Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes




Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes

– Refinancing transaction with proceeds to be utilized to repurchase or repay the 2026 Convertible Notes prior to or at maturity

CARLSBAD, Calif.–(BUSINESS WIRE)–Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today the pricing of $700.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030 (the “notes”) in a private placement (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $70.0 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on November 17, 2025, subject to customary closing conditions.

The notes will be general unsecured obligations of Ionis, and will not bear regular interest and the principal amount of the notes will not accrete. The notes will mature on December 1, 2030, unless earlier converted, redeemed or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $682.8 million (or approximately $751.2 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis.

Ionis expects to use approximately $267.6 million of the net proceeds from the offering to repurchase for cash $200.0 million in aggregate principal amount of its 0% Convertible Senior Notes due 2026 (the “2026 notes”) pursuant to the concurrent note repurchase transactions described below. Ionis expects to use the remaining net proceeds from the offering for additional repurchases of the 2026 notes from time to time following the offering, including the repayment of any remaining 2026 notes at maturity, and for general corporate purposes.

Before September 1, 2030, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after September 1, 2030 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 10.1932 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $98.10 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 35.0% over the last reported sale price of $72.67 per share of Ionis’ common stock on November 12, 2025. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid special interest, if any.

Ionis may not redeem the notes prior to December 6, 2028. Ionis may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on a redemption date on or after December 6, 2028 if the last reported sale price of Ionis’ common stock has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ionis provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. However, Ionis may not redeem less than all of the outstanding notes unless at least $100.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Ionis sends the related notice of redemption. No sinking fund is provided for the notes.

If Ionis undergoes a “fundamental change” (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Ionis delivers a notice of redemption, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption during the related redemption period (as defined in the indenture that will govern the notes), as the case may be.

Concurrently with the pricing of the notes in the offering, Ionis entered into separate and individually negotiated transactions with certain holders of the 2026 notes to repurchase for cash $200.00 million in aggregate principal amount of the 2026 notes on terms negotiated with each holder (each, a “concurrent note repurchase transaction”). This press release is not an offer to repurchase the 2026 notes, and the offering of the notes is not contingent upon the repurchase of any of the 2026 notes.

In connection with any repurchase of the 2026 notes, Ionis expects that holders of the 2026 notes who agree to have their 2026 notes repurchased and who have hedged their equity price risk with respect to such notes (the “hedged holders”) will unwind all or part of their hedge positions by purchasing Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or Ionis’ common stock.

The notes and any shares of Ionis’ common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

About Ionis Pharmaceuticals

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has marketed medicines and a leading pipeline in neurology, cardiometabolic and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients.

Ionis’ Forward-looking Statement

This press release includes forward-looking statements regarding the offering, including statements regarding the anticipated completion and timing of the offering, the expected repurchase of 2026 notes, including the concurrent note repurchase transactions, the expected unwind by the hedged holders of their hedge positions and the anticipated effects of such actions, and Ionis’ expected use of proceeds from the offering. Any statement describing Ionis’ expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including, without limitation, changes in market conditions, whether Ionis will be able to satisfy closing conditions related to the offering, whether and on what terms Ionis may repurchase or repay any of the 2026 notes, the concurrent note repurchase transactions, the actions of the hedged holders and unanticipated uses of capital. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024 and most recent Form 10-Q, which are on file with the Securities and Exchange Commission, as well as other subsequent filings Ionis makes with the Securities and Exchange Commission from time to time. Copies of these and other documents are available from Ionis.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals^® is a trademark of Ionis Pharmaceuticals, Inc.

Contacts

Ionis Investor Contact:
D. Wade Walke, Ph.D.

IR@ionisph.com
760-603-2331

Ionis Media Contact:
Hayley Soffer

media@ionis.com
760-603-4679

enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants




enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

BOSTON & MONTREAL–(BUSINESS WIRE)–enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the pricing of its previously announced underwritten public offering of 12,558,823 common shares at a public offering price of $8.50 per share and pre-funded warrants to purchase 2,735,295 shares of its common shares at an offering price of $8.4999 per pre-funded warrant, in each case, before underwriting discounts and commissions. The aggregate gross proceeds to enGene from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by enGene, are expected to be approximately $130 million. All securities to be sold in the offering will be offered by enGene. In addition, enGene has granted to the underwriters a 30-day option to purchase up to 2,294,117 additional common shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 14, 2025, subject to the satisfaction of customary closing conditions.

Jefferies, Leerink Partners and Wells Fargo Securities are acting as joint book running managers for the offering. Raymond James and Van Lanschot Kempen are acting as co-lead managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

The securities described above are being offered by enGene pursuant to its effective shelf registration statement on Form S-3 (File No. 333-283201) filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 13, 2024 and declared effective on November 21, 2024. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, or by emailing prospectus_department@jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Wells Fargo Securities, LLC, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at (800) 645-3751 (option #5), or by email at WFScustomerservice@wellsfargo.com.

No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other 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 other jurisdiction.

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan® (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s management teams’ expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements, and they may also include statements express or implied, about enGene’s expectations regarding the offering, including the timing, structure and completion of the offering on the anticipated size and terms, the grant to the underwriters of the option to purchase additional shares and the potential value and clinical benefit of enGene’s product candidates. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

Many factors, risks, uncertainties, and assumptions could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, general economic conditions, , and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

Contacts

For media contact:

media@engene.com

For investor contact:

investors@engene.com

Niagen Bioscience Announces Results from First-Ever Randomized Controlled Trial Exploring Niagen (Patented Nicotinamide Riboside, NR) Supplementation in Long COVID




Niagen Bioscience Announces Results from First-Ever Randomized Controlled Trial Exploring Niagen (Patented Nicotinamide Riboside, NR) Supplementation in Long COVID

Findings show a significant increase in NAD+ levels and within-group benefits in fatigue, depression, and sleep quality

LOS ANGELES–(BUSINESS WIRE)–$NAGE #Biotech—Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today shared promising results from the first-of-its-kind clinical trial published today in The Lancet peer-reviewed journal eClinicalMedicine demonstrating that daily supplementation with Niagen^®, Niagen Bioscience’s patented nicotinamide riboside (NR) ingredient, significantly increased NAD+ levels and improved executive functioning, fatigue, depression, and sleep quality, when compared to their baseline levels, in some individuals with long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC).

The 58 participant, randomized, double-blind, placebo-controlled study was led by Edmarie Guzmán-Vélez, PhD, formerly an Assistant Professor in the Department of Psychiatry and the McCance Center for Brain Health at Massachusetts General Hospital, and now Assistant Professor in the Department of Neurology at the Robert Wood Johnson Medical School, and the Center for Health Aging Research (CHAR) at the Institute for Health, Rutgers University.

“These findings demonstrate that ten weeks of Niagen NR supplementation increased NAD+ levels and improved long COVID symptoms of fatigue, sleep quality, and depression, compared to symptoms before treatment,” said Rob Fried, Chief Executive Officer of Niagen Bioscience. “As part of our mission to advance the science of cellular health, we are pleased to see Niagen NR used in research exploring the lasting impact of COVID-19 and look forward to future studies that further our understanding of NAD+ augmentation in recovery and resilience.”

Long COVID continues to affect a significant number of individuals around the globe, with no proven treatments available. According to the U.S. Centers for Disease Control and Prevention, between August and September 2024, 5.3% of adults in the U.S. reported that they are currently experiencing long COVID.

“Our goal with this study was to understand whether increasing NAD+ levels with NR could improve cognitive performance primarily, but also other common symptoms in individuals with long COVID,” said Dr. Guzmán-Vélez. “We saw encouraging within-group improvements in fatigue, sleep, and mood, although we did not observe statistically significant differences between people taking NR and those taking a placebo. These findings suggest that restoring NAD+ remains a promising avenue for recovery and advancing our understanding of how to help individuals affected by long COVID. More research is needed to confirm and expand on these findings.”

The Connection Between NAD+ & Long COVID

A multi-system disorder, long COVID symptoms persist months or years after infection, including common fatigue, breathlessness, cognitive impairment or “brain fog” (attention, memory, sleep), muscle aches, depression, and anxiety (Taher et al., 2025, Soriano et al., 2022, Ely et al., 2024, Taquet et al., 2022, Davis et al., 2021). Emerging evidence suggests that interacting mechanisms underlie long COVID, including immune dysregulation, mitochondrial dysfunction, oxidative stress, disrupted cellular energy metabolism, and depletion of NAD+, a molecule crucial for cellular energy and repair (Block et al., 2022).

“Long COVID presents with a wide range of symptoms because coronaviruses disturb NAD+ and thereby disturb multiple organ systems,” commented Charles Brenner, PhD, Alfred E Mann Family Foundation Chair in Diabetes and Cancer Metabolism at City of Hope, Chief Scientific Advisor to Niagen Bioscience, and study co-author. “What is encouraging is that despite variability among patients, we observed consistent signals of improvement with elevation of NAD+ levels. This suggests that restoring the NAD+ system can restore multiple biological pathways implicated in long COVID — including mitochondrial function, inflammation, and cellular repair. It is a compelling indication that NAD+ biology can be effectively targeted in conditions of metabolic stress such as long COVID.”

Study Overview

This 24-week, randomized, double-blind, placebo-controlled, parallel group study analyzed the effects of elevating NAD+ with Niagen NR supplementation on cognitive and symptomatic recovery in individuals with long COVID.

A total of 58 non-hospitalized adults (mean age, 45.1 years) with persistent symptoms following COVID-19 infection were randomized to receive either Niagen NR (2,000 mg/day) for 20 weeks or placebo for 10 weeks, followed by Niagen NR for an additional 10 weeks. The study included a two-week placebo lead-in period and a two-week follow-up period.

The primary endpoint analyzed the change in cognitive performance, measured using validated scales and tests, including the Everyday Cognition (ECog), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and Trail Making Test-B (TMT-B). Secondary endpoints were assessed using standardized scales to evaluate fatigue, mood, and sleep quality (FSS, BDI, BAI, and PSQI).

Study Highlights

• NAD+ levels increased up to 3.1-fold after 5–10 weeks of Niagen NR supplementation, confirming NAD+ restoration in whole blood.
• In the post-hoc exploratory analysis, significant within-group improvements were observed in fatigue severity (FSS), sleep quality (PSQI), and depressive symptoms (BDI) following 10 weeks of Niagen NR supplementation.
• Niagen NR was well-tolerated, with no significant differences in adverse events between the Niagen NR and placebo groups.
• Statistically significant differences between the Niagen NR and placebo groups were not observed for primary or secondary outcomes, likely due to the small sample size and high dropout rates resulting from reinfection, relocation, and medication changes, which reduced statistical power. This underscores the need for larger studies to further understand the observed trends in symptom improvement.

Relevance

This study is the first randomized controlled trial to demonstrate that Niagen NR supplementation safely and effectively elevates NAD+ levels in individuals with long COVID, a condition marked by fatigue, cognitive dysfunction, and sleep disturbance.

While between-group differences were not statistically significant, these findings show within-group improvements from baseline in key symptoms and establish NAD+ restoration as a measurable biological response, suggesting a potential therapeutic role of NAD+ in post-viral recovery and energy metabolism.

These results build upon a growing body of evidence linking NAD+ repletion to improved mitochondrial function and cellular resilience, suggesting a possible new avenue for addressing persistent symptoms associated with long COVID. Further large-scale, placebo-controlled studies are warranted to build upon these early findings.

The study was funded by the McCance Center for Brain Health at Mass General Hospital and by Niagen Bioscience. While Niagen Bioscience partially funded the study and provided Niagen NR and placebo materials, it had no role in study design, conduct, outcomes, analyses, or study publication.

For additional information on the science supporting Niagen, visit www.niagenbioscience.com.

About Niagen Bioscience:

Niagen Bioscience, Inc. (NASDAQ: NAGE), formerly ChromaDex Corp., is the global leader in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience^™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen^® (patented nicotinamide riboside, or NR), the most efficient, well-researched, high-quality, and legal NAD+ booster available.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

Forward Looking Statements:

This 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, including, without limitation, statements related to the potential health benefits of Niagen^® (nicotinamide riboside) supplementation, the interpretation of clinical study findings, future research directions, and matters related to the infringement or non-infringement of intellectual property rights. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “potential,” “possible,” “probable,” “believes,” “seeks,” “may,” “will,” “should,” “could,” or the negative of such terms, or other similar expressions.

Forward-looking statements are based on current expectations, assumptions, and scientific understanding, and are subject to numerous risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those described or implied. These risks and uncertainties include, but are not limited to: the inherent variability of scientific research and clinical outcomes; the possibility that future studies may not confirm the results described herein; the ability to obtain and maintain necessary regulatory approvals; the scientific, regulatory, and commercial challenges inherent in dietary supplements and healthy-aging research; market acceptance of the Company’s products and educational initiatives; the outcome of ongoing or future clinical studies; the protection and enforcement of intellectual property; competition; and other factors described in Niagen Bioscience’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Q.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement, and Niagen Bioscience undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by applicable law.

Contacts

Niagen Bioscience Media Contact:
Kendall Knysch, Senior Director of Public Relations & Communications

310.405.5227

kendall.knysch@niagenbio.com

Niagen Bioscience Investor Relations Contact:
ICR, LLC

Reed Anderson

(646) 277-1260

Stephanie Carrington

(646) 277-1282

niagenir@icrinc.com

LabGenius Therapeutics Announces Poster Presentation at the ESMO Immuno-Oncology Congress 2025




LabGenius Therapeutics Announces Poster Presentation at the ESMO Immuno-Oncology Congress 2025

LONDON–(BUSINESS WIRE)–#AI—LabGenius Therapeutics (“LabGenius”), a drug discovery company combining artificial intelligence (AI) and high-throughput experimentation to advance next-generation multispecific antibodies for solid tumours, today announced a scientific poster will be presented at the ESMO Immuno-Oncology Congress 2025, being held December 10 – 12, 2025, at the Queen Elizabeth II Centre in London, United Kingdom. LabGenius’ presentation will debut the pre-clinical in vivo efficacy (>90% tumour growth inhibition) and tolerability data for their lead asset, a highly tumour selective bispecific T-cell engager (TCE).

Poster Presentation Details

Bispecific TCE Overview

For the selected target, LabGenius has developed a selectivity-enhanced TCE. The company’s lead optimisation platform, EVA™, was used to discover and concomitantly optimise a TCE with improved killing selectivity, potency, efficacy, and manufacturability. The biological mechanism underlying this enhanced selectivity is based on the principle of avidity. By harnessing avidity-driven selectivity, the optimised TCE can distinguish between healthy and diseased cells based on differential tumour-associated antigen expression.

About LabGenius Therapeutics

LabGenius Therapeutics is a drug discovery company pioneering the discovery of next-generation therapeutic antibodies. The company’s discovery platform, EVA™, integrates several cutting-edge technologies drawn from the fields of artificial intelligence, robotic automation and synthetic biology. LabGenius Therapeutics operates a hybrid business model that includes partnering with biotech and pharmaceutical companies in parallel with pursuing a wholly-owned therapeutic pipeline. For more information, please visit www.labgeniustx.com, or connect on LinkedIn.

Contacts

Media: press@labgeni.us
Corporate / business development: partnerships@labgeni.us

Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression




Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression

MONTREAL–(BUSINESS WIRE)–Indero is proud to announce the successful completion of an internally funded study that introduces a novel approach to evaluating topical new chemical entities (NCE) in early-phase clinical research. This innovative method leverages quantitative gene expression analysis to assess drug efficacy rapidly and cost effectively.

Dr. Robert Bissonnette, Executive Chairman and Founder of Indero, who initiated and led the study, shared his excitement about the results:

“Our goal was to rethink how to study topical drugs in early phase studies. The results of this study demonstrate that microdosing for only 3 days can provide meaningful efficacy signals. Within just 24 hours, we observed alterations in gene expression after applying a microdose of mid-potency corticosteroid on the skin of patients. By 72 hours, Th2, Th22 and Th17-specific biomarkers were significantly reduced. This outcome is exactly what we hoped for and opens the door to faster, smarter drug development strategies, demonstrating the potential for this method to be used effectively in early phase 1 studies.” The study highlights several advantages of this approach:

• Rapid efficacy insights with limited preclinical toxicology requirements and reduced phase 1 costs (3-day study vs. 8–12 weeks).
• Ability to compare multiple NCEs, concentrations, and vehicles within the same patient in short-duration studies.
• Opportunity to benchmark NCEs against approved topical drugs efficiently.

Emma Guttman, Professor and Chair of Dermatology at Mount Sinai, who performed gene expression analysis, emphasized its impact:

“This strategy represents a paradigm shift in topical drug development. It allows physicians and researchers to accelerate innovation while minimizing patient exposure and resource use. The implications for both industry and patients are tremendous,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair, Department of Dermatology and Director, Asness Family Center of Excellence in Eczema and Allergic Conditions, and Director, Laboratory of Inflammatory Skin Diseases, the Icahn School of Medicine at Mount Sinai.

This breakthrough puts Indero ahead in dermatology research, creating a faster, safer, and more affordable way to develop topical treatments.

About Indero

Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach which includes everything from protocol design and patient recruitment to trial monitoring and biometrics provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at global scale.

Contacts

For more information:
Valerie Coveney

Communications Specialist

Indero

Vcoveney@inderocro.com

Fresenius Kabi’s Adaptive Nomogram used on Aurora Xi Plasmapheresis System Now Operating Nationwide at BioLife Plasma Centers




Fresenius Kabi’s Adaptive Nomogram used on Aurora Xi Plasmapheresis System Now Operating Nationwide at BioLife Plasma Centers

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#CommittedToLife–Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today the successful completion of the U.S. rollout of the Adaptive Nomogram technology used on its Aurora Xi Plasmapheresis System across BioLife Plasma Services’ network of plasma donation centers. The implementation, which began in March 2025 in a phased approach, has been completed ahead of schedule, marking a significant milestone in helping plasma centers advance plasma collection efficiency and donation personalization.

The Adaptive Nomogram technology, used with Fresenius Kabi’s Aurora Xi Plasmapheresis System, optimizes plasma collection by tailoring donation volumes based on each donor’s individual body attributes. This data-driven approach enables more personalized and efficient plasma collection, supporting both donor safety and the sustainability of the plasma supply.

“We are proud to see our Adaptive Nomogram technology fully deployed at BioLife Plasma Services’ donation centers and delivering measurable impact while meeting BioLife’s expectations,” said Dr. Christian Hauer, President, MedTech at Fresenius Kabi. “This innovation brings a new level of personalization to plasma donations, helping our customers enhance efficiency and strengthen the sustainability of the plasma supply that is essential for lifesaving therapies.”

The nationwide rollout at BioLife Plasma Services’ donation centers began in March 2025 with pilot centers and was executed in a strategic, phased manner to ensure a smooth integration process while maintaining donor and plasma safety.

“Completing the rollout of this technology ahead of schedule reflects the thoughtful and phased approach taken that allowed us to avoid any business disruption while improving operational efficiency and continuing to maintain the safety of our plasma donors,” said Hema Tallman, Senior Vice President and Global Head of BioLife Plasma Services. “Working closely with Fresenius Kabi on this implementation has enabled us to strengthen our plasma supply and continue providing people in need with the life-sustaining and lifesaving medicines that BioLife produces from plasma.”

About Fresenius Kabi

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

For more information, please visit www.fresenius-kabi.com. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

Contacts

Media contact
Matt Kuhn (847) 220-3033

matt.kuhn@fresenius-kabi.com

DiaMedica Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Highlights




DiaMedica Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Highlights

• Preeclampsia Phase 2 IST Trial: Part 1a Dose Escalation Cohort Complete with Expansion Cohort Now Enrolling; Screening for Part 3, Fetal Growth Restriction Cohort, Expected to Start in Coming Weeks
• Held in Person pre-IND meeting with U.S. FDA to Discuss Plans for the Initiation of a U.S. Phase 2 DM199 Study in Preeclampsia
• AIS enrollment in ReMEDy2 Phase 2/3 Trial Nearing 50% of Target of 200 Patients for the Interim Analysis Expected in 2H 2026
• $55 million in Cash, Cash Equivalents and Investments, Anticipated Runway into 2H 2027
• Conference Call and Webcast on November 13 at 8:00 AM ET / 7:00 AM CT

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction and acute ischemic stroke (AIS), today provided a business update and reported financial results for the third quarter ended September 30, 2025. Management will host a conference call on Thursday, November 13, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2025 financial results.

“We are pleased to see the completion of cohort 10 and the initiation of enrollments in the Part 1a expansion cohort in the ongoing Phase 2 investigators sponsored trial (IST) in preeclampsia,” said Rick Pauls, President and CEO of DiaMedica. “Regarding our development program for PE in the United States, we believe that we had a productive in-person pre-IND meeting with the FDA and are awaiting minutes from the meeting. We plan to provide an update after we receive the minutes. Enrollment in our ReMEDy2 Phase 2/3 trial in acute ischemic stroke continues to progress as we are nearing 50% of our interim target of 200 patients.”

Recent Corporate Highlights

Preeclampsia Phase 2 IST Clinical Development:

• Part 1a (PE, planned delivery within 72 hours): Completed cohort 10, showing results consistent with cohorts 6-9. Enrollment has advanced to an expansion cohort of up to 12 additional participants at the expected therapeutic dose level. Completion of this cohort is expected in 1H 2026.
• Part 1b (PE, planned delivery within 72 hours) and Part 2 (early onset PE with expectant management): based on clinical learnings from Part 1a, a protocol amendment for Parts 1b and 2 is being implemented to refine treatment regimens.
• Part 3 (fetal growth restriction): Screening for participants who do not have PE but have early onset fetal growth restriction is expected to begin in the coming weeks.

Preeclampsia in Person Pre-IND meeting with FDA:

• Given the complexities inherent in conducting clinical studies involving pregnant women, a very vulnerable patient group, DiaMedica requested a pre-IND meeting with the FDA to obtain feedback prior to submitting an IND application for preeclampsia.
• The FDA granted DiaMedica an in-person meeting, which has been recently held. DiaMedica plans to provide an update regarding the meeting once final meeting minutes are received.

Acute Ischemic Stroke ReMEDy2 Phase 2/3 Clinical Developments:

• Enrollment in DiaMedica’s Phase 2/3 ReMEDy2 (the ReMEDy2 trial – NCT065216) trial is nearing 50% of the target of 200 participants for the interim analysis.

Financial Results Highlights for the Third Quarter Ended September 30, 2025

• Cash Position and Runway – Cash and short-term investments were $55.3 million as of September 30, 2025, compared to $44.1 million as of December 31, 2024. The increase in combined cash and short-term investments is due to the net proceeds received from July private placement. Based on its current plans, DiaMedica anticipates its current cash and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the second half of 2027.
• Cash Flows – Net cash used in operating activities for nine months ended September 30, 2025 was $21.3 million compared to $15.6 million for the same period in 2024. The increase in cash used in operating activities resulted primarily from the increased net loss in the nine months ended September 30, 2025 as compared with the prior year period, partially offset by changes in operating assets and liabilities during the current year period.
• Research and Development (R&D) – R&D expenses were $6.4 million and $17.9 million for the three and nine months ended September 30, 2025, respectively, up from $5.0 million and $12.6 million for the same periods in the prior year. The increase in both periods was due primarily to cost increases driven by the continued progress of the ReMEDy2 clinical trial, including its global expansion, progress with the Phase 2 IST in PE and the expansion of the clinical team during the current and prior year periods. These increases were partially offset by cost reductions related to manufacturing process development work performed and completed in the prior year period.
• General and Administrative (G&A) – G&A expenses were $2.6 million and $7.3 million for the three and nine months ended September 30, 2025, respectively, up from $1.9 million and $5.7 million for the three and nine months ended September 30, 2024, respectively. The increases in both periods resulted primarily from increased non-cash share-based compensation and increased personnel costs incurred in conjunction with expanding our team. Increases in investor relations, patent and professional fees also contributed to the increases in both periods.
• Net Loss – Net losses were $8.6 million and $24.0 million for the three and nine months ended September 30, 2025, respectively, up from $6.3 million and $16.5 million for the three and nine months ended September 30, 2024, respectively.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and third quarter 2025 financial results on Thursday, November 13, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica’s website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 20, 2025, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 9449322#.

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” or “will,” the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the Company’s expectations regarding the timing and nature of FDA meeting minutes, its application for an IND for the study of DM199 as a treatment for preeclampsia and fetal growth restriction and its conducting a Phase 2 trial in these indications; continued ReMEDy2 trial enrollment and timing of the interim analysis; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to; the risk that existing preclinical and clinical data from DM199 as a treatment for preeclampsia may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain an IND for the clinical study of DM199 for PE and fetal growth restriction and ultimately regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke, the timing of ReMEDy2 trial enrollment, regulatory applications and related filing and approval timelines; the expectation of steady or increased rates of enrollment in the ReMEDy2 trial will not continue to increase as anticipated; the possible occurrence of future adverse events associated with or unfavorable results from DiaMedica’s current trials and their potential to adversely effect current of future trials; the possibility of unfavorable results from DiaMedica’s ongoing or future clinical trials of DM199; and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the adaptive design of the ReMEDy2 trial and the possibility that the targeted enrollment and other aspects of the trial could change depending upon certain factors, including additional input from the FDA and the blinded interim analysis; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia and acute ischemic stroke and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including the most recent quarterly report on Form 10-Q for the quarterly period ended September 30, 2025. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Except as required by law, including the securities laws of the United States, we do not intend to update any forward-looking statements to conform these statements to actual results or to changes in our expectations.

Contacts

Contact:
Scott Kellen

Chief Financial Officer

Phone: (763) 496-5118

skellen@diamedica.com

For Investor Inquiries:
Mike Moyer

Managing Director, LifeSci Advisors, LLC

Phone: (617) 308-4306

mmoyer@lifesciadvisors.com

Media Contact:
Madelin Hawtin

LifeSci Communications

mhawtin@lifescicomms.com

HealthWarehouse.com Reports Results for Third Quarter 2025




HealthWarehouse.com Reports Results for Third Quarter 2025

Reports 7% decline in sales due to slowing DTC sales and shifts in GLP-1 market

CINCINNATI–(BUSINESS WIRE)–HealthWarehouse.com, Inc. (OTCQB:HEWA) announced today that its net sales for the third quarter ended September 30, 2025, totaled $8.4 million, a 7% decrease from the quarter ended September 30, 2024. The Company reported a net loss of $72,000 and Adjusted EBITDA of $343,000 for the quarter. Year to date, the Company reported sales of $39.1 million, a 97% increase over the prior year, net income of $334,000 and Adjusted EBITDA of $1.4 million.

HealthWarehouse.com, a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (NABP). HealthWarehouse.com provides a platform focused on increasing access to and reducing costs of healthcare products for consumers and business partners nationwide.

Joseph Peters, President and CEO, commented, “As anticipated, our sales growth for the quarter slowed as our sales of compounded versions of certain GLP-1 prescription medications declined. The FDA had temporarily approved sales of compounded GLP-1s during market shortages of branded versions. Despite the slowing of growth, we generated positive cash flow and we built up our cash balances during the quarter, proving the economic scalability of our business model. Additionally, we are optimistic about new product launches that will allow us to continue to serve longstanding partners. These products diversify our catalog following the removal of certain medications from the shortage list.”

HealthWarehouse.com continues to invest in proprietary technology to remain at the forefront of new developments and offerings in the world of healthcare, focusing on patient experience, operational efficiency, and scalability.

“We remain optimistic about our future as our partners have diversified their offerings and we have a strong pipeline of new opportunities for our partner service business. In addition, we are well equipped to help manufacturers launch direct-to-patient programs and are eager to develop new opportunities in that market,” added Peters. “We have established ourselves as a reliable service provider for high volume partners and we have shown our expertise in processing orders that require cold-chain shipping services. I appreciate the effort put forth by our team of dedicated employees, as they continue to provide world class service to our customers.”

Overview of Results for Three and Nine Months Ended September 30, 2025

Net Sales: Total net sales for the three and nine months ended September 30, 2025, were $8.4 million and $39.1 million, respectively, a decrease of $612,000 (6.8%) for the three-month period and an increase of $19.2 million (96.6%) for the nine-month period versus the same periods in 2024.

Prescription sales were $7.7 million and $37.1 million for the three and nine months ended September 30, 2025, respectively, a decrease of $655,000 (7.9%) and an increase of $19.2 million (107.0%), respectively, compared with the same periods in 2024. The decrease in sales for the three-month period was due to a $531,000 decline in direct-to-consumer prescription business and a $28,000 decline in the partner services business. The increase in prescription sales for the nine-month period was due to growth in partner services revenue of $21.4 million, offset by a $2.2 million decline in the direct-to-consumer prescription business.

Sales of over-the-counter products were $689,000 and $1.8 million for the three and nine months ended September 30, 2025, respectively, an increase of $67,000 (10.8%) and $74,000 (4.2%), respectively, over the same periods in 2024, primarily due to increases in marketplace sales.

Gross Profit: Gross profit for the three and nine months ended September 30, 2025, was $3.6 million and $13.3 million, respectively, representing a decrease of $194,000 for the three-month period and an increase of $3.6 million for the nine-month period compared with the same periods in 2024. The decrease in the three-month period was the result of lower sales offset by improved gross margin. The increase in the nine-month period was the result of higher sales offset by lower margins on our partner services prescription business. Gross margin percentages were 42.8% and 34.0% for the three and nine months ended September 30, 2025, respectively, which were 0.8 percentage point higher and 14.9 percentage points lower, respectively, versus prior-year periods. The reduction was primarily due to lower margins in the Partner Services prescription businesses.

Operating Expenses: Selling, general and administrative expenses were $3.6 million and $12.8 million for the three and nine months ended September 30, 2025, respectively, which were increases of $5,000 (0.1%) and $2.8 million (27.6%), respectively, compared to the same periods in 2024. Expenses for the three-month period included increases in legal, rent, advertising, software and engineering, and salaries expenses, offset by decreases in shipping and shipping supplies, and credit card expenses. Expense increases for the nine-month period included increases in shipping and shipping supplies, salaries primarily related to higher direct pharmacy labor, legal, advertising and rent, which were offset by decreases in credit card fees and employee benefits expenses.

Net Income (Loss) and Adjusted EBITDA: The Company reported net loss of $72,000 and net income of $334,000 for the three and nine months ended September 30, 2025, respectively, compared with net income of $74,000 and net loss of $522,000, respectively, for the same periods in 2024.

Earnings before interest, taxes, depreciation and amortization (“EBITDA”), as adjusted for stock-based compensation and certain non-recurring charges (“Adjusted EBITDA”), were $343,000 for the three months and $1.4 million for the nine months ended September 30, 2025. That compares with Adjusted EBITDA of $405,000 and $495,000, respectively, for the three and nine months ended September 30, 2024. EBITDA and Adjusted EBITDA are non-GAAP financial measures. Definitions of these non-GAAP terms and a reconciliation to GAAP measures are provided below.

Use of Non-GAAP Financial Measures

HealthWarehouse.com, Inc. (the “Company”) prepares its consolidated financial statements in accordance with the United States generally accepted accounting principles (“GAAP”). In addition to disclosing financial results prepared in accordance with GAAP, the Company discloses information regarding EBITDA and Adjusted EBITDA, which are commonly used. In addition to adjusting net income or net loss to exclude interest, taxes, depreciation and amortization, including amortization of right of use lease asset, (“EBITDA”), Adjusted EBITDA also excludes stock-based compensation, and certain nonrecurring charges. EBITDA and Adjusted EBITDA are not measures of performance defined in accordance with GAAP. However, Adjusted EBITDA is used internally in planning and evaluating the Company`s performance. Accordingly, management believes that disclosure of this metric offers lenders and other shareholders an additional view of the Company`s operations that, when coupled with GAAP results, provides a more complete understanding of the Company’s financial results.

Adjusted EBITDA should not be considered as an alternative to net income, net loss or to net cash provided by or used in operating activities as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the Company`s performance.

Reconciliation of Net Loss (GAAP) to Adjusted EBITDA (Non-GAAP)

About HealthWarehouse.com

HealthWarehouse.com, Inc. (OTCQB: HEWA), a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (“NABP”). HealthWarehouse.com provides a platform focused on increasing access and reducing costs of healthcare products for consumers and business partners nationwide. Based in Florence, Kentucky, the Company operates America’s Leading Online Pharmacy and is a pioneer in affordable healthcare. As one of the first National Association of Boards of Pharmacy Approved Digital Pharmacies, HealthWarehouse.com services the mission of providing affordable healthcare and incredible patient services to help Americans. Learn more at www.HealthWarehouse.com

Forward-Looking Statements

This announcement and the information incorporated by reference herein contain “forward-looking statements” as defined in federal securities laws, including but not limited to Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which statements are based on our current expectations, estimates, forecasts and projections. Statements that are not historical facts, including statements about the beliefs, expectations and future plans and strategies of the Company, are forward-looking statements. Actual results may differ materially from those expressed in forward looking statements or in management’s expectations. Important factors which could cause or contribute to actual results being materially and adversely different from those described or implied by forward looking statements include, among others, risks related to competition, management of growth, access to sufficient capital to fund our business and our growth, new products, services and technologies, potential fluctuations in operating results, international expansion, outcomes of legal proceedings and claims, fulfillment center optimization, seasonality, commercial agreements, acquisitions and strategic transactions, foreign exchange rates, system interruption, cyber-attacks, access to sufficient inventory, government regulation and taxation and fraud. More information about factors that potentially could affect HealthWarehouse.com’s financial results is included in HealthWarehouse.com’s audited Annual Reports and Quarterly Reports available at otcmarkets.com and prior filings with the Securities and Exchange Commission.

Contacts

Dan Seliga, Chief Financial Officer, (800) 748-7001

Shift Bioscience Publishes Improved Metric Calibration Framework for Robust Genetic Perturbation Modeling Using AI Virtual Cells




Shift Bioscience Publishes Improved Metric Calibration Framework for Robust Genetic Perturbation Modeling Using AI Virtual Cells

• AI virtual cells outperform key baselines on well-calibrated metrics, challenging prior reports of poor model performance
• Foundational research reinforces the use of virtual cell models to accelerate target identification pipelines

CAMBRIDGE, England–(BUSINESS WIRE)–Shift Bioscience (Shift), a biotechnology company uncovering the biology of cell rejuvenation to end the morbidity and mortality of aging, today announced the release of new research detailing an improved framework for evaluating benchmark metric calibration in virtual cell models¹. Using well-calibrated metrics, the study demonstrates that virtual cell models consistently outperform key baselines, providing valuable and actionable biological insights to accelerate target identification pipelines.

Genetic perturbation response models are a subset of AI virtual cells used to predict how cells will respond to various genetic alterations, including up- and down-regulation of genes. These models are a valuable tool to augment target identification pipelines, providing a rapidly scalable, in silico solution to identify promising genetic targets without the time and resource requirements of wet lab experiments. However, recently published papers have questioned the utility of these models to correctly identify gene targets, noting concerns that virtual cell models fail to outperform simple, uninformative baselines in some experiments.

In this latest study from Shift Bioscience, the team demonstrated that incidents of poor model performance largely reflect metric miscalibration, with commonly-used metrics routinely failing to distinguish robust predictions from uninformative ones, particularly in datasets with weaker perturbations. Building on this finding, the team developed an improved framework for metric calibration. Using 14 perturb-seq datasets, the team identified several rank-based and DEG (Differentially Expressed Gene)-aware metrics that are well-calibrated across datasets.

Virtual cell models evaluated using these well-calibrated metrics were able to consistently outperform uninformative mean, control and linear baselines, providing clear evidence that virtual cell models can distinguish biologically significant signals when appropriate calibration is applied. These results challenge prior reports that genetic perturbation models do not work, and suggest that AI Virtual Cells can be effectively applied for target discovery.

Henry Miller, Ph.D., Head of Machine Learning, Shift Bioscience, commented: “This latest research from our talented team provides clear evidence that the reports of poor performance in AI virtual cells is largely due to limitations of metrics, not due to issues with the models. We showed that when models are evaluated on well-calibrated metrics, they perform quite well and consistently outperform key baselines. We believe that this work opens the door to more widespread use of virtual cells and reinforces our confidence in the virtual cell models that are helping to drive our target identification program for cell rejuvenation.”

1. Deep Learning-Based Genetic Perturbation Models Do Outperform Uninformative Baselines on Well-Calibrated Metrics

Contacts

Jake Brown

jake.brown@zymecommunications.com

Qorium Secures €22m Investment to Accelerate Cultivated Leather Commercialisation




Qorium Secures €22m Investment to Accelerate Cultivated Leather Commercialisation

Invest-NL, LIOF and several private investors join Brightlands Venture Partners and Sofinnova Partners in supporting the Dutch biotech firm’s growth

MAASTRICHT, Netherlands–(BUSINESS WIRE)–Qorium, the Dutch biotechnology company pioneering cultivated leather, today announced it has secured a €22 million investment from Invest-NL and LIOF alongside existing investors Brightlands Venture Partners and Sofinnova Partners. An influential group of high net worth individuals have also participated in the round while the Invest-NL investment is made under the InvestEU guarantee scheme of the European Commission.

The cultivated leather market is projected to grow rapidly as demand increases for consistent and high-quality real leather. Qorium’s technology produces beautiful, uniform real leather from a few animal cells, eliminating the need for livestock farming while improving final leather products, reducing production waste and significantly reducing the environmental impact vs. animal-derived leather.

This latest round builds on €8 million in seed funding and marks another important milestone in Qorium’s journey from scientific breakthrough to commercial reality. The company is successfully producing sustainable real leather, is installing new bioreactor systems at its Maastricht facilities, and has established several commercial partnerships. With this Series A investment, Qorium is poised to scale production.

“This investment is a powerful vote of confidence in our mission to transform the leather industry,” says Qorium CEO Michael Newton. “By combining cutting-edge science with deep leather expertise and sustainable practices, we are creating real leather that offers better performance than traditional animal-derived leather, without the environmental and ethical costs. With Invest-NL, LIOF, and others now on board, we can take the next steps towards reinventing real leather and bring it to market at scale.”

“At Invest-NL, we invest in technologies that drive systemic change. Qorium’s leather is a breakthrough innovation that can transform one of the world’s most polluting industries,” says Lisette Kersting-van der Boog from Invest-NL. “By producing real leather without livestock, Qorium shows how biotechnology can build a more sustainable materials system. We are proud to support this Dutch frontrunner in scaling their impact.”

Guillaume Baxter, Partner at Sofinnova Partners, echoes the sentiment: “We’ve been on this journey with Qorium from the start, backing both the science of Dr. Mark Post and the deep leather experience of Rutger Ploem. This investment reflects Qorium’s impressive progress to date and our strong belief in the economic and sustainability potential of its leather. We are confident that this momentum will only continue.”

This latest round of funding strengthens Qorium’s position as a frontrunner in the global shift towards sustainable materials and underscores growing investor confidence in the field of cultivated leather. Qorium will appoint a new director to its board in the coming weeks.

To learn more about Qorium, visit qorium.com

Contacts

For media enquiries:
Sarah Taylor

Sarah@stbailey.com