Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutics 3rd 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 star followed by 1 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, 11th of November, 2021. At this time, I would like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel.

Thank you. Good afternoon, everyone, and welcome to Onconova's third 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 yet seen this press release, it is available in the investors and media section of our website at www.onconova.com. On today's call, You'll first hear from our president and CEO, Dr. Steve Fruchman, who will give a high-level overview on our recent progress and future outlook. Our chief medical officer, Dr. Mark Gelder, will then provide a more detailed update on our recent clinical and scientific progress before handing it off to Mark Guerin, our chief financial officer, to review our third quarter financial results. Following these formal remarks, We will then finish the call with a question and answer session. Before passing the call off to Steve, I'd like to remind everyone that statements made by management during this conference call 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. Akanova 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. And we hope you are all remaining safe amid an ongoing but improving pandemic here in the U.S. Before we begin, we would like to say a very special thanks to a group of very special people. On this Veterans Day, we say thank you all who serve to keep us safe and risk their own well-being in doing so. Thank you so much. I am pleased to update you on the progress at Ankanova Therapeutics. Since our last earnings call, we have made progress across our pipeline and have achieved key milestones. We also believe our progress during the third quarter has had us on track to achieve additional milestones across our pipeline. In our lead program, Evaluate ON123300, which we recently renamed Nerazacycline, we continue to enroll patients in two complementary Phase I trials in the U.S. and in China. As a reminder, nerazacyclib 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. The two Phase I trials are evaluating different administration schemes for neurazocyclibs, both of which are based on the administration schemes of CDK4-6 inhibitors that are already approved to treat hormone receptor positive compared to negative metastatic breast cancer. We plan to use the results of our trials to determine Neurazocytin's recommended dose, and we remain on track to do this in the first half of 2022. Beyond our lead program, We recently reported encouraging data from the investigator-initiated Phase 1-2A trial evaluating regocertin in combination with the PD-1 checkpoint inhibitor nivolumab in patients with advanced KRAS-mutated non-small cell lung cancer. These results which Dr. Gelder will discuss in greater detail, support the potential anti-cancer activity of the regocertib-nevolumab combination, differentiates regocertib from other RAS pathway modulators that only target a particular KRAS mutation, and suggests that regocertib may augment the efficacy of checkpoint inhibitors. We believe these findings not only bode well for the continued clinical development of regocertib in combination with checkpoint inhibition in KRAS mutated non-small cell lung cancer, but may potentially have broad implications across several high unmet indications such as advanced melanoma. For those of you who are interested in learning more about these data, I strongly encourage you to view the replay of our webinar announcing the data, which featured expert perspectives from the trial's principal investigator, Dr. Raj Velaswamy of the Mount Sinai Medical Center in New York, and Dr. Scott Antonia, professor of medicine at the Duke Cancer Institute and the director of its Center for Cancer Immunotherapy. This webinar can be found on the events and presentations page of our website. We also continue to make progress in our investigator-initiated study evaluating regocertib in recessive dystrophic epidermolysis bullosa, or RDEB, complicated by squamous cell carcinoma of the skin. This is a very rare and tragic condition with a high unmet medical need. RDEB is invariably fatal as there are no curative therapies available and immune oncology agents which are the current standard of care, the squamous cell carcinoma, have yielded disappointing results. Dr. Gelder will speak more about the disease and ongoing trial in a few moments. The progress made in our clinical programs during the third quarter ultimately enabled us to achieve notable milestones, and we then strengthened our balance sheet with 21 million in gross proceeds from an equity financing. We plan to use the proceeds from this financing to support the continued development of our pipeline and to potentially drive its expansion through the in-licensing of an additional complementary product candidate. With that, I'll now hand the call over to Dr. Gelder to provide you with more detail on our critical programs and development strategy. Mark?