Onconova Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to Onconova Therapeutics third quarter 2023 financial results and business update conference call. At this time, all participants are in the 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 number one on your touchtone phone. If anyone has a difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, November 14, 2023. At this time, I would like to turn the call over to Bruce Mantle of Lifestyle Advisors.

Thank you, operator, and welcome everyone to Anca Nova's third quarter 2023 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.onconova.com. Following my introduction, we will hear from Onconova's President and CEO, Dr. Steve Fruchman, Chief Medical Officer, Dr. Victor Moyo, and Chief Operating Officer and Chief Financial Officer, Mark Guerin. Ankanova's VP of Global Medical Affairs and Research and Development, Mina Arora, will also be available during a Q&A session following the prepared remarks. Before we begin, I would 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 filings. With that, I will now turn the call over to Onconova's President and CEO, Dr. Steve Frothman.

Thanks, Bruce, and thanks to everyone who is joining us today for this call. I'll open by saying that Onconova has made excellent progress in the third quarter of 2023. During the call today, our Chief Medical Officer, Dr. Victor Moyo, and our Chief Operating Officer and Chief Financial Officer, Mark Gurin, and I will provide you with an update on our lead program, Neurasa Cycle. Review the data from our recent scientific presentation. outline our upcoming milestones, provide a brief update on the RegoCerta development program, summarize our third quarter financial results and outlook on our cash runway, and of course, importantly, open the call for your questions. As you know, our mission means to develop novel proprietary products for patients with hard-to-treat cancer and with an unmet medical need. Starting with our lead program, our internal efforts are dedicated to basic preparations for nirazacyclin, our proprietary multi-kinase inhibitor of CD8.6, as well as other components for cell growth and DNA synthesis. The CDK4-6 class of inhibitory drugs has changed the face of cancer care in several indications, particularly in hormone receptor positive to negative metastatic breast cancer. Mirazic cyclin, was designed by Ankanova scientists as a potent next generation entrance into this multi-billion dollar drug class. In addition to its multi-kinase activity, we believe Nerazociclib may be differentiated from the other approved CDK4-6 inhibitors because of the potential. for an improved tolerability profile, and based on our preclinical studies, improved efficacy as well. The ability to act on targets beyond CDK4 and 6 may lower the risk of drug resistance faced by other CDK4-6 inhibitors. Our expansive preclinical studies have helped to define Nerazacyclib's ability to impact on additional vital targets involved in cell signaling and cancer survival, including the proteins ARC5, also known as NUAC1, CSF1R, and BUB1. All important in how cancer establishes its presence in sites of metastatic disease, as well as proliferation of the cancer cells. We have selected low-grade endometrial cancer to be our lead registration indication for Neurasocycline in combination with the hormone therapy Letrozole. We believe this is the right choice in endometrial cancer for two main reasons. Number one, the proposed registrational trial has a high technical and regulatory success, probability of success. Publication of positive studies with other CDK4 and 6 inhibitors and letrozole combinations and compendia data indicating off-label use support the potential for a high probability of technical success. These data and the lack of an approved label underscore the unmet medical need and support the potential for high regulatory success. The second reason is the initial data from our dose ranging studies suggest The Razocyclic has the potential to be safer than the other DDK4-6 approved inhibitors with a wide dosing window that supports an excellent therapeutic index. Note that during our call today, we may use the acronym ALGEEC to describe this indication in endometrial cancer. To be registrational trial ready, we plan to, one, complete the dose escalation segment of our phase one and two programs and define a recommended phase two dose or RP2D. Secondly, engage with the FDA on the pivotal trial design under construction. Number three, work with key external clinical experts on the design and conduct of this trial, including the Gynecologic Oncology Group, or GOG, and the European Network for Gynecologic Oncology Trials, or NGOT. Our plan is to conduct the registration trial as part of our ongoing collaboration with both of these very prestigious groups. We intend to provide more information on each of these steps over the next few quarters. As you know, there are three early stage studies underway in the neurazocyclic program, including monotherapy and combination trials. Given Neuradicyclid's multi-kinase mechanism of action, we have conducted our dose escalation studies very carefully. While Victor will summarize the status of these studies based on the clinical and biological target engagement and the acceptable overall safety we are observing, we have decided to dose escalate to at least one more dosing cohort to fully evaluate the safety profile of Nuraziciclib and achieve the optimal recommended phase two dose. As a result of the phase one, two program, Nuraziciclib may continue into the first quarter of 2024. We believe this is very good news for the program because it underscores the potential for Neurazociclib to have a differentiated safety profile and a wide therapeutic index. Changing gears, I would like to touch briefly on our second program, that is Regocertib. As you know, in keeping with our focus on capital efficiency, We have been exploring the clinical utility of RegoCertib through a series of signal-finding, investigator-sponsored trials focused on solid tumor indications driven by RegoCertib's impact on one of two mechanisms. The first is the PLK1 pathway involved in scramus ocrossanoma complicating recessive dystrophic epidermolysis pilosa, and the second mutated KRAS protein seen in KRAS mutated non-small cell lung cancer in combination with checkpoint inhibitors. As outlined in our second quarter call, we are focused on mapping out a registration study plan for the ultra-rare indication of RdEB-associated squamous cell carcinoma. that we would define that as RDEB associated SCC in this call. We selected this to be the lead registration or indication based on the very impressive clinical responses we have seen to date in previously refractory patients and with the significant unmet medical need for this desperate patient population. As you know, we had a Type B meeting with the FDA in June. Based on this meeting and feedback from the agency, and as outlined in our second quarter call, we intend to develop a protocol for a registration or trial following interactions with the rare disease group at FDA in pursuit of an orphan designation for RdBev-associated squamous cells. We plan to provide an update on next steps in the first half of 2024. Looking ahead to the rest of this year and into 2024, we are focusing on achieving the following milestone. In the RASA cycle, we intend to, one, continue the dose escalation segment of the Phase 1-2 program, which may bring us into the first quarter of 2024, so we can add at least one more dosing cohort to this study. Number two, provide a readout on neurotic cycle safety and pharmacology in the first half of 2024, once we have completed the dose escalation studies. Number three, provide an update on our registration trial readiness over the next couple of quarters, including the definition of the recommended phase two dose, our engagement with the FDA and the pivotal trial design, and obtaining rare disease indication, orphan disease indication, and our work with internal, external clinical experts, including the GOG and NDI. Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications, such as breast cancer and ovarian cancer. For rego certum, As I just noted, in the first half of 2024, we continue to plan to provide an update on the next steps to obtain orphan drug designation and for the registration program. Before I hand the call over, I would like to warmly congratulate Victor, formerly taking on the role of Chief Medical Officer, and warmly welcome Nina Arroyo as Vice President of Global Medical Affairs Research and Development. Victor and I previously worked together at J&J, where he was instrumental in getting approval for some of the most revolutionary and impactful drugs in both supportive care and hematology oncology. Both of them are accomplished experts in their fields and bring significant and wide depth of experience in drug development. I believe Victor's extensive track record as a clinical researcher in drug development in oncology and MENA's unique medical affairs expertise in rare diseases and oncology will be instrumental to the company's success as we prepare the clinical plan and regulatory strategy for New Azacyclib and Regocertib. Now, I would like to turn the call over to Victor to provide some more details on the Narada Cyclic Program. Victor?