Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Uncanova Therapeutics First Quarter 2022 Financial Results and Business Update conference call. At this time, all participants are on a listen-only mode. Following management's prepared remarks, we open to ask a question at that time. Please press star followed by one on your touchtone phone. If anyone has any difficulties hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, May 11, 2022. At this time, I'd like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel.

Thank you, Operator, and welcome everyone to Ancanova's first quarter 2022 Financial Results and Business Update conference call. Earlier this afternoon, we issued a press release reporting our 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.ancanova.com. Today's call will begin with our President and CEO, Dr. Steve Fruchman, providing an overview of our recent progress in corporate strategy. Dr. Fruchman will then ask our Chief Medical Officer, Dr. Mark Gelder, to review our clinical programs. Our CFO, Mark Guerin, will then report our first quarter financial results before we move on to a question and answer session. Before turning the call over 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 S&T filings. With that, it is my pleasure to turn the call over to Steve.

Thank you, Avi, and good afternoon, everyone. Our clinical programs continued to make strong progress over the past months as we efficiently executed on the corporate strategy we've spoken about on our past earnings calls. This strategy has us internally focused on our neurazacycline program while leveraging relationships thought leaders from industry and academia to continue the development of RegoCertib through investigative-sponsored studies based on the mechanism of action of RegoCertib to target cancer indications of interest. As many listening may recall, Nerazacycline is an orally available, multi-targeted, kinase inhibitor. It has a low nanomolar affinity for CDK4 and 6 and other kinases that play important roles in tumor cell proliferation, metastasis, and survival. It can also stimulate anti-cancer immunity through the inhibition of the CSF1 receptor. and disrupt several pathways linked to the described mechanisms of drug resistance for this class of drugs. We believe this inhibitory profile positions nerazacycline to be a highly differentiated and potentially a best-in-class therapy, and we look forward to the publication of an abstract at the upcoming ASCO 2022 meeting that describes this topic further. Currently, two ongoing phase one trials are evaluating nerazacycline in patients with solid tumors. These trials are collectively designed to inform the development of later stage studies and also seek to begin clinically demonstrating the advantages of neurazocyclips differentiated pharmacologic profile. Dr. Mark Gelder will be speaking about these studies in more depth. So for now, I'll just remind everyone that they evaluate both a continuous dosing schedule and a three weeks on, one week off schedule. These dosing regimens mimic the drug administration schemes for those of the FDA-approved CDK4 and 6 inhibitors. I'm pleased to say today that each of Nuragic's Phase I trials remains on track and that we expect to identify the optimal recommended phase two dose in the second half of this year. As these trials continue to progress, the indications and treatment regimens we plan to pursue in later stage studies are coming into focus. While it would be premature to talk about the specifics of these studies before they are finalized, I will say now that indications such as hormone receptor positive, HER2 negative breast cancer, multiple myeloma, and mantle cell lymphoma among those in addition to others that are drawing our interest. This interest is based both on preclinical data and the fact that hormone receptor positive HER2 negative breast cancer is the only indication in which CDK4-6 inhibitors are currently FDA approved. But with the knowledge of the unfortunate reality that resisted to the currently approved drugs are very commonly seen. Shifting gears, I'll now briefly mention that some high-level updates on regocertib, which targets the RAS and PLK1 pathways. Regocertib also acts as an immune modulator due to its ability to generate novel antigens on cancer cell membranes, which promotes the infiltration of autologous T cells into the tumor microenvironment and thus recognize the cancer cells as foreign. And they have the opportunity to thus control their proliferation. There are currently two investigated sponsored studies of regocertib ongoing, with a third expected to begin by the end of June. Two of these studies seek to leverage regocertib's immunomodulatory effects by examining it in combination with a PD-1 checkpoint inhibitor. Last year, we reported preliminary data from the first of these studies, which is in KRAS mutated non-small cell lung cancer. These data were highly encouraging as we observed responses with different KRAS mutations who had failed prior checkpoint inhibitor therapies. This finding differentiates regocertum from other approved KRAS targeted agents since responses are seen in different KRAS mutations and thus demonstrates RegoSERTA's potential to be both KRAS mutation independent and to also overcome the mechanisms driving checkpoint inhibitor resistance in KRAS mutated non-small cell lung cancer. We look forward to the continued progress of this trial and we expect to report additional data at a major medical meeting by the end of this year. We expect the second trial of the RegoCertib checkpoint inhibitor combination therapy to begin later this quarter. This study will enroll patients with metastatic melanoma who are refractory to checkpoint blockade. I'm pleased to report today that the FDA recently approved this trial to proceed after reviewing its design, which Dr. Mark Gelder will speak about shortly. In addition to the ongoing and planned investigative sponsored studies I just mentioned, regocertib is also being evaluated as a monotherapy in an investigator-sponsored study in recessive dystrophic epidermolysis bullosa, also known as R-DEV, complicated by squamous cell carcinoma of the skin. Unlike the two combination studies I mentioned, this trial seeks to take advantage of RegoCert's ability to potently inhibit the PLK1 pathway. On our last earnings call, I discussed some very exciting initial data from the trial which showed a durable, complete response. of over a year in an extensively pretreated patient with R-deb and metastatic refractory squamous cell carcinoma who remains in complete remission today. Though single patient data must always be viewed with caution, it's important to realize that RDEB-associated squamous cell carcinoma is an ultra-rare disease that tragically is invariably fatal. Additionally, we think these initial data could have an important read through into several more prevalent squamous cell indications, which is a concept that Mark Gelder will discuss in a few moments. However, before Mark begins his contribution to today's call, I'd like to first extend my thanks to those responsible for the progress we will be discussing. This includes all of our shareholders, employees, partners, and investigators. Of course, most importantly, this list also includes the brave patients who participated in our clinical trials as well as their families. It's the unmet needs of patients that inspire the Ankanova team as we work to develop our clinical programs based on expert science. With that, I'll now turn the call over to Mark Gelder. Mark?