Full Press Release Details
Closed transactions with MannKind Corporation validating the potential value of iSPERSE™ technology
Pursuing strategic alternatives to further leverage iSPERSE™ and optimize the potential of PUR3100
Completed PUR1900 wind down activities
Cash runway projected into Q4 2026
FRAMINGHAM, Mass.,Nov. 8, 2024/PRNewswire/ --Pulmatrix, Inc.("Pulmatrix" or the "Company") (Nasdaq:PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE™ technology, today announced third quarter financial results for 2024 and provided a corporate update on its clinical assets.
Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the third quarter has been to continue our cost saving measures, complete the wind down activities for the Phase2bstudy for PUR1900 and close the transactions with MannKind. Repositioning ourselves as a virtual company has allowed us to improve our balance sheet and continue to focus on strategic alternatives that leverage the potential of PUR3100 and our iSPERSE™ technology."
Third Quarter 2024 and Recent Program and Corporate Highlights
PUR3100
PUR1800
PUR1900
iSPERSE™ Technology
Third Quarter 2024 Financial Results
Revenues decreased approximately$1.4 millionto$0.4 millionfor the three months endedSeptember 30, 2024, compared to$1.8 millionfor the three months endedSeptember 30, 2023. The decrease is primarily related to decreased revenue under the Cipla Agreement related to fewer reimbursable expenses incurred due to the wind down of the PUR1900 Phase2bclinical trial, as compared to the corresponding period in the previous year.
Research and development expenses decreased approximately$3.2 millionto$0.8 millionfor the three months endedSeptember 30, 2024, compared to$4.0 millionfor the three months endedSeptember 30, 2023. The decrease was primarily due to less employment and other operating cost following the MannKind cross-license agreement announced inMay 2024(the "MannKind Transaction"), which included a transfer of the Company's leased office and laboratory facilities, as well as less cost incurred on the PUR1900 program, for which the winding down of the Phase2bclinical trial was completed during the three months endedSeptember 30, 2024.
General and administrative expenses increased approximately$0.5 millionto$2.2 millionfor the three months endedSeptember 30, 2024, compared to$1.7 millionfor the three months endedSeptember 30, 2023. The increase was primarily due to one-time employee separation costs.
The Company's total cash and cash equivalents balance as ofSeptember 30, 2024, was$10.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the fourth quarter of 2026.
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.
About iSPERSE™ TechnologyOur innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE™ is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE™ can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.
For more on the Company's inhaled product candidates please visit:https://www.pulmatrix.com/pipeline.html.
Forward-Looking StatementsCertain 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, CFA917-679-9282[email protected]
| PULMATRIX, INC.Consolidated Balance Sheets(in thousands, except share and per share data) | ||||||||
| September 30,2024 | December 31,2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,782 | $ | 19,173 | ||||
| Accounts receivable | 23 | 928 | ||||||
| Prepaid expenses and other current assets | 641 | 742 | ||||||
| Total current assets | 11,446 | 20,843 | ||||||
| Property and equipment, net | - | 1,158 | ||||||
| Operating lease right-of-use asset | - | 10,309 | ||||||
| Long-term restricted cash | 10 | 1,472 | ||||||
| Other long-term assets | 54 | 176 | ||||||
| Total assets | $ | 11,510 | $ | 33,958 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 373 | $ | 1,915 | ||||
| Accrued expenses and other current liabilities | 217 | 947 | ||||||
| Operating lease liability | - | 429 | ||||||
| Deferred revenue | - | 618 | ||||||
| Total current liabilities | 590 | 3,909 | ||||||
| Deferred revenue, net of current portion | - | 3,727 | ||||||
| Operating lease liability, net of current portion | - | 8,327 | ||||||
| Total liabilities | 590 | 15,963 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 sharesdesignated Series A convertible preferred stock; no shares issued and outstandingat September 30, 2024 and December 31, 2023 | - | - | ||||||
| Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285shares issued and outstanding at September 30, 2024 and December 31, 2023 | - | - | ||||||
| Additional paid-in capital | 306,090 | 305,592 | ||||||
| Accumulated deficit | (295,170) | (287,597) | ||||||
| Total stockholders' equity | 10,920 | 17,995 | ||||||
| Total liabilities and stockholders' equity | $ | 11,510 | $ | 33,958 | ||||
| PULMATRIX, INC.Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited) | ||||||||||||||||
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | $ | 366 | $ | 1,753 | $ | 7,803 | $ | 5,096 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 814 | 3,963 | 7,160 | 12,002 | ||||||||||||
| General and administrative | 2,209 | 1,729 | 5,836 | 5,609 | ||||||||||||
| Loss on MannKind Transaction | - | - | 2,618 | - | ||||||||||||
| Total operating expenses | 3,023 | 5,692 | 15,614 | 17,611 | ||||||||||||
| Loss from operations | (2,657) | (3,939) | (7,811) | (12,515) | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 101 | 217 | 394 | 675 | ||||||||||||
| Other expense, net | (31) | (52) | (156) | (198) | ||||||||||||
| Total other income, net | 70 | 165 | 238 | 477 | ||||||||||||
| Net loss | $ | (2,587) | $ | (3,774) | $ | (7,573) | $ | (12,038) | ||||||||
| Net loss per share attributable to common stockholders – basic and diluted | $ | (0.71) | $ | (1.03) | $ | (2.07) | $ | (3.30) | ||||||||
| Weighted average common shares outstanding – basic and diluted | 3,652,285 | 3,652,285 | 3,652,285 | 3,651,785 |