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Conavi Medical Corp. Announces Closing of $20M Public Offering

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NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES TORONTO, April 23, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI; OTC: CNVIF) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce that it has closed its previously announced, upsized equity offering for aggregate gross proceeds of $20 million (the “Offering”). The net proceeds from the Offering will be used to advance and complete the development and pre-clinical testing of its Novasight 3.0 technology, with the goal of submitting a 510(k) clearance application to the U.S. Food and Drug Administration in Q3 of 2025. The Company also intends to use the net proceeds for working capital and other general corporate purposes. Bloom Burton Securities Inc. acted as sole and exclusive agent for the Offering. Under the Offering, subscribers either purchased common shares at $0.40 per common share (the “Common Shares”) or pre-funded common share purchase warrants for $0.39999 per pre-funded common share purchase warrant (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”). Investors purchased a total of 50,000,000 Securities (consisting of 32,500,000 Common Shares and 17,500,000 Pre-Funded Warrants) for gross proceeds of $20 million. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of a subscriber entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire. In Canada, the Securities purchased pursuant to the Offering were qualified for sale by way of a short form prospectus dated April 15, 2025, which was filed in British Columbia, Alberta and Ontario. The Securities were purchased by way of private placement in the United States, pursuant to exemptions from the registration requirements under the U.S. Securities Act of 1933 (the “U.S. Securities Act”), and pursuant to all applicable U.S. state securities laws. In addition, the Securities were also sold by way of private placement in certain other jurisdictions outside of Canada and the United States pursuant to and in compliance with applicable securities laws. CPOINT Capital Corp., an insider of the Company, purchased 625,000 Common Shares under the Offering and Juno Pharmaceuticals LP, an insider of the Company, purchased 1,250,000 Common Shares under the Offering. The subscriptions for Common Shares by CPOINT Capital Corp. and Juno Pharmaceuticals LP are related party transactions within the meaning of applicable Canadian securities laws. The subscriptions by such insiders are exempt from the formal valuation and minority approval requirements applicable to related party transactions on the basis that the value of the transactions insofar as they involve related parties is less than 25% of the Company’s market capitalization. The Board of Directors of the Company has approved the Offering. A material change report in respect of the related party transactions could not be filed earlier than 21 days prior to the closing of the Offering due to the limited time between the commitment by such insiders to purchase the subject Common Shares and the closing of the Offering. The securities described herein have not been, and will not be, registered under the U.S. Securities Act, or any U.S. state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or to U.S. Persons (as such terms are defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable U.S. state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Company’s securities. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit http://www.conavi.com/. Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated use of proceeds from the Offering. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the short form prospectus dated April 15, 2025 and the joint information circular of the Company dated August 30, 2024 (both of which are on the Company’s profile at www.sedarplus.ca). Although Conavi has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. CONTACT: CONTACT:
Stefano Picone
Chief Financial Officer
(416) 483-0100

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Longeveron® Issues Letter to Shareholders Highlighting Corporate Strategy, Recent Progress and Key Priorities and Goals for 2025

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Wa’el Hashad

Wa’el Hashad, CEO, Longeveron

MIAMI, April 22, 2025 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders. Dear Fellow Shareholders, Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeveron’s founding mission – developing cutting-edge cellular therapy research to impact patients’ lives for the better by addressing unmet medical needs. We have come a long way pursuing that mission and now have clarity on the pathway to our first potential Biological License Application (BLA) submission. Today, I am excited to update you on our overall strategy, progress, and key priorities and goals for 2025. Strategic Overview and 2024 Progress:Over the past decade, stem cell therapy has seen remarkable strides, transforming from a promising field into one delivering tangible clinical outcomes. We’ve seen the solidification of cell therapy’s role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care. Longeveron has been at the forefront of this evolution in medicine. Our lead investigational product is laromestrocel (Lomecel-B™), a stem cell therapy derived from culture-expanded mesenchymal stem cells (MSCs) that are sourced from bone marrow of young healthy adult donors. The number of functional MSCs in the body declines as we age, which has driven interest in their use for aging-related conditions. Their unique properties — including the ability to reduce inflammation, promote tissue repair and regeneration, modulate immune responses, and improve vascularization — also support their application in some rare cardiovascular diseases/conditions with high unmet medical need. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions. A decade ago, our stem cell therapy vision was an academic idea. Today, laromestrocel represents a pipeline in a product opportunity that has delivered positive results from multiple clinical trials: Phase 1 & 2 in Alzheimer’s disease, Phase 1 & 2 in Aging-related Frailty, Phase 1 in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease. We are currently conducting a pivotal Phase 2b clinical trial for HLHS. Our development programs for these 3 initial indications address market opportunities of what we estimate to be approximately ~$5+ billion, ~$4+ billion and up to ~$1 billion, respectively. Earlier this year, the World Health Organization’s International Nonproprietary Names (INN) Expert Committee approved “laromestrocel” as the non-proprietary name for Lomecel-B™ — a key milestone in the development and future commercialization of our stem cell therapy. As we did this past year, in 2025, we will continue focusing our efforts on two of our most promising programs: HLHS and Alzheimer’s disease. Hypoplastic Left Heart Syndrome (HLHS): HLHS is a rare pediatric disease in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Because the left ventricle is the chamber that normally pumps blood to the body, infants born with this condition have a profound reduction in blood flow and thus cannot get the normal supply of oxygen to their organs. In order for the children to survive, they must undergo a complicated, three-stage heart reconstruction surgery over the course of the first 5 years of their lives. Despite this surgical reconstruction, only 50% of the affected children survive to age 15 without heart transplantation. Our program is designed to boost/improve the heart function in these children with the goal of potentially enhancing their survival. In our Phase I clinical trial (ELPIS I) evaluating laromestrocel in 4-month-old infants with HLHS, we observed 100% transplant-free survival up to five years following treatment. This contrasts with an approximately 20% mortality rate observed in historical control data. Five-year post-treatment long-term survival data from the ELPIS I Phase 1 clinical trial was presented at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting in October 2024. We are currently nearing completion of enrollment for our Phase 2b study, ELPIS II, which is evaluating laromestrocel as a potential adjunct treatment to the standard of care for HLHS. ELPIS II has achieved nearly 95% enrollment, and we expect to complete enrollment in the second quarter of this year. In September 2024, we completed a Type C meeting with the U.S. FDA regarding our HLHS development program and the pathway toward a potential BLA submission. We reached foundational alignment on the primary endpoint and secondary endpoints for the ELPIS II trial. The FDA confirmed that, contingent on positive results, ELPIS II may be considered a pivotal trial and potentially acceptable for BLA submission seeking full traditional approval. With this regulatory clarity, we are now focused on BLA preparedness and enabling activities for the HLHS program. Notably, because this program has received Rare Pediatric Disease Designation, we may be eligible to receive a Priority Review Voucher (PRV) if our BLA is approved. We may use the PRV internally or sell to a third party. Historically, PRVs have commanded values exceeding $100 million. Alzheimer’s Disease: The laromestrocel Alzheimer’s disease (AD) program continues to garner important recognition and support. In 2024, data from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel in mild Alzheimer’s disease were presented as a featured research oral presentation at the 2024 Alzheimer’s Association International Conference held at the end of July and as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in October. We are very excited about the trial’s positive results. The trial met its primary objective of demonstrating safety, with laromestrocel being well-tolerated. In addition, we observed encouraging trends suggesting a potential slowing or prevention of disease progression in patients treated with laromestrocel compared to placebo. This program has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, providing us with the opportunity for enhanced and frequent communication with the FDA to facilitate the development and review process.In March of this year, results from the trial were published in Nature Medicine. Also in March of this year, we held a Type B meeting with the FDA to discuss the regulatory pathway for a potential BLA for laromestrocel in mild Alzheimer’s disease. We reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial. To support an accelerated path to potential approval, the FDA agreed to consider a BLA submission based on positive interim results from this planned single study. With this regulatory clarity in hand, we are focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program. Our Core Business Objectives:Our strategic plan is built on the strength of the science underlying our stem cell therapy laromestrocel. For 2025, we are focused on four key objectives: Advance HLHS Program as the Main Near-Term Value Driver: Pivotal Phase 2 clinical trial (ELPIS II) is nearing enrollment completion.Regulatory pathway clarified with U.S. FDA.Potential to initiate rolling BLA submission in 2026.Potential to receive a Rare Pediatric Disease priority review voucher associated with HLHS upon BLA approval which could have significant monetary value and further enhance our product’s value proposition upon approval. HLHS BLA and Commercialization Readiness: Successful meeting with FDA confirmed ELPIS II could be pivotal.2025 will see significant focus on organizational readiness for potential BLA filing for HLHS in 2026. Our goal is to accomplish BLA readiness this year ahead of data readout to potentially shorten the timeline to BLA submission.Emphasis on Chemistry, Manufacturing, and Controls (CMC) preparedness.Hired industry veteran Chief Technology Officer to support BLA preparedness.We are committed to helping HLHS patients worldwide. In 2025, we intend to take initial steps connecting with non-U.S. regulatory bodies, including EMA (European Union), MHRA (United Kingdom), PMDA (Japan) and HealthCanada.Recognizing substantial revenue potential from worldwide commercialization, we anticipate capitalizing on recent rare disease pricing trends and the unique aspects of our treatment. Strategic Collaborations for Alzheimer’s Disease: We believe our Alzheimer’s disease program holds immense potential. Due to the large size of the affected population, it involves larger-scale studies and commercialization requirements. This scale of development effort necessitates significant investment, prompting our focus on potential strategic partnerships with biotech/pharmaceutical companies and/or non-dilutive funding sources.We believe the clarity on the pathway to potential BLA submission and the need for only a single pivotal clinical trial enhance the attractiveness and economic benefits of the program to potential partners. Efficient Resource Management and Capital Allocation: We strive to be prudent stewards of shareholder capital and focus allocating it to the organization’s top priorities to effectuate optimal resource utilization and alignment with strategic objectives.We prudently manage expenses. In 2024, we reduced total operating expenses 13% while continuing to effectively advance our development programs. Financial Position and Capital Strategy:Longeveron is working diligently to effectively advance our development programs while managing expenses and our capital. We will need additional capital to achieve our business strategy and objectives. We indicated in our recently filed Annual Report on Form 10K that we anticipated our existing cash and cash equivalents would fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. However, as we also indicated, as a result of our successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, we have started to ramp up BLA enabling activities to prepare for a potential filing with the FDA in 2026 if the current ELPIS II trial is successful. We expect our operating expenses and capital expenditure requirements to accelerate this year as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. We intend to seek additional financing and non-dilutive funding options to support these activities, and additional non-dilutive funding and/or strategic partners to support the AD development program. We anticipate that our current cash projections may be impacted by these ramped up activities and any financing transactions we enter into. 2025 Goals and PrioritiesOur goals for 2025 center on efficient, effective execution of our strategic plan with an emphasis on three primary operational goals: ELPIS II Completion: We anticipate completion of ELPIS II enrollment in the second quarter of 2025. We will then focus on supporting our investigative sites through completion of the 12-month primary endpoint follow-up period and preparation for data collection and analysis at the end of the study.HLHS BLA Preparedness: We intend to accomplish the majority of BLA readiness in 2025 to support a potentially shortened time frame from clinical trial readout to BLA submission.Alzheimer’s Disease Program Partnering: We plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for AD to engage with potential funding/commercialization partners. OutlookLongeveron has made tremendous progress in two important stem cell development programs over the past 12 months, successfully delivering on our strategic plan. We are now approaching multiple potentially transformational milestones over the next 12 months including completion of enrollment in our pivotal Phase 2b clinical trial in HLHS which may establish the timeline for a potential BLA submission for HLHS, and potential partnering for the Alzheimer’s disease program. Our team’s expertise and industry experience enable the organization to accomplish so much with a small team and few resources. Generating several positive initial results across five clinical trials in three indications, continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics. We believe Longeveron’s demonstrated track record of successful clinical execution, strength of data generated to date and the potential size of addressable markets provide for a compelling investment opportunity. We deeply appreciate the support of our stakeholders and look forward to continued collaboration and progress in the future. Sincerely,Wa’el HashadCEO, Longeveron Forward-Looking Statements Certain statements in this letter that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d

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Imperative Care Announces Appointment of Todd Van Horn to Chief Financial Officer

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CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc. today announced the appointment of Todd Van Horn as Chief Financial Officer. “Imperative Care is deeply committed to bringing together a strong balance of leaders with complementary expertise and a shared passion for elevating patient care,” said Fred Khosravi, CEO of Imperative Care. “We are […]

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Stereotaxis to Report First Quarter 2025 Financial Results on May 12, 2025

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ST. LOUIS, April 22, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2025 first quarter on Monday, May 12, 2025 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. EST that day to discuss the Company’s results and corporate developments.

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Windtree Therapeutics Reports Year-End 2024 Financial Results and Provides Key Business Updates

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WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates. “The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company,” said Jed Latkin, CEO of Windtree. “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians express a high need for drug innovation. During the year, we announced positive results of our SEISMiC Extension Phase 2 istaroxime clinical study in early cardiogenic shock (SCAI Stage B) and also began our cardiogenic shock SEISMiC C (SCAI Stage C) Phase 2 study with an interim assessment planned for Q3 2025. In addition, we added a regional licensing partnership with Lee’s Pharmaceutical for greater China.for istaroxime, our preclinical dual mechanism SERCA2a activators and rostafuroxin. We are also continuing discussions with potential partners for our cardiovascular drug candidates.” Mr. Latkin further added, “Importantly, we also announced our new corporate strategy in early 2025 to become a revenue-generating biotech by using Company equity to acquire small biotech companies struggling to maximize the commercial potential of their FDA-approved products. We believe this could be a positive transformation and an opportunity to provide near-term value to our shareholders. As part of our strategy, we are actively evaluating revenue-generating opportunities across various sectors that align with our capabilities and strategic vision.” Mr. Latkin was appointed CEO in December of 2024. He has nearly three decades of financial and biotech experience including prior experience as the CEO of a public biotech company. Mr. Latkin served as the CEO of Navidea Biopharmaceuticals where he started as Chief Financial Officer and executed multiple deals and raised substantial funding. He has also served as CEO of Black Elk Energy Offshore in 2014 as part of Nagel Avenue Capital which he joined after ten years on Wall Street with a variety of investment banking organizations and funds, including ING, Morgan Stanley and Citigroup Securities. Most recently, Mr. Latkin served as the Chief Operating Officer and head of finance at ProPhase Labs, conducting deals and managing broad aspects of the business. Key Business Update Announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock in September 2024.Initiated enrollment in the global SEISMiC C trial evaluating istaroxime in SCAI Stage C cardiogenic shock—a more severely ill population than previously studied—building on positive SEISMiC A and B results; the placebo-controlled, double-blind study will assess istaroxime’s impact on systolic blood pressure and cardiac function alongside standard inotropic/vasopressor therapy, with a planned interim data review in Q3 2025 to inform Phase 3 readiness and regulatory discussions in early 2026.Launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while continuing to progress the Company’s cardiovascular and oncology development pipeline.Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company will leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.Completed istaroxime cardiogenic shock national phase filings of patent applications around the world, including in the U.S., Germany, France, Italy, Japan and China. These filings claimed priority to PCT/US2023/018998 entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock”.  This application is currently pending before the United States Patent and Trademark Office (USPTO), Application no. 18/858,086. Filed a new PCT patent application for istaroxime and its derivatives targeting the prevention of acute myocardial arrhythmias—building on encouraging data from clinical trials in acute heart failure and early cardiogenic shock, as well as preclinical models showing enhanced efficacy of istaroxime metabolites in improving cardiac function and reducing ischemia-induced arrhythmias.Received a Notice of Allowance from the USPTO for a patent covering an intravenous istaroxime formulation for acute heart failure, and filed a related patent application in India targeting the prevention of life-threatening arrhythmias in heart failure patients—further strengthening the company’s global intellectual property portfolio. Completed national phase filings for the istaroxime patent titled “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGENIC SHOCK AND CARDIOGENIC SHOCK” (PCT/US2023/018998; U.S. Application No. 18/858,086) in key global markets including the U.S., Germany, France, Italy, Japan, and China—further strengthening international IP protection for its lead cardiovascular asset.Issued Japanese patent (No. 7603605, expiring 2040) for its novel aPKCi inhibitor platform targeting hedgehog pathway-dependent cancers—covering both topical and oral formulations, with potential applications in cancers such as basal cell carcinoma and small cell lung cancer, including use in combination therapies with HDAC inhibitors to enhance anti-cancer efficacy.Seeking to leverage positive Phase 2b results in early cardiogenic shock to secure non-dilutive funding through partnerships for istaroxime and next-generation oral SERCA2a activators outside Greater China; engaged New Growth Advisors to manage inbound interest and lead a broader out-licensing effort, while existing partner Lee’s Pharmaceuticals progresses toward a planned Phase 3 trial in acute heart failure in 1H 2025 under a deal worth up to $138 million in milestones plus royalties.Licensing partner Lee’s Pharmaceutical (HK) Ltd. is preparing to initiate a Phase 3 program for acute heart failure in Greater China, fully funding all development activities in the region; Windtree retains final protocol approval and is collaborating closely with Lee’s as it advances its global cardiogenic shock program in parallel. Select 2024 Year-End Financial Results Research and development (“R&D”) expenses were $16.3 million for the year ended December 31, 2024, compared to $8.3 million for the year ended December 31, 2023. The increase in research and development expenses is primarily due to (i) a $7.5 million charge related to acquired in-process R&D from the Varian asset purchase; and (ii) a $2.2 million increase in costs associated with the continued development of istaroxime, including the SEISMiC Extension study and start-up activities for the SEISMiC C study; partially offset by (iii) a $0.9 million reduction in royalty payments related to amendments to certain license agreements; (iv) a $0.6 million decrease in personnel costs due to headcount reductions; and (v) a $0.3 million decrease in non-cash stock-based compensation expense. General and administrative expenses for the year ended December 31, 2024 were $8.7 million, compared to $9.2 million for the year ended December 31, 2023. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.6 million in non-cash stock-based compensation expense; (ii) a decrease of $0.4 million in personnel costs due to headcount reductions; (iii) a decrease of $0.3 million in severance expense related to a former executive; and (iv) a decrease of $0.4 million in insurance costs; partially offset by (v) an increase of $1.2 million in professional fees, primarily related to increased legal fees and costs associated with the July 2024 private placements. For the year ended December 31, 2024, the Company reported a net loss of $1.8 million, compared to a net loss of $20.3 million for the year ended December 31, 2023. Net loss for the year ended December 31, 2024 includes a $14.4 million non-cash gain on debt extinguishment, a $10.5 million non-cash net gain related to the change in fair value of common stock warrant liability, and a non-cash loss on impairment of goodwill of $1.1 million. Net loss for the year ended December 31, 2023 includes a non-cash loss on impairment of goodwill of $3.1 million. The Company reported a net loss attributable to common stockholders of $5.5 million ($104.35 per basic share) for the year ended December 31, 2024, which includes a deemed dividend of $3.6 million on the Series C Preferred Stock. Net loss attributable to common stockholders was $20.3 million ($4,718.74 per basic share) for the year ended December 31, 2023. As of December 31, 2024, the Company reported cash and cash equivalents of $1.8 million. Subsequent to December 31, 2024, the Company (i) sold an additional 0.2 million shares of common stock under its equity line of credit purchase agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C preferred stock; (ii) received net proceeds of $0.3 million related to warrant exercises; and (iii) issued certain debt notes for aggregate net proceeds $0.5 million. As a result, the Company believes that it has sufficient resources available to fund its business operations through April 2025.   Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which will be filed with the Securities and Exchange Commission on April 15, 2025 and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations. About Windtree Therapeutics Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian; risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information: Eric Curtisecurtis@windtreetx.com  WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIESConsolidated Balance Sheets   (in thousands, except share and per share data)   December 31,2024  December 31,2023          ASSETS        Current assets:        Cash and cash equivalents $1,779  $4,319 Prepaid expenses and other current assets  795   1,060 Total current assets  2,574   5,379          Property and equipment, net  111   183 Restricted cash  9   150 Operating lease right-of-use assets  1,051   1,444 Intangible assets  24,130   25,250 Total assets $27,875  $32,406          LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY        Current liabilities:        Accounts payable $1,879  $809 Accrued expenses  1,706   1,618 Operating lease liabilities – current portion  508   436 ELOC commitment note payable  328   – Derivative liability – ELOC commitment note  299   – Common stock warrant liability  305   – Loans payable – current portion  333   233 Other current liabilities  359   900 Total current liabilities  5,717   3,996          Operating lease liabilities – non-current portion  653   1,161 Restructured debt liability – contingent milestone payments  –   15,000 Other liabilities  3,800   3,800 Deferred tax liabilities  4,528   5,058 Total liabilities  14,698   29,015          Mezzanine equity:        Series C redeemable preferred stock, $0.001 par value; 18,820 and 0 shares authorized; 11,757 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively  3,181   – Series B redeemable preferred stock, $0.001 par value; 5,500 and 0 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively  –   – Total mezzanine equity  3,181   –          Stockholders’ equity:        Preferred stock, $0.001 par value; 4,975,680 and 5,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively  –   – Common stock, $0.001 par value; 120,000,000 shares authorized; 256,397 and 6,664 shares issued and outstanding at December 31, 2024 and 2023, respectively  –   – Additional paid-in capital  859,660   851,268 Accumulated deficit  (846,610)  (844,823)Treasury stock (at cost); 1 share  (3,054)  (3,054)Total stockholders’ equity  9,996   3,391 Total liabilities, mezzanine equity & stockholders’ equity $27,875  $32,406  WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations   (in thousands, except share and per share data)   Year Ended   December 31,   2024  2023          Expenses:        Research and development $16,276  $8,341 General and administrative  8,743   9,198 Impairment of goodwill  –   3,058 Impairment of intangible assets  1,120   – Total operating expenses  26,139   20,597 Operating loss  (26,139)  (20,597)         Other (expense) income:        Gain on debt extinguishment  14,437   – Change in fair value of common stock warrant liability  10,482   – Interest income  70   325 Interest expense  (235)  (50)Other (expense) income, net  (408)  31 Total other income, net  24,346   306          Loss before income taxes  (1,793)  (20,291)Deferred income tax benefit  6   – Net loss $(1,787) $(20,291)Exchange of Series B preferred stock  (79)  – Deemed dividend on Series C preferred stock  (3,621)  – Net loss attributable to common stockholders $(5,487) $(20,291)         Net loss per share attributable to common stockholders        Basic and diluted $(104.35) $(4,718.84)         Weighted average number of common shares outstanding        Basic and diluted  52,583   4,300 

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Conavi Medical Corp. Announces Pricing of Public Offering of Common Shares

Financial by Comments are Disabled

NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES A&R PROSPECTUS AND FINAL PROSPECTUS ACCESSIBLE ON SEDAR+ TORONTO, April 15, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI; OTC: CNVIF) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce the pricing and terms of its previously announced public offering. The offering is of common shares of the Company (“Common Shares”) or pre-funded common share purchase warrants of the Company in lieu of Common Shares (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”) (the “Offering”). The Offering is being conducted on a commercially reasonable efforts agency basis for the issuance of a minimum of 37,500,000 Securities and a maximum of 50,000,000 Securities at a price of $0.40 per Common Share or $0.39999 per Pre-Funded Warrant, for gross proceeds of between $15,000,000 and $20,000,000. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of any purchaser entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire. The Company intends to use the net proceeds from the Offering to advance and complete the development and pre-clinical testing of its Novasight 3.0 technology, with the goal of submitting a 510(k) clearance application to the U.S. Food and Drug Administration in Q3 of 2025. The Company also intends to use the net proceeds for working capital and other general corporate purposes. The Offering is expected to be completed pursuant to the terms and conditions of an agency agreement entered into between the Company and Bloom Burton Securities Inc. (the “Agent”). The Company will file today a final short form prospectus (the “Final Prospectus”) with the securities regulatory authorities in the provinces of Alberta, British Columbia and Ontario. There will not be any sale of Securities until a receipt for the Final Prospectus has been issued. The Offering is expected to close on or about April 22, 2025, or such other date as may be mutually agreed to by the Company and the Agent (the “Closing Date”). The Offering is subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals, including approval of the TSX Venture Exchange (“TSXV”). The Company will pay to the Agent a cash fee equal to 7.0% of the gross proceeds raised under the Offering, and grant the Agent compensation options equal to 7.0% of the aggregate number of Securities issued under the Offering (the “Compensation Options”), provided however the Agent will receive a reduced cash commission of 3.5% and no Compensation Options in respect of Securities sold to certain purchasers on a president’s list to be agreed to between the Company and the Agent. Each Compensation Option shall entitle the Agent to buy one Common Share at the same price per Common Share as under the Offering. The Compensation Options shall be exercisable until that date which is 24 months following the Closing Date. In addition, the Securities are anticipated to be offered by way of private placement in certain jurisdictions outside of Canada pursuant to and in compliance with applicable securities laws. This press release is not an offer to sell or the solicitation of an offer to buy the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons absent registration or an applicable exemption from U.S. registration requirements. “United States” and “U.S. persons” have the meanings ascribed to them in Regulation S under the U.S. Securities Act. Access to the amended and restated preliminary prospectus dated March 20, 2025 (the “A&R Prospectus”), the Final Prospectus and any amendments to such documents will be provided in accordance with securities legislation relating to procedures for providing access to a short form prospectus and any amendment thereto. The A&R Prospectus is, and the Final Prospectus will be accessible on SEDAR+ at www.sedarplus.ca. Alternatively, an electronic or paper copy of the A&R Prospectus and the Final Prospectus (when filed), and any amendment to such documents may be obtained without charge, from the Agent by email at ECM@bloomburton.com, by telephone at 416-640-7585 or by providing the contact with an email address or address, as applicable. The A&R Prospectus and the Final Prospectus (when filed) contain important, detailed information about the Company and the Offering. Prospective investors should read the A&R Prospectus and the Final Prospectus (when filed) before making an investment decision. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit http://www.conavi.com/. Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated terms and jurisdictions of the Offering; securities offered thereunder; the timing of the Offering, including the anticipated Closing Date and timing for the Final Prospectus; use of proceeds from the Offering; fees anticipated to be paid to the Agent and terms thereof; and regulatory and exchange approvals, including the listing of the Common Shares offered pursuant to the Offering on the TSXV. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the A&R Prospectus dated March 20, 2025 and the joint information circular of the Company dated August 30, 2024 (both of which are on the Company’s profile at www.sedarplus.ca). Although Conavi has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. CONTACT: CONTACT:
Stefano Picone
Chief Financial Officer
(416) 483-0100

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