Arcutis Announces Promotion of Mas Matsuda to Executive Vice President and Chief Legal Officer to Support Next Phase of Growth




Arcutis Announces Promotion of Mas Matsuda to Executive Vice President and Chief Legal Officer to Support Next Phase of Growth

WESTLAKE VILLAGE, Calif., March 05, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the promotion of Mas Matsuda, JD, currently senior vice president and general counsel, to executive vice president, chief legal officer, and corporate secretary. Mr. Matsuda will continue to lead the Company’s legal, compliance, and governance strategy in support of the continued growth of the Company, commercialization of the ZORYVE^® (roflumilast) portfolio, and protection of the Company’s intellectual property, as well as any corporate transactions.

“I am thrilled to announce Mas’ promotion,” said Frank Watanabe, president and chief executive officer of Arcutis. “Since joining Arcutis, Mas has been a trusted adviser and an instrumental leader, strengthening our legal and compliance foundation while supporting the successful development and growth of ZORYVE. As we highlighted in our recent fourth quarter and full-year results, Arcutis is entering an exciting next phase of growth. Mas’ strategic judgment, deep expertise, and steady leadership will be critical as we continue to expand our commercial presence and advance our portfolio.”

Mr. Matsuda joined Arcutis in January 2022 as general counsel and corporate secretary, leading legal and compliance strategy and serving as secretary to the Board of Directors. He has helped guide the Company through a period of significant commercial growth, including six FDA approvals of the Company’s advanced targeted topical, ZORYVE, while building and scaling the Company’s legal, compliance, and governance framework. Prior to Arcutis, Mr. Matsuda served as senior vice president, general counsel, chief compliance officer, and corporate secretary at Halozyme Therapeutics, Inc. and previously held numerous legal positions including vice president, law, global commercial operations at Amgen.

“Over the past four years, Arcutis has evolved into a leader in medical dermatology with a successful ZORYVE franchise and an advancing pipeline,” said Mas Matsuda, JD. “I am proud to continue contributing to the Company’s momentum and look forward to working alongside our leadership team as we enter the next phase of growth, delivering meaningful innovation for individuals suffering from immune-mediated skin diseases and positioning the Company for sustained, long-term success.”

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform, coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

INDICATIONS
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the Company’s potential growth and pipeline advancement. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bfa6aea2-02c7-4796-b448-9743b310ac22

Evaxion plans to file 2025 annual report later today




Evaxion plans to file 2025 annual report later today

COPENHAGEN, Denmark, March 5, 2026 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will slightly delay the filing and publication of its 2025 annual report, planned before opening of Nasdaq CM today, due to unforeseen technical issues with external vendors.  

The report has been finalized as planned and will be filed and published as soon as possible. The technical issues relate to regulatory filing demands and have nothing to do with the report itself. 

As a consequence of the technical delay, the conference call and webcast planned for today will be moved to tomorrow: Friday March 6 at 8.30 ET/14.30 CET.   

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. 

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. 

Contact information  

Evaxion A/S 
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai 

About Evaxion  

Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. 

With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development 

We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options.  

For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website.  

Forward-looking statement  

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.  

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2025 Financial Results




Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2025 Financial Results

SOUTH SAN FRANCISCO, Calif., March 05, 2026 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2025.

“Our team has made tremendous progress recently in the global Phase 2 B-SUPREME study of pevifoscorvir sodium,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “With the completion of the planned enrollment in the HBeAg- cohort, we are continuing to enroll participants in the HBeAg+ cohort and look forward to the interim analyses in the first and second half of 2026. Additionally, the Phase 2 B-SUPREME study may demonstrate that pevifoscorvir sodium affects the three pillars of HBV disease pathogenesis: replication, integration, and maintenance of the viral reservoir. We are also excited to announce the advancement, in partnership with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”), of ALG-170675, a dual mechanism antisense oligonucleotide (ASO) into IND-enabling studies. Lastly, adding James Hassard as Executive Vice President, Chief Commercial Officer has allowed us to begin laying the groundwork for the future of our best-in-class programs.”

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

• The Phase 2 B-SUPREME study (NCT06963710) of pevifoscorvir sodium in subjects with chronic HBV infection completed the planned enrollment of 60 HBeAg- participants in January 2026. HBeAg+ participants continue to enroll in the study.
• The first protocol defined interim analysis includes approximately 60% (or 36) HBeAg- participants that complete 12 weeks of the treatment period, with this enrollment threshold reached in Q4 2025.
• A second protocol defined interim analysis is planned when approximately 50% (or 55) HBeAg+ participants complete 24 weeks of the treatment period, with this enrollment threshold reached in January 2026.
• Topline data for both the HBeAg- and HBeAg+ cohorts are expected in 2027.
• 96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) with post-treatment data expected to be presented at upcoming scientific meetings.

ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

• Along with our partner Xiamen Amoytop Biotech Co., Ltd. (Amoytop), ALG-170675 was recently selected to proceed into IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in China, Taiwan, Hong Kong and Macau.
• This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg mRNA and activates the immune response through TLR-8 agonism.

ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

• Recently presented in vivo data in diet induced obese (DIO) mice treated with semaglutide (SEMA), tirzepatide (TIRZEP), or a combination of ALG-055009 and SEMA or TIRZEP for 28 days demonstrated synergistic weight loss in the combination groups compared to monotherapy groups. SEMA monotherapy resulted in a maximum of 23.9 ±2.6% body weight loss, while the combination of SEMA and ALG-055009 had an additional 8.6% decrease for a maximum 33% body weight loss. The low and high doses of TIRZEP led to a maxima of 27.1 ±2.7% and 34.4 ±1.6% body weight loss, respectively. Combination of TIRZEP (low) or TIRZEP (high) with ALG-055009 induced an additional 11.7% and 5.8% decrease for a maximum of 39% and 40% body weight loss respectively.
• Furthermore, the additional weight loss in the combination therapy of either incretin receptor agonist and ALG-055009 was mainly due to additional loss of fat mass, with no significant effect on lean mass or food consumption as compared to incretin receptor agonist monotherapy. The data suggest the potential for a significant benefit of adding ALG-055009 to an incretin receptor agonist therapy for weight loss, especially in combination with a low-dose of a potent incretin receptor agonist, such as tirzepatide.
• Evaluation of a variety of options to fund continued development, including potential out-licensing is ongoing.

Business Updates

• James Hassard was appointed Executive Vice President, Chief Commercial Officer to build the Company’s global commercial capabilities.

Financial Results for the Fourth Quarter and Full Year 2025

Cash, cash equivalents and investments totaled $77.8 million as of December 31, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the third quarter of 2026.

Net loss for the three months ended December 31, 2025 was $19.9 million or basic and diluted net loss per common share of $(1.91), compared to net loss of $82.2 million or basic and diluted net loss per common share of $(13.08) for the three months ended December 31, 2024.

Net loss for the year ended December 31, 2025 was $24.2 million or basic and diluted net loss per common share of $(2.45), compared to net loss of $131.2 million or basic and diluted net loss per common share of $(20.94) for the year ended December 31, 2024.

Research and development (R&D) expenses for the three months ended December 31, 2025 were $17.0 million, compared with $16.0 million for the same period of 2024. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.7 million, compared with $1.0 million for the same period of 2024.

R&D expenses for the year ended December 31, 2025 were $69.5 million, compared with $70.3 million for the same period of 2024. The decrease was due to increased government funds received for the coronavirus program which offset related costs.

General and administrative (G&A) expenses for the three months ended December 31, 2025 were $4.9 million, compared with $5.2 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.6 million, compared with $0.7 million for the same period of 2024.

G&A expenses for the year ended December 31, 2024 were $20.7 million, compared with $22.8 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses.

Interest and other income, net, for the three months ended December 31, 2025 was income of $0.8 million compared with income of $0.6 million for the same period in 2024.

Interest and other income, net, for the year ended December 31, 2025 was income of $3.9 million compared with income of $4.4 million for the same period of 2024.

Change in fair value of 2023 common warrants for the three months ended December 31, 2025, was income of $1.2 million compared with a loss of $62.1 million for the same period of 2024.

Change in fair value of common warrants for the year ended December 31, 2025, was income of $60.2 million compared with a loss of $46.1 million for the same period of 2024.

About Aligos

Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, obesity, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.

For more information, please visit www.aligos.com or follow us on LinkedIn or X.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to the expected data releases, data presentations and data readouts for pevifoscorvir sodium; the expected data presentations for ALG-055009; potential success of the Company’s development programs including with respect to ALG-170675; and the company’s expectation that its cash, cash equivalents and investments provide sufficient funding of planned operations into the third quarter of 2026. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2025 and Aligos’ Annual Report on Form 10-K to be filed with the Securities and Exchange Commission on March 5, 2026 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. 

Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com

_____________________________________________

(1)   The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Collegium to Present New Real-World Data at PainConnect 2026




Collegium to Present New Real-World Data at PainConnect 2026

STOUGHTON, Mass., March 05, 2026 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it will present two posters featuring real-world data from its portfolio of differentiated pain medications at PainConnect 2026, the American Academy of Pain Medicine (AAPM)’s Annual Meeting, taking place in Salt Lake City, Utah from March 5-8, 2026. The presentations highlight real-world clinical insights from Collegium’s pain portfolio and reflect the Company’s continued focus on generating evidence that helps inform everyday practice.

“Understanding how therapies perform in real-world settings is essential to informing pain treatment,” said Thomas Smith, M.D., Chief Medical Officer. “These analyses contribute important context that can inform clinical practice and ongoing scientific dialogue.”

The poster presentations will take place Friday, March 6, on TV 1 at The Grand America Hotel.

APPROVED USE
BELBUCA® (buprenorphine buccal film) CIII is:
• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not to be taken on an “as needed” basis.

IMPORTANT SAFETY INFORMATION about BELBUCA®

Important information about BELBUCA:

• Get emergency help or call 911 right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
• Taking BELBUCA with other opioid medicines, benzodiazepines, gabapentinioids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law.
• Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not use BELBUCA if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

Before taking BELBUCA, tell your healthcare provider if you have a history of:

• head injury, seizures
• heart rhythm problems (long QT syndrome)
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• problems urinating
• tooth problems, including a history of cavities
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take BELBUCA, do not take more of BELBUCA without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking BELBUCA.
• pregnant or planning to become pregnant. Use of BELBUCA for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening I not recognized and treated.
• breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death.

When taking BELBUCA:

• Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.
• See the detailed Instructions for Use for information about how to apply BELBUCA.
• Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.
• After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.
• After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
• Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA. Avoid touching or moving the buccal film with your tongue or fingers.
• Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.
• Call your healthcare provider if the dose you are using does not control your pain.
• Do not stop using BELBUCA without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While using BELBUCA DO NOT:

• Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die.

The possible side effects of BELBUCA are:

• nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of BELBUCA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Please see full Prescribing Information, including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide or speak to your healthcare provider if you have questions about BELBUCA.

About Collegium Pharmaceutical, Inc.

Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and a rapidly growing neuropsychiatry business. Collegium’s strategy includes growing its commercial portfolio, with ADHD as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “forecasts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our 2026 financial guidance, including projected product revenues, adjusted operating expenses and adjusted EBITDA, statements related to the projected launch of the authorized generic versions of Nucynta and Nucynta ER and anticipated shared net profits following the launch of such authorized generic versions, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company’s current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenues, capital requirements and need for additional financing. These and other risks are described under the heading “Risk Factors” in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contacts:
Ian Karp
Vice President, Investor Relations
ir@collegiumpharma.com

Danielle Jesse
Director, Investor Relations
ir@collegiumpharma.com

Media Contact:
Jessica Cotrone
Senior Vice President, Communications & Corporate Affairs
communications@collegiumpharma.com

BioRestorative Therapies, Inc. to Participate in the Be+Well Beauty and Wellness Show in New York City, March 8-10, 2026




BioRestorative Therapies, Inc. to Participate in the Be+Well Beauty and Wellness Show in New York City, March 8-10, 2026

Company to engage industry partners and distribution channels as part of expanding BioCosmeceutical commercialization strategy

MELVILLE, N.Y., March 05, 2026 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused on stem cell-based therapies and products, today announced that members of its commercial leadership team will participate in the Be+Well Beauty and Wellness Show taking place March 8-10, 2026 at the Javits Center in New York City. The Be+Well trade show is one of the largest professional beauty, spa, and wellness trade events in the U.S., bringing together 35,000+ beauty and wellness professionals, 600+ exhibiting brands, and 180+ classes and interactive educational opportunities.

BioRestorative will attend the event as part of its ongoing efforts to expand commercialization awareness and distribution opportunities for its BioCosmeceutical platform, which applies regenerative biologics technology to the rapidly evolving aesthetics and longevity markets. The event brings together leading companies, clinics, medspas, distributors, and wellness brands across the beauty, aesthetics, and professional skincare industries.

Crystal Romano, Head of Global Commercial Operations, together with her team, will lead the Company’s engagement at the conference, meeting with potential business and marketing partners, distributors, and practitioners to discuss product adoption, marketing collaborations, and the expanded commercial deployment of the Company’s proprietary regenerative skincare technologies.

“The Be+Well show provides an important opportunity to engage directly with industry stakeholders as we expand awareness of our BioCosmeceutical platform and highlight our unique approach, which intersects skincare, aesthetics, and regenerative medicine,” said Ms. Romano. “Our approach reflects BioRestorative’s broader regenerative medicine expertise, applying biologically active secretome components—including exosomes, growth factors, and signaling proteins—to products designed for professional aesthetics, medical-grade skincare environments, and at-home regenerative regimens. As we see in the market, clinics, medspas, and beauty and self-care venues are rapidly adopting these solutions, with exosome treatments now used globally, signaling the clear shift from cosmetic improvement to true biological performance. Regenerative technologies continue to reshape the aesthetics and longevity markets, and we believe our biologics manufacturing capabilities and scientific foundation position us to participate meaningfully in this emerging category,” Ms. Romano concluded.

BioRestorative is uniquely positioned to lead in this market by entering as a biotechnology company rather than a traditional beauty brand. As a cGMP-compliant, ISO-7 cleanroom cell manufacturing organization advancing therapeutic products under rigorous cell and tissue protocols, the Company brings fully integrated regenerative manufacturing and scientific infrastructure to a category largely driven by marketing-focused skincare brands. This foundation provides vertical control over cell sourcing, processing, quality systems, and scalable manufacturing, driving consistency, supply reliability, and long-term defensibility. BioRestorative’s therapeutic heritage also creates scientific credibility and regulatory discipline, critical differentiators in an emerging market, and enables the Company to translate regenerative science into differentiated, premium biocosmeceutical products.

“As we outlined in our recent letter to shareholders, expanding our BioCosmeceutical platform is an important component of BioRestorative’s broader strategy to generate commercial traction while advancing our clinical pipeline,” said Lance Alstodt, President, BioRestorative Chief Executive Officer and Chairman. “Our highly differentiated, vertically integrated regenerative beauty platform is engineered for scale, credibility, and premium monetization. In addition, we hope that global distribution partnerships, enterprise clinical adoption, and a high-margin direct-to-consumer engine will enable us to capture volume, validation, and recurring revenue simultaneously. This scalable, defensible platform combines biotech differentiation with beauty-level margins, positioning BioRestorative to possibly emerge as a leading company in next-generation regenerative skincare. Events such as Be+Well allow us to engage directly with the clinics, practitioners, and distribution partners that are shaping the future of regenerative aesthetics. We look forward to deepening relationships within this community and to providing updates on our progress as our commercialization efforts continue to develop.”

About the Be+Well Beauty and Wellness Show

For over a century, the International Beauty Show (IBS) and International Esthetic, Cosmetic & Spa Conference (IECSC) have been where beauty, hair, esthetics, cosmetics, spa, and wellness professionals have come to perfect their craft, discover top brands from over 600+ Exhibitors and get world-class education in 180+ classes. Now, both shows unite under one powerful brand: Be+Well | Beauty and Wellness Show. Be+Well | Beauty and Wellness Show brings together the people, products, and ideas driving the beauty and wellness industry forward. Our shows are where products launch, trends emerge, and professionals gather to shape what’s next. The show will be held March 8-10, 2026 at the Javits Center, New York City.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform:

• Disc/Spine Program (brtxDISC^™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain
• Metabolic Program (ThermoStem^®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss
• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial products are formulated and manufactured in our cGMP, ISO-7 certified clean room facility. Each product features a cell-based secretome enriched with exosomes, proteins, growth factors, peptides, and other carefully selected active ingredients. This proprietary biologic portfolio has been thoughtfully engineered to support skin health and longevity while addressing visible signs of aging and enhancing overall cosmetic performance. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Investors
CORE IR
investors@biorestorative.com

Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD™ 2026 Conference




Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD™ 2026 Conference

Kensington, MD, USA and Munich/Martinsried, Germany, March 05, 2026 (GLOBE NEWSWIRE) — Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD™ 2026 Conference

Kensington, MD, USA, and Munich/Martinsried, Germany, March 05, 2026 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, will present pre-clinical data with a next-generation amyloid- (Aβ) aggregation modulator at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026). The conference will take place March 17 – 21, 2026 in Copenhagen, Denmark.

The following poster will be presented:

Title: New oral prodrug of the Aβ aggregation modulator GAL-201 shows significantly improved pharmacokinetic profile
Poster number: #706; Board number: 02-480
Poster Session: Shift 2, March 20 – 21, 2026
Presenters: Katrin Riemann, Ph.D. and Hermann Russ, M.D. Ph.D., Galimedix Therapeutics

The poster will discuss two prodrugs of GAL-201 and their oral bioavailability.

International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026)
AD/PD™ 2026 provides a forum where leading international experts can gather to explore the latest research, clinical trials, and treatments for Alzheimer’s and Parkinson’s. The AD/PD™ Conference has grown to be one of the leading events in the field of neurodegenerative disorders with over 5,500 participants from more than 70 countries and over 2,500 abstracts in 2025. This year, the conference program will include forum discussions, symposia, as well as oral and poster presentations devoted to the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development and clinical trials in AD, PD and other related neurological disorders.

Galimedix is developing orally administered small molecules specifically designed to target misfolded Aβ and suppress the formation of soluble, toxic Aβ aggregates in the brains of people with Alzheimer’s disease. A Phase 1 study evaluating orally administered GAL-101, a first-in-class Aβ aggregation modulator, was recently completed and data demonstrated that GAL-101 was clinically safe and well tolerated and effectively crossed the blood-brain barrier. Target engagement could be shown in CSF and plasma. Phase 2 development in Alzheimer’s and other indications is planned. In addition, GAL-101 eye drops are being investigated in the Phase 2 eDREAM study in patients with geographic atrophy, a severe form of dry age-related macular degeneration, an A-associated retinal disease.

About Galimedix Therapeutics, Inc.
Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry age-related macular degeneration (AMD), glaucoma and Alzheimer’s disease – Galimedix’s initial areas of focus.

Contact
Alexander Gebauer, MD, PhD
Galimedix Therapeutics, Inc.
Co-founder and Executive Chairman
info@galimedix.com

Media inquiries:

Attachment

• 20260305_Press Release_Curtain_Raiser AD-PD2026 Conference

CONTACT: Contact
Alexander Gebauer, MD, PhD
Galimedix Therapeutics, Inc.
Co-founder and Executive Chairman
info@galimedix.com

Media inquiries:

Anne Hennecke                        U.S.
MC Services AG                        Laurie Doyle
Tel: +49 (0)170 7134018        Tel: +1-339-832-0752
galimedix@mc-services.eu         

Oculis to Participate in Upcoming Investor Conferences




Oculis to Participate in Upcoming Investor Conferences

ZUG, Switzerland, March 05, 2026 (GLOBE NEWSWIRE) — Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, announced today that Oculis’ management will participate in upcoming investor conferences in March.

Oculis is pleased to present updates of its innovative, highly differentiated, late-stage portfolio as it enters a pivotal phase in its transformation into a leader in neuro-ophthalmology and ophthalmology. Key highlights include: Privosegtor (PIONEER program) granted breakthrough therapy designation for optic neuritis (ON) as Oculis advances the registrational program in two optic neuropathies to address a potential market opportunity of $7B+ in the U.S. alone; OCS-01 (DIAMOND Phase 3 trials) topline results in diabetic macular edema (DME) on track for Q2 2026; Licaminlimab (PREDICT-1 registrational trial) being evaluated as the first genotype-based development program to drive precision medicine in dry eye disease (DED).

With a strong balance sheet and robust pipeline, Oculis is well-positioned to deliver 6 pivotal readouts with the current funding, to fulfil its mission to save sight and improve eye care with groundbreaking treatments.

Leerink Global Healthcare Conference
March 8-11, Miami, FL, USA
Company presentation by Riad Sherif, M.D., Chief Executive Officer, on March 10^th, 10:40 AM ET.
Webcast link: Register here

Leerink Partners Mountain Meeting
March 22-25, Jackson Hole, WY, USA
Oculis management will participate in one-on-one meetings.

LifeSci Capital Biotech Forum
March 26, New York City, NY, USA
Oculis management will participate in one-on-one meetings.

The company will be available for one-on-one meetings during the conferences. Interested investors should contact their respective representative at the sponsoring institutions to request meetings.

Webcast links, when available, are posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

-ENDS-

About Oculis

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

Oculis Contacts
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 development plans for Privosegtor, OCS-01, and Licaminlimab; the initiation, timing, progress and results of clinical trials of Privosegtor, OCS-01, and Licaminlimab; and Oculis’ research and development programs, regulatory and business strategy, future development plans, and management, 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 U.S. Securities and Exchange Commission (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.