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Over 20 filings are ketamine-based and over 5 are dextromethorphan (DXM)-based; applications total more than 2,700 pages of scientific and technical data; Company expects to disclose the full combination portfolio later this year

AUSTIN, Texas, Sept. 10, 2026 (GLOBE NEWSWIRE) -- EPIK Biosciences (“EPIK” or the “Company”) today announced continued progress as a drug development company advancing proprietary synergistic combination medicines for mental health disorders, severe and chronic pain, and substance use disorders. Brandon Romanek, Founder and CEO of EPIK, is the inventor of the Company’s portfolio of medicines. This announcement follows EPIK’s first press release, issued May 5, 2026: EPIK Biosciences Launches to Pioneer Ketamine-Powered Psychedelic Therapies to Transform Treatment of Mental Health, Pain, and Addiction.

The medicines in development at EPIK are supported by 34 provisional drug patent applications totaling more than 2,700 pages of scientific and technical data. Provisional drug patent applications were filed as a deliberate first step. That approach preserves flexibility as development continues. Why this path was chosen will be made very clear when the Company introduces the full portfolio. The filings cover compositions, co-formulations, unit doses, kits, methods of making, methods of use, dosing regimens, and immediate, delayed, and extended-release profiles, as well as multiple delivery formats.

Indications of use covered in the filings include:

• Depression, including major depressive disorder (MDD) and treatment-resistant depression (TRD)
• Anxiety
• Post-traumatic stress disorder (PTSD)
• Severe, acute, chronic, and neuropathic pain
• Fibromyalgia
• Seizure disorders
• Substance use disorders, including opioid-sparing and opioid-replacement approaches
• Alcohol use disorder
• Cannabis use disorder
  
  

Additional indications of use described in the filings will be announced at a later date, including any the Company may later consider for an FDA development path.

Over 20 of the filings are ketamine-based. Over 5 of the filings are dextromethorphan (DXM)-based. Additional central nervous system (CNS) programs in the portfolio are not being detailed at this time. Specific combination partners and full formulation details are not being disclosed. EPIK expects to make additional portfolio details public later this year.

Delivery formats covered in the filings include sublingual oral lozenges, sublingual oral films, sublingual oral wafers, oral liquid formulations, intranasal formulations, topical formulations, rectal suppositories, and parenteral co-formulations, including intravenous (IV) administration. Sublingual oral formulations, topical formulations, and parenteral co-formulations, including intravenous (IV) administration, are the formats primarily in development at this time. The majority of the delivery methods are designed for home use, not for a clinic or hospital setting.

EPIK is working with Casimir Jones, S.C., one of the leading life sciences and biotechnology intellectual property firms, on patent strategy and prosecution. David A. Casimir, J.D., Ph.D., Founding Partner of Casimir Jones and Co-Founder of Porta Sophia, a nonprofit psychedelic prior art library dedicated to protecting the public domain and supporting responsible patenting, said, “This is an extensive, detailed portfolio. The filings are specific on composition, delivery, dosing, and use, and they are written to be defensible. The portfolio captures the company’s lead programs with patent applications that pair already FDA-approved, non-Schedule I compounds with inventive, patient-friendly formulations and form factors, a foundation we believe positions EPIK well as development continues.”

EPIK has completed pharmacokinetic studies on lead formulations and has initiated toxicology work in rats. The Company expects to have the full toxicology results well before the end of the year. All the active ingredients used in EPIK’s medicines are already FDA-approved compounds and are not Schedule I controlled substances. The Company intends to pursue a 505(b)(2) regulatory path using these compounds in synergistic combinations and plans to hold a pre-IND meeting with the U.S. Food and Drug Administration no later than February 2027. EPIK expects to announce additional company updates over the next two months.

“We cannot thank David Casimir and his team at Casimir Jones enough for all the outstanding work they have done for EPIK since they were retained this year, and for their belief in my vision,” said Brandon Romanek, Founder, CEO, and inventor of the Company’s portfolio of medicines. “We believe the synergistic combination medicines we are working on are very different from anything else being developed in the psychedelic and central nervous system (CNS) space. They are being designed for a lower side-effect profile, and most of our medicines are intended for home use. I strongly believe our combination medicines will have major implications for a variety of medical conditions and can change a lot of lives. Our primary goal is to help make the world a better place.

“The worldwide opioid epidemic remains one of the greatest public-health failures of our time. Tens of thousands of Americans still die from opioid-involved overdoses every year, and millions more are exposed to the risks of prescribed opioids. We believe combination medicines designed as alternatives to opioids — with a lower side-effect profile and intended for use outside a hospital — could change that. Our goal is a future where medicines like these are what physicians reach for first, and opioids are reserved for rare, medically necessary cases, mostly in a hospital setting. We see the same opportunity in anxiety, where too many patients are still started on benzodiazepines.

“What matters now is that EPIK Biosciences is fully prepared before we disclose the full combination portfolio. We expect to make the portfolio public by the end of the year, though that timing is not certain. I am beyond grateful, blessed, and ecstatic with EPIK’s vast portfolio, our team, and our partners.”

About EPIK Biosciences

EPIK Biosciences is an Austin-based drug development company building a proprietary platform rooted in NMDA receptor modulation. The Company is advancing ketamine-based and dextromethorphan (DXM)-based synergistic combination medicines and multi-route delivery systems for mental health disorders, severe and chronic pain, and substance use disorders. Through formulation science and a focused intellectual property strategy, EPIK aims to expand access to treatments that address some of the most pressing healthcare challenges worldwide. Readers who have not seen EPIK’s first press release can read it here. Additional information is available at www.epikbio.com.

Forward-Looking Statements

Any statements that are not historical facts in this press release are forward-looking statements under the Private Securities Litigation Reform Act of 1995 (PSLRA). These statements may include words such as “expects,” “plans,” “will,” “may,” “believes,” “intends,” and similar terms. They cover development plans, regulatory strategy, intellectual property, indications of use, a planned pre-IND meeting with the FDA, home use, timing of additional announcements, toxicology results, and potential therapeutic applications.

Forward-looking statements are based on current expectations and involve risks and uncertainties. Actual results may differ. Provisional drug patent applications do not guarantee that any patent will be issued. Statements regarding side-effect profiles have not been established in human clinical trials. EPIK intends that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA and undertakes no obligation to update these statements except as required by law.

Investor and Company Contact

info@epikbio.com | 1-855-420-EPIK (3745)