,827 | |
Capital in progress | |
| 600 | | |
| - | |
Office furniture and equipment | |
| 387 | | |
| 217 | |
Computer equipment | |
| 237 | | |
| 275 | |
Leasehold improvements | |
| - | | |
| 664 | |
Total property and equipment | |
| 2,863 | | |
| 2,983 | |
Less accumulated depreciation and amortization | |
| (1,697 | ) | |
| (2,748 | ) |
Property and equipment, net | |
$ | 1,166 | | |
$ | 235 | |
Depreciation
and amortization expense for the nine months ended September 30, 2023 and 2022 was $96 and $123, respectively. During the nine months
ended September 30, 2023 and 2022, the Company disposed of certain property and equipment primarily in connection with moving to its
new office, resulting in a loss on disposal of $8.
6.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
September 30, 2023 | | |
December 31, 2022 | |
Wages and incentives | |
$ | 904 | | |
$ | 1,130 | |
Clinical and consulting | |
| 704 | | |
| 475 | |
Accrued purchases of property and equipment | |
| 664 | | |
| - | |
Legal and patents | |
| 49 | | |
| - | |
Other | |
| 214 | | |
| 33 | |
Total accrued expenses and other current liabilities | |
$ | 2,535 | | |
$ | 1,638 | |
7.
Significant Agreements
Development
and Commercialization Agreement with Cipla Technologies LLC (“Cipla”)
On
April 15, 2019, the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla
for the co-development and commercialization, on a worldwide exclusive basis, of PUR1900, the Company’s inhaled iSPERSE™
drug delivery system (the “Product”) enabled formulation of the antifungal drug, itraconazole, which is only available
as an oral drug, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis (“ABPA”)
in patients with asthma. The Company entered into an amendment to the Cipla Agreement on November 8, 2021 (the “Amendment”),
and all references to the Cipla Agreement herein refer to the Cipla Agreement, as amended.
The
Company received a non-refundable upfront payment of $22.0 million (the “Upfront Payment”) under the Cipla Agreement. Upon
receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers
the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”):
all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory
materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly
related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding
most specifically the Company’s iSPERSE™ technology. A portion of the Upfront Payment was deposited by
the Company into a bank account, along with an equal amount from the Company, and was dedicated to the development of the Product (the
“Initial Development Funding”). The Initial Development Funding was depleted during the year ended December 31, 2021, and
the Company and Cipla are now each responsible for a portion of the development costs actually incurred as described below (the “Co-Development
Phase”).
Pursuant
to the Amendment, the Company and Cipla will each initially be responsible for 60% and 40%, respectively, of the Company’s overhead
costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”).
Upon the achievement of each development milestone set forth in the table below, Cipla will reimburse the Company an amount equal to
10% of the cumulative aggregate Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially
bringing the sharing of Direct Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will
continue to aggregate and be reimbursed by Cipla to the Company if the Company achieves the subsequent development milestone for that
trial set forth in the table below. The Company will share all other development costs with Cipla that are not Direct Costs, such as
the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis.
Phase
2b Development Plan – Development Milestones |
|
Development
Milestone |
|
Milestone
Date |
|
|
|
25%
of patients enrolled in Phase 2b clinical study are dosed |
|
June
30, 2023 |
|
|
|
Company
delivers summary of key efficacy and safety data to include FEV1, IgE, ACQ-6, number of subjects withdrawn, any severe
adverse events related to the medication and an overall summary table of adverse events (“Topline Results”) to the joint
steering committee (“JSC”) |
|
June
30, 2024 |
Phase
3 Development Plan – Development Milestones |
|
Development
Milestone |
|
Milestone
Date |
|
|
|
25%
of patients enrolled in Phase 3 clinical study dosed |
|
To
be proposed by JSC |
|
|
|
Company
delivers Topline Results to the JSC |
|
To
be proposed by JSC |
|
|
|
The
Prescription Drug User Fee Act |
|
To
be proposed by JSC |
As
of November 6, 2023, the Company has dosed 25% of patients by the date of this report but this first Phase 2b development milestone
was not achieved by June 30, 2023. Delayed regulatory approval in certain foreign jurisdictions and slower than expected enrollment
contributed to missing this milestone. The associated cumulative aggregated Holdback Payment (as defined herein) could still have
been reimbursed by Cipla to the Company if the Company achieved the subsequent development milestone of delivering topline data by
June 30, 2024. However, as the Company is currently anticipating topline results in the second half of 2024, after the related June
30, 2024 milestone date has passed, the Company currently expects that it will therefore not be reimbursed the aggregated Holdback Payment. All such previously referred to regulatory approvals
in this paragraph have since been obtained and enrollment is ongoing.
Accounting
Treatment
The
Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks
and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of Accounting Standards Codification
(“ASC”) 808, Collaborative Arrangements (“ASC 808”). The Company concluded that Cipla is a customer since
they contracted with the Company to obtain research and development services and a license to the Assigned Assets, each of which is an
output of the Company’s ordinary activities, in exchange for consideration. Therefore, the Company has applied the guidance in
ASC 606, Revenue from Contracts with Customers (“ASC 606”) to account for the research and development services and
a license within the contract. The Company determined that the research and development services and license to the Assigned Assets are
considered highly interdependent and highly interrelated and therefore are considered a single combined performance obligation because
Cipla cannot benefit from the license without the performance by the Company of the research and development services. Such research
and development services are highly specialized and proprietary to the Company and therefore not available to Cipla from any other third
party.
The
Company initially determined the total transaction price to be $22.0 million – comprised of $12.0 million for research and development
services for the Product and $10.0 million for the irrevocable license to the Assigned Assets. Any consideration related to the Co-Development
Phase was not initially included in the transaction price as such amounts are subject to the variable consideration constraint. Additionally,
upon commercialization, Cipla and the Company will share equally, both positive and negative total free cash-flows earned by Cipla in
respect of the Product. However, the Company has not included such free cash-flows in the transaction price as these milestones are constrained
until after the commercialization of the Product.
The
Company concluded that the Amendment represented a contract modification that is treated for accounting purposes as the termination of
the Cipla Agreement and a creation of a new contract (the “Amended Cipla Agreement”). Accordingly, the modification is accounted
for on a prospective basis. The total transaction price for the Amended Cipla Agreement includes variable consideration from the Amendment
as well as $7.4 million deferred under the Cipla Agreement as of the Amendment execution date.
Revenue
is recognized for the Amended Cipla Agreement as the research and development services are provided using an input method, according
to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the Company’s obligations. In
management’s judgment, this input method is the best measure of the transfer of control of the combined performance obligation.
The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated
balance sheets, with amounts expected to be recognized in the next 12 months recorded as current.
During
the three and nine months ended September 30, 2023, the Company recognized $1.8 million and $5.1 million, respectively, in revenue related
to the research and development services and irrevocable license to the Assigned Assets in the Company’s consolidated statements
of operations. Of the revenue recognized during the three and nine months ended September 30, 2023, $0.2 million and $0.8 million, respectively,
was included in deferred revenue at the beginning of the period. As of September 30, 2023, the aggregate transaction price related to
the Company’s unsatisfied obligations was $5.0 million and was recorded in deferred revenue, $1.0 million of which was current.
8.
Common Stock
In
May 2021, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with H.C. Wainwright and Co.,
LLC (“HCW”) to act as the Company’s sales agent with respect to the issuance and sale of up to $20.0 million of the
Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM Offering”). Sales
of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed
with the SEC on May 26, 2021, and subsequently declared effective on June 9, 2021 (File No. 333-256502), and a related prospectus. HCW
acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices
and applicable state and federal laws, rules and regulations and the rules of The NASDAQ Capital Market (“Nasdaq”). If expressly
authorized by the Company, HCW may also sell the Company’s common stock in privately negotiated transactions. There is no specific
date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds
of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the
gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.
During
the nine months ended September 30, 2023, the Company sold 13,100 shares of its common stock under the Sales Agreement at a weighted-average
price of approximately $4.25 per share, which resulted in net proceeds of approximately $53 thousand.
9.
Warrants
There
were no warrants issued or exercised during the nine months ended September 30, 2023. Warrants to purchase up to 123,310 shares of common
stock at $149.99 per share expired during the nine months ended September 30, 2023. The following represents a summary of the warrants
outstanding and exercisable at September 30, 2023, all of which are equity-classified:
Schedule of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
April 8, 2019 | |
$ | 26.99 | | |
April 8, 2024 | |
| 65,907 | | |
| 65,907 | |
April 8, 2019 | |
$ | 33.74 | | |
April 3, 2024 | |
| 39,871 | | |
| 39,871 | |
February 12, 2019 | |
$ | 36.62 | | |
February 7, 2024 | |
| 5,548 | | |
| 5,548 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
February 4, 2019 | |
$ | 42.49 | | |
January 30, 2024 | |
| 1,732 | | |
| 1,732 | |
January 31, 2019 | |
$ | 42.49 | | |
January 26, 2024 | |
| 511 | | |
| 511 | |
December 3, 2018 | |
$ | 77.99 | | |
June 3, 2024 | |
| 46,876 | | |
| 46,876 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,161,493 | | |
| 1,145,538 | |
10.
Stock-based Compensation
The
Company sponsors the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan (the “Incentive
Plan”). As of September 30, 2023, the Incentive Plan provided for the grant of up to 636,322 shares of the Company’s common
stock, of which 267,541 shares remained available for future grant. In addition, the Company sponsors two legacy plans under which no
additional awards may be granted. As of September 30, 2023, the two legacy plans have a total of 32 options outstanding, all of which
are fully vested and for which common stock will be issued upon exercise.
The
following table summarizes stock option activity for the nine months ended September 30, 2023:
Summary of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2023 | |
| 304,823 | | |
$ | 28.66 | | |
| 7.98 | | |
$ | - | |
Granted | |
| 118,472 | | |
$ | 3.98 | | |
| | | |
| | |
Forfeited or expired | |
| (58,320 | ) | |
$ | 19.96 | | |
| | | |
| | |
Outstanding — September 30, 2023 | |
| 364,975 | | |
$ | 22.04 | | |
| 7.74 | | |
$ | - | |
Exercisable — September 30, 2023 | |
| 208,835 | | |
$ | 32.51 | | |
| 7.02 | | |
$ | - | |
The
Company records stock-based compensation expense related to stock options based on their grant-date fair value. During the nine months
ended September 30, 2023 and 2022, the Company used the Black-Scholes option-pricing model to estimate the fair value of stock option
grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards
represent management’s best estimates. The weighted-average grant-date fair value of options granted during the nine months ended
September 30, 2023 was $3.27 per share. The weighted-average assumptions used in determining fair value of the stock options for the
nine months ended September 30, 2023 and 2022 are as follows:
Schedule of Calculation of Fair Value Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected option life (years) | |
| 6.0 | | |
| 6.0 | |
Risk-free interest rate | |
| 3.53 | % | |
| 2.03 | % |
Expected volatility | |
| 104.24 | % | |
| 113.28 | % |
Expected dividend yield | |
| - | % | |
| - | % |
The
expected life of the Company’s options was determined using the simplified method as a result of limited historical data regarding
the Company’s activity. The risk-free interest rate was obtained from U.S. Treasury rates for the expected life of the stock options.
The Company’s expected volatility was based upon the historical volatility of the Company’s common stock. The dividend yield
considers that the Company has not historically paid dividends and does not expect to pay dividends in the foreseeable future.
As
of September 30, 2023, there was $1.0 million of unrecognized stock-based compensation expense related to unvested stock options granted
under the Company’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately
2.0 years.
The
following table presents total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022:
Schedule of Stock-based Compensation Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 57 | | |
$ | 65 | | |
$ | 188 | | |
$ | 189 | |
General and administrative | |
| 149 | | |
| 212 | | |
| 569 | | |
| 646 | |
Total stock-based compensation expense | |
$ | 206 | | |
$ | 277 | | |
$ | 757 | | |
$ | 835 | |
11.
Commitments and Contingencies
Research
and Development Activities
The
Company contracts with various other organizations to conduct research and development activities, including clinical trials. As of September
30, 2023, the Company had aggregate commitments to pay approximately $4.0 million remaining on these contracts, of which the Company
expects to be reimbursed $2.0 million under the Cipla Agreement. Of the gross amount of $4.0 million in commitments, $3.8 million is
expected to be incurred over the next 12 months. The scope of the services under contracts for research and development activities may
be modified and the contracts, subject to certain conditions, may generally be cancelled by the Company upon written notice. In some
instances, the contracts, subject to certain conditions, may be cancelled by the third party.
Legal
Proceedings
In
the ordinary course of its business, the Company may be involved in various legal proceedings involving contractual and employment relationships,
patent or other intellectual property rights, and a variety of other matters. The Company is not aware of any pending legal proceedings
that would reasonably be expected to have a material impact on the Company’s financial position or results of operations.
12.
Leases
New
Corporate Headquarters
The
Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during
the nine months ended September 30, 2023. On January 7, 2022, the Company executed a lease agreement with Cobalt Propco 2020, LLC for
its new corporate headquarters at 36 Crosby Drive, Bedford, Massachusetts. The leased premises comprise approximately 20,000 square feet
of office and lab space, and the lease provides for base rent of $0.1 million per month, expected to begin in December 2023, which will
increase 3% each year over the ten-year noncancellable term. The Company has the option to extend the lease for one additional five-year
term and is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises.
The
lease commenced on August 1, 2023, following substantial completion of construction to prepare the premises for the Company’s
use, and the Company has included the lease as a component of its operating lease right-of-use asset and operating lease liabilities
upon commencement. The improvements to prepare the leased premises for the Company’s intended use have been funded by (i) the
landlord, through a tenant allowance of $3.9
million, (ii) a landlord-funded advance on tenant improvements of $0.5
million which will be repaid over the lease term, and (iii) approximately $2.4
million funded by the Company.
Other
Leasing Activities
During
the first quarter of 2023, the Company executed a two-month lease extension for its previous corporate headquarters in Lexington, Massachusetts,
through August 31, 2023. The Company terminated that lease extension, as planned, during the third quarter of 2023.
The
Company also leases small office equipment which is primarily short-term or immaterial in nature. Therefore, no right-of-use assets and
lease liabilities are recognized for these leases.
The
components of lease expense for the Company for the three and nine months ended September 30, 2023 and 2022 were as follows:
Schedule of Components of Lease Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 553 | | |
$ | 357 | | |
$ | 1,349 | | |
$ | 1,072 | |
Variable lease cost | |
| 203 | | |
| 206 | | |
| 484 | | |
| 556 | |
Total lease cost | |
$ | 756 | | |
$ | 563 | | |
$ | 1,833 | | |
$ | 1,628 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 2,699 | | |
$ | 431 | | |
$ | 3,562 | | |
$ | 1,046 | |
Weighted-average remaining lease term — operating leases | |
| | | |
| | | |
| 10.2 years | | |
| | |
Weighted-average discount rate — operating leases | |
| | | |
| | | |
| 11.00 | % | |
| | |
Maturities
of lease liabilities due under these lease agreements as of September 30, 2023 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2023 (three months) | |
$ | 171 | |
2024 | |
| 1,289 | |
2025 | |
| 1,326 | |
2026 | |
| 1,364 | |
2027 | |
| 1,402 | |
2028 and thereafter | |
| 9,154 | |
Total lease payments | |
| 14,706 | |
Less: interest | |
| (6,085 | ) |
Total lease liabilities | |
$ | 8,621 | |
| |
| | |
Reported as of September 30, 2023 | |
| | |
Lease liabilities — short term | |
$ | 199 | |
Lease liabilities — long term | |
| 8,422 | |
Total lease liabilities | |
$ | 8,621 | |
13.
Income Taxes
The
Company had no income tax expense due to operating losses incurred for the three and nine months ended September 30, 2023 and 2022.
Management
of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined
that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation
allowance was recorded as of September 30, 2023 and December 31, 2022.
The
Company applies ASC 740, Income Taxes, for the financial statement recognition, measurement, presentation, and disclosure of uncertain
tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves
have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect
of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. The
Company has no material uncertain tax positions as of September 30, 2023 and December 31, 2022.
14.
Net Loss Per Share
Basic
and diluted earnings (loss) per share are computed using the two-class method, which is an earnings allocation method that determines
earnings (loss) per share for common shares and participating securities. The participating securities consist of the Company’s
Series A Preferred Stock. The undistributed earnings are allocated between common shares and participating securities as if all earnings
had been distributed during the period. In periods of loss, no allocation is made to the Series A Preferred Stock and diluted net loss
per share is the same as basic net loss per share because common stock equivalents are excluded as their inclusion would be antidilutive.
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an antidilutive impact:
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | |
Options to purchase common stock | |
| 364,975 | | |
| 307,918 | |
Warrants to purchase common stock | |
| 1,161,493 | | |
| 1,284,803 | |
Total potentially dilutive securities excluded | |
| 1,526,468 | | |
| 1,592,721 | |
15.
Subsequent Events
The
Company has completed an evaluation of all subsequent events after the balance sheet date of September 30, 2023 through the date the
condensed consolidated financial statements were issued to ensure that the condensed consolidated financial statements include appropriate
disclosure of events both recognized in the condensed consolidated financial statements as of September 30, 2023, and events which occurred
subsequently but were not recognized in the condensed consolidated financial statements. The Company has concluded that no subsequent
events have occurred that require disclosure, except as disclosed within the condensed consolidated financial statements.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations is intended to provide a reader of our financial statements
with a narrative from the perspective of our management on our financial condition, results of operations, liquidity, and certain other
factors that may affect our future results. The information set forth below should be read in conjunction with the condensed consolidated
financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q as well as the audited consolidated
financial statements and the notes thereto contained in our Annual Report on Form 10-K filed with the SEC on March 30, 2023. Unless stated
otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company”
and similar terms refer to Pulmatrix, Inc., a Delaware corporation and its subsidiaries.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical fact contained
herein, including statements regarding our business plans or strategies, projected or anticipated benefits or other consequences of our
plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues,
earnings, or other aspects of our operating results, are forward-looking statements. Words such as “anticipates,” “assumes,”
“believes,” “can,” “could,” “estimates,” “expects,” “forecasts,”
“guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,”
“projects,” “targets,” and “would,” and their opposites and similar expressions, as well as statements
in future tense, are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of
future performance or results and may not be accurate indications of when such performance or results will actually be achieved. Forward-looking
statements are based on information we have when those statements are made or our management’s good faith belief as of that time
with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially
from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include,
but are not limited to:
|
● |
the impact of the coronavirus
(“COVID-19”) endemic and its continuing effects on the global economy and on the Company’s ongoing and planned
clinical trials; |
|
|
|
|
● |
our history of recurring
losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy
of our liquidity to pursue or complete our business objectives; |
|
|
|
|
● |
our inability to carry
out research, development and commercialization plans; |
|
|
|
|
● |
our inability to manufacture
our product candidates on a commercial scale on our own or in collaborations with third parties; |
|
|
|
|
● |
our inability to complete
preclinical testing and clinical trials as anticipated; |
|
|
|
|
● |
our collaborators’
inability to successfully carry out their contractual duties; |
|
|
|
|
● |
termination of certain
license agreements; |
|
|
|
|
● |
our ability to adequately
protect and enforce rights to intellectual property, or defend against claims of infringement by others; |
|
|
|
|
● |
difficulties in obtaining
financing on commercially reasonable terms, or at all; |
|
|
|
|
● |
intense competition in
our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical,
manufacturing, marketing and sales, distribution, personnel and resources than we do; |
|
|
|
|
● |
entry of new competitors
and products and potential technological obsolescence of our products; |
|
|
|
|
● |
adverse market and economic
conditions; |
|
|
|
|
● |
our ability to maintain
compliance with Nasdaq’s listing standards; |
|
|
|
|
● |
loss of one or more key
executives or scientists; and |
|
|
|
|
● |
difficulties in securing
regulatory approval to market our product candidates. |
For
a more detailed discussion of these and other risks that may affect our business and that could cause our actual results to differ from
those projected in these forward-looking statements, see the risk factors and uncertainties described under the heading “Risk Factors”
in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, Item 1A of our Annual Report on Form 10-K. The forward-looking
statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We
do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date on which any
such statement is made or to reflect the occurrence of unanticipated events, except as required by law.
“iSPERSE™”
is one of our trademarks used in this Quarterly Report on Form 10-Q. Other trademarks appearing in this report are the property of their
respective holders. Solely for convenience, these and other trademarks, trade names and service marks referred to in this report appear
without the ®, TM and SM symbols, but those references are not intended to indicate, in any way, we or the owners of such
trademarks will not assert, to the fullest extent under applicable law, their rights to these trademarks and trade names.
Overview
Business
We
are a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and
treat respiratory and other diseases with significant unmet medical needs using our patented iSPERSE™ technology. Our proprietary
product pipeline includes treatments for serious lung diseases, such as allergic bronchopulmonary aspergillosis (“ABPA”)
and Chronic Obstructive Pulmonary Disease (“COPD”), and central nervous system (“CNS”) disorders such as acute
migraine. Our product candidates are based on our proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to
improve therapeutic delivery to the lungs by optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes.
We
design and develop inhaled therapeutic products based on our proprietary dry powder delivery technology, iSPERSE™ (inhaled Small
Particles Easily Respirable and Emitted), which enables delivery of small or large molecule drugs to the lungs by inhalation for local
or systemic applications. The iSPERSE™ powders are engineered to be small, dense particles with highly efficient dispersibility
and delivery to airways. iSPERSE™ powders can be used with an array of dry powder inhaler technologies and can be formulated with
a broad range of drug substances including small molecules and biologics. We believe the iSPERSE™ dry powder technology offers
enhanced drug loading and delivery efficiency that outperforms traditional lactose-blend inhaled dry powder therapies.
We
believe the advantages of using the iSPERSE™ technology include reduced total inhaled powder mass, enhanced dosing efficiency,
reduced cost of goods, and improved safety and tolerability profiles.
Our
goal is to develop breakthrough therapeutic products that are safe, convenient, and more effective than the existing therapeutic products
for respiratory and other diseases where iSPERSE™ properties are advantageous.
Our
current pipeline is aligned to this goal as we develop iSPERSE™-based therapeutic candidates which target the prevention and treatment
of a range of diseases, including CNS disorders and pulmonary diseases. These therapeutic candidates include PUR1900 for the treatment
of ABPA in patients with asthma and in patients with cystic fibrosis (“CF”), PUR3100 for the treatment of acute migraine,
and PUR1800 for the treatment of acute exacerbations of chronic obstructive pulmonary disease (“AECOPD”). Each program is
enabled by its unique iSPERSE™ formulation designed to achieve specific therapeutic objectives.
We
intend to capitalize on our iSPERSE™ technology platform and our expertise in inhaled therapeutics to identify new product candidates
for the prevention and treatment of diseases with significant unmet medical needs and to build our product pipeline beyond our existing
candidates. In order to advance clinical trials for our therapeutic candidates and leverage the iSPERSE™ platform to enable delivery
of partnered compounds, we intend to form strategic alliances with third parties, including pharmaceutical and biotechnology companies
or academic or private research institutes.
We
expect to continue to incur significant expenses and operating losses for at least the next several years based on our drug development
plans. We expect our expenses and capital requirements will increase substantially in connection with our ongoing activities, as we:
|
● |
Complete PUR1900 Phase
2b Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and Allergic Bronchopulmonary Aspergillosis
(ABPA) (clinicaltrials.gov NCT05667662). |
|
|
|
|
|
The
current Phase 2b study of PUR1900, our inhaled iSPERSE™ formulation of the antifungal drug itraconazole for ABPA in patients
with asthma and CF, began dosing patients in the first quarter of 2023. The PUR1900 Phase 2b study includes a sixteen-week dosing
regimen and is a randomized, double-blind, multi-center, placebo-controlled study to evaluate PUR1900’s safety and efficacy.
The multi-center study is being conducted in the United States, United Kingdom, Australia and France. Endpoints include safety,
tolerability, and potential efficacy outcomes to identify potential registrational endpoints in adult patients with asthma and ABPA.
We currently anticipate topline data from this study in the second half of 2024.
In
June 2023, “Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic
Modelling, Based on Phase 1 Clinical Data” was published in the American Association of Pharmaceutical Scientists (AAPS) Journal.
This study demonstrates the lower risk of drug-drug interaction with inhaled itraconazole (PUR1900) than with oral itraconazole.
Thus, if effective, PUR1900 may be able to be safely administered even in patients taking drugs contraindicated with oral itraconazole,
hence potentially improving treatment options for patients with ABPA and asthma. |
|
|
|
|
● |
Pursue further clinical
studies for PUR3100, an orally inhaled dihydroergotamine (“DHE”) including a Phase 2 clinical study for the treatment
of acute migraine. We received FDA acceptance of our Investigational New Drug Application (“IND”) and a “study
may proceed” letter in September 2023, positioning PUR3100 as Phase 2-ready for potential financing or partnership discussions. |
|
|
|
|
|
We
developed PUR3100, an iSPERSE™ formulation of DHE in 2020. We completed good laboratory practice (“GLP”) toxicology
studies in 2021 and 2022. In 2022, we initiated a Phase 1 study designed as a double-blinded trial to assess the safety, tolerability,
and pharmacokinetics of three dose levels of single doses of inhaled PUR3100 with intravenous (“IV”) placebo, as compared
to IV DHE (DHE mesylate injection) with inhaled placebo. On September 26, 2022, we announced that patient dosing was completed.
On
January 4, 2023, we announced the Phase 1 topline results, indicating that PUR3100 was safe and tolerated with fewer
gastrointestinal side effects in all doses compared to IV DHE. PUR3100 showed a five-minute Tmax and Cmax
within the targeted therapeutic range for all three doses tested. The Phase 1 study data were presented at the American Headache
Society 65th Annual Meeting in June 2023.
Based
on the rapid systemic exposure in the therapeutic range and the improved side effect profile relative to IV dosing, we believe the
PUR3100 formulation of DHE may differentiate from approved DHE products or those in development. If effectiveness is demonstrated,
PUR3100 may offer the convenience of being self-administered with a pharmacokinetic profile that may potentially provide rapid onset
of action.
In
September 2023, we announced the FDA’s acceptance of our Phase 2 IND application for PUR3100 and receipt of a “study may
proceed” letter for a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of
PUR3100 will be investigated in patients with acute migraine. The Company is currently pursuing potential partnership opportunities
to further develop this product candidate. |
|
|
|
|
● |
Continue to advance
PUR1800, focusing on the development of an inhaled kinase inhibitor for treatment of AECOPD. The Company plans to pursue an appropriate
partner as a path forward to advance PUR1800 into a Phase 2 clinical trial. |
|
|
|
|
|
We completed preclinical
safety studies for PUR1800, our iSPERSE™ formulation of RV1162, in 2018 and advanced our formulation and
process development efforts to support clinical testing in stable moderate-severe COPD patients. We completed a Phase 1b safety,
tolerability, and pharmacokinetics clinical study of PUR1800 for subjects with stable moderate-severe COPD and received topline data
from the Phase 1b clinical study in the first quarter of 2022. We analyzed data from the completed Phase 1b clinical study of PUR1800
for AECOPD and presented study results at the American Academy of Allergy, Asthma & Immunology (AAAAI) conference in the first
quarter of 2023. We completed all data analysis to inform a study design for a potential Phase 2 efficacy and safety study, treating
subjects with AECOPD. |
|
● |
Capitalize on our proprietary
iSPERSE™ technology and our expertise in inhaled therapeutics and particle engineering to identify new product candidates
for prevention and treatment of diseases with significant unmet medical needs. |
|
|
|
|
|
To add additional inhaled
therapeutics to our development pipeline and facilitate additional collaborations, we are leveraging our iSPERSE™ technology
and our management’s expertise in inhaled therapeutics and particle engineering to identify potential product candidates. These
potential product candidates are potentially safer and more effective than the current standard of care for prevention and treatment
of diseases with significant unmet medical needs. |
|
● |
Invest in protecting
and expanding our intellectual property portfolio and file for additional patents to strengthen our intellectual property rights. |
|
|
|
|
|
The status of our patent
portfolio changes frequently in the ordinary course of patent prosecution. As of September 30, 2023, our patent portfolio related
to iSPERSE™ included approximately 142 granted patents, 19 of which are granted US patents, with expiration
dates from 2024 to 2037, and approximately 57 additional pending patent applications in the US and other jurisdictions. Our in-licensed
portfolio related to kinase inhibitors included approximately 276 granted patents, 33 of which are granted US patents, with expiration
dates from 2029 to 2035, and approximately 23 additional pending patent applications in the US and other jurisdictions. On March
1, 2022, we filed a Patent Cooperation Treaty application that discloses and claims certain formulations and methods of use relevant
to our PUR3100 program. |
|
|
|
|
● |
Seek partnerships and
license agreements to support the product development and commercialization of PUR3100 and PUR1800. |
|
|
|
|
|
In
order to advance our clinical programs, we may seek partners or licensees in areas of pharmaceutical and clinical development. |
Therapeutic
Candidates
PUR1900
In
2018, we completed a Phase 1 study of PUR1900 in normal healthy volunteers and asthma patients. On April 15, 2019, we entered into the
Cipla Agreement with Cipla for the co-development and commercialization, on a worldwide, except for the Cipla Territory defined below,
exclusive basis, of PUR1900, our inhaled iSPERSE™ drug delivery system (the “Product”) enabled formulation
of the antifungal drug, itraconazole, which is only available as an oral drug, for the treatment of all pulmonary indications, including
ABPA in patients with asthma. We entered into the Amendment to the Cipla Agreement on November 8, 2021, and all references to the Cipla
Agreement herein refer to the Agreement, as amended.
The
Cipla Agreement will remain in effect in perpetuity, unless otherwise earlier terminated in accordance with its terms. In the event of
circumstances affecting the continuity of development of the Product in line with the Cipla Agreement or certain development milestones
are not achieved within a specified timeframe discussed in greater detail below, the JSC will evaluate the cause and effect and make
a recommendation as to the most optimal option available to Cipla and us. In such events, the parties are not obligated to follow the
recommendation of the JSC and, a Terminating Party may elect to terminate its obligation to fund additional costs and expenses for the
development and/or commercialization of the Product. If the non-Terminating Party wishes to continue the development of the Product,
it will have the right to purchase the rights of the Terminating Party in the Product at its fair market value. If both Cipla and we
abandon the development program, Cipla and we shall make commercially reasonable efforts to monetize the Product and development program
in connection with the Pulmonary Indications. Cipla and we will equally share the proceeds.
Pursuant
to the Amendment, we and Cipla will each initially be responsible for 60% and 40%, respectively, of our Direct Costs. Upon the achievement
of each development milestone set forth in the table below, Cipla will reimburse us an amount equal to 10% of the cumulative aggregate
Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially bringing the sharing of Direct
Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will continue to aggregate and be
reimbursed by Cipla to us if we achieve the subsequent development milestone for that trial set forth in the table below. We will share
all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing
costs and other third-party costs, on a 50/50 basis.
Pursuant
to the Cipla Agreement, (i) all development and commercialization activities with respect to the Product in the Cipla Territory will
be conducted exclusively by Cipla at Cipla’s sole cost and expense, and (ii) Cipla shall be entitled to all profits from the sale
of the Product in the Cipla Territory, except that if Cipla successfully transfers manufacturing of the Product for the Cipla Territory
to a manufacturing site determined by Cipla, we will become entitled to a royalty equal to 2% of net sales in the Cipla Territory.
In
partnership with Cipla, we initiated a Phase 2 clinical study in 2019, entitled: “A Randomized, Double-Blind, Multicenter, Placebo-Controlled,
Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation
(PUR1900) in Adult Asthmatic Patients with ABPA.” This clinical study was terminated in July 2020 due to the impact of the COVID-19
pandemic on patient enrollment and clinical study conduct at the time.
Following
termination of the initial Phase 2 clinical study, we conducted a Type C meeting with the FDA on January 27, 2021, in order to discuss
the program overall development plan and the current Phase 2b clinical study design. The current Phase 2b clinical study design includes
a 16-week dosing regimen with an 8-week follow up and is intended to explore potential efficacy endpoints, whereas the terminated Phase
2 clinical study had comprised only a 4-week dosing regimen with safety and tolerability as its primary endpoint. The longer dosing regimen
of the new Phase 2b clinical study is supported by the 6-month inhalation toxicology study in dogs completed in April 2020. The new development
plan, including the planned current Phase 2b clinical study, was approved on November 8, 2021. On February 6, 2023, we announced the
first patient dosed in the Phase 2b study.
In
addition to the terms of the Cipla Agreement described above, if any of the below development milestones are not met by the date that
is nine months after the applicable deadline for achieving such development milestone, either party may elect to terminate its obligation
to fund additional development costs, in which case either (i) the non-Terminating Party can acquire the rights of the Terminating Party
for fair market value or (ii) the parties will monetize the Product. The table below sets forth the development milestones.
Phase 2b Development Plan – Development Milestones
Development
Milestone |
|
Milestone
Date |
|
|
|
25% of patients enrolled
in Phase 2b clinical study are dosed |
|
June 30, 2023 |
|
|
|
Company delivers Topline
Results to the JSC |
|
June 30, 2024 |
Phase 3 Development Plan – Development Milestones
Development
Milestone |
|
Milestone
Date |
|
|
|
25% of patients enrolled
in Phase 3 clinical study dosed |
|
To be proposed by JSC |
|
|
|
Company delivers Topline
Results to the JSC |
|
To be proposed by JSC |
|
|
|
The Prescription Drug User
Fee Act |
|
To be proposed by JSC |
As
of November 6, 2023, we have dosed 25% of patients by the date of this report but this first Phase 2b development milestone was not
achieved by June 30, 2023. Delayed regulatory approval in certain foreign jurisdictions and slower than expected enrollment
contributed to missing this milestone. The associated cumulative aggregated Holdback Payment (as defined below) could still have
been reimbursed by Cipla to us if we achieved the subsequent development milestone of delivering topline data by June 30, 2024.
However, as we currently anticipate topline data in the second half of 2024, after the related June 30, 2024 milestone date has
passed, we currently expect that we will therefore not be reimbursed the aggregated Holdback Payment. All such previously referred
to regulatory approvals in this paragraph have since been obtained and enrollment is ongoing.
PUR3100
In
2020, we developed PUR3100, the iSPERSE™ formulation of DHE, for the treatment of acute migraine. Over 38 million
people suffer from migraine in the United States. Currently DHE is only available as intravenous infusion or intranasal delivery. If
approved for commercialization, PUR3100 should be the first orally inhaled DHE treatment for acute migraine and be an alternative to
other acute therapies, such as oral and intravenous triptans that currently represent the majority of the annual migraine prescriptions
in the United States. Given the oral inhaled route of delivery, PUR3100 is anticipated to provide a rapid onset of migraine symptom relief
with a favorable tolerability profile.
A
total of three 14-day GLP toxicology studies have
been completed with PUR3100 to support single dose clinical studies. Preparations are underway
for chronic toxicology to support long-term dosing and an eventual new drug application (“NDA”).
We
have completed several interactions with the FDA, and they have confirmed that, in addition to the planned Phase 2 and Phase 3 studies,
long-term safety should be assessed in a minimum of one hundred patients for six months of dosing and fifty patients for twelve months
of dosing. The FDA also confirmed that it will be necessary to perform a safety study administering PUR3100 to otherwise healthy patients
with asthma before an NDA is submitted.
On
September 26, 2022, we announced the completion of patient dosing in a Phase 1 clinical study, performed in Australia, designed to assess
not only safety, tolerability, and pharmacokinetics of PUR3100 in humans, but also provide preliminary comparative bioavailability data
to support the use of the 505(b)(2) pathway for marketing authorization. The study design was a double-dummy, double-blinded trial to
assess the safety, tolerability, and pharmacokinetics of three dose levels of single doses of inhaled PUR3100 with IV placebo, as compared
to IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-six healthy subjects were enrolled and each of the four groups contained
at least six subjects. On January 4, 2023, we announced topline results. PUR3100 was well-tolerated and there was a lower incidence of
nausea in PUR3100 dose groups compared to IV DHE, and we presented the Phase 1 study data at the American Headache Society 65th
Annual Meeting in June 2023.
In
contrast to IV DHE, no vomiting was observed in any of the PUR3100 dose groups. Oral inhalation of PUR3100 achieved peak exposures in
the targeted therapeutic range at all doses and the Tmax occurred at five minutes after dosing.
Based
on the rapid systemic exposure in the therapeutic range and the improved side effect profile relative to IV dosing, we believe the PUR3100
formulation of DHE is highly differentiated from other DHE products already approved or in development. We believe PUR3100 can be immediately
and conveniently self-administered and has a pharmacokinetic profile that may potentially advance the treatment of patients with acute
migraine.
In
September 2023, we announced that the FDA accepted the PUR3100 IND and the receipt of a “study may proceed” letter for the
clinical study: “A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled,
Single Event Study to Evaluate the Safety, Tolerability, and Efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in
the Acute Treatment of Migraine”. We anticipate that this Phase 2 clinical study
will initiate once financing or partnership arrangements have been made.
PUR1800
PUR1800
is a Narrow Spectrum Kinase Inhibitor, engineered with our iSPERSE™ technology, being developed for the treatment of acute exacerbations
in chronic obstructive pulmonary disease (AECOPD). PUR1800 targets p38 MAP kinases (p38MAPK), Src kinases, and Syk kinases. These kinases
play a critical role in chronic inflammation and airway remodeling.
We
completed the Phase 1b safety, tolerability, and pharmacokinetics clinical study of PUR1800 for patients with stable moderate-severe
COPD. Topline data was delivered in the first quarter of 2022.
The
clinical study, performed at the Medicines Evaluation Unit in Manchester, UK, was a randomized, three-way crossover double-blind study
with 14 days of daily dosing which included placebo and one of two doses of PUR1800, and included a 28-day follow up period after each
treatment period. A total of 18 adults with stable chronic obstructive pulmonary disease COPD were enrolled. Safety and tolerability
as well as systemic PK were evaluated.
PUR1800
was well tolerated and there were no observed safety signals. The PK data indicate that PUR1800 results in low and consistent systemic
exposure when administered via oral inhalation. The topline data, along with the results from chronic toxicology studies, was delivered
in the first quarter of 2022 and presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) conference in the first
quarter of 2023 and support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory disease.
We completed all data analysis to inform a study design for a potential Phase 2 efficacy and safety study, treating subjects with AECOPD.
We plan to pursue an appropriate partner as a path forward to advance PUR1800 into a Phase 2 clinical trial.
Toxicology
studies in rats and dogs, with durations of six and nine months respectively, are complete. The data from both studies demonstrated that
PUR1800 is safe and well tolerated with chronic dosing, with little to no progression of findings from 28-day studies. We believe that
this indicates potential for chronic dosing of PUR1800, enabling us to explore PUR1800 therapy for chronic respiratory disease such as
steroid resistant asthma, COPD, or idiopathic pulmonary fibrosis. While the program is currently in development for treatment of acute
exacerbation of AECOPD, these positive toxicology study results could expand potential indications and value of the program.
Financial
Overview
Revenues
To
date, we have not generated any product sales. The revenue for the three and nine months ended September 30, 2023 and 2022 was primarily
generated by the collaboration and license agreement with Cipla on our PUR1900 program.
For
more discussion on the collaboration or licensing agreements, please see Note 7, Significant Agreements, of the condensed consolidated
financial statements included in this Quarterly Report on Form 10-Q.
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical candidates,
and include:
|
● |
employee-related expenses,
including salaries, benefits and stock-based compensation expense; |
|
|
|
|
● |
expenses incurred under
agreements with CROs or CMOs, and consultants that conduct our clinical trials and preclinical activities; |
|
|
|
|
● |
the cost of acquiring,
developing and manufacturing clinical trial materials and lab supplies; |
|
|
|
|
● |
facility, depreciation
and other expenses, which include direct and allocated expenses for rent, maintenance of our facility, insurance and other supplies;
|
|
|
|
|
● |
costs associated with preclinical
activities and clinical regulatory operations; and |
|
|
|
|
● |
consulting and professional
fees associated with research and development activities |
We
expense research and development costs to operations as incurred. We recognize costs for certain development activities, such as clinical
trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations
or information provided to us by our vendors.
Research
and development activities are central to our business model. We utilize a combination of internal and external efforts to advance product
development from early-stage work to clinical trial manufacturing and clinical trial support. External efforts include work with consultants
and substantial work at CROs and CMOs. We support an internal research and development team and facility for our pipeline and other potential
development programs. To move these programs forward along our development timelines, a large portion (approximately 86%) of our staff
are research and development employees. In addition, we maintain an office and research and development facility which includes capital
equipment for the manufacture and characterization of our iSPERSE™ powders for our development efforts. As we
identify opportunities for iSPERSE™ in additional indications, we anticipate additional headcount, capital, and
development costs will be incurred to support these programs. Because of the numerous risks and uncertainties associated with product
development, however, we cannot determine with certainty the duration and completion costs of these or other current or future preclinical
studies and clinical trials. The duration, costs and timing of clinical trials and development of our product 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 product candidate will depend
on numerous factors, including competition, manufacturing capability and commercial viability.
General
and Administrative Expenses
General
and administrative expenses consist principally of salaries, benefits and related costs such as stock-based compensation for personnel
and consultants in executive, finance, business development, corporate communications and human resource functions, facility costs not
otherwise included in research and development expenses, patent filing fees and legal fees. Other general and administrative expenses
include travel expenses, expenses related to being a publicly traded company and professional fees for consulting, auditing and tax services.
We
anticipate that our general and administrative expenses will increase in the future as they relate to audit, legal, regulatory, and tax-related
services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance,
investor relations costs and other costs associated with being a public company. Additionally, if and when we believe a regulatory approval
of a product candidate appears likely, we anticipate an increase in staffing and related expenses as a result of our preparation for
commercial operations, especially as it relates to the sales and marketing of our product candidates.
Critical
Accounting Policies, Judgments and Estimates
This
management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated
financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the
disclosure of contingent assets and liabilities in our condensed consolidated financial statements. On an ongoing basis, we evaluate
our most critical estimates and judgments, including those related to revenue recognition and the accrual and recognition of research
and development expenses. We base our estimates on historical experience, known trends and events, and various other factors that are
believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions.
There
were no changes to our critical accounting policies during the nine months ended September 30, 2023, including estimates, assumptions,
and judgments as compared to those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations
included in our Annual Report. It is important that the discussion of our operating results that follow be read in conjunction with the
critical accounting policies disclosed in our Annual Report.
Results
of Operations
Comparison
of the Three Months Ended September 30, 2023 and 2022
The
following table sets forth our results of operations for each of the periods set forth below (in thousands):
| |
Three Months Ended September 30, | | |
| |
| |
2023 | | |
2022 | | |
Change | |
Revenues | |
$ | 1,753 | | |
$ | 1,872 | | |
$ | (119 | ) |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 3,963 | | |
| 5,287 | | |
| (1,324 | ) |
General and administrative | |
| 1,729 | | |
| 1,685 | | |
| 44 | |
Total operating expenses | |
| 5,692 | | |
| 6,972 | | |
| (1,280 | ) |
Loss from operations | |
| (3,939 | ) | |
| (5,100 | ) | |
| 1,161 | |
Other income (expense): | |
| | | |
| | | |
| | |
Interest income | |
| 217 | | |
| 102 | | |
| 115 | |
Other expense, net | |
| (52 | ) | |
| (54 | ) | |
| 2 | |
Net loss | |
$ | (3,774 | ) | |
$ | (5,052 | ) | |
$ | 1,278 | |
Revenues
— Revenues were $1.8 million for the three months ended September 30, 2023, as compared to $1.9 million for the three months
ended September 30, 2022, a decrease of $0.1 million. The decrease is related to revenues under the Cipla Agreement during the period.
Research
and development expenses — Research and development expenses were $4.0 million for the three months ended September 30,
2023, as compared to $5.3 million for the three months ended September 30, 2022, a decrease of approximately $1.3 million. The decrease
was primarily due to decreased spend of $0.7 million in costs related to our PUR3100 program, $0.4 million in costs related to our PUR1900
program, $0.1 million in costs related to our PUR1800 program and $0.1 million of employment and operating costs.
General
and administrative expenses — General and administrative expenses were $1.7 million for both the three months ended September
30, 2023 and 2022, as an increase in facilities costs was offset by a decrease in personnel costs.
Comparison
of the Nine Months Ended September 30, 2023 and 2022
The
following table sets forth our results of operations for each of the periods set forth below (in thousands):
| |
Nine Months Ended September 30, | | |
| |
| |
2023 | | |
2022 | | |
Change | |
Revenues | |
$ | 5,096 | | |
$ | 4,363 | | |
$ | 733 | |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 12,002 | | |
| 13,773 | | |
| (1,771 | ) |
General and administrative | |
| 5,609 | | |
| 5,212 | | |
| 397 | |
Total operating expenses | |
| 17,611 | | |
| 18,985 | | |
| (1,374 | ) |
Loss from operations | |
| (12,515 | ) | |
| (14,622 | ) | |
| 2,107 | |
Other income (expense): | |
| | | |
| | | |
| | |
Interest income | |
| 675 | | |
| 118 | | |
| 557 | |
Other expense, net | |
| (198 | ) | |
| (116 | ) | |
| (82 | ) |
Net loss | |
$ | (12,038 | ) | |
$ | (14,620 | ) | |
$ | 2,582 | |
Revenues
— Revenues were $5.1 million for the nine months ended September 30, 2023, as compared to $4.4 million for the nine months
ended September 30, 2022, an increase of $0.7 million. The increase is related to revenues under the Cipla Agreement during the period.
Research
and development expenses — Research and development expenses were $12.0 million for the nine months ended September 30,
2023, as compared to $13.8 million for the nine months ended September 30, 2022, a decrease of approximately $1.8 million. The decrease
was primarily due to decreased spend of $2.1 million in costs related to our PUR3100 program and $0.5 million in costs related to our
PUR1800 program, partially offset by increased spend of $0.7 million in costs related to our PUR1900 program and $0.1 million of employment
and operating costs.
General
and administrative expenses — General and administrative expenses were $5.6 million for the nine months ended September
30, 2023, as compared to $5.2 million for the nine months ended September 30, 2022, an increase of $0.4 million. The increase was primarily
due to an increase in incurred legal and professional services costs, partially offset by a decrease in personnel costs.
Liquidity
and Capital Resources
Through
September 30, 2023, we incurred an accumulated deficit of $285.5 million, primarily as a result of expenses incurred through a combination
of research and development activities related to our various product candidates and general and administrative expenses supporting those
activities. We have financed our operations since inception primarily through the sale of preferred and common stock, the issuance of
convertible promissory notes, term loans, and collaboration and license agreements. Our total cash and cash equivalents balance as of
September 30, 2023 was $21.3 million.
We
anticipate that we will continue to incur losses, and that such losses will increase over the next several years due to development costs
associated with our iSPERSE™ pipeline programs. We expect that our research and development and general and administrative expenses
will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination
of equity offerings, debt financings, other third-party funding and other collaborations and strategic alliances. We are currently exploring
financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100.
We
expect that our existing cash and cash equivalents as of September 30, 2023 will enable us to fund our operating expenses and capital
expenditure requirements for at least the next 12 months following the date of this Quarterly Report on Form 10-Q and into the first
quarter of 2025. Such projections do not include any contingent milestone payments but do include operational efficiencies and prioritization
of spending implemented in the second quarter of 2023. 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, achievement of contingent milestones and commercialization of pharmaceutical
products, we are unable to estimate the exact amount of our operating capital requirements.
We
have no material off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources
that is material to investors.
The
following table sets forth the major sources and uses of cash for each of the periods set forth below (in thousands):
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Net cash used in operating activities | |
$ | (13,974 | ) | |
| (14,310 | ) |
Net cash used in investing activities | |
| (371 | ) | |
| (77 | ) |
Net cash provided by financing activities | |
| 53 | | |
| 1,230 | |
Net decrease in cash, cash equivalents, and restricted cash | |
$ | (14,292 | ) | |
| (13,157 | ) |
Net
cash used in operating activities
Net
cash used in operating activities for the nine months ended September 30, 2023 was $14.0 million, which was primarily the result of a
net loss of $12.0 million and $4.0 million in cash outflows associated with changes in operating assets and liabilities, partially offset
by $2.0 million of net non-cash adjustments.
Net
cash used in operating activities for the nine months ended September 30, 2022 was $14.3 million, which was primarily the result of a
net loss of $14.6 million and $1.7 million in cash outflows associated with changes in operating assets and liabilities, partially offset
by $2.0 million of net non-cash adjustments.
Net
cash used in investing activities
Net
cash used in investing activities for the nine months ended September 30, 2023 and 2022 was due to purchases of property and equipment.
Net
cash provided by financing activities
Net
cash provided by financing activities for the nine months ended September 30, 2023 resulted from proceeds from the issuance of common
stock, net of issuance costs, under the ATM Offering.
Net
cash provided by financing activities for the nine months ended September 30, 2022 resulted from proceeds from the issuance of common
stock, net of issuance costs, partially offset by the payment of preferred stock issuance costs from a registered direct offering in
December 2021.
Financings
In
May 2021, we entered into the Sales Agreement with HCW to act as our sales agent with respect to the issuance and sale of up to $20,000,000
of our shares of common stock, from time to time in an ATM Offering. Sales of common stock under the Sales Agreement are made pursuant
to an effective shelf registration statement on Form S-3, which was filed with the SEC on May 26, 2021, and subsequently declared effective
on June 9, 2021 (File No. 333-256502), and a related prospectus. HCW acts as our sales agent on a commercially reasonable efforts basis,
consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of
Nasdaq. If expressly authorized by us, HCW may also sell our common stock in privately negotiated transactions. There is no specific
date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds
of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the
gross proceeds from the sale of our common stock pursuant to the Sales Agreement. During the nine
months ended September 30, 2023, we sold 13,100 shares of common stock under the Sales Agreement at a weighted-average price of approximately
$4.25 per share, which resulted in net proceeds of approximately $53 thousand.
Known
Trends, Events and Uncertainties
In
May 2023, the World Health Organization determined that COVID-19 no longer fit the definition of a public health emergency and the
U.S. government announced its plan to let the declaration of a public health emergency associated with COVID-19 expire on May 11,
2023. The COVID-19 endemic and its ongoing effects are expected to remain a serious endemic threat for an indefinite future period
and may continue to create significant economic uncertainty and volatility in the credit and capital markets, supply
chain issues, global shortages of supplies, materials and products, and contribute to rising global inflation. In addition, the
ongoing conflict between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions and countermeasures, are difficult to predict, and could
adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which
may in turn adversely affect our business and operations. We may not be able to raise sufficient additional capital and may
tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there
is no assurance that these initiatives will be successful.
Other
than as discussed above and elsewhere in this report, we are not aware of any trends, events or uncertainties that are likely to have
a material effect on our financial condition.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
Our
Principal Executive Officer and Principal Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures
(as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”))
as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure
controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit
under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and
forms, and is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer
as appropriate to allow timely decisions regarding required disclosure.
In
designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management
necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes
in Internal Controls over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2023 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time, we may be involved in litigation that arises through the normal course of business. As of the date of this filing, we are
not aware of any material legal proceedings to which we or any of our subsidiaries is a party or to which any of our property is subject,
nor are we aware of any such threatened or pending litigation or any such proceedings known to be contemplated by governmental authorities.
We
are not aware of any material proceedings in which any of our directors, officers, or affiliates or any registered or beneficial stockholder
of more than 5% of our common stock, or any associate of any of the foregoing, is a party adverse to or has a material interest adverse
to, us or any of our subsidiaries.
Item
1A. Risk Factors.
Investing
in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in Part I, Item
1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 in addition to
the other information included in this Form 10-Q before making an investment decision regarding our common stock. If any of these risks
actually occur, our business, financial condition, or operating results would likely suffer, possibly materially, the trading price of
our common stock could decline, and you could lose part or all of your investment.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
|
(a) |
Unregistered Sales of
Equity Securities |
None.
|
(b) |
Issuer Purchases of
Equity Securities. |
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
None.
Item
6. Exhibits.
See
“Index to Exhibits” following the signature page to this Form 10-Q for a list of exhibits filed or furnished with this Form
10-Q.
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.
|
PULMATRIX, INC. |
|
|
|
Date: November 9, 2023 |
By: |
/s/ Teofilo
Raad |
|
|
Teofilo Raad |
|
|
Chief Executive Officer
and President |
|
|
(Principal Executive
Officer) |
|
|
|
Date: November 9, 2023 |
By: |
/s/ Peter
Ludlum |
|
|
Peter Ludlum |
|
|
Interim Chief Financial
Officer |
|
|
(Principal Financial
and Accounting Officer) |
INDEX
TO EXHIBITS
Exhibit
31.1
CERTIFICATIONS
UNDER SECTION 302
I,
Teofilo Raad, certify that:
1. |
I have reviewed
this Quarterly Report on Form 10-Q of Pulmatrix, 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: November 9, 2023 |
|
|
|
/s/ Teofilo
Raad |
|
Teofilo Raad |
|
President and Chief Executive Officer |
|
(Principal Executive Officer) |
|
Exhibit
31.2
CERTIFICATIONS
UNDER SECTION 302
I,
Peter Ludlum, certify that:
1. |
I have reviewed
this Quarterly Report on Form 10-Q of Pulmatrix, 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: November 9, 2023 |
|
|
|
/s/ Peter
Ludlum |
|
Peter Ludlum |
|
Interim Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
|
Exhibit
32.1
CERTIFICATIONS
UNDER SECTION 906
Pursuant
to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code),
each of the undersigned officers of Pulmatrix, Inc., a Delaware corporation (the “Company”), does hereby certify, to such
officer’s knowledge and in the capacity of an officer, that:
The
Quarterly Report for the quarter ended September 30, 2023 (the “Form 10-Q”) of the Company fully complies with the requirements
of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in
all material respects, the financial condition and results of operations of the Company as of, and for, the periods presented in the
Form 10-Q.
Date: November
9, 2023 |
By: |
/s/
Teofilo Raad |
|
|
Teofilo Raad |
|
|
President
and Chief Executive Officer
(Principal
Executive Officer) |
|
|
|
Date: November 9, 2023 |
By: |
/s/ Peter
Ludlum |
|
|
Peter Ludlum |
|
|
Interim Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 06, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-36199
|
|
Entity Registrant Name |
PULMATRIX,
INC.
|
|
Entity Central Index Key |
0001574235
|
|
Entity Tax Identification Number |
46-1821392
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
36
Crosby Drive
|
|
Entity Address, Address Line Two |
Suite 100
|
|
Entity Address, City or Town |
Bedford
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
01730
|
|
City Area Code |
(781)
|
|
Local Phone Number |
357-2333
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
PULM
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
3,652,285
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v3.23.3
Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 21,336
|
$ 35,628
|
Restricted cash |
153
|
153
|
Accounts receivable |
841
|
1,298
|
Prepaid expenses and other current assets |
899
|
1,068
|
Total current assets |
23,229
|
38,147
|
Property and equipment, net |
1,166
|
235
|
Operating lease right-of-use asset |
10,686
|
710
|
Long-term restricted cash |
1,472
|
1,472
|
Other long-term assets |
217
|
389
|
Total assets |
36,770
|
40,953
|
Current liabilities: |
|
|
Accounts payable |
707
|
1,188
|
Accrued expenses and other current liabilities |
2,535
|
1,638
|
Operating lease liability |
199
|
857
|
Deferred revenue |
988
|
1,339
|
Total current liabilities |
4,429
|
5,022
|
Deferred revenue, net of current portion |
4,038
|
4,822
|
Operating lease liability, net of current portion |
8,422
|
|
Total liabilities |
16,889
|
9,844
|
Commitments and contingencies (Note 11) |
|
|
Stockholders’ equity: |
|
|
Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2023 and December 31, 2022 |
|
|
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 and 3,639,185 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively |
|
|
Additional paid-in capital |
305,395
|
304,585
|
Accumulated deficit |
(285,514)
|
(273,476)
|
Total stockholders’ equity |
19,881
|
31,109
|
Total liabilities and stockholders’ equity |
$ 36,770
|
$ 40,953
|
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v3.23.3
Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
500,000
|
500,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
3,652,285
|
3,639,185
|
Common stock, shares outstanding |
3,652,285
|
3,639,185
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
6,746
|
6,746
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 1,753
|
$ 1,872
|
$ 5,096
|
$ 4,363
|
Operating expenses |
|
|
|
|
Research and development |
3,963
|
5,287
|
12,002
|
13,773
|
General and administrative |
1,729
|
1,685
|
5,609
|
5,212
|
Total operating expenses |
5,692
|
6,972
|
17,611
|
18,985
|
Loss from operations |
(3,939)
|
(5,100)
|
(12,515)
|
(14,622)
|
Other income (expense) |
|
|
|
|
Interest income |
217
|
102
|
675
|
118
|
Other expense, net |
(52)
|
(54)
|
(198)
|
(116)
|
Total other income, net |
165
|
48
|
477
|
2
|
Net loss |
$ (3,774)
|
$ (5,052)
|
$ (12,038)
|
$ (14,620)
|
Net loss per share attributable to common stockholders basic |
$ (1.03)
|
$ (1.45)
|
$ (3.30)
|
$ (4.32)
|
Net loss per share attributable to common stockholders diluted |
$ (1.03)
|
$ (1.45)
|
$ (3.30)
|
$ (4.32)
|
Weighted average common shares outstanding basic |
3,652,285
|
3,478,157
|
3,651,785
|
3,383,171
|
Weighted average common shares outstanding diluted |
3,652,285
|
3,478,157
|
3,651,785
|
3,383,171
|
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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v3.23.3
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
$ 1,081
|
|
$ 301,008
|
$ (254,640)
|
$ 47,449
|
Balance, shares at Dec. 31, 2021 |
1,830
|
3,222,037
|
|
|
|
Stock-based compensation |
|
|
281
|
|
281
|
Net loss |
|
|
|
(4,973)
|
(4,973)
|
Conversion of preferred stock to common stock |
$ (541)
|
|
541
|
|
|
Conversion of preferred stock to common stock, shares |
(915)
|
76,250
|
|
|
|
Adjustment due to reverse stock split |
|
|
|
|
|
Adjustment due to reverse stock split, shares |
|
12,635
|
|
|
|
Balance at Mar. 31, 2022 |
$ 540
|
|
301,830
|
(259,613)
|
42,757
|
Balance, shares at Mar. 31, 2022 |
915
|
3,310,922
|
|
|
|
Balance at Dec. 31, 2021 |
$ 1,081
|
|
301,008
|
(254,640)
|
47,449
|
Balance, shares at Dec. 31, 2021 |
1,830
|
3,222,037
|
|
|
|
Net loss |
|
|
|
|
(14,620)
|
Balance at Sep. 30, 2022 |
|
|
304,306
|
(269,260)
|
35,046
|
Balance, shares at Sep. 30, 2022 |
|
3,639,185
|
|
|
|
Balance at Mar. 31, 2022 |
$ 540
|
|
301,830
|
(259,613)
|
42,757
|
Balance, shares at Mar. 31, 2022 |
915
|
3,310,922
|
|
|
|
Stock-based compensation |
|
|
277
|
|
277
|
Net loss |
|
|
|
(4,595)
|
(4,595)
|
Conversion of preferred stock to common stock |
$ (540)
|
|
540
|
|
|
Conversion of preferred stock to common stock, shares |
(915)
|
76,250
|
|
|
|
Balance at Jun. 30, 2022 |
|
|
302,647
|
(264,208)
|
38,439
|
Balance, shares at Jun. 30, 2022 |
|
3,387,172
|
|
|
|
Issuance of common stock, net of issuance costs |
|
|
1,382
|
|
1,382
|
Issuance of common stock, net of issuance costs, shares |
|
252,013
|
|
|
|
Stock-based compensation |
|
|
277
|
|
277
|
Net loss |
|
|
|
(5,052)
|
(5,052)
|
Balance at Sep. 30, 2022 |
|
|
304,306
|
(269,260)
|
35,046
|
Balance, shares at Sep. 30, 2022 |
|
3,639,185
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
304,585
|
(273,476)
|
31,109
|
Balance, shares at Dec. 31, 2022 |
|
3,639,185
|
|
|
|
Issuance of common stock, net of issuance costs |
|
|
53
|
|
53
|
Issuance of common stock, net of issuance costs, shares |
|
13,100
|
|
|
|
Stock-based compensation |
|
|
296
|
|
296
|
Net loss |
|
|
|
(4,448)
|
(4,448)
|
Balance at Mar. 31, 2023 |
|
|
304,934
|
(277,924)
|
27,010
|
Balance, shares at Mar. 31, 2023 |
|
3,652,285
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
304,585
|
(273,476)
|
31,109
|
Balance, shares at Dec. 31, 2022 |
|
3,639,185
|
|
|
|
Net loss |
|
|
|
|
(12,038)
|
Balance at Sep. 30, 2023 |
|
|
305,395
|
(285,514)
|
19,881
|
Balance, shares at Sep. 30, 2023 |
|
3,652,285
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
304,934
|
(277,924)
|
27,010
|
Balance, shares at Mar. 31, 2023 |
|
3,652,285
|
|
|
|
Stock-based compensation |
|
|
255
|
|
255
|
Net loss |
|
|
|
(3,816)
|
(3,816)
|
Balance at Jun. 30, 2023 |
|
|
305,189
|
(281,740)
|
23,449
|
Balance, shares at Jun. 30, 2023 |
|
3,652,285
|
|
|
|
Stock-based compensation |
|
|
206
|
|
206
|
Net loss |
|
|
|
(3,774)
|
(3,774)
|
Balance at Sep. 30, 2023 |
|
|
$ 305,395
|
$ (285,514)
|
$ 19,881
|
Balance, shares at Sep. 30, 2023 |
|
3,652,285
|
|
|
|
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v3.23.3
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (12,038)
|
$ (14,620)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
96
|
123
|
Amortization of operating lease right-of-use asset |
1,171
|
1,033
|
Stock-based compensation |
757
|
835
|
Loss on disposal of property and equipment |
8
|
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
457
|
(409)
|
Prepaid expenses and other current assets |
169
|
(1,042)
|
Other long-term assets |
172
|
(428)
|
Accounts payable |
(481)
|
478
|
Accrued expenses and other current liabilities |
233
|
1,515
|
Operating lease liability |
(3,383)
|
(1,007)
|
Deferred revenue |
(1,135)
|
(788)
|
Net cash used in operating activities |
(13,974)
|
(14,310)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(371)
|
(77)
|
Net cash used in investing activities |
(371)
|
(77)
|
Cash flows from financing activities: |
|
|
Proceeds from issuance of common stock, net of issuance costs |
53
|
1,382
|
Preferred stock issuance costs |
|
(152)
|
Net cash provided by financing activities |
53
|
1,230
|
Net decrease in cash, cash equivalents and restricted cash |
(14,292)
|
(13,157)
|
Cash, cash equivalents and restricted cash — beginning of period |
37,253
|
55,465
|
Total cash, cash equivalents and restricted cash |
22,961
|
42,308
|
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: |
|
|
Cash and cash equivalents |
21,336
|
40,683
|
Restricted cash |
153
|
153
|
Long-term restricted cash |
1,472
|
1,472
|
Supplemental disclosures of non-cash investing and financing information: |
|
|
Operating lease right-of-use asset obtained in exchange for operating lease liability |
9,323
|
|
Purchases of property and equipment not yet paid |
664
|
|
Conversion of preferred stock to common stock |
|
$ 1,081
|
X |
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v3.23.3
Organization
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
1.
Organization
Pulmatrix,
Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical-stage biopharmaceutical
company focused on the development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery
platform, iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense
particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies
and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE™-based
therapeutic candidates targeted at prevention and treatment of a range of respiratory and other diseases with significant unmet medical
needs.
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v3.23.3
Summary of Significant Accounting Policies and Recent Accounting Standards
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies and Recent Accounting Standards |
2.
Summary of Significant Accounting Policies and Recent Accounting Standards
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “Annual Report”).
The
financial information as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, is unaudited. In
the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation
of the interim financial information have been included. The balance sheet data as of December 31, 2022 was derived from audited consolidated
financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results
that may be expected for any other interim period or for a full fiscal year.
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required 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, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive and recognize revenue, estimates related
to clinical trial accruals and upfront deposits, incremental borrowing rate, and accounting for income taxes and the related valuation
allowance.
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and nine months ended September 30, 2023, revenue from one customer accounted for 100% of revenue recognized in the accompanying
condensed consolidated financial statements. For the three and nine months ended September 30, 2022, revenue from one customer accounted
for approximately 99% of revenue recognized in the accompanying condensed consolidated financial statements. As of September 30, 2023
and December 31, 2022, one customer accounted for 100% of accounts receivable.
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the nine months ended September 30, 2023, the Company did not make any changes to its significant
accounting policies, except as described below with respect to recent accounting pronouncements.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt
any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its condensed consolidated
financial statements.
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) ASU 2016-13, Financial Instruments—Credit Losses
(Topic 326)—Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which has been subsequently
amended. The provisions of ASU 2016-13 modify the impairment model for financial instruments to utilize an expected loss methodology
in place of the currently used incurred loss methodology and require consideration of a broader range of reasonable and supportable information
to inform credit loss estimates. The Company adopted the standard as of January 1, 2023. The adoption of this standard did not have a
material effect on the Company’s condensed consolidated financial statements.
As
of September 30, 2023, there are no new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
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v3.23.3
Fair Value of Financial Instruments
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value of Financial Instruments |
3.
Fair Value of Financial Instruments
As
of September 30, 2023 and December 31, 2022, the Company did not hold any financial assets or liabilities that were measured at fair
value on a recurring or nonrecurring basis. During the nine months ended September 30, 2023, there were no transfers between Level 1,
Level 2 and Level 3.
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v3.23.3
Prepaid Expenses and Other Current Assets
|
9 Months Ended |
Sep. 30, 2023 |
Prepaid Expenses And Other Current Assets |
|
Prepaid Expenses and Other Current Assets |
4.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
September 30, 2023 | | |
December 31, 2022 | |
Insurance | |
$ | 361 | | |
$ | 286 | |
Software and hosting costs | |
| 83 | | |
| 99 | |
Clinical and consulting | |
| 50 | | |
| 517 | |
Other | |
| 405 | | |
| 166 | |
Total prepaid expenses and other current assets | |
$ | 899 | | |
$ | 1,068 | |
|
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v3.23.3
Property and Equipment, Net
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
5.
Property and Equipment, Net
Property
and equipment, net consisted of the following:
Schedule of Property and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Laboratory equipment | |
$ | 1,639 | | |
$ | 1,827 | |
Capital in progress | |
| 600 | | |
| - | |
Office furniture and equipment | |
| 387 | | |
| 217 | |
Computer equipment | |
| 237 | | |
| 275 | |
Leasehold improvements | |
| - | | |
| 664 | |
Total property and equipment | |
| 2,863 | | |
| 2,983 | |
Less accumulated depreciation and amortization | |
| (1,697 | ) | |
| (2,748 | ) |
Property and equipment, net | |
$ | 1,166 | | |
$ | 235 | |
Depreciation
and amortization expense for the nine months ended September 30, 2023 and 2022 was $96 and $123, respectively. During the nine months
ended September 30, 2023 and 2022, the Company disposed of certain property and equipment primarily in connection with moving to its
new office, resulting in a loss on disposal of $8.
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v3.23.3
Accrued Expenses and Other Current Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
6.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
September 30, 2023 | | |
December 31, 2022 | |
Wages and incentives | |
$ | 904 | | |
$ | 1,130 | |
Clinical and consulting | |
| 704 | | |
| 475 | |
Accrued purchases of property and equipment | |
| 664 | | |
| - | |
Legal and patents | |
| 49 | | |
| - | |
Other | |
| 214 | | |
| 33 | |
Total accrued expenses and other current liabilities | |
$ | 2,535 | | |
$ | 1,638 | |
|
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v3.23.3
Significant Agreements
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Significant Agreements |
7.
Significant Agreements
Development
and Commercialization Agreement with Cipla Technologies LLC (“Cipla”)
On
April 15, 2019, the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla
for the co-development and commercialization, on a worldwide exclusive basis, of PUR1900, the Company’s inhaled iSPERSE™
drug delivery system (the “Product”) enabled formulation of the antifungal drug, itraconazole, which is only available
as an oral drug, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis (“ABPA”)
in patients with asthma. The Company entered into an amendment to the Cipla Agreement on November 8, 2021 (the “Amendment”),
and all references to the Cipla Agreement herein refer to the Cipla Agreement, as amended.
The
Company received a non-refundable upfront payment of $22.0 million (the “Upfront Payment”) under the Cipla Agreement. Upon
receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers
the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”):
all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory
materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly
related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding
most specifically the Company’s iSPERSE™ technology. A portion of the Upfront Payment was deposited by
the Company into a bank account, along with an equal amount from the Company, and was dedicated to the development of the Product (the
“Initial Development Funding”). The Initial Development Funding was depleted during the year ended December 31, 2021, and
the Company and Cipla are now each responsible for a portion of the development costs actually incurred as described below (the “Co-Development
Phase”).
Pursuant
to the Amendment, the Company and Cipla will each initially be responsible for 60% and 40%, respectively, of the Company’s overhead
costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”).
Upon the achievement of each development milestone set forth in the table below, Cipla will reimburse the Company an amount equal to
10% of the cumulative aggregate Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially
bringing the sharing of Direct Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will
continue to aggregate and be reimbursed by Cipla to the Company if the Company achieves the subsequent development milestone for that
trial set forth in the table below. The Company will share all other development costs with Cipla that are not Direct Costs, such as
the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis.
Phase
2b Development Plan – Development Milestones |
|
Development
Milestone |
|
Milestone
Date |
|
|
|
25%
of patients enrolled in Phase 2b clinical study are dosed |
|
June
30, 2023 |
|
|
|
Company
delivers summary of key efficacy and safety data to include FEV1, IgE, ACQ-6, number of subjects withdrawn, any severe
adverse events related to the medication and an overall summary table of adverse events (“Topline Results”) to the joint
steering committee (“JSC”) |
|
June
30, 2024 |
Phase
3 Development Plan – Development Milestones |
|
Development
Milestone |
|
Milestone
Date |
|
|
|
25%
of patients enrolled in Phase 3 clinical study dosed |
|
To
be proposed by JSC |
|
|
|
Company
delivers Topline Results to the JSC |
|
To
be proposed by JSC |
|
|
|
The
Prescription Drug User Fee Act |
|
To
be proposed by JSC |
As
of November 6, 2023, the Company has dosed 25% of patients by the date of this report but this first Phase 2b development milestone
was not achieved by June 30, 2023. Delayed regulatory approval in certain foreign jurisdictions and slower than expected enrollment
contributed to missing this milestone. The associated cumulative aggregated Holdback Payment (as defined herein) could still have
been reimbursed by Cipla to the Company if the Company achieved the subsequent development milestone of delivering topline data by
June 30, 2024. However, as the Company is currently anticipating topline results in the second half of 2024, after the related June
30, 2024 milestone date has passed, the Company currently expects that it will therefore not be reimbursed the aggregated Holdback Payment. All such previously referred to regulatory approvals
in this paragraph have since been obtained and enrollment is ongoing.
Accounting
Treatment
The
Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks
and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of Accounting Standards Codification
(“ASC”) 808, Collaborative Arrangements (“ASC 808”). The Company concluded that Cipla is a customer since
they contracted with the Company to obtain research and development services and a license to the Assigned Assets, each of which is an
output of the Company’s ordinary activities, in exchange for consideration. Therefore, the Company has applied the guidance in
ASC 606, Revenue from Contracts with Customers (“ASC 606”) to account for the research and development services and
a license within the contract. The Company determined that the research and development services and license to the Assigned Assets are
considered highly interdependent and highly interrelated and therefore are considered a single combined performance obligation because
Cipla cannot benefit from the license without the performance by the Company of the research and development services. Such research
and development services are highly specialized and proprietary to the Company and therefore not available to Cipla from any other third
party.
The
Company initially determined the total transaction price to be $22.0 million – comprised of $12.0 million for research and development
services for the Product and $10.0 million for the irrevocable license to the Assigned Assets. Any consideration related to the Co-Development
Phase was not initially included in the transaction price as such amounts are subject to the variable consideration constraint. Additionally,
upon commercialization, Cipla and the Company will share equally, both positive and negative total free cash-flows earned by Cipla in
respect of the Product. However, the Company has not included such free cash-flows in the transaction price as these milestones are constrained
until after the commercialization of the Product.
The
Company concluded that the Amendment represented a contract modification that is treated for accounting purposes as the termination of
the Cipla Agreement and a creation of a new contract (the “Amended Cipla Agreement”). Accordingly, the modification is accounted
for on a prospective basis. The total transaction price for the Amended Cipla Agreement includes variable consideration from the Amendment
as well as $7.4 million deferred under the Cipla Agreement as of the Amendment execution date.
Revenue
is recognized for the Amended Cipla Agreement as the research and development services are provided using an input method, according
to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the Company’s obligations. In
management’s judgment, this input method is the best measure of the transfer of control of the combined performance obligation.
The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated
balance sheets, with amounts expected to be recognized in the next 12 months recorded as current.
During
the three and nine months ended September 30, 2023, the Company recognized $1.8 million and $5.1 million, respectively, in revenue related
to the research and development services and irrevocable license to the Assigned Assets in the Company’s consolidated statements
of operations. Of the revenue recognized during the three and nine months ended September 30, 2023, $0.2 million and $0.8 million, respectively,
was included in deferred revenue at the beginning of the period. As of September 30, 2023, the aggregate transaction price related to
the Company’s unsatisfied obligations was $5.0 million and was recorded in deferred revenue, $1.0 million of which was current.
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v3.23.3
Common Stock
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Common Stock |
8.
Common Stock
In
May 2021, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with H.C. Wainwright and Co.,
LLC (“HCW”) to act as the Company’s sales agent with respect to the issuance and sale of up to $20.0 million of the
Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM Offering”). Sales
of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed
with the SEC on May 26, 2021, and subsequently declared effective on June 9, 2021 (File No. 333-256502), and a related prospectus. HCW
acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices
and applicable state and federal laws, rules and regulations and the rules of The NASDAQ Capital Market (“Nasdaq”). If expressly
authorized by the Company, HCW may also sell the Company’s common stock in privately negotiated transactions. There is no specific
date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds
of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the
gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.
During
the nine months ended September 30, 2023, the Company sold 13,100 shares of its common stock under the Sales Agreement at a weighted-average
price of approximately $4.25 per share, which resulted in net proceeds of approximately $53 thousand.
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v3.23.3
Warrants
|
9 Months Ended |
Sep. 30, 2023 |
Warrants |
|
Warrants |
9.
Warrants
There
were no warrants issued or exercised during the nine months ended September 30, 2023. Warrants to purchase up to 123,310 shares of common
stock at $149.99 per share expired during the nine months ended September 30, 2023. The following represents a summary of the warrants
outstanding and exercisable at September 30, 2023, all of which are equity-classified:
Schedule of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
April 8, 2019 | |
$ | 26.99 | | |
April 8, 2024 | |
| 65,907 | | |
| 65,907 | |
April 8, 2019 | |
$ | 33.74 | | |
April 3, 2024 | |
| 39,871 | | |
| 39,871 | |
February 12, 2019 | |
$ | 36.62 | | |
February 7, 2024 | |
| 5,548 | | |
| 5,548 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
February 4, 2019 | |
$ | 42.49 | | |
January 30, 2024 | |
| 1,732 | | |
| 1,732 | |
January 31, 2019 | |
$ | 42.49 | | |
January 26, 2024 | |
| 511 | | |
| 511 | |
December 3, 2018 | |
$ | 77.99 | | |
June 3, 2024 | |
| 46,876 | | |
| 46,876 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,161,493 | | |
| 1,145,538 | |
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v3.23.3
Stock-based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based Compensation |
10.
Stock-based Compensation
The
Company sponsors the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan (the “Incentive
Plan”). As of September 30, 2023, the Incentive Plan provided for the grant of up to 636,322 shares of the Company’s common
stock, of which 267,541 shares remained available for future grant. In addition, the Company sponsors two legacy plans under which no
additional awards may be granted. As of September 30, 2023, the two legacy plans have a total of 32 options outstanding, all of which
are fully vested and for which common stock will be issued upon exercise.
The
following table summarizes stock option activity for the nine months ended September 30, 2023:
Summary of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2023 | |
| 304,823 | | |
$ | 28.66 | | |
| 7.98 | | |
$ | - | |
Granted | |
| 118,472 | | |
$ | 3.98 | | |
| | | |
| | |
Forfeited or expired | |
| (58,320 | ) | |
$ | 19.96 | | |
| | | |
| | |
Outstanding — September 30, 2023 | |
| 364,975 | | |
$ | 22.04 | | |
| 7.74 | | |
$ | - | |
Exercisable — September 30, 2023 | |
| 208,835 | | |
$ | 32.51 | | |
| 7.02 | | |
$ | - | |
The
Company records stock-based compensation expense related to stock options based on their grant-date fair value. During the nine months
ended September 30, 2023 and 2022, the Company used the Black-Scholes option-pricing model to estimate the fair value of stock option
grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards
represent management’s best estimates. The weighted-average grant-date fair value of options granted during the nine months ended
September 30, 2023 was $3.27 per share. The weighted-average assumptions used in determining fair value of the stock options for the
nine months ended September 30, 2023 and 2022 are as follows:
Schedule of Calculation of Fair Value Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected option life (years) | |
| 6.0 | | |
| 6.0 | |
Risk-free interest rate | |
| 3.53 | % | |
| 2.03 | % |
Expected volatility | |
| 104.24 | % | |
| 113.28 | % |
Expected dividend yield | |
| - | % | |
| - | % |
The
expected life of the Company’s options was determined using the simplified method as a result of limited historical data regarding
the Company’s activity. The risk-free interest rate was obtained from U.S. Treasury rates for the expected life of the stock options.
The Company’s expected volatility was based upon the historical volatility of the Company’s common stock. The dividend yield
considers that the Company has not historically paid dividends and does not expect to pay dividends in the foreseeable future.
As
of September 30, 2023, there was $1.0 million of unrecognized stock-based compensation expense related to unvested stock options granted
under the Company’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately
2.0 years.
The
following table presents total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022:
Schedule of Stock-based Compensation Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 57 | | |
$ | 65 | | |
$ | 188 | | |
$ | 189 | |
General and administrative | |
| 149 | | |
| 212 | | |
| 569 | | |
| 646 | |
Total stock-based compensation expense | |
$ | 206 | | |
$ | 277 | | |
$ | 757 | | |
$ | 835 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
11.
Commitments and Contingencies
Research
and Development Activities
The
Company contracts with various other organizations to conduct research and development activities, including clinical trials. As of September
30, 2023, the Company had aggregate commitments to pay approximately $4.0 million remaining on these contracts, of which the Company
expects to be reimbursed $2.0 million under the Cipla Agreement. Of the gross amount of $4.0 million in commitments, $3.8 million is
expected to be incurred over the next 12 months. The scope of the services under contracts for research and development activities may
be modified and the contracts, subject to certain conditions, may generally be cancelled by the Company upon written notice. In some
instances, the contracts, subject to certain conditions, may be cancelled by the third party.
Legal
Proceedings
In
the ordinary course of its business, the Company may be involved in various legal proceedings involving contractual and employment relationships,
patent or other intellectual property rights, and a variety of other matters. The Company is not aware of any pending legal proceedings
that would reasonably be expected to have a material impact on the Company’s financial position or results of operations.
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v3.23.3
Leases
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
Leases |
12.
Leases
New
Corporate Headquarters
The
Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during
the nine months ended September 30, 2023. On January 7, 2022, the Company executed a lease agreement with Cobalt Propco 2020, LLC for
its new corporate headquarters at 36 Crosby Drive, Bedford, Massachusetts. The leased premises comprise approximately 20,000 square feet
of office and lab space, and the lease provides for base rent of $0.1 million per month, expected to begin in December 2023, which will
increase 3% each year over the ten-year noncancellable term. The Company has the option to extend the lease for one additional five-year
term and is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises.
The
lease commenced on August 1, 2023, following substantial completion of construction to prepare the premises for the Company’s
use, and the Company has included the lease as a component of its operating lease right-of-use asset and operating lease liabilities
upon commencement. The improvements to prepare the leased premises for the Company’s intended use have been funded by (i) the
landlord, through a tenant allowance of $3.9
million, (ii) a landlord-funded advance on tenant improvements of $0.5
million which will be repaid over the lease term, and (iii) approximately $2.4
million funded by the Company.
Other
Leasing Activities
During
the first quarter of 2023, the Company executed a two-month lease extension for its previous corporate headquarters in Lexington, Massachusetts,
through August 31, 2023. The Company terminated that lease extension, as planned, during the third quarter of 2023.
The
Company also leases small office equipment which is primarily short-term or immaterial in nature. Therefore, no right-of-use assets and
lease liabilities are recognized for these leases.
The
components of lease expense for the Company for the three and nine months ended September 30, 2023 and 2022 were as follows:
Schedule of Components of Lease Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 553 | | |
$ | 357 | | |
$ | 1,349 | | |
$ | 1,072 | |
Variable lease cost | |
| 203 | | |
| 206 | | |
| 484 | | |
| 556 | |
Total lease cost | |
$ | 756 | | |
$ | 563 | | |
$ | 1,833 | | |
$ | 1,628 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 2,699 | | |
$ | 431 | | |
$ | 3,562 | | |
$ | 1,046 | |
Weighted-average remaining lease term — operating leases | |
| | | |
| | | |
| 10.2 years | | |
| | |
Weighted-average discount rate — operating leases | |
| | | |
| | | |
| 11.00 | % | |
| | |
Maturities
of lease liabilities due under these lease agreements as of September 30, 2023 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2023 (three months) | |
$ | 171 | |
2024 | |
| 1,289 | |
2025 | |
| 1,326 | |
2026 | |
| 1,364 | |
2027 | |
| 1,402 | |
2028 and thereafter | |
| 9,154 | |
Total lease payments | |
| 14,706 | |
Less: interest | |
| (6,085 | ) |
Total lease liabilities | |
$ | 8,621 | |
| |
| | |
Reported as of September 30, 2023 | |
| | |
Lease liabilities — short term | |
$ | 199 | |
Lease liabilities — long term | |
| 8,422 | |
Total lease liabilities | |
$ | 8,621 | |
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
13.
Income Taxes
The
Company had no income tax expense due to operating losses incurred for the three and nine months ended September 30, 2023 and 2022.
Management
of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined
that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation
allowance was recorded as of September 30, 2023 and December 31, 2022.
The
Company applies ASC 740, Income Taxes, for the financial statement recognition, measurement, presentation, and disclosure of uncertain
tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves
have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect
of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. The
Company has no material uncertain tax positions as of September 30, 2023 and December 31, 2022.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Net Loss Per Share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
14.
Net Loss Per Share
Basic
and diluted earnings (loss) per share are computed using the two-class method, which is an earnings allocation method that determines
earnings (loss) per share for common shares and participating securities. The participating securities consist of the Company’s
Series A Preferred Stock. The undistributed earnings are allocated between common shares and participating securities as if all earnings
had been distributed during the period. In periods of loss, no allocation is made to the Series A Preferred Stock and diluted net loss
per share is the same as basic net loss per share because common stock equivalents are excluded as their inclusion would be antidilutive.
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an antidilutive impact:
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | |
Options to purchase common stock | |
| 364,975 | | |
| 307,918 | |
Warrants to purchase common stock | |
| 1,161,493 | | |
| 1,284,803 | |
Total potentially dilutive securities excluded | |
| 1,526,468 | | |
| 1,592,721 | |
|
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
15.
Subsequent Events
The
Company has completed an evaluation of all subsequent events after the balance sheet date of September 30, 2023 through the date the
condensed consolidated financial statements were issued to ensure that the condensed consolidated financial statements include appropriate
disclosure of events both recognized in the condensed consolidated financial statements as of September 30, 2023, and events which occurred
subsequently but were not recognized in the condensed consolidated financial statements. The Company has concluded that no subsequent
events have occurred that require disclosure, except as disclosed within the condensed consolidated financial statements.
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v3.23.3
Summary of Significant Accounting Policies and Recent Accounting Standards (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “Annual Report”).
The
financial information as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, is unaudited. In
the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation
of the interim financial information have been included. The balance sheet data as of December 31, 2022 was derived from audited consolidated
financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results
that may be expected for any other interim period or for a full fiscal year.
|
Use of Estimates |
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required 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, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive and recognize revenue, estimates related
to clinical trial accruals and upfront deposits, incremental borrowing rate, and accounting for income taxes and the related valuation
allowance.
|
Concentrations of Credit Risk |
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and nine months ended September 30, 2023, revenue from one customer accounted for 100% of revenue recognized in the accompanying
condensed consolidated financial statements. For the three and nine months ended September 30, 2022, revenue from one customer accounted
for approximately 99% of revenue recognized in the accompanying condensed consolidated financial statements. As of September 30, 2023
and December 31, 2022, one customer accounted for 100% of accounts receivable.
|
Summary of Significant Accounting Policies |
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the nine months ended September 30, 2023, the Company did not make any changes to its significant
accounting policies, except as described below with respect to recent accounting pronouncements.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt
any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its condensed consolidated
financial statements.
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) ASU 2016-13, Financial Instruments—Credit Losses
(Topic 326)—Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which has been subsequently
amended. The provisions of ASU 2016-13 modify the impairment model for financial instruments to utilize an expected loss methodology
in place of the currently used incurred loss methodology and require consideration of a broader range of reasonable and supportable information
to inform credit loss estimates. The Company adopted the standard as of January 1, 2023. The adoption of this standard did not have a
material effect on the Company’s condensed consolidated financial statements.
As
of September 30, 2023, there are no new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
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v3.23.3
Prepaid Expenses and Other Current Assets (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Prepaid Expenses And Other Current Assets |
|
Schedule of Prepaid Expenses and Other Current Assets |
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
September 30, 2023 | | |
December 31, 2022 | |
Insurance | |
$ | 361 | | |
$ | 286 | |
Software and hosting costs | |
| 83 | | |
| 99 | |
Clinical and consulting | |
| 50 | | |
| 517 | |
Other | |
| 405 | | |
| 166 | |
Total prepaid expenses and other current assets | |
$ | 899 | | |
$ | 1,068 | |
|
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v3.23.3
Property and Equipment, Net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property
and equipment, net consisted of the following:
Schedule of Property and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Laboratory equipment | |
$ | 1,639 | | |
$ | 1,827 | |
Capital in progress | |
| 600 | | |
| - | |
Office furniture and equipment | |
| 387 | | |
| 217 | |
Computer equipment | |
| 237 | | |
| 275 | |
Leasehold improvements | |
| - | | |
| 664 | |
Total property and equipment | |
| 2,863 | | |
| 2,983 | |
Less accumulated depreciation and amortization | |
| (1,697 | ) | |
| (2,748 | ) |
Property and equipment, net | |
$ | 1,166 | | |
$ | 235 | |
|
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v3.23.3
Accrued Expenses and Other Current Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
September 30, 2023 | | |
December 31, 2022 | |
Wages and incentives | |
$ | 904 | | |
$ | 1,130 | |
Clinical and consulting | |
| 704 | | |
| 475 | |
Accrued purchases of property and equipment | |
| 664 | | |
| - | |
Legal and patents | |
| 49 | | |
| - | |
Other | |
| 214 | | |
| 33 | |
Total accrued expenses and other current liabilities | |
$ | 2,535 | | |
$ | 1,638 | |
|
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v3.23.3
Warrants (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Warrants |
|
Schedule of Warrants Outstanding |
Schedule of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
April 8, 2019 | |
$ | 26.99 | | |
April 8, 2024 | |
| 65,907 | | |
| 65,907 | |
April 8, 2019 | |
$ | 33.74 | | |
April 3, 2024 | |
| 39,871 | | |
| 39,871 | |
February 12, 2019 | |
$ | 36.62 | | |
February 7, 2024 | |
| 5,548 | | |
| 5,548 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
February 4, 2019 | |
$ | 42.49 | | |
January 30, 2024 | |
| 1,732 | | |
| 1,732 | |
January 31, 2019 | |
$ | 42.49 | | |
January 26, 2024 | |
| 511 | | |
| 511 | |
December 3, 2018 | |
$ | 77.99 | | |
June 3, 2024 | |
| 46,876 | | |
| 46,876 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,161,493 | | |
| 1,145,538 | |
|
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v3.23.3
Stock-based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Summary of Stock Option Activity |
The
following table summarizes stock option activity for the nine months ended September 30, 2023:
Summary of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2023 | |
| 304,823 | | |
$ | 28.66 | | |
| 7.98 | | |
$ | - | |
Granted | |
| 118,472 | | |
$ | 3.98 | | |
| | | |
| | |
Forfeited or expired | |
| (58,320 | ) | |
$ | 19.96 | | |
| | | |
| | |
Outstanding — September 30, 2023 | |
| 364,975 | | |
$ | 22.04 | | |
| 7.74 | | |
$ | - | |
Exercisable — September 30, 2023 | |
| 208,835 | | |
$ | 32.51 | | |
| 7.02 | | |
$ | - | |
|
Schedule of Calculation of Fair Value Assumptions |
Schedule of Calculation of Fair Value Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected option life (years) | |
| 6.0 | | |
| 6.0 | |
Risk-free interest rate | |
| 3.53 | % | |
| 2.03 | % |
Expected volatility | |
| 104.24 | % | |
| 113.28 | % |
Expected dividend yield | |
| - | % | |
| - | % |
|
Schedule of Stock-based Compensation Expenses |
The
following table presents total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022:
Schedule of Stock-based Compensation Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 57 | | |
$ | 65 | | |
$ | 188 | | |
$ | 189 | |
General and administrative | |
| 149 | | |
| 212 | | |
| 569 | | |
| 646 | |
Total stock-based compensation expense | |
$ | 206 | | |
$ | 277 | | |
$ | 757 | | |
$ | 835 | |
|
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v3.23.3
Leases (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
Schedule of Components of Lease Expenses |
The
components of lease expense for the Company for the three and nine months ended September 30, 2023 and 2022 were as follows:
Schedule of Components of Lease Expenses
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 553 | | |
$ | 357 | | |
$ | 1,349 | | |
$ | 1,072 | |
Variable lease cost | |
| 203 | | |
| 206 | | |
| 484 | | |
| 556 | |
Total lease cost | |
$ | 756 | | |
$ | 563 | | |
$ | 1,833 | | |
$ | 1,628 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 2,699 | | |
$ | 431 | | |
$ | 3,562 | | |
$ | 1,046 | |
Weighted-average remaining lease term — operating leases | |
| | | |
| | | |
| 10.2 years | | |
| | |
Weighted-average discount rate — operating leases | |
| | | |
| | | |
| 11.00 | % | |
| | |
|
Schedule of Maturities of Lease Liabilities |
Maturities
of lease liabilities due under these lease agreements as of September 30, 2023 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2023 (three months) | |
$ | 171 | |
2024 | |
| 1,289 | |
2025 | |
| 1,326 | |
2026 | |
| 1,364 | |
2027 | |
| 1,402 | |
2028 and thereafter | |
| 9,154 | |
Total lease payments | |
| 14,706 | |
Less: interest | |
| (6,085 | ) |
Total lease liabilities | |
$ | 8,621 | |
| |
| | |
Reported as of September 30, 2023 | |
| | |
Lease liabilities — short term | |
$ | 199 | |
Lease liabilities — long term | |
| 8,422 | |
Total lease liabilities | |
$ | 8,621 | |
|
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v3.23.3
Net Loss Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding |
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an antidilutive impact:
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | |
Options to purchase common stock | |
| 364,975 | | |
| 307,918 | |
Warrants to purchase common stock | |
| 1,161,493 | | |
| 1,284,803 | |
Total potentially dilutive securities excluded | |
| 1,526,468 | | |
| 1,592,721 | |
|
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- DefinitionDate accounting standards update was adopted, in YYYY-MM-DD format.
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Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 2,863
|
$ 2,983
|
Less accumulated depreciation and amortization |
(1,697)
|
(2,748)
|
Property and equipment, net |
1,166
|
235
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
1,639
|
1,827
|
Capital In Progress [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
600
|
|
Office Furniture And Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
387
|
217
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
237
|
275
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
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|
$ 664
|
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v3.23.3
Significant Agreements (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Product Liability Contingency [Line Items] |
|
|
|
|
|
Agreement description |
|
|
Pursuant
to the Amendment, the Company and Cipla will each initially be responsible for 60% and 40%, respectively, of the Company’s overhead
costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”).
Upon the achievement of each development milestone set forth in the table below, Cipla will reimburse the Company an amount equal to
10% of the cumulative aggregate Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially
bringing the sharing of Direct Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will
continue to aggregate and be reimbursed by Cipla to the Company if the Company achieves the subsequent development milestone for that
trial set forth in the table below. The Company will share all other development costs with Cipla that are not Direct Costs, such as
the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis
|
|
|
Transaction cost |
$ 22,000
|
|
$ 22,000
|
|
|
Revenue |
1,753
|
$ 1,872
|
5,096
|
$ 4,363
|
|
Deferred revenue, current |
988
|
|
988
|
|
$ 1,339
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Proceeds from related party debt |
|
|
22,000
|
|
|
Transaction price |
|
|
7,400
|
|
|
Revenue recognized |
200
|
|
800
|
|
|
Deferred revenue |
5,000
|
|
5,000
|
|
|
Deferred revenue, current |
1,000
|
|
1,000
|
|
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Research and Development Service [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Transaction cost |
12,000
|
|
12,000
|
|
|
Revenue |
1,800
|
|
5,100
|
|
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Irrevocable License [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Transaction cost |
$ 10,000
|
|
$ 10,000
|
|
|
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v3.23.3
Schedule of Warrants Outstanding (Details)
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Warrant One [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Dec. 17, 2021
|
Warrants, Exercise Price | $ / shares |
$ 14.99
|
Warrants, Expiration Date |
Dec. 15, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
36,538
|
Number of Shares Underlying Warrants, Exercisable Total |
36,538
|
Warrant Two [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Dec. 17, 2021
|
Warrants, Exercise Price | $ / shares |
$ 13.99
|
Warrants, Expiration Date |
Dec. 17, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
281,047
|
Number of Shares Underlying Warrants, Exercisable Total |
281,047
|
Warrant Three [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 16, 2021
|
Warrants, Exercise Price | $ / shares |
$ 49.99
|
Warrants, Expiration Date |
Feb. 11, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
65,003
|
Number of Shares Underlying Warrants, Exercisable Total |
65,003
|
Warrant Four [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Aug. 07, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
90,743
|
Number of Shares Underlying Warrants, Exercisable Total |
90,743
|
Warrant Five [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Aug. 07, 2020
|
Warrants, Exercise Price | $ / shares |
$ 44.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
10,939
|
Number of Shares Underlying Warrants, Exercisable Total |
10,939
|
Warrant Six [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 23, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
77,502
|
Number of Shares Underlying Warrants, Exercisable Total |
77,502
|
Warrant Seven [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 13, 2020
|
Warrants, Exercise Price | $ / shares |
$ 44.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
21,846
|
Number of Shares Underlying Warrants, Exercisable Total |
21,846
|
Warrant Eight [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 13, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
334,800
|
Number of Shares Underlying Warrants, Exercisable Total |
334,800
|
Warrant Nine [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Apr. 08, 2019
|
Warrants, Exercise Price | $ / shares |
$ 26.99
|
Warrants, Expiration Date |
Apr. 08, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
65,907
|
Number of Shares Underlying Warrants, Exercisable Total |
65,907
|
Warrant Ten [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Apr. 08, 2019
|
Warrants, Exercise Price | $ / shares |
$ 33.74
|
Warrants, Expiration Date |
Apr. 03, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
39,871
|
Number of Shares Underlying Warrants, Exercisable Total |
39,871
|
Warrant Eleven [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 12, 2019
|
Warrants, Exercise Price | $ / shares |
$ 36.62
|
Warrants, Expiration Date |
Feb. 07, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
5,548
|
Number of Shares Underlying Warrants, Exercisable Total |
5,548
|
Warrant Twelve [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 12, 2019
|
Warrants, Exercise Price | $ / shares |
$ 26.79
|
Warrants, Expiration Date |
Aug. 12, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
66,675
|
Number of Shares Underlying Warrants, Exercisable Total |
66,675
|
Warrant Thirteen [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 04, 2019
|
Warrants, Exercise Price | $ / shares |
$ 42.49
|
Warrants, Expiration Date |
Jan. 30, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
1,732
|
Number of Shares Underlying Warrants, Exercisable Total |
1,732
|
Warrant Fourteen [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jan. 31, 2019
|
Warrants, Exercise Price | $ / shares |
$ 42.49
|
Warrants, Expiration Date |
Jan. 26, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
511
|
Number of Shares Underlying Warrants, Exercisable Total |
511
|
Warrant Fifteen [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Dec. 03, 2018
|
Warrants, Exercise Price | $ / shares |
$ 77.99
|
Warrants, Expiration Date |
Jun. 03, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
46,876
|
Number of Shares Underlying Warrants, Exercisable Total |
46,876
|
Warrant Eighteen [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jun. 15, 2015
|
Warrants, Exercise Price | $ / shares |
$ 1,509.99
|
Number of Shares Underlying Warrants, Outstanding Total |
15,955
|
Number of Shares Underlying Warrants, Exercisable Total |
|
Warrants, Expiration Date, Description |
Five years after milestone achievement
|
Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Shares Underlying Warrants, Outstanding Total |
1,161,493
|
Number of Shares Underlying Warrants, Exercisable Total |
1,145,538
|
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v3.23.3
Summary of Stock Option Activity (Details) - Equity Option [Member] - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Offsetting Assets [Line Items] |
|
|
Number of Options, Outstanding, Balance |
304,823
|
|
Weighted Average Exercise Price, Outstanding, Balance |
$ 28.66
|
|
Weighted Average Remaining Contractual Term (Years), Outstanding |
7 years 8 months 26 days
|
7 years 11 months 23 days
|
Aggregate Intrinsic Value, Balance |
|
|
Number of Options, Granted |
118,472
|
|
Weighted Average Exercise Price, Granted |
$ 3.98
|
|
Number of Options, Forfeited or expired |
(58,320)
|
|
Weighted Average Exercise Price, Forfeited or expired |
$ 19.96
|
|
Number of Options, Outstanding, Balance |
364,975
|
304,823
|
Weighted Average Exercise Price, Outstanding, Balance |
$ 22.04
|
$ 28.66
|
Aggregate Intrinsic Value, Balance |
|
|
Number of Options, Exercisable |
208,835
|
|
Weighted Average Exercise Price, Outstanding, Exercisable |
$ 32.51
|
|
Weighted Average Remaining Contractual Term (Years), Exercisable |
7 years 7 days
|
|
Aggregate Intrinsic Value, Exercisable |
|
|
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Schedule of Stock-based Compensation Expenses (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 206
|
$ 277
|
$ 757
|
$ 835
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
57
|
65
|
188
|
189
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 149
|
$ 212
|
$ 569
|
$ 646
|
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v3.23.3
Schedule of Components of Lease Expenses (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Lease cost |
|
|
|
|
Fixed lease cost |
$ 553
|
$ 357
|
$ 1,349
|
$ 1,072
|
Variable lease cost |
203
|
206
|
484
|
556
|
Total lease cost |
756
|
563
|
1,833
|
1,628
|
Other information |
|
|
|
|
Cash paid for amounts included in the measurement of lease liabilities |
$ 2,699
|
$ 431
|
$ 3,562
|
$ 1,046
|
Weighted-average discount rate - operating leases |
10 years 2 months 12 days
|
|
10 years 2 months 12 days
|
|
Weighted-average discount rate - operating leases |
11.00%
|
|
11.00%
|
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v3.23.3
Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Leases |
|
|
2023 (three months) |
$ 171
|
|
2024 |
1,289
|
|
2025 |
1,326
|
|
2026 |
1,364
|
|
2027 |
1,402
|
|
2028 and thereafter |
9,154
|
|
Total lease payments |
14,706
|
|
Less: interest |
(6,085)
|
|
Total lease liabilities |
8,621
|
|
Lease liabilities — short term |
199
|
$ 857
|
Lease liabilities — long term |
8,422
|
|
Total lease liabilities |
$ 8,621
|
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v3.23.3
v3.23.3
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding (Details) - shares shares in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Weighted average shares outstanding |
1,526,468
|
1,592,721
|
1,526,468
|
1,592,721
|
Options to Purchase Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Weighted average shares outstanding |
364,975
|
307,918
|
364,975
|
307,918
|
Warrants to Purchase Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Weighted average shares outstanding |
1,161,493
|
1,284,803
|
1,161,493
|
1,284,803
|
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Pulmatrix (NASDAQ:PULM)
Historical Stock Chart
From Apr 2024 to May 2024
Pulmatrix (NASDAQ:PULM)
Historical Stock Chart
From May 2023 to May 2024