Traws Pharma, Inc. (TRAW) Earnings Call Transcript & Summary

Good morning and welcome to Onconova Therapeutics conference call to discuss the top line INSPIRE pivotal Phase III data. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] And I would now like to turn the conference call over to Avi Oler, Senior Vice President of Corporate Development & General Counsel.

Thank you, operator. Good morning and welcome to Onconova's conference call to discuss the INSPIRE top line data. Earlier this morning, we issued a press release outlining the results. If you have not seen this press release, it is available on the Investor Relations page of our website at www.onconova.com. On today's call, Dr. Steve Fruchtman, Onconova's President and CEO, will discuss the data and next steps with the company's pipeline. Following Steve's remarks, we will move to the Q&A portion of the call, which will be joined by Ric Woodman, our Chief Medical Officer; and Mark Guerin, our Chief Financial Officer. Lastly, Steve will come back with some final comments. Before we begin, I remind everyone that statements made today 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. Please see the forward-looking statements disclaimer in the press release issued this morning and the risk factors in the company's current and future filings with the SEC. With that, I now turn the call over to Steve.

Thank you, Avi. Good morning, everyone, and thank you for joining today's call. Before we begin, Onconova would like to thank the MDS community for its participation in the INSPIRE trial. We report these results with great disappointment and we remain deeply embedded to every patient, physician and family member involved in the study. We are also appreciative of the long-standing support from our investor base. As outlined in our press release earlier this morning, INSPIRE, the company's pivotal Phase III study, assessing the efficacy and safety of IV rigosertib in higher-risk MDS patients did not meet its primary endpoint of improved survival. Results of INSPIRE demonstrated that the intent-to-treat analysis patients randomized to receive IV rigosertib achieved an overall survival of 6.4 months versus 6.3 months for the physician's choice arm with a p value of 0.33 in the overall high-risk MDS population. Overall survival in the pre-specified very high risk MDS subgroup of patients was also not significantly different between the 2 study arms. There was an increase in overall survival in the physician's choice arm post-interim analysis that was unexpected. The company is conducting additional analyses. Safety analysis indicates that IV rigosertib was generally well tolerated, with reported adverse events similar to those observed in clinical studies with IV rigosertib in MDS. Onconova will cease further development activity in MDS, including its pre-registrational activities and the initial commercialization activities. The company will review pipeline and in-licensing opportunities, both internally and with external advisors. We plan to take learnings from the genomic analysis of the INSPIRE trial to inform the future development of rigosertib. While the INSPIRE data readout in high-risk MDS is a disappointment, as a RAS pathway inhibitor, oral rigosertib could address a number of oncology settings outside of hematology. We also look forward to the continued expansion of our investigator-initiated study program with oral rigosertib beyond the ongoing Phase I/IIa study in KRAS-mutated lung adenocarcinoma into additional solid tumors. Our novel CDK4/6 and ARK inhibitor, ON 123300, could also represent a meaningful advance over existing products. The company has built a product pipeline that includes multiple agents, including oral rigosertib and ON 123300. Both compounds target what Onconova considers to be meaningful cancer pathways and we look forward to further efforts with these programs and others in the coming quarters. Onconova retains rights to these compounds in major commercial markets, including the U.S. and Europe. More specifically, earlier this year, we announced the initiation of a Phase I/IIa study, exploring an oral rigosertib plus nivolumab combination in KRAS-mutated lung cancer patients. We anticipate studies in additional RAS pathway driven cancers as part of our investigator-initiated development program. Given their utility in multiple cancer settings, checkpoint inhibitors, such as nivolumab are among the world's top selling pharmaceutical products and continue to obtain FDA approval for broader indications. In our view, this makes our novel combination approach with rigosertib a potentially meaningful option to pursue in lung cancer as well as other solid tumors. Beyond rigosertib, ON 123300 is our first-in-class inhibitor of CDK4/6 as well as ARK5. We plan to file a U.S. IND in the fourth quarter of 2020. We believe ON 123300 has the potential to treat numerous cancers, including refractory metastatic breast cancer, where CDK4/6 inhibitors are already commercially available. CDK inhibitors have emerged as promising products and compounds targeting very large cancer indications, such as hormone receptor positive metastatic breast cancer. Due to its unique targeting of ARK5 as well as CDK4/6, we believe ON 123300 could overcome many of the existing products' limitations, potentially making it suitable for certain cancers that may not be responsive to the current generation of CDK4/6 inhibitors. In addition, our very early preclinical work with rigosertib in COVID-19 continues. In late July, Onconova announced preclinical data suggesting rigosertib inhibited SARS-CoV-2 replication in vero cells. Based on these findings, Onconova applied to multiple government agencies to seek funding and to participate in therapeutic trials under the NIH umbrella to conduct human studies in COVID disease. We caution that our work in this area is very early, and there is no assurance that we will gain the government funding required for us to move forward. We hope to provide greater clarity sometime during the second half of this year. With that, we'd like to open the call for questions. After the questions and answers, I will finish with some closing remarks. Operator, please open the Q&A session and thank you.

Thank you. [Operator Instructions] And our first question comes from the line of Joe Pantginis with H.C. Wainwright.

I'm sorry about the results -- not the result, obviously, we were all expecting or anticipating for this summer, but obviously need to look forward right now. So I just have a -- first, a logistical question. So when you say just stopping all hematology, I assume you said, so that means even the oral program.

Good morning, Joe. I'll take that. What we referred to is we will not conduct the oral program in combination with azacitidine in first-line high-risk MDS, we will not continue that program.

Understood. Okay. Great. So...

Our other programs -- Joe, our other programs, as I mentioned, with oral rigosertib will continue in KRAS-mutated solid tumors.

Got it. Got it. Just wanted to make sure. And then, I guess, a little bit, and it is early now, and you have to look at a lot of things at this point. But do you have any speculation right now with regard to the physician's choice arm performing better? Obviously, there really weren't any real advances in the field in -- especially in high-risk MDS. So I'm just curious if you have any speculation at this point about what might have happened in that arm?

So as you know, at interim, there was a promising survival signal in favor of rigosertib over physician's choice. Post interim, the physician's choice on survival improved dramatically when compared to both the patients prior to the interim analysis and also when compared to the literature. And you are right, Joe. There are not many novel new opportunities for patients with high-risk MDS who fail azacitidine, thus, the physician's choice has been consistent, I would say, over the past decade. So we do not understand why there was a market in true meant if survival on the physician's choice arm compared to historical studies, and we will continue to try to explore that [ but ] have to gain additional understanding.

I guess I would push that one step forward. Do you have any evidence that there were any, say, particular novel agents that were not necessarily associated with MDS that might have been included in the PC arm?

Well, Joe, we looked at things like bone marrow transplant, for instance, the use of venetoclax, which has now come into both acute leukemia and being used for higher risk, and it appears on a preliminary review to be quite equal in both arms.

Got it. Got it. Okay. Sorry for the data today, but happy that you have some nice upcoming news flow though.

Thank you, Joe.

And ladies and gentlemen, I'm not showing any further questions in the queue at this time. I'd like to turn the call back to the speakers for any closing remarks.

Thank you all for participating in today's call. While the INSPIRE trial did not achieve what we hoped it would, Onconova remains a company focused on meeting the unmet medical needs for oncology patients. As we transition to our next corporate phase, we'd like again to thank the MDS community, the physicians, the patients and our investors for their tremendous support over the years. Milestones, we look forward to in the near and medium term include the following. One, the continued expansion of the rigosertib investigator-initiated study program into additional solid tumor types. Two, U.S. IND submission for ON 123300 during the fourth quarter of 2020, followed by a clinical trial initiation. Third and lastly, determining next steps in COVID-19 research. We truly appreciate your continued interest in our programs at Onconova. Operator, you may now end the call. And thank you again.

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.