BioSyent Releases Financial Results for Q3 and YTD 2025




BioSyent Releases Financial Results for Q3 and YTD 2025

MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2025. Key highlights include:

• Return on Average Equity for TTM September 30, 2025 was 22% as compared to 20% for TTM September 30, 2024
• During YTD 2025, repurchased for cancellation a total of 19,500 common shares under a Normal Course Issuer Bid (NCIB)
• Paid quarterly cash dividends of $0.05 per common share on March 14, 2025, June 13, 2025, and September 15, 2025
• Declared subsequent cash dividend of $0.05 per common share to be paid on December 15, 2025

“BioSyent delivered strong third quarter financial results,” commented Mr. René Goehrum, President and CEO of BioSyent. “Each of our three businesses performed well during the quarter, with total Company sales increasing by 28% overall. Though we experienced some gross margin compression on changes in sales mix, our overall EBITDA¹ margin in Q3 2025 remained consistent with the comparative period at 30% to sales as operating expenses were maintained in proportion to sales growth. On a year-to-date basis, total Company sales increased by 27% with an EBITDA¹ margin of 29% to sales. Our FeraMAX® and Tibella® / Tibelia® products continue to generate profitable sales growth, both in Canada and internationally. In just over one year since our September 2024 acquisition of the worldwide rights to Tibella® / Tibelia®, this product has generated incremental sales and profit growth in line with our initial expectations. As we enter the final weeks of the year, we remain focused on continued profitable growth and momentum in our businesses through the end of 2025 and into 2026.”

The CEO’s presentation on the Q3 and YTD 2025 Results is available at the following link: www.biosyent.com/investors/

The Company’s Interim Unaudited Condensed Consolidated Financial Statements and Management’s Discussion and Analysis for the three and nine months ended September 30, 2025 and 2024 will be posted on www.sedarplus.ca on November 20, 2025.

For a direct market quote for the TSX Venture Exchange and other Company financial information, please visit www.tmxmoney.com.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 11,262,282 common shares outstanding.

1. EBITDA is a Non-IFRS Financial Measure. The term EBITDA does not have any standardized meaning under International Financial Reporting Standards (IFRS) and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest income or expense, income taxes, depreciation and amortization.

   A reconciliation of EBITDA to NIAT for the three months, nine months, and trailing twelve months ended September 30, 2025 and 2024 is provided in the table below:

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals. Neither TSX Venture Exchange nor its Regulation 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.

BioSyent Declares Fourth Quarter 2025 Dividend




BioSyent Declares Fourth Quarter 2025 Dividend

MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) is pleased to announce that its Board of Directors has declared a quarterly dividend of $0.05 per common share, payable in Canadian Dollars on December 15, 2025, to shareholders of record at the close of business on November 28, 2025. This fourth quarter 2025 dividend compares with the third quarter 2025 dividend of $0.05 per common share. This dividend qualifies as an ‘eligible dividend’ for Canadian income tax purposes. The declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 11,262,282 common shares outstanding.

For a direct market quote for the TSX Venture Exchange and other Company financial information please visit www.tmxmoney.com.

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.

Neither TSX Venture Exchange nor its Regulation 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.

PROCEPT BioRobotics® to Present at Upcoming 37th Annual Piper Sandler Healthcare Conference on December 2, 2025




PROCEPT BioRobotics® to Present at Upcoming 37th Annual Piper Sandler Healthcare Conference on December 2, 2025

SAN JOSE, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) — PROCEPT BioRobotics (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced that members of management will present at the upcoming 37th Annual Piper Sandler Healthcare Conference in New York City. Management is scheduled to present on Tuesday, December 2 at 8:30 a.m. Eastern Time.

A live webcast of each event, as well as an archived recording, will be available on the “Investors” section of the Company’s website at: https://ir.procept-biorobotics.com. The webcasts will be archived and available for replay for at least 90 days after the event.

About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics’ mission is to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions that positively impact patients and drive value. PROCEPT BioRobotics manufactures the AQUABEAM^® and HYDROS^® Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com

Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension




Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension

Phase 3 Study initiating in First Quarter of 2026

Single Pivotal Study Accelerates Potential FDA Approval
Timeline by Approximately 3 Years

BOSTON and ATLANTA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in PAH. The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), is expected to be initiated in the first quarter of 2026.

IKT-001 is an investigational novel pro-drug of imatinib mesylate (“imatinib”). Imatinib is an anti-proliferative tyrosine kinase inhibitor, TKI, with potential best-in-class improvements in pulmonary vascular resistance (“PVR”) and 6-minute walk distance (“6MWD”) of 45 meters⁽¹⁾ based on Phase 3 IMPRES and Phase 2 studies⁽²⁾. Despite the IMPRES Phase 3 study of imatinib demonstrating improved exercise capacity and hemodynamics in patients with advanced PAH, high discontinuations impacted the results. IKT-001 is a prodrug of imatinib which is engineered to realize the potential of imatinib in PAH and lower discontinuations in the forthcoming Phase 3 study.

The Company previously planned to initiate a Phase 2b study in 150 subjects in PAH prior to advancing to a pivotal Phase 3 study. However, the Company submitted a Type C Meeting request to the U.S. Food & Drug Administration (“FDA”) to, among other things, obtain feedback on an immediate transition to a pivotal Phase 3 study design. 

Following receipt from the FDA of the Written Response from the Type C interaction, the Company now plans to initiate a two-part adaptive Phase 3 study. We expect Part A of IMPROVE-PAH will be a double blind, placebo-controlled study in 140 patients with a primary endpoint of PVR at Week 24. We expect Part B will adopt an identical format to Part A except the primary endpoint will be 6MWD at Week 24 in 346 patients. We believe this adaptive Phase 3 study design has important advantages including; (1) permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001; (2) uninterrupted enrollment between Part A and Part B; and (3) the ability to, if necessary, undertake a sample size re-estimation for Part B based on Part A findings. Given the Company was well-advanced in initiating the previous Phase 2b study design, the Company expects to initiate IMPROVE-PAH in the first quarter of 2026, with this study expected to be conducted in up to approximately 180 sites around the world.

“Our revised study plan for IKT-001 in PAH permits a single pivotal study format and thereby has the potential to advance our timeline to Phase 3 topline data readout and a potential NDA filing by approximately three years. We are excited about the recent progress we have made,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “Importantly, the written responses from FDA will allow the Company to adopt a 12-week dose-titration phase which we believe will potentially allow patients to get to the higher tolerable doses where imatinib has previously demonstrated the greatest benefit in exercise capacity and hemodynamics. With over two decades of imatinib clinical experience, together with IKT-001’s expected improved gastrointestinal tolerability profile and adaptive study design for IMPROVE-PAH, we believe this supports a potential higher probability of success and we are looking forward to study initiation next quarter.” 

About Inhibikase (www.inhibikase.com)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, PAH, that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.

Social Media Disclaimer

Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use LinkedIn as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the potential effects of IKT-001; expectations regarding the Company’s Phase 3 trial of IKT-001 in PAH, including design, timing of initiation and its impact on the Company’s timeline; and the Company’s future activities, or future events or conditions. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to initiate and execute a global Phase 3 trial to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

(1) Placebo-adjusted 6MWD improvement of 45 meters at week 24 in patients at 400 mg for >50% of treatment. See Hoeper et al; Circulation 2013 Suppl. Appendix. (2) The referenced Phase 3 IMPRES and Phase 2 Studies were conducted by Novartis Pharmaceutical Corporation

Olema Oncology Announces Closing of $218.5 Million Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares




Olema Oncology Announces Closing of $218.5 Million Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

SAN FRANCISCO, Nov. 20, 2025 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,500,000 additional shares of common stock, at a price to the public of $19.00 per share. The gross proceeds to Olema from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $218.5 million.

TD Cowen, Evercore ISI, Guggenheim Securities, LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. acted as book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on January 6, 2025 and declared effective on January 15, 2025, and a related registration statement on Form S-3MEF that was filed with the SEC pursuant to Rule 462(b) on November 18, 2025, which became automatically effective on November 18, 2025. Copies of the final prospectus supplement and accompanying prospectus relating to the offering can be accessed at no charge through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective ER degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts.

Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com

Cognition Therapeutics to Participate in 37th Annual Piper Sandler Healthcare Conference




Cognition Therapeutics to Participate in 37th Annual Piper Sandler Healthcare Conference

PURCHASE, N.Y., Nov. 20, 2025 (GLOBE NEWSWIRE) — Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates designed to treat neurodegenerative disorders, announced that the Company’s president and CEO, Lisa Ricciardi will participate in an “unplugged” fireside discussion at the annual Piper Sandler Healthcare Conference. The conference will take place December 2-4, 2025 at The Lotte New York Palace hotel.

Details of Cognition’s fireside discussion are as follows:
Event: 37th Annual Piper Sandler Healthcare Conference  
Date/Time: Wednesday, December 3rd at 4:30p.m. Eastern Time
Webcast: https://event.webcasts.com/starthere.jsp?ei=1742473&tp_key=1130844555

A live audio webcast of the presentation will be available on the company’s investor relations site. An archived replay will be available for 90 days following the event.

About Cognition Therapeutics, Inc.  
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START Study (NCT05531656) in early Alzheimer’s disease is ongoing. We believe zervimesine can regulate pathways that are impaired in these diseases through its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference call, other than statements of historical facts or statements that relate to present facts or current conditions are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of global political changes and global economic conditions, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

This press release was published by a CLEAR® Verified individual.

Keros Therapeutics Announces Final Results of Tender Offer




Keros Therapeutics Announces Final Results of Tender Offer

LEXINGTON, Mass., Nov. 20, 2025 (GLOBE NEWSWIRE) — Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), today announced the final results of its cash tender offer (the “Tender Offer”) to repurchase up to 10,950,165 shares of its common stock, at a fixed purchase price of $17.75 per share, for an aggregate purchase price of up to approximately $194.4 million. The Tender Offer expired at 5:00 p.m. Eastern Time on November 18, 2025. The expiration of the Tender Offer concludes the Company’s previously announced $375 million capital return program.

Based on the final count by Computershare Trust Company, N.A., the depositary for the Tender Offer (the “Depositary”), a total of 17,712,262 shares of Keros common stock were validly tendered and not validly withdrawn, which includes shares that were tendered through notice of guaranteed delivery.

In accordance with the terms and conditions of the Tender Offer, the Company accepted for purchase a total of 10,950,165 shares, for an aggregate purchase price of approximately $194.4 million, excluding fees and expenses related to the Tender Offer. Because more than 10,950,165 shares were tendered in the Tender Offer, shares were accepted for purchase on a pro rata basis, except for conditional tenders that will automatically be regarded as withdrawn if the condition was not satisfied. Keros has been informed by the Depositary that the final proration factor for the Tender Offer is approximately 62.30%. The shares purchased represent approximately 35.91% of Keros’ outstanding common stock as of November 18, 2025.

The Depositary will promptly pay for all shares accepted for purchase pursuant to the Tender Offer using the Company’s existing cash and cash equivalents and return all other shares tendered and not purchased.

Stockholders with questions about the Tender Offer may contact MacKenzie Partners, Inc., the information agent for the Tender Offer, toll-free at (800) 322-2885, at (212) 929-5500 or in writing at 7 Penn Plaza, New York, NY 10001. Stockholders may also contact Goldman Sachs & Co. LLC, the dealer manager for the Tender Offer, at (212) 902-8556.

About Keros Therapeutics, Inc.
Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis.

Cautionary Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “continue,” “expects,” “enable,” “intention,” “potential” and “will” or similar expressions are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: developments or changes in economic or market conditions; developments or changes in the securities markets, developments or changes in Keros’ business, financial condition or cash flows, and other risks detailed in Keros’ reports filed with the Securities and Exchange Commission (the “SEC”), including its quarterly report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 5, 2025, and its other documents subsequently filed with or furnished to the SEC. Keros disclaims any intent or obligation to update these forward-looking statements.

Contacts
Investor Contact:
Justin Frantz
jfrantz@kerostx.com
617-221-6042

Media Contact:
Mahmoud Siddig / Adam Pollack / Brooks Hussey
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449

SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM




SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

Ghent – Belgium, Nov. 20, 2025 (GLOBE NEWSWIRE) — SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
20 November 2025, 6:00 pm CET

Ghent, Belgium, 20 November 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today that it issued a subscription request notice in accordance with the terms of the share subscription facility agreement (the “Facility“) entered into on 17 March 2025 between the Company and GEM Global Yield LLC SCS (“GEM“). Under the terms of the Facility, GEM has agreed, subject to certain conditions, to commit an amount of up to EUR 20 million in cash (with the Company’s option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down), within a maximum term of three years, in exchange for new shares in the Company and subject to certain share lending arrangements being in place. For more information about the Facility, reference is made to the Company’s press release dated 18 March 2025 (which can be accessed here).

The new subscription request notice is expected to be settled into new shares on or around 22 December 2025. The number of new shares the Company has requested GEM to subscribe for amounts to up to 1,995,014 shares in the Company (the “Draw Down Amount“). The issue price of the relevant new shares to be issued will be equal to 90% of the average volume weighted average price (VWAP) of the Company’s shares during a forward-looking pricing period and will be subject to certain corrections. Following the aforementioned pricing period, GEM will have to subscribe for a number of new shares ranging between a minimum of 50% and a maximum of 150% of the Draw Down Amount (subject to certain adjustments as set out in the Facility).

For more information, please contact:
Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. In Sequana Medical’s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life^1,2.

Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements³. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

The alfapump® System is currently not approved in Canada.

DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

¹ Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
² As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

³ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period.

Attachments

• Sequana Medical — Press Release (ENG) (20 November 2025)
• Sequana Medical — Press Release (NL) (20 November 2025)

GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market




GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); November 20, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the Company’s voluntary delisting of American Depositary Shares (“ADSs”) representing its ordinary shares from The Nasdaq Global Select Market (“Nasdaq”) has become effective. Each ADS represents one ordinary share of the Company. The Company has also filed a Form 15F with the Securities and Exchange Commission (“SEC”) to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), in respect of the ADSs and the ordinary shares. The Company expects that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F.

Information for ADS Holders

The Bank of New York Mellon serves as depositary (the “Depositary”) for the Company’s ADS facility. Each ADS represents one ordinary share. GENFIT intends to terminate the Deposit Agreement, dated March 26, 2019, among the Company, the Depositary and owners and holders of ADSs (the “Deposit Agreement”) on or about February 6, 2026. As a result, the existing facility will be terminated effective at 5:00 PM (Eastern Time) on February 5, 2026.

Under the terms of the Deposit Agreement, ADS holders will have until February 9, 2026 to surrender ADSs for delivery of the underlying ordinary shares. If they surrender ADSs for delivery of the underlying ordinary shares, they must pay a cancellation fee of up to $0.05 per ADS and a cable fee of $17.50. In order to exchange ADSs for the Company’s ordinary shares, ADS holders should instruct their brokers to surrender ADSs to The Bank of New York Mellon (DTC No. 2504). In connection with this surrender, brokers should include ongoing ordinary share delivery instructions in the comments field within DTC, including information such as the name and BIC of the appropriate local bank/broker and/or appropriate delivery code, beneficiary name and account number. U.S. brokers holding ADSs on behalf of their clients, can reach out to DRSettlements@BNYMellon.com for questions regarding the conversion and settlement process.

Subsequent to February 9, 2026, the Depositary may elect to sell the underlying ordinary shares. If the Depositary has sold such shares, holders of ADSs must surrender such securities in order to obtain payment of the sale proceeds of the underlying ordinary shares, net of the expenses of sale, any applicable U.S. or local taxes or government charges and a cancellation fee of up to $0.05 per ADS.

To surrender American Depositary Receipts (“ADRs”), the address of the Depositary is: The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286, Attention: Depositary Receipt Administration. Registered or overnight mail is the suggested method of delivering ADRs to the Depositary. For Settlement specific inquiries, please contact DRSettlements@BNYMellon.com.

Investors may still present ADSs to The Bank of New York Mellon. Investors will receive either the underlying ordinary shares (if those have not yet been sold by the Depositary) or the cash received by the Depositary received upon sale of underlying ordinary shares, net of fees, if those underlying ordinary shares were sold. For more information, investors should contact DRSettlements@BNYMellon.com.

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo^® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo^® is now marketed in several countries.¹  

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+^® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about the Company’s expectation that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors
Tel : + 33 3 20 16 40 00 | investors@genfit.com

GENFIT | Press relations

Stephanie BOYER | Tel : + 33 3 20 16 40 00 | stephanie.boyer@genfit.com

1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo^®

Attachment

• GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM




SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

Ghent – Belgium, Nov. 20, 2025 (GLOBE NEWSWIRE) — SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
20 November 2025, 6:00 pm CET

Ghent, Belgium, 20 November 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today that it issued a subscription request notice in accordance with the terms of the share subscription facility agreement (the “Facility“) entered into on 17 March 2025 between the Company and GEM Global Yield LLC SCS (“GEM“). Under the terms of the Facility, GEM has agreed, subject to certain conditions, to commit an amount of up to EUR 20 million in cash (with the Company’s option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down), within a maximum term of three years, in exchange for new shares in the Company and subject to certain share lending arrangements being in place. For more information about the Facility, reference is made to the Company’s press release dated 18 March 2025 (which can be accessed here).

The new subscription request notice is expected to be settled into new shares on or around 22 December 2025. The number of new shares the Company has requested GEM to subscribe for amounts to up to 1,995,014 shares in the Company (the “Draw Down Amount“). The issue price of the relevant new shares to be issued will be equal to 90% of the average volume weighted average price (VWAP) of the Company’s shares during a forward-looking pricing period and will be subject to certain corrections. Following the aforementioned pricing period, GEM will have to subscribe for a number of new shares ranging between a minimum of 50% and a maximum of 150% of the Draw Down Amount (subject to certain adjustments as set out in the Facility).

For more information, please contact:
Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. In Sequana Medical’s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life^1,2.

Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements³. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

The alfapump® System is currently not approved in Canada.

DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

¹ Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
² As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

³ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period.

Attachments

• Sequana Medical — Press Release (ENG) (20 November 2025)
• Sequana Medical — Press Release (NL) (20 November 2025)