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

Greetings, and welcome to the Onconova Therapeutics Corporate Update and Strategic Combination with Trawsfynydd Therapeutics call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Bruce Mackle with LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and welcome, everyone. Joining me today are Dr. Steven Fruchtman, President and CEO of Onconova and President and CSO, Oncology of Traws Pharma; Mark Guerin, Chief Financial Officer of Onconova and Traws Pharma and Dr. Werner Cautreels, incoming CEO of Traws Pharma. Before we begin, please note that today's call contains forward-looking statements, the accuracy of which depends on future events outside Onconova, Trawsfynydd and Traws Pharma's control and therefore, could cause actual results to differ materially from those forward-looking statements. The forward-looking statements are made as of the date of this call only. Additional information regarding the risks and uncertainties and other important factors, any of which could cause actual results to differ from those contained in these forward-looking statements are described in the section titled Risk Factors in Onconova's annual report on Form 10-K filed yesterday, April 1, 2024, and in other filings that Traws makes and will make with the SEC. With that, I will now turn the call over to Dr. Steve Fruchtman.

Thanks, Bruce, and everyone who is joining us today. This morning at 7 a.m. Eastern Standard Time, Onconova and Trawsfynydd, issued a joint press release to announce that the companies have entered into a definitive merger agreement to combine in an all-stock transaction. The new combined company will be named Traws Pharma. Traws Pharma will be focused on developing next-generation, best-in-class antivirus for influenza, COVID and other respiratory infections and defining the recommended Phase II dose for narazaciclib in cancer. During this morning's call, Mark Guerin will review the transaction, including details related to a concurrent private placement. Werner Cautreels will provide an introduction to Traws Pharma, and then we will have a question-and-answer session with 2 additional members of the Traws' team, Dr. Robert Redfield, Chief Medical Officer; and Dr. David Pauza, Chief Scientific Officer of Virology at Traws Pharma. Now I would like to turn the call over to Mark.

Thank you, Steve, and good morning, everyone. As Steve said, this morning, Onconova and Trawsfynydd announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction. I'll take the next few minutes to review the transaction. And for simplicity, I will describe the details using rounded numbers and refer you to the press release for specific detailed information. I will cover the merger, the private placement, the ownership composition and equity value of the transaction and the contingent value right also called CVR. So starting with the merger. Under the terms of the agreement, Onconova acquired 100% of Trawsfynydd outstanding equity interest. The combined company will be in trading on NASDAQ under the new ticker symbol TRAW commencing prior to the opening of trading tomorrow, Wednesday, April 3, 2024. For the private placement in connection with the merger, Traws announced that it will raise $14 million in a committed private placement financing by OrbiMed and Torrey Pines. Private placement is expected to close tomorrow, April 3, 2024. Upon closing of the private placement, Traws expects to have an excess of $28 million in cash and cash equivalents from the proceeds of the private placement and cash from both companies. These proceeds will be used to advance the Traws programs through multiple clinical data catalysts, including completion of the dose ranging study for narazaciclib. Regarding the ownership breakout and fully diluted equity value of the transaction. Here's a summary of the shares that on kind of issued in the transaction. Again, we've used rounded numbers for simplicity during this call. In connection with the merger, the stockholders of Trawsfynydd received an aggregate of approximately 3.5 million shares of common stock and approximately 10,400 shares of newly issued Series C nonvoting convertible preferred stock with a conversion ratio of preferred to common at 1:10,000 also known as the Series C preferred stock. Also in connection with the private financing, OrbiMed and Torrey Pines received an aggregate of approximately 497,000 shares of common stock and approximately 1,600 shares of Series C preferred stock with the same 1:10,000 conversion ratio I just noted. What this represents an ownership on a fully diluted basis is 75.7% for Trawsfynydd, 13.7 million for Onconova and 10.6% for new investors, with a combined fully diluted equity value of $132 million, excluding transaction fees. The shares of common stock, which are issuable upon conversion of the Series C preferred stock shall be subject to stockholder approval and compliance with the rules of the NASDAQ stock market. Finally, regarding the contingent value right or CVR, in connection with the transaction, a nontransferable continued value right will be distributed to Onconova stockholders of record as of the close of business on April 15, 2024. Holders of the CVR will be entitled to receive certain proceeds received by Onconova, if any, related to the disposition, net sales or monetization of narazaciclib and rigosertib. I'm happy to take any questions on the transaction during the Q&A. I'd now like to hand the call over to incoming Traws CEO, Werner Cautreels. Werner?

Thank you, Mark, and again, good morning, everybody. I want to start by telling you that I'm very pleased to announce the combination of Onconova and Trawsfynydd at this important time and to join the combined company as CEO. I'd like to take the next few minutes to introduce you to the team and then provide a high-level overview of the programs and the upcoming milestones. We look forward to provide more details on the programs as the year unfolds. In this section, I will therefore cover the management team and the Board. An overview of the influenza COVID-19 and narazaciclib programs and the road map of the upcoming milestones through 2024 and into 2025. And then we will open the floor for questions. Traws Pharma will focus on developing next-generation, best-in-class antivirals for influenza and COVID-19 and other respiratory infections. And we will define the recommended Phase II dose for the oncology compound narazaciclib. Traws will be supported by a group of highly respected advisers with unparalleled expertise in both viral disease and in oncology. So let's start with the people, and first, the Traws management team. That will include me as the incoming CEO; Steven Fruchtman, as President and CSO, Oncology; Mark Guerin as CFO and Dr. Robert Redfield as the Chief Medical Officer; David Pauza from Trawsfynydd as CSO of virology and also Nikolay Savchuk from Trawsfynydd and a general partner of Torrey Pines as COO. Turning to the Board of Directors. It will be comprised of Trawsfynydd's Chairman, Dr. Iain Dukes, a venture partner at OrbiMed, who will be the Executive Chairman; myself as the income CEO, Dr. Nikolay Savchuk from Trawsfynydd and a general partner of Torrey Pines as well as 4 existing Onconova directors, and those are Trafford Clarke, James Marino, Theresa Shoemaker and Jack Stover. As we turn to the pipeline, I want to tell you what attached me to lead Traws Pharma. I am joined Traws at an important inflection point as the company readies to initiate Phase II studies in the second half of 2024 for the lead antiviral programs for influenza and COVID-19. From the start, the people and the science at Trawsfynydd and the potential to develop best-in-class antivirals has been at the core of my enthusiasm for joining what is now called Traws Pharma. I believe that the pipeline that also includes narazaciclib is very promising and at an important time -- and an important point in time with the potential to generate several short-term value inflection points and meaningful Phase II data over the next 9 to 18 months. Not only do we have a strong management team and exceptional world-class advisers, that we are supported by lead investors OrbiMed and Torrey Pines. I want to touch on each of the 3 programs next. We'll plan to cover any questions with the Traws team members present today, including former CDC Director, Dr. Robert Redfield, Dr. David Pauza, and as well, Dr. Steven Fruchtman. First, for TRX100 or viroksavir, which is a cap dependent endonuclease inhibitor for influenza currently in Phase I. Viroksavir targets the cab dependent endonuclease of influenza and is a potent inhibitor of influenza virus application, including A and B strains. Preclinical data showed that TRX100 inhibits viral replication of pandemic-potential influenza viruses circulating in nature. And importantly, also in oseltamivir and baloxavir-resistant viruses. Trawsfynydd completed a first Phase I study last year, that demonstrated safety and tolerability in healthy volunteers. The study also provided pharmacokinetic and pharmacodynamic data to support the potential use of a single oral dose administration for either treatment or prophylaxis. Looking ahead to the next milestones for viroksavir. First, we plan to conduct a Phase I dose extension study to evaluate 2 additional higher doses prior to the initiation of Phase II studies in the second half of 2024. Top line data from the Phase II study are expected in the first half of 2025. Second, for TRX01 or travaltrevir. Travaltrevir is a potent oral inhibitor of the SARS-CoV-2 Mpro protease that is also known as the 3CL proteus. The compound is effective against the original like the Delta and omicron variance of SARS-CoV-2 with potentially superior properties to nirmatrelvir which is Pfizer's Mpro inhibitor, PAXLOVID. One of the most important potential differentiating features of travaltrevir is that it does not require co-administration with the human cytochrome P450 inhibitor, such as ritonavir, therefore, avoiding potential significant drug interactions. This feature provides the opportunity to expand the number of eligible patients. Travaltrevir has been shown to be safe in GLP tox studies with no adverse events in the expected human dose range. The drug candidate's pharmacokinetic profile may enable a once-daily 10 day treatment regimen, which could reduce the likelihood of viral rebound. Looking ahead to the next milestones for travaltrevir. First, screening in normal volunteers was initiated in the Phase I first-in-human single and multiple dose study, and that was done in the first quarter of 2024. We expect to report top line data of this Phase I trial in the second half of 2024. We plan to initiate the Phase II study with travaltrevir in the second half of 2024. That study will enroll people with moderate to severe COVID-19 and we anticipate reporting top line data in the first half of 2025. I want to provide also an update on Narazaciclib. Onconova's next-generation CDK4/6 inhibitor in development for low-grade endometrial cancer or LGEEC. Narazaciclib's mechanism of action in LGEEC has been validated by Phase II studies with other approved CDK4/6 inhibitors like palbociclib from Pfizer, ribociclib from Novartis and abemaciclib from Lilly. Narazaciclib has several characteristics that could differentiate it from other agents including reduced gastrointestinal and hematological toxicities, which may permit daily administration without the need for drug holidays as they are employed by other approved agents to manage severe bone marrow suppression. Together with additional pharmacological aspects, these features could provide narazaciclib with a better efficacy safety ratio compared to approved products. The program is currently in Phase I/II studies with and without the hormone therapy letrozole, and these studies are designed to define the recommended Phase II dose. Therefore, the next milestone for narazaciclib is the definition of a recommended Phase II dose and the definition of the development strategy for LGEEC and potential order indications. In closing, I believe that Traws has a unique opportunity to improve the care of respiratory viruses, such as influenza and COVID-19 as well as to improve treatment in cancer patients with LGEEC and potentially other indications. With several clinical catalysts ahead, a world-class team and strong investor support, I believe that Traws Pharma is well positioned to achieve important value inflection points over the next 9 to 18 months, and we look forward to keep you updated on our progress. With that, I will turn it over to the operator for Q&A.

[Operator Instructions] Our first question comes from the line of Ahu Demir with Ladenburg Thalmann.

Congrats on the merger. I have 2 questions. I'll start with the antiviral pipeline. Could you highlight the major differentiations of travaltrevir compared to other protein inhibitors for COVID-19?

Thank you for your question. I think this is a good question for our CSO of virology, David Pauza. Can you take that question, David?

Yes. Thank you, Werner. The TRX01 for COVID is best-in-class for potency, both in terms of biochemical assays and assays for virus replication reduction in vitro. The compound also has a superior pharmacologic profile with excellent safety. And we plan for the initial studies to be a 10-day dose regimen which is a significant differentiation from all other compounds in the market. The 10 day dose regimen is intended, as Werner mentioned earlier, to suppress the rate of rebound, which is at very high levels in current therapeutics and in the current disease condition.

And David, I would just add -- this is Redfield. I would just add the other distinguishing feature, say, against the competitor like PAXLOVID is that it does not require any co-administration of a PK enhancer like ritonavir.

That's helpful. So my other question will be about oncology pipeline. For narazaciclib, is there a point to make a go-no-go decision? Curious about that. And also, it sounds like rigosertib is not part of the pipeline. So there is no effort to move forward with that in [indiscernible] Is that correct?

Thank you. like for any pipeline, of course, this will all be data-driven. But on the oncology aspects, maybe Steve, can you add some more color to that?

Sure. Werner, and thank you for your question, Ahu. As you know, we're very excited about the potential for narazaciclib. Of course, from the safety potential, this drug can be given every day once a day, which is unique amongst all the health [indiscernible] CDK4/6 inhibitors. Two of these drugs require a 1-week holiday to prevent -- to permit the bone marrow cells to replicate. Of course, in that week, [indiscernible] tumor cells may also have the capacity to replicate and not be inhibited during the drug holiday. So based on our studies to date narazaciclib does not require such a drug holiday. We've not seen significant diarrhea. We've not seen interstitial lung disease, which has been reported with all the other CDK4/6 inhibitors. So again, we hope based on safety and ultimately, efficacy we hope to bring narazaciclib to the market. Regarding rigosertib, as you know, this has had quite profound and impressive results in the ultra-rare disease of squamous cell carcinoma, complicating our [indiscernible]. The plan at this point is the FDA has been very helpful for us to understand the pathway to often designation which is the first step in the development pathway for future studies with rigosertib, and we anticipate that those interactions with the [indiscernible] Group at FDA will continue.

Got it. And if I can sneak one more question just here -- one more question. $28 million cash, what is the runway given the multiple programs that you plan to run?

Thank you for that question, We have definitely a view on the company's resources. Regarding the financial resources, the cash balance at closing of about $28 million will allow us to reach the milestones of the 3 assets that we give priority to in the pipeline. That is to complete Phase I for the influenza project, complete Phase I for the COVID project and reach the recommended Phase II dose for narazaciclib. We will also work on the initiation of the next steps for the clinical development of the projects, and the $28 million will allow us to do that.

[Operator Instructions] Ladies and gentlemen, I'm showing no other questions. Thank you. This concludes our Q&A session, and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.