– Positive Phase 3 pivotal trial results for cebranopadol accepted as a Scientific Abstract oral presentation –

– Positive results from ALLEVIATE-1 Phase 3 pivotal trial for cebranopadol which demonstrates statistically significant pain reduction compared to placebo in patients after abdominoplasty will be presented –

– A symposium on dual-NMR agonists, a promising new analgesic class for treating pain, will be hosted by Tris Pharma and feature leading industry researchers –

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced that the company will have multiple cebranopadol presentations during the upcoming PAINWeek Annual Meeting, taking place on September 2-5, 2025, in Las Vegas, Nevada.

The positive Phase 3 pivotal trial results will be presented as a Scientific Abstract Oral presentation to highlight data supporting cebranopadol, currently under development, as a much-needed novel treatment option for patients with moderate-to-severe acute pain. Tris Pharma will also host a symposium focused on dual-NMR agonism, a promising new mechanism of action to treat moderate-to-severe acute pain as effectively as oxycodone and with the potential for significantly lower adverse events such as respiratory depression, euphoria and dependence.

“We are excited to engage with the medical community at PAINWeek and highlight the potential of dual-NMR agonists to dramatically change how we treat pain,” said Ketan Mehta, founder and CEO at Tris Pharma. “The data we are presenting underscore both the need for better treatments for acute pain and highlight the potential role this novel mechanism could play in fulfilling that goal.”

Tris Pharma Presentations

Scientific Abstract Oral Presentation

• Poster Presentation: Results of a Randomized, Placebo-Controlled, Phase 3 Trial of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
• Presenter: James Hackworth, Ph.D., Chief Business Officer, at Tris Pharma
• Date/Time: Thursday, September 4, 2025, from 4:05PM to 4:15PM
• Location: Exhibit Hall

Details of the Lunch Symposium

• Symposium: Dual-NMR Agonists to Overcome the Current Shortfalls in the Management of Severe Acute Pain: Break the Mold in Pain Biology
• Presenters: Jeffrey Gudin, M.D., University of Miami Miller School of Medicine; Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, WVU School of Pharmacy; Megan J. Shram, Ph.D., Altreos Research Partners, Inc.
• Date and Time: Tuesday, September 2, 2025, from 12:00PM – 1:00PM
• Location: Brera Room

About Acute Pain

Acute pain affects millions of patients each year and is caused by injury, surgery, illness, trauma, burns or painful medical procedures, which can last up to three months, and typically resolves once the underlying cause is treated or healed. Moderate-to-severe acute pain can often only be effectively treated with opioid analgesics such as oxycodone, especially following joint replacements and other orthopedic procedures, invasive surgeries, and major traumas and burns.

About Cebranopadol (TRN-228)

Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual-NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). These receptors are partially homologous to each other and they play both complementary and distinct roles to modulate pain biology pathways. Studied in over 33 clinical trials in more than 2,300 patients, cebranopadol’s profile has been well characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first dual-NMR pain-relief therapy with the demonstrated ability to provide efficacy equivalent to oxycodone with less potential for misuse or risk of physical dependence, addiction or overdose.

Cebranopadol’s novel mechanism of action has potential in treating patients with substance use disorders (SUDs). Tris plans to continue to evaluate cebranopadol’s potential to help patients break the cycle of opioid addiction. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol’s potential to treat OUDs and SUDs.

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

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