Hunter Capital RTO 1 AB (publ) ("Hunter Capital RTO 1" or the "Company") announces that ResoTher Pharma A/S ("ResoTher"), the Company's proposed reverse acquisition target, has reported top-line Phase 2a results for RTP-026 in patients with ST-elevation myocardial infarction ("STEMI"). The results showed a strong safety and tolerability profile together with encouraging and consistent efficacy signals across several parameters for cardiac function and myocardial infarct size. The results constitute a key condition precedent under the previously announced letter of intent regarding the proposed reverse acquisition. This condition precedent has now been fulfilled.
Most notably, in the Phase 2a study both RTP-026 dose groups demonstrated an 8 percentage point improvement in median left ventricular ejection fraction ("LVEF") at Day 90, compared with an improvement of 2.5 percentage points for placebo. This corresponds to a 3.2-fold greater improvement in cardiac function in both active treatment groups compared with placebo.
The results were observed despite patients in the active treatment groups presenting with greater disease severity at baseline than patients in the placebo group.
Together, the results provide further clinical support for the continued development of RTP-026 and further strengthen the strategic rationale for the proposed reverse acquisition.
The Phase 2a readout constituted a key condition precedent under the LOI between Hunter Capital RTO 1 and ResoTher for proceeding with the proposed reverse acquisition. Following the strong safety and encouraging efficacy top-line results reported by ResoTher, this condition precedent has been fulfilled.
The parties will therefore continue to advance the proposed transaction in accordance with the LOI. The remaining condition precedent is that ResoTher shall have raised, or otherwise have access to, at least SEK 65 million in additional financing. Together with the approximately SEK 15 million previously raised, this would bring the total financing to approximately SEK 80 million.
Completion of the proposed reverse acquisition remains subject to fulfilment of this remaining condition, completion of the transaction process and execution of definitive transaction documentation, as applicable.
The randomized, double-blind and placebo-controlled Phase 2a study enrolled 66 patients with severe STEMI undergoing standard treatment with percutaneous coronary intervention ("PCI"). The study was designed primarily to evaluate the safety and tolerability of ascending doses of RTP-026 and to explore potential efficacy signals.
Patients were randomized to RTP-026 at doses of 25 µg/kg or 75 µg/kg, or placebo. Treatment was administered as three intravenous infusions within 24 hours following PCI.
At Day 90, median LVEF improved:
This represents an improvement of 8 percentage points in both RTP-026 groups compared with 2.5 percentage points in the placebo group.
Importantly, patients randomized to RTP-026 presented with greater disease severity at baseline than patients receiving placebo.
Anterior or septal infarctions were present in 50% of patients in each RTP-026 treatment group compared with 31.3% in the placebo group. Patients in the 75 µg/kg group also had considerably higher baseline levels of cardiac troponin T ("cTnT") and CK-MB, two important biomarkers of myocardial injury.
Despite these baseline differences, the active treatment groups demonstrated encouraging signals across several measures of cardiac injury and recovery.
At 24 hours following PCI, median cTnT levels had increased by approximately 129% in the 25 µg/kg group and 65% in the 75 µg/kg group, compared with approximately 615% in the placebo group.
Median infarct size at Day 90 was also numerically smaller in both RTP-026 treatment groups:
Taken together, the findings show a consistent numerical pattern across cardiac function, myocardial injury and final infarct size, supporting continued clinical development of RTP-026.
RTP-026 was safe and well tolerated in this high-risk STEMI population at doses of up to three infusions of 75 µg/kg.
No new safety signal was identified, no patients withdrew due to adverse events, and no fatal cases or rehospitalisations due to major adverse cardiovascular events were reported.
Serious treatment-emergent adverse events were reported in three patients receiving active treatment. All were assessed by the treating clinicians as being related to the underlying disease and not to RTP-026. One serious treatment-emergent adverse event was reported in the placebo group and was considered possibly treatment related.
The Phase 2a study was primarily designed to establish safety and tolerability and explore preliminary efficacy signals and was therefore not statistically powered to demonstrate efficacy.
Based on the encouraging safety, tolerability and preliminary efficacy findings from the Phase 2a study, ResoTher has commenced preparations for an international Phase 2b Proof-of-Concept study with RTP-026.
The Phase 2b programme is intended to further evaluate the treatment effect of RTP-026 in a larger patient population. ResoTher is preparing to initiate the study towards the end of 2026.
Jacob Eriksson, CEO of Hunter Capital RTO 1, comments:
"Today's results represent a major milestone in the proposed transaction with ResoTher. The Phase 2a readout has fulfilled a key condition precedent under the LOI, allowing the parties to continue advancing the proposed transaction.
Beyond the transaction itself, we are highly encouraged by the clinical findings, which were better than we had expected. The study demonstrated strong safety and tolerability together with consistent efficacy signals across several clinically relevant parameters. At Day 90, median LVEF improved by 8 percentage points in both RTP-026 treatment groups, compared with 2.5 percentage points in the placebo group, despite patients receiving RTP-026 presenting with greater disease severity at baseline.
The consistency of the observed signals across cardiac function, myocardial injury and infarct size further strengthens our conviction in ResoTher and the strategic rationale for the proposed reverse acquisition.
With this important transaction condition now fulfilled and ResoTher preparing RTP-026 for Phase 2b development, we believe the company is entering an important next stage of its clinical and corporate development."
RTP-026 is an investigational, first-in-class Annexin A1 mimetic designed to engage biological pathways involved in the natural resolution of inflammation.
The approach is intended to promote resolution of excessive inflammation, support tissue repair and potentially protect organ function without broadly suppressing the immune system.
RTP-026 is currently in clinical development as a potential cardioprotective treatment for patients with STEMI undergoing PCI.
ResoTher Pharma is a clinical-stage biotechnology company focused on the development of a novel class of Annexin A1-based resolution therapeutics for the treatment of acute hyperinflammatory disorders.
The company's activities centre on a scientific invention originating from the William Harvey Research Institute at Queen Mary University of London, to which ResoTher owns the rights.
Its lead drug candidate, RTP-026, is in Phase 2 clinical development as a potential cardioprotective treatment intended to reduce post-PCI inflammatory cardiac tissue damage and improve cardiac function.
Hunter Capital RTO 1 and ResoTher have entered into a letter of intent regarding a proposed reverse acquisition whereby ResoTher is intended to become the operating business of Hunter Capital RTO 1.
Further information regarding the proposed transaction will be communicated as the process progresses.
For further information, please contact:
Jacob Eriksson, VD
Email: jacob.eriksson@hunterrto.se
Website: www.hunterrto.se