WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) recently reported financial results for the third quarter ended September 30, 2023 and provided key business updates.
“During the third quarter, we initiated our plan to move the istaroxime program in cardiogenic shock to Phase 3 readiness by advancing two clinical trials. First, we began building upon the positive data from the SEISMiC study by progressing the SEISMiC Extension Study for dose optimization in U.S., Europe and Latin American countries and sites. Additionally, we continued to progress start-up activities for a study of istaroxime in more severe SCAI Stage C cardiogenic shock patients that, with adequate resourcing, we anticipate will begin enrollment in the fourth quarter,” said Craig Fraser, Chief Executive Officer of Windtree. “Additionally, this quarter noted progress with our next generation, dual mechanism SERCA2a activators, including additional research and the awarding by the U.S. Patent and Trademark Office of a new composition of matter patent. Beyond multiple development activities, we are engaged in business development discussions. This is a busy time for Windtree, and over this and the next few quarters, we expect to deliver several milestones and events.”
Key Business Updates
- Progressed study and research site startup activities and regulatory filings in the U.S., Europe, and Latin America for both the SEISMiC Extension Study and the SCAI Stage C Study for istaroxime in cardiogenic shock.
- In August 2023, the Company announced that the United States Patent and Trademark Office issued US Patent No. 11,730,746 providing patent coverage for the dual mechanism SERCA2a Activators. The new composition of matter patent, titled: “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” provides patent protection through late 2039.
- Company management recently attended several investor conferences including the Dawson James Small Cap Growth Conference; and the ThinkEquity Conference; and participated in a panel discussion titled, “Cardiac Kids: Late-Stage Advancement for Cardiovascular Disorders,” at the Lytham Partners Fall 2023 Investor Conference.
- Cash and cash equivalents as of September 30, 2023 were $7.4 million.
Select Third Quarter 2023 Financial Results
For each of the quarters ended September 30, 2023 and 2022, the Company reported an operating loss of $4.7 million. Included in operating loss for the third quarter of 2022 is non-cash expense of $0.5 million related to the impairment of goodwill.
Research and development expenses were $2.1 million for the third quarter of 2023, compared to $1.5 million for the third quarter of 2022. The increase in research and development expenses is primarily due to (i) an increase of $0.6 million due to the initiation of the SEISMiC Extension study during the third quarter of 2023 and planning and start-up costs for the potential study of istaroxime in more severe SCAI Stage C cardiogenic shock; and (ii) a $0.6 million reversal of royalty expense in the third quarter of 2022 related to the KL4 surfactant platform; partially offset by (iii) a decrease of $0.4 million in personnel costs related to reductions in headcount; (iv) a decrease of $0.1 million related to the KL4 surfactant platform as the Company continues to focus its resources on the development of its istaroxime pipeline; and (v) a decrease of $0.1 million in non-cash stock-based compensation expense.
General and administrative expenses for the third quarter of 2023 were $2.6 million, compared to $2.7 million for the third quarter of 2022. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.3 million in non-cash stock-based compensation expense due to the timing of equity grants during 2023 compared to 2022; (ii) a decrease of $0.2 million in personnel costs due to headcount reductions; (iii) a decrease of $0.2 million in incentive bonus expense; and (iv) a decrease of $0.1 million in insurance costs; partially offset by (v) an increase of $0.4 million in severance expense related to a former executive; and (vi) an increase of $0.3 million in professional fees.
The Company reported a net loss of $4.4 million ($0.86 per basic share) on 5.1 million weighted-average common shares outstanding for the quarter ended September 30, 2023, compared to a net loss of $4.1 million ($6.51 per basic share) on 0.6 million weighted average common shares outstanding for the comparable period in 2022.
As of September 30, 2023, the Company reported cash and cash equivalents of $7.4 million, which is expected to be sufficient to support the Company’s development activities and fund its business operations through the first quarter of 2024.
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, which will be filed with the Securities and Exchange Commission on November 9, 2023, and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.
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