Rain Enhancement Technologies Holdco Inc
Rain Enhancement Technologies Holdco Inc Q2 FY2022 earnings call
August 6, 2022 · fiscal period ended 2022-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-08-06
Management highlights
- Completed enrollment in Phase 3 MANTRA trial for liposarcoma with 175 patients, exceeding 160-patient target and five months ahead of prior year-end guidance. Phase 2 MANTRA-2 trial progressing with 11 sites activated in U.S. - For Q2 2022, net loss was $17.6 million vs $8.2 million in Q2 2021. R&D expenses were $14.3 million vs $5.5 million in Q2 2021, driven by milademetan clinical trials. As of June 30, 2022, cash, cash equivalents, and short-term investments totaled $106 million, providing runway into mid-2024.
Segment performance
No distinct product segments with financial breakdown provided; focus on milademetan clinical programs.
Guidance
- Phase 3 MANTRA trial top-line data expected in first half of 2023; if data supportive, submit NDA for milademetan in liposarcoma in U.S. with potential submissions in Europe and other regions. - Phase 2 MANTRA-2 trial anticipates interim data of first 10 evaluable patients in fourth quarter 2022. - Anticipate commencing MANTRA-3 trial in Merkel cell carcinoma and MANTRA-4 trial (milademetan + atezolizumab) before year-end.
Risks
- Forward-looking statements made are based on current assumptions and may not materialize. Actual results may differ due to risks in clinical trials, regulatory approvals, and other uncertainties detailed in Rain’s filings with the SEC.
Q&A highlights
Q: How does competitor data on MDM2 inhibitor in LPS relate to milademetan’s competitive positioning?
A: Bob Doebele states competitor’s entry validates Rain’s approach using MDM2 as a validated cancer target.
Q: What drove acceleration in MANTRA enrollment and timing of top-line data?
A: Richard Bryce credits clinical team and physician/patient enthusiasm; expects top-line data in first half of 2023.
Q: Duration of response in MANTRA-2 and status of RAD52 program?
A: Bob Doebele says MANTRA-2 anticipates interim data of first 10 evaluable patients in Q4 2022; RAD52 program is progressing but spend has been mitigated for milademetan.
Q: Concerns about control arm performance in MANTRA trial?
A: Bob Doebele says no indication the control arm (trabectedin) will outperform historical data.
Q: Is there crossover in the MANTRA trial?
A: Avanish Vellanki states there is no crossover in the MANTRA trial.
Q: Discussion on MANTRA-4 trial site participation?
A: Bob Doebele says MANTRA-4 is a basket design similar to MANTRA-2, expecting faster enrollment due to larger patient population.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
August 6, 2022Full transcript unavailable for redistribution
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