Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutic Second Quarter 2022 Financial Results and Business Update Conference Call. At this time, all participants are in 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 the star key followed by the number one. As a reminder, this call is being recorded today, August 11, 2022. At this time, I'd like to turn the call over to Bruce Mackle of LifeSite Advisors. Please go ahead.

Thank you, Operator, and welcome everyone to Onconova's second quarter 2022 financial results and business update conference call. Earlier this afternoon, Onconova issued a press release reporting its financial results and business progress. If you have not yet seen this press release, it is available in the Investors and Media section of the company's website. at www.ankanova.com. Following my introduction, Ankanova President and CEO, Dr. Steve Fruchman, will provide an overview of the company's recent highlights and future outlook, followed by Chief Medical Officer, Dr. Mark Gelder, who will discuss progress across Ankanova's pipeline. And lastly, Chief Operating Officer and Chief Financial Officer, Mark Guerin, will report the company's second quarter financial results. These prepared remarks will then be followed by a question and answer session. Before turning the call over to Ankanova's management team, I'd like to remind everyone that statements made 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, Onconova 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 filing. With that, it is my pleasure to turn the call over to Steve.

Thank you, Bruce, and good afternoon to all our listeners today. This past quarter was an important period of execution for Ancanova as we saw progress across our development pipeline. As we advanced through the second half of the year, we remain focused internally on the advancement of our lead neurazocyclic development program, which as a reminder, consists of two phase one all-comer solid tumor studies designed primarily to evaluate the safety and tolerability of our orally available multi-targeted kinase inhibitor. The two administration schemes being tested in these trials mirror those of currently approved CDK4-6 inhibitors and will identify the best recommended phase 2 dose and schedule of administration of neurazocycline going forward. We have completed four dosing cohorts. in both phase one studies and the safety data continues to look very favorable to date, mirroring our robust preclinical data set. Key components of this preclinical data set were featured in an abstract recently published at the American Society of Clinical Oncology annual meeting. These data which Dr. Mark Gelder will discuss in greater detail, show neurazocyclic potently inhibits CDK4 and 6 and other kinases implicated in tumor growth, cancer cell survival, and metastasis, as well as their immunomodulatory activities. We believe this inhibitory profile may confer nerazacycline with safety and efficacy advantages over currently available agents, highlighting its best-in-class potential. As you are aware, the CDK inhibitors are multibillion-dollar franchises to address the need for patients with hormone receptor-positive HER2-negative metastatic breast cancer. Looking forward for Neurasa cyclib, we expect the continued advancement of its phase one trials to allow for the second selection of a recommended phase two dose, which we anticipate having before the end of this year. We continue to home in on the indications and treatment regimen we will pursue in later stage studies and will be informed by the results of the phase one program throughout this process. To better enable these efforts, we recently amended the protocol of our phase one study to allow for the collection of pharmacodynamic data using the cutting edge Divitam assay. This assay is designed to measure thymidine kinase activity, a marker of cell proliferation that is believed to be predictive of CDK4N6 inhibitory activity or target engagement. This approach of having a biomarker to determine target engagement, rather than the classic phase one approach of observing clinical toxicity and then pulling back to a previous and lower dose for future trials is a methodology that the FDA endorses, and Dr. Gelder will give us greater details about this approach. Though we, of course, need to finalize the specifics of our planned future trials before they are announced, I reiterate that we are interested in multiple indications for neurazocyclin's potential. These include hormone receptor positive HER2 negative breast cancer that is refractory to the FDA approved drugs, multiple myeloma, macular cell lymphoma, and based on the mechanism of action of neurazocyclin, other potential indications as well. This interest is drawn from both preclinical work and the pressing unmet need for improved options in these and additional indications. Turning our attention now to rego certum, I'll first emphasize that our strategy of utilizing investigative-sponsored trials with key opinion leaders to pursue the development of regocertum has not changed. This enables us to dedicate our primary focus and resources to our lead neurotic cyclic programs. As you may recall, regocertum can attack cancers through several different mechanisms, as it has the ability to modulate the mutated an overexpressed RAS pathway, the PLK1 pathway, and the tumor immune microenvironment. Our planned investigator-sponsored trial in checkpoint inhibitor refractory metastatic melanoma seeks to leverage regocertib's role as an immune modulator. This trial, which will evaluate regocertib in combination with the PD-1 checkpoint inhibitor pembrolizumab, builds upon published preclinical data presented at prominent meetings, such as the AACR, and journals that came out of the work at Vanderbilt University that showed regocertib promoting the infiltration of T cells into the tumor microenvironment. Of course, PD-1 inhibitors work by stimulating the cancer-killing activity of T cells, increasing the number of T cells within tumors is expected to enhance the efficacy of these exciting agents. A key goal of the melanoma trial is to demonstrate the anti-cancer activity of the rigor-certified prembolizumab combination in patients showing resistance to checkpoint blockade. This is similar to another ongoing investigator-sponsored trial, which is evaluating regocertum plus the PD-1 inhibited nivolumab in KRAS-mutated non-small cell lung cancer. Preliminary data from this trial strongly supports the hypothesis behind the soon-to-open melanoma study. We look forward to the continued progress of both investigated sponsored studies, evaluating regocertum with an anti-PD-1 agent, and anticipate reporting additional data from the KRAS-mutated non-small cell lung cancer later this quarter and an abstract that has been submitted to the European Society of Medical Oncology, or ESBO. In addition to these two rego-assertive studies, we are also seeing extremely encouraging results in the investigative sponsored trial evaluating rego-assertive monotherapy in squamous cell carcinoma of the skin associated with the ultra-rare disease dystrophic epidermolysis villosa, or RDEP. Initial single-patient data from this trial showed a sustained, complete response in this difficult-to-treat indication, and the patient is still in complete remission today and continuing on single-agent regocertum for over one year. This importantly provides clinical proof of concept for regocertib's ability to inhibit the PLK1 pathway, which is a crucial enzyme that is overexpressed in odd-depth associated squamous cell carcinoma and other more prevalent squamous cell cancers as well. As mentioned on our last call, This result is driving conversations with leading clinicians and scientists interested in potentially pursuing additional investigative sponsored trials. This highlights how our collaborative strategy with Rego Certum allows us to increase our avenues for value creation in a capital efficient manner. With that, I'll pass the call off to Dr. Mark Gelder to speak more about our clinical programs. Mark.