Tasman Therapeutics Advancing Oral Ketamine Program to Pivotal Phase 3 Studies

Biotech Industry Leader Dan Browne Appointed CEO

- Tasman’s R-107 is an investigational, Phase 3, extended-release, oral ketamine tablet and monotherapy for patients with treatment resistant depression (“TRD”).

- BEDROC Phase 2 randomized, placebo-controlled, double-blinded, dose-finding study met its primary endpoint, demonstrating R-107 had a rapid onset, durable effect, and statistically significant improvement in TRD symptoms over 12 weeks compared with placebo.

- $175M Series A fundraising is underway to support the global Phase 3 clinical program in the US, EU and other international study locations.

- Tasman hires CEO Dan Browne who co-founded and led Revance Therapeutics, Inc. and its IPO and neuromodulator platform. He currently serves on the Galderma Group AG Board of Directors.

- R-107 has blockbuster potential with peak sales projected to be >US$2Bn.

SAN FRANCISCO, April 3, 2025 – Tasman Therapeutics, Inc. (Tasman) has announced plans to raise $175 million in Series A funding to support the late-stage clinical development and eventual commercialization of R-107. This innovative extended-release oral ketamine tablet is being investigated as a monotherapy for patients with Treatment-Resistant Depression (TRD), a condition that presents significant challenges in mental health care. R-107 represents a potential breakthrough in addressing the needs of individuals living with difficult-to-treat depression.

Dan Browne, CEO of Tasman Therapeutics.

After an extensive search, biotech industry veteran Dan Browne has been appointed as Tasman CEO in order to advance the company’s neuroscience and neuropsychiatric programs. He will be attending investor meetings in New York, Boston, and San Francisco in late April.

Tasman is a newly incorporated, US-based subsidiary and spin-out from Douglas Pharmaceuticals Ltd. (Douglas), New Zealand's largest pharmaceutical company. Tasman will be headquartered in the San Francisco Bay Area and independently financed. Douglas, a private company founded in 1967 with global sales of branded, complex generic, and 505(b)(2) formulations, will provide continuing operational and manufacturing support.

“Over the past several years, I’ve considered leading a number of biopharmaceutical companies,” said Browne, who founded Revance Therapeutics in 1999, leading it to a multi-billion-dollar market capitalization during his tenure as CEO. “Tasman, however, is the organization that has truly engaged both my mind and heart. We are all connected to someone who has been consumed by depression. I firmly believe this company has the power to transform lives with a safe, rapid, and effective medication—one that brings hope, healing, and lasting change.

Through my extensive experience in biopharmaceuticals, I recognized ketamine’s many positive properties. However, current treatments—administered intravenously or via nasal spray in clinics—often lead to dissociation and instability in patients. We believe our product can overcome this limitation, offering a safer and more controlled solution."

Tasman’s pivotal Phase 3 ROCKET Program is set to begin patient enrollment in the second half of 2025. This program will generate crucial data on the safety, onset of effect, and durability of a novel oral ketamine monotherapy designed for at-home administration. Tasman aims to present their findings to the FDA in 2027, paving the way for potential commercialization in 2028.

In the randomized, placebo-controlled Phase 2 BEDROC dose finding study, R-107 demonstrated rapid and durable antidepressant efficacy with minimal dissociation and blood pressure change. Approximately 75% of TRD patients achieved remission within one week of treatment initiation, and the 180 mg dose group showed a statistically significant 6.1-point reduction in depression symptoms assessed by the Mongomery-Åsberg Depression Rating Scale (MADRS) compared to placebo at the end of the 12-week study. Unlike other ketamine-based treatments that require in-clinic administration and monitoring, R-107 is designed to be self-administered at home, significantly expanding access and dignity to patients that suffer from TRD.

R-107's robust safety profile in studies to date is enabled by a proprietary extended-release formulation that reduces the acute dissociative effects of ketamine allowing R-107 to be self-administered at-home safely. The “slow peak” would also reduce the drug’s abuse potential, said Prof Allan Young of Kings College London and co-author of the study findings.

In a post-Phase 2 trial open-label compassionate supply program, 106 TRD patients have been prescribed R-107 for an average duration of more than 2 years without dissociation or significant adverse events reported while taking the product at home without onsite monitoring.

R-107 has potential for expedited regulatory pathways in the US and EU, with potential market entry as early as 2028 and strong IP protection in place through to at least 2037, excluding potential extensions. Douglas has also collected positive responses to the R-107 Target Product Profile from Key Opinion Leaders and payers in US and EU markets.

“We are very excited that we have found someone of Dan’s caliber to lead Tasman and R-107 into this next phase of our journey to bring a safe, efficacious and convenient therapeutic to millions of patients who suffer difficult to treat depression. We very much look forward to welcoming new investors into Tasman so that we can take R-107 through our Phase 3 clinical program, to registration and commercialization” said Jeff Douglas, Managing Director of Douglas and Tasman.

About Dan Browne

Mr. Browne brings more than 30 years of entrepreneurial and executive leadership experience in the life science industry with more than 20 years of expertise in advancing highly potent biologic protein & oligopeptide conjugations, as well as molecular and transmembrane transport of large and small molecule products targeting neurologic, dermatologic, and cardiovascular markets. He is recognized for changing the competitive landscape from discovery and development of DAXXIFY™ the first FDA approved long-acting protein/peptide neuromodulator for neurologic and dermatologic applications. During his tenure, Mr. Browne led clinical, regulatory, finance, and commercial operations, successfully raising over $900 million in private and public capital.

Mr. Browne currently serves as an independent director at GALDERMA GROUP AG, a public Swiss-listed company and the largest pure-play global dermatology company in the world and on several private healthcare company boards.

About R-107

R-107 is an innovative proprietary extended-release oral tablet of racemic ketamine, being developed as a monotherapy for Treatment-Resistant Depression (TRD). Poised to be the first oral monotherapy for TRD, R-107 offers the groundbreaking advantage of safe self-administration in the comfort of patients' homes. Protected by patents through at least 2037, with potential for extensions, R-107 has garnered positive feedback from Key Opinion Leaders and payers across U.S. and EU markets regarding its Target Product Profile.

Nature Medicine publication: BEDROC Study

Pre-Print of Cell Reports Medicine publication: BEDROC-1 Study

About Difficult to Treat Depression and Treatment-Resistant Depression

Treatment-Resistant Depression affects approximately 20 million patients in the United States and Europe. TRD is defined as depression that hasn't responded to at least two different oral antidepressant treatments. Current treatment options for TRD are limited in efficacy and tolerability, with many requiring clinic-based administration and monitoring.

About Tasman Therapeutics

Tasman Therapeutics is a newly incorporated, clinical-stage pharmaceutical company focused on developing innovative treatments for neuropsychiatric disorders. The company's lead product candidate, R-107, is an extended-release oral ketamine tablet in development for Treatment-Resistant Depression.

About Douglas Pharmaceuticals

Douglas Pharmaceuticals is New Zealand's largest pharmaceutical company, employing over 700 people and exporting to more than 40 countries globally. Founded in 1967 by pharmacist Sir Graeme Douglas, the company develops, manufactures, and distributes novel and complex generic formulations and products, with a preference for those with strong intellectual property positions and technical complexity in areas of high unmet need.

For further information, please contact:

Tasman Therapeutics, Inc.

Knight Marketing Communications Ltd.

Kevin Knight

Mobile: 214-732-9392

Email: kknightpr@gmail.com

Douglas Pharmaceuticals Ltd

Lisa Craigie

Chief Legal & Commercial Officer

Email: lisac@douglas.co.nz

DAXXIFY® is a registered trademark of Revance Therapeutics, Inc.

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