Tenaya Therapeutics, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference
Review the key takeaways and the transcript of this earnings call.
- The company is focused on developing precision medicines for heart disease, including gene therapies and small molecules.
- Their lead gene therapy, TN201, targets MYBPC3-associated hypertrophic cardiomyopathy (HCM) affecting approximately 120,000 patients in the US, with key endpoints including reduction of left ventricular mass index (LVMI) and symptom improvement.
- TN201 has shown strong and encouraging data with a favorable safety profile at higher doses in an ongoing expansion cohort.
- A natural history study in pediatric patients is ongoing to explore early intervention possibilities, with regulatory discussions covering both adult and pediatric populations.
- The second gene therapy program, TN401, targets PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) affecting 70,000 to 75,000 US patients, aiming to reduce premature ventricular contractions (PVCs).
- TN401 has demonstrated about a 60-67% reduction in PVCs with a clean safety profile, and durability data will be presented in Q4 along with a regulatory update.
- The small molecule program, 301, is an HDAC6 inhibitor with completed phase one data showing safety, target engagement, and a probable daily dosing regimen.
- The company is reintroducing 301 due to internal data conviction and external validation, planning to announce phase two study designs and indications in Q4, with phase two expected to start in the second half of next year.
- Cash on hand was $78 million at the end of Q2, providing runway through Q3 next year, but pivotal phase two studies are not included in this runway and will require additional financing.
- A recent collaboration with Asylum generated a $10 million upfront payment and potential milestones over $1 billion, focusing on identifying novel genetic targets for CAR-T cardiology indications.
- Management emphasized the importance of upcoming Q4 updates on regulatory clarity for TN201 and TN401 and phase two plans for 301 as key near-term milestones.
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Transcript
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Whitney Ijem. I am one of the biotech analysts here at Canaccord, and it is my pleasure to be joined by Tenaya. I think I said good afternoon. Tenaya, this afternoon, pleased to be joined by Eric Hyllengren, CFO. Thank you for making the trip. Thank you for coming. We have a lot to cover, so diving right in. For anybody who is not familiar with the story, can you provide just a high-level overview of what attracted you to the company, because you are relatively new, and what is the team trying to build over the next 5-10 years?
Yeah, great one. Thanks for having me, Whitney. I have been in the chair almost a month, so still new guy. When I thought about Tenaya and joining the company, really it is about the mission. We are looking for precision medicines for heart disease. We are modality agnostic, so we have gene therapy, we have small molecule, but really we are trying to address the underlying cause of the disease, and so the mission of the company really resonated with me. Also, the science, when I looked at the data presented to date, strong data, very encouraging. The team. The team that I met with during the interview process, very excited and energized to succeed in this space. We have a big year here, Q4, and we will get into this, but regulatory updates coming, our plans for advancing our small molecule TN-301.
Also we will talk about those in Q4, so a lot of near-term events for the company as well.
Okay. Excellent. Maybe starting with TN-201, gene therapy. Can you just briefly review what that is? What is MYBPC3-associated HCM, and the kind of key unmet need in this patient population?
Right. As you said, with MYBPC3 in HCM, we are talking about about 120,000 patients in the U.S. here. That is about 20% of all HCM. Really what we see with these patients is a thickening of the left ventricle, so the heart is not able to pump blood where it needs to go in the body effectively. There is really a lack of effective treatments out there, especially with folks with more severe disease. We feel like targeting this area really our gene therapy can improve outcomes and results for these folks.
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