Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update




Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update

• Significant achievements in 2025, enabling multiple near-term clinical milestones across late-stage portfolio, starting with the forthcoming topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026
• Key expansion in neuro-ophthalmology with Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER registrational program in optic neuropathies with a potential U.S. market opportunity of over $7 billion
• Cash, cash equivalents, and short-term investments of $268.7 million as of December 31, 2025, providing cash runway into 2029

ZUG, Switzerland, March 3, 2026 — Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the fourth quarter and full year ended December 31, 2025, and provided an overview of the Company’s progress.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “Oculis has delivered a transformative 2025, marked by significant clinical progress across our late-stage portfolio and a strategic expansion into neuro-ophthalmology. The compelling Phase 2 ACUITY results for Privosegtor in optic neuritis led to a pivotal FDA Breakthrough Therapy designation and anchored the launch of our global PIONEER registrational program. We believe Privosegtor holds immense potential as a first-in-class neuroprotective platform for a range of neuro-axonal diseases. 2026 is positioned to be a landmark year for the company with a roadmap featuring three major expected registrational milestones: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01, a potential first-in-class eye drop in DME, anticipated in Q2, the PREDICT-1 trial results for Licaminlimab with a precision medicine approach in dry eye disease planned in Q4, and the commencement of three registrational trials with Privosegtor as part of the PIONEER program. The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, with the aim of redefining the standard of care in ophthalmology and neuro-ophthalmology.”

Recent Clinical Highlights and Upcoming Milestones:

Privosegtor:

• Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON), a sight-threatening neuro-ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. Designation is supported by the Phase 2 ACUITY trial results, in which Privosegtor + steroid showed substantial improvements in vision and consistent anatomical and biological neuroprotective benefits compared with placebo + steroid. These novel findings reinforced Privosegtor’s potential as a neuroprotective treatment across both neuro-ophthalmic and neurological diseases.
• Following a successful meeting with the FDA in the fall of 2025, Oculis launched the PIONEER program, which includes three pivotal trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION). These two optic neuropathies represent a market opportunity estimated at $7+ billion in the U.S. alone. The first registrational trial in the program, PIONEER-1 in ON, was initiated in Q4 of 2025, with clinical sites activation progressing as planned.

OCS-01:

• Both Phase 3 DIAMOND trials with OCS-01, which aims to be the first eye drop therapy for DME, have enrolled over 800 patients and are nearing completion. Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission to the FDA is planned for Q4 2026.  
• While the U.S. DME market is currently valued at approximately $3 billion, only a fraction of the 1.8 million people diagnosed^1,2,3 with the disease are successfully managed. This leaves a staggering 1.3 million patients underserved by the current standard of care^1,2,3. OCS-01 is intended to be strategically positioned to capture this ‘lost’ majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections.

Licaminlimab:

• Oculis recently initiated the first genotype-based registrational trial, PREDICT-1, to drive precision medicine in dry eye disease (DED) with Licaminlimab. In prior Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from five-fold greater in signs and seven-fold greater in symptoms. Topline results from PREDICT-1 are expected in Q4 2026.
• In the U.S. approximately 10 million patients suffer from moderate to severe DED. Current disease management relies on trial and error, and only 13% of patients experience sustained relief, leading to high discontinuation rates within the first six months, underscoring the strong need for a targeted, effective treatment approach. Licaminlimab has the potential to transform the current treatment paradigm by providing a precision medicine approach with efficacy, rapid onset of action, and a comfort level similar to artificial tears.

Q4 and Full Year 2025 Financial Highlights:

As of December 31, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 213.0 million or $268.7 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash, cash equivalents and short-term investments was primarily due to equity financings closed in February and November 2025 for aggregate gross proceeds of $210.0 million (CHF 178.9 million). Research and development expenses were CHF 13.3 million or $16.6 million for the three months ended December 31, 2025, compared to CHF 11.8 million or $13.4 million in the same period in 2024. The increase was primarily due to advancements in clinical development activities of our late-stage portfolio and associated personnel expenses. General and administrative expenses were CHF 7.8 million or $9.7 million for the three months ended December 31, 2025, compared to CHF 5.5 million or $6.3 million in the same period in 2024. The increase was primarily driven by personnel expenses and external professional services costs. Year-to-date net loss was CHF 99.0 million or $119.1 million for the year ended December 31, 2025, compared to CHF 85.8 million or $97.4 million for the same period in 2024. The increase was primarily due to an increase in operating expenses driven by the OCS-01 Phase 3 DIAMOND trials, increased personnel costs and a CHF 7.4 million or $8.9 million increase in foreign exchange revaluation loss, offset by a CHF 3.2 million or $3.9 million decrease in the non-cash fair value adjustment on warrant liabilities resulting from warrant exercises during the year offset by increases in the fair value of outstanding warrants.

Upcoming Events:

Medical Conferences and Industry Events

• COPHy Annual Congress, Mar. 20-21, Krakow, Poland
• NANOS Annual Meeting, Mar. 20-24, Boston, MA, U.S.
• AAN Annual Meeting, Apr. 18-21, Chicago, IL, U.S.
• Eyecelerator, May 1, Denver, CO, U.S.
• ARVO, May 3-7, Denver, CO, U.S.

Investor Conferences

• Leerink Partners Global Healthcare Conference, Mar. 8-11, Miami, FL, U.S.
• Leerink Partners Mountain Meeting, Mar. 22-25, Jackson Hole, WY, U.S.
• Needham Healthcare Conference, Apr. 13-16, Virtual
• Van Lanschot Kempen Life Sciences Conference, Apr. 15-16, Amsterdam, Netherlands

Consolidated Statements of Financial Position (Unaudited)

Consolidated Statements of Loss (Unaudited)

– ENDS-

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

1. Decision Resources Group: DME – DR Landscape Forecast – Disease Landscape Forecast 2020
2. Iris Registry – Baseline characteristics and demographics of treatment naïve patients at diagnosis (Table S1)
3. Gonzalez 2016 Early and Long-term Responses to VEGF Therapy in DME: Analysis of protocol I data

Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update




Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update

ZUG, Switzerland, March 03, 2026 (GLOBE NEWSWIRE) —

• Significant achievements in 2025, enabling multiple near-term clinical milestones across late-stage portfolio, starting with the forthcoming topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026 
• Key expansion in neuro-ophthalmology with Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER registrational program in optic neuropathies with a potential U.S. market opportunity of over $7 billion
• Cash, cash equivalents, and short-term investments of $268.7 million as of December 31, 2025, providing cash runway into 2029

Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the fourth quarter and full year ended December 31, 2025, and provided an overview of the Company’s progress.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “Oculis has delivered a transformative 2025, marked by significant clinical progress across our late-stage portfolio and a strategic expansion into neuro-ophthalmology. The compelling Phase 2 ACUITY results for Privosegtor in optic neuritis led to a pivotal FDA Breakthrough Therapy designation and anchored the launch of our global PIONEER registrational program. We believe Privosegtor holds immense potential as a first-in-class neuroprotective platform for a range of neuro-axonal diseases. 2026 is positioned to be a landmark year for the company with a roadmap featuring three major expected registrational milestones: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01, a potential first-in-class eye drop in DME, anticipated in Q2, the PREDICT-1 trial results for Licaminlimab with a precision medicine approach in dry eye disease planned in Q4, and the commencement of three registrational trials with Privosegtor as part of the PIONEER program. The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, with the aim of redefining the standard of care in ophthalmology and neuro-ophthalmology.”

Recent Clinical Highlights and Upcoming Milestones:

Privosegtor:

• Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON), a sight-threatening neuro-ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. Designation is supported by the Phase 2 ACUITY trial results, in which Privosegtor + steroid showed substantial improvements in vision and consistent anatomical and biological neuroprotective benefits compared with placebo + steroid. These novel findings reinforced Privosegtor’s potential as a neuroprotective treatment across both neuro-ophthalmic and neurological diseases.
• Following a successful meeting with the FDA in the fall of 2025, Oculis launched the PIONEER program, which includes three pivotal trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION). These two optic neuropathies represent a market opportunity estimated at $7+ billion in the U.S. alone. The first registrational trial in the program, PIONEER-1 in ON, was initiated in Q4 of 2025, with clinical sites activation progressing as planned.

OCS-01:

• Both Phase 3 DIAMOND trials with OCS-01, which aims to be the first eye drop therapy for DME, have enrolled over 800 patients and are nearing completion. Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission to the FDA is planned for Q4 2026.  
• While the U.S. DME market is currently valued at approximately $3 billion, only a fraction of the 1.8 million people diagnosed^1,2,3 with the disease are successfully managed. This leaves a staggering 1.3 million patients underserved by the current standard of care^1,2,3. OCS-01 is intended to be strategically positioned to capture this ‘lost’ majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections.

Licaminlimab:

• Oculis recently initiated the first genotype-based registrational trial, PREDICT-1, to drive precision medicine in dry eye disease (DED) with Licaminlimab. In prior Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from five-fold greater in signs and seven-fold greater in symptoms. Topline results from PREDICT-1 are expected in Q4 2026.
• In the U.S. approximately 10 million patients suffer from moderate to severe DED. Current disease management relies on trial and error, and only 13% of patients experience sustained relief, leading to high discontinuation rates within the first six months, underscoring the strong need for a targeted, effective treatment approach. Licaminlimab has the potential to transform the current treatment paradigm by providing a precision medicine approach with efficacy, rapid onset of action, and a comfort level similar to artificial tears.

Q4 and Full Year 2025 Financial Highlights:

As of December 31, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 213.0 million or $268.7 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash, cash equivalents and short-term investments was primarily due to equity financings closed in February and November 2025 for aggregate gross proceeds of $210.0 million (CHF 178.9 million). Research and development expenses were CHF 13.3 million or $16.6 million for the three months ended December 31, 2025, compared to CHF 11.8 million or $13.4 million in the same period in 2024. The increase was primarily due to advancements in clinical development activities of our late-stage portfolio and associated personnel expenses. General and administrative expenses were CHF 7.8 million or $9.7 million for the three months ended December 31, 2025, compared to CHF 5.5 million or $6.3 million in the same period in 2024. The increase was primarily driven by personnel expenses and external professional services costs. Year-to-date net loss was CHF 99.0 million or $119.1 million for the year ended December 31, 2025, compared to CHF 85.8 million or $97.4 million for the same period in 2024. The increase was primarily due to an increase in operating expenses driven by the OCS-01 Phase 3 DIAMOND trials, increased personnel costs and a CHF 7.4 million or $8.9 million increase in foreign exchange revaluation loss, offset by a CHF 3.2 million or $3.9 million decrease in the non-cash fair value adjustment on warrant liabilities resulting from warrant exercises during the year offset by increases in the fair value of outstanding warrants.

Issuance of New Treasury Shares

The Company has today issued 2,000,000 registered ordinary shares (nominal value CHF 0.01 per share) out of its existing capital band (Kapitalband), recorded as treasury shares (the “New Shares”), to enable future sales, if any, under the existing sales agreement with Leerink Partners LLC relating to the Company’s at-the-market (“ATM”) offering program. The total number of registered shares issued by the Company as per its Articles of Association is now 59,169,475. The New Shares have not been sold under the ATM offering program and will be held in reserve as treasury shares. For more details on the ATM offering program, please refer to the Company’s previous press release dated May 17, 2024, and to the Company’s SEC filings.

Upcoming Events:

Medical Conferences and Industry Events

• COPHy Annual Congress, Mar. 20-21, Krakow, Poland
• NANOS Annual Meeting, Mar. 20-24, Boston, MA, U.S.
• AAN Annual Meeting, Apr. 18-21, Chicago, IL, U.S.
• Eyecelerator, May 1, Denver, CO, U.S.
• ARVO, May 3-7, Denver, CO, U.S.

Investor Conferences

• Leerink Partners Global Healthcare Conference, Mar. 8-11, Miami, FL, U.S.
• Leerink Partners Mountain Meeting, Mar. 22-25, Jackson Hole, WY, U.S.
• Needham Healthcare Conference, Apr. 13-16, Virtual
• Van Lanschot Kempen Life Sciences Conference, Apr. 15-16, Amsterdam, Netherlands

Consolidated Statements of Financial Position (Unaudited)

Consolidated Statements of Loss (Unaudited)

– ENDS-

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

1. Decision Resources Group: DME – DR Landscape Forecast – Disease Landscape Forecast 2020
2. Iris Registry – Baseline characteristics and demographics of treatment naïve patients at diagnosis (Table S1)
3. Gonzalez 2016 Early and Long-term Responses to VEGF Therapy in DME: Analysis of protocol I data

Sana Biotechnology Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates




Sana Biotechnology Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates

Shared 12-month clinical results of ongoing UP421 type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression are safe and well-tolerated, evade detection by the immune system, and continue to function one year post-transplant

New England Journal of Medicine published positive 12-week clinical results of the UP421 type 1 diabetes study

Incorporating the tested hypoimmune technology to develop SC451, a hypoimmune-modified, stem cell-derived therapy, as a one-time treatment for patients with type 1 diabetes, with a goal of normal blood glucose, with no insulin and no immunosuppression

Made significant progress with SC451 across manufacturing, regulatory, and clinical trial preparedness, including the non-clinical testing plan and manufacture of the master cell bank

Expect to file investigational new drug application (IND) for SC451 in type 1 diabetes and begin Phase 1 trial as early as this year

Expect to generate first-in-human data in blood cancers as early as this year for the next-generation in vivo CAR T product candidate, SG293, a CD8-targeted fusosome that delivers a CD19-directed CAR

Demonstrated deep B-cell depletion and immune reset with a single treatment in non-human primates with surrogate SG293

Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at the market offering facility (ATM) and equity financing in 2025

Q4 2025 cash position of $138.4 million and expected cash runway into late 2026

SEATTLE, March 03, 2026 (GLOBE NEWSWIRE) — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2025.

“Meaningful scientific and operational progress in 2025 has positioned us well to generate human proof-of-concept data over the next 12-18 months for SC451 in type 1 diabetes and SG293 in blood cancers,” said Steve Harr, Sana’s President and Chief Executive Officer. “Clinical data for UP421, a study which is now out beyond a year, provide the first known example of transplanting an allogeneic cell therapy for the treatment of type 1 diabetes without any immunosuppression. These results, when combined with progress in the field of transplanting pancreatic islets, make us optimistic that SC451, which incorporates the same hypoimmune gene edits into a more scalable manufacturing platform, can lead to a functional cure for people with type 1 diabetes, meaning normal blood glucose, no more insulin injections, and no immunosuppression. Moving to the fusogen platform, we made improvements to our in vivo CAR T platform with our next‑generation SG293 candidate, offering the potential for a simple, one-time, off-the-shelf treatment without the use of conditioning chemotherapy for the treatment of B cell cancers and B cell-mediated autoimmune diseases. We look forward to beginning clinical trials for both of these therapies this year. With two powerful platforms advancing in parallel, we look to drive meaningful clinical benefit for patients.”

Corporate Highlights

Published positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.

• UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) was to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. 
• Results of the study through one year after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with mixed meal tolerance tests performed over the course of the study, consistent with insulin secretion in response to a meal. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection.
• The New England Journal of Medicine (NEJM) published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression” (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. NEJM also published an accompanying editorial that further describes both the Sana technology and progress in the field (DOI: 10.1056/NEJMe2507578).

Advancing our focused pipeline across two platforms:

• Hypoimmune Platform – Type 1 diabetes – Sana continues development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, which uses the same HIP technology as UP421. Sana has had multiple interactions with regulators over the last year, including FDA INTERACT and Pre-IND meetings, the results of which increase confidence in its manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan. Sana expects to file an IND and begin a Phase 1 clinical trial for SC451 as early as this year.
• Fusogen Platform – In vivo CAR T cells – Sana continues to develop its next-generation in vivo CAR T product candidate, SG293, which uses Sana’s proprietary fusogen delivery-based technology. SG293 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver. Preclinical data demonstrate that a SG293 surrogate achieves cell-specific delivery and deep B-cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana intends to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases and expects to generate first-in-human data as early as this year.

Published preclinical data in Nature Biotechnology demonstrating potent in vivo gene editing of hematopoietic stem cells (HSCs) in the bone marrow with systemic delivery in preclinical murine models using fusogen technology:

• The article describes a study that evaluated a systemically delivered virus-like particle (VLP) using the fusogen technology to target and gene edit HSCs in vivo. Results show potent and cell-specific in vivo delivery and gene editing of HSCs in the bone marrow in several murine models, with stable gene editing of long-term HSCs.
• This broadens the application of fusogen technology beyond T cells to a second cell type, HSCs, and underscores the ability to deliver diverse payloads, including CRISPR gene-editing and base-editing machinery.

Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in 2025; expected cash runway into late 2026.

• Closed public offering in August 2025 of 24.3 million shares of Sana’s common stock, including 3.4 million shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, and pre-funded warrants to purchase 1.5 million shares of Sana’s common stock. The gross proceeds from this offering were $86.3 million before deducting underwriting discounts and commissions and offering expenses.
• Raised gross proceeds of $47.4 million in 2025 from sales of common stock through Sana’s ATM.

Strengthened leadership with the appointment of new Chief Financial Officer

• In the first quarter of 2026, appointed Brian Piper as Executive Vice President, Chief Financial Officer. Mr. Piper has decades of experience in financial management within the biotechnology sector – including CFO roles at Scorpion Therapeutics, Antares Therapeutics, and Prelude Therapeutics – and has successfully led financings and worked with companies to maximize their assets.

Fourth Quarter 2025 Financial Results

GAAP Results

• Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2025 were $138.4 million compared to $152.5 million as of December 31, 2024. The decrease of $14.1 million was primarily driven by cash used in operations of $143.8 million, partially offset by net proceeds from equity financings of $126.4 million, proceeds from stock option exercises and Sana’s employee stock purchase plan of $2.7 million, and other cash inflows.
• Research and Development Expenses: For the three and twelve months ended December 31, 2025, research and development expenses, inclusive of non-cash expenses, were $34.9 million and $132.0 million, respectively, compared to $45.1 million and $215.7 million for the same periods in 2024. The decreases of $10.2 million and $83.7 million for the three and twelve months ended December 31, 2025 compared to the same periods in 2024, respectively, were primarily due to the portfolio prioritization announced in the fourth quarter of 2024, which resulted in a reduction of the scope of research, laboratory, and clinical development activities, lower personnel-related costs, including non-cash stock-based compensation, and a decrease in facility and other allocated costs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $15.2 million, respectively, for the three and twelve months ended December 31, 2025, and $3.9 million and $23.4 million for the same periods in 2024.
• Research and Development Related Success Payments and Contingent Consideration: For the three and twelve months ended December 31, 2025, Sana recognized non-cash expenses of $14.1 million and $29.4 million, respectively, compared to non-cash gains of $13.4 million and $8.9 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price.
• General and Administrative Expenses: General and administrative expenses for the three and twelve months ended December 31, 2025, inclusive of non-cash expenses, were $12.2 million and $44.3 million, respectively, compared to $17.3 million and $64.0 million for the same periods in 2024. The decrease of $5.1 million for the three months ended December 31, 2025 compared to the same period in 2024 was primarily due to personnel-related costs incurred in connection with the portfolio prioritization announced in the fourth quarter of 2024. The decrease of $19.7 million for the twelve months ended December 31, 2025 compared to the same period in 2024 was primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $3.2 million and $10.3 million for the three and twelve months ended December 31, 2025, respectively, compared to $2.5 million and $14.3 million for the same periods in 2024.
• Impairment of Long-Lived Assets: For the twelve months ended December 31, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to $1.9 million for the same period in 2024. The non-cash impairment of $44.6 million recorded in the second quarter of 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding its near-term manufacturing needs, Sana expects to use CDMOs to meet its manufacturing needs at present and has suspended further build-out of internal manufacturing capabilities. Impairment of long-lived assets in 2024 consists of non-cash losses recognized for the impairment of certain laboratory equipment and leasehold improvements as a result of the portfolio prioritization in the fourth quarter of 2024.
• Net Loss: Net loss for the three and twelve months ended December 31, 2025 was $58.8 million, or $0.21 per share, and $244.2 million, or $0.96 per share, respectively, compared to $49.1 million, or $0.21 per share, and $266.8 million, or $1.16 per share, for the same periods in 2024.

Non-GAAP Measures

• Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the twelve months ended December 31, 2025 was $138.5 million compared to $195.1 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to portfolio prioritizations, and the purchase of property and equipment.
• Non-GAAP General and Administrative Expenses: Non-GAAP general and administrative expenses for the three and twelve months ended December 31, 2025 were $12.2 million and $44.3 million, respectively, compared to $11.4 million and $58.2 million for the same periods in 2024. Non-GAAP general and administrative expense excludes personnel-related costs related to the portfolio prioritization in the fourth quarter of 2024.
• Non-GAAP Net Loss: Non-GAAP net loss for the three and twelve months ended December 31, 2025 was $44.7 million, or $0.16 per share, and $170.1 million, or $0.67 per share, respectively, compared to $54.8 million, or $0.23 per share, and $263.1 million, or $1.14 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025 and 2024.

A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

About Sana

Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of human data, and potential indications for and the potential impact and benefits of its platforms and product candidates; expectations with respect to the impact of regulatory interactions and the ability to move forward with the Company’s SC451 manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan; the potential ability for SG293 to be a simple, one-time, off-the-shelf treatment without the use of conditioning chemotherapy; expectations with respect to manufacturing and scalability of SC451 and the potential ability for SC451 in type 1 diabetes to be a single treatment that restores normal blood glucose without insulin or immunosuppression and lead to a functional cure for people with type 1 diabetes; expectations regarding the significance and impact of data from preclinical studies and clinical trials of the Company’s product candidates and technologies, including the potential breadth of application and ability of the fusogen technology to deliver diverse payloads, and an IST utilizing HIP-modified primary pancreatic islet cells; expectations regarding the Company’s cash runway; expectations regarding the use of CDMOs; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated March 3, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Investor Relations & Media:
Nicole Keith
investor.relations@sana.com
media@sana.com

Non-GAAP Financial Measures

To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense, non-GAAP general and administrative expense, and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provide investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies.

These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allow for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:

Fate Therapeutics to Participate in Leerink Partners 2026 Global Healthcare Conference




Fate Therapeutics to Participate in Leerink Partners 2026 Global Healthcare Conference

SAN DIEGO, March 03, 2026 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that management will participate in a fireside chat and host investor meetings at the Leerink Partners 2026 Global Healthcare Conference on Monday, March 9, 2026 in Miami, Florida.

Management will participate in a fireside chat at 9:20 AM ET on Monday, March 9. A live webcast of the fireside chat can be accessed under “Events & Presentations” in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company’s website following the event.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Contact:

Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com

LifeMD to Participate in Two Investor Conferences During March




LifeMD to Participate in Two Investor Conferences During March

NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services, today announced that management will be participating in the following investor conferences during the month of March:

• Mizuho Securities Healthcare Technology Conference 2026, March 5. Management will hold virtual one-on-one meetings with investors throughout the day.
• KeyBanc Capital Markets Healthcare Forum, March 17-18. Management will participate in a virtual fireside chat on Wednesday, March 18^th at 9:00 a.m. Eastern time and a virtual panel titled “The Outlook for the GLP-1 Market: New Injection Modalities vs. Orals” at 12:00 p.m. Eastern time. In addition, management will hold one-on-one virtual meetings.

About LifeMD, Inc.

LifeMD^® is a leading provider of virtual primary care. LifeMD offers telemedicine, access to laboratory and pharmacy services, and specialized treatment across more than 200 conditions, including primary care, men’s and women’s health, weight management, and hormone therapy. The Company leverages a vertically integrated, proprietary digital care platform, a 50-state affiliated medical group, a state-of-the-art affiliated pharmacy, and a U.S.-based patient care center to increase access to high-quality and affordable care. For more information, please visit LifeMD.com.

Investor Contact
Marc Benathen, Chief Financial Officer
marc@lifemd.com

Media Contact
Jessica Friedeman, Chief Marketing Officer
press@lifemd.com

Lexicon Pharmaceuticals to Participate in Three Upcoming March Investor Conferences




Lexicon Pharmaceuticals to Participate in Three Upcoming March Investor Conferences

THE WOODLANDS, Texas, March 03, 2026 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Company management will participate in an upcoming fireside chat at the 2026 Leerink Partners Global Healthcare Conference in Miami on Wednesday, March 11, at 10:00 a.m.

Lexicon will also be participating in 1×1 investor meetings at the 2026 Jefferies Biotech on the Beach Summit, March 10–11, and at the Barclays 28th Global Healthcare Conference, March 10-12.

A live recording and replay of the Leerink fireside chat can be accessed via the Events page of the Company’s website at https://investors.lexpharma.com/.

About Lexicon Pharmaceuticals     
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com.

For Investor and Media Inquiries: 
Lisa DeFrancesco  
Lexicon Pharmaceuticals, Inc. 
lexinvest@lexpharma.com 

Dianthus Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Dianthus Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW YORK and WALTHAM, Mass., March 03, 2026 (GLOBE NEWSWIRE) — Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced that it granted equity awards on March 2, 2026, to three newly-hired, non-executive employees. The inducement grants were approved by the Company’s independent Compensation Committee and were made as material inducements to acceptance of employment with Dianthus in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement grants consist of non-qualified stock options to purchase an aggregate of 26,000 shares of the Company’s common stock with a 10-year term and an exercise price of $55.26 per share. The options vest as to 25% on the first anniversary of the vesting commencement date and in equal monthly installments for the following 36 months. The inducement grants are subject to the terms and conditions of the Dianthus Therapeutics, Inc. Equity Inducement Plan, and the terms and conditions of a stock option agreement.

About Dianthus Therapeutics
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.

To learn more, please visit www.dianthustx.com and follow us on LinkedIn. 

Contact
Jennifer Davis Ruff
Dianthus Therapeutics
jdavisruff@dianthustx.com

Vaxart to Host Upcoming Conference Calls




Vaxart to Host Upcoming Conference Calls

Full year 2025 business update and financial results conference call to be held March 12 at 4:30 p.m. ET

Stockholder fireside chat to be held on March 13 at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., March 03, 2026 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT) today announced it will host two upcoming webcast conference calls.

Full Year 2025 Business Update and Financial Results
Vaxart will provide a business update and report financial results for the full year ended December 31, 2025, after the market close on Thursday, March 12, 2026. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET. / 1:30 p.m. PT.

The full year financial results conference call can be accessed using the following information:

Webcast: Click here
Date: Thursday, March 12, 2025 – 4:30 p.m. ET
Domestic: (877) 407-0895
International: (201) 689-8783
Conference ID: 13758532

Stockholder Fireside Chat
Members of Vaxart’s senior management team will participate in a virtual fireside chat on Friday, March 13, 2026 at 4:30 p.m. ET. / 1:30 p.m. PT as part of its regular series to answer frequently asked questions from its stockholders.

A live webcast of the fireside chat will be available on the Company’s website at www.vaxart.com or by clicking here.

Investors may submit written questions in advance of the conference call to ir@vaxart.com or through the webcast portal.

A replay of the full year financial results and stockholder fireside chat webcasts will be available on the Company’s website at www.vaxart.com following the conclusion of the events.

About Vaxart 
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Contact

Vaxart Media and Investor Relations:
FINN Partners
IR@vaxart.com
(646) 871-8481

TimelyCare Honored as Virtual Student Health and Wellness Services Company of the Year 2026 by Education Insider




TimelyCare Honored as Virtual Student Health and Wellness Services Company of the Year 2026 by Education Insider

Recognition Highlights Transformative Mental Health Outcomes and Student Retention

Fort Worth, TX, March 03, 2026 (GLOBE NEWSWIRE) — TimelyCare, education’s most trusted virtual health and well-being provider, has proudly been named Virtual Student Health and Wellness Services Company of the Year 2026 by Education Insider.

The recognition followed reader nominations and a multi-stage editorial review conducted by Education Insider’s editorial board and industry experts. TimelyCare was honored for delivering measurable mental health outcomes while strengthening institutional capacity and student success.

“We are glad to announce TimelyCare as the Virtual Student Health and Wellness Services Company of the Year 2026”, said Gabriel Hernandez, Managing Editor, Education Insider. “TimelyCare is a leading virtual health and well-being platform serving higher education and K12 communities nationwide. Delivering 24/7 mental health and medical support, it expands access to care, strengthens campus resources, and drives measurable outcomes that enhance student success and institutional resilience.”

TimelyCare’s model is built on a clear standard: care should lead to measurable improvement. Using clinically validated tools such as the General Anxiety Disorder(GAD-7) and Patient Health Questionnaire (PHQ-9) scales, TimelyCare tracks symptom reduction and remission among students receiving therapy. After three or more sessions, 76 percent of students achieve reliable improvement or remission from depression or anxiety.

The impact extends beyond clinical progress. Nearly eight in 10 students report they are more likely to remain enrolled, improve their grades and graduate after using TimelyCare. Partner institutions report retention rates that average 1.3 percentage points higher than those of comparable schools without the service.

“Every data point represents a student working to stay enrolled and move forward,” said Luke Hejl, co-founder and CEO of TimelyCare. “We measure symptom improvement and partner with institutions to understand how well-being influences persistence and completion. When students feel better, they engage more fully in campus life and stay on track toward graduation.”

TimelyCare expands campus capacity by providing 24/7 virtual mental health and medical care while maintaining institutional oversight and continuity with on-campus services. The company is the only virtual provider focused on student mental health to receive URAC Telehealth Accreditation, underscoring its commitment to clinical quality, governance and accountability.

As institutions prioritize both student well-being and enrollment stability, TimelyCare continues to scale its impact across educational eral communities nationwide.

About TimelyCare
TimelyCare is a clinically accountable virtual care provider built specifically for education. Trusted by nearly 500 campuses across the U.S., TimelyCare combines URAC-accredited clinical standards with a measurement-based approach and a partnership-first model to help institutions champion well-being with clarity, accountability, and real-world impact. Through a seamless, easy-to-access platform, TimelyCare offers a comprehensive range of services, including a crisis line, mental health counseling, on-demand emotional support, medical care, psychiatric care, health coaching, success coaching, basic needs assistance, faculty and staff guidance, peer support, and self-guided wellness tools. TimelyCare drives clinically validated improvements in depression and anxiety, supporting healthier learning environments.

Contact Info

Gina Katzmark
gina.katzmark@timelycare.com
+1 218-310-2259

Attachment

• TimelyCare

Testosterone Booster Supplement for Men Over 50 — TestoPrime Medically Accredited by Clinicians’ Choice in 2026




Testosterone Booster Supplement for Men Over 50 — TestoPrime Medically Accredited by Clinicians’ Choice in 2026

As of March 2026, TestoPrime is available in over 130 countries and holds the Clinicians’ Choice medical accreditation as natural testosterone supplement for men.

New York City, NY, March 03, 2026 (GLOBE NEWSWIRE) — TestoPrime Testostone Booster for Men Over 50 Facts

• Product: TestoPrime Natural Testosterone Booster
• Accreditation: Clinicians’ Choice — formally endorsed by qualified health professionals as of 2026
• Formula: 12 clinically studied ingredients at therapeutic doses, including D-Aspartic Acid (2,000 mg), KSM-66® Ashwagandha (668 mg), and Panax Ginseng (8,000 mg)
• Manufacturing: FDA-approved, GMP-certified, ISO-standard facilities — United States and United Kingdom
• Guarantee: Industry-leading lifetime money-back guarantee
• Availability: testoprime.com — ships to 130+ countries worldwide
• Spokesperson: Steve Niddich, Head of Product Innovation, TestoPrime

As men age past 50, maintaining healthy testosterone levels, lean muscle, and the kind of sustained mental sharpness that drives real quality of life becomes increasingly difficult. 

Testosterone production declines at a rate of roughly 1–2% per year beginning in a man’s 30s — and by the time 50 arrives, that compounding hormonal drop is impossible to ignore. Fatigue sets in earlier. 

Muscle becomes harder to build and easier to lose. The drive, confidence, and physical vitality that once felt effortless start slipping away quietly and persistently. That’s where a clinically supported, natural testosterone booster like TestoPrime can make a profound and lasting difference.

Why Testosterone Matters More After 50

Testosterone is the foundational male hormone governing far more than gym performance. It regulates energy metabolism, mood stability, body composition, bone density, cognitive function, sexual health, and cardiovascular resilience. When levels fall — and they inevitably do — the downstream effects touch every dimension of a man’s daily life.

Stubborn abdominal fat accumulates even when diet remains unchanged. Strength plateaus and then reverses. Brain fog replaces mental clarity. Emotional motivation flattens. The drive to compete, to perform, and to engage — both in and out of the bedroom — diminishes in ways that can feel deeply personal and disorienting.

The problem is compounded by the fact that most men don’t immediately recognize low testosterone as the underlying cause. They attribute the changes to stress, poor sleep, or simply “getting older” — and quietly accept a reduced quality of life rather than addressing the hormonal root cause directly.

“We created TestoPrime for the millions of men struggling with low endogenous androgen, especially those over 40 and 50,” said Steve Niddich, Head of Product Innovation at TestoPrime. “Our mission is to provide the best testosterone booster, backed by real science and premium natural ingredients, so men can feel strong, confident, and healthy — at any age.”

As of March 2026, TestoPrime has earned the prestigious Clinicians’ Choice designation — reviewed and formally endorsed by leading qualified health professionals as the most effective natural testosterone booster for mature men — reinforcing its position as a globally recognized market leader in the testosterone supplement category.

Key Benefits of TestoPrime Backed by Science

For men over 50, declining testosterone levels can show up across every area of physical and mental health. Supplementing intelligently — with the right clinically studied ingredients at therapeutic doses — can help reverse these effects naturally, without prescription medications, without injections, and without the risks associated with testosterone replacement therapy (TRT).

Key benefits backed by science include:

• Increased physical and mental energy on demand — even after long, demanding days at the office or on the job
• Support for protein synthesis to help burn unwanted body fat and build lean, visible muscle mass
• Improved mood, motivation, and confidence through restored hormonal balance
• Reduction of brain fog and enhancement of daily cognitive clarity
• Healthy libido support and sexual performance improvement driven by optimized hormone levels
• Cortisol management — since chronically elevated stress hormones actively and directly suppress testosterone production
• Cardiovascular and metabolic wellness, particularly relevant for men prioritizing long-term heart health after 50
• Zero need for prescriptions, doctor visits, hormone injections, or synthetic gels

TestoPrime: A Complete Formula Overview

Read more on Testoprime Testosterone Supplements

What separates TestoPrime from the overcrowded field of testosterone supplements is the depth, transparency, and clinical foundation of its 12-ingredient formula. Rather than relying on a single amino acid or a proprietary blend that obscures dosages, TestoPrime combines multiple clinically studied pathways for testosterone support — each ingredient chosen based on its proven, unique ability to support testosterone production without digestive complications or unwanted side effects.

D-Aspartic Acid (2,000 mg)

D-Aspartic Acid is the cornerstone of TestoPrime’s formula — and for good reason. This naturally occurring amino acid stimulates the release of luteinizing hormone (LH) from the pituitary gland, which in turn signals the testes to ramp up testosterone synthesis. Multiple peer-reviewed studies confirm that D-Aspartic Acid can increase testosterone levels by up to 42% within a matter of weeks — making it one of the most potent, well-validated natural testosterone precursors available today.

At 2,000 mg per serving, TestoPrime delivers D-Aspartic Acid at a dose aligned with the clinical research — not the underfilled, token doses common in lesser supplements.

KSM-66® Ashwagandha Extract (668 mg)

KSM-66® is widely regarded as the world’s most bioavailable and extensively studied form of ashwagandha root extract. Its role in testosterone support operates primarily through the cortisol-testosterone relationship — one of the most overlooked mechanisms in men’s hormonal health.

Cortisol and testosterone exist in a physiological tug-of-war. When cortisol remains chronically elevated — as it does under the persistent professional and personal pressures that define life after 50 — testosterone production is actively suppressed. KSM-66® directly addresses this by lowering cortisol levels, reducing perceived stress, and restoring the internal hormonal environment in which testosterone can thrive. Clinical studies have also linked ashwagandha supplementation with improvements in muscle strength, exercise recovery, and sexual health in men.

Panax Ginseng (8,000 mg)

Few botanicals carry the weight of clinical evidence that Panax Ginseng does — and fewer still are as well-suited to the specific challenges men face after 50. Panax Ginseng, sometimes called Korean Red Ginseng, has been studied extensively for its ability to support natural testosterone levels, improve physical stamina, and enhance sexual function.

At 8,000 mg, TestoPrime includes one of the most generous Panax Ginseng dosages available in any over-the-counter testosterone supplement — far exceeding what most competitors include. Users consistently report improved endurance, stronger workout performance, and noticeably enhanced libido when supplementing with therapeutic-dose ginseng over time.

Fenugreek Extract (800 mg)

Fenugreek has emerged as one of the most compelling natural testosterone support ingredients of the past decade. Its active compounds — particularly furostanolic saponins — are believed to work by inhibiting enzymes that convert testosterone into estrogen, helping men maintain higher circulating testosterone levels as they age.

Clinical data also supports fenugreek’s role in supporting libido, improving insulin sensitivity, and promoting a healthier body composition. For men over 50 who are concerned about estrogen conversion — a real and often underappreciated aspect of male hormonal aging — fenugreek’s inclusion at 800 mg represents a meaningful and targeted addition to the formula.

Vitamin D (8,000 IU)

The connection between vitamin D deficiency and low testosterone is now well established in the clinical literature. Research consistently shows that men with insufficient vitamin D levels carry measurably lower testosterone than men who are vitamin D sufficient — and that supplementation meaningfully supports testosterone restoration in deficient individuals.

The challenge is that vitamin D deficiency is extraordinarily common in men over 50, particularly those in northern climates or with predominantly indoor lifestyles. TestoPrime delivers 8,000 IU per serving — a clinically relevant dose designed to correct deficiency and sustain the optimal levels associated with healthy hormonal function and long-term wellbeing.

Zinc (40 mg)

Zinc is not optional for healthy testosterone production — it is essential. Clinical data confirms that zinc is necessary for androgen synthesis, and that even mild zinc deficiency can cause marked decreases in circulating testosterone levels. For men over 50, where both dietary zinc intake and absorption efficiency tend to decline with age, supplementing at an effective dose is a straightforward and scientifically supported strategy for protecting hormone levels.

At 40 mg per serving, TestoPrime provides zinc at a dose that meaningfully addresses the deficiency patterns commonly seen in mature men — without excess. It’s a simple ingredient, but an indispensable one.

Green Tea Extract (4,000 mg)

Green tea extract brings dual utility to the TestoPrime formula. Its potent antioxidant profile — driven primarily by catechins like EGCG — helps manage oxidative stress, which is directly linked to testosterone degradation at the cellular level. Beyond antioxidant support, green tea extract also assists with fat oxidation and metabolic rate, supporting the body composition goals that matter most to active men over 50.

Pomegranate Extract (360 mg, 40% Ellagic Acid)

Pomegranate Extract standardized to 40% ellagic acid is one of the formula’s most underappreciated contributors. Research has linked pomegranate consumption to improved testosterone levels, enhanced blood flow, and reduced markers of oxidative damage — all three of which are directly relevant to the daily challenges men over 50 face.

Enhanced circulation supports workout performance, recovery, and sexual health. Reduced oxidative stress supports healthy testosterone synthesis. And the anti-inflammatory properties of ellagic acid contribute to the kind of systemic cellular health that underpins long-term male vitality.

Vitamin B6 (5.6 mg) & Vitamin B12 (7.5 mcg)

B vitamins play a foundational role in cellular energy metabolism — the biochemical process through which every cell in the body generates usable energy. For men dealing with the fatigue and low drive commonly associated with declining testosterone, B6 and B12 provide meaningful support for the energy pathways that stimulant-free supplements need to activate.

Vitamin B6 also plays a specific role in hormonal regulation — supporting the synthesis and conversion of several key neurotransmitters and reducing the hormonal imbalances that can amplify the symptoms of low testosterone day to day.

Black Pepper Extract — BioPerine® (5 mg)

BioPerine® — a patented black pepper extract standardized to 95% piperine — is included in TestoPrime for one specific and clinically validated purpose: bioavailability enhancement. Piperine has been demonstrated in multiple studies to increase the absorption of co-supplemented nutrients by up to 30% — ensuring that the full therapeutic impact of every other ingredient in the formula is actually delivered at the cellular level where it counts.

It’s a small dose with a disproportionately large impact on overall formula efficacy.

Garlic Extract (1,200 mg)

Garlic extract rounds out the formula with a combination of direct hormonal and cardiovascular benefits that make it particularly well-suited to men over 50. Research links garlic’s active compound — allicin — with increased testosterone production and a measurable reduction in cortisol, reinforcing the formula’s broader cortisol-management strategy.

Garlic also brings meaningful cardiovascular support through its ability to promote healthy blood pressure and circulation — benefits that extend well beyond the gym and into the domain of long-term heart health that becomes increasingly central to men’s wellness priorities after 50.

What Makes TestoPrime Different

As of March 2026, TestoPrime has empowered hundreds of thousands of men globally — available in over 130 countries — to reclaim their strength, confidence, and vitality without testosterone replacement therapy, without steroids, and without a prescription. Here is what sets the formula apart from the competition:

Clinicians’ Choice Accreditation. TestoPrime has been formally reviewed and endorsed by leading qualified health professionals — earning the prestigious Clinicians’ Choice designation that validates its status as the most expert-recommended natural testosterone booster for men over 50 in 2026. This is a distinction very few supplements in the category can legitimately claim.

Transparent, Full-Dose Formula. Every ingredient in TestoPrime is disclosed at its exact clinical dose — no proprietary blend obscuring what you’re actually getting, and no underfilled inclusions designed to support label claims rather than real-world results. What you see on the label is precisely what you get.

Synergistic, Multi-Pathway Design. Rather than relying on a single ingredient, TestoPrime combines 12 clinically studied compounds — D-Aspartic Acid, KSM-66® Ashwagandha, Panax Ginseng, Fenugreek, Zinc, Vitamin D, and targeted botanical extracts — to simultaneously target multiple pathways of testosterone production, cortisol management, and cellular energy support. The result is a more comprehensive, more consistent lift in T-levels than any single-ingredient approach can deliver.

FDA-Approved, GMP-Certified Manufacturing. TestoPrime is manufactured in FDA-approved, GMP-certified, ISO-standard facilities in both the United States and the United Kingdom — a dual-market quality standard that very few competitors can match. Every batch undergoes third-party lab testing for purity, potency, and safety before reaching consumers.

Clean Label Commitment. TestoPrime is entirely free from nuts, soy, dairy, grain, gluten, fillers, artificial additives, and synthetic dyes. The formula is vegan-friendly and non-GMO — designed to be clean, accessible, and suitable for a wide range of dietary preferences and lifestyles.

Designed for Real Life. Four capsules each morning before breakfast. No cycling required, no complicated protocols, no messy mixing or shaker bottles. It fits seamlessly into any daily routine — whether you’re heading to the gym at 5 AM or sitting down to a board meeting at 8.

Lifetime Money-Back Guarantee. Every purchase of TestoPrime is backed by an industry-leading lifetime satisfaction guarantee — a full refund if you’re not completely satisfied, with zero hassle and zero questions asked. That level of commitment is a direct reflection of genuine confidence in the formula’s real-world results.

Real Men. Real Results.

“Since using TestoPrime, my energy and drive are back. I’m lifting more, sleeping better, and feel like myself again — at 54.” — Mark T., Texas

“The best testosterone booster I’ve tried. Natural ingredients, no side effects, and my muscle mass is finally coming back.” — James R., New York

“Since I’ve been taking TestoPrime I definitely have more energy to play with my kids, am less stressed, and I feel much happier in myself. This supplement is a game-changer.” — Verified Customer

“TestoPrime works. Not only does it help with recovery and strength — I feel like my day-to-day focus on daily tasks is way sharper.” — Verified Customer

Most men report noticing improvements in energy, motivation, and workout performance within the first two to three weeks of consistent daily use. For deeper hormonal restoration — including measurable changes in body composition, libido, and sustained mental clarity — allow four to six weeks of uninterrupted supplementation for the most meaningful results.

Key Ingredients to Look For in Any Testosterone Booster

When evaluating testosterone supplements as a man over 50, these are the scientifically validated ingredients that actually move the needle:

• D-Aspartic Acid: The most studied direct stimulator of luteinizing hormone and testosterone synthesis. Effective dose: 2,000 mg or above
• Ashwagandha (KSM-66® preferred): The most bioavailable form; addresses the cortisol-testosterone relationship directly. Look for standardized extracts — not generic root powder
• Panax Ginseng: A clinically validated botanical with documented effects on testosterone, libido, and physical stamina. Therapeutic doses begin at 6,000 mg or higher
• Vitamin D (high-dose): Increasingly recognized as essential for hormonal health in men over 40. Effective supplementation typically requires 5,000–10,000 IU for men with existing deficiency
• Zinc: Non-negotiable for testosterone synthesis. Underdosing is common in lesser formulas — look for 30 mg or above
• Fenugreek Extract: Supports free testosterone by reducing estrogen conversion — a particularly valuable mechanism for men over 50
• Bioavailability Enhancers (BioPerine®): Often overlooked, but critical for ensuring that every other ingredient actually reaches the bloodstream at effective levels

Safety & Usage

For healthy adults over 18, TestoPrime is safe for long-term daily use when taken as directed — four capsules each morning before breakfast, no cycling protocol required. The formula contains zero stimulants, zero synthetic hormones, and carries no known adverse side effects in otherwise healthy men. It will not appear on drug tests and requires no prescription.

Men currently taking anticoagulant therapy, antidiabetic medications, blood pressure drugs, or thyroid medications should consult with their healthcare provider before beginning any testosterone support regimen. Starting with the recommended serving size and monitoring your response over the first two to three weeks is always advisable for new users — particularly those with complex medical histories.

TestoPrime is not testosterone replacement therapy. It does not introduce exogenous hormones into the body. It works by supporting, stimulating, and optimizing the body’s own natural testosterone production pathways — making it a fundamentally different and significantly safer approach than TRT or androgen-based pharmaceuticals.

TestoPrime Testosterone Supplement Conclusion

For men over 50 looking to restore energy, rebuild lean muscle, sharpen mental focus, reclaim libido, and support long-term cardiovascular and metabolic health through a clean, transparent, science-backed approach, TestoPrime stands in a category of its own.

Medically accredited by Clinicians’ Choice. Manufactured in FDA-approved, GMP-certified facilities on both sides of the Atlantic. Formulated with 12 clinically studied ingredients at therapeutic doses. Backed by hundreds of thousands of verified users across more than 130 countries. Protected by an industry-leading lifetime money-back guarantee that makes trying it genuinely risk-free.

Low testosterone is not inevitable. And it’s not something men over 50 simply have to accept.

Give your testosterone the natural support it deserves.

Visit testoprime.com to explore the full formula, read verified customer reviews, and choose the package that fits your health goals.

About TestoPrime / Wolfson Brands (UK) Limited
TestoPrime is produced by Wolfson Brands (UK) Limited — a globally recognized leader in science-backed health and wellness innovation. With a relentless focus on transparency, clinical validation, and customer satisfaction, TestoPrime continues to set the international standard for premium natural testosterone supplementation as of 2026.

Registered Address: 12 Payne Street, Glasgow, G4 0LF, United Kingdom
Website: www.testoprime.com Customer Support: support@testoprime.com
Media Contact: Steve Niddich, Head of Product Innovation — support@testoprime.com

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before beginning any supplement program.

Frequently Asked Questions (FAQs)

1. What is the best testosterone booster supplement for men over 50 in 2026?
As of March 2026, TestoPrime is the top-rated natural testosterone booster for men over 50 — earning the Clinicians’ Choice accreditation after rigorous review by qualified health professionals. Its 12-ingredient formula combines D-Aspartic Acid, KSM-66® Ashwagandha, Panax Ginseng, Fenugreek, Vitamin D, Zinc, and complementary botanicals to support testosterone production across multiple biological pathways — all without prescriptions, injections, or synthetic hormones.

2. How long does it take for TestoPrime to work?
Most men notice initial improvements in energy, motivation, and workout performance within two to three weeks of consistent daily use. For meaningful changes in body composition, sustained libido support, and deeper hormonal restoration, allow four to six weeks of uninterrupted supplementation. Consistency is key — TestoPrime works best as part of a committed daily wellness routine, not as an occasional supplement.

3. Is TestoPrime safe for long-term daily use?
Yes. TestoPrime is formulated with natural, clinically studied ingredients and is entirely free from stimulants, synthetic hormones, fillers, and common allergens. It is designed for safe, continuous daily use without cycling. Men with existing cardiovascular conditions, or those on blood pressure, anticoagulant, or thyroid medications should consult their healthcare provider before starting.

4. Does TestoPrime replace testosterone replacement therapy (TRT)?
No — and that is precisely the point. TestoPrime supports and stimulates the body’s own natural testosterone production; it does not introduce synthetic or exogenous hormones. For men who want to avoid the costs, medical requirements, side-effect risks, and hormonal dependency associated with TRT, TestoPrime offers a clinically grounded natural alternative that addresses the root causes of declining testosterone directly.

5. What makes TestoPrime different from other testosterone boosters on the market?
Three things set TestoPrime apart in 2026: full ingredient transparency at clinical doses (no proprietary blends), the Clinicians’ Choice medical accreditation earned through rigorous professional review, and a manufacturing standard — FDA-approved, GMP-certified, ISO-quality facilities in both the US and UK — that most competitors cannot match. Add a lifetime satisfaction guarantee and a formula free from every major allergen and synthetic additive, and the difference becomes clear.

6. Can TestoPrime support libido and sexual health as well as physical performance?
Absolutely. Healthy testosterone levels are foundational to male sexual health, and the same hormonal mechanisms that drive workout energy, muscle synthesis, and recovery also underpin libido and sexual vitality. TestoPrime’s inclusion of Panax Ginseng, Fenugreek, and KSM-66® Ashwagandha — all supported by clinical data for their effects on male sexual function — makes it a well-rounded option for men over 50 seeking a natural, non-prescription approach in this area.

7. Is TestoPrime vegan and free from common allergens?
Yes. The full TestoPrime formula is vegan-friendly, non-GMO, and free from nuts, soy, dairy, grain, gluten, fillers, artificial additives, and synthetic dyes — designed to be clean, transparent, and accessible for a wide range of dietary preferences and health profiles.

8. How should I take TestoPrime for best results?
Take four capsules each morning before breakfast — every day, without cycling. No complicated protocols, no pre-workout timing requirements, no shaker bottles or measuring. For men who train regularly, daily supplementation provides the consistent hormonal foundation that underpins both everyday vitality and athletic performance. The three- or six-bottle supply options are recommended for men committed to seeing the full scope of results over time.

9. Where can I buy TestoPrime, and what guarantee does it come with?
TestoPrime is available exclusively through the official website at testoprime.com — ensuring product authenticity, best-available pricing, and direct access to customer support. It ships to the USA, UK, Canada, Australia, and over 130 countries worldwide. Every purchase is backed by a lifetime money-back guarantee, making it entirely risk-free to try.

10. Is TestoPrime medically accredited?
Yes. As of 2026, TestoPrime holds the Clinicians’ Choice designation — formally reviewed and endorsed by leading qualified health professionals as the most effective natural testosterone booster for men over 40 and 50. Combined with manufacturing in FDA-approved, GMP-certified facilities and ISO-standard third-party testing, this accreditation positions TestoPrime at the top of the medically credible testosterone supplement market today.

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• TestoPrime

CONTACT: 12 Payne Street, Glasgow, G4 0LF, United Kingdom
Website: www.testoprime.com Customer Support: support@testoprime.com
Media Contact: Steve Niddich, Head of Product Innovation — support@testoprime.com