Oculis to Present at Upcoming North American Neuro-Ophthalmology Society Annual Meeting

Oculis to Present at Upcoming North American Neuro-Ophthalmology Society Annual Meeting




Oculis to Present at Upcoming North American Neuro-Ophthalmology Society Annual Meeting

ZUG, Switzerland, 16 March, 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 the presentation of the ACUITY Phase 2 data with Privosegtor at the North American Neuro-Ophthalmology Society (NANOS) 52nd Annual Meeting.

This premier annual gathering of neuro-ophthalmology experts worldwide provides a scientific forefront platform for presenting transformative clinical data amongst leading clinicians, researchers, and thought leaders.

As a Platinum Sponsor of the 2026 Congress, Oculis is proud to support the most influential global scientific meeting in neuro-ophthalmology, reinforcing its commitment to advancing scientific progress in this field.

NANOS 2026
March 20-24, Boston, MA, USA

“Improved Low-Contrast Visual Acuity and Reduction in Retinal Ganglion Cell Loss with Privosegtor in Acute Optic Neuritis: Results from a Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial”.

  • Presenter: Professor Martin S. Zinkernagel, M.D., Ph.D., Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland
  • Date/Time: Monday March 23, 8:48 AM EDT 

The presentation of the Phase 2 ACUITY trial results investigating Privosegtor in patients with optic neuritis (ON) will focus on the significant improvements in low contrast visual acuity and promising neuroprotective structural and biological effects observed in the study. Privosegtor, a peptoid small molecule with the ability to cross both the blood brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis, with broad potential applicability in other neuro-ophthalmic and neurological diseases. Following Breakthrough Therapy designation from the U.S. Food and Drug Administration for ON, Oculis is advancing the PIONEER registrational program for Privosegtor in optic neuropathies, with the PIONEER-1 trial in optic neuritis initiated in Q4 2025. 

Riad Sherif, M.D., Chief Executive Officer of Oculis, said “Our commitment to advancing the field of neuro-ophthalmology has never been stronger. The ACUITY Phase 2 results with Privosegtor highlight meaningful progress toward delivering a much-needed neuroprotective therapy to patients with optic neuritis and other optic neuropathies. The opportunity to present the groundbreaking data from this trial at NANOS, recognized as the most important global forum for neuro-ophthalmic science, represents a significant milestone for Oculis and for patients. As a Platinum Sponsor for this year’s congress, we are honored to support and partner with the scientific community in shaping the future of neuroprotective therapies.”

Martin Zinkernagel, M.D., Ph.D., is Professor and Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, as well as director of the internationally renowned Bern Photographic Reading Center at the University of Bern. Professor Zinkernagel is highly recognized in the field with over 270 publications spanning his research interests in retinal imaging, ophthalmic data analysis using artificial intelligence, and the influence of the gut microbiome in retinal disease. He earned his M.D. at the University of Zurich and his PhD in ocular immunology and gene therapy from the University of Western Australia.

–END–

About Privosegtor

Privosegtor, a novel peptoid small-molecule candidate that crosses the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.

Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis

Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. annual incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis1,2. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)3. ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

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; and Oculis’ future development plans, 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. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
  2. Weidong Gu et al. (2023) Incidence of Optic Neuritis and the Associated Risk of Multiple Sclerosis for Service Members of U.S. Armed Forces, Military Medicine, vol. 188, March/April 2023
  3. Guier CP, Kaur K, Stokkermans TJ. Optic Neuritis. January 2025. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK557853 

Dvorak Botanicals Launches Low-Dose Hemp-Derived THC Gummies Focused on Mindful Consumption

Dvorak Botanicals Launches Low-Dose Hemp-Derived THC Gummies Focused on Mindful Consumption




Dvorak Botanicals Launches Low-Dose Hemp-Derived THC Gummies Focused on Mindful Consumption

Atlanta, GA, March 16, 2026 (GLOBE NEWSWIRE) — Dvorak Botanicals, a new premium hemp-derived THC brand founded by Atlanta-based entrepreneur Dane Dvorak, has launched with a focus on controlled-dose hemp products that support more intentional and balanced ways for adults to relax.

Dvorak Botanicals’ 2.5mg hemp-derived THC gummies in Yuzu and Peach, designed for a controlled, low-dose experience.

The company’s initial product line features low-dose hemp-derived Delta-9 THC gummies. Each gummy contains 2.5 mg of THC, allowing users to control their experience through gradual dosing. The gummies are packed in 20-count containers and formulated with premium flavor profiles such as yuzu and peach, reflecting the company’s emphasis on elevated ingredients and approachable formulations.

The launch comes as consumer interest in mindful consumption continues to grow. Many adults are exploring alternatives to traditional alcohol-centered social experiences or high-potency cannabis products. By focusing on controlled, low-dose formats, Dvorak Botanicals aims to offer a more approachable option for adults looking to unwind, connect socially, and incorporate cannabis into their routines.

“Many cannabis products are designed for intensity, but not necessarily for balance,” said Dane Dvorak, founder of Dvorak Botanicals. “We wanted to create something that allows adults to ease into the experience, control their dosage, and enjoy THC thoughtfully.”

All Dvorak Botanicals products undergo third-party laboratory testing for potency and purity to help ensure product consistency and transparency for consumers. The gummies are formulated using hemp-derived Delta-9 THC in accordance with federal hemp regulations.

In addition to direct-to-consumer sales through the company’s website, Dvorak Botanicals products are currently carried by select independent boutiques across Georgia, including Soberish, Ghost Apothecary, and The Zero Co. The company partners with retailers that align with its design-focused and wellness-oriented brand philosophy and is actively expanding its retail presence through the region. Dvorak Botanicals plans to grow into a broader wellness platform built around intentional relaxation and thoughtful dosing practices.

“Our focus starts with cannabinoids,” Dvorak added, “but the larger goal is to build a brand people trust for premium products and more mindful ways to relax.”

To learn more, please visit https://dvorakbotanicals.com.

About Dvorak Botanicals
Dvorak Botanicals is a modern hemp-derived THC brand created for adults exploring more balanced ways to relax and socialize. The company combines thoughtful dosing with elevated product design to create approachable cannabinoid experiences. Dvorak Botanicals is focused on building a lifestyle brand that supports mindful consumption and contemporary wellness habits.

 

Media Contact
Company Name: Dvorak Botanicals
Contact Person: Dane Dvorak
Contact Number: 404-436-2280
Email: support@dvorakbotanicals.com
Country: United States
Website: https://dvorakbotanicals.com
Social Media Handles: @Dvorak.botanicals

CONTACT: Media Contact
Company Name: Dvorak Botanicals
Contact Person: Dane Dvorak
Contact Number: 404-436-2280
Email: support@dvorakbotanicals.com
Country: United States
Website: https://dvorakbotanicals.com
Social Media Handles: @Dvorak.botanicals

GN Store Nord A/S enters into agreement to sell its Hearing business to Amplifon S.p.A. for DKK 17.0 billion

GN Store Nord A/S enters into agreement to sell its Hearing business to Amplifon S.p.A. for DKK 17.0 billion




GN Store Nord A/S enters into agreement to sell its Hearing business to Amplifon S.p.A. for DKK 17.0 billion

Today, GN Store Nord A/S (“GN”) has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. (“Amplifon”), a leading global hearing care retailer. The transaction values the Hearing business at DKK 17.0 billion1 on a cash-free and debt-free basis and will be settled with DKK 12.6 billion2 in cash and 56 million shares in Amplifon. The transaction is subject to customary regulatory approvals and completion of the Hearing business separation from GN and is expected to complete by the end of 2026.

Amplifon and GN will together create a global integrated leader in audiology combining hearing technology leadership with high-quality, innovative hearing care to offer comprehensive solutions to both audiology professionals and patients. The combination will create the industry leader in hearing care solutions and services worldwide with benefits to audiologists, consumers, and investors.

Following the transaction, GN will fully focus to drive success in the large and attractive audio and video peripherals markets. GN is well positioned with leading brands, premium product differentiation, and technology leadership in sound processing and low-power edge AI. Financially, GN will drive margin expansion supported by the product differentiation and its scalable and agile operations setup, while the asset-light business model will support healthy cash flows.

As the proceeds from the transaction is larger than GN’s net interest-bearing debt, GN expects to use the proceeds to 1) significantly reduce debt, 2) invest in the ongoing business to support sustainable and profitable growth as well as 3) returning capital to shareholders, subject to applicable law and in line with the dividend policy.

GN Store Nord Chair Jukka Pekka Pertola said:
We are excited to transform GN into a pure technology company. We have unique positions and capabilities making us well positioned to further grow in the large audio and video peripherals market in a focused way. While we will miss all of our great employees in Hearing, we are proud that we, together with Amplifon, will create an industry leading player in global audiology. We are convinced that the transaction and steps ahead will be beneficial to our customers, employees and investors.
  
GN Store Nord CEO Peter Karlströmer said:
We are today acting on an opportunity to create a global leader in audiology together with Amplifon. The new company has every chance to develop into an industry leader driving further innovation and success in hearing care. For GN, this also creates an opportunity to further strengthen our position in the large and attractive audio and video peripherals markets. We have unique brands, talents, and capabilities and a rich set of opportunities. We have in the last few years strengthened GN significantly financially and operationally. As we open up this new chapter, we are focused on driving success as an innovative technology company with global reach and scale. This is very exciting for GN’s customers, employees, and investors.

Amplifon CEO Enrico Vita said: “Today marks a turning point for Amplifon. We are announcing the most transformative acquisition in our 75-year-long history, that will fundamentally change the future of the hearing care industry worldwide and create significant and long-term value for all our stakeholders. With combined revenues of approximately €3.3 billion, a presence in more than 100 countries, a cutting-edge R&D platform, leading manufacturing capabilities, and an unparalleled commercial network, we will be forming a truly global vertically integrated leader in audiology. Importantly, Amplifon will continue to preserve and enhance Hearing’s unique identity, heritage, and strengths, recognizing its brand value, culture, and distinct capabilities as key contributors to the future success of the combined organization. We look forward to working closely with the exceptional team at Hearing to improve hearing health for millions of people globally”

Background
Over the past years, GN has significantly strengthened its strategic focus and execution capabilities across the group, supported by substantial investments in innovation, technology, and its supply chain. These efforts have created a solid foundation for sustainable and profitable growth. During this period, the Board and Executive Management received several unsolicited expressions of interest, including from Amplifon, and subsequently engaged in exploratory discussions. One of these led to Amplifon making a financially and strategically compelling proposal with a high degree of deal certainty. After extensive deliberation and a thorough evaluation process, the Board and Executive Management unanimously decided to pursue and accept the proposal from Amplifon.

Transaction Highlights

  • Consideration: DKK 17.0 billion3 on a cash-free and debt-free basis, comprised of DKK 12.64 billion in cash (subject to customary true up closing mechanism adjustments) and 56 million shares in Amplifon, allowing GN to retain upside to the strong strategic value proposition of the transaction. Once the transaction closes, GN will hold approximately 16%5 of the current outstanding share capital in Amplifon, subject to customary lock-up
  • Hearing Perimeter: Includes the entire Hearing business comprising of c. 5,500 employees globally, the ReSound, Beltone and other hearing brands, all hearing product IP, R&D, manufacturing and operations (including relevant sites used by the Hearing business), and Beltone network partnerships. The transaction does not include the current financial investment in Nations Benefits LLC. In 2025, the Hearing business generated revenue of DKK 7,214 million and reported pro-forma EBITDA of DKK 1,185 million6.
  • Shareholders’ agreement: At closing, GN and Ampliter S.r.I, Amplifon’s controlling shareholder, are expected to enter into a shareholders’ agreement providing for GN’s right to propose a representative for appointment to Amplifon’s Board of Directors, together with customary transfer restrictions and lock-up undertakings in respect of the Amplifon shares received by GN as consideration. Additionally, Ampliter S.r.l., and core shareholder, Tamburi Investment Partners S.P.A., confirmed their financial support to the Transaction, including investment in a future equity raise conducted by Amplifon.
  • Carve-out: Prior to closing of the transaction, the Hearing business will be separated from GN through a carve-out, including a statutory demerger of the Hearing business in accordance with the Danish Companies Act. The de-merger is expected to take place as a taxable transaction.
  • Transitional Arrangements: Certain shared services and support functions by GN will continue to be provided on a temporary basis following the closing of the transaction via customary transitional services agreements between the parties.
  • Fairness Opinions: J.P. Morgan Securities plc has provided to the Board of Directors of GN an opinion as of 16 March 2026 based on the factors, assumption and procedures specified therein, which confirms that the transaction value is fair from a financial point of view (the “Fairness Opinion”). J.P. Morgan provided its Fairness Opinion solely for the benefit and information of the Board of Directors of GN in its evaluation of the transaction, and the Fairness Opinion may not be relied upon by any third party or used for any other purpose. Additionally, Nordea Corporate Finance, part of Nordea Danmark, Filial af Nordea Bank Abp, Finland (“Nordea”), has as Independent Financial Advisor, provided to the Board of Directors of GN an opinion as of 16 March 2026 based on the factors, assumptions and procedures specified therein, which confirms that the transaction value is fair for GN from a financial point of view (the “Independent Fairness Opinion”). Nordea provided its Independent Fairness Opinion solely for the benefit and information of the Board of Directors of GN Store Nord A/S in its evaluation of the transaction, and the Independent Fairness Opinion may not be relied upon by any third party or used for any other purpose.
  • Closing conditions: The transaction is subject to customary conditions, including merger control and other regulatory approvals from relevant authorities and completion of the Hearing business separation from GN.
  • Anticipated Closing Date: The transaction is expected to close by the end of 2026. GN remains committed to serving the customers of the Hearing business and will continue delivering high-quality, innovative products.

Financial implications and guidance
As a direct consequence of the transaction, Hearing will be classified as discontinued operations, and associated assets and liabilities as held-for-sale.

GN’s financial guidance for 2026 now excludes discontinued operations and therefore only reflects Enterprise and Gaming. Consequently, the organic revenue guidance is now expected to be 2-8%, based on unchanged divisional assumptions of 0-6% organic revenue growth in Enterprise, and 7-13% organic revenue growth in Gaming.

To drive the necessary changes of this significant transaction, GN will incur one-off costs, including but not limited to transaction and carve-out costs, which will impact group EBITA in 2026. Following the establishment of a standalone operating system structure, the company is expected to re-introduce a profitability guidance.

Financial guidance 2026 Organic revenue growth
GN 2% to 8%

The current long-term financial targets are suspended; however, the company’s ambition to drive strong profitable growth remains unchanged. GN is in a strong position to deliver healthy growth, strong profitability and an attractive cash conversion.

Capital Markets Day
GN intends to hold a Capital Markets Day post-closing of the transaction. The Capital Markets Day will cover among other subjects the future strategy, long-term financial targets, capital allocation policy, including further clarifications on distributing excess capital to shareholders.

Press Conference
GN will host a press conference at 09:30 CET on 16 March 2026.
Contact Group Media Manager Helge Coroli Frandsen at hcfrandsen@gn.com to sign up.

Investor and analyst conference call
GN will hold will host a teleconference at 12:00 CET on 16 March 2026. Please visit www.gn.com/investor to access the teleconference. Presentation material will be available on the website prior to the start of the teleconference.

Advisors
J.P. Morgan Securities plc is acting as exclusive financial advisor, and Gorrissen Federspiel Advokatpartnerselskab and Gianni & Origoni are acting as legal advisors, and PricewaterhouseCoopers has provided due diligence services to GN.

This announcement contains inside information within the meaning of Article 7 of Regulation (EU) No 596/2014 (the Market Abuse Regulation).

For further information, please contact:

Investor Relations
Rune Sandager +45 45 75 92 57

Media Relations
Steen Frentz Laursen +45 20 65 34 20

About GN  
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technologies that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with our unique expertise and the broadest portfolio of products and services in our history – bringing people closer to what is important to them.

We market our solutions with the brands Jabra, ReSound, SteelSeries, Beltone, Interton, BlueParrott, Danavox, and FalCom in 100 countries. Founded in 1869, GN Group employs more than 7,500 people and is listed on Nasdaq Copenhagen (GN.CO).

Visit our homepage GN.com – and connect with us on LinkedIn, Facebook and Twitter

About Amplifon
Amplifon, global leader in the hearing care retail market, empowers people to rediscover all the emotions of sound. Amplifon’s around 20,600 people worldwide strive every day to understand the unique needs of every customer, delivering exclusive, innovative and highly personalized products and services, to ensure everyone the very best solution and outstanding experience. The Group, with annual revenues of around 2.4 billion euros, operates through a network of around 10,000 locations in 25 Countries and 5 continents. More information about the Group is available at: https://corporate.amplifon.com.

The forward-looking statements in this announcement reflect the management’s current expectations of certain future events and financial results. Statements regarding the future are, naturally, subject to risks and uncertainties, which may result in considerable deviations from the outlook set forth. Furthermore, some of these expectations are based on assumptions regarding future events, which may prove incorrect. Changes to such expectations and assumptions will not be disclosed on an ongoing basis, unless required pursuant to general disclosure obligations to which GN is subject.

Factors that may cause actual results to deviate materially from expectations include – but are not limited to – general economic developments and developments in the financial markets as well as foreign exchange rates, risks related to the above mentioned transaction, technological developments, changes and amendments to legislation and regulations governing GN markets, changes in the demand for GN products, competition, fluctuations in sub-contractor supplies, and developments in ongoing litigation (including but not limited to class action and patent infringement litigation in the United States).
For more information, please see the “Management’s report” and “Risk management” sections in the Annual Report. This announcement should not be considered an offer to sell or buy securities in.


1 Share component value based on €10.52 per Amplifon share as of 13 March 2026

2 Cash component of EUR 1,690m converted to DKK at DKK/EUR 0.134

3 Share component value based on €10.52 per Amplifon share as of 13 March 2026

4 Cash component of EUR 1,690m converted to DKK at DKK/EUR 0.134

5 Assumes Amplifon completes up to EUR 0.75bn equity raise as per Amplifon’s communication to the market. Should Amplifon not complete any equity raise, GN’s shareholding at closing would amount to 19.8%

6 EBITDA includes group cost allocations and certain carve-out costs that the buyer will not take over, as well as other transaction adjustments of around DKK 230 million in total

Tecan presents 2025 results and provides details on program to reignite profitable growth

Tecan presents 2025 results and provides details on program to reignite profitable growth




Tecan presents 2025 results and provides details on program to reignite profitable growth

Ad hoc announcement pursuant to Article 53 of the SIX Exchange Regulation Listing Rules

Tecan presents 2025 results and provides details on program to reignite profitable growth

Financial results for the full year 2025 – Summary

  • Sales of CHF 882.5 million (2024: CHF 934.3 million), down 1.6% in local currencies for the year, with second-half sales growth of 0.4%
  • Order entry increased by 3.8% in local currencies for the full year and by 8.6% in the second half
  • Adjusted EBITDA of CHF 142.1 million (2024: CHF 164.4 million), adjusted EBITDA margin of 16.1% (2024: 17.6%), impacted by adverse foreign exchange effects and tariffs, partly offset by cost-reduction measures and underlying improvements
  • Net profit impacted by non-cash impairment charges of CHF 139.5 million resulting in a reported net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million)
  • Strong operating cash flow of CHF 138.0 million (2024: CHF 148.5 million),
    cash conversion increased to 118% of reported EBITDA (2024: 100%)
  • Proposal for an unchanged dividend of CHF 3.00 per share

Outlook

  • Outlook for 2026
    • Sales expected to increase in the low single-digit percentage range in local currencies, with the relevant market anticipated to remain broadly flat
    • Adjusted EBITDA margin forecast at 15.5-16.5% of sales, reflecting a -110 basis points headwind from FX and tariffs
    • This margin expectation includes an underlying profitability improvement of 50-150 basis points from the transformation program
  • Medium-term outlook maintained
    • Ambition to achieve sales of CHF 1 billion and a 20% adjusted EBITDA margin by 2028, supported by the ongoing transformation program contributing 200-300 basis points

Männedorf, Switzerland, March 16, 2026 – The Tecan Group (SIX Swiss Exchange: TECN) today announced its audited financial results for 2025, reporting a return to sales growth and strong order entry in the second half of the year. Tecan also initiated its short-term financial outlook for 2026 and reaffirmed its medium-term outlook. Later today, the company will host a Capital Markets Update, providing further details on the key drivers supporting its medium-term growth and profitability ambitions.

Tecan CEO Monica Manotas commented: «Our 2025 performance does not reflect Tecan’s potential. We are acting decisively to change that. Our core is intact, and our balance sheet is strong. Through our transformation program, built on portfolio optimization, commercial excellence, and operational excellence, we are focused on returning to profitable growth now, while positioning our company for what is next and beyond.

While the return to growth in our industry is gradual, the forces shaping its future, AI integration, automation, scientific complexity, economic pressure, are powerful and durable. We expect them to drive significant growth in laboratory automation over the coming decade, and we intend to outgrow the market by leading its AI- and data-driven future.

To achieve that, we have launched “Rewired”, a transformation program to future-proof Tecan and excel at both innovation and execution. Technology leadership and the ability to translate it into profitable growth are decisive, for customers and shareholders alike. We will pursue this with financial discipline, rigorous capital allocation, and the strategic focus needed to realize Tecan’s long-term potential.»

Financial results full-year and second half of 2025

Order entry and sales
Order entry for the Group reached CHF 900.9 million for full-year 2025 (2024: CHF 903.6 million), declining by 0.3% in Swiss francs but growing by 3.8% in local currencies. The book-to-bill ratio was above 1 in both business segments. In the second half, order entry grew by 8.6% in local currencies and by 2.6% in Swiss francs.

Group sales for 2025 decreased by 1.6% in local currencies and 5.5% in Swiss francs, totalling CHF 882.5 million (2024: CHF 934.3 million). In the second half of the year, Tecan returned to moderate sales growth, with sales increasing by 0.4% in local currencies. Sales declined by 5.2% in Swiss francs to CHF 443.0 million (2024: CHF 467.1 million).
These sales results were previously communicated in a trading statement on January 9, 2026.

Profitability and Cash Flow
Adjusted EBITDA1 (operating profit before depreciation and amortization) was CHF 142.1 million, down from CHF 164.4 million in 2024. The adjusted EBITDA margin decreased to 16.1% of sales (2024: 17.6%). Margins were significantly impacted by adverse foreign exchange effects (-130 basis points) and tariffs (-70 basis points), partly offset by underlying improvements (+50 basis points). Excluding the combined 200 basis point headwind from foreign exchange effects and tariffs, the adjusted EBITDA margin was 18.1%, in line with the outlook communicated on March 12, 2025. Reported EBITDA was CHF 117.1 million, compared to CHF 148.0 million in the prior year, corresponding to reported margins of 13.3% and 15.8%, respectively.

Net profit was impacted by non-cash impairment charges of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines in the Partnering Business. Tecan will leverage synergies between its design and development capabilities and Paramit’s manufacturing capabilities, discontinuing dedicated design functions acquired in 2021. As a result of the impairment charges, the company reported a net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million). In addition to a lower operating profit, net profit was further weighed down by a reduced financial result, mainly reflecting negative foreign exchange effects and the translation of US dollar-denominated assets into Swiss francs. Reported basic earnings per share were CHF -8.74 (2024: CHF 5.30). Adjusted net profit2 amounted to CHF 87.0 million (2024: CHF 103.1 million), with adjusted earnings per share2 of CHF 6.87 (2024: CHF 8.08).

Cash flow from operating activities was CHF 138.0 million, compared to CHF 148.5 million in 2024. Cash conversion improved to 118% of reported EBITDA (2024: 100%). Thanks to solid cash flow management, Tecan’s net liquidity position (cash and cash equivalents plus short-term time deposits, less bank liabilities, loans, and the outstanding bond) increased to CHF 160.8 million as of December 31, 2025, up from CHF 153.7 million on December 31, 2024.
Through its share buyback program, from August 2025 to December 31, 2025, Tecan purchased own shares with a value of CHF 24.8 million. The program allows for the repurchase of registered shares with a value of up to CHF 120 million.

Information by business segment

Life Sciences Business (end-customer business)
Sales in the Life Sciences Business reached CHF 377.1 million (2024: CHF 397.0 million), representing a decrease of 1.0% in local currencies and 5.0% in Swiss francs. In the second half, sales declined by 3.2% in local currencies. During 2025, demand for instruments in Academia & Government was significantly impacted by budget uncertainty and volatile public funding, particularly in the US and China. Biopharma sales were slightly below the prior year in local currencies, with order entry picking up significantly in the second half. Diagnostic accounts continued to see solid sales and order growth in local currencies throughout the year.
Order entry in the Life Sciences Business increased in the low single-digit percentage range in local currencies for the full year, with an acceleration in the second half. The book-to-bill ratio remained above 1 in 2025.

Reported EBIT in the Life Sciences Business segment (earnings before interest and taxes) was CHF 25.7 million (2024: CHF 39.5 million), with the reported operating profit margin decreasing to 6.7% of sales (2024: 9.8%). The segment absorbed the majority of the negative impact from foreign exchange rates and tariffs. In addition, as part of the portfolio optimization, Tecan decided to exit selected activities at Tecan Genomics, resulting in a CHF 5.3 million asset write-off. Cost control measures partially offset these negative effects. Adjusted EBITDA3 for the segment was CHF 63.4 million (2024: CHF 79.1 million), reflecting an adjusted EBITDA margin of 16.5% of sales (2024: 19.6%).

Partnering Business (OEM business)
The Partnering Business recorded sales of CHF 505.4 million (2024: CHF 537.3 million), representing a decrease of 2.0% in local currencies and 5.9% in Swiss francs. In the second half, sales increased by 3.3% in local currencies.
Overall weak demand for life science instrumentation negatively impacted sales of Cavro OEM components and Paramit CDMO manufacturing services. In contrast, strength in diagnostics drove solid growth in local currencies for in-vitro diagnostics systems in the Synergence product line.
Order entry in the Partnering Business grew at a mid-single-digit rate in local currencies for the full year. As expected, order entry accelerated significantly in the second half, with growth in the low double-digit percentage range. The book-to-bill ratio was also above 1 for this segment in 2025.

Reported EBIT in the Partnering Business amounted to a loss of CHF 103.6 million (2024: profit of CHF 46.6 million), primarily due to the non-cash impairment charge of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines. Adjusted EBITDA3 for the segment was CHF 89.7 million (2024: CHF 91.1 million), reflecting an adjusted EBITDA margin of 17.7% of sales (2024: 16.9%). The adjusted EBITDA margin increased, mainly due to a positive product mix and strong cost control, which outweighed the adverse effects of foreign exchange and tariffs.

Proposals to the Annual General Meeting

Based on the solid cash flows for the full year 2025 and as an expression of the confidence in Tecan’s future and of the commitment to shareholder returns, the Board of Directors will propose an unchanged dividend of CHF 3.00 per share at the Annual General Meeting on April 15, 2026. Half of the dividend, i.e., CHF 1.50, will again be paid out from the available capital contribution reserve and is therefore not subject to withholding tax.

In addition to the changes in the Board of Directors announced on December 4, 2025, Guillaume Daniellot will also be proposed as a new independent member of the Board of Directors. Guillaume Daniellot has been serving as CEO of the Straumann Group since January 2020, after previously holding various senior management roles within the company. Earlier in his career, he held positions in hospital product management at Coloplast and B. Braun, and in sales and marketing at Dentsply France. He holds a Bachelor’s degree in physics from the University of Dijon, a Master in marketing from FGE in Tours, and a Master’s in business administration from ESC European School of Management, Paris. Guillaume will complement the Board with his extensive knowledge of the medtech industry and his proven leadership in global healthcare markets.

Outlook

For 2026, Tecan expects end markets to recover gradually. However, a full normalization is not anticipated, and market growth is expected to range from a moderate decline to moderate growth. With anticipated improvements in certain customer segments, but continued uncertainty in others, Tecan is initiating its short-term financial outlook for 2026, expecting sales to increase in the low single-digit percentage range in local currencies.

Foreign exchange rates and the annualized impact from tariffs will continue to weigh on profitability in 2026. Tecan assumes a combined headwind of 110 basis points on the adjusted EBITDA margin from these external factors4. Including these effects, Tecan forecasts an adjusted EBITDA margin – excluding restructuring, acquisition, and integration-related costs – of 15.5% to 16.5% of sales. This forecast also reflects an underlying profitability improvement of 50 to 150 basis points as a result of the ongoing transformation program.

Tecan also reiterates its medium-term outlook, which will be further detailed at today’s Capital Markets Update, including an update on the key drivers supporting this outlook. Tecan expects a continued gradual improvement in end markets, with market growth increasing to a range of 1% to 3% in the years 2027-2028. Tecan’s ambition is to achieve sales of CHF 1 billion⁴ and a 20% adjusted EBITDA margin⁴ by 2028. This will be supported by the ongoing “Rewired” transformation program, which is expected to contribute 200-300 basis points through incremental revenue and efficiencies across operations, commercial, G&A, and R&D.

From 2029 onwards, Tecan assumes a return to normal market conditions, with market growth in the previous range of 3% to 5%. In this environment, Tecan expects to return to average organic growth rates in the mid- to high-single-digit percentage range in local currencies, while continuously improving profitability.

Annual Report and Webcast

The full 2025 Annual Report and the 2025 Sustainability Report were also published today and can be accessed on the company’s website www.tecan.com under Investor Relations.

Tecan will hold an analyst and media conference to discuss the 2025 annual results today at 14:00 (CET) in Zurich. The event will also feature a Capital Markets Update, including an update on the key drivers supporting the company’s medium-term outlook. The presentation will be relayed by live audio webcast, which interested parties can access at www.tecan.com. A link to the webcast will be provided immediately prior to the event. A replay of the webcast will be available after the presentation on www.tecan.com for a period of 12 months.

The dial-in numbers for the conference call are as follows (Access Code: 127505):
Switzerland: +41 22 518 90 26

UK: +44 20 3936 2999
United States: +1 646 233 4753
Participants should, if possible, dial in 15 minutes before the start of the event.

Key upcoming dates

  • The Annual General Meeting of Tecan’s shareholders will take place on April 15, 2026
  • A Q1 2026 Qualitative Update will be published on May 12, 2026
  • The 2026 Interim Report will be published on August 11, 2026
  • A Q3 2026 Qualitative Update will be published on November 5, 2026

1 The adjusted operating profit before depreciation and amortization excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 25.0 million)

2 The calculation of adjusted net profit and adjusted earnings per share excludes restructuring costs, acquisition- and integration-related costs (CHF 25.0 million), accumulated amortization of acquired intangible assets (CHF 23.3 million), and one-off, non-cash impairment charges of CHF 139.5 million. They were calculated using the reported Group tax rate of 9.9%.

3 The adjusted operating profit before depreciation and amortization for the Life Sciences Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 8.1 million). The adjusted operating profit before depreciation and amortization for the Partnering Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 14.4 million).

4 Assumes tariff rates in effect as of December 31, 2025. Any changes to tariff rates may impact the outlook. Profitability expectations for 2026 and for the medium-term sales and adjusted EBITDA margin outlook are based on an average exchange rate forecast of one euro equaling CHF 0.92 and one US dollar equaling CHF 0.80.

About Tecan
Tecan (www.tecan.com) improves people’s lives and health by empowering customers to scale healthcare innovation globally from life science to the clinic. Tecan is a pioneer and global leader in laboratory automation. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments, components and medical devices that are then distributed by partner companies. Founded in Switzerland in 1980, the company has 3,000 employees, with manufacturing, research and development sites in Europe, North America and Asia, and maintains a sales and service network in over 70 countries. In 2025, Tecan generated sales of CHF 883 million (USD 1,063 million; EUR 939 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191).

For further information:

Tecan Group
Martin Brändle
Senior Vice President, Corporate Communications & IR
Tel. +41 (0) 44 922 84 30
Fax +41 (0) 44 922 88 89
investor@tecan.com
www.tecan.com

Attachment

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China




InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

BEIJING, March 15, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China and the second globally.

ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally.

Degradation of VAV1 can effectively inhibit T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, thereby exerting anti-inflammatory and immunomodulatory effects and alleviating autoimmune and inflammatory pathological processes. Preclinical studies have shown that ICP-538 induces deep degradation of VAV1, leading to a significant reduction in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are committed to developing innovative drugs in the field of autoimmune diseases. As a novel therapy, the VAV1 molecular glue degrader offers three major advantages: high target selectivity, mediation of multiple mechanisms of action, and high efficacy. We are pleased to see that we have rapidly advanced clinical development, and we believe that ICP-538 will become a better treatment option for patients with autoimmune diseases.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-Looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contact
 
Media Investors
Chunhua Lu  
86-10-66609879 86-10-66609999
chunhua.lu@innocarepharma.com ir@innocarepharma.com

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas




Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Transition brings enhanced patient experience and Botox, lip filler, and other med spa treatments

Avere Beauty Logo

Avere Beauty Logo

PITTSBURGH, March 15, 2026 (GLOBE NEWSWIRE) —  Pittsburgh Aesthetics, a physician-led medical aesthetics practice in Mars, Pennsylvania, announced today that it will officially operate under the Avere Beauty brand beginning March 16, 2026. The rebrand unifies the practice under a single identity, offering a consistent, high-quality patient experience while expanding access to advanced med spa services across the Pittsburgh region.

The transition reflects Avere Beauty’s commitment to patient-centered care, ensuring that individuals seeking aesthetic treatments continue to receive the same personalized attention while benefiting from a broader range of services and locations.

What Patients Can Expect:

  • Same care team & location: The Mars office will continue to operate at 179 Scharberry Ln, providing the same experience and care patients know and trust.
  • Expanded med spa services: Patients can continue to access a full suite of services, including Botox, lip filler, biostimulators, PDO threads, facials, Hydrafacials, laser treatments, and weight loss programs. Laser tattoo removal and weight loss services will be available Mid-April
  • Brand updates: Over the coming weeks, patients will notice updated signage, digital platforms, and communications reflecting the Avere Beauty brand.
  • Scheduling continuity: Current appointments will proceed as planned, with new booking details shared via email, text, and the website.
  • Expanded access across locations: In addition to Mars, Avere Beauty operates in Lawrenceville (3453 Butler Street, Pittsburgh, PA 15201), Export/Murrysville (5100 Old William Penn Hwy, Export, PA 15632), and Blawnox (307 Freeport Road, Pittsburgh, PA 15238). These locations offer increased appointment availability and access to the practice’s full med spa offerings.

Avere Beauty Foyer

Avere Beauty Foyer

Founder’s Vision

Alyssa Luciano, RN, an ICU nurse with over fifteen years of experience, founded Avere Beauty to create a med spa that blends professional expertise with a welcoming and educational environment. “Our mission is to provide aesthetic treatments that empower patients and enhance confidence,” said Luciano. Her approach emphasizes natural aesthetics, transparency, and individualized care. The Mars location now offers advanced treatments, including Botox lip filler, Sculptra, and multiple lasers – helping patients achieve natural-looking results tailored to their goals.

Driving Growth

Frank Udavcak, Chief Operations Officer, leads Avere Beauty’s expansion and marketing strategy. With a background in content creation, pharmaceutical branding, and storytelling, Udavcak has guided the practice’s growth and helped bring its physician-led services to more communities in the Pittsburgh area.

This rebrand and expansion aim to strengthen the patient experience, offering more appointment availability and new med spa services.

For more information or to book an appointment, visit Avere Beauty online.

About Avere Beauty

Avere Beauty is a med spa based in Pittsburgh, Pennsylvania, dedicated to providing personalized aesthetic treatments in a comfortable, educational environment. Founded by Alyssa Luciano, RN, the practice offers a full range of services including Botox, lip filler, facials, Hydrafacials, laser treatments, PDO threads, and weight loss programs. With multiple locations across the Pittsburgh region, Avere Beauty combines professional expertise with a patient-centered approach to deliver natural-looking, high-quality results.

Media Contact:
Sophie Brinkman
Avere Beauty
sophie@averebeauty.com
https://www.averebeauty.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b128c7a3-6481-4b96-8f9f-2efb6540cf54

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/89ffce74-3bea-4619-8603-628af8b99de4

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate




Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: “Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8. 

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis13. 

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA14. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
SVP Investor Relations and Corporate Communications
kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  

Ms. Annie Kasparian  
Director Investor Relations and Corporate Communications  
annie.kasparian@telixpharma.com 

Telix Investor Relations (Australia)

Ms. Charlene Jaw
Associate Director Investor Relations
charlene.jaw@telixpharma.com

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

1 Brand name subject to final regulatory approval.
2 Positron emission tomography.
3 Telix ASX disclosure April 28, 2025.
4 Telix ASX disclosure October 6, 2020.
5 Telix ASX disclosure April 16, 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
6 Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V1.2025.
7 L-type amino acid transporters 1 and 2.
8 ClinicalTrials.gov ID: NCT07100730.
9 Goodenberger et al. Cancer Genet. 2012.
10 Mesfin et al. StatPearls. 2024.
11 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
12 Park et al. Journal of Clinical Oncology. 2010.
13 Ostrom et al. Neuro Oncol. 2018.
14 Telix ASX disclosure March 21, 2025.

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses




Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Orange and Irvine beds sit empty while community looks to County to deliver on its word

IRVINE, Calif., March 15, 2026 (GLOBE NEWSWIRE) — Two state-of-the-art behavioral health campuses in Orange County are ready to serve all residents, regardless of insurance type. One remains closed. The other is operating under restrictions that limit who can access care.

This week, Be Well Orange County (Be Well OC) launched its “Red Tape” campaign, a movement calling on the County of Orange to open the Irvine Campus and provide access to all residents, regardless of insurance type at both campuses in Irvine and Orange.

To remove the red tape limiting access to care, Be Well OC launched a Change.org petition for the community to sign, asking the County to deliver on its promises.

“Seven years ago, Orange County said access to behavioral health care was fragmented and out of reach. Be Well OC together with public, private, faith-based, academic, healthcare organizations, and others, took steps to solve that problem, building world-class facilities ready to serve everyone. But today the problem continues, red tape is keeping access limited and in the case of the new Irvine campus, the doors are closed. We need your help to open them,” said Phillip Franks, CEO, Be Well OC.

At the Be Well OC Orange Campus, access to the residential treatment programs is limited to County-approved referrals through their behavioral health programs. Since one must come through the County system, which serves roughly 1/3 of the County population, 2/3 of Orange County residents with employer-sponsored, private insurance or MediCare are unable to access services at the campus. In addition, the County-approved referral list for residential programs at the Orange Campus does not include any Orange County hospitals, despite having invested millions in both campuses

“Two-thirds of the Orange County taxpayers who funded these facilities are denied access based on their insurance type. This is the opposite of the Be Well OC vision the community rallied behind – including the County Board of Supervisors. Why are they going back on their promises?” said Dr. Richard Afable, Chairman of the Board, Be Well OC.

Zero Orange County General Fund (local discretionary tax dollars) were used to build the Be Well campuses:

  • Orange Campus — $40M project
    • Hospitals — $12M
    • CalOptima Health — $11.4M
    • California Mental Health Services Act (MHSA) and California Senate Bill 82 funding — $16.6M
  • Irvine Campus — $114M project
    • State of California funding — $50M
    • Federal funding — $4M
    • American Rescue Plan Act (ARPA) funds — $20M
    • Mental Health Services Act (MHSA) funding — $20M
    • CalOptima Health — $15M
    • Hospitals — $5M

In addition to the limited access to the Orange Campus, the Sobering Center was closed by the Orange County Health Care Agency, without explanation in 2024, and remains closed to date.

“The County continues to try to sow distrust in Be Well through their public comments and legal filings, with the ultimate goal of gaining ownership of millions in real estate assets,” continued Franks. “We won’t be distracted. We look forward to our day in court and remain focused on making the campuses accessible to all.”

According to a recent online survey conducted by independent research firm, Mackenzie, among 403 Orange County, Ca. residents from Jan. 8-13, 2026: (Results are statistically valid at a 95% confidence level with a margin of error of approximately +/-4.9%):

  • 65% of residents either personally sought behavioral health care, or knew someone who did, in the past year.
  • 28% of those who sought help, or knew someone who did in the past year, were unable to access the care they needed.
  • Overall, 66% say expanded behavioral health services are extremely or very urgent.

The Irvine Campus is ready to start serving the community. The County has yet to approve the sublease agreement, though it has been submitted to the County for approval on multiple occasions, preventing Be Well OC from entering into leases with County contracted providers, thus causing delays in opening the campus.

“In my work as a rabbi, a therapist, and a chaplain, I have sat with people at their most vulnerable – in pain, and in desperate need of support. I have watched mental health challenges tear through families and communities without warning and without discrimination, and I have seen firsthand what happens when people cannot access care. The opening of the Irvine Campus to all, and the full accessibility of the Orange Campus are not policy discussions; they are moral imperatives,” said Rabbi Richard Steinberg, congregational rabbi in Irvine and Be Well OC Founding Board Member.

Visit Change.org/CutTheRedTapeOC to sign the petition today and express support for opening the Irvine Campus and expanding access to care for all Orange County residents.

ABOUT BE WELL OC
Be Well OC is a transformative initiative bringing together public, private, academic and faith-based organizations to create a coordinated system of behavioral health care and support for all Orange County residents regardless of ability to pay. The Be Well OC behavioral health system, which includes mental health crisis stabilization and substance use services, features two state-of-the-art mental health and wellness facilities in Orange and Irvine, a mobile response program, and a navigation center for individuals and families. Be Well OC’s movement spans across all of Orange County and a range of needs, from prevention and early intervention to crisis aversion, crisis management, acute care and recovery. For more information visit bewelloc.org.

MEDIA CONTACT
Karena Bibbins
karena@ideahall.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76f5638e-553d-4fcf-a250-63ed1d5df1e6

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear




First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

New data shows positive real-world impact of the world’s first and only one-year CGM, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes

Eversense 365 delivered comparable adherence and outcomes between the first and second six-month period, indicating high accuracy and performance from a single sensor across an entire year

GERMANTOWN, Md., March 14, 2026 (GLOBE NEWSWIRE) — Senseonics, a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces new data from a real-world evidence study which demonstrates the sustained performance and positive impact of Eversense 365 across the full one-year period. These findings were presented during an oral presentation entitled ‘Real-World Evaluation Of The Implantable One Year Eversense 365 CGM System’ at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place on March 11-14 in Barcelona, Spain.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Francine Kaufman, M.D., Chief Medical Officer at Senseonics. “Since Eversense 365 was launched in the US, we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

Strong adherence and positive outcomes
The study evaluated the first 5,059 real-world Eversense 365 CGM sensors to be used by patients in the US, all with open-loop insulin regimens. The analysis revealed strong patient adherence, glucometrics and hypoglycemic outcomes, demonstrating how Eversense 365 can support effective management of diabetes over a full one-year period with just one implantable CGM sensor.

Patients using Eversense 365 had an average transmitter wear time of 93.8%, with comparable results for the first and second six-month periods, indicating a year of consistent and meaningful system use. This resulted in a mean Glucose Management Indicator (GMI) of 7.14% and a mean Time in Range (TIR) of 66%, demonstrating effective glycemic control. GMI is an established metric that provides an estimated A1C using only CGM data, with a lower value indicating better management and reduced health risks. GMI is often used alongside TIR to provide a more complete picture of glycemic control.

Furthermore, over 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets, reinforcing that Eversense 365 is the most accurate CGM in low glucose ranges1,2,3, where errors can have the greatest impact on patient safety and treatment decisions. The real-world analysis also showed that glucometrics and hypoglycemic outcomes were comparable for both the first six months and second six months of wear

Specific age group benefits
Additionally, analysis by age revealed that Eversense 365 supported positive glucometrics and outcomes across all age groups. However, glycemic outcomes were seen to improve with increasing age, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70%, with over 85% achieving hypoglycemic targets. The trend was also observed with adherence, with over 95% average wear time in those 65 years and older. This suggests that, whilst all age groups can benefit from Eversense 365, there may be particular benefits and positive outcomes in older populations.

Furthermore, the analysis suggested that Eversense 365 could bring specific benefits to young adults (aged 18-25), who typically have poorer glycemic control. Encouragingly, this age group had a mean GMI of 7.3% with a mean wear time over 90%, which again demonstrates strong adherence.

Encouraging early analysis of AID combination
Two weeks after the commercial launch of the twiist™ Automated Insulin Delivery (AID) system with Eversense 365, real-world data was also analyzed from the first ~120 people who had used the combined system for more than seven days. The glucose outcomes were extremely encouraging with a mean GMI of 6.79%, mean TIR of 77% and time in hypoglycemia of 2.7%, all meeting the international consensus targets. twiist is the first AID system to be compatible with Eversense 365 and, whilst still in the early stages, the initial data analysis suggests that this powerful combination is already having a positive clinical impact. Senseonics plans to present a longer-term real-world analysis later this year.

Brian Hansen, Chief Commercial Officer at Senseonics, added: “We are proud to present these data at ATTD, which is always a fantastic opportunity to connect with the diabetes ecosystem and discuss the latest developments in technology and care. The meeting is particularly timely for us this year following the recent CE mark approval and upcoming launch of Eversense 365 in select European markets. We are gaining momentum commercially in the US and look forward to bringing the benefits of this unique, implantable CGM to new patients and geographies.”

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States Food and Drug Administration in September of 2024 and launched across the country in October of the same year. In January 2026, Eversense 365 received European CE Mark approval and Senseonics expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

As the only implantable CGM available, Eversense 365 offers patients a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions. Eversense 365’s unique approach allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

1 Senseonics. (2026) Eversense 365 Continuous Glucose Monitoring System User Guide. LBL-7702-01-001
2 Abbott. (2024) Freestyle Libre 3 PLUS User Guide ART49385-001
3 Dexcom (2025) G7 15 Day User Guide AW00078-10 MT-00078-10


About Eversense

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Senseonics
Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Senseonics Media Contact

Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Eversense365@FTIConsulting.com

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026

Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026




Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026

SAN CARLOS, Calif., March 14, 2026 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion,” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that Juan Pablo Frías, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (“ATTD”) in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (“T2D”).

“We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. We believe icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology. We are excited about the upcoming two new Phase II studies which are designed to specifically address those patients that had the best responses in our trial COVALENT-111.”

COVALENT-111 Study Design and Results
COVALENT-111 was a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last seven years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (“BMI”) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications.

The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat population. As previously reported, study dosing was temporarily interrupted due to a clinical hold imposed by the U.S. Food and Drug Administration. The topline efficacy analysis presented here includes the patient population (N=163) who had completed at least 80% of their planned dosing prior to the clinical hold (without other significant protocol deviations) and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm.

The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment. Among the severe insulin-deficient patients (n=10), icovamenib achieved anHbA1c reduction that improved over time reaching 1.2% at Week 52 ((p=0.01 vs placebo). The strongest performing arm for this prespecified population was Arm B (n=6; 100mg QD for 12 weeks), with a mean HbA1c reduction of 1.5% (p=0.01). Severe insulin-deficient diabetes (“SIDD”) is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need. In this subgroup, C-peptide index fold change increased by 24% from baseline, suggesting improved endogenous insulin secretion.

The 52-week analysis also showed clinically meaningful glycemic improvement in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry (all arms n=12). In this subgroup, 8 or 12 weeks of icovamenib treatment resulted in HbA1c reduction that improved over time reaching 1.2% at Week 52 (p=0.05 vs placebo). C-peptide index fold change increased by 35% from baseline in this subgroup, further supporting improvement in beta cell function.

Icovamenib maintained a favorable safety profile throughout the 52-week observation period.
There were no treatment-related serious adverse events or discontinuations due to adverse events. Across all dosing arms, icovamenib was generally well tolerated.

ATTD 2025 Presentation:
The abstract will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics. The presentation will be available on Biomea Fusion’s Investor Relations Page under the Events section https://investors.biomeafusion.com/news-events.

Key Anticipated Milestones
Icovamenib – Diabetes

  • 52-week follow-up data from type 1 diabetes (“T1D”) patients in COVALENT-112 who completed ≥80% of protocol-specified dosing with the read-out expected in the second quarter of 2026.
  • 26-week primary endpoint data from the Phase II COVALENT-211 and COVALENT-212 studies anticipated in the fourth quarter of 2026.

BMF-650 – Obesity

  • Initial 28-day clinical weight-reduction data from Phase I GLP-131 study anticipated in the second quarter of 2026.

About Icovamenib
Icovamenib is an orally administered investigational small molecule in clinical development for the treatment of diabetes. Icovamenib targets menin, a transcriptional regulator implicated in beta-cell dysfunction, and has been observed to induce transient reductions in menin protein levels in pancreatic islets, thereby modulating pathways associated with insulin secretion and glycemic control. As a potential short course therapy, icovamenib could become an important addition to the diabetes treatment landscape particularly addressing those patients that failed their standard of care therapies.

About Menin’s Role in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — T1D (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a regulatory brake on beta cell turnover and growth, supporting the hypothesis that menin inhibition may enable regeneration of functional cells. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of T2D.

About Type 2 Diabetes and Severe Insulin-Deficient Diabetes
Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in excessive glucose in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease. According to the Centers for Disease Control and Prevention, more than 38 million Americans (~11% of the population) have diabetes, and 98 million adults have prediabetes. Diabetes also represents one of the largest economic burdens on the U.S. healthcare system, with approximately one in four healthcare dollars spent on diabetes care. Within the population of people with T2D, SIDD is a clinically recognized subtype of T2D characterized by profoundly impaired insulin secretion (significantly reduced beta cell function) and poor glycemic control. People with diabetes with severe insulin deficiency often present with higher HbA1c levels at diagnosis, lower BMI compared to insulin-resistant patients, and a rapid decline in beta cell function. This group represents a very high unmet medical need, with the highest risk of complications such as retinopathy and neuropathy and typically progresses the fastest to insulin therapy. Addressing the underlying beta cell dysfunction in this population offers an important opportunity to slow or potentially reverse disease progression.

About Biomea Fusion  
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at www.biomeafusion.com and follow us on LinkedIn, X and Facebook. 

Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase II (COVALENT-111) study, our Phase IIb (COVALENT-211) study, our Phase IIb (COVALENT-212) study and our Phase I (GLP-131) study; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com