Q & A Highlights

Q: Are you developing the oral semaglutide individually or as a validation tool for other incretins, and how does this align with your capital constraints? A: Our primary focus is on RT-114 due to capital constraints. The semaglutide program, RT-116, is a discovery program used to validate delivery of incretins, showing 107% bioavailability. We are not planning a clinical study for RT-116 at this time. The semaglutide molecule could be developed for markets where it might be launched sooner than in the US.

Q: Do you have the capital to conduct Phase 1 trials, and what are the expected costs of goods sold for these products? A: We have budgeted for the RT-114 Phase 1 trial. Regarding costs, we aim to be competitive with injectables, not small molecules, due to their different cost structures. Our manufacturing investments should help achieve a competitive cost of goods.

Q: Why does RT-114 show less variability in weight loss compared to PG-102 subcutaneous injections, and how might this translate to patients? A: The transenteric route is more efficient than subcutaneous, showing rapid onset and less variability. We expect similar results in clinical studies, potentially showing less variability in humans as well.

Q: How will tolerability guide the early clinical development of RT-114, and what flexibility do you have in dosing? A: Tolerability is key for differentiation. The oral formulation allows flexibility in dosing, such as splitting doses to improve tolerability. This flexibility is similar to how some patients manage semaglutide dosing.

Q: What are the implications of the higher peak concentration of RT-114 compared to subcutaneous delivery? A: We will monitor for nausea and vomiting, which can correlate with higher peaks. If necessary, we can adjust titration schedules or split doses to manage these effects. Preclinical studies suggest lower doses may reduce adverse events.

Q: Can you discuss any business development interest in the RaniPill platform? A: Partnering remains a focus, with interest in obesity, immunology, and rare diseases. We have ongoing research collaborations and are exploring multiple partnership opportunities.

Q: How does ProGen's PG-102 compare to Zealand's GLP-1/GLP-2 in terms of weight loss and titration speed? A: It's difficult to compare across studies, but ProGen's PG-102 showed more sustained weight loss in preclinical studies. The FC fusion protein nature of PG-102 allows for rapid titration, which is advantageous.

Q: Do you plan additional animal studies for RT-114 before clinical trials, and how confident are you in seeing similar human data? A: No additional preclinical work is planned before clinical trials. We are confident based on previous studies showing good bioavailability and similar preclinical results, but the clinical study will ultimately confirm this.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.