Pulmatrix Announces First Quarter 2024 Financial Results and Provides Corporate Update
Pulmatrix, Inc. reported $16.3 million cash, with a cash runway into Q1 2026. The partnership amendment with Cipla led to the halt of PUR1900 Phase 2b study, reducing cash burn. Cipla will now develop PUR1900 outside the US. Revenue increased to $5.9 million, net income rose to $0.8 million, and R&D expenses decreased. PUR3100 is Phase 2-ready, while PUR1800 showed positive results for AECOPD treatment.
Revenue increased to $5.9 million for Q1 2024, up from $1.5 million in Q1 2023.
Net income rose to $0.8 million for Q1 2024, from a net loss of $4.4 million in Q1 2023.
R&D expenses decreased to $3.5 million for Q1 2024, down from $3.9 million in Q1 2023.
PUR3100 is Phase 2-ready with FDA acceptance and Phase 1 trial results.
PUR1800 showed positive results in Phase 1b study for AECOPD treatment.
The halt of the PUR1900 Phase 2b study was a negative event for Pulmatrix.
Decreased spend in the PUR3100 program may impact its development progress.
Legal and professional services costs decreased, which could affect operational efficiency.
Insights
The reported cash and cash equivalents of
Regarding the partnership amendment with Cipla, the shift of financial responsibility to Cipla for the development of PUR1900 is a strategic move that significantly reduces Pulmatrix's cash burn. This reallocation of resources can refocus the company's efforts on other pipeline projects. However, the 2% royalty agreement on future net sales positions Pulmatrix as a minor beneficiary of PUR1900's potential success, which might be a point of contention for investors looking for greater returns from the product's commercialization.
The increase in revenue is substantial, from
The decision to halt the Phase 2b study of PUR1900 and Cipla's assumption of development costs indicates a strategic pivot. This move could be interpreted as focusing on drug candidates with a potentially faster path to market and addressing areas with high unmet medical needs. Pulmatrix's commitment to advance PUR3100 into Phase 2 trials for acute migraine treatment, leveraging its iSPERSE™ technology, underscores the company's confidence in its pipeline's transformative potential and technological platform.
Furthermore, the clinical progress of PUR3100 could be a catalyst for the stock, given the market demand for innovative migraine treatments. However, the need for financing or partnership arrangements could introduce uncertainty regarding the project's immediate future.
Third amendment made in Q1 to Cipla partnership results in the wind down of the PUR1900 Phase 2b study and allows for a significant reduction in expected cash burn for Pulmatrix
Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval outside
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "Our focus in the first quarter has been to continue our cost saving measures including the wind down of the Phase 2b study for PUR1900 and on strategic alternatives that leverage the potential of PUR3100, iSPERSE™ technology and our extended cash resources."
First Quarter 2024 and Recent Program and Corporate Highlights
PUR3100
- In 2023, Pulmatrix announced the FDA's acceptance of an IND application for PUR3100 and receipt of a "study may proceed" letter for a Phase 2 study, positioning PUR3100 as Phase 2-ready. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™, will be investigated in patients with acute migraine.
- The planned Phase 2 trial builds on the Phase 1 trial results, which were published in 2023 and presented at the American Headache Society 65th Annual Meeting in June 2023. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group.
- Pulmatrix is currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100.
PUR1800
- In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD), indicating PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.
- Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800.
PUR1900
- In agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900. PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. The decision to stop the study was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. The Company remains on track to complete all Phase 2b wind down activities by the third quarter of 2024.
- After the study wind down, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive
2% royalties on any potential future net sales by Cipla outsidethe United States . Withinthe United States , Pulmatrix and Cipla will seek to monetize PUR1900.
First Quarter 2024 Financial Results
Revenues increased
Research and development expenses decreased approximately
General and administrative expenses decreased
Net income increased
The Company's total cash and cash equivalents balance as of March 31, 2024, was
PULMATRIX, INC. | ||||||||
Consolidated Balance Sheets | ||||||||
(in thousands, except share and per share data) | ||||||||
March 31, 2024 | December 31, 2023 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 16,300 | $ | 19,173 | ||||
Accounts receivable | 570 | 928 | ||||||
Prepaid expenses and other current assets | 712 | 742 | ||||||
Total current assets | 17,582 | 20,843 | ||||||
Property and equipment, net | 1,108 | 1,158 | ||||||
Operating lease right-of-use asset | 10,094 | 10,309 | ||||||
Long-term restricted cash | 1,472 | 1,472 | ||||||
Other long-term assets | 135 | 176 | ||||||
Total assets | $ | 30,391 | $ | 33,958 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 721 | $ | 1,915 | ||||
Accrued expenses and other current liabilities | 1,677 | 947 | ||||||
Operating lease liability | 383 | 429 | ||||||
Deferred revenue | 363 | 618 | ||||||
Total current liabilities | 3,144 | 3,909 | ||||||
Deferred revenue, net of current portion | - | 3,727 | ||||||
Operating lease liability, net of current portion | 8,229 | 8,327 | ||||||
Total liabilities | 11,373 | 15,963 | ||||||
Stockholders' equity: | ||||||||
Preferred stock, | - | - | ||||||
Common stock, | - | - | ||||||
Additional paid-in capital | 305,790 | 305,592 | ||||||
Accumulated deficit | (286,772) | (287,597) | ||||||
Total stockholders' equity | 19,018 | 17,995 | ||||||
Total liabilities and stockholders' equity | $ | 30,391 | $ | 33,958 | ||||
PULMATRIX, INC. | |||||||||
Consolidated Statements of Operations | |||||||||
(in thousands, except share and per share data) | |||||||||
(unaudited) | |||||||||
Three Months Ended March 31, | |||||||||
2024 | 2023 | ||||||||
Revenues | $ | 5,885 | $ | 1,499 | |||||
Operating expenses | |||||||||
Research and development | 3,512 | 3,874 | |||||||
General and administrative | 1,626 | 2,210 | |||||||
Total operating expenses | 5,138 | 6,084 | |||||||
Income (loss) from operations | 747 | (4,585) | |||||||
Other income (expense) | |||||||||
Interest income | 160 | 222 | |||||||
Other expense, net | (82) | (85) | |||||||
Total other income (expense), net | 78 | 137 | |||||||
Net income (loss) | $ | 825 | $ | (4,448) | |||||
Net income (loss) per share attributable to common stockholders – basic and diluted | $ | 0.23 | $ | (1.22) | |||||
Weighted average common shares outstanding – basic and diluted | 3,652,285 | 3,650,769 |
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for CNS disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
For more on the Company's inhaled product candidates please visit:
https://www.pulmatrix.com/pipeline.html.
Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by 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 are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Timothy McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com
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SOURCE Pulmatrix Inc.
FAQ
What was Pulmatrix's cash balance at the end of Q1 2024?
Pulmatrix had $16.3 million in cash and cash equivalents at the end of Q1 2024.
What led to the reduction in expected cash burn for Pulmatrix in Q1 2024?
The third amendment to the Cipla partnership resulted in the wind down of the PUR1900 Phase 2b study, reducing expected cash burn for Pulmatrix.
What is the status of PUR3100?
PUR3100 is Phase 2-ready with FDA acceptance and positive Phase 1 trial results.
What were the financial results for Pulmatrix in Q1 2024?
Revenues increased to $5.9 million, net income rose to $0.8 million, and R&D expenses decreased for Pulmatrix in Q1 2024.
What are the future plans for PUR1800?
Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.