Windtree Therapeutics

Windtree Therapeutics Announces Reverse Stock Split

Retrieved on:

Thursday, April 18, 2024

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WARRINGTON, Pa., April 18, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NASDAQ: WINT) (“Windtree” or the “Company”), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today announced that the Company’s Board of Directors has approved a 1-for-18 reverse stock split of its issued and outstanding common stock, par value of $0.001 per share (the “Reverse Stock Split”).

Key Points:

WARRINGTON, Pa., April 18, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NASDAQ: WINT) (“Windtree” or the “Company”), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today announced that the Company’s Board of Directors has approved a 1-for-18 reverse stock split of its issued and outstanding common stock, par value of $0.001 per share (the “Reverse Stock Split”).
No fractional shares of common stock will be issued as a result of the Reverse Stock Split.
The Reverse Stock Split impacts all holders of the Company’s common stock proportionally and will not impact any stockholders’ percentage ownership of common stock (except to the extent the reverse stock split results in any stockholder owning only a fractional share, in which case such share shall be rounded up to one whole share).
Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split, subject to such broker’s particular processes, and will not be required to take any action in connection with the Reverse Stock Split.

Windtree Acquires Early-Stage, Novel Oncology Platform and Completes $1.5 Million Convertible Note Bridge Financing

Retrieved on:

Monday, April 8, 2024

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The Company also completed a $1.5 million convertible note bridge financing.

Key Points:

The Company also completed a $1.5 million convertible note bridge financing.
The acquired Varian asset platform is a novel, potential high-potency, specific, aPKCi with possible broad use in oncology as well as certain rare malignant diseases.
“Completion of the Varian asset acquisition and the bridge financing represents a potentially transformative next step for Windtree.
Additional details are available by reading the Company’s Current Report on Form 8-K relating to the Varian asset acquisition and senior convertible note bridge financing, which was filed with the Securities and Exchange Commission on April 8, 2024.

Tris Pharma Appoints Michael Magee as Vice President, Quality & Compliance

Retrieved on:

Wednesday, February 7, 2024

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the appointment of Michael Magee as vice president, quality and compliance.

Key Points:

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the appointment of Michael Magee as vice president, quality and compliance.
Mr. Magee will lead and further strengthen Tris Pharma’s continued development and management of quality and compliance operations via the current Good Manufacturing Practices (cGMP) Compliance function of the organization.
“Michael brings a wealth of knowledge and a deep understanding of the regulatory and quality landscape, which will be instrumental in maintaining our unwavering commitment to developing therapeutics of the highest quality across ADHD, pain, addiction and neurological disorders,” said Nicholas Cappuccino, Ph.D., chief quality officer, senior vice president of quality & compliance at Tris Pharma.
“I look forward to collaborating with Michael to further elevate our quality assurance and regulatory compliance practices.”

Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Retrieved on:

Thursday, February 1, 2024

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

Key Points:

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.
SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias.
Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.
Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock.

Windtree Therapeutics Announces Engagement of Strategic Advisor to Support Assessment of Strategic Alternatives

Retrieved on:

Wednesday, January 31, 2024

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WARRINGTON, Pa., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that it has engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic alternatives for the Company with the goal of maximizing stockholder value.

Key Points:

WARRINGTON, Pa., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that it has engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic alternatives for the Company with the goal of maximizing stockholder value.
“While there has been positive data and progress, we believe the opportunity is under-recognized and under-valued in the current financial markets, however, it has resulted in in-bound business development interest.
Beyond traditional licensing, the Company will explore the potential for an acquisition, merger, further licensing, company sale or other strategic transactions.
The engagement of Ladenburg as strategic advisor is intended to support the board’s process and assessment of opportunities.

Windtree Eliminates $15 Million Contingent Liability to Deerfield Management Company

Retrieved on:

Thursday, January 25, 2024

Heart, Windtree Therapeutics, Istaroxime, Therapy, Cardiogenic shock, White lung, Pharmaceutical industry

Windtree out-licensed global rights to AEROSURF® in 2022.

Key Points:

Windtree out-licensed global rights to AEROSURF® in 2022.
“We appreciate the support of Deerfield in our efforts to strengthen our financial position with the completion of this transaction and the expected elimination the $15 million contingent liability.
As a result, we believe we have meaningfully strengthened and simplified our balance sheet,” said Craig Fraser, Windtree's President and Chief Executive Officer.
Along with significantly cutting our cash burn rate since the second half of 2022, I believe we have strengthened the company through recent transactions such as this one.

Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator

Retrieved on:

Tuesday, January 2, 2024

WARRINGTON, Pa., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced new preclinical data on the Company’s lead product candidate, istaroxime, and another preclinical pipeline drug candidate, CVie-216, showing reductions in ventricular arrythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury. Istaroxime and CVie-216 are each designed to act on pumps in the cardiac cells that are important in calcium handling. Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a.

Key Points:

Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a.
Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies, including a study that evaluated patients with early cardiogenic shock.
Windtree is continuing to obtain data to evaluate the potential benefits of SERCA2a activation on arrythmia risk in all ongoing clinical trials.
This study demonstrated a reduction in arrythmias in the istaroxime and CVie-216 pretreated groups compared to the control group.

Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock

Retrieved on:

Monday, December 18, 2023

Blood pressure, Cardiogenic shock, AHF, Istaroxime, Windtree Therapeutics, SCAI, Therapy, Heart, Seismology, Patient, Safety, Pharmaceutical industry

WARRINGTON, Pa., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that the Company recently enrolled the first subject in its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock. Study results are expected in mid-2024.

Key Points:

The study of hospitalized patients with early cardiogenic shock (SCAI Stage B) due to acute heart failure (AHF) will evaluate two dose regimens of istaroxime compared to placebo.
In the previous SEISMiC study in early cardiogenic shock, patients were infused with drug or placebo for 24 hours.
The Company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients.
The istaroxime cardiogenic shock SCAI Stage C study is expected to enroll up to 20 subjects with SCAI Stage C cardiogenic shock due to AHF.

Windtree Therapeutics Announces Issuance of New Pure SERCA2a Activator Patent

Retrieved on:

Thursday, November 16, 2023

European Patent Office, Therapy, Ageing, Windtree Therapeutics, Heart, Patient, Heart failure, European Patent Convention, Diagnosis, Patent, Family, Hospital, PURE, Pharmaceutical industry

3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates.

Key Points:

3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates.
The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline.
The new European patent, titled: “ANDROSTANE DERIVATIVES WITH ACTIVITY AS PURE OR PREDOMINANTLY PURE STIMULATORS OF SERCA2A FOR THE TREATMENT OF Heart Failure,” provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action.
Windtree believes activation of SERCA2a represents a potentially important advancement in heart failure treatment for patients,” said Craig Fraser, CEO of Windtree Therapeutics.

Windtree Therapeutics Reports Third Quarter 2023 Financial Results and Provides Key Business Updates

Retrieved on:

Thursday, November 9, 2023

Cardiogenic shock, Research, LIKE, Therapy, Security (finance), Extension, Seismology, Patient, Insurance, HEART, Conference, SCAI, Patent, Pharmaceutical industry, Cryptocurrency, Windtree Therapeutics

WARRINGTON, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2023 and provided key business updates.

Key Points:

WARRINGTON, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today 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.
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.
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.