WARRINGTON, Pa., April 08, 2024 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Firm”) (NasdaqCM: WINT), at present introduced that on April 2, 2024 the Firm entered into an asset buy settlement with Varian Biopharmaceuticals, Inc. (“Varian”) to amass sure of its belongings, together with a proprietary atypical protein kinase C iota inhibitor (aPKCi). The Firm additionally accomplished a $1.5 million convertible be aware bridge financing.
The acquired Varian asset platform is a novel, potential high-potency, particular, aPKCi with doable broad use in oncology in addition to sure uncommon malignant illnesses. The asset platform contains two formulations: VAR-101 (topical) and VAR-102 (oral).
In consideration of the acquisition of the Varian belongings, on April 2, 2024, the Firm issued to sure of Varian’s creditor traders a complete of 5,500 shares of Collection B Convertible Most well-liked Inventory, par worth $0.001 per share (the “Most well-liked Shares”), which have an preliminary conversion value of $0.3603, which is topic to adjustment to no decrease than $0.0721. Dividends on the Most well-liked Shares shall accrue at 10.0% each year, topic to restricted exceptions. With profitable improvement, the Firm would pay as much as $2.3 million in milestone funds upon the achievement of sure regulatory and scientific improvement milestones referring to the acquired belongings with the Firm having the choice to pay such milestone funds both in money or the Firm’s widespread inventory.
Protein kinase inhibitors are a category of anti-cancer therapeutics which have made a big influence on the remedy of cancers. Among the many kinase targets for additional improvement are the Protein Kinase C (“PKC”) household, that are key parts of many signaling pathways that drive the formation of most cancers. aPKCi is a promising atypical PKC iota isozyme with outlined oncogenic function in a number of signaling pathways, and within the initiation and improvement of a number of tumor sorts. GLI-1 is a transcription issue on the terminal finish of the Hedgehog (Hh) signaling pathway, and plenty of different essential pathways, together with RAS-RAF, TGFb, and P14K-AKT-mTOR. In lots of tumor sorts, excessive ranges of GLI-1 expression is a unfavourable prognostic marker. Pre-clinical knowledge of the acquired platform confirmed dose dependent modulation of basal cell carcinoma cell viability and GLI-1 pathway modulation in vitro, in addition to dose dependent anti-tumor exercise in xenograft mouse fashions of non-small cell lung most cancers and pancreatic ductal carcinoma. The protein kinase inhibitor provides to Windtree’s product candidate portfolio of novel pre-clinical and late-stage scientific product candidates and improvement applications, together with SERCA2a activators and applications in out-licensed partnership.
“Completion of the Varian asset acquisition and the bridge financing represents a doubtlessly transformative subsequent step for Windtree. Including an progressive protein kinase inhibitor that has what we consider is an thrilling pre-clinical knowledge package deal with two formulations in improvement to our current portfolio of product candidates creates a further alternative for worth creation as we advance and look to associate our late and early-stage SERCA2a activator platform, together with istaroxime,” stated Craig Fraser, Chief Government Officer of Windtree. “We see potential utility in each uncommon and extra prevalent tumor sorts, each in monotherapy and together with different brokers. We consider there will probably be choices for focused illness choice and differentiation because of the potential for top specificity and topical formulation to deal with numerous pores and skin cancers. Within the weeks to return, I stay up for offering updates on using this newly acquired capital and plans for our portfolio and applications, together with licensing exercise for istaroxime and our SERCA2a activators in addition to our firm technique to have a stronger steadiness sheet and alternatives to additional leverage our expertise to develop the enterprise.”
Along with the asset buy, on April 2, 2024, the Firm entered right into a securities buy settlement with sure traders whereby the Firm agreed to promote to such traders $1.5 million in senior convertible notes (the “Notes”) for combination gross proceeds of $1.5 million (the “Notes Providing”). The Notes have an preliminary conversion value of $0.3603, which is topic to adjustment upon the prevalence of specified occasions to no decrease than $0.0721 (topic to any inventory cut up, inventory dividend, inventory mixture, recapitalization or different related transaction). The Firm could, at its possibility, redeem the Notes topic to sure situations and phrases within the securities buy settlement. The Notes could convert in a subsequent financing or will accrue curiosity at a price of 10% each year and mature on January 2, 2025, except beforehand transformed or redeemed. The Firm intends to make use of the web proceeds from the Notes Providing for normal company functions.
The Firm agreed to hunt stockholder approval for the issuance of all the Firm’s widespread inventory issuable upon conversion of the Notes and the Most well-liked Shares in accordance with the foundations and rules of the Nasdaq Inventory Market.
Further particulars can be found by studying the Firm’s Present Report on Kind 8-Ok referring to the Varian asset acquisition and senior convertible be aware bridge financing, which was filed with the Securities and Trade Fee on April 8, 2024.
About Istaroxime
Istaroxime is a first-in-class dual-mechanism remedy designed to enhance each systolic and diastolic cardiac perform. Istaroxime is a optimistic inotropic agent that will increase myocardial contractility by way of inhibition of Na+/Ok+- ATPase with a complimentary mechanism that facilitates myocardial leisure by way of activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Information from a number of Section 2 research in sufferers with early cardiogenic shock or acute decompensated coronary heart failure show that istaroxime infused intravenously considerably improves cardiac perform and blood stress with out growing coronary heart price or the incidence of cardiac rhythm disturbances.
About Pure SERCA2a Activators
These compounds activate SERCA2a and Windtree Therapeutics’ analysis and improvement program is evaluating these preclinical product candidates, together with oral and intravenous SERCA2a activator coronary heart failure compounds.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology firm targeted on advancing early and late-stage progressive therapies for vital situations and illnesses. Windtree’s portfolio of product candidates contains istaroxime, a Section II candidate with SERCA2a activating properties for acute coronary heart failure and related cardiogenic shock, pre-clinical SERCA2a activators for coronary heart failure and VAR-101 and VAR-102, pre-clinical precision aPKCi inhibitors which are being developed for potential in uncommon and broad oncology functions. Windtree additionally has a licensing enterprise mannequin with partnership out-licenses at the moment in place.
Ahead Wanting Statements
This press launch comprises forward-looking statements throughout the that means of The Non-public Securities Litigation Reform Act of 1995. The Firm could, in some circumstances, use phrases corresponding to “predicts,” “believes,” “potential,” “proposed,” “proceed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “could,” “may,” “may,” “will,” “ought to” or different phrases that convey uncertainty of future occasions or outcomes to establish these forward-looking statements. Such statements are based mostly on data obtainable to the Firm as of the date of this press launch and are topic to quite a few essential components, dangers and uncertainties that will trigger precise occasions or outcomes to vary materially from the Firm’s present expectations. Examples of such dangers and uncertainties embrace: the Firm’s means to safe important further capital as and when wanted; the Firm’s means to acquire approval for the issuance of all the Firm’s widespread inventory issuable upon conversion of the Notes and the Most well-liked Shares; dangers and uncertainties related to the success and development of the scientific improvement applications for istaroxime and the Firm’s different product candidates, together with pre-clinical candidates corresponding to VAR-101 and VAR-102; the Firm’s means to entry the debt or fairness markets; the Firm’s means to handle prices and execute on its operational and price range plans; the outcomes, value and timing of the Firm’s scientific improvement applications, together with any delays to such scientific trials referring to enrollment or website initiation; dangers associated to know-how transfers to contract producers and manufacturing improvement actions; delays encountered by the Firm, contract producers or suppliers in manufacturing drug merchandise, drug substances, and different supplies on a well timed foundation and in enough quantities; dangers referring to rigorous regulatory necessities, together with that: (i) the U.S. Meals and Drug Administration or different regulatory authorities could not agree with the Firm on issues raised throughout regulatory evaluations, could require important further actions, or could not settle for or could withhold or delay consideration of functions, or could not approve or could restrict approval of the Firm’s product candidates, and (ii) modifications within the nationwide or worldwide political and regulatory surroundings could make it tougher to realize regulatory approvals and dangers associated to the Firm’s efforts to keep up and defend the patents and licenses associated to its product candidates; dangers that the Firm could by no means understand the worth of its intangible belongings and must incur future impairment prices; dangers associated to the dimensions and development potential of the markets for the Firm’s product candidates, and the Firm’s means to service these markets; the Firm’s means to develop gross sales and advertising capabilities, whether or not alone or with potential future collaborators; the speed and diploma of market acceptance of the Firm’s product candidates, if accepted; the financial and social penalties of the COVID-19 pandemic and the impacts of political unrest, together with on account of geopolitical pressure, together with the battle between Russia and Ukraine, the Folks’s Republic of China and the Republic of China (Taiwan), and the evolving occasions in Israel and Gaza, and any sanctions, export controls or different restrictive actions which may be imposed by america and/or different international locations which may have an opposed influence on the Firm’s operations, together with by way of disruption in provide chain or entry to potential worldwide scientific trial websites, and thru disruption, instability and volatility within the international markets, which may have an opposed influence on the Firm’s means to entry the capital markets. These and different dangers are described within the Firm’s periodic studies, together with its Annual Report on Kind 10-Ok, Quarterly Experiences on Kind 10-Q and Present Experiences on Kind 8-Ok, filed with or furnished to the Securities and Trade Fee and obtainable at www.sec.gov. Any forward-looking statements that the Firm makes on this press launch converse solely as of the date of this press launch. The Firm assumes no obligation to replace forward-looking statements whether or not on account of new data, future occasions or in any other case, after the date of this press launch.
Contact Info:
Eric Curtis
ecurtis@windtreetx.com
