Viridian Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)




Viridian Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that the Compensation Committee of the company’s Board of Directors, made up entirely of independent directors, approved the grant of non-qualified stock options to purchase an aggregate of 175,000 shares of the company’s common stock to one new employee (the “Inducement Grant”) on July 1, 2025 (the “Grant Date”). The Inducement Grant has been granted outside of the company’s Amended and Restated 2016 Equity Incentive Plan (the “Plan”) but remains subject to the terms and conditions of such Plan. The Inducement Grant was granted as an inducement material to the individual entering into employment with Viridian in accordance with Nasdaq Listing Rule 5635(c)(4).

The Inducement Grant has an exercise price per share that is equal to the closing price of Viridian’s common stock on the Grant Date. The Inducement Grant will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 36 equal monthly installments, subject to the employee’s continued employment with Viridian through the applicable vesting dates.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED.

In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Contacts

IR@viridiantherapeutics.com
Media@viridiantherapeutics.com

Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model




Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model

ERLANGEN, Germany & BERLIN–(BUSINESS WIRE)–The novel compound AC102 almost completely reversed tinnitus in a preclinical model after a single dose. At the same time, the damaged connections between the auditory nerve and inner ear sensory cells were restored. These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure. As there is currently no causal treatment for tinnitus, there is a high medical need.

In the current study, AC102 was administered to the middle ear of one experimental group after acoustic trauma, while a second group received a placebo. Although both groups initially showed signs of tinnitus, they nearly disappeared in the AC102 group after five weeks – in clear contrast to the placebo group. Additionally, the AC102 group showed significantly less loss of synaptic connections between the inner ear and the auditory nerve than the placebo group. This damage is considered to be a potential cause of tinnitus: “Our results suggest regeneration of inner ear structures that are critical for tinnitus and could be an important milestone and a glimmer of hope for a causal treatment of tinnitus,” says the study’s first author, Dr. Konstantin Tziridis from Erlangen University Hospital.

About two-thirds of sudden hearing loss patients also suffer from tinnitus, which persists in around 30% of cases. Although 10-15% of adults experience tinnitus, no effective causal treatment exists. AC102 has the potential to become a new treatment option. In a preclinical acoustic trauma model, it almost completely reversed sudden hearing loss. Since tinnitus often accompanies sudden hearing loss, AudioCure is investigating AC102’s potential efficacy also against tinnitus in its ongoing study. AudioCure’s CEO, Dr. Reimar Schlingensiepen, emphasizes: “Constant ear noise caused by tinnitus can be even more stressful for many patients than the hearing loss itself. With AC102, we hope to eventually have an effective remedy for both conditions. This would be a great relief for patients and doctors who have no approved drug treatment available at present.” AC102 has already been tested for safety and tolerability in a clinical study and is currently being examined in a Europe-wide Phase-2-study in patients for its effectiveness in sudden hearing loss and tinnitus.

Contacts

AudioCure Pharma GmbH

Frauke Luers

Phone: +49 30 2218 397-0

E-Mail: pr@ac-clinical.com
Web: www.audiocure.com

Biosynth Expands Berlin Site with a New Commercial Bioconjugation Suite




Biosynth Expands Berlin Site with a New Commercial Bioconjugation Suite

The new suite extends GMP bioconjugate production for intermediates and active pharmaceutical ingredients from early clinical phase through to late clinical phases and commercial supply.

STAAD, Switzerland–(BUSINESS WIRE)–Biosynth, a leading developer and supplier of critical raw materials and services for life sciences and diagnostics, is pleased to announce the opening of its expanded GMP bioconjugation facility at its existing Berlin site. This strategic expansion significantly enhances Biosynth’s specialized manufacturing capabilities in conjugate vaccines and conjugate drugs, activated PEGs, and polymer-based drug delivery excipients as part of its global manufacturing network.

Thomas Eisele, Chief Operations Officer, stated, “We are thrilled to officially open the new expansion to our bioconjugation facility in Berlin, which represents a significant enhancement to our existing operations. This suite enables the scalable, diverse, high-quality conjugation services that our customers need to advance to the next generation of therapies.”

Frank Leenders, General Manager for the Berlin site, commented, “The construction of our new facility, including class D and C cleanrooms, represents a natural evolution of our Berlin operation—in many ways we are growing alongside our customers. The additional refurbishment of our existing facility enhances our GMP manufacturing capabilities, reinforcing our commitment to meeting the evolving needs of our customers.”

“Conjugation chemistry, advanced polymers and bioconjugation production are critical areas for many of our life science customers,” added Marie Leblanc, Executive Vice President, Life Sciences. “Being able to support projects fully, from initial bioconjugate process development to commercial GMP supply, enables us to provide specialized conjugation solutions for diagnostics and therapeutics—strengthening our position as a trusted partner in the Life Science industry.”

About Biosynth

Biosynth is a leading supplier of critical raw materials and services for the life sciences industry. With a deep commitment to quality, Biosynth serves pharmaceutical, diagnostics and life sciences research customers through its global network of R&D and production sites. Headquartered in Switzerland, Biosynth partners with customers worldwide to accelerate innovation and ensure reliability at every stage of development and manufacturing. For more information, please visit www.biosynth.com.

Contacts

Media Contacts

Biosynth

Aimee Cossins

+44 7984 525560

marketing@biosynth.com

Transition of Promotional Activities for Allergen Immunotherapy Drug Actair® in Japan




Transition of Promotional Activities for Allergen Immunotherapy Drug Actair® in Japan

BAAR, Switzerland & OSAKA, Japan & TOKYO–(BUSINESS WIRE)–Stallergenes Greer, Shionogi & Co., Ltd. (“Shionogi”) and CEOLIA Pharma Co. Ltd (“CEOLIA”) today announced the transition of promotional activities for Actair® in Japan. Actair® is Stallergenes Greer’s sublingual immunotherapy tablet for the treatment of patients suffering from house dust mite induced allergic rhinitis.

After ending the license agreement established in 2010 with Shionogi, which had been responsible for developing, registering, and commercialising Actair® in Japan, Stallergenes Greer has appointed CEOLIA as its new promotional partner in the country starting July 3. To ensure the continuity of both patient care and support for healthcare professionals, Shionogi will continue during a transition period to serve as the Marketing Authorisation Holder (MAH) in Japan and remain responsible for the importation, manufacturing and distribution of Actair®. Shionogi will also provide active support to CEOLIA by transferring knowledge and offering operational assistance.

Stallergenes Greer acknowledges Shionogi’s contribution and sustained commitment to improving allergy care in Japan. The company welcomes CEOLIA as a trusted new partner and looks forward to working closely together to further advance access to allergen immunotherapy treatments and continue to improve the quality of life of patients with respiratory allergies.

ABOUT STALLERGENES GREER

Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries.

For more information, visit www.stallergenesgreer.com.

ABOUT SHIONOGI & Co. Ltd

Shionogi has identified “Contributing to a Healthy and Prosperous Life” as one of its key material issues. The group is committed to building a society where everyone can live vibrantly and true to themselves. With a continued focus on areas of high unmet medical needs, Shionogi strives to deliver innovative treatments that improve the quality of life (QOL) for patients and their families.

For more information, visit https://www.shionogi.com/jp/ja/

ABOUT CEOLIA

CEOLIA, founded in 2010, is a pharmaceutical company dedicated to serving all healthcare needs in the otolaryngology (ENT) field. With a mission and philosophy to serve and contribute to people’s health and happiness, we develop and manufacture and market ethical drugs, medical devices, and diagnostic reagents in the ENT field. For more information, visit https://www.ceolia.co.jp/.

Contacts

Stallergenes Greer

Communications

Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

Shionogi

SHIONOGI Website Inquiry Form: www.shionogi.com/global/en/contact

CEOLIA

Tel: +81 3 3243 1135

CEOLIA Website enquiry form: www.ceolia.co.jp/en/contact/enquiry_form

Token Calls Out Another Preventable Breach: Hawaiian Airlines Attack Echoes Aflac, Underscores Need for Phishing-Proof MFA




Token Calls Out Another Preventable Breach: Hawaiian Airlines Attack Echoes Aflac, Underscores Need for Phishing-Proof MFA

ROCHESTER, N.Y.–(BUSINESS WIRE)–#BioKey–In the wake of Hawaiian Airlines’ disclosure of a cybersecurity incident that disrupted internal IT systems, Token, the leader in biometric, passwordless authentication, issued a stark reminder: this breach, like others before it, was entirely preventable.

Security researchers suspect the same threat group, Scattered Spider, is behind the attack—relying again on real-time phishing and spoofed websites to bypass weak multi-factor authentication (MFA) like push approvals and authenticator apps.

“These aren’t sophisticated attacks,” said Kevin Surace, Chair of Token. “They’re simple relays, executed through fake websites. And they work because companies are still trusting outdated MFA like TOTP codes or app prompts or authentication apps. Hawaiian Airlines just joined a growing list that includes insurers, retailers, and airlines—because legacy authentication is no match for modern phishing.”

Token’s products—Token Ring and Token BioStick—are purpose-built to stop these attacks dead in their tracks.

Why Token Stops What Others Can’t

The breach playbook is now well known:

1. A spoofed website tricks an employee into logging in.
2. The attacker relays the credentials and MFA code to the real site (or tricks the employee into authorizing the attacker on their authentication application).
3. Access is granted—because the authentication method trusts the user, not the origin.

Token products don’t make that mistake.

Token uses biometric fingerprint verification, local cryptographic keys, and origin-checking to ensure only the legitimate user, on the right device, accessing the right site, locally, can log in.

“Even if an employee fell for the phishing link, Token would have blocked the login. The fake site simply wouldn’t pass the cryptographic check, and, in fact, the Token product would have never even been engaged, since proximity is required,” Surace added.

Unlike passkeys—which can be synced across cloud accounts and exploited through account takeovers—Token’s credentials are stored in tamper-proof hardware, tied to a specific domain, and can only be unlocked with a live biometric scan local to the computer logging in. That means no code to intercept, no password to steal, and no cloud account to hijack.

Proven in the Real World

Just days ago, Token warned the industry after the Aflac breach that the use of weak MFA continues to leave companies wide open to phishing attacks. Now, Hawaiian Airlines finds itself in the same position.

“How many breaches do we need before we replace security theater with real security?” Surace asked. “Token isn’t just another MFA solution. It’s phishing-proof, fool-proof, and deployable in a single day.”

About Token

Token’s mission is to eliminate identity-based attacks with the world’s strongest authentication. Token Ring and Token BioStick provide true passwordless, biometric MFA that cannot be phished, replayed, relayed or spoofed. Built on FIDO2 biometric standards, Token is trusted by organizations where security failures are not an option.

For more information, visit www.tokenring.com.

Contacts

Media Contact:
Dan Chmielewski

Madison Alexander PR

949-231-2965

dchm@madisonalexanderpr.com

4basebio Introduces New Branding to Reflect Next Phase of Growth Enabling Development of Advanced Genetic Therapies




4basebio Introduces New Branding to Reflect Next Phase of Growth Enabling Development of Advanced Genetic Therapies

Expanding capabilities in delivering scalable, high-quality synthetic DNA solutions to the global market

CAMBRIDGE, England–(BUSINESS WIRE)–4basebio PLC (AIM: 4BB) (“4basebio”), a specialist in synthetic DNA manufacturing and nucleic acids for next-generation therapeutics, today announced refreshed branding and the launch of its new website, reflecting the company’s continued growth and success in this rapidly advancing field.

Since completing its £40 million investment in November 2024, 4basebio has achieved several major milestones in its mission to deliver scalable, high-quality synthetic DNA solutions to the global market. Notably, in April this year, the Company received MHRA GMP certification for the manufacture and supply of synthetic DNA for clinical use¹.

The updated brand identity introduces a refined visual system, including a modernised logo, refreshed colour palette, and a suite of new imagery. The Company’s redesigned website provides a more intuitive access point for partners and customers, providing detailed information and support for 4basebio’s expanding capabilities across synthetic DNA, mRNA, gene editing, and plasmid-free manufacturing. With a newly curated content hub, users can also access a range of specialist resources, including data, whitepapers, articles, case studies and more.

“This brand refresh marks an exciting milestone for 4basebio,” said Heikki Lanckriet, CEO of 4basebio. “As we continue to scale our operations and deepen our work with partners across RNA, cell and gene therapy, and vaccine development, we wanted our identity to reflect the sophistication and innovation that define our approach. Our new website and branding communicate not just who we are, but where we’re going.”

The rebrand aligns with 4basebio’s broader commercial strategy, which includes an increased presence at industry events, expanded customer engagement efforts, and a continued focus on delivering high-quality synthetic DNA starting materials for next-generation genetic medicines.

To learn more about 4basebio’s technology platforms, manufacturing services, GMP certification and recent partnerships, visit the new website: www.4basebio.com.

1. Press Release (2^nd April 2025): 4basebio receives MHRA GMP licence for manufacture and supply of synthetic DNA

Contacts

Media Contact
Jake Brown

Email: jake.brown@zymecommunications.com
Tel: +44 (0) 7759 162 147

Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial




Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial

• SENS-501, including the surgical delivery of the gene therapy, shows a good safety profile in all patients treated so far
• Three-month results from a SENS-501 treated toddler in the first cohort demonstrate early promising hearing improvement
• The second cohort assessing a higher dose of SENS-501 is ongoing and recruitment is close to being completed

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced preliminary positive data from the first cohort of the Phase 1/2 Audiogene clinical trial evaluating the low dose of SENS-501, the Company’s gene therapy candidate being developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. The second cohort at a higher dose is ongoing and recruitment is close to being completed.

The results from all patients dosed to date (5) confirm that SENS-501 and the corresponding surgical procedure are well tolerated by all participating infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the injection, as per study protocol) having received a gene therapy injection. Intracochlear administration of SENS-501 was uneventful, and no serious adverse events or serious side effects were reported.

Three patients were enrolled into Cohort 1 and received a low dose of SENS-501 of 1.5^E11 vg/vector/ear, corresponding to the minimally effective dose in preclinical studies. The primary objective is to assess the safety and feasibility of the intra-cochlear administration of SENS-501. In Cohort 1, early signs of hearing improvement were observed in Patient 3, aged 11 months at the time of injection. The clinical response observed in Patient 3 was evaluated using standard hearing tests carried out by the investigators (Auditory Brainstem Response ABR, Pure Tone Audiometry PTA, and Patient (Parents) Reported Outcomes PROs).

Three-month data from the Patient 3 include:

• Positive ABR responses at two frequencies, with the best frequency reaching 70 dB.
• Improvement of hearing levels across two speech frequencies with best frequency reaching 90 dB level, per PTA.
• Meaningful changes in responses to sounds and voices as reported by the parents with an IT-MAIS score increase of 16 points (145% relative improvement from baseline), and met expected auditory milestones based on an age-based parent questionnaire and according to the patient’s age (LittlEARS).

The recruitment in Cohort 2, utilizing a second and higher dose level, is nearly complete. The Company plans to provide the next update when Cohort 2 data have reached sufficient maturity to determine next steps for the program.

Professor Catherine Birman, ENT surgeon, otolaryngologist, and Senior Staff Specialist at the Children’s Hospital at Westmead, Australia, commented: “I’m thrilled to report the preliminary Cohort 1 data of SENS-501 in the first infants and toddlers treated with this highly innovative therapy. Treatment with SENS-501 had a good safety profile and the onset of early auditory responses observed in Patient 3 of the first cohort is very encouraging, especially given the very low dose of vector injected, which is primarily intended at assessing the safety of the therapeutic and of the intracochlear surgical procedure. I look forward to Patient 3’s next visit and continuing the Audiogene study with the second cohort to assess a higher dose of SENS-501. Treating children under 31 months of age and naive of cochlear implants is a much-needed undertaking, as restoring hearing in the first three years of childhood has the potential to result in de-novo language acquisition. We thank Sensorion for their commitment to this patient population.”

The Phase 1/2 clinical trial Audiogene (ClinicalTrials.gov ID: NCT06370351), developed in the frame of the strategic partnership with the Institut Pasteur and led by Professor Natalie Loundon, Coordinating Investigator, M.D., Director of the Center for Research in Pediatric Audiology, Pediatric Otolaryngologist and Head and Neck Surgeon, Necker Enfants Malades, AP-HP, in Paris, France, aims to evaluate the safety and efficacy of an intra-cochlear injection of SENS-501 for the treatment of OTOF gene-induced hearing loss in paediatric patients aged 6 to 31 months and naive of cochlear implants at the time of the gene therapy treatment.

Audiogene consists of a dose-escalation part, comprising two cohorts of three patients each, assessing a low dose of SENS-501 in Cohort 1 (1.5^E11 vg/vector/ear) and a higher dose of SENS-501 in Cohort 2 (4.5^E11 vg/vector/ear). The dose-escalation part will be followed by a dose-expansion cohort at the selected dose. While safety is the primary endpoint of the dose escalation study, Auditory Brainstem Response, twelve months following the injection, will be the primary endpoint for the dose expansion part. Audiogene is the first gene therapy clinical trial addressing a unique homogeneous population of infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the gene therapy injection). Addressing this young patient population aims at maximizing the chances of these infants and toddlers to acquire language (below three years old, when brain plasticity is optimal). Furthermore, and uniquely to Audiogene’s gene therapy program, all enrolled patients should not have current or previous cochlear implantation in the treated or contralateral ear, allowing to best document the contribution of the gene therapy in speech development.

About SENS-501

SENS-501 (OTOF-GT) is an innovative gene therapy program developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. This gene plays a key role in the transmission of auditory signals between the hair cells of the inner ear and the auditory nerve. When this gene is defective, affected individuals are born with severe to profound hearing loss.

The aim of SENS-501 (OTOF-GT) is to restore hearing by introducing a functional copy of the OTOF gene directly into hair cells via viral vector technology (AAV). This therapy aims to restore the normal process of converting sound into electrical signals, enabling patients to regain their hearing ability. Currently in the clinical research phase, this gene therapy program represents significant hope for families affected by this rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a commitment to scientific innovation in the field of hearing, with the potential to dramatically improve the quality of life of patients suffering from genetic deafness. This gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital, the Institut Pasteur, and the Fondation pour l’Audition. The project is partially financed by the French National Research Agency, through the “investing for the future” program (ref: ANR-18-RHUS-0007).

The OTOF gene targeted by the Audiogene trial was discovered in 1999 at the Institut Pasteur, by Prof. Christine Petit’s team (Institut reConnect, Institut de l’Audition, Pasteur Institute), who also unraveled the pathophysiology of the corresponding deafness (DFNB9).

About Sensorion

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates.

It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.

Sensorion’s portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion’s small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.

www.sensorion.com

Label: SENSORION

ISIN: FR0012596468

Mnemonic: ALSEN

Disclaimer

This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Contacts

Investor Relations
Noémie Djokovic, Investor Relations and Communication Associate

ir.contact@sensorion-pharma.com

Press Relations
Ulysse Communication

Bruno Arabian / 00 33(0)6 87 88 47 26

barabian@ulysse-communication.com
Nicolas Entz / 00 33 (0)6 33 67 31 54

nentz@ulysse-communication.com

PHC Announces Exclusive Distribution of MaxCyte® ExPERT™ Platform in Japan




PHC Announces Exclusive Distribution of MaxCyte® ExPERT™ Platform in Japan

— Enabling Scalable, Non-Viral Cell Engineering for Research, Biomanufacturing, and Therapeutic Development —

TOKYO–(BUSINESS WIRE)–The Biomedical Division of PHC Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereafter referred to as “PHCbi”), a subsidiary of PHC Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo, hereafter referred to as “PHCHD”) announces it has signed an exclusive agreement with MaxCyte, Inc. to distribute the MaxCyte ExPERT platform^(*1) in Japan. In Singapore, SciMed (Asia) Pte Ltd, a subsidiary of PHCHD, separately entered into an exclusive distribution agreement with MaxCyte and launched the ExPERT platform in the country in June. MaxCyte is a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics. Under this partnership, PHCbi will offer sales and service support for MaxCyte’s instruments, consumables, and solutions, providing researchers and manufacturers with access to a clinically proven, non-viral cell engineering platform.

MaxCyte’s ExPERT instrument portfolio is the next generation of leading, clinically and commercially validated electroporation technology for complex and scalable cell engineering. By enabling high transfection efficiency and cell viability, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enabling the next wave of biological and cellular therapeutics.

PHCbi will distribute and support the full range of MaxCyte platforms covered under this agreement, including the ExPERT ATx®, ExPERT STx®, ExPERT GTx® and ExPERT VLx® as well as related consumables such as processing assemblies and electroporation buffers. These platforms are used by researchers worldwide and have been referenced in more than 70 clinical programs as of Q1 2025.

Chikara Takauo, Director of PHC Corporation and General Manager of PHCbi, commented: “We are pleased to add the MaxCyte’s ExPERT instruments to our cell culture technology portfolio. Guided by our vision of ‘contributing to the evolution and progress of therapeutic modalities,’ we are committed to expanding new solutions that address the challenges of QCD (Quality, Cost, and Delivery) in cell and gene therapy (CGT) manufacturing processes. The addition of MaxCyte’s ExPERT portoflio allows us to better support scientists and cell therapy developers by providing them with a powerful, non-viral tool to advance their cell-based research and development processes and ultimately accelerate the adoption of CGT.”

The addition of MaxCyte’s ExPERT platform complements PHCbi’s ongoing efforts to further enhance the efficiency of CGT development and manufacturing processes while improving cell quality and safety. PHCbi recently introduced the LiCellMo^TM live-cell metabolic analyzer^(*2) for research use, incorporating PHC’s core In-Line Monitoring technology. In addition, PHCbi is developing the LiCellGrow^TM cell expansion system, which is being designed to optimize the cell culture environment by automatically exchanging culture medium based on the metabolic state of cells. Together with the MaxCyte’s platform, these solutions reflect PHCbi’s commitment to delivering comprehensive support for researchers and developers working in areas such as regenerative medicine, immunotherapy, and bioproduction as well as accelerating cell-based innovation in Japan and Singapore.

PHCbi will showcase the ExPERT Platform at the 7th Regenerative Medicine EXPO Tokyo 2025 in Japan, which will be held at Japan’s Tokyo Big Sight from July 9 to July 11, 2025.

7th Regenerative Medicine EXPO Tokyo 2025

Dates: July 9 (Wed.) – 11 (Fri.), 2025

Venue: Tokyo Big Sight Japan, West Exhibition Halls (PHCbi Booth No.: W5-30)

Official Website: INTERPHEX Week Tokyo / Regenerative Medicine Expo Tokyo

About the Biomedical Division of PHC Corporation

Established in 1969, PHC Corporation is a Japanese subsidiary of PHC Holdings Corporation (TSE 6523), a global healthcare company that develops, manufactures, sells, and services solutions across diabetes management, healthcare solutions, life sciences and diagnostics. The Biomedical Division supports the life sciences industry helping researchers and healthcare providers in around 110 countries and regions through its PHCbi-branded laboratory and equipment and services including CO₂ incubators and ultra-low temperature freezers.

www.phchd.com/global/phc

About PHC Holdings Corporation (PHC Group)

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care, Epredia, LSI Medience Corporation, Wemex and Mediford. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, diagnostics and life sciences. PHC Group’s consolidated net sales in FY2024 were JPY 361.6 billion with global distribution of products and services in more than 125 countries.

www.phchd.com/global

About SciMed (Asia) Pte Ltd

SciMed (Asia) Pte Ltd, headquartered in Singapore, is an established and leading provider of products and services for biomedical, life sciences, healthcare, drug discovery, pharmaceutical, laboratories, industrial tests, and agricultural markets. SciMed has become the wholly owned subsidiary of PHC Holdings Corporation in 2023, advancing sales and marketing in life sciences business across Southeast Asia, India, and Oceania.

scimed.phchd.com

About MaxCyte, Inc.

At MaxCyte, we are committed to building better cells together. As a leading cell-engineering company, we are driving the discovery, development and commercialization of next-generation cell therapies. Our best-in-class Flow Electroporation™ technology and SeQure DX™ gene editing risk assessment services enable precise, efficient and scalable cell engineering. Supported by expert scientific, technical and regulatory guidance, our platform empowers researchers from around the world to engineer diverse cell types and payloads, accelerating the development of safe and effective treatments for human health. For more than 25 years, we’ve been advancing cell engineering, shaping the future of medicine. Learn more at maxcyte.com and follow us on X and LinkedIn.

Contacts

Contact for media inquiries:

Investor Relations & Corporate Communications Department

PHC Holdings Corporation

TEL: +81-3-6778-5311

E-mail: phc-pr@gg.phchd.com

Contact for product and service:

Marketing Department, Biomedical Division PHC Corporation

E-mail: masayo.okada@phchd.com

Bay Psychiatric Associates Hosts Open House for Healthcare Providers




Bay Psychiatric Associates Hosts Open House for Healthcare Providers

SAN MATEO, Calif.–(BUSINESS WIRE)–#BayAreaHealth–Bay Psychiatric Associates is excited to announce a successful Open House event at its newly expanded San Mateo location, held on Wednesday, May 7th, 2025. This event welcomed healthcare providers interested in learning more about the clinic’s comprehensive mental health services, including Ketamine/Spravato, Transcranial Magnetic Stimulation (TMS), and Outpatient Services such as Psychotherapy and Medication Management.

Founded in 1994, Bay Psychiatric Associates has long been a trusted leader in mental health care in the Bay Area. To meet the growing demand for advanced treatment options, the clinic has expanded its services. The multidisciplinary team, including psychiatrists and dedicated support staff, works collaboratively to ensure patients receive effective, accessible, and compassionate care.

The Open House featured guided tours of the facility, opportunities to meet the clinic’s medical and administrative staff, and an in-depth overview of the latest in psychiatric care. Hors d’oeuvres and refreshments were provided, and the event also served as a networking opportunity for local healthcare professionals to connect and discuss potential referral partnerships.

“We’re thrilled to open our doors to healthcare providers in the community and share the innovative treatments we offer to help individuals manage mental health conditions,” said Dr. Roberto Estrada, Interventional Psychiatry Medical Director at Bay Psychiatric Associates. “Our team has worked tirelessly to ensure that our services are not only effective but also accessible to those who need them most. We look forward to discussing these advancements with our colleagues in the healthcare field.”

About Bay Psychiatric Associates

Bay Psychiatric Associates is a leading mental health provider in the Bay Area, specializing in innovative treatments for mental health conditions, including Transcranial Magnetic Stimulation (TMS), Spravato (esketamine), and ketamine therapy. The clinic’s multidisciplinary team is dedicated to providing the highest quality care to patients struggling with depression, anxiety, and other mental health disorders. Outpatient clinics are located in Berkeley, San Francisco, Corte Madera, and San Mateo. Learn more via our website.

Contacts

Media Contact:
Saralee Son

Project Manager

Bay Psychiatric Associates

Phone: (510) 843-2220, x153

Email: saralee@baypsychiatric.com

Cybin Reports Fiscal Year 2025 Financial Results and Recent Business Highlights




Cybin Reports Fiscal Year 2025 Financial Results and Recent Business Highlights

– Dosing is underway in the Phase 3 CYB003 PARADIGM program which comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH™ and EMBRACE™) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 patients¹ –

– Strengthened commercial preparations and manufacturing capabilities through partnerships with Osmind and Thermo Fisher Scientific, respectively –

– APPROACH expects to enroll 220 participants at approximately 45 clinical sites across the United States¹ –

– Initiation of second CYB003 pivotal study EMBRACE and completion of CYB004 Phase 2 study in general anxiety disorder expected around mid-2025¹ –

– Cash totaled C$135 million as of March 31, 2025 –

This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplement dated February 10, 2025, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023, April 8, 2024, and January 6, 2025.

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported audited financial results for its fiscal year ended March 31, 2025, and recent business highlights.

“During the past 12 months, we have continued to focus on building out the strong foundation that underpins the clinical and regulatory milestones we anticipate in the coming year,” said Doug Drysdale, Chief Executive Officer of Cybin. “Heartened by U.S. Food and Drug Administration Commissioner Dr. Martin Makary’s recent comments in support of prioritizing this innovative scientific work, as well as the burgeoning government and media attention the field is receiving, we remain steadfastly committed to advancing our two lead programs, CYB003 and CYB004, toward potential approval and commercialization.”

“Developing novel therapies to address the unmet need in mental health care requires dedication, scientific rigor, and the integration of expertise across domains. To help us accelerate our clinical goals, we have entered into several strategic collaborations, including with Osmind and Thermo Fisher Scientific, and have formed strategic partnership agreements among our clinical trial sites. In this way, we leverage the competencies, resources, and infrastructures of these key stakeholders with a goal of expediting the development pathway. Cybin’s lead clinical programs – CYB003, our Phase 3 pivotal program for the adjunctive treatment of major depressive disorder, and CYB004, our Phase 2 program in generalized anxiety disorder – continue to advance, and we look forward to sharing future updates.”

Recent Business and Pipeline Highlights:

Announced additional strategic clinical site partnerships (“SPAs”) to support PARADIGM. The SPAs are designed to facilitate collaboration among sites, cultivate long-term partnerships, enhance efficiency in trial operations, and improve overall site performance.

Engaged Thermo Fisher Scientific, a world-class manufacturing partner, to provide U.S.-based manufacturing for the CYB003 program. Thermo Fisher Scientific offers leading Contract Development and Manufacturing Organization services and has a successful track record across the manufacturing spectrum. Cybin broadened its existing strong relationship with Thermo Fisher Scientific to include the development of both the drug substance and drug product capsules for CYB003. Cybin has engaged Thermo Fisher Scientific as its manufacturing partner in the United States, including partnering with Thermo Fisher Scientific’s pharma services sites in Florence, South Carolina, for Phase 3 clinical supply and future commercialization, and Cincinnati, Ohio, for Phase 3 capsule production.

Partnered with Osmind, a leading service provider to psychiatry practices in the U.S., with the objective of accelerating commercial preparation for clinical-stage pipeline. Osmind advances psychiatry through technology and services to bring innovative mental health treatments to patients in need. Cybin expects to leverage Osmind’s 800-clinic network, point-of-care software, and real-world data to support commercial preparation for its clinical-stage pipeline.

Strengthened intellectual property portfolio with two additional U.S. patents in support of lead clinical programs CYB003 and CYB004. To-date, Cybin’s growing intellectual property portfolio comprises more than 90 granted patents and over 230 pending applications. The recently issued patents are as follows:

• U.S. patent 12,291,499 includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041.
• U.S. patent 12,318,477 is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular injection, including CYB004.

Clinical Program Update

CYB003: Summary of Phase 2 12-Month Efficacy Data in MDD Patients

• 100% of participants receiving two doses of 16 mg were responders.
• 71% of participants receiving two doses of 16 mg were in remission.
• Mean change from baseline in MADRS was approximately -23 points after two 16 mg doses.

CYB004: Phase 2 proof-of-concept study in generalized anxiety disorder (“GAD”) is underway

• The Phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed.
• The Phase 2 study is being conducted at sites in the U.S. and is expected to complete around mid-2025.¹

Q4 and Fiscal-Year 2025 Financial Highlights

• Cash totaled C$135 million as of March 31, 2025.
• Net loss was C$31 million for the quarter ended March 31, 2025, compared to a net loss of C$21 million in the same period last year.
• Net loss was C$113 million for the year ended March 31, 2025, compared to a net loss of C$78 million in the same period last year.
• Cash-based operating expenses consisting of research, general, and administrative costs totaled C$31 million for the quarter ended March 31, 2025, compared to C$24 million, in the same period last year.
• Cash-based operating expenses consisting of research, general, and administrative costs totaled C$100 million for the year ended March 31, 2025, compared to C$65 million, in the same period last year.
• Cash flows used in operating activities were C$21 million for the quarter ended March 31, 2025, compared to C$21 million in the same period last year.
• Cash flows used in operating activities were C$101 million for the year ended March 31, 2025, compared to C$69 million in the same period last year.

About Cybin

Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.

Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Notes:

1. There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See “Cautionary Notes and Forward-Looking Statements”.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plans to complete its Phase 2 study for CYB004 around mid-year 2025; the ability of the Company to enroll participants and add additional clinical sites for the PARADIGM program; the Company’s expectation to enroll 220 participants at approximately 45 clinical sites across the United States for the APPROACH study; initiation of EMBRACE study around mid-year 2025; the anticipated approval and commercialization of CYB003 and CYB004; the ability to accelerate commercial preparation of clinical-stage programs through the Company’s partnership with Osmind; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company’s operations; and the risk factors set out in each of the Company’s management’s discussion and analysis for the year ended March 31, 2025 and the Company’s annual information form for the year ended March 31, 2025, which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Contacts

Investor & Media Contact:
Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com