Rain Enhancement Technologies Holdco Inc Q4 FY2022 earnings call

• Name change to Rain Oncology in late 2022 to reflect focus on precision oncology.
• Milademetan (mila) is an oral small molecule inhibitor of the MDM2 p53 complex, aiming to reactivate p53.
• Phase 1 study results published in JCO showed restoration of p53 levels and activity in patients.
• MANTRA study: Phase 3 in de-differentiated liposarcoma (DDLPS) expected to have top-line data in Q2 2023; MANTRA-2 basket study enrolling patients with MDM2 amplified p53 wild type solid tumors; MANTRA-4 study to start mid-year, combining milademetan with atezolizumab.
• Terminated RAD52 preclinical research program due to lack of meaningful success in screening novel inhibitors.
• Year-end cash position $130 million, providing runway for current and planned trials.

No specific product segment financial performance reported as Rain Oncology focuses on a single clinical program.

• Anticipate top-line data from Phase 3 MANTRA trial in DDLPS in second quarter of 2023.
• MANTRA-4 study expected to start mid-year.
• Previously provided cash runway guidance updated to be reassessed after MANTRA top-line results.

• Forward-looking statements subject to risks and uncertainties described in SEC filings.
• Uncertainty around the data from MANTRA-2 study and its implications for future development paths.
• Potential delays in trial timelines, such as the MANTRA-4 study start being pushed back due to FDA suggestions.

Q: Michael Schmidt asked about MANTRA-2 enrollment and events in MANTRA.

A: Avanish Vellanki discussed enrollment acceleration and not disclosing event numbers.

Q: Joseph Catanzaro asked about trial database locking and MANTRA-4 immune checkpoint inhibitor exposure.

A: Richard Bryce discussed database cleaning timeline and MANTRA-4 enrolling checkpoint immune refractory patients.

Q: Soumit Roy asked about MANTRA-2 genomic mutation analysis.

A: Robert Doebele mentioned extensive analysis using Tempus XT test.

Q: Jeff Jones asked about MANTRA-2 response thresholds and MDM2 copy number.

A: Robert Doebele discussed 30% response rate threshold and no correlation between MDM2 copy number and sensitivity.

Q: Yigal Nochomovitz asked about MANTRA-2 combos, RAD-52 lessons, and MANTRA event frequency.

A: Avanish Vellanki and Robert Doebele discussed potential combos, RAD-52 assay issues, and event checking every two weeks.

Q: Sam Slutsky asked about MANTRA control arm and inclusion/exclusion.

A: Robert Doebele discussed trabectedin literature and no major inclusion/exclusion changes.

Q: Graig Suvannavejh asked about MANTRA study powering and cash runway guidance.

A: Richard Bryce discussed hazard rate and Nelson Cabatuan discussed cash runway guidance change.

Q: Mitchell Kapoor asked about MANTRA-2 patient populations and MANTRA-4 pushback.

A: Avanish Vellanki and Richard Bryce discussed patient responses and MANTRA-4 protocol adjustments.

Q: Tony Butler asked about PDL-1 antibody rationale and progression mechanisms.

A: Robert Doebele discussed PD-L1/PD-1 equivalence and resistance via p53 mutations.

Q: Kumar Raja asked about MANTRA-2 path B and patient populations.

A: Avanish Vellanki discussed confirmed responses and tumor type predominance.