Pulmatrix Inc
For the period ended Mar 31, 2024. Filed May 10, 2024.
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Mar 31, 2024 · Filed May 10, 2024
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Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements (Unaudited)
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*™, 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 central nervous system, respiratory and other diseases with important 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, 2023, filed with the SEC on March 28, 2024 (the “Annual Report”).
The financial information as of March 31, 2024, and for the three months ended March 31, 2024 and 2023, 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, 2023 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.
Based on its current operating plan, the Company believes that its cash and cash equivalents as of March 31, 2024, will be adequate to fund its currently anticipated operating expenses for at least twelve months from the date these condensed consolidated financial statements are issued. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities; commercialize product candidates; or conduct any substantial, additional development requirements requested by the FDA. Additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional capital, it will be required to significantly decrease the amount of planned expenditures and may be required to cease operations. In addition, any disruption in the capital markets could make any financing more challenging, and there can be no assurance that Pulmatrix will be able to obtain such financing on commercially reasonable terms or at all. Curtailment of operations would cause significant delays in the Company’s efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations of the Company.
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 and estimates related to clinical trial accruals and upfront deposits.
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 months ended March 31, 2024, revenue from one customer accounted for 96% of revenue recognized in the accompanying condensed consolidated financial statements. For the three months ended March 31, 2023, revenue from one customer accounted for 100% of revenue recognized in the accompanying condensed consolidated financial statements. As of March 31, 2024, two customers accounted for 97% of accounts receivable. As of December 31, 2023, 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 three months ended March 31, 2024, the Company did not make any changes to its significant accounting policies.
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. The Company did not adopt any new accounting pronouncements during the three months ended March 31, 2024 that had a material effect on its condensed consolidated financial statements.
In December 2023, the FASB issued Accounting Standard Update 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures(“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard becomes effective for the annual period beginning on January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements.
As of March 31, 2024, there are no other new, or existing recently issued, accounting pronouncements that are of significance, or potential significance, that impact the Company’s condensed consolidated financial statements.
3. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Clinical and consulting | $184 | $30 |
| Insurance | 134 | 232 |
| Software and hosting costs | 85 | 108 |
| Other | 309 | 372 |
| Total prepaid expenses and other current assets | $712 | $742 |
4. Property and Equipment, Net
Property and equipment, net consisted of the following:
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Laboratory equipment | $1,811 | $1,656 |
| Leasehold improvements | 454 | - |
| Office furniture and equipment | 401 | 401 |
| Computer equipment | 237 | 237 |
| Capital in progress | - | 600 |
| Total property and equipment | 2,903 | 2,894 |
| Less accumulated depreciation and amortization | (1,795) | (1,736) |
| Property and equipment, net | $1,108 | $1,158 |
Depreciation and amortization expense for the three months ended March 31, 2024 and 2023 was $59 and $32, respectively.
5. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Clinical and consulting | $578 | $347 |
| Wages and incentives | 558 | 70 |
| Accrued purchases of property and equipment | 244 | 389 |
| Legal and patents | 144 | 42 |
| Other | 153 | 99 |
| Total accrued expenses and other current liabilities | $1,677 | $947 |
6. 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 “Second Amendment”) and a subsequent amendment on January 6, 2024 (the “Third Amendment”). 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, at which point the Company and Cipla each became responsible for a portion of the development costs actually incurred as described below (the “Co-Development Phase”).
Pursuant to the Second Amendment, the Company and Cipla were each 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”). 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.
Pursuant to the Third Amendment, the Company and Cipla agreed that, during the period commencing on January 6, 2024 and ending July 30, 2024 (the “Wind Down Period”), the Company will complete all Phase 2b activities, assign or license all patents to Cipla and their registration with the appropriate authorities in regions other than the United States, complete a physical and demonstrable technology transfer and secure all data from the Phase 2b study for inclusion in the safety database. The Company will share costs with Cipla during the Wind Down Period in the same proportions in effect with the Second Amendment discussed above, but subject to a maximum reimbursement amount by Cipla as approved by the joint steering committee.
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.
Revenue is recognized for the 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.
The Company concluded that the Third Amendment is a contract modification that should be accounted for as part of the existing contract. During the three months ended March 31, 2024 and 2023, the Company recognized $5.7 million and $1.5 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, respectively. The Company recognized $4.0 million of revenue during the three months ended March 31, 2024, primarily associated with the cumulative catch-up from the in-period contract modification, that had been included in deferred revenue at the beginning of the period. As of March 31, 2024, the aggregate transaction price related to the Company’s unsatisfied obligations was $0.4 million and was recorded in deferred revenue, all of which was current.
7. 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”). Upon filing of the Annual Report, the Company continued to be subject to General Instruction I.B.6 of Form S-3, pursuant to which in no event will the Company sell its common stock in a registered primary offering using Form S-3 with a value exceeding more than one-third of its public float in any 12 calendar month period so long as its public float remains below $75,000,000. Therefore, the amount that may be able to be raised using the ATM Offering will be significantly less than $20,000,000, until such time as the Company’s public float held by non-affiliates exceeds $75,000,000.
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 three months ended March 31, 2024, no shares of the Company’s common stock were sold under the Sales Agreement.
8. Warrants
There wereno warrants issued or exercised during the three months ended March 31, 2024. During the three months ended March 31, 2024, warrants to purchase up to 7,791 shares of common stock at a weighted average exercise price of $38.31 per share expired. Subsequent to March 31, 2024, but before the date these condensed consolidated financial statements were issued, warrants to purchase up to 105,778 shares of common stock at a weighted average exercise price of $29.53 per share expired. The following represents a summary of the warrants outstanding and exercisable at March 31, 2024, all of which are equity-classified:
| 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 | $26.79 | August 12, 2024 | 66,675 | 66,675 |
| 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 | 1,153,702 | 1,137,747 | ||
9. 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 March 31, 2024, the Incentive Plan provided for the grant of up to 818,936 shares of the Company’s common stock, of which 470,800 shares remained available for future grant. In addition, the Company sponsors two legacy plans under which no additional awards may be granted. As of March 31, 2024, the two legacy plans have a total of 8 options outstanding, all of which are fully vested and for which common stock will be issued upon exercise.
There were no options granted, exercised, forfeited or expired during the three months ended March 31, 2024. The following table summarizes stock options outstanding and exercisable as of March 31, 2024:
| Number of Options · Weighted- Average Exercise Price · Weighted- Average Remaining Contractual Term (Years) · Aggregate Intrinsic Value | |||||
|---|---|---|---|---|---|
| Outstanding — January 1, 2024 | 344,306 | $20.92 | 7.54 | $ | - |
| Outstanding — March 31, 2024 | 344,306 | $20.92 | 7.29 | $ | - |
| Exercisable — March 31, 2024 | 222,747 | $28.64 | 6.72 | $ | - |
The Company records stock-based compensation expense related to stock options based on their grant-date fair value. As of March 31, 2024, there was $0.6 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 1.8 years.
The following table presents total stock-based compensation expense for the three months ended March 31, 2024 and 2023:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $116 | $72 |
| General and administrative | 82 | 224 |
| Total stock-based compensation expense | $198 | $296 |
10. Commitments and Contingencies
Research and Development Activities
The Company contracts with various other organizations to conduct research and development activities, including clinical trials. 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. As of March 31, 2024, the Company had no material noncancellable commitments not expected to be reimbursed under the Cipla Agreement.
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.
11. Leases
Corporate Headquarters
The Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during the third quarter of 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 thelease provides for base rent of $0.1 million per month, payment of which began in March 2024, and 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.
Other Leasing Activities
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 months ended March 31, 2024 and 2023 were as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lease cost | ||
| Fixed lease cost | $407 | $378 |
| Variable lease cost | 102 | 113 |
| Total lease cost | $509 | $491 |
| Other information | ||
| Cash paid for amounts included in the measurement of lease liabilities | $335 | $431 |
| Weighted-average remaining lease term — operating leases | 9.7 years | 0.4 years |
| Weighted-average discount rate — operating leases | 11.00% | 8.40% |
Maturities of lease liabilities due under these lease agreements as of March 31, 2024 are as follows:
| Operating Leases | |
|---|---|
| Maturity of lease liabilities | |
| 2024 (nine months) | $969 |
| 2025 | 1,328 |
| 2026 | 1,366 |
| 2027 | 1,404 |
| 2028 | 1,444 |
| 2029 and thereafter | 7,722 |
| Total lease payments | 14,233 |
| Less: interest | (5,621) |
| Total lease liabilities | $8,612 |
| Lease liabilities — short term | $383 |
| Lease liabilities — long term | 8,229 |
| Total lease liabilities | $8,612 |
12. Income Taxes
Although the Company had net income for the three months ended March 31, 2024, the Company hadno income tax expense due to expected operating losses for the full fiscal year. The Company hadno income tax expense for the three months ended March 31, 2023 due to operating losses incurred for that period.
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 March 31, 2024 and December 31, 2023.
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 March 31, 2024 and December 31, 2023.
13. Net Income (Loss) Per Share
Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is calculated by dividing the weighted-average number common shares outstanding during the period, after taking into consideration any potentially dilutive effects from outstanding stock options or warrants.
Basic and diluted net income (loss) per share were the same for the three months ended March 31, 2024 and 2023, as the effect of potentially dilutive securities would have been anti-dilutive.
The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an anti-dilutive impact:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Options to purchase common stock | 344,306 | 418,948 |
| Warrants to purchase common stock | 1,153,702 | 1,284,803 |
| Total options and warrants to purchase common stock | 1,498,008 | 1,703,751 |
14. Subsequent Events
The Company has completed an evaluation of all subsequent events after the balance sheet date of March 31, 2024 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 March 31, 2024, 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.