Helus just updated their ClinicalTrials.gov page today for HPL003 phase 3 and everything remains on track! Exciting times ahead

Eric So just finished his fireside chat at the Jefferies Healthcare conference. See below for a summary (made by AI) of his conversation

Section-by-section transcript summary

1. Opening and company overview

• The interviewer introduces Eric, interim CEO of Helus Pharma.
• Eric describes Helus as a novel serotonergic agonist company focused on mental health, though he says he does not think “psychedelic space” fully captures the company’s approach.
• He says the company uses deuteration and other techniques to modify compounds in order to improve brain penetration, durability, and treatment duration.

2. Pipeline overview

• Eric says the company has two programs:
  • MDD program using a deuterated psilocin molecule
  • GAD program using deuterated DMT
• For the MDD program, he says the key milestone is topline phase 3 data in Q4 2026.
• For the GAD program, he says it is in phase 2 and uses deuteration to extend DMT’s duration to about 90 minutes and smooth the plasma curve.

3. MDD program efficacy claims

• Eric says the MDD asset has shown what he calls “incredible results.”
• He cites:
  • 71%+ remission rates after 12 months
  • longer durability
  • a 13+ point MADRS separation at the primary endpoint in phase 2
  • nearly 23-point separation at 12 months.
• He frames the upcoming phase 3 readout as potentially transformative for company value.

4. Regulatory environment and FDA relationship

• The interviewer asks how the regulatory environment has evolved.
• Eric says the company’s experience with the FDA has been phenomenal and that the agency has been highly engaged in helping shape the trial design.
• He says the company received Breakthrough Therapy Designation under the Biden administration and that support continued under the Trump administration.
• He also references the White House priority voucher program, noting that Helus was one of three companies named in a press release, which he interprets as a sign of decreasing stigma and stronger institutional support.

5. Commercial context: Spravato and Compass

• The interviewer asks what Helus can learn from Spravato and Compass.
• Eric says Spravato’s roughly $2B run rate shows meaningful commercial demand.
• He says Spravato treats roughly 40–50K patients but requires 30–50 treatments per year, which creates clinic capacity issues and limits new-patient throughput.
• He says Compass may help validate the category if approved, and that any evidence of better durability than Spravato could matter commercially.
• He argues Helus could be differentiated if its efficacy and durability hold up, especially with just two doses.

6. Helus commercial differentiation

• Eric says the company’s commercial case rests on three main points:
  1. Durability: two doses with long-lasting effect
  2. Adjunctive use: patients remain on existing background medications
  3. IP strength: 350+ patent filings, 100+ granted, with protection to at least 2041
• He says clinics have told the company they would be willing to invest in infrastructure if the product performs as expected, because they could treat more patients and potentially make more money.
• He emphasizes that the drug is being studied in a more “real-world” setting because patients do not need to discontinue background medications.

7. Phase 3 study design

• The interviewer asks about the phase 3 design and how it differs from phase 2.
• Eric says the study includes:
  • 220 patients
  • 110 placebo / 110 active
  • 16 mg dose on day 1
  • second dose on day 21
  • 6-week primary endpoint
  • 12-week total study duration
• He says the second dose is intended to reinforce durability.

8. Enrollment progress and timing

• The interviewer asks whether enrollment is on track for the Q4 readout.
• Eric says the company is definitely on track.
• He says May was a banner month and that recruitment exceeded forecast, with a strong June screening funnel as well.

9. Powering and placebo discussion

• The interviewer asks how the study is powered.
• Eric declines to give the exact powering assumptions, but says observers can infer some of it from the 220-patient design and says the trial is sufficiently powered and maybe even a little overpowered.
• They then discuss the phase 2 placebo response, which the interviewer says seemed unusually low.
• Eric says placebo behaved in what he views as an ideal pattern: some early movement followed by a return toward baseline, while the active arm maintained separation.

10. Open-label extension / durability disclosure

• The interviewer asks whether the company might share open-label extension data when topline data is released.
• Eric says this is still under discussion with the FDA and that it may involve a blinded long-term extension rather than a standard open-label design.
• He says the company wants to share more when possible, but not in a way that could interfere with blinding or study integrity.

11. Safety and tolerability

• The interviewer asks about safety, including suicidal ideation.
• Eric says they did not see that in phase 2 and describes the program as extraordinarily safe and well tolerated.
• He says blood-pressure-related adverse events subsided after treatment.

12. Monitoring requirements and treatment-day experience

• The interviewer asks how long patients are monitored.
• Eric says peak effects occur at around 90 minutes, followed by two hours of post-treatment monitoring, and says a 4–6 hour monitoring window is reasonable in phase 3.
• He says the treatment does not involve psychotherapy during the session.
• Patients use blindfolds and headphones, making it an inward experience, and the company uses a preparatory program called Embark to prepare patients for what to expect.

13. Second phase 3 study and label questions

• The interviewer asks about the second phase 3 trial.
• Eric says the second phase 3 launched earlier in 2026 and includes three arms:
  • placebo
  • 8 mg
  • 16 mg
• He says it is not powered to show separation between the two active doses; instead, the lower dose is intended to address FDA interest in using the lowest feasible dose.
• On label expectations, he says it is still premature, but hopes for something like adjunctive MDD with a two-dose protocol.

14. Staffing and future care model

• The interviewer asks about staffing requirements.
• Eric says the phase 3 protocol uses two monitors, one in person and one remote.
• He says practice could evolve in the future, potentially allowing several patients to be monitored simultaneously, but he frames the real priority as patient outcomes rather than workflow efficiency.

15. Reimbursement

• The interviewer asks about payer work and reimbursement for both drug and monitoring time.
• Eric says CPT codes already exist, citing experience from Spravato, and says he can imagine stacked reimbursement covering the full session.
• He argues that if Spravato can be reimbursed for repeated sessions, a therapy requiring less total chair time per year should also be reimbursable.

16. HLS-04 / deuterated DMT program

• The interviewer closes by asking about the company’s other program, referred to as HLS-04 / HELP-004, the deuterated DMT asset.
• Eric says the company’s primary focus remains the HLS-03 MDD readout in Q4 2026 and execution on that program.
• He says the DMT program showed signs of efficacy and durability in phase 2, but needs more dosing work.
• He says the company plans to advance it in a fiscally responsible way and hints that there may be additional updates soon.

17. Closing

• The interviewer thanks Eric and wishes him luck on the Q4 data readout.
• Eric thanks him and says it was a pleasure to participate.