Traws Pharma, Inc. (TRAW) Corporate Update Call Transcript

Traws Pharma, Inc. (NASDAQ:TRAW) Corporate Update Call August 15, 2024 8:00 AM ET

Company Participants

Bruce Mackle – LifeSci Advisors, IR
Werner Cautreels – CEO
Mark Guerin – CFO

Conference Call Participants

Chong Liu – Ladenburg Thalmann

Operator

Operator

Ladies and gentlemen, welcome to Traws Pharma, Inc. Corporate Update Call. At this time all participants are in a listen-only mode. Following managements prepared remarks we’ll hold a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded today, August 15, 2024.

At this time, I would like to turn the call over to Bruce Mackle of Lifesci Advisors.

Bruce Mackle

Thank you, operator, and welcome everyone, to Traws Pharma, Inc.’s Corporate Update Conference Call. This morning, Traws issued a press release reporting its second quarter 2024 financial results and corporate update. If you have not yet seen this press release, it is available in the Investors & Media section of the company’s website at www.trawspharma.com.

Following my introduction, we will hear from Traws’ Chief Executive Officer, Dr. Werner Cautreels; and Chief Financial Officer, Mark Guerin.

Before we begin, I would like to remind everyone that statements made 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, Traws 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, I will turn the call over to Werner.

Werner Cautreels

Thanks, Bruce, and thanks to everyone for joining us today. The last several months have been transformational and very positive for Traws Pharma. Thanks to the excellent execution of everyone on our teams, we have substantially advanced our clinical pipeline. While the data analysis is still ongoing, we believe that we will have a very good picture of the preliminary pharmacokinetics, preferred dosing plans and safety for each of our product candidates.

During the call today, our CFO, Mark Guerin and I, we will summarize the latest progress with our clinical pipeline, including expected upcoming milestones. We will briefly review our financials and the transaction that created Traws Pharma and then also take your questions.

Traws Pharma’s mission is to build solutions for important medical challenges and alleviate the burden of viral infections and cancer. In April, we completed the merger agreement that created Traws Pharma. This transaction expanded our investor base to include recognized healthcare investors, OrbiMed and Torrey Pines, and also broadens our portfolio.

Our pipeline of potentially best-in-class oral small molecule medicines now includes antiviral therapies with two programs for serious respiratory infections, influenza and COVID-19, as well as oncology with two agents that target essential steps in the cell cycle for solid tumor cancers.

In the coming months, we look forward to completing and reporting the top line data from each of our ongoing clinical studies and to sharing plans for the initiation of Phase II studies in our antiviral program. At the same time, we are progressing our investigator-sponsored trials, or IST, strategy in oncology. We believe that these data could pave the way for key readouts in 2025. I’m excited about our portfolio based on each candidates’ differentiated and potential best-in-class profile.

With that, I’d like briefly to take you through each of the programs, starting with our program for influenza, including avian or bird flu. Tivoxavir marboxil is our influenza candidate. It targets the influenza cap-dependent endonuclease, which is highly conserved across flu strains, including bird flu, making it a potential universal agent for flu. We believe that our compound may provide an important contribution to alleviate influenza, including seasonal and pandemic infections, both as a treatment as well as in certain prophylactic settings.

Preclinical data and top line results from single-ascending dose, or SAD studies suggest that tivoxavir marboxil has the potential to achieve our target product profile as a single-dose treatment that is well-tolerated and active against influenza A or B, also known as pandemic potential viruses, as well as against oseltamivir- and baloxavir-resistant viruses. We are dosing the first cohorts in a Phase I extension study in Australia. This placebo-controlled trial is being conducted in healthy volunteers and is evaluating three tivoxavir marboxil doses, including two doses from the previous successful Phase I dose escalation study at 80 and 120 milligrams and one new increased dose, 240 milligrams.

The study will assess pharmacokinetics, pharmacodynamics and safety and is expected to define the dosing plan for a future Phase II study.

Next steps for this program are to announce top line Phase I dose extension studies results from Australia expected in Q4 of this year and prepare for the initiation of a Phase II study expected to begin in Q4 of this year or Q1 of 2025.

Ratutrelvir is for COVID candidate. It targets Mpro, which is the 3CL protease. We believe that the major differentiator is that the compound does not require combination use of CYP-inhibitor, such as ritonavir. CYP-inhibitors are used to slow down the metabolism of the active compound, as demonstrated by nirmatrelvir. But CYP-inhibitors can also result in potentially significant drug-drug interactions with other medications as can be observed in the older, more vulnerable patient populations. We are aiming for a 10-day once-a-day treatment.

Clinical trial-enabling studies suggest that ratutrelvir should be well-tolerated and is active against COVID strains that may be resistant to approved agents such as nirmatrelvir and that includes Delta and Omicron strains. We just completed dosing in a Phase I single-ascending dose, SAD and multiple-ascending dose, MAD study in healthy volunteers in Australia. The study SAD segment was designed to assess five doses ranging from 15 milligrams to 600 milligrams. And the MAD segment was designed to evaluate two dose levels, 150 milligrams and 600 milligrams, dosed daily for 10 days.

We expect the study to provide pharmacokinetics, pharmacodynamics and safety data that should define the dosing plan for an upcoming Phase II efficacy study. So the next step for this program are to announce top line results from Phase I SAD and MAD studies, and that is expected in Q4 of this year, and prepare for the initiation of a Phase II efficacy study expected to begin in Q4 of this year or Q1 of 2025.

Now switching gears, I’d like to provide you with a brief update on our oncology programs, starting with narazaciclib. Narazaciclib is a multi-kinase inhibitor targeting CDK4-plus and other kinases with potential for use in multiple solid tumors. We recently completed Phase I/II dose escalation studies for the compound, evaluated both as a monotherapy and in combination with letrozole in patients with recurrent metastatic low-grade endometrioid endometrial cancer and other gynecologic malignancies.

The studies were designed to define the dose-limiting toxicity and maximal tolerated dose of the combination that should result in the recommended Phase II dose for further clinical trials. Next steps for narazaciclib will utilize the investigator-sponsored trial, or IST strategy. Upcoming milestones includes the release of top line data from the recently completed Phase I/II dose escalation studies at an upcoming medical meeting and identify the recommended Phase II dose and initiation of ISTs in multiple myeloma and breast cancer. And that’s from the second half of this year and beyond.

Our second oncology candidate is rigosertib. Rigosertib is also a multi-kinase inhibitor targeting cell cycle proteins, including PLK-1, with potential use in the ultra-rare disease of advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa. And that is also known as RDEB-associated SCC. We have been utilizing an IST strategy to develop rigosertib in this ultra-rare disease. Data from these studies have been presented at international medical meetings, including more recently at the Society of Investigative Dermatology held in July of this year, which highlighted ongoing studies conducted at the University Hospital in Salzburg, Austria and Thomas Jefferson University in Philadelphia.

We have been encouraged by the ongoing investigator interest for rigosertib and support the IST-led RDEB program, including compassionate use filings in both U.S. and other countries.

With that, I would like to turn it over to our CFO, Mark?

Mark Guerin

Thank you, Werner, and good morning, everyone. Traws’ financial results for the quarter ended June 30, 2024, represents the first post-transaction quarterly report of the combined company.

The press release issued this morning includes explanatory statements related to the financial results for this last quarter. I’ll refer you to our recent 10-Q filing for a review of the full financial statements. You can also access the press release and 10-Q on the Investor Relations section of our website.

Turning to our financials, the net loss that we reported for the quarter ended June 30, 2024, of $123.1 million, or $4.87 per basic and diluted common share, reflects a noncash charge of $117.5 million related to in-process R&D from Onconova’s April 2024 acquisition of Trawsfynydd. Traws Pharma closed the second quarter of 2024 with cash and equivalents of $16.9 million compared to $20.8 million as of December 31, 2023. We continue to close attention to our spending level while progressing our compounds in the clinic to reach the milestones that Werner discussed earlier. Based on these efforts and our current projections, we believe our cash will be sufficient to fund our ongoing clinical trials and operations through yearend.

Building further on Werner’s comments, we believe the transaction and concurrent $14 million private placement meaningfully expanded our portfolio and enhanced the company’s investor base with the addition of OrbiMed and Torrey Pines.

I would like to turn the call back to Werner.

Werner Cautreels

Thanks, Mark. In closing, and with thanks to Mark and his team, and thanks to our experienced product development and clinical operations team, we believe that the progress we have made so far this transformational year is completely consistent with our expectations and plan. Over the next six plus months, we expect to advance our antivirals into Phase II studies and define the clinical strategy in oncology. We believe that each of our upcoming milestones has the potential to solidify the target product profile for each program.

And again, starting with flu, for our single-dose compound, tivoxavir marboxil, we expect to announce top line Phase I dose extension results from Australia in Q4 of this year and initiate the Phase II study in Q4 of this year or Q1 of 2025. For COVID, or CYP-independent COVID compound, ratutrelvir, we expect to also announce top line results from our Phase I SAD and MAD studies in Australia in Q4 of this year and initiate the Phase II efficacy study in Q4 of this year or Q1 of 2025.

In oncology, for narazaciclib, we intend to release the top line results from our Phase I/II study at an upcoming medical meeting. In addition, we plan to identify the recommended Phase II dose and initiate ISTs in multiple myeloma and breast cancer from the second half of this year onwards.

For rigosertib, we plan to support the IST-led program, including compassionate use filings for patients with RDEB.

We thank you for joining us today and look forward to updating you on our continued progress. Before we open the call for questions, I would like to express our gratitude to the investigators, patients and their families and everyone at the study sites. Their contribution has been very important to the progress of our clinical research.

With that, operator, we would like to begin the Q&A session. Please go ahead.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question is from Ahu Demir with Ladenburg Thalmann.

Chong Liu

This is Chong for Ahu Demir. Thank you for taking our questions. We have a couple of questions. And the first one is regarding the influenza program. So we know we will expect to see a Phase I study in the fourth quarter of this year. Could you please give us some color on the details of the data, like how many patients will be on PK, PD and the safety data?

Werner Cautreels

Yes, thank you for your question. Indeed, we are currently dosing the first cohort in that human volunteer study. It’s a Phase I study. It’s a single dose as we have intended also for further therapeutic use and it’s placebo-controlled. And I think a total of about 24 or 26 human volunteers will be included. That will complete the study as we have already available from a previous trial.

Chong Liu

Then how about the Phase II study design, what population do you plan to target? And what is the timeline for the Phase II? When do we expect to see the data?

Werner Cautreels

We are currently analyzing the Phase I data. And that will take still a little while. So before we have the full analysis of the Phase I data, I think it’s premature to talk about the final design of our Phase II trial. And we will certainly report on that when those data are becoming available.

Chong Liu

Great. And our next question is regarding the narazaciclib. So what is the status of the program in the endometrial? Like how many patients get involved? And do you plan to advance the nara in the endometrial Phase II?

Werner Cautreels

From the Phase I/II studies, the total patient numbers was, I think, approximately 35 or 40. Again there the analysis is ongoing. The endometrial is currently not our priority. And as explained, we will follow an IST strategy in multiple myeloma and breast with the investigator-supported studies.

Chong Liu

So can you please give us a rationale like why we want to initiate the nara in multiple melanoma and breast cancer? Did you see any early sign from the Phase I study?

Werner Cautreels

The profile, the pharmacological profile of the compound has generated high interest with the investigators in those two areas because of the multiple targets profile of the compound. And that was the motivation for them to propose such a study.

Chong Liu

Okay. Thank you. That’s very helpful.

Operator

[Operator Instructions] I’m showing no further questions in queue. Ladies and gentlemen, thank you for your participation on today’s conference call. This concludes today’s event. You may now disconnect.