Q3 2019 Highlights
Pulmatrix achieved clinical and business milestones which reflect the Company's progress. These milestones include the following:
"We are excited with the Pulmazole program momentum over the past quarter. With regulatory approval to commence patient enrollment now achieved in all countries, we activated 12 additional study sites in the third quarter and anticipate increased patient enrollments from the 19 study sites now active," said Ted Raad, chief executive officer of Pulmatrix. "In addition to the Pulmazole program progress, we continue to advance the PUR1800 program towards a Phase 1b study start in first half of 2020. Both the Pulmazole Phase 2 and the PUR1800 Phase 1b studies are fully funded with data read-outs expected in the second half of 2020."
As of September 30, 2019, Pulmatrix had $27.9 million in cash, compared to $2.6 million as of December 31, 2018. In April 2019, Pulmatrix completed a financing that resulted in $16.6 million of total gross proceeds and executed a Definitive Agreement with Cipla for the co-development and commercialization of Pulmazole. In early May 2019, Pulmatrix received a $22 million upfront payment from Cipla. Following the completion of the initiated Phase 2 clinical trial, Pulmatrix and Cipla will equally share costs related to the future development and commercialization of Pulmazole and will equally share worldwide free cash flow from future sales of Pulmazole.
Pulmatrix generated $1.4 million of revenue in the third quarter of 2019, compared to no revenues in the third quarter of 2018. The revenue for the third quarter of 2019 was the result of the recognition of income pursuant to the Cipla Agreement.
Research and development expenses for the third quarter of 2019 were $3.3 million, compared to $3.1 million for the same period last year. The increase was primarily due to increased clinical development costs on the Pulmazole project, partially offset by decreases in clinical development costs on the PUR1800 project and decreased employment costs. General and administrative expenses for the both third quarter of 2019 and for the third quarter of 2018 were $1.8 million.
Net loss was $3.6 million for the third quarter of 2019 and $4.8 million for the third quarter of 2018. The reduction in net loss was primarily due to the increase in revenue recognized.
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis ("ABPA"), and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease ("COPD"). Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
Certain statements in this press release 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, 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; and 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 annual report on Form 10-K filed with the Securities and Exchange Commission on February 19, 2019, as amended on July 24, 2019, 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.
Financial Tables to Follow
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Timothy McCarthy, CFA
SOURCE Pulmatrix, Inc.