Q2 2024 Traws Pharma Inc Earnings Call
Speaker Change: Ladies and gentlemen, thank you for standing by. Welcome to TRAS Pharma Inc. corporate update call. At this time all participants are in a listen-only mode.
Speaker Change: Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star followed by 1 on your touchtone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance.
Bruce Mackle: 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 Traw's Pharma, Inc.'s Corporate Update Conference Call.
Speaker Change: 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 and media section of the company's website at www.trawspharma.com.
Speaker Change: Following my introduction, we will hear from TRAW's Chief Executive Officer, Dr. Werner Coutrails, and Chief Financial Officer, Mark Guerin.
Speaker Change: 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
Speaker Change: that can cause actual results to differ materially.
Speaker Change: Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change.
Speaker Change: Except as required by law, TRAWS disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.
Speaker Change: 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.
Speaker Change: With that, I will turn the call over to Werner.
Werner: Thanks, Bruce, and thanks to everyone for joining us today.
Werner: The last several months have been transformational and very positive for TRANSFARMA.
Werner: Thanks to the excellent execution of everyone on our teams, we have substantially advanced our clinical pipeline.
Werner: While the data analysis is still ongoing, we believe that we will have a very good picture of the preliminary pharmacokinetics.
Werner: preferred dosing plans and safety for each of our product candidates.
Speaker Change: During the call today, for CFO Mark Guerin and I, we will summarize the latest progress with our clinical pipeline, including expected upcoming milestones.
Speaker Change: We will briefly review our financials and the transaction that created Trolls Pharma and then also take your questions.
Speaker Change: Transpharma's mission is to build solutions for important medical challenges and alleviate the burden of viral infections and cancer.
Speaker Change: In April, we completed the merger agreement that created TRANSFARMA.
Speaker Change: This transaction expands our investor base to include recognized healthcare investors.
Speaker Change: Warbemete and Tori Pines, and also Broaden's work portfolio.
Speaker Change: Our pipeline of potentially best-in-class oral small molecule medicines.
Speaker Change: now includes antiviral therapies.
Speaker Change: 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.
Speaker Change: In the coming months, we look forward to completing and reporting the top-line data from each of our ongoing clinical studies.
Speaker Change: and to sharing plans for the initiation of Phase II studies in our antiviral program.
Speaker Change: At the same time, we are progressing our investigator-sponsored trials or ISP strategy in oncology.
Speaker Change: We believe that this data could pave the way for key results in 2025.
Speaker Change: I'm excited about our portfolio based on each candidate's differentiated and potential best-in-class profile.
Speaker Change: With that, I'd like briefly to take you through each of the programs.
Speaker Change: starting with our program for influenza including avian or bird flu.
Speaker Change: Ivo Xavier Marbuxil is our influenza candidate.
Speaker Change: It targets the influenza-cab-dependent endonuclease, which is highly conserved across flu strains, including bird flu.
Speaker Change: making it a potential universal agent for flu.
Speaker Change: We believe that our compound may provide an important contribution to alleviate influenza, including seasonal and pandemic infections.
Speaker Change: both as a treatment as well as in certain prophylactic settings.
Speaker Change: Preclinical data and top-line results from single ascending dose or SAD studies.
Speaker Change: suggest that the Voxavir Marboxil
Speaker Change: as the potential.
Speaker Change: to achieve our target product profile as a single-dose treatment that is well-tolerated
Speaker Change: and active against influenza A or B.
Speaker Change: also known as Pandemic Potential Viruses, as well as against Opheltamivir and Baloxavir-resistant viruses.
Speaker Change: We are dosing the first cohort in a Phase I extension study in Australia.
Speaker Change: This placebo-controlled trial is being conducted in healthy volunteers and is evaluating three Evoxavir-Marbexil doses, including two doses from the previous successful Phase I dose escalation study.
Speaker Change: at 80 and 120 milligrams and one new increased dose, 240 milligrams.
Speaker Change: The study will assess pharmacokinetics, pharmacodynamics, and safety.
Speaker Change: and is expected to define the dosing plan for a future phase 2 study.
Speaker Change: Next steps for this program are to announce top line phase one dose extension studies.
Speaker Change: results from Australia expected in Q4 of this year and prepare for the initiation of a phase 2 study expected to begin in Q4 of this year or Q1 of 2025.
Speaker Change: Ratut Velveer is our COVID candidate.
Speaker Change: It targets Mpro, which is the 3Cl protease.
Speaker Change: We believe that the major differentiator is that a compound does not require combination use of a CYP inhibitor such as ritonavir.
Speaker Change: FIP inhibitors are used to slow down the metabolism of the active compound.
Speaker Change: as demonstrated by Nirmal Trivedi.
Speaker Change: But SIPP inhibitors can also result in potentially significant drug-drug interactions with other medications.
Speaker Change: as can be observed in the older, more vulnerable patient populations.
Speaker Change: We are aiming for a 10-day, once-a-day treatment.
Speaker Change: Clinical trial-enabling studies suggest that raputrelvir should be well-tolerated and is active against COVID strains that may be resistant to approved agents such as mimetrelvir, and that includes Delta and Omicron strains.
Speaker Change: We just completed dosing in the phase 1 single ascending dose, SAD, and multiple ascending dose, MAD, study in healthy volunteers in Australia.
Speaker Change: The study FAD segment was designed to assess five doses ranging from 15 milligrams to 600 milligrams.
Speaker Change: And the MAD segment was designed to evaluate two dose levels, 150 mg and 600 mg, dosed daily for 10 days.
Speaker Change: We expect the study to provide pharmacokinetics,
Speaker Change: pharmacodynamics and safety data that should define the dosing plan for an upcoming phase 2 efficacy study.
Speaker Change: 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.
Speaker Change: and prepare for the initiation of a Phase II efficacy study expected to begin in Q4 of this year or Q1 of 2025.
Speaker Change: Now, switching gears, I'd like to provide you with a brief update on our oncology programs, starting with Naraza Saqib.
Speaker Change: Marazacyclib is a multi-kinase inhibitor targeting CDK4 plus and other kinases with potential for use in multiple solid tumors.
Speaker Change: We recently completed phase 1, 2 dose escalation studies for the compound.
Speaker Change: evaluated both as a monotherapy and in combination with letrozole in patients with recurrent metastatic low-grade endometrioid endometrial cancer and other gynecologic malignancies.
Speaker Change: The studies were designed to define the dose-limiting toxicity.
Speaker Change: and maximal tolerated dose of the combination.
Speaker Change: that should result in the recommended phase 2 dose for further clinical trials.
Speaker Change: The next steps for NarazoCyclib will utilize the Investigator Sponsored Trial, or IST, strategy.
Speaker Change: Upcoming milestones include the release of top-line data from the recently completed phase 1 two-dose escalation studies at an upcoming medical meeting.
Speaker Change: and identify the recommended phase two dose and initiation of ISDs in multiple myeloma and breast cancer. And that's from the second half of this year and beyond.
Speaker Change: Our second oncology candidate is Hugo Sertu.
Speaker Change: Rigocertib is also a multikinase inhibitor, targeting cell cycle proteins including PLK1.
Speaker Change: 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.
Speaker Change: We have been utilizing an ISP strategy to develop regocertin in this ultra-rare disease.
Speaker Change: Data from these studies have been presented at international medical meetings.
Speaker Change: 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.
Speaker Change: We have been encouraged by the ongoing investigative interest for your circuit and support the IST-led RDEB program including compassionate use filings in both the U.S. and other countries.
Speaker Change: With that, I would like to turn it over to our CFO , Mark.
Mark Guerin: Thank you, Werner, and good morning, everyone. Trough's financial results for the quarter ended June 30, 2024 represent the first post-transaction quarterly report of the combined company.
Mark Guerin: 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 10Q filing for a review of the full financial statements.
Mark Guerin: You can also access the press release and 10-Q on the Investor Relations section of our website.
Speaker Change: Turning to our financials, the net loss that we reported for the quarter ended June 30th, 2024, of $123.1 million, or $4.87 per basic and diluted common share.
Speaker Change: reflects a non-cash charge of $117.5 million related to in-process R&D from Ankonova's April 2024 acquisition of Trust Vent.
Charles Warma: Charles Farmer closed the second quarter of 2024 with cash and equivalents of $16.9 million compared to $20.8 million as of December 31, 2023.
Charles Warma: We continue to pay close attention to our spending levels while progressing our compounds in the clinic to reach the milestones that Werner discussed earlier.
Speaker Change: Based on these efforts and our current projections, we believe our cash will be sufficient to fund our ongoing clinical trials and operations through year end.
Speaker Change: 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 OrbitMed and Torrey Pines.
Speaker Change: I would like to turn the call back to Warner.
Warner: Thanks, Mark.
Warner: In closing, and with thanks to Mark and his team, and thanks to our experienced product development and clinical operations team.
Warner: We believe that the progress we have made so far this transformational year is completely consistent with our expectations and plan.
Warner: Over the next six plus months, we expect to advance our antivirals into Phase II studies and define the clinical strategy in oncology.
Warner: We believe that each of our upcoming milestones has the potential.
Warner: to solidify the target product profile for each program.
Warner: And again, starting with flu, for our single-dose compound, Divoxavir-Marboxil, we expect to announce top-line phase one dose extension results from Australia.
Warner: in Q4 of this year, and initiate a Phase II study in Q4 of this year or Q1 of 2025.
Warner: For COVID or SIP-independent COVID compounds, you have two trial views.
Warner: We expect to also announce the planned results from our Phase 1 SAD and MAD studies in Australia in Q4 of this year and initiate a Phase 2 efficacy study in Q4 of this year or Q1 of 2025.
Warner: In Oncology, for Nereza Cyclic, we intend to release the top-ranked results from our Phase I-II study at an upcoming medical meeting.
Warner: In addition, we plan to identify the recommended phase 2 dose and initiate ISTs in multiple myeloma and breast cancer.
Warner: from the second half of this year onwards.
Warner: For Egocertib, we plan to support the IST-LIT program, including compassionate use filings for patients with RDEB.
Warner: We thank you for joining us today and look forward to updating you on our continued progress.
Speaker Change: 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.
Speaker Change: Their contribution has been very important to the progress of our clinical research.
Speaker Change: With that, operator, we would like to begin the Q&A session. Please go ahead.
Speaker Change: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
Speaker Change: And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: We will pause for one moment to poll for questions.
Speaker Change: [inaudible]
Speaker Change: I am your friend. I am your friend. I am your friend. I am your friend.
Speaker Change: Our first question is from Ahu Demir with Lattenberg Thalmann. Please proceed.
Speaker Change: Hello, this is Chung for Akwu Demir.
Speaker Change: Thank you for taking our questions.
Chung: We have a couple of questions, and the first one is regarding the influenza program.
Chung: So, we know we will expect to see a Phase I study in the fourth quarter this year. Could you please give us some color on the details of the data, like how many patients and will there be PK, PD, and safety data?
Speaker Change: Yeah, thank you for your question.
Speaker Change: Thank you very much.
Speaker Change: currently dosing the first cohort in that human volunteer study. It's a phase one study. It's a single dose, as we have intended also for further therapeutic use.
Speaker Change: 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.
Speaker Change: 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?
Speaker Change: We are currently analyzing the phase one data, and that will take still a little while. So before we have the full analysis of the phase one data, I think it's premature to talk about the final design over phase two.
Speaker Change: trial, and we will certainly report on that when those data are becoming available.
Speaker Change: Great.
Speaker Change: Our next question is regarding the narcissus cyclip. So what is the status of the program in the endometria? Like, how many patients get involved? Will plan to advance the narrow in the endometria in phase two?
Speaker Change: From the Phase I, II studies, the total patient numbers was, I think, approximately 35 or 40.
Speaker Change: Again there the analysis ongoing. The endometrial is currently not our priority and as explained we will follow an IST strategy in multiple myeloma and breast.
Speaker Change: which are investigators supported studies.
Speaker Change: Thank you.
Speaker Change: Can you please give us a rationale like why we want to initiate the NARA in the multiple melanoma and breast cancer? Did you see any early signs from the phase one study?
Speaker Change: The profile, the pharmacological profile of the compound has
Speaker Change: 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.
Speaker Change: Okay, thank you. That's very helpful.
Speaker Change: As a reminder, it is star 1 on your telephone keypad. If you would like to ask a question, we will pause for a brief moment to see if there are any final questions.
Speaker Change: Robert LeBoyer, Edouard Mullarky,
Speaker Change: [inaudible]
Speaker Change: 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.
Speaker Change: and many more. And this is the end of the video. Thank you for watching. I hope you enjoyed it. I'll see you in the next video.