Full Press Release Details
Announces Year-End and Q4 Financial 2022 Results and Provides Corporate Update
Phase 2b study dosed first patients in Q1 2023
Phase 1 study achieves positive topline results as announced in Q1 2023
million in cash and cash equivalents at the end of 2022 providing cash runway into Q2 2024
Mass., March 30, 2023 - Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative
inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE technology, today
announced fourth quarter and year-end financial results for 2022 and provided a corporate update on its development programs.
Raad, Chief Executive Officer of Pulmatrix commented,
"2022 was a year of significant progress for all of our development programs, setting the stage for significant milestone accomplishments
in 2023. In 2022, we completed the Phase 1b study of PUR1800 for acute exacerbations in chronic obstructive pulmonary disease (AECOPD),
for which the data was presented this year. We also initiated and completed a Phase 1 study of PUR3100, our orally inhaled formulation
of dihydroergotamine (DHE) for acute migraine, allowing us to begin 2023 by announcing data that we believe illustrates a potentially
positive pharmacokinetic and pharmacodynamic profile for PUR3100 - including a rapid systemic exposure within the targeted therapeutic
range, and fewer side effects compared to intravenous (IV) dosing. Finally, we prepared for a Phase 2b study of PUR1900 in allergic bronchopulmonary
aspergillosis (ABPA) and announced the first patient dosed in Q1 2023. We are grateful for the potential opportunity to positively impact
patients with these programs and are proud of the Company's accomplishments throughout last year and into this year."
and Recent Program and Corporate Highlights
Corporate Highlights
Quarter and Year-End Financial Results
was $6.1 million for the year ended December 31, 2022, as compared to $5.2 million for the year ended December 31, 2021; an increase
of $0.9 million. The increase was related to $4.6 million more revenues under the collaboration with Cipla Technologies LLC during 2022,
which was partially offset by a $3.7 million decrease in license-related revenues under a former collaboration with Johnson & Johnson
Enterprise Innovation, Inc.
and development expense was $18.2 million for the year ended December 31, 2022, as compared to $15.4 million for the year ended December
31, 2021; an increase of $2.8 million. The increase was primarily due to an increased spend of $2.9 million in costs related to the Company's
PUR1900 program and $2.6 million of employment and operating costs, partially offset by decreased spend of $2.7 million in costs primarily
related to Pulmatrix's PUR1800 program.
and administrative expense was $6.8 million for the year ended December 31, 2022, as compared to $6.4 million for the year ended December
31, 2021; an increase of $0.4 million. The increase was primarily due to increased professional services costs of $0.4 million.
total cash and cash equivalents balance as of December 31, 2022 was $35.6 million. The Company anticipates that its cash position is
sufficient to fund operations into Q2 2024.
thousands, except share and per share data)
| December 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 35,628 | $ | 53,840 | ||||
| Restricted cash | 153 | - | ||||||
| Accounts receivable | 1,298 | 67 | ||||||
| Prepaid expenses and other current assets | 1,068 | 871 | ||||||
| Total current assets | 38,147 | 54,778 | ||||||
| Property and equipment, net | 235 | 321 | ||||||
| Operating lease right-of-use asset | 710 | 2,093 | ||||||
| Long-term restricted cash | 1,472 | 1,625 | ||||||
| Other long-term assets | 389 | - | ||||||
| Total assets | $ | 40,953 | $ | 58,817 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,188 | $ | 839 | ||||
| Accrued expenses and other current liabilities | 1,638 | 1,233 | ||||||
| Operating lease liability | 857 | 1,431 | ||||||
| Deferred revenue | 1,339 | 939 | ||||||
| Total current liabilities | 5,022 | 4,442 | ||||||
| Deferred revenue, net of current portion | 4,822 | 6,069 | ||||||
| Operating lease liability, net of current portion | - | 857 | ||||||
| Total liabilities | 9,844 | 11,368 | ||||||
| Stockholders' equity: | ||||||||
| Preferred Stock, $0.0001 par value - 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no and 1,830 shares issued and outstanding at December 31, 2022 and 2021, respectively | - | 1,081 | ||||||
| Common stock, $0.0001 par value - 200,000,000 shares authorized; 3,639,185 and 3,222,037 shares issued and outstanding at December 31, 2022 and 2021, respectively | - | - | ||||||
| Additional paid-in capital | 304,585 | 301,008 | ||||||
| Accumulated deficit | (273,476 | ) | (254,640 | ) | ||||
| Total stockholders' equity | 31,109 | 47,449 | ||||||
| Total liabilities and stockholders' equity | $ | 40,953 | $ | 58,817 |
Statements of Operations
thousands, except share and per share data)
| Year ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenues | $ | 6,071 | $ | 5,169 | ||||
| Operating expenses: | ||||||||
| Research and development | 18,240 | 15,382 | ||||||
| General and administrative | 6,778 | 6,377 | ||||||
| Impairment of goodwill | - | 3,577 | ||||||
| Total operating expenses | 25,018 | 25,336 | ||||||
| Loss from operations | (18,947 | ) | (20,167 | ) | ||||
| Other income/(expense): | ||||||||
| Interest income | 309 | 7 | ||||||
| Other expense, net | (198 | ) | (11 | ) | ||||
| Total other income/(expense), net | 111 | (4 | ) | |||||
| Net loss | (18,836 | ) | (20,171 | ) | ||||
| Less: Deemed dividend - beneficial conversion feature of preferred stock | - | (3,197 | ) | |||||
| Net loss attributable to common stockholders | $ | (18,836 | ) | $ | (23,368 | ) | ||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (5.46 | ) | $ | (8.63 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 3,447,701 | 2,708,558 |
is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central
nervous system ("CNS") disorders using its patented iSPERSE technology. The Company's proprietary product pipeline
includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary
Disease ("COPD") and CNS 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.
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," "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 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.