Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Ankanova Therapeutics full year 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 one on your touchstone phone. If anyone has difficulty hearing the conference, please press star zero for the top of your system. As a reminder, this call is being recorded today, March 17th, 2022. At this time, I would like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel.

Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel. Avi Oller, Senior Vice President of Corporate Development and General Counsel If you have not yet seen this press release, it is available in the investors' media section of our website at www.openova.com. On today's call, you'll first hear from our President and CEO, Dr. Steve Bruchman, who will give a high-level overview on our recent progress and plans for 2022. Our Chief Medical Officer, Dr. Mark Yelder, will then provide a more detailed clinical and scientific update before handing the call to Mark Guerin, our Chief Financial Officer, to review our full year 2021 financial results. Following these formal remarks, we will then finish the call with a question and answer session. Before passing the call 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, 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, and good afternoon, everybody. Thank you for joining us, and we wish all a very happy St. Patrick's Day. It is my pleasure to give an overview of our progress over the past few months. We believe this progress has us on track for an exciting 2022 with key milestones expected throughout the year. Our lead asset, nerazacycline, continues to advance through its phase one program in patients with advanced solid tumors, which includes two separate and complementary clinical trials in the United States and China. For those of you who are new to the Ankanova story, nerazacyclib is a multi-kinase inhibitor with a low nanomolar activity against CDK4 and 6 and other kinases important for cancer cell proliferation and motility, two processes that are intimately involved in tumor proliferation and metastatic disease. In these phase one trials, we are evaluating the razocycline with both a daily dosing schedule and also a three weeks on, one week off dosing schedule. Designing our Phase I program in this fashion allows us to evaluate Narizocyclib with dosing schedules that are currently used for FDA-approved CDK4-6 inhibitors. We believe this approach will lead to an optimized, recommended Phase II dose to bring into the clinic and to the generation of data that differentiates our lead asset from competing agents. Looking ahead for Neurazacyclib, we plan to use the findings from the phase one program to identify a recommended phase two dose in the second half of the year. This would then inform the design of a Phase II basket trial in multiple indications to begin thereafter, as well as one or more additional studies that will be designed to evaluate the safety and efficacy of Nuraziciclib alone or in combination with other anti-cancer agents. Dr. Mark Gelder our Chief Medical Officer, will be discussing these concepts further in a few moments. Outside our lead program, we continue to leverage collaborations with industry partners and key opinion leaders at academic institutions to further the clinical development of RegoCertib, which targets the RAS, and polo-like kinase or PLK1 pathways. Rigocertib has also been shown to act as an immune modulator and to recruit T cells into the tumor microenvironment via the presentation of novel antigen on the host tumor cell membranes and is being studied in multiple investigator-sponsored trials. In the fourth quarter, we announced preliminary data from one of these investigator-sponsored trials, which is evaluating regocertib monotherapy in recessive dystrophic epidermolysis bullosa, or RDEB, which is frequently complicated by squamous cell carcinoma of the skin. Though these initial data from a single patient in this ultra-rare disease, we believe they represent an important update given the invariable fatal nature of this extremely rare disease, the lack of available therapies, and the fact that we observed a durable, complete response of over a year in an extensively pre-treated patient. In addition to the RDEB trial, oral regocertib also continues to be evaluated in combination with the PD-1 checkpoint inhibitor nivolumab in an investigator-sponsored trial in KRAS-mutated non-small cell lung cancer. This phase 1 slash 2A trial seeks to leverage regocertib's dual mechanism of action as an immune modulator and as a down regulator of the RAS mutated pathway in order to enhance the efficacy of checkpoint inhibitors And this trial has already generated compelling preliminary data, which is agnostic to the type of KRAS mutation present. And this was discussed at length on our last quarter's earnings call. Looking ahead, we expect to report additional data from this trial later this year. We are also working to further leverage RegoCertib's role as an immune modulator and its potential to enhance the efficacy of checkpoint inhibitors through the upcoming initiation of an additional investigator-sponsored study in patients with advanced metastatic melanoma. Similar to the non-small cell lung cancer trial, this study is designed to evaluate regocertib in combination with an anti-PD-1 inhibitor, though in this case, the PD-1 inhibitor will be pembrolizumab. Now, before I hand the call over to Dr. Gelzer to provide some more detail on the clinical programs I just mentioned, I'd like to once again say that we at AnkaNova continue to dedicate our primary focus and resources to the neurazocyclic program. While RegoCertib has recently generated compelling data in both non-small cell lung cancer and RDEB-associated squamous cell carcinoma, we plan to pursue its continued clinical development primarily through investigator-sponsored trials at leading academic institutions. We believe this strategy will enable an optimal risk-benefit balance as we work to unlock additional value for stakeholders by addressing pressing unmet medical needs with RegoCertical. Finally, I'd like to recognize a notable corporate achievement from last quarter, which was the addition of Dr. Adar Makovsky-Silverstein as our Director of Corporate Development. Adara joined Ankanova from Amgen, where she was responsible for evaluating external scientific opportunities across all therapeutic areas and managing processes within business development and across functional teams. She has extensive scientific expertise in oncology, having worked in some of the leading laboratories and biotech companies in the US, which will be an invaluable asset as we work to advance our pipeline and evaluate opportunities for its potential strategic expansion through in-licensing. So with that, I'll now hand the call over to Dr. Gelder to speak a bit more about our ongoing and planned clinical trials. Mark?