Rain Enhancement Technologies Holdco Inc Q3 FY2022 earnings call

• Avanish Vellanki discussed the milademetan program, including the early data from the MANTRA-2 study, revised guidance for the MANTRA pivotal trial, and the $50 million registered offering. - Robert Doebele reviewed the MANTRA-2 data, noting early unconfirmed partial responses, safety consistency with prior Phase 1 study, insights on tumor kinetics, and initial activity in diverse tumor types. - Richard Bryce provided updates on clinical programs, including completing enrollment in the MANTRA pivotal trial, starting the MANTRA-4 study, deprioritizing the MANTRA-3 study, and emphasizing focus on high-value indications for the milademetan franchise.

For the third quarter ended September 30, 2022, Rain Therapeutics reported a net loss of $18 million compared to a net loss of $18.4 million in the third quarter of 2021. Research and development expenses were $14.5 million in Q3 2022, slightly lower than $15.3 million in Q3 2021, primarily due to a $5.5 million milestone fee to Daiichi Sankyo in Q3 2022, partially offset by higher external R&D costs for milademetan and payroll-related costs for R&D personnel. General and administrative expenses were $3.9 million in Q3 2022, higher than $3.2 million in Q3 2021, due to higher payroll-related costs for G&A personnel, outside consulting, legal costs, and other third-party G&A costs. As of September 30, 2022, Rain had $90.7 million in cash, cash equivalents, and short-term investments. After a $50 million registered offering, the pro forma cash balance is over $140 million with a cash runway well into 2025.

• Refined top-line data for the MANTRA pivotal trial to the first quarter of 2023 from the prior guidance of the first half of 2023. - Deprioritized the MANTRA-3 study for milademetan in Merkel cell carcinoma, prioritizing the MANTRA-4 study. - MANTRA-2 study ongoing with enrollment of approximately 65 patients across solid tumors using the same dosing regimen as the MANTRA trial.

• Forward-looking statements are subject to risks and uncertainties described in Rain’s annual report on Form 10-K for the year ended December 31, 2021, and subsequent SEC filings. - Uncertainties in clinical trial outcomes, including variability in response rates and safety profiles, and challenges in achieving regulatory approval.

Q: Michael Schmidt asked about the MDM2 amplification cutoff and market size in the MANTRA-2 study.

A: Robert Doebele responded that the market size is approximately 8,000 patients per year, and the copy number cutoff was adjusted from 12 to 8 based on observed activity in that range.

Q: Yigal Nochomovitz inquired about cost savings from deprioritizing MANTRA-3 and the impact of lowering the copy number cutoff.

A: Avanish Vellanki said cost savings from deprioritizing MANTRA-3 are slightly less than a quarter's cash burn, and Robert Doebele stated lowering the copy number cutoff increases the market opportunity by over 40%.

Q: Jeff Jones asked about timing of enrollment in the solid tumor Basket Trial and AEs observed.

A: Avanish Vellanki said no additional guidance on MANTRA-2 milestones, and Richard Bryce noted the AE profile is consistent with prior Phase 1 studies and anti-nausea medications are at the physician's discretion.

Q: Mitchell Kapoor asked about top-line Phase 3 LPS data and benchmarks for positivity.

A: Avanish Vellanki said they won't provide detailed data on the top line, and emphasized progression-free survival doubling as a key clinically-meaningful benefit rather than response rate.

Q: Soumit Roy asked about tumor response rate and deepening of response in the Basket Trial.

A: Robert Doebele stated they don't yet know if milademetan will have similar kinetics to TKIs, and Avanish Vellanki mentioned swim lane plots were included in prior presentations but no additional specifics on response deepening were given.