5/5/2023

speaker
Operator
Conference Operator

Good morning and welcome to Oncolitics Biotech's first quarter 2023 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 Communications. Please go ahead.

speaker
John Patton
Director of Investor Relations and Communications

Thank you, Operator, and good morning, everyone. Earlier this morning, Oncodex issued a press release providing recent operational highlights and financial results for the first quarter of 2023. A replay of today's call will be available on the events and presentation section of the Oncodex website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A. 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 Pallavi Rep, including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pallavi Rep as a cancer therapeutic, the design, aims, and anticipated benefits of the company's current pending clinical trials, and anticipated timing of the release of additional data, the company's plans and expectations regarding potential registrational studies, the business development plans and strategies, the company's financial runway, 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 known and unknown risk delays, uncertainties, and other factors not under the company's control that may cause the actual results, performance, or achievements of the company to be materially different from the 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 are believed to a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with inactual property protection, financial projections, actions by regulatory agencies, and those are the 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. Speaking on today's call will be OnClinics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Thomas Heinemann, Global Head of Business Development, Andrew DiGuttadaro, and Chief Financial Officer, Kurt Gluck. I will now turn the call over to Matt to begin management's remarks. Please go ahead, Matt.

speaker
Dr. Matt Coffey
Chief Executive Officer

Thanks, John. It's my pleasure to provide an overview of our recent highlights and outlooks for the coming months. I'll start with the exciting news that came out just last week when we announced the results from our randomized Bracelet-1 trial in HR-positive HER2-negative metastatic breast cancer will be shared in an oral presentation at the upcoming ASCO annual meeting. ASCO is one of the world's most well-regarded oncology conferences and will provide an excellent venue to discuss our results with potential partners and the broader breast cancer community. With Bracelet's ASCO Abstract set to be published later this month, we are weeks away from a crucial milestone for Pella-Briorep, or Pella, as I'll often refer to it. As I've mentioned on previous calls, Bracelet 1 represents Pella's last major step on the path to a pivotal study in HR-positive HER2-negative metastatic breast cancer. Key goals for the trial are to inform and design a subsequent licensure-enabling study and to validate prior randomized Phase II data that showed Pella driving as statistically significant, near doubling of median overall survival when combined with Paclitaxel in this indication. Given Bracelet's importance to Pella's value proposition, setting the stage for its upcoming readout will be the primary focus of today's call. As we look ahead to Bracelet's one upcoming readout and beyond, we believe we are well positioned for growth with a pipeline that includes two core pillars. namely our HR-positive HER2-negative breast cancer and pancreatic cancer programs. Both of these programs represent meaningful registration opportunities supported by compelling proof-of-concept clinical data and FDA fast-track designations. We expect to have additional guidance on the optimal registration enabling pathways for these programs later this year, highlighting just how excited these times are for Oncolytics. With that, I will now pass the call off to Tom.

Disclaimer

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