Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the On Canova Therapeutics Second Quarter 2021 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press a star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, August 12, 2021. At this time, I would like to turn the call over to Avi Alder, Senior Vice President of Corporate Development and General Counsel. Please go ahead.

Thank you. Good afternoon, everyone, and welcome to Ancanova's second quarter 2021 financial results and business update conference call. Earlier this afternoon, we issued a press release reporting our quarterly financial results and business progress. If you have not seen this press release, it is available in the investors and media section of our website at www.oncanova.com. On today's call, Dr. Steve Frothman, our president and CEO, will give a high level overview on our recent progress and future outlook. And then Dr. Mark Gelder, our recently appointed chief medical officer, will introduce himself and provide a more detailed update on our clinical and scientific progress over the past few months. Finally, Mark Guerin, our Chief Financial Officer, will then review our second quarter financial results and we'll move to the Q&A portion of the call. Before we begin, I'd like to remind everyone that statements made during this conference call by management will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, Ankenova disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances. For more information on forward-looking statements, please review the disclaimer in today's press release and the risk factors in the company's SEC filings. With that, it is my pleasure to turn the call over to Steve.

Thank you, Avi. Good afternoon, everyone, and thank you for joining us. As the COVID-19 pandemic continues to progress in regions of our country, and the world. We hope you and your loved ones are remaining safe. As has been the case throughout the pandemic, we remain committed to successfully navigating any challenges that may be posed to execute on our clinical and corporate objectives. Thanks to the talent and dedication of our employees, partners, and investigators, we recently wrapped up a highly productive quarter and have achieved both clinical and corporate milestones since our last earnings call. In our lead program, evaluating ON123300, or simply called 123, we began dosing patients in our U.S., phase one trial, evaluating an everyday continuous dosing schedule. As a reminder, 1, 2, 3 is a novel multi-kinase inhibitor targeting CDK4 and 6 and additional kinases involved in tumor genesis, including ARK5, which is reported to be involved in cancer cell survival and the mechanisms of how cancer cells metastasize. I'll let Dr. Mark Gelder speak in more detail about our 123 Clinical Development Program and the importance of this phase one study in a few minutes. But we'll say now, that the trial is continuing to advance and we remain on track to determine the recommended phase two dose of 1, 2, 3 by the first half of next year. The recommended phase two dose will be determined based on data from this clinical trial in the US as well as the ongoing phase one trial in China. evaluating there a three weeks on, one week off dosing schedule of 1, 2, 3. Both administration schemes under study are based on the two different dosing schemes of the FDA approved CDK4, 6 inhibitors in hormone receptor positive HER2 negative metastatic breast cancer. Outside our lead program, we also saw substantial progress in investigator-initiated programs evaluating regocertib in various indications. In the Phase I-II trial of regocertib, in combination with a checkpoint inhibitor, nivolumab, all three dose escalation cohorts defined in the current protocol have been completed without the maximum tolerated dose of all regocertib having been reached. Based on this positive finding, regarding safety, a protocol amendment is being prepared to allow for the evaluation of increased doses of regocertib in combination with nivolumab. Preliminary data from the trial to date have also shown evidence of the combination's anti-cancer activity in the trial's challenging patient population. These preliminary data will be presented at the upcoming third annual RAS Targeted Drug Development Summit taking place from September 21st through the 23rd of 2021. Support for this ongoing trial of regocertib and nivolumab in lung cancer comes from preclinical studies demonstrating regocertib's ability to reverse the immunosuppressive tumor microenvironment that frequently hampers the efficacy of checkpoint inhibitors. These studies were recently featured in a peer-reviewed publication from Vanderbilt University in the journal Molecular Cancer. The published results provide a strong scientific rationale for combining regocertib with checkpoint inhibitors. And based on these findings, an additional investigator-initiated trial designed to evaluate a regocertib checkpoint inhibitor combination in melanoma is undergoing final protocol evaluation. In addition, we are studying regocertib in a very rare, tragic, and invariably fatal condition called recessive dystrophic epidermolysis bullosa, complicated by squamous cell carcinoma of the skin. There are no curative therapies for these patients, and more recently, the standard of care for squamous cell carcinoma has been immuno-oncology agents, which in this setting have yielded disappointing results. This disease is caused by loss of collagen 7, which anchors our skin cells in place. And due to the lack of collagen 7, the skin denudes. And over time, most patients develop squamous cell carcinoma in their early 20s with overexpression of polo-like kinase 1. Based on drug screens for inhibitors of polo-like kinase 1, Regocertib was found to be the most potent inhibitor of polio-like kinase 1. An investigator-initiated study was started with a world expert in this ultra-rare disease in Austria with a second site soon to be opened in the United Kingdom. The first patient has been dosed at the site in Austria and we look forward to entering additional patients on the study and giving you follow-up. Alongside our clinical and scientific accomplishments, we have also achieved a notable corporate milestone during the second quarter by having Dr. Mark Gelder join Ankanova as our chief medical officer. As Mark will tell you about himself in a few moments, our ability to recruit such a well-qualified and highly talented individual was due in part to the strength of our assets and the momentum we've generated in our clinical programs. So with that, I'll now hand the call over to Dr. Gelder to provide you with some more detail on our programs and our overarching clinical development strategy. Mark?