5/14/2025

speaker
Operator
Conference Operator

Good afternoon, and welcome to OnClinic's Biotech's first quarter conference call. All participants are now in listen-only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Patton, Director of Investor Relations and Communication. Please go ahead.

speaker
John Patton
Director of Investor Relations and Communication

Thank you, Operator. Today, we'll provide an update on the quarter and a review of our financials. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Pella Rear Rep, including statements regarding the company's ongoing CEO search, our mission, strategies, and milestones, the company's belief as to the potential and mechanism of action of Pella Rear Rep as a cancer therapeutic, our potential registrational opportunities for Pella Rear Rep, and our plans and strategies related thereto, our plans to continue enrollment in Goblet Cohort 5, our ongoing business development initiatives, and other statements related to anticipated developments in the company's business. These statements are based on management's current expectations and beliefs, and are subject to a number of factors which involve none and no known risk delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncologics expresses an expectation or belief as to future results, Such expectations or beliefs are expressed in good faith, and our beliefs have a reasonable basis, but there can be no assurance that these statements or expectations or beliefs will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property production, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC. OnClinics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. On today's call, I'm joined by Chair of OnClinic's Board of Directors and Interim CEO, Wayne Pisano, Chief Medical Officer, Dr. Tom Heinemann, VP of Business Development, Christophe Degas, and Chief Financial Officer, Kirk Loke. The team will be available for Q&A at the end of this call. And with that, I'll hand it over to Wayne.

speaker
Wayne Pisano
Chair of the Board of Directors and Interim CEO

Good afternoon, everyone, and thank you, John. I know it's only been a short time since we last provided a corporate update, so today's call will be relatively brief. I'll run through the important developments from the quarter and then ask Tom to discuss our clinical progress and Christoph to share a business development update. Then Kirk will say a few words about our financials. To start, I want to let you know that our CEO search is active and we've met several excellent candidates. With an asset like Pella RealRep, which has potential in numerous consequential indications, we are aiming to find a leader who can steward Pella with a laser focus on clinical trial execution. Our clinical data continues to exceed expectations, and we believe the further development of Pella will allow it to fulfill its potential as a valuable treatment option for patients with several difficult-to-treat malignancies, including pancreatic cancer, breast cancer, and anal carcinoma, all of which have a high unmet medical need. Additionally, the new CEO will provide invaluable leadership and strategic decision-making surrounding our planned registration-enabling study, evaluating Pella and Paclitaxel in advanced or metastatic HR-positive, HR-2-negative breast cancer. And I hope to be able to announce our new CEO in the near future. Pella Riorette, or Pella as we often call it, is a unique and versatile immunotherapeutic agent that we believe has tremendous potential to help a wide range of cancer patients. As discussed during a key opinion leader event in March, Professor Alexander Egermont described Pella's benefits, including intravenous administration, the ability to be taken to tumor sites via monocytes and lymphocytes, and that it doesn't create anti-aging antibodies, allowing T cells to reach the tumor for long-lasting responses, all without infecting normal healthy cells. During the same call, Professor Martine Picard, a leading expert in breast cancer, shared her experience in the clinic and confirmed intravenous administration is much preferred to any intratumoral interventions. She also discussed Pella's opportunity in breast cancer and the multitude of registrational opportunities for an asset like Pella. She confirmed support for the continued advancement of Pella based on two randomized studies confirming its ability to provide an overall survival benefit in breast cancer. She also discussed her belief that there could be an opportunity for Pella to benefit patients at an earlier stage of treatment, possibly in a curative setting. Additionally, in the first quarter, we were able to showcase the versatility of Pella and gastrointestinal cancers when we presented data at ASCO GI in both pancreatic and anal cancers. Tom will lead the discussion of that clinical data shortly. Looking forward, we'll be sharing pancreatic cancer data at this year's ASCO meeting, highlighting Pella's unique mechanism of action, which stimulates both innate and adaptive immune responses. I'd now like to turn the call over to Tom for an update on our clinical progress and plans. Tom?

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