Onconova Therapeutics, Inc.
Q1 2021 Earnings Call Transcript

Published: 17 May 2021

[Operator:]

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

[Abraham Oler:]

Thank you. Good afternoon, everyone, and welcome to Onconova's First Quarter 2021 Financial Results and Business Update Conference Call. Earlier this afternoon, we issued a press release reporting our quarterly 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.onconova.com.

[Steven Fruchtman:]

Thank you, Avi. Good afternoon, everyone, and thank you for joining us today. As the COVID-19 pandemic is being brought under greater control in some, but tragically not in all geographies through the scientific advances of colleagues from around the world, we hope you and your loved ones remain safe and healthy. Despite the hurdles COVID placed on the conduct of clinical research, Onconova remains committed to executing on our goals and advancing our pipeline candidates through the clinic. Let me begin with a review of our business progress, starting with our lead product, ON 123300 or simply referred to as 123. As a reminder, 123 is a proprietary first-in-class multi-kinase inhibitor, targeting CDK4, CDK6 and ARK5. It works by simultaneously inhibiting both the cell cycle and cellular metabolism through CDKs and ARK5, respectively, which may be overexpressed in a number of cancers. In vitro data show that 123 maybe cytotoxin to cancer cells, meaning it kills cancer cells, rather than merely inhibiting their growth, which is how the currently available CDK inhibitors typically work. We believe that was a mechanism of action targeting CDK4, CDK6, ARK5 and other kinases such as FLT3, 123 represents an innovative approach for treating solid tumors and hematologic molindone that are refractory who have become resistant to the current CDK4/6 inhibitors.

[Mark Guerin:]

Thanks, Steve, and good afternoon, everyone. I'll begin with a quick review of our first quarter expenses, and then I'll discuss our cash position and cash runway. Research and development expenses for the first quarter of 2021 were $1.9 million, which compares with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the recently completed Phase III INSPIRE study in the 2021 period. General and administrative expenses for the first quarter of 2021 were $2.2 million, which compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting expenses and insurance costs in the 2021 period. We reported a net loss for the first quarter of 2021 of $4.7 million or $0.02 per share on 219.2 million weighted average common shares outstanding. This compares with a net loss for the first quarter of 2020 of $5.1 million or $0.03 per share on 160.3 million weighted average common shares outstanding. During the first quarter, the company strengthened its balance sheet with net proceeds of $35.2 million from 2 equity offerings. Our cash and cash equivalents as of March 31, 2021, were $48 million versus $19 million as of December 31, 2020. We believe that this cash position will be sufficient to fund our ongoing clinical trials and business operations for more than 18 months and through the achievement of significant milestones, including pursuing corporate development opportunities.

[Steven Fruchtman:]

Mark, thank you. In summary, we have several key near-term milestones and value drivers ahead of us

[Operator:]

. And you have a question from Dr. Joe Pantginis from H.C. Wainwright.

[Sara Nik:]

This is Sara Nik on for Joe. I actually have two questions. You mentioned you recently started rigosertib study in the patients with recessive dystrophic epidermolysis bullosa. I was just wondering if you could go a little bit more into the endpoint, especially when the landscape for treating the underlying diseases likely dramatically changing soon with gene therapy, specifically the chronic wounds in these patients are so inflamed? Usually, how does this how does something like this impact the assessment of SCC responses?

[Steven Fruchtman:]

Well, thank you for that Sara, but you've already answered your own question in a way. So these -- it sounds like you know a lot about this very rare condition, this very rather tragic condition. So these patients have terrible blistering of their skin. They denude their skin. They have a tremendous inflammatory component, their skin gets infected. There's nothing that is efficacious for these patients. So the endpoint will basically be observation of their skin, observation of the blistering that involves a skin the inflammatory component that is elicited by that blistering and to see if we go sort of an impact on the skin condition. Many of the patients concomitantly also have developed as a result of their underlying epidermolysis bullosa, squamous cell carcinoma. So if they have squamous cell carcinoma and the patients eligible for the trial all do, then as typically for a cancer trial, the squamous -- the size of the squamous cell carcinoma will be measured and to see if control is achieved in these patients, given either IV or oral rigosertib, and that choice is made based on clinical parameters that I discussed.

[Sara Nik:]

Okay. And my second question, you touched on this a bit, with the lung study having reached its pie dose in the protocol, can you go a bit more into what the communication strategy is from the investigator around this study?

[Steven Fruchtman:]

Yes. So we are in frequent communication with the investigator. We anticipate soon to do an interim analysis, looking at efficacy in the patients treated so far. Because at the highest dose, a sufficient number of DLTs has not been observed. The investigator will have the option with our approval Bianca Nova to continue to dose escalate or rigosertib until a sufficient number of DLTs are observed because in combination with full dose nivolumab, we want to be confident that we have the best dose of oral rigosertib in combination with nivolumab. So Phase II trial in this indication potentially can be conducted. So that will be -- that decision will be made after an interim analysis is looked at. And if any additional DLTs are seen, if not, there is the option to continue to dose escalate.

[Operator:]

And I'm showing no further questions in the queue. At this time, I'd like to turn the call back to the speakers for any closing remarks.

[Steven Fruchtman:]

So thank you again to all of you for participating on today's update call. As we've discussed, Onconova has several near-term milestones and value drivers right ahead of us. We look forward to executing on our business plan and keeping you apprised of our progress. We appreciate the continued interest in our programs and for your support. Thanks again, and have a nice evening. Take care.

[Operator:]

Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.