Onconova Therapeutics, Inc.
Q4 2021 Earnings Call Transcript

Published: 17 Mar 2022

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutics’ Full Year 2021 Financial Results and Business Update Conference Call. As a reminder, this call is being recorded today, March 17, 2022. At this time, I would like to turn the call over to Avi Oler, Senior Vice President of Corporate Development and General Counsel.

[Avi Oler:]

Thank you, operator. Good afternoon, everyone. And welcome to Onconova’s full year 2021 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 & Media section of our website at www.onconova.com. On today’s call you will first hear from our President and CEO, Dr. Steve Fruchtman, who will give a high-level overview on our recent progress and plans for 2022. Our Chief Medical Officer, Dr. Mark Gelder, 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 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, 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, it is my pleasure to turn the call over to Steve.

[Steve Fruchtman:]

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 narazaciclib continues to advance through its Phase 1 program in patients with advanced solid tumors, which includes two separate and complimentary clinical trials in the United States and China. For those of you who are new to the Onconova story narazaciclib is a multikinase inhibitor with a low nanomolar activity against CDK4 and CDK6 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 1 trials, we are evaluating narazaciclib with both a daily dosing schedule and also a three weeks on, one week off dosing schedule. Designing our Phase 1 program in this fashion allows us to evaluate narazaciclib with dosing schedules that are currently used for FDA approved CDK4/6 inhibitors. We believe this approach lead to an optimized, recommended Phase 2 dose to bring into the clinic and to the generation of data that differentiates our lead asset from competing agents. Looking ahead for narazaciclib, we plan to use the findings from the Phase 1 program to identify a recommended Phase 2 dose in the second half of the year. This would then inform the design of a Phase 2 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 narazaciclib 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 rigosertib, which targets the Ras and polo-like kinase or PLK1 pathways. Rigosertib 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 rigosertib 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 extensively pretreated patients. In addition to the RDEB trial, oral rigosertib 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 1/2a trial seeks to leverage rigosertib’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 rigosertib’s role as an immune modulator and its potential to enhance the efficacy of check inhibitors through the upcoming initiation of 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 rigosertib 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. Gelder to provide some more detail on the clinical programs I just mentioned, I’d like to once again say that we at Onconova continue to dedicate our primary focus and resources to the narazaciclib program. While rigosertib 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 present unmet medical needs with rigosertib. Finally, I like to recognize a notable corporate achievement from last quarter, which was the addition of Dr. Adar Makovski-Silverstein as our Director of Corporate Development. Adar joined Onconova for 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 U.S., which will be an invariable and valuable 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?

[Mark Gelder:]

So, thank you, Steve. And thanks to all of those who have joined us today. I’ll begin today with our narazaciclib program. As Steve mentioned, narazaciclib is a multi-targeted kinase inhibitor that targets CDK 4 and 6 as well as several additional kinases at low nanomolar concentrations. We believe it has the potential to be a highly differentiated therapy due to several key characteristics such as its preclinical safety profile, which shows that it appears to cause less myelosuppression and neutropenia compared to palbociclib, the most widely prescribed CDK4/6 inhibitor today. Preclinical data suggesting potent inhibition of CDK2, a kinase understood to be essential to DNA replication and one of several potential mechanisms of resistance in the hormone receptor positive HER2-negative metastatic breast cancer population to the approved CDK4/6 inhibitors. Additionally, its ability to inhibit ARK5, which promotes the survival of cancer cells in hypoxic microenvironments, serves an important role in cell adhesion and metastasis and may play a role in drug resistance. Its ability to inhibit CSF1 receptor, or CSF1R, which results in the stimulation of antitumor immunological effects and its ability to inhibit the growth of cancer cell lines resistant to palbociclib. We believe this differentiated pharmacologic profile positions narazaciclib to be studied even beyond areas where other CDK4/6 inhibitors inhibitors are currently approved both as a single agent and in combination with a myriad of other anticancer compounds. To begin evaluating this hypothesis, narazaciclib is being studied in two Phase 1 trials

[Mark Guerin:]

Thanks, Mark, and good afternoon, everyone. Starting with a quick review of our full year expenses. Research and development expenses were $7.3 million for 2021 compared with $16.9 million for 2020. The decrease was primarily related to the company’s focus in 2021 on its Phase 1 program with narazaciclib, following the completion of the Phase 3 INSPIRE study in 2020. General and administrative expenses were $9.4 million for 2021 compared with $8.3 million for 2020. This increase was primarily related to costs related to special and annual general meeting expenses incurred in the 2021 period. We reported a net loss for the full year of 2021 of $16.2 million or $0.96 per share on 16.8 million weighted average shares outstanding compared with a net loss of $25.2 million or $2.17 per share for 2020 on 11.6 million weighted average shares outstanding. Cash and cash equivalents as of December 31, 2021, were $55.1 million compared with $19 million as of December 31, 2020. The company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least two years. This completes my financial review. I’ll now turn the call back to Steve.

[Steve Fruchtman:]

Thank you, Mark. Before moving on to our Q&A, permit me to first summarize the key value-creating milestones we are expecting throughout the rest of this New Year. In our lead narazaciclib program, we expect to select a recommended Phase 2 dose in the second half of the year based on findings from our ongoing Phase 1 program. This would then be followed by the initiation of a Phase 2 basket trial in indications such as hormone receptor positive, HER2-negative metastatic breast cancer. Outside of our lead program, we expect an investigator-sponsored trial evaluating rigosertib in combination with pembrolizumab in advanced melanoma patients to begin in the first half of this year. We also expect additional data from the Phase 1/2a trial of rigosertib plus nivolumab in KRAS-mutated non-small cell lung cancer agnostic to the type of KRAS mutation present to be reported in 2022. Finally, we continue to actively evaluate the science and market size behind various opportunities to potentially expand our pipeline through strategic licensing and collaborations. Though I emphasize that we have very strong conviction around the value of our current pipeline and their potential to deliver value to our investors and the patients in need based on the results we have shared with you today and our ongoing and planned studies. And with that review of our clinical progress and finances, we’ll now open the call for questions. Operator?

[Operator:]