Pulmatrix, Inc. (NASDAQ:PULM) today announced first quarter financial results for 2022 and provided a corporate update.
Ted Raad, Chief Executive Officer of Pulmatrix commented, "We have prioritized capital towards extending our cash runway through the Pulmazole Phase 2b top-line data anticipated in Q2 2024. We anticipate dosing for the Phase 2b study to begin in Q1 2023. Also in 2022, we will further analyze the PUR1800 Phase 1b data to finalize a potential Phase 2 study design while we execute to deliver PUR3100 Phase 1 top-line data in Q4 2022."
First Quarter 2022 and Recent Program Highlights
Pulmazole (PUR1900)
- The Pulmazole Phase 2b efficacy study will include a 16-week dosing regimen with potential registration efficacy endpoints, is on track to begin dosing patients in Q1 2023. With a focus on capital conservation, we have extended our projected cash runway through the anticipated top-line data readout in Q2 2024.
PUR3100
- On January 25, 2022, the Company conducted a Type C meeting with the FDA to add additional clarification around some of the written pre-IND responses in relation to the overall non-clinical and clinical program. Management concluded that conducting the Phase 1 study in Australia should allow the Company to generate the most comprehensive dataset for inclusion in an IND for Phase 2 in the United States, while also providing the most time efficient path to Phase 1 data in 2022.
PUR1800
- On March 21, 2022, the Company announced top-line data from a Phase 1b clinical study of PUR1800 assessing the safety, tolerability and pharmacokinetics of PUR1800 in patients with stable COPD after dosing the first patient in February 2021. We are analyzing the Phase 1b clinical study data for future publication and to finalize design of a potential Phase 2 efficacy study in treatment of AECOPD.
First Quarter Corporate Highlights
- On February 28, the Company completed a reverse stock-split at a ratio of 1-for-20 which reduced the number of outstanding shares of the Company's common stock from approximately 65.9 million shares to 3.3 million shares.
- On March 1, the Company announced the hiring of Dr. Margaret Wasilewski as the Company's Chief Medical Officer. Dr. Wasilewski leverages over 25 years of experience in pharmaceutical drug development.
- On March 17, the Company announced that it regained compliance for its listing on Nasdaq, allowing continued access to capital markets and liquidity for its investors.
First Quarter 2022 Financial Results
Revenue was $1.2 million for the first quarter ended March 31, 2022, compared to $1.4 million for the same period in 2021, a decrease of $0.2 million. Revenue for 2022 from the collaboration and license agreement with Cipla on the Company's Pulmazole program increased, offset by no revenues from a previous JJEI License Agreement for the Company's PUR1800 kinase inhibitor.
For the three months ended March 31, 2022, research and development expenses were $4.1 million compared to $3.9 million for the same period in 2021, an increase of $0.3 million. The increase was primarily due to increased spend of $0.7 million in employment costs and $0.1 million in rent costs, partially offset by decreased spend of $0.3 million on preclinical costs related to our PUR1800 program and $0.2 million on clinical and manufacturing costs related to the Pulmazole program.
General and administrative expenses were $2.0 million for the three months ended March 31, 2022, compared to $1.6 million for the three months ended March 31, 2021, an increase of $0.4 million. The increase was primarily due to increased spend of $0.1 million in employment costs, $0.3 million on consulting and legal, and $0.1 million on audit, tax and public company expense, partially offset by decreased patent expense of $0.1 million.
Our total cash and cash equivalents balance as of March 31, 2022 was $47.5 million. We expect that our existing cash and cash equivalents as of March 31, 2022 will enable us to fund our projected operating expenses and capital expenditures into Q2 2024.
PULMATRIX, INC. | ||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) | ||||||||||||
(in thousands, except share and per share data) | ||||||||||||
Three Months Ended | ||||||||||||
March 31, | ||||||||||||
2022 | 2021 | |||||||||||
Revenues | $ | 1,160 | $ | 1,390 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 4,149 | 3,856 | ||||||||||
General and administrative | 1,974 | 1,619 | ||||||||||
Total operating expenses | 6,123 | 5,475 | ||||||||||
Loss from operations | (4,963) | (4,085) | ||||||||||
Other income (expense): | ||||||||||||
Interest income | 1 | 3 | ||||||||||
Other expense, net | (11) | (22) | ||||||||||
Total other income (expense) | (10) | (19) | ||||||||||
Net loss | $ | (4,973) | $ | (4,104) | ||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | (1.51) | $ | (1.78) | ||||||||
Weighted average common shares outstanding - basic and diluted | 3,297,280 | 2,301,610 | ||||||||||
PULMATRIX, INC. | ||||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||||
(in thousands, except share and per share data) | ||||||||||
March 31, 2022 | December 31, 2021 | |||||||||
(unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 47,534 | $ | 53,840 | ||||||
Accounts receivable | 1,113 | 67 | ||||||||
Prepaid expenses and other current assets | 1,961 | 871 | ||||||||
Total current assets | 50,608 | 54,778 | ||||||||
Property and equipment, net | 319 | 321 | ||||||||
Operating lease right-of-use asset | 1,751 | 2,093 | ||||||||
Long-term restricted cash | 1,625 | 1,625 | ||||||||
Total assets | $ | 54,303 | $ | 58,817 | ||||||
Liabilities and stockholders' equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | 1,227 | 839 | ||||||||
Accrued expenses | 1,067 | 1,233 | ||||||||
Operating lease liability | 1,566 | 1,431 | ||||||||
Deferred revenue | 1,517 | 939 | ||||||||
Total current liabilities | 5,377 | 4,442 | ||||||||
Deferred revenue, net of current portion | 5,739 | 6,069 | ||||||||
Operating lease liability, net of current portion | 430 | 857 | ||||||||
Total liabilities | 11,546 | 11,368 | ||||||||
Commitments and contingencies (Note 12) | ||||||||||
Stockholders' equity: | ||||||||||
Series A convertible preferred stock, $0.0001 par value — 6,746 shares authorized at March 31, 2022 and December 31, 2021; 915 and 1,830 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 540 | 1,081 | ||||||||
Common stock, $0.0001 par value — 200,000,000 shares authorized at March 31,2022 and December 31, 2021; 3,310,922 and 3,222,037 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | - | - | ||||||||
Additional paid-in capital | 301,830 | 301,008 | ||||||||
Accumulated deficit | (259,613) | (254,640) | ||||||||
Total stockholders' equity | 42,757 | 47,449 | ||||||||
Total liabilities and stockholders' equity | $ | 54,303 | $ | 58,817 | ||||||