Full Press Release Details
Pulmatrix Announces Second
Quarter 2022 Financial Results and Provides Corporate Update
is on track for Phase 2b study start in Q1 2023
Phase 1 study is underway with data anticipated in Q4 2022
Q2 with $42.9 million in cash and cash equivalents
LEXINGTON, Mass., August
8, 2022 - Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies
to address serious disease using its patented iSPERSE technology, today announced second quarter financial results for 2022 and
provided a corporate update related to its development programs.
Raad, Chief Executive Officer of Pulmatrix commented, "Our focus this quarter has been on advancing both PUR3100 and Pulmazole
towards important data catalysts. We initiated patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE), in a Phase 1 study
with data anticipated in Q4 2022. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 and
intravenous dihydroergotamine (DHE). This will allow us to better understand the potential efficacy and tolerability profile of PUR3100."
Mr. Raad continued, "We also commenced study start-up activities for the Pulmazole Phase 2b study and remain on track to initiate
patient dosing in Q1 2023. Pulmazole has the potential to be the first approved therapy for treatment of Allergic Bronchopulmonary Aspergillosis
(ABPA) in patients with Asthma."
Second Quarter 2022 and Recent Program Highlights
Second Quarter 2022 Financial
Revenue was $1.3 million for the second quarter ended
June 30, 2022, compared to $2.2 million for the same period in 2021, a decrease of $0.9 million. The decrease in revenue was due to no
revenues recorded for this period for the PUR1800 program offset by a $1.0 million increase in revenues recorded this period over same
period in 2021 on the Cipla Agreement for Pulmazole (PUR1900).
For the three months ended June 30, 2022, research
and development expenses were $4.3 million compared to $4.5 million for the same period in 2021, a decrease of $0.2 million. The decrease
was primarily due to decreased spending of $0.9 million in preclinical and clinical costs related to the PUR 1800 program and $0.5 million
in preclinical and manufacturing costs related to the PUR 3100 program, partially offset by increased spending of $0.6 million in clinical
and manufacturing costs related to the Pulmazole program, $0.5 million in employment costs and $0.1 million in facility costs.
General and administrative expenses were unchanged
at $1.6 million for the three months ended June 30, 2022 compared to the same period in 2021.
cash equivalents balance as of June 30, 2022 was $42.9 million. Pulmatrix expects its existing cash and cash equivalents as of June 30,
2022 will enable it to fund operating expenses and capital expenditure into Q2 2024.
On February 28, Pulmatrix
completed a reverse stock-split at a ratio of 1-for-20 (the "Reverse Split") which reduced the number of outstanding shares
of the Company's common stock from approximately 65.9 million shares to 3.3 million shares.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 42,905 | $ | 53,840 | ||||
| Restricted cash | 153 | - | ||||||
| Accounts receivable | 645 | 67 | ||||||
| Prepaid expenses and other current assets | 2,142 | 871 | ||||||
| Total current assets | 45,845 | 54,778 | ||||||
| Property and equipment, net | 306 | 321 | ||||||
| Operating lease right-of-use asset | 1,407 | 2,093 | ||||||
| Long-term restricted cash | 1,472 | 1,625 | ||||||
| Other long-term assets | 368 | - | ||||||
| Total assets | $ | 49,398 | $ | 58,817 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 728 | 839 | ||||||
| Accrued expenses | 1,610 | 1,233 | ||||||
| Operating lease liability | 1,702 | 1,431 | ||||||
| Deferred revenue | 1,561 | 939 | ||||||
| Total current liabilities | 5,601 | 4,442 | ||||||
| Deferred revenue, net of current portion | 5,358 | 6,069 | ||||||
| Operating lease liability, net of current portion | - | 857 | ||||||
| Total liabilities | 10,959 | 11,368 | ||||||
| Commitments and contingencies (Note 12) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value - 500,000 shares authorized at June 30, 2022 and December 31, 2021; 6,746 shares designated Series A convertible preferred stock; no and 1,830 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | - | 1,081 | ||||||
| Common stock, $0.0001 par value - 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 3,387,172 and 3,222,037 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 302,647 | 301,008 | ||||||
| Accumulated deficit | (264,208 | ) | (254,640 | ) | ||||
| Total stockholders' equity | 38,439 | 47,449 | ||||||
| Total liabilities and stockholders' equity | $ | 49,398 | $ | 58,817 |
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues | $ | 1,331 | $ | 2,254 | $ | 2,491 | $ | 3,644 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 4,337 | 4,541 | 8,486 | 8,397 | ||||||||||||
| General and administrative | 1,553 | 1,562 | 3,527 | 3,181 | ||||||||||||
| Total operating expenses | 5,890 | 6,103 | 12,013 | 11,578 | ||||||||||||
| Loss from operations | (4,559 | ) | (3,849 | ) | (9,522 | ) | (7,934 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 15 | 2 | 16 | 5 | ||||||||||||
| Other expense, net | (51 | ) | (5 | ) | (62 | ) | (27 | ) | ||||||||
| Total other expense, net | (36 | ) | (3 | ) | (46 | ) | (22 | ) | ||||||||
| Net loss | $ | (4,595 | ) | $ | (3,852 | ) | $ | (9,568 | ) | $ | (7,956 | ) | ||||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (1.36 | ) | $ | (1.37 | ) | $ | (2.87 | ) | $ | (3.10 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 3,372,090 | 2,812,454 | 3,334,891 | 2,565,984 |
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.