Newtown May 18, 2020 (Thomson StreetEvents) -- Edited Transcript of Onconova Therapeutics Inc earnings conference call or presentation Thursday, May 14, 2020 at 8:30:00pm GMT

* Abraham N. Oler

Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel

Onconova Therapeutics, Inc. - CFO

Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development

* Steven M. Fruchtman

Onconova Therapeutics, Inc. - CEO, President & Director

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Ladies and gentlemen, thank you for standby, and welcome to the Onconova Therapeutics First Quarter 2020 Earnings and Corporate Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. Avi Oler, Senior Vice President, Corporate Development and General Counsel. Thank you, sir. Please go ahead.

Abraham N. Oler, Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel [2]

Thank you, operator. Good afternoon and welcome to Onconova's First Quarter 2020 Corporate Update and Financial Results Conference Call. Earlier this afternoon, we issued a press release outlining our financial results and business progress during the quarter. If you have not seen this press release, it is available on the Investor Relations page of our website at http://www.onconova.com.

On today's call, Dr. Steve Fruchtman, President and CEO, will discuss the company's recent highlights and anticipated clinical and business milestones. After Steve completes his opening remarks, Mark Guerin, our Chief Financial Officer, will review first quarter financial results. Following Mark's report, we will move to the Q&A portion of the call, which will be joined by Dr. Rick Woodman, our Chief Medical Officer. Lastly, Steve will come back with some final comments and a review of our upcoming milestones.

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 afternoon and the risk factors in the company's current and future filings with the SEC.

With that, it is my pleasure to now turn the call over to Steve.

Thank you, Avi. Good afternoon, everyone, and thank you for joining today's call. First, our hearts go out to the many individuals and families impacted by the devastating COVID-19 pandemic. The world has truly changed, and we hope that brilliant scientists from around the world can bring new therapies and preventions to this devastating plague.

Onconova demonstrated significant progress during the first quarter of 2020, highlighted by the completion of enrollment of our pivotal Phase III INSPIRE trial in higher-risk myelodysplastic syndromes. We are fortunate to have achieved full enrollment prior to the profound impact of the worldwide COVID-19 pandemic, which has forced disruptions to research studies at many hospitals and cancer centers across our globe.

With enrollment now completed, Onconova's pivotal Phase III INSPIRE trial is advancing to the next pivotal catalyst. Based on historical survival trends in the INSPIRE trial, we continue to anticipate reporting top line survival data in the second half of 2020. And we expect to present the results of the INSPIRE trial at a major medical meeting later this year. With INSPIRE enrollment now complete, we are preparing for when we reach 288 survival events before analyzing and releasing top line survival data.

To shorten time lines for our anticipated NDA submission to the FDA, we have already begun NDA work prior to data readout. We are working with regulatory consultancy experts on our NDA document for the U.S. FDA as well as on the MAA document for the EMA to be in position to expedite our health authority applications when data becomes available.

We are also advancing our plans to be ready for commercialization. And to develop internal Onconova expertise, we have nominated a commercial expert, Ms. Terri Shoemaker, to our Board, who was instrumental in the commercialization of azacitidine, the most frequently prescribed pharmaceutical agent in higher-risk MDS.

As you recall, INSPIRE is an open-label, randomized, controlled, international study designed to determine the efficacy, safety and tolerability of single-agent intravenous rigosertib in the treatment of patients with second-line, high-risk MDS. Patients in this study are less than 82 years of age and have progressed on, relapsed or failed to respond to previous treatment with the standard of care hypomethylating agent therapy. The study randomized patients to receive either intravenous rigosertib with best support of care or the physician's choice of therapy with best support of care.

The primary end point of this study is overall survival of all randomized patients in the intent-to-treat population. There is also a second opportunity for an FDA approval, which is the sequential analysis of the overall survival of the very high-risk subgroup as defined by the revised International Prognostic Scoring System. Should rigosertib prolong survival in the INSPIRE trial in a statistically significant manner, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years.

Today, we disclosed that at the European Hematologic Association's upcoming virtual congress, Onconova and our collaborators at MD Anderson Cancer Center and the centers participating on the INSPIRE trial have an accepted presentation. The presentation, which was just posted to the European Hematology Association's website, detail the impact of the RAS pathway mutations on patients failing azacitidine and is entitled, Mutations in RAS Pathway Genes Correlates with Type of Failure to Azacitidine: Genomic Analysis at Randomization onto the INSPIRE Trial.

As you know, advances in the understanding of genomics have revolutionized cancer care. Participants on the INSPIRE trial received deep genomic sequencing of their blood or bone marrow at randomization and at multiple time points in their treatment during the study. The genomic data from the INSPIRE trial identifies the most common mutations in high-risk MDS following azacitidine failure, including those of the RAS pathway that may be targeted by rigosertib. We believe this data presentation will further advance the learnings about MDS, the important role of genomics and the possible place of rigosertib treatment for MDS and other RAS-driven cancers.

We have made important progress with our additional pipeline programs as well. In addition to the INSPIRE trial, we are advancing plans for a pivotal Phase II/III combination trial of oral rigosertib and azacitidine in adult patients with HMA-naive, higher-risk MDS. We received feedback from the FDA in 2019 and are preparing a Phase II/III protocol for submission based on their guidance. We anticipate meeting with the FDA in the third quarter of this year after submitting a Type C meeting request to consult with FDA. We anticipate this new registration trial will begin later this year following the FDA feedback and following the survival pivotal data readout from our INSPIRE study.

We have also received notification that the Phase I trial, which forms the basis for this new pivotal trial with oral rigosertib combined with azacitidine in HMA-naive, high-risk MDS patients, has been accepted for publication in Leukemia Research and anticipate its publication in the upcoming months.

In addition to studying rigosertib in MDS, we are primed for additional rigosertib development progress, including the to be initiated Phase I/IIa study of rigosertib plus nivolumab in Stage 4 KRAS-mutated lung adenocarcinomas following the reopening of clinical cancer research programs post the COVID-mandated stoppage as well as additional planned indications for rigosertib in other KRAS-mutated cancers and our pipeline programs. The study in KRAS-mutated lung adenocarcinoma will be an investigator-sponsored trial, and we anticipate the first patient will be enrolled following the mitigation of the burden of the COVID pandemic that has been placed on our academic medical centers.

While checkpoint inhibitors represent a significant advancement in the standard of care in treating lung cancer and have achieved blockbuster status many times over, tremendous unmet medical need continues to exist following disease progression. In our view, this makes our novel combination approach with rigosertib a very attractive option to pursue in lung cancer and potentially beyond.

And beyond rigosertib, ON123300 is our investigational first-in-class dual inhibitor of CDK4/6 and ARK5. We believe ON123300 has the potential to treat numerous cancers, including refractory metastatic breast cancer, with CDK4/6 inhibitors already commercially available. For those who are not familiar with this field, CDK inhibitors have emerged as promising 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 and 6, we believe ON123300 has the potential to overcome many of the existing agents' limitations, making it potentially suitable for certain cancers that may not be responsive to the current generation of commercially available CDK4/6 inhibitors. If successful, we believe ON123300 could address this very large market opportunity.

We maintain global rights of ON123300 outside of China. Our partner in China for this compound is HanX Biopharmaceuticals, who funded the Chinese IND-enabling studies. The Chinese IND was approved in January of 2020 by the Chinese health authority. We anticipate a Phase I study may begin in China in the second half of 2020. We also intend for the Chinese IND-enabling studies to comply with our FDA standards. To the U.S. and the rest of the world outside of China, our manufacturer for ON123300 is now qualified. We plan to file a U.S. IND in the fourth quarter of 2020 after obtaining the required manufacturing data.

With regard to business development. During the first quarter, we reacquired rigosertib rights in Greater China. As a result, Onconova controls the rights for rigosertib in the U.S., Europe and China, which are among the largest pharmaceutical markets in the world. Last year, we announced plans to launch an early access program with Inceptua Medicines Group. We anticipate launching this program in select countries in the second half of this year. We expect to continue to evaluate opportunities as we progress from one milestone to the next milestone.

As a reminder, our upcoming Annual General Meeting of Stockholders is coming up on May 27. I encourage stockholders to vote at our upcoming Annual General Meeting. Our proxy materials are available on our website. I am very excited that Onconova's Board of Directors has nominated life science industry veteran, Terri Shoemaker, to join the Board at this time. As mentioned, Terri has highly relevant experience in the MDS space. Terri was a key executive in the launch of azacitidine in MDS and will be a very valuable addition to our Board of Directors. We believe her experience in developing and managing commercial organizations in the life science industry will be instrumental in our efforts moving forward as we prepare for potential commercialization of rigosertib.

And now I'd like to turn the call over to Mark Guerin, our Chief Financial Officer, for a discussion of our financial results for first quarter 2020. Mark?

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Mark Patrick Guerin, Onconova Therapeutics, Inc. - CFO [4]

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Thanks, Steve, and good afternoon, everyone. Cash and cash equivalents as of March 31, 2020, totaled $31 million compared to $22.7 million as of December 31, 2019. As previously noted, common stock warrant exercises since our financing transaction in November 2019 have added $10.6 million of cash to our balance sheet. Also, of the almost 29 million stock warrants outstanding as of March 31, 2020, over 80% of them were in-the-money as of May 13. Based on our current projections, we expect that our cash and cash equivalents will be sufficient to fund our ongoing trials and operations into the third quarter of 2021.

Our net loss was $5.1 million for the quarter ended March 31, 2020, compared to $7.6 million for the comparable period in 2019. Research and development expenses were $3.4 million for the quarter ended March 31, 2020, and $4.1 million for the comparable period in 2019. General and administrative expenses were $1.8 million for the quarter ended March 31, 2020, and $3.2 million for the comparable period in 2019.

This completes my financial review. I'll now turn the call back to Steve.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [5]

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Thank you so much, Mark. With that, we'd like to open the call for questions. After the Q&A, I'll finish with some final closing remarks. Operator, please open the call to Q&A session, and thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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Glad you're all doing well. So I have 3 questions, 2 of which, I think, are pretty much logistical. The first one is with regard to INSPIRE, it's great that you enrolled everyone right now and things are progressing and the time lines are still on track. So I was just curious, as part of your -- I guess, call it, your statistical assumptions now with COVID, is there a potential for any loss to follow up for any of these patients that you might not hear about some of these events? Or is it not a concern?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [3]

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I'll ask Rick to take that question, and thank you, Joe.

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [4]

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Yes, Joe. Thank you. The main challenge with the COVID pandemic for our global study has been monitoring of the sites. Fortunately, the number of patients in which we are not able to confirm survival events is extremely small. And we anticipate that continuing in part due to the efforts of our CRO and the clinical research assistance in the field and the team in Onconova as well as some good luck. And I think that we anticipate for the remainder of the collection of survival events that we will be able to continue doing that monitoring. But it is a challenge, and the monitors and the team have -- had to develop unique ways in which to interact with the sites because of the pandemic.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [5]

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Got it, Rick. And then my second logistical question, if you will. I know we discussed this in the past, but sometime has elapsed, and I just want to make sure if your thinking is still the same with regard to the communication strategy around putting out the data for INSPIRE. So since you're looking to present them at a major medical meeting in the second half, I'll just say presumably ASH, would you look to then have one of those typical top line press releases to say, okay, it hit, and we'll give the further data at an upcoming conference? Or not hit as...

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [6]

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Avi, why don't -- I'll ask Avi to take that one, if I may. Go ahead, Avi.

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Abraham N. Oler, Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel [7]

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Sure. Sure thing. In terms of communication, Joe, thanks for the question, but you're exactly right that we would anticipate announcing the data when it is ready at a top line level and presenting full data at an upcoming major medical meeting such as ASH or another major medical meeting.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [8]

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Got it. And then my question is -- or my third and last question. With regard to the upcoming Type C meeting, obviously, you've already had a lot of productive discussions with the FDA around the study design. So I guess I would ask it 2 ways. What's your wish list of what you want to get out of there? And what are the key outstanding things that you need to get solidified?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [9]

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Rick?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [10]

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Yes, Joe. So I think the first part to your question is that we want to get agreement from the FDA on a novel, unique, adaptive design, a combination of a Phase II/III. And this adaptive design we presented at ASH and some of the unique features. We feel this design is particularly advantageous for us in a variety of ways as well as the medical community and the health authorities. And I think it is the additional challenge that we have is developing, particularly, as we indicated in the abstract at ASH, a very rigorous and robust interim analysis that allows us to move forward into the Phase III part of the study.

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Operator [11]

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Your next question comes from the line of Naureen Quibria with Maxim Group.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [12]

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So first, I guess, starting first with INSPIRE. Can you remind us or are you able to disclose what the current event rate is right now? And is there an average number of events that you're seeing per month? Are you able to discuss that in any detail?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [13]

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I think I'll try my hand at that, and thank you very much. We did reveal, I believe mid-March, that we have over 85% of our survival events that we require of the 288. And the reality is it's quite variable. We do monitor by month every -- the survival events that we see, it is variable. But based on what we are observing, we anticipate reaching pivotal data the second half of 2020. So before the end of the year. It's harder -- it's very hard to make a more accurate prediction than that.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [14]

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Edited Transcript of ONTX earnings conference call or presentation 14-May-20 8:30pm GMT - Yahoo Finance

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