On May 11, 2021 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 first quarter 2021 financial results and provides a business update (Press release, Pulmatrix, MAY 11, 2021, View Source [SID1234579674]).
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Q1 and Recent Highlights:
PUR1800
Pulmatrix regained full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson’s Enterprise Innovation’s (JJEI) decision to terminate the Company’s license, development and commercialization agreement. JJEI’s termination of the agreement had no material impact on our financial projections.
Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD (AECOPD) and other chronic airway diseases.
Initiated the Phase 1b clinical study of PUR1800, dosing 5 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies.
With existing 28-day toxicology results, the Company expects that completion of the PUR1800 Phase 1b will enable a Ph2 efficacy trial in AECOPD. The results from 6 and 9-month toxicology studies underway may expand the PUR1800 opportunity to additional indications which require chronic dosing.
PUR3100
PUR3100 development candidate, a dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery in acute migraine.
Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE.
Pulmazole
Successfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole.
On May 10, 2021, we sent a letter to Cipla Technologies LLC ("Cipla") notifying Cipla that it is in material breach of our Development and Commercialization Agreement (the "Cipla Agreement"), dated April 15, 2019, due to Cipla’s anticipatory breach of its obligation under the Cipla Agreement to fund 50% of the development costs for Pulmazole. We have given Cipla 30 days from the date of the letter to reaffirm that it will perform the Agreement in accordance with its terms or we will exercise our contractual right to terminate the agreement for Cipla’s material breach and reacquire all rights to Pulmazole for 25% of its fair market value. In either outcome, Pulmatrix intends to advance Pulmazole clinically to Ph2b.
Hosted KOL investor event featuring presentations by Stewart J. Tepper, M.D., F.A.H.S, Geisel School of Medicine at Dartmouth and Stephen Silberstein, M.D., F.A.C.P., Thomas Jefferson University, detailing the current landscape and unmet need for acute migraine, the potential of novel DHE therapies, and the development plan and preclinical data for PUR3100
Progressing IND-enabling studies with Phase 1/Phase 2 clinical study anticipated to begin Q1 2022.
Corporate:
Completed a registered direct offering with gross proceeds of $40 million extending the Company’s cash runway to fully fund data readouts across its development pipeline including PUR1800 Phase 1b and PUR3100 Phase 1 / Phase 2 studies.
"The first quarter of 2021 has marked a number of significant milestones for Pulmatrix," said Ted Raad, Chief Executive Officer of Pulmatrix. "Each of our iSPERSE enabled programs, ranging from asthma, COPD, and migraine, represents an opportunity to address significant unmet needs of large patient populations. We are pleased to now have the kinase inhibitor portfolio back in our proprietary pipeline following the termination of the development and licensing agreement with Johnson & Johnson. We also remain steadfast in our objective to bring Pulmazole to market and address significant unmet need of patients suffering from ABPA. Our recent notice to Cipla Technologies demonstrates that commitment. With our strong balance sheet, we believe that we can fund operations through planned data milestones for PUR1800 and PUR3100 and, if we ultimately re-acquire Pulmazole from Cipla, begin our Ph2b study."
Financials
As of March 31, 2021, Pulmatrix had $63.4 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.
Revenue for the first quarter of 2021 was $1.4 million, compared to $2.8 million for the same period in 2020. The revenue for the first quarter of 2021 and 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI.
Research and development expense was $3.9 million in the first quarter of 2021 compared to $5.3 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased costs associated with the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study partially offset by preclinical and manufacturing costs for the PUR3100 program.
General and administrative expense was $1.6 million for the first quarter of 2021 compared to $2.2 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased employment, patent, and consulting costs.
Net loss was $4.1 million for the first quarter of 2021 compared to a net loss of $4.7 million for the same period of 2020.