Pharma Equity Group (“PEG” or “the Company”) announced on Monday, September 1st, 2025, that the Company’s subsidiary, Reponex Pharmaceuticals A/S (“Reponex”), has received regulatory approval to initiate a pivotal Phase II clinical trial of the drug candidate RNX-011. The trial aims to investigate the treatment of secondary peritonitis, a serious and life-threatening intra-abdominal infection associated with high mortality.
Analyst Group’s view of the approval to initiate clinical trial for RNX-011
We view the regulatory approval to initiate a pivotal Phase II study with RNX-011 as a strategically important milestone for PEG, significantly strengthening the asset’s credibility in relation to potential partnering discussions. The study design is commercially oriented, with the primary endpoint focused on reducing severe postoperative complications – the critical data that potential pharma partners require in order to enter into licensing agreements. Given the high unmet medical need in secondary peritonitis and the lack of effective localized therapies, positive outcomes could position RNX-011 as a first-in-class treatment option with strong partnering potential. While the small sample size (32 patients) limits the breadth of the dataset, we believe that a clear signal of efficacy and safety would be sufficient to support further development and represent a key inflection point for PEG to convert partner dialogues into tangible cash flows. Moreover, a favorable outcome would not only de-risk the investment case but also strengthen PEG’s bargaining position in negotiations with potential licensing partners.
The Phase II Clinical Trial
Reponex has received regulatory approval to initiate a pivotal Phase II clinical trial with RNX-011 for secondary peritonitis, a life-threatening intra-abdominal infection with high mortality. The randomized, placebo-controlled trial will evaluate a novel triple-action combination therapy (fosfomycin, metronidazole, GM-CSF) administered intraperitoneally during surgery.
The study aims to demonstrate that RNX-011 can reduce serious postoperative complications, such as abscesses and re-operations, which represents the key commercial endpoint for potential partners and payers. Secondary endpoints include biomarkers of inflammation (IL-6) and patient recovery (QoR-15), providing mechanistic support for the clinical effect.
Enrollment will comprise 32 patients, with first inclusion expected in Q4-25. The approval marks a critical milestone, validating the Company’s scientific strategy and positioning PEG for future partnering discussions.
In summary, Analyst Group is of the opinion that the regulatory approval for the pivotal Phase II trial with RNX-011 represents a strategically important milestone that strengthens PEG’s position in upcoming partnering discussions. Positive clinical progression, particularly signals of efficacy and safety in reducing severe postoperative complications, would not only de-risk the investment case but also serve as one of the main value drivers going forward. Coupled with securing adequate funding to support the ongoing clinical program, we view these factors as the most critical triggers for unlocking PEG’s long-term potential.
Analyst Group’s view of PEG as an investment
With a new strategy announced in H1-25, PEG is transitioning toward a diversified investment platform within life sciences, anchored by two Phase II assets with near-term commercialization po-tential: RNX-011 (peritonitis) and RNX-051 (colorectal cancer). Both are expected to enter pivotal trials in H2-25, with partnering discussions aimed at de-risking execution and securing co-funding. The strategy leverages a capital-light model of drug repositioning and out-licensing, enabling PEG to scale efficiently while maintaining a lean cost base. Supported by a strengthened leadership team and sharpened strategic focus, the Company is well-positioned to unlock meaningful shareholder value, contingent on securing adequate funding to capitalize on upcoming clinical and commercial catalysts. A potential present value of DKK 0.6 per share is derived in our Base scenario using an rNPV model. Analyst Group maintains that the substantial potential of PEG’s drug candidates is not currently reflected in the Company’s current valuation.
