Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Lumos Pharma Inc (LUMO, Financial) successfully completed end-to-Phase 2 meeting with the FDA, discussing promising data from Phase 2 trials and Phase 3 design for LUM-201.
- Both Phase 2 OraGrowtH trials met their primary and secondary endpoints, demonstrating the potential of LUM-201 as an effective treatment for moderate pediatric growth hormone deficiency.
- The FDA recognized LUM-201's unique mechanism as a novel growth hormone promoter, different from traditional growth hormone products, which could lead to a more favorable regulatory pathway.
- Updated data from the OraGrowtH trials showed durable effects and substantial improvement over baseline in annualized height velocity, supporting the long-term efficacy of LUM-201.
- Lumos Pharma Inc (LUMO) is planning a placebo-controlled Phase 3 trial with a design that could enhance the likelihood of regulatory approval and market introduction of LUM-201.
Negative Points
- Lumos Pharma Inc (LUMO) reported a net loss of $10.4 million for the quarter ended March 31, 2024, which increased from a net loss of $7.3 million in the same period the previous year.
- The company's cash reserves decreased from $36 million at the end of 2023 to $23.2 million by March 31, 2024, indicating significant cash burn that could impact its operational capabilities without additional funding.
- Research and development expenses increased by $2.9 million due to higher licensing and clinical trial expenses, adding financial pressure as the company progresses towards Phase 3 trials.
- There is a need for additional funding to finance the upcoming Phase 3 trial, which poses a risk if not met timely, potentially delaying the trial's initiation.
- The company faces the challenge of proving the clinical significance of LUM-201's growth benefits compared to placebo in the upcoming Phase 3 trial to satisfy FDA requirements for approval.
Q & A Highlights
Q: Can you provide an update on your expected bar for success in connection to growth for the upcoming Phase 3 study?
A: (John McKew - President, Chief Scientific Officer) We need to show clinically meaningful growth. We've agreed with the FDA that subjects must achieve 6.7 centimeters per year growth at the end of 12 months in our Phase 2 trial, which we define as the minimal clinically meaningful growth to continue treatment with LUM-201.
Q: Why did you choose the specific dose of 1.6 Mg per kg per day for the Phase 3 trial?
A: (John McKew - President, Chief Scientific Officer) The 1.6 Mg per kg per day dose showed the highest AHV across the three doses tested, and there was no significant difference in AHV between the 1.6 and 3.2 Mg per kg per day doses, indicating a pharmacodynamic plateau.
Q: How do you plan on funding the Phase 3 beyond the end of 3Q 2024?
A: (Lori Lawley - Chief Financial Officer, Principal Accounting Officer) We plan to finance the Phase 3 trial through the investment community and potentially through strategic or regional licensing deals, which would provide non-dilutive financing.
Q: What are the enrollment criteria for the Phase 3 trial compared to Phase 2?
A: (Pisit Pitukcheewanont - Chief Medical Officer) The majority of the inclusion-exclusion criteria are similar to Phase 2, with minor adjustments such as lowering the upper limit of age enrollment by one year to ensure no subjects enter the tender stage 2 during the 12-month trial period.
Q: Can you comment on your manufacturing readiness for the Phase 3 Trial and regulatory filings?
A: (John McKew - President, Chief Scientific Officer) We have filed a patent for a new drug product form for Phase 3, which includes a mini tablet in a capsule, allowing easier routes of administration for children. Bridging studies are complete, and we are prepared to provide Phase 3/commercial material.
Q: What geographical breakdown do you anticipate for the Phase 3 trial sites in the US versus outside the US?
A: (Pisit Pitukcheewanont - Chief Medical Officer) We plan to enroll about 150 subjects with a two-to-one randomization of LUM-201 to placebo. Approximately 90 sites are planned, potentially across 14 countries, with the final number depending on responses from a site survey being conducted globally.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
