Mr. Brent Zettl reports

ZYUS LIFE SCIENCES ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 2A UTOPIA-1 TRIAL EVALUATING NOVEL NON-OPIOID PAIN DRUG IN PATIENTS WITH ADVANCED CANCER

Zyus Life Sciences Corp. has released positive top-line results from its phase 2a Utopia-1 (unique treatment of oncology pain in advanced cancer) clinical trial evaluating dosing, safety and efficacy of Trichomylin softgel capsules in patients with advanced cancer experiencing moderate to severe cancer-related pain.

• Phase 2a Utopia-1 trial results showed Trichomylin softgel capsules demonstrated clinically relevant efficacy signals using multiple pain assessments.
• Trichomylin softgel capsules were well tolerated, with no related serious adverse events observed, supporting the sustainability of an individualized titration dosing regimen.
• Trichomylin softgel capsules demonstrated opioid-reducing potential, identified as a key finding that warrants further investigation as a potential co-primary end point in future clinical trials. This aligns with the United States Food and Drug Administration (the FDA) draft guidance (issued September, 2025, and updated May, 2026), which encourages pharmaceutical development programs that both expand novel analgesic options and decrease opioid analgesic exposure and prevent new addiction.
• Data supports advancement of Trichomylin softgel capsules into larger randomized controlled trials to further evaluate safety, pain management efficacy and opioid reduction.

Phase 2a Utopia-1 study design

The recently completed phase 2a Utopia-1 trial was conducted at three Canadian sites: McGill University Health Center, CancerCare Manitoba and Centre Hospitalier de l'Universite de Montreal. A total of 11 patients were enrolled (five men, six women; mean age 60.7 years) and maintained on standard-of-care pain management, including long-acting opioids, throughout the trial. The study design used an individualized titration dosing design for Trichomylin softgel capsules as additional pain management. The phase 2a Utopia-1 trial design enabled the evaluation of key objectives, including dosing via individualized titration, safety and tolerability, pain management, quality of life, and opioid use.

Phase 2a Utopia-1 top-line results

Based on internal analyses of data available as of the date of this announcement, the phase 2a Utopia-1 trial fulfilled its role as a signal-generating study, achieving encouraging findings among key objectives.

Among the full set of 11 patients enrolled and treated with Trichomylin softgel capsules:

• Dosing: 91 per cent of patients successfully titrated to an individualized, stable dose level;
• Safety: no treatment-related serious adverse events were observed.

In the subset of seven evaluable patients that adhered to the treatment and assessment plan:

• Pain analyses signaled a clinically relevant decrease in pain (a predefined greater than or equal to 30-per-cent threshold for improvement) across multiple pain assessments at the end of Trichomylin softgel capsules dosing:
  • Average pain: 43 per cent of patients met the threshold for pain on average;
  • Pain severity: 29 per cent of patients met the threshold for pain severity;
  • Pain interference: 57 per cent of patients met the threshold for pain interference.
• Changes in symptoms of pain, fatigue and insomnia signaled health-related quality of life improvements.
• At the end of Trichomylin softgel capsule dosing, 29 per cent of evaluable patients rated their overall condition as much improved, consistent with the predefined threshold for clinical relevance, while 57 per cent rated their overall condition as minimally improved.

In a secondary analysis of opioid use, a signal of reduced rescue opioid use was observed during treatment with Trichomylin softgel capsules. All patients in the evaluable subset were prescribed opioids for breakthrough pain:

• Rescue opioid use: Seven of seven patients were prescribed rescue opioid medications.
• Rescue opioid use: Two of seven patients did not require use of their rescue opioids during dosing of Trichomylin softgel capsules.
• Rescue opioid reduction: Of the five of seven patients that used rescue opioids, the distribution of average rescue opioid use across Trichomylin softgel capsules dosing phases revealed that approximately 79 per cent occurred in the titration phase, which then decreased to approximately 6 per cent during stable dosing of Trichomylin softgel capsules.

"Trichomylin softgel capsules are positioned between NSAIDs, which are often insufficient for moderate-to-severe pain, and opioids, which are effective but carry risks of dependency and abuse," said Scott Livingstone, vice-president, clinical operations, of Zyus. "The phase 2a Utopia-1 trial is an important step in generating the clinical evidence to support the continued development of Trichomylin softgel capsules as a potential non-opioid treatment option."

"These phase 2a Utopia-1 results are an encouraging step toward understanding how Trichomylin softgel capsules may complement standard of care for pain control," said Dr. Julie Stakiw, chief medical officer of Zyus. "Patients reported improvements beyond pain reduction, including fatigue and sleep, and these findings support advancing into long-term studies of safety, efficacy and the potential for opioid reduction."

Next steps

In addition to positive signals for efficacy, safety and opioid reduction, the phase 2a Utopia-1 trial generated important scientific and operational insights to inform the potential advancement of Trichomylin softgel capsules into future controlled clinical trials. Final interpretation of the results and planning for the next clinical trial will be informed by validated analyses of the programmed dataset, which are currently in progress. The company plans to incorporate opioid-reduction, for both long-acting and breakthrough opioids, as a co-primary end point alongside pain efficacy in future trials. This objective is intended to align with the Food and Drug Administration's draft guidance, development of non-opioid analgesics for chronic pain, released September, 2025 (updated May, 2026).

The company plans to present top-line results from its phase 2a Utopia-1 trial at the Montreal International Palliative Care Congress (MIPCC 2026) in October, 2026, as well as at future scientific meetings. Zyus also aims to submit the results for publication in a peer-reviewed journal.

"The opioid crisis has underscored the need for additional alternative treatment options for patients living with chronic pain. These phase 2a Utopia-1 results represent an important milestone in the continued clinical and regulatory development of our lead drug candidate," said Brent Zettl, president and chief executive officer of Zyus. "We are sincerely grateful to the patients who chose to participate in this trial. While facing advanced cancer and the challenges associated with their illness, their willingness to contribute to clinical research has helped advance our understanding of potential new treatment options for patients living with cancer-related pain."

About Trichomylin softgel capsules

• Patented fixed-dose combination formulation containing Cannabichromene (CBC), a new chemical entity protected by an issued company patent;
• Demonstrated preclinical analgesic activity in neuropathic and inflammatory pain models comparable to or exceeding that of standard-of-care pain medications;
• Multiple mechanisms of action across voltage-gated sodium channels, anti-inflammatory pathways and the endocannabinoid system, aim to provide broad and robust therapeutic pain management effects;
• Favourable safety profile expected to be compatible with patients taking opioids, enabling the potential for opioid-reduction.

About Zyus Life Sciences Corp.

Zyus is a clinical-stage life sciences company advancing a pipeline of novel, non-opioid pharmaceutical drug candidates targeting a significant unmet need in the global pain management market. Through rigorous scientific research and clinical development, Zyus is building a robust intellectual property portfolio to protect its innovative therapies and strengthen long-term shareholder value. The company is focused on advancing its proprietary drug candidates through clinical development and toward regulatory approval, with the goal of providing non-opioid treatment options for patients with chronic and neuropathic pain.

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