On March 26, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology reported its 2019 financial results and provides a business update (Press release, Pulmatrix, MAR 26, 2020, View Source [SID1234555886]).

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"2019 was a transformative year at Pulmatrix marked by significant clinical and corporate milestones," said Ted Raad, Chief Executive Officer of Pulmatrix. "We built significant momentum with regulatory accomplishments, strategic partnerships expanding our global reach, and most importantly, the advancement of both Pulmazole and PUR1800 programs. Our PUR1800 licensing agreement with the Lung Cancer Initiative at Johnson & Johnson and Pulmazole strategic partnership with Cipla Technologies LLC demonstrate the strength of Pulmatrix’s iSPERSE platform to enhance the safety and efficacy of promising drug candidates and we are thrilled to be collaborating with these leading, global partners."

Mr. Raad continued, "On the clinical front, we initiated our ongoing Phase 2 clinical study of Pulmazole for the treatment of ABPA, which we believe has the potential to change the standard of care for patients with asthma and ABPA. In collaboration with Johnson & Johnson, we plan to initiate the PUR1800 Ph1b clinical study and chronic toxicology studies in mid-2020. In parallel, we are working to advance a new proprietary iSPERSE enabled 505(b)(2) program into the clinic in 2021. However, the novel coronavirus may adversely impact the planned timelines for each of these trials should institutions need to suspend enrollments or should we voluntarily suspend enrollment at sites due to risks related to the coronavirus. We will evaluate these issues on an ongoing basis."

2019 and Recent Highlights:

Initiated Phase 2 trial evaluating Pulmazole, an inhaled iSPERSE formulation of the antifungal itraconazole, for the treatment of Allergic Bronchopulmonary Aspergillosis ("ABPA") in patients with asthma.
Announced kinase inhibitor licensing and development agreement with the Lung Cancer Initiative at Johnson & Johnson. The agreement provides the Lung Cancer Initiative option to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception. Under the terms of the agreement, Pulmatrix received a $7.2M upfront payment with eligibility for additional milestone and royalty payments.
Entered into strategic partnership with Cipla Technologies LLC ("Cipla") for the worldwide development and commercialization of Pulmazole. Under the terms of the partnership, Pulmatrix received a $22M upfront payment, fully funding the Phase 2 study. The partnership leverages Cipla’s expertise in respiratory drug development and global commercialization capability and footprint (the "Cipla collaboration").
Received U.S. FDA Fast Track designation for Pulmazole for the treatment of ABPA.
Strengthened intellectual property portfolio with issuance of US patent covering iSPERSE formulations for Pulmazole.
Announced research collaboration with Nocion Therapeutics to explore inhaled drug delivery technologies.
Completed $16.6M public offering extending cash runway through data for ongoing Pulmazole Phase 2 program.
Strengthened Board of Directors with appointment of life sciences executive Rick Batycky.
Financials

As of December 31, 2019, Pulmatrix had $23.4 million in cash and cash equivalents, compared to $2.6 million for the year ended December 31, 2018.

Revenue for 2019 was $7.9 million, compared to $0.2 million for 2018. The increase was the result of the recognition of revenue pursuant to the Cipla Collaboration.

Research and development expense was $12.8 million in 2019 compared to $13.0 million in 2018. The decrease year–over–year was primarily due to decreased spend of $1.6 million in employment costs as a result of decreased share based compensation expense and $0.6 million on the PUR1800 project as a result of the completion of a pre-clinical toxicology study in 2018, partially offset by increased spend of $2.0 million on the Pulmazole project.

General and administrative expense was $8.5 million for 2019 and $7.5 million for 2018. The increase year-over-year was due to a $0.3 million royalty payment made to the Cystic Fibrosis Foundation which resulted from the Cipla Collaboration and increases of $0.3 million of legal and patent costs, $0.2 million of employment costs and $0.2 million in professional consulting expense.

Goodwill had an impairment charge of $7.3 million in 2019 compared to a $0.1 million charge in 2018.

Net loss for 2019 and 2018 were both $20.6 million. The net loss in 2019 was primarily attributable to spend on the Pulmazole project as we advance our Phase 2b clinical study and PUR1800 manufacturing costs for the upcoming Phase 1b clinical study.