Pulmatrix Announces Third Quarter 2022 Financial Results and Provides Corporate Update
Pulmatrix, Inc. (PULM) reported Q3 2022 revenues of $1.9 million, a $0.8 million increase year-over-year. The rise was mainly due to revenue from the PUR1900 program. However, total revenues are down from $4.713 million in the nine months ended September 2021 to $4.363 million in the same period of 2022. R&D expenses rose $1.3 million to $5.3 million, largely driven by PUR1900 clinical costs. The company has $40.7 million in cash, expected to cover operations into Q2 2024, and is advancing both PUR3100 and PUR1900 towards pivotal trial stages.
- Q3 2022 revenues increased by $0.8 million to $1.9 million compared to Q3 2021.
- Cash and cash equivalents at the end of Q3 2022 total $40.7 million, supporting operations into Q2 2024.
- Total revenues for the nine months ended September 30, 2022, decreased from $4.713 million in 2021 to $4.363 million.
- R&D expenses increased by $1.3 million to $5.3 million, driven by higher clinical costs.
PUR1900 (Pulmazole) on track for Phase 2 study start in Q1 2023
PUR3100 Phase 1 study top line data anticipated in early Q1 2023
LEXINGTON, Mass., Nov. 10, 2022 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE™ technology, today announced third quarter financial results for 2022 and provided a corporate update related to its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix commented, "In this quarter we have advanced both PUR3100 and PUR1900 towards important data catalysts. We completed patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE) being developed for the treatment of acute migraine, in a Phase 1 study with data expected to be released in early Q1 2023. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 compared to intravenous DHE. This will allow us to better understand the potential efficacy and tolerability profile of PUR3100, which we believe could be beneficial to patients suffering from acute migraine. We also commenced study start-up activities for the PUR1900 Phase 2 study and remain on track to initiate patient dosing in the first quarter of 2023. PUR1900 has the potential to be the first approved therapy for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma."
Third Quarter 2022 and Recent Program Highlights
PUR1900 in development for ABPA
- Pulmatrix initiated study start-up activities for the Phase 2 safety and efficacy study of PUR1900 in patients with asthma and ABPA. This will include a 16-week dosing regimen and endpoints that would potentially support a Phase 3 trial.
PUR3100 in development for acute migraine
- On September 26, 2022, Pulmatrix announced completion of patient dosing in its Phase 1 trial evaluating PUR3100.
- Phase 1 study database lock to occur in November with top-line data anticipated to be released in early Q1 2023.
PUR1800 in development for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for AECOPD for presentation at a relevant medical conference in 2023. These data will inform the design of a potential Phase 2 study in the treatment of AECOPD.
Third Quarter 2022 Financial Results
Revenues increased
For the three months ended September 30, 2022, research and development expenses increased
General and administrative expenses were unchanged at
During the three months ended September 30, 2022, the Company sold 252,013 shares of its common stock at a weighted-average price of approximately
Cash and cash equivalents as of September 30, 2022 was
PULMATRIX, INC. | ||||||||
September 30, 2022 | December 31, | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 40,683 | $ | 53,840 | ||||
Restricted cash | 153 | - | ||||||
Accounts receivable | 476 | 67 | ||||||
Prepaid expenses and other current assets | 1,913 | 871 | ||||||
Total current assets | 43,225 | 54,778 | ||||||
Property and equipment, net | 265 | 321 | ||||||
Operating lease right-of-use asset | 1,060 | 2,093 | ||||||
Long-term restricted cash | 1,472 | 1,625 | ||||||
Other long-term assets | 428 | - | ||||||
Total assets | $ | 46,450 | $ | 58,817 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | 1,155 | 839 | ||||||
Accrued expenses and other current liabilities | 2,748 | 1,233 | ||||||
Operating lease liability | 1,281 | 1,431 | ||||||
Deferred revenue | 1,140 | 939 | ||||||
Total current liabilities | 6,324 | 4,442 | ||||||
Deferred revenue, net of current portion | 5,080 | 6,069 | ||||||
Operating lease liability, net of current portion | - | 857 | ||||||
Total liabilities | 11,404 | 11,368 | ||||||
Commitments and contingencies (Note 12) | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, | - | 1,081 | ||||||
Common stock, | - | - | ||||||
Additional paid-in capital | 304,306 | 301,008 | ||||||
Accumulated deficit | (269,260) | (254,640) | ||||||
Total stockholders' equity | 35,046 | 47,449 | ||||||
Total liabilities and stockholders' equity | $ | 46,450 | $ | 58,817 |
PULMATRIX, INC. | ||||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||||
Revenues | $ | 1,872 | $ | 1,069 | $ | 4,363 | $ | 4,713 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 5,287 | 4,026 | 13,773 | 12,423 | ||||||||||||||||||
General and administrative | 1,685 | 1,656 | 5,212 | 4,837 | ||||||||||||||||||
Goodwill impairment | - | 3,577 | - | 3,577 | ||||||||||||||||||
Total operating expenses | 6,972 | 9,259 | 18,985 | 20,837 | ||||||||||||||||||
Loss from operations | (5,100) | (8,190) | (14,622) | (16,124) | ||||||||||||||||||
Other income (expense), net: | ||||||||||||||||||||||
Interest income | 102 | 1 | 118 | 6 | ||||||||||||||||||
Other (expense) income, net | (54) | 5 | (116) | (22) | ||||||||||||||||||
Total other income (expense), net | 48 | 6 | 2 | (16) | ||||||||||||||||||
Net loss | $ | (5,052) | $ | (8,184) | $ | (14,620) | $ | (16,140) | ||||||||||||||
Net loss per share attributable to | $ | (1.45) | $ | (2.91) | $ | (4.32) | $ | (6.08) | ||||||||||||||
Weighted average common shares outstanding – | 3,478,157 | 2,812,454 | 3,383,171 | 2,654,099 | ||||||||||||||||||
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD"), and neurologic disorders such as acute migraine. 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.
Forward-Looking Statements
Certain statements in this letter that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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,", "extended", "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 impact of the novel coronavirus (COVID-19) on the Company's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on 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 SEC, 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. 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.
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