Inhibikase Therapeutics Announces Third Quarter 2025 Financial Results and Highlights Recent Activity




Inhibikase Therapeutics Announces Third Quarter 2025 Financial Results and Highlights Recent Activity

BOSTON and ATLANTA, Nov. 14, 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 reported financial results for the quarter ended September 30, 2025 and highlighted recent developments.

“During our third quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “We expect to initiate our Phase 2b clinical study of IKT-001, our prodrug of imatinib mesylate, in PAH during the fourth quarter of 2025.”

Recent Developments:

• Advancement of IKT-001 as a therapy in PAH:
  • The proposed Phase 2b IMPROVE-PAH trial is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. The Company’s bioequivalence studies previously confirmed that 500 mg of IKT-001 has comparable exposure in humans to 383 mg of imatinib. The primary efficacy endpoint is change in pulmonary vascular resistance at Week 26. Secondary endpoints include 6-minute walk distance, World Health Organization functional class, and pharmacokinetics. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least 50 patients at 12-weeks of follow-up.
  • The Company has been actively working with potential sites and presently expects to initiate IMPROVE-PAH in the fourth quarter of 2025.
• Appointed veteran biopharma executive Timothy Pigot as the Company’s Chief Commercial and Strategy Officer.
• The Company also expects to present at the Jefferies Global Healthcare Conference in London on Monday, November 17^th, 2025.

Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $77.3 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the quarter ended September 30, 2025, was $11.9 million, or $0.13 per share, compared to a net loss of $5.8 million, or $0.65 per share in the quarter ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was $35.5 million, or $0.40 per share, compared to a net loss of $15.4 million, or $2.03 per share, for the nine months ended September 30, 2024.

R&D Expenses: Research and development expenses were $7.6 million for the quarter ended September 30, 2025, compared to $4.2 million for the quarter ended September 30, 2024. Research and development expenses were $23.4 million for the nine months ended September 30, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $1.8 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $10.0 million for the nine months ended September 30, 2024.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2025 were $5.6 million, compared to $1.6 million for the quarter ended September 30, 2024. Selling, general and administrative expenses for the nine months ended September 30, 2025 were $16.8 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $5.6 million for the nine months ended September 30, 2024.

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 and YouTube 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, the initiation of the Company’s Phase 2b trial of IKT-001 in PAH, including timing related thereto, 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 commence and execute a Phase 2b 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

—tables to follow—

Biotricity Strengthens Path to Scalable Profitability with Sustained Margins & Operational Efficiency in Second Quarter Fiscal 2026




Biotricity Strengthens Path to Scalable Profitability with Sustained Margins & Operational Efficiency in Second Quarter Fiscal 2026

REDWOOD CITY, CA, Nov. 14, 2025 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB:BTCY) (“Biotricity” or the “Company”), an innovative Technology-as-a-Service (TaaS) company committed to redefining the landscape of the healthcare industry with state-of-the-art remote monitoring and diagnostic solutions, today announced its financial results for its second quarter of fiscal 2026, ended September 30, 2025. Leveraging best-in-class technology, strategic execution, and automation-driven operational efficiencies to maintain margins and expand its footprint, the company is delivering a clear path towards scalable, sustainable growth.

Dr. Waqaas Al-Siddiq, Biotricity Founder & CEO, said, “This quarter demonstrates the scalability and strength of our model as we continue to sharpen operational efficiency through proprietary AI-driven automation to maintain margins and accelerate growth. These efforts have strengthened our commercial execution and positioned us to capture the rising demand across the cardiac monitoring landscape.”

The rapid adoption of our next-generation cardiac monitoring device, Biocore Pro, and the launch of large-scale cardiac monitoring pilots across leading hospital networks validate our ability to scale both technology and impact. Building on this momentum, we are extending our reach into international markets to increase accessibility and strengthen our global footprint, expanding the availability of advanced cardiac diagnostics worldwide. At the same time, our strategic entry into adjacent fields such as sleep and pulmonology continues to diversify our portfolio and reinforce Biotricity’s position as a leader in connected healthcare. Our focus is to deliver a comprehensive suite of diagnostic tools that empower clinicians with deeper, more accessible insights for preventive and precision care.”

Q2-FY26 Financial Highlights

• Revenue increased 19% to $3.9 million from $3.3 million in the corresponding prior year period
• Gross margin was 81.9% for the three months ended June 30, 2025, as compared to 75.3% in the corresponding prior year quarter. This reflects the expansion of our recurring technology fee revenue base, efficiency gains from proprietary AI-driven operational automation, and ongoing improvements in monitoring and cloud cost structure.
• Net loss decreased to $0.77 million, or $0.03 per share, from a net loss of $1.7 million, or $0.07 per share; this was a 53.3% improvement from the corresponding prior year quarter.

Operating Highlights for Q2-FY26 and the Future

• Q2-FY26 recurring (TaaS) Technology Fees rose a robust 4.2% from the corresponding prior year period, to $3.5 million, representing 88.7% of total revenue for Q2-FY26
• The Company sustained its record of strong customer retention, driven by high-quality, cardiologist- and patient-friendly services that prioritize diagnostic accuracy and ease of use.
• The Company made meaningful progress in securing regulatory approval across key international markets, including Canada, Saudi Arabia, and Argentia, laying the foundation for broader distribution in the coming years.
• The Company continued expanding its U.S. market presence, with penetration across thousands of cardiologists in hundreds of centers, though a combination of direct sales force efforts and strategic alliances with three of the top GPOs that collectively represent 90% of U.S. hospitals.

Full details of the Company’s financial results will be filed with the SEC on Form 10-K and available by visiting www.sec.gov.

Financial Results and Business Update Conference Call

Management will host a conference call on Friday, November 14th, 2025 at 4:30 p.m. ET to discuss its financial results for fiscal second quarter of 2026 and provide a business update. Additional details are available under the Investor Relations section of the Company’s website: https://www.biotricity.com/investors/

Event: Biotricity Fiscal 2026 Second Quarter Financial Results and Business Update Call
Date: Friday, November 14^th, 2025
Time: 4:30pm ET (1:30pm PT)
Toll Free: 1-877-269-7751
International: 1-201-389-0908
Webcast URL: https://viavid.webcasts.com/starthere.jsp?ei=1740411&tp_key=f4feb0c9ef

Investors can begin accessing the webcast 15 minutes before the call, where an operator will register your name and organization. The call will be in listen-only mode.

A replay of the call will be available approximately three hours after the live call via the Investors section of the Biotricity website at https://www.biotricity.com/investors/.

Toll Free Replay Number: 1-844-512-2921
International: 1-412-317-6671
Replay Access ID: 13756814
Expiration: Friday, November 28, 2025 at 11:50 PM ET

About Biotricity Inc.

Biotricity is reforming the healthcare market by bridging the gap in remote monitoring and chronic care management. Doctors and patients trust Biotricity’s unparalleled standard for preventive & personal care, including diagnostic and post-diagnostic solutions for chronic conditions. The Company develops comprehensive remote health monitoring solutions for the medical and consumer markets. To learn more, visit www.biotricity.com.

Important Cautions Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “seek,” “project,” or “goal” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements may include, without limitation, statements regarding (i) the plans, objectives and goals of management for future operations, including plans, objectives or goals relating to the design, development and commercialization of any of the Company’s products or services, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance, (iv) the regulatory regime in which the Company operates or intends to operate and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of its products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

Contacts:
Tik Tok
Instagram
Amazon
Blogs

Biotricity Investor Relations:
Investors@biotricity.com

SOURCE: Biotricity, Inc.

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury




FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

Silver Spring, Md., Nov. 14, 2025 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of the labeling limits the therapy’s indication to ambulatory patients four years of age and older with Duchenne muscular dystrophy (DMD). These actions follow reports of fatal acute liver failure in non-ambulatory patients treated with the product.  

Elevidys is an AAVrh74 adeno-associated virus (AAV) vector-based gene therapy approved for the treatment of DMD in certain patients. In June 2025, the FDA issued a CBER Safety Communication following two reports of fatal acute liver failure in non-ambulatory pediatric males with DMD after receiving Elevidys. In response, the manufacturer voluntarily paused distribution of Elevidys for use in non-ambulatory patients.  

In both fatal cases, patients developed markedly elevated liver enzymes and required hospitalization within two months of Elevidys infusion. An additional serious, non-fatal case of acute liver injury has involved complications such as mesenteric vein thrombosis, bowel ischemia and necrosis, and portal hypertension.  

After a comprehensive evaluation of the available safety data, FDA has now approved substantial labeling revisions for Elevidys, including:  

• Addition of a Boxed Warning describing the risk of serious liver injury and acute liver failure, including fatal outcomes;  
• Limiting the indication to ambulatory patients with DMD who are 4 years of age and older with a confirmed mutation in the DMD gene;  
• Removal of the indication for non-ambulatory patients with DMD;  
• Addition of a Limitations of Use statement to guide clinical decision-making;  
• Updates to the Warnings and Precautions, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies, and Patient Counseling Information sections; and  
• Inclusion of a new Medication Guide for patients and caregivers.  

Key Safety Information for Patients and Health Care Providers  

The revised labeling includes specific safety information and monitoring recommendations:  

• Liver monitoring: Weekly liver function tests are advised for at least three months after treatment. Patients should remain near an appropriate medical facility for at least two months post-infusion.  
• Prompt medical attention: Patients should contact their health care provider immediately if they experience yellowing of the skin or eyes, if they miss or vomit corticosteroid doses, or if the patient experiences a change in mental status.  
• Infection risk: Corticosteroid therapy may suppress immune function, increasing susceptibility to infections and serious complications including death.  
• Cardiac monitoring: Weekly testing for cardiac injury (troponin-I) is advised for one month following treatment.  
• Contraindications: Elevidys should not be used in patients with deletions involving DMD exons 8 and/or 9.   
• Limitations of Use: Elevidys is not recommended in patients with preexisting liver impairment, recent vaccinations, or recent/active infections.  

Postmarketing Requirements  
The FDA is requiring the manufacturer to conduct a postmarketing observational study to further assess the risk of serious liver injury. The study will enroll approximately 200 patients with DMD and follow them for at least 12 months after administration of Elevidys, with periodic liver function assessments.  

Reporting Adverse Events  
Health care professionals and patients are encouraged to report adverse events, including cases of liver injury, to the FDA MedWatch program:  

• Online at www.fda.gov/medwatch
• By phone: 1-800-FDA-1088  

Adverse events may also be reported to Sarepta Therapeutics, Inc. at 1-888-727-3782.

The FDA remains committed to the continued evaluation of the safety and effectiveness of gene therapies and will provide updates as new information becomes available.  

Contact Info

U.S. Food and Drug Administration
FDAPressAlerts@fda.hhs.gov
+1 202-690-6343

SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES




SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES

Ghent Belgium, Nov. 14, 2025 (GLOBE NEWSWIRE) — SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT

AND NEW NUMBER OF SHARES

PRESS RELEASE
REGULATED INFORMATION
14 November 2025, 6:00 pm CET

Ghent, Belgium, 14 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, as a result of a subscription to new shares by GEM Global Yield LLC SCS (“GEM“), the Company’s share capital has increased on 14 November 2025 from EUR 6,813,075.23 to EUR 7,054,460.23 and the number of issued and outstanding shares has further increased from 65,759,928 to 68,089,899 ordinary shares, through the issuance of a total of 2,329,971 new shares at an issue price of (rounded) EUR 0.6614 per share to the benefit of GEM. The aforementioned capital increase has been completed in the framework of the settlement of a fifth subscription request notice issued by the Company to GEM under the share subscription facility agreement entered into on 17 March 2025 between a.o. the Company and GEM (the “Facility“), and which had been approved in principle by the Company’s board of directors within the framework of the authorised capital on 8 April 2025. 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 total current number of outstanding subscription rights amounts to 7,489,576, which entitles their holders (if exercised) to subscribe to 8,656,304 new shares with voting rights in total, namely:

• up to 261,895 new shares can be issued upon the exercise of 90,780 share options that are still outstanding under the ‘Executive Share Options’ plan for staff members and consultants of the Company, entitling the holder thereof to acquire ca. 2.88 new shares when exercising one of his or her share options (the “Executive Share Options“);
• up to 687,784 new shares can be issued upon the exercise of 687,784 share options (each share option having the form of a subscription right) that are still outstanding under the ‘2018 Share Options’ plan for directors, employees and other staff members of the Company and its subsidiaries, entitling the holder thereof to acquire one new share when exercising one of his or her share options (the “2018 Share Options“);
• up to 188,370 new shares can be issued upon the exercise of 188,370 share options (each share option having the form of a subscription right) that are still outstanding under the ‘2021 Share Options’ plan for directors, employees and other staff members of the Company and its subsidiaries, entitling the holder thereof to acquire one new share when exercising one of his or her share options (the “2021 Share Options“);
• up to 1,000,000 new shares can be issued upon the exercise of 1,000,000 share options (each share option having the form of a subscription right) that are still outstanding under the ‘2023 Share Options’ plan for directors, employees and other staff members of the Company and its subsidiaries, entitling the holder thereof to acquire one new share when exercising one of his or her share options (the “2023 Share Options“);
• up to 1,000,000 new shares can be issued upon the exercise of 1,000,000 share options (each share option having the form of a subscription right) that are still outstanding under the ‘2025 Share Options’ plan for directors, employees and other staff members of the Company and its subsidiaries, entitling the holder thereof to acquire one new share when exercising one of his or her share options (the “2025 Share Options“);
• up to 302,804 new shares can be issued to Bootstrap Europe S.C.SP. upon the exercise of 10 warrants (each warrant having the form of a subscription right) that are still outstanding that have been issued by the extraordinary shareholders meeting of 27 May 2022 (the “Bootstrap Warrants“);
• up to 1,567,819 new shares can be issued to Kreos Capital VII Aggregator SCSp. upon the exercise of 875,000 warrants (each warrant having the form of a subscription right) that are still outstanding that have been issued by the extraordinary shareholders meeting of 20 December 2024 (the “Kreos Warrants“)¹;
• up to 1,057,632 new shares can be issued upon exercise of 1,057,632 subscription rights that are still outstanding that have been issued by the board of directors (within the framework of the authorized capital) on 27 April 2023 and 10 May 2023 in the framework of the private placement of new shares and new subscription rights (the “2023 Investor Warrants“); and
• up to 2,590,000 new shares can be issued to GEM upon the exercise of 2,590,000 warrants (each warrant having the form of a subscription right) that are still outstanding that have been issued by the extraordinary shareholders meeting of 22 May 2025, entitling GEM to acquire one new share when exercising one of its warrants (the “GEM Warrants“).

This announcement is made in accordance with Article 15 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

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^2,3.

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 requirements⁴. 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 The exercise price of the Kreos Warrants is equal to the lowest subscription price paid or agreed to be paid for a share in the share capital of the Company pursuant to any round of equity financing (or other financing convertible or exchangeable into equity) by the Company (taking into account any discounts including those arising on conversion or cancellation or indebtedness and/or interest thereon, but not taking into account any further anti-dilution adjustment mechanisms included in such rights or securities) prior to the exercise of the Kreos Warrants, and subject to certain exempted events that shall not be taken into account when determining the applicable exercise price per underlying new share. The number of new shares issuable upon exercise of the Kreos Warrants has been calculated on the basis of an exercise price that is equal to the lowest applicable issue price of the new shares issued on 24 January 2025 in the framework of contributions in kind of certain receivables (i.e., EUR 0.5581 per share).
² Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
³ As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

⁴ 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 — Fifth GEM Subscription — Closing PR (ENG) 14 November 2025
• Sequana Medical — Fifth GEM Subscription — Closing PR (NL) 14 November 2025

Press Release Biocartis NV: Biocartis Showcases Growing Impact of Idylla™ Platform at AMP 2025




Press Release Biocartis NV: Biocartis Showcases Growing Impact of Idylla™ Platform at AMP 2025

PRESS RELEASE, 11/14/2025, 10:00 AM EST

Biocartis Showcases Growing Impact of Idylla™ Platform at AMP 2025

Multiple abstracts and a corporate workshop highlight Idylla™’s growing role in oncology diagnostics

Itasca, IL, United States, 14 November 2025 – Biocartis, an innovative molecular diagnostics company, is pleased to announce that multiple abstracts highlighting the growing adoption of the Idylla™ Platform in research and clinical collaborations are being presented at the Association for Molecular Pathology (AMP) Annual Meeting, that is currently taking place in Boston, MA. In addition, Biocartis hosted a successful AMP workshop on rapid EGFR testing.

Highlights from the Idylla™ abstracts include:

• Evaluation of the Idylla™ GeneFusion Assay for First-Line Ultrarapid Detection of NTRK Fusions in Solid Tumor Samples (Gloria et al., 2025)
  Collaborative work between MD Anderson Cancer Center, Mayo Clinic, and Biocartis demonstrated high concordance of the Idylla™ GeneFusion Assay with RNA-based NGS in 190 retrospectively collected samples, confirming the assay as a reliable ultrarapid solution for NTRK fusion detection.
• Routine Implementation of the Idylla™ Fusion Assay: An Assessment of Performance Based on Prospective Reflex Testing of Non-Small Cell Lung Carcinoma in a Large Laboratory Setting (Yakoub et al., 2025)
  Memorial Sloan Kettering Cancer Center and Biocartis reported high sensitivity (98.9%) and specificity (95%) in 658 prospectively collected samples, confirming the Idylla™ GeneFusion Assay’s performance for routine reflex testing, including rare events such as MET exon 14 skipping.
• Ultra-Rapid, Extraction-Free qPCR Based POLE-POLD1 Mutation Screening in Solid Tumors (Nafa et al., 2025)
  The Idylla™ POLE-POLD1 Mutation Assay showed 98.4% accuracy in 122 solid tumor samples with excellent reproducibility, minimal sample input requirements, and rapid turnaround compared to Sanger or NGS methods.
• Clinical Validation of Tissue and Plasma Companion Diagnostic Devices for Amivantamab Plus Lazertinib as Treatment in EGFR-Mutant Advanced Non-Small Cell Lung Cancer (Cruz-Guilloty et al., 2025)
  High concordance between tissue- and plasma-based testing was observed, demonstrating the role of Idylla™ EGFR Mutation Assay in supporting precision oncology clinical trials.
• Enhancing NSCLC Diagnostics with the Idylla™ Platform: Insights from the INDIGO Study (Gregorio et al., 2025)
  Integration of Idylla™ EGFR, KRAS and GeneFusion Assays in six Spanish centers significantly increased biomarker detection rates and reduced turnaround times from 4–30 days to 0–6 days, facilitating more timely treatment decisions.

• Real-World Experience of Idylla™ GeneFusion Assay in Non- Small Cell Lung Carcinoma Regarding the Diagnostic Utility of Expression Imbalance Calls (Caffes et al., 2025)
  Mayo Clinic data highlighted the practical utility of expression imbalance (EI) calls for identifying uncommon fusions with the Idylla™ GeneFusion Assay. Orthogonal confirmation is recommended for EI-only results to guide targeted therapies.

• Quality Assessment of a Melanoma Workflow with Upfront Rapid BRAF/NRAS Testing with Negative Results Reflexed to Next- Generation Sequencing (Herr et al., 2025)
  Dartmouth Hitchcock Medical Center demonstrated a tiered workflow using Idylla™ for rapid BRAF and NRAS testing, followed by NGS for negative cases, efficiently capturing clinically relevant mutations while minimizing missed variants.

In addition to these abstracts, Biocartis hosted the AMP workshop “Rapid EGFR Testing in Cytopathology: A Practical Implementation Experience”, presented by Dr. Roberto Ruiz-Cordero, Associate Professor and Director of Cytopathology at the University of Miami. During the workshop, Dr. Ruiz-Cordero shared practical insights from the prospective FACILITATE study on rapid EGFR testing in tissue and cytology samples, demonstrating how the Idylla™ EGFR Mutation Assay complements NGS in lung cancer tissue and cytology samples, particularly for Quantity Non-Sufficient (QNS) cases. Attendees learned how rapid molecular testing can reduce turnaround time, accelerate therapeutic decisions, and support practical, real-world implementation in the cytopathology laboratory.

Roger Moody, Chief Executive Officer at Biocartis, commented: “The AMP Annual Meeting provides a unique opportunity to highlight the impact of Idylla™ in precision diagnostics. The abstracts presented this year, alongside our practical workshop, showcase how our Idylla™ Platform supports fast, reliable molecular testing that advances personalized medicine strategies.”

For more information about Idylla™, visit us at AMP booth 421 or contact the Biocartis team.

—– END —–

More information:

Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium

Biocartis US Inc. 2 Pierce Place, Suite 1510, Itasca, IL 60143, US

www.biocartis.com | info@biocartis.com

About Biocartis

Biocartis is committed to helping cancer patients worldwide access the right treatment faster. With our proprietary Idylla™ Platform, we deliver in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Our expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer.

Learn more at www.biocartis.com and follow us on LinkedIn, Facebook and X (Twitter).

Disclaimers

Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR, KRAS, BRAF, NRAS-BRAF-EGFR S492R & POLE-POLD1 Mutation Assays and Idylla™ GeneFusion Assay are for Research Use Only (RUO), not for use in diagnostic procedures. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © November 2025, Biocartis NV. All rights reserved.

MediPharm Announces Complete Dismissal of Defamation Action Initiated by Apollo, Nobul and Regan McGee Under Ontario Anti-SLAPP Law




MediPharm Announces Complete Dismissal of Defamation Action Initiated by Apollo, Nobul and Regan McGee Under Ontario Anti-SLAPP Law

TORONTO, Nov. 14, 2025 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm” or the “Company”), a pharmaceutical company specialized in precision-based cannabinoids, today announced that the Superior Court of Justice – Ontario (Commercial List) (the “Court”) has fully dismissed the statement of claim (CV-25-00742450-0000) (the “Claim”) issued by Apollo Technology Capital Corporation (“Apollo”), Nobul Technologies Inc. (“Nobul”), and Regan McGee (together with Apollo and Nobul, the “Plaintiffs”) on May 5, 2025, against MediPharm’s Chief Executive Officer, David Pidduck, and Chairman of the Board, Chris Taves.

Further to the Company’s press release dated May 28, 2025, in which the Company announced that the Plaintiffs agreed to dismiss the frivolous $50 million conflict of interest claim against the Company’s litigation counsel, in its entirety on a with-prejudice basis (the “May 2025 Court Dismissal”), MediPharm is pleased to announce that the Court has now granted the anti-SLAPP motion brought by Mr. Pidduck and Mr. Taves under the “anti-SLAPP” provisions of section 137.1(3) of the Courts of Justice Act (Ontario) (the “Motion”), dismissing the remaining libel allegations against them in full.

The Plaintiffs sought, amongst other things, damages in the amount of $50 million against Mr. Pidduck and Mr. Taves for defamation relating to a letter that was sent to a former executive of a MediPharm subsidiary working alongside Apollo on April 29, 2025 (the “April 29 Letter”), in connection with the proxy contest initiated by the Plaintiffs. In making its decision to grant the Motion, and dismiss all remaining aspects of the Claim in full, the Court noted the following:

“I find that the April 29 Letter is typical of a lawyer’s letter that one would expect in these circumstances.”

“In my view there is ample evidence confirming the truth of the assertions/concerns in the April 29 Letter and, again, no evidence to the contrary.”

“I find that the plaintiffs have utterly failed to meet the onus required of them, and I find that the defendants have on balance established valid defences in the case of each of the four defences they assert.”

“The plaintiffs have produced no evidence that the April 29 Letter caused any harm, let alone the “serious harm” that they must show under s. 137.1(4)(b).”

The successful grant of the Motion by the Court today follows both the May 2025 Court Dismissal, and the subsequent dismissal by the Court of the application issued by Apollo and Nobul against the Company on May 16, 2025 relating to, amongst other things, appointing a third-party independent chair to preside over the Annual and Special Meeting of Shareholders of the Company on June 16, 2025 (the “Application”). Costs that are owed to MediPharm as a result of the full dismissal of the Application, have yet to be paid by Apollo and Nobul.

MediPharm also wishes to alert its shareholders that certain prior press releases related to Apollo were amended and disseminated under the Company’s name and/or filed on its SEDAR+ profile without its authorization, and consent on Friday, November 7, 2025 and Monday, November 10^th, 2025 (the “Unauthorized Press Releases”). The Unauthorized Press Releases relate to press releases previously disseminated by the Company on May 13, 2025, and May 15, 2025 (the “Actual Press Releases”). MediPharm is actively working with the relevant third party press release distribution platform to resolve this matter.

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. MediPharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment License from Health Canada, becoming the only company in North America to hold a commercial-scale domestic Good Manufacturing Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company’s current foreign drug manufacturing site registration with the US FDA.

In 2023, MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm’s reach to medical patients in Canada via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical Australia PTY Ltd. and Beacon Medical Germany GMBH. This acquisition also included Harvest Medical Clinics in Canada which provides medical cannabis patients with Physician consultations for medical cannabis education and prescriptions.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

Website: www.medipharmlabs.com

Investor Contact:
MediPharm Labs Investor Relations
Telephone: +1 416.913.7425
Email: investors@medipharmlabs.com

Cautionary Note Regarding Forward-Looking Information:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, costs to be paid to MediPharm relating to the dismissal of the Application. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ continuous disclosure filings, available on the SEDAR+ website at www.sedarplus.ca. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

Resolutions from the Extraordinary General Meeting of Novo Nordisk A/S




Resolutions from the Extraordinary General Meeting of Novo Nordisk A/S

Bagsværd, Denmark, 14 November 2025 – Today, Novo Nordisk A/S held its Extraordinary General Meeting, which was convened to elect new members of the Board of Directors.

At the Extraordinary General Meeting, Helge Lund (chair), Henrik Poulsen (vice chair) and the Board members Laurence Debroux, Andreas Fibig, Sylvie Grégoire, Christina Law and Martin Mackay stepped down from the Board of Directors.

Resolutions adopted at the Extraordinary General Meeting
Elections

• Election of Lars Rebien Sørensen as chair of the Board of Directors.
• Election of Cees de Jong as vice chair of the Board of Directors.
• Election of Britt Meelby Jensen and Stephan Engels as members of the Board of Directors

All elections are for the period until the next Annual General Meeting, on 26 March 2026.

At the Extraordinary General Meeting, Lars Rebien Sørensen, chair of the Board of Directors of the Novo Nordisk Foundation, said: “My mandate is very clear. I have two important tasks together with the Board: First, to support the CEO and the management in its transformation plans to regain its competitive leadership, and second, prepare the way for my successor. Let me also stress, that as the future chair I will attend to the interests of not only the Novo Nordisk Foundation but all shareholders of the company. I am looking forward to engaging with and having a dialogue with the minority shareholders to understand their views.”

Composition of the Board of Directors and its committees
After the Extraordinary General Meeting, the Board of Directors appointed members of its committees.

The Board of Directors, including its committees, is now composed as follows:

• Lars Rebien Sørensen (chair of the Board and chair of the People and Governance Committee)
• Cees de Jong (vice chair of the Board, chair of the Remuneration Committee and member of the Audit Committee)
• Elisabeth Dahl Christensen (employee-elected board member and member of the Remuneration Committee)
• Stephan Engels (chair of the Audit Committee and member of the Remuneration Committee and People and Governance Committee)
• Liselotte Hyveled (employee-elected board member and member of the Research & Development Committee)
• Mette Bøjer Jensen (employee-elected board member and member of the Audit Committee)
• Britt Meelby Jensen (member of the Remuneration Committee and member of the Research & Development Committee)
• Kasim Kutay (chair of the Research & Development Committee)
• Thomas Rantzau (employee-elected board member and member of the People and Governance Committee)

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.  

Contacts for further information

Company announcement No 35 / 2025

Attachment

• CA251114_Resolutions from the EGM

Wayman Place Partners with SafeSpace Global to Enhance Resident Safety with Non-Wearable Elopement Detection




Wayman Place Partners with SafeSpace Global to Enhance Resident Safety with Non-Wearable Elopement Detection

Knoxville, TN , Nov. 14, 2025 (GLOBE NEWSWIRE) — SafeSpace Global Corporation (OTCID:SSGC), a global leader in multimodal AI technology, is pleased to announce a partnership with Wayman Place, a trusted senior living community known for its personalized approach to care and commitment to resident well-being. As part of the agreement, SafeSpace Global Corporation will be implementing a non-wearable elopement detection technology across Wayman Place’s assisted living community.

This innovative system adds an additional layer of protection to Wayman Place’s existing safety measures, supporting caregivers with real-time visibility while allowing them to spend more time interacting with residents and providing care at the bedside, all while maintaining residents’ comfort, dignity, and independence.

“At Wayman Place, safety and independence go hand in hand,” said Bobbie Lane, Administrator at Wayman Place. “Our partnership with SafeSpace Global reflects our continued investment in tools that help our team respond quickly, proactively detect incidents, and ensure peace of mind for residents and families.”

“Wayman Place has prioritized both dignity and safety for residents,” said Katie Piperata, VP of Senior Living at SafeSpace Global. “We’re honored by their trust in us to provide technology that enhances staff visibility and responsiveness without replacing the human touch, so caregivers can focus on what matters most — caring and engaging with residents.”

Located in Longwood, Florida, Wayman Place provides individualized care, engaging activities, and modern amenities designed for comfort, security, and peace of mind. This partnership underscores the community’s ongoing commitment to advancing care through thoughtful innovation that empowers staff and enhances resident experience.

For more information about Wayman Place, visit waymanplace.com.

To learn more about SafeSpace Global’s technology for senior living and healthcare, visit safespaceglobal.ai.

About SafeSpace Global Corporation

SafeSpace Global Corporation is a publicly traded, fully reporting audited company specializing in multimodal AI technology solutions, dedicated to enhancing safety and security across various sectors, including healthcare, education, transportation, manufacturing, incarceration, and commercial industries. The Company’s mission is to help save lives worldwide by developing advanced AI technologies designed to enhance situational awareness and mitigate risks in critical environments. The Company is currently marketing five products and solutions, including its initial product, SafeSpace^® Fall Monitoring, which utilizes advanced AI monitoring tools to enhance resident safety in senior living, reduce the risk of injuries, and improve overall care efficiency. Additionally, the Company has expanded its services and offerings beyond senior living facilities, into schools and transportation where it has recently launched several innovative solutions.

For more information, visit www.safespaceglobal.ai or contact SafeSpace’s media team at contact@safespaceglobal.ai.

Media Contact:
Justin Freishtat
(410) 458-8780
SafeSpace Global Corporation
Email: Justin.Freishtat@safespaceglobal.ai

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are subject to uncertainty and may not come to fruition. Readers are cautioned not to place undue reliance on any forward-looking statement including statements that list numbers and dates.

###

IO Biotech Reports Third Quarter 2025 Financial Results and Provides Business Highlights




IO Biotech Reports Third Quarter 2025 Financial Results and Provides Business Highlights

• Topline data from Phase 3 (IOB-013) clinical trial in advanced melanoma presented at ESMO; data highlights improvements in PFS achieved in overall population and across virtually all subgroups, although statistical significance on the PFS primary endpoint was narrowly missed
• Meeting scheduled with FDA in December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in patients with advanced melanoma
• Pre-clinical data for additional T-win platform pipeline candidates IO112 targeting arginase 1 and IO170 targeting transforming growth factor (TGF)-β were presented at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting
• Ended the third quarter with approximately $31 million in cash and cash equivalents, which is expected to support operations through the first quarter of 2026
• Corporate presentations planned for the Jefferies Global Healthcare Conference in London on November 18, 2025, and the Piper Sandler 37th Annual Piper Sandler Healthcare Conference on December 3, 2025

NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today reported financial results for the third quarter of 2025 and recent business highlights.

“We remain keenly focused on our mission to develop novel, immune-modulatory, off-the-shelf cancer therapies for the treatment of multiple types of tumors including melanoma, lung, and head and neck cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Although the IOB-013 study narrowly missed statistical significance on the primary PFS endpoint, the results of the study support the mechanism of action of our therapeutic cancer vaccines and, we believe, have significantly de-risked the program. We look forward to discussing the next Phase 3 study design for Cylembio with the FDA in December and remain committed to bringing Cylembio to cancer patients seeking alternative treatment options as quickly as possible.”

Recent Business Highlights

• The company presented topline results of its Phase 3 pivotal trial (IOB-013/KN-D18) evaluating the company’s lead investigational vaccine, Cylembio^® (imsapepimut and etimupepimut, adjuvanted), in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) for the treatment of advanced melanoma in an oral presentation at the 2025 European Society for Medical Oncology (ESMO) congress. The trial evaluated Cylembio in combination with pembrolizumab vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated a clinically relevant improvement in progression free survival (PFS) compared to pembrolizumab alone, which was also observed in virtually all subgroups, but the trial narrowly missed statistical significance.
• The company has a meeting with the United States (US) Food and Drug Administration (FDA) scheduled in December to align on the design of a potential new Phase 3 registrational trial for the treatment of advanced melanoma.
• The company also presented a poster at ESMO of final data from the Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 plus pembrolizumab for 1L treatment of advanced non-small cell lung cancer (NSCLC) and recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN) highlighting encouraging landmark PFS and overall survival (OS) rates.
• The company presented two posters at the SITC annual meeting with pre-clinical data for two additional T-win vaccine candidates. Data presented in a poster for its next therapeutic vaccine candidate expected to enter clinical development, IO112 targeting arginase 1, demonstrated anti-tumor activity with dynamic changes in the tumor microenvironment (TME) driven by the vaccine-targeted modulation of immunosuppressive myeloid cells, including tumor-associated macrophages (TAMs). Data presented in the poster for an additional candidate, IO170 targeting Transforming Growth Factor (TGF)-β, demonstrated induction of immune responses that could inhibit tumor growth and reduce lung metastasis.

Investor Conferences Participation

• Jefferies Global Healthcare Conference in London: Mai-Britt Zocca, PhD, President and CEO, will give a company presentation beginning at 3:00 PM GMT on November 18, 2025.
• Piper Sandler 37th Annual Piper Sandler Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will participate in a fireside chat beginning at 3:00 PM ET on December 3, 2025.

The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at https://investors.iobiotech.com.

Third Quarter 2025 Financial Results

• Total operating expenses for the three months ended September 30, 2025, were $19.4 million, compared to $26.5 million for the three months ended September 30, 2024.
• Research and development expenses were $13.7 million for the three months ended September 30, 2025, compared to $20.2 million for the three months ended September 30, 2024. The company recognized $0.6 million in research and development equity-based compensation for the three months ended September 30, 2025 and 2024, respectively.
• General and administrative expenses were $5.6 million for the three months ended September 30, 2025, compared to $6.3 million for the three months ended September 30, 2024. The company recognized $0.9 million in general and administrative equity-based compensation for the three months ended September 30, 2025 and $1.0 million for the three months ended September 30, 2024.
• Cash and cash equivalents as of September 30, 2025 were $30.7 million, compared to $60.0 million at December 31, 2024. During the three months ended September 30, 2025, the company increased cash, cash equivalents and restricted cash by $2.5 million primarily due to the draw down of €12.5 million in gross proceeds from our Tranche B loan with the European Investment Bank on July 4, 2025 and net proceeds of $6.6 million from the issuance of common stock in connection with our at-the-market program. The company now expects that it will have sufficient cash to run the company through the first quarter of 2026.

About Cylembio^®

Cylembio^® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio^® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio^® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio^® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win^® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio^®, in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including statements regarding the timing or outcome of communications and meetings with regulatory authorities including the FDA, the timing or outcome of the submission of marketing applications, including a BLA, for Cylembio, the timing or outcome of the launch of Cylembio, and statements regarding other current or future clinical trials, their timing, progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Contact:

Investors and Media:

Maryann Cimino, Director of Investor Relations & Corporate Communications
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com

Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens




Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens

• Prof Lemmens underscores large unmet medical need in intracerebral hemorrhage 
• “Very encouraging” data from Phase 2a trial with lead asset BIOX-101
• Bioxodes is preparing for a possibly registrational Phase 2b trial, could bring BIOX-101 to market by late 2030

Gosselies, Belgium, 14 November 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has held a webcast on the breakthrough potential of its lead candidate BIOX101 to treat intracerebral hemorrhage (ICH) and discussed the data with Prof Dr Robin Lemmens, KU Leuven, the Principal Investigator of its Phase 2a BIRCH clinical trial. Prof Lemmens, a world-renowned stroke expert and head of the stroke unit at the University Hospital Leuven, underscored the urgent need to address the large unmet medical need in intracerebral hemorrhage, and provided his insights from the successful Phase 2a clinical study with BIOX-101. Bioxodes CEO Marc Dechamps presented the company’s strategy in bringing BIOX-101 to market, possibly as early as late 2030.

“The trial results are very encouraging especially as it relates to safety. We need to take the next step and launch the Phase 2b trial to see if we find an effect of reducing the edema volume which is the main purpose of the drug,” said Prof Dr Robin Lemmens. “BIOX-101 is a very important drug target to be evaluated in clinical trials. For ICH, unfortunately we don’t have many alternatives to offer to patients. There is a high unmet medical need to try and identify better therapeutic solutions for patients who present ICH.” To view a replay of the event with Prof Lemmens, please use this link.

In September, the Data Monitoring Committee unanimously endorsed proceeding to a Phase 2b/3 trial after the company stopped recruiting since the BIRCH Phase 2a trial had already achieved its objectives and announced strong second interim results. All patients treated with the candidate experienced a reduction in hematoma, a key clinical finding further supported by biomarker measurements, all of which trended in support of this and other clinical observations. Functional outcomes were also highly encouraging, with signals of recovery appearing more favorable than those seen in the standard-of-care control group. More patients regained independence on day 90 after BIOX-101 treatment than in the standard-of-care. Bioxodes is now preparing for a global multi-center Phase 2b trial in ICH. If successful, this could be sufficient to submit BIOX-101 for conditional marketing authorizations in the U.S. by late 2030 and in Europe in early 2031. The company will also develop BIOX-101 to treat ischemic stroke.

“The presentation by Prof Lemmens was a unique opportunity to learn about the clinical experience with stroke directly from an unrivalled expert. He made it very clear that intracerebral hemorrhage presents a large unmet medical need that could be addressed by BIOX-101 if further studies confirm the signals we have seen in our Phase 2a trial. I look forward to taking the next steps to bring BIOX-101 to patients, possibly as early as late 2030,” said Marc Dechamps, Chief Executive Officer at Bioxodes.

Marketed anticoagulants cannot be used to treat ICH because they often increase bleeding. BIOX-101 is the first-in-class therapeutic candidate with anti-clotting effect that has not been shown to increase bleeding and has also been shown to exert potent synergistic anti-inflammatory effects in the BIRCH trial, which is expected to contribute to better outcomes for ICH patients.

Intracerebral hemorrhage (ICH) is a devastating condition with no approved therapies, accounting for 40% of all stroke-related deaths, despite making up just 15% of cases. Mortality approaches 50% at 30 days, and approximatively half of all ICH-related deaths happen within the first 24 hours. Fewer than 20% of survivors achieve functional independence after six months, often due to secondary damage resulting from the untreatable bleeding and associated inflammation, which causes secondary ischemia, neuroinflammation and neuronal damage, amongst others.

BIOX-101 is a proprietary recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 is an investigational anticoagulant that reduces clotting without increasing bleeding. It does this by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. The product also exerts anti-inflammatory effects by inhibiting activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier. Bioxodes has completed a positive Phase 2a clinical proof of concept trial of BIOX-101 to treat ICH and is currently planning a Phase 2b trial in ICH and Phase 2 trials of BIOX-101 to treat acute ischemic stroke and an undisclosed indication.

Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat stroke. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for treatment and prevention of thromboinflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779.

Attachment

• 20251114 Bioxodes PR KOL event (final)