Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Antenova Therapeutics third quarter 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. And please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, Please press star zero for operator, press star zero for operator assistance. As a reminder, this call is being recorded today, November 12th, 2020. 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, operator. Good afternoon, everyone, and welcome to Ancanova's third quarter 2020 financial results and business update conference call. Earlier this afternoon, we issued a press release reporting our financial results and business progress during the quarter. If you have not seen this press release, it is available in the investors and media section of our website at www.ancanova.com. On today's call, Dr. Steve Fruchman, Our President and CEO will discuss the company's recent highlights and anticipated clinical and business milestones. And then Mark Guerin, our Chief Financial Officer, will review third quarter financial results. Following Mark's report, we'll move to the Q&A portion of the call. And we'll be joined by Dr. Rick Woodman, our Chief Medical Officer. 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. Ankanova disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances. Please see the forward-looking statements disclaimer in the press release issued this afternoon and the risk factors in the company's current and future filings with the SEC. With that, it is my pleasure now to turn the call over to Steve.

Thank you, Avi. Good afternoon, everyone, and thank you for joining us this afternoon. We hope you and your loved ones are safe and remain healthy. The COVID-19 pandemic has certainly impacted us all in how we live and work together. At Ankenova, we are still awaiting word on our funding request to the National Institute of Allergy and Infectious Diseases Branch of the National Institutes of Health and the Biomedical Advanced Research and Development Authority, also known as BARDA, for the possible funding of clinical trials with regocertib in patients with COVID-19 disease. However, cancer and the development of effective new anti-cancer therapies remains a significant health issue and is our corporate focus. We believe Ankenova is well positioned to play an important role in developing differentiated therapeutics for cancer care. During the third quarter, our product pipeline advanced nicely with ON123300 entering the clinic. In a phase one study in China, an oral regocertib entering a Phase I investigator-initiated study in combination with the PD-1 inhibitor nivolumab in KRAS-mutated non-small cell lung cancer. The senior management team at Ankenova brings substantial drug development expertise and a previously of successes in anti-cancer drug development to our company, Akanova. Our core expertise is to identify promising drug candidates, develop and test them, and ultimately to commercialize them. Both Dr. Rick Woodman and I are medical oncologists by training with careers in academia prior to joining industry. And the Onconova team has developed and brought to market numerous successful oncology products during our careers to date. At Onconova, our lead pipeline product is ON123300, which is a proprietary first-in-class multi-kinase inhibitor targeting CDK4-6 and ARK5. ON123300 simultaneously inhibits both cell cycle and cellular metabolism through CDK and ARK5 respectively, and in vitro has been shown to be cytotoxic to cancer cells, thus killing cancer cells rather than cytostatic or merely inhibiting the growth of cancer cells. The currently commercially available CDK inhibitors are typically cytostatic. We believe with this mechanism of action targeting both CDK4, 6, and ARK5, ON123300 represents an innovative potential approach for treating solid tumorous and hematologic malignancies that are refractory or have become resistant to the commercially available CDK4-6 inhibitors. Based on preclinical models, ON123300 may have utility for patients with certain types of breast cancer and non-Hodgkin's lymphoma. And based on these preclinical models, ON123300 may also have broader utility potentially for advanced mantle cell lymphoma, multiple myeloma, colorectal cancer, hepatocellular carcinoma, and inoperable glioblastoma due to the preclinical evidence that ON123300 can cross the blood-brain barrier. We are particularly pleased that during the third quarter, ON123300 entered the clinic in China with our partner, Honex Biopharmaceuticals. The Honex Phase I Dose Escalation Study began in September. As of today, the first cohort of three patients, each who has breast cancer, has been enrolled. The phase one study in China is a standard three by three dose escalation study with each cohort requiring three or six patients depending on the number of dose-limiting toxicities observed, if any are observed. This phase one study is expected to enroll patients with advanced relapsed refractory cancer at two sites in China, and together with our planned phase one study in the U.S. will inform the future development of O.N. 1, 2, 3, 300. In the U.S., we are preparing to file an investigational new drug application with the FDA by the end of this year, with patient enrollment expected to begin in the first half of 2021. We expect that our Phase 1 dose escalation and dose expansion study will differ from the Honex study in both dosages and treatment cycles, but believe the data from these two studies will generate important information to inform anticipated later stage studies. Our current plan is for the phase one trial in the U.S. to assess safety, tolerability, and pharmacokinetics of ON123300 administered orally at increasing doses starting at 40 milligrams daily or higher for consecutive 28-day cycles in patients with relapsed or refractory advanced cancer, including but not limited to patients with hormone receptor positive and HER2 negative metastatic breast cancer with clinical resistance to the approved second generation CDK4-6 inhibitors. Once the recommended phase two dose is established, our plan is to enroll at least 36 hormone receptor positive HER2 negative postmenopausal metastatic breast cancer patients with resistance to the approved second generation CDK4-6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin's lymphoma with a special interest based on preclinical studies in mantle cell lymphoma. This trial design differs from the study in China in that Hanex will dose patients daily for 21 days. And in the US, we will study continuously daily dosing for a 28-day cycle. Notably, of the three currently approved CDK4-6 inhibitors, two were tested and used for dosing in 21-day cycles, and one was tested in a 28-day cycle. All three are blockbuster drugs marketed by well-known pharmaceutical companies. We expect these two phase one studies, the one in China and the one in the US, to collectively increase the number of patients studied and thus to augment our understanding of the safety profile of ON123300. Although designed as a classical phase one study, to establish safety, these studies may also provide preliminary important efficacy signals. We believe the results of two simultaneous phase one studies will also inform and enhance the development of subsequent later stage studies to be conducted. Let me now turn to our second pipeline product, oral regocertib, which is directed to patients with cancer who may carry a KRAS mutation. Following the negative overall survival data readout of our Phase III-inspired trial testing intravenous regocertib, in higher risk myodysplastic syndromes, we are encouraged by investigator-initiated studies aimed at alternative diseases characterized by KRAS mutations that are underway or proposed with oral regocertib. On our last call, we shared with you that during the third quarter, a phase one dose escalation study had been already initiated at a leading medical center in New York City, exploring the use of oral regocertib in progressive KRAS mutated non-small cell lung cancer patients in combination with a PD-1 inhibitor, more specifically, the immune checkpoint inhibitor nivolumab, or Abdevo. As of today, this study has enrolled five patients. It is designed to identify the recommended phase two dose, to further study the combination in future studies, and to characterize the safety profile of the combination treatment. Dosing results of this phase one trial are expected in 2021. Note that the most recent dosing cohort has already received the 560 milligram twice daily dose of oral RegoCertib, which is the highest dose the current protocol is designed to deliver. It is likely this will be the dose we are taking into phase two testing. However, if no additional dose-limiting toxicities are observed with additional patients entered into the current trial, then further dose increases of regocertib may be considered with an amended protocol. More than half of non-small cell lung cancers are classified as lung adenocarcinomas. Of these, the largest subset has a KRAS mutation as the predominant genetic driver of the cancer. Given their utility in multiple cancer settings, checkpoint inhibitors are among the world's top-selling pharmaceutical products, and they continue to gain FDA approval for new indications. In our view, this makes our novel combination approach with Rigocertum a potentially meaningful option to pursue in lung cancer and other disorders with KRAS mutations managed with immuno-oncology therapies. We hope these studies will offer patients who've progressed on first-line therapy with a potential efficacious second-line approach. In addition, a multi-site an investigator-initiated Phase 1b-2 study with regocertum monotherapy has opened. This is studying patients with advanced squamous cell carcinoma associated with recessive, dystrophic epidermolysis bullosa and an extremely rare genetic mutation of RAS, an area associated of high unmet medical need. The first patient is expected to be enrolled in 2021. Additional investigator-initiated preclinical studies with oral regocertib are being proposed, including melanoma and renal cell carcinoma, which we expect will also be in combination with a PD-1 inhibitor. As I mentioned, our focus at Ancanova is on advancing our cancer therapeutic pipeline to help patients. Based on robust preclinical data, we are keen to investigate the potential of ON123300 in the clinic and to further the promise of oral rego-certificate for new indications. We are also actively evaluating strategic opportunities to further advance and enhance our portfolio of proprietary anti-cancer agents. We look forward to keeping all of you updated on our progress with these very important initiatives. And now, I'd like to turn the call over to Mark Guerin, our Chief Financial Officer, for a discussion of our financial results for the third quarter of 2020. Mark, please.