Rain Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Progress – Year-end cash position of $130.5 million provides runway to complete all ongoing and planned clinical trials of milademetan, including the Phase 3 MANTRA trial in liposarcoma, Phase 2 MANTRA-2 basket trial, and planned Phase 1/2 MANTRA-4 basket trial – – Topline data for Phase 3 pivotal MANTRA trial expected in second quarter of 2023 – – Phase 2 MANTRA-2 trial continues to enroll – – Phase 1/2 MANTRA-4 trial anticipated to commence in mid-2023 – – Management to host conference call and webcast today at 5:00 PM Eastern Time – NEWARK, Calif., March 9, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today reports financial results for the fourth quarter and full year ended December 31, 2022, along with an update on the Company's key corporate highlights and upcoming milestones. “We are excited for the release of the topline MANTRA data in the second quarter of this year, which has the potential to assert the importance of p53’s role across cancers,” said Avanish Vellanki, co-founder and chief executive officer of Rain. “We anticipate a read-through to opportunity for p53 restoration in other tumor types, and believe milademetan’s safety profile may evidence its potential to be used in combination with a plethora of other agents. We remain hopeful that a well-tolerated reactivator of p53 in wildtype p53 cancers has the potential to become a meaningful option for patients, either as a monotherapy or as an essential combo agent used broadly in clinical practice.” Dr. Robert Doebele, MD, PhD, president and chief scientific officer of Rain continued, “We have already observed early monotherapy activity of milademetan from the MANTRA-2 trial, across a diverse set of solid tumor types, which may suggest a sound therapeutic strategy with single-agent milademetan, and possibly through combination regimens as well. We look forward to initiating our Phase 1/2 MANTRA-4 trial in advanced solid tumors exhibiting loss of the CDKN2A gene, with combination of milademetan and Roche’s atezolizumab.” 2022 Key Research and Development (R&D), Corporate Highlights and Upcoming Milestones · Phase 3 Dedifferentiated Liposarcoma (DD LPS) Trial (MANTRA) o Topline data expected in the second quarter of 2023 o Subject to supportive clinical data, Rain anticipates filing regulatory applications in the United States and Europe thereafter · Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors o As of the latest data cutoff on October 26, 2022, 10 patients were efficacy-evaluable with copy number greater than or equal to 8 by central testing. o Observed rapid anti-tumor effect of milademetan in heavily pretreated, refractory patients, with a median of four prior therapies o Safety profile as of the latest data cutoff is preliminarily consistent with a prior Phase 1 milademetan trial o Clinical trial continues to enroll · Phase 1/2 Basket Trial (MANTRA-4) in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene o Commencement of MANTRA-4 to evaluate the combination of milademetan with Roche’s FDA-approved immune-oncology therapy, atezolizumab, anticipated in mid-2023 · Recent publication titled, “A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas” in the Journal of Clinical Oncology o Phase 1 trial evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of milademetan in patients with advanced cancers o Intermittent dosing schedule of 260 mg qd, 3/14 days of milademetan resulted in favorable safety profile and clinical activity in DD LPS patients, and may provide for a more favorable tolerability profile across a multitude of future therapeutic indications o Phase 1 data in advanced DD LPS provides foundation for the registrational Phase 3 MANTRA trial · RAD52 Research Program o Program terminated to focus use of financial and personnel resources on milademetan clinical program · $50.0 Million Registered Offering of Common Stock o Completed a $50.0 million registered offering of common stock and non-voting common stock on November 8, 2022, which resulted in net proceeds of $53.2 million, including the exercise of overallotment Our updated corporate presentation is available at the “Corporate Presentation” section of the Rain website. Fourth Quarter and Full Year 2022 Financial Results For the three months and year ended December 31, 2022, Rain reported a net loss of $22.7 million and $75.7 million, respectively, as compared to a net loss of $18.0 million and $51.4 million for the same periods in 2021, respectively. Net loss per share for the three months and year ended December 31, 2022, was $0.70 and $2.71, respectively, as compared to a net loss per share of $0.68 and $2.65 for the same periods in 2021, respectively. R&D expenses were $19.1 million and $61.4 million for the three months and year ended December 31, 2022, respectively, as compared to $14.7 million and $40.8 million for the same periods in 2021, respectively. The increases were primarily related to clinical trial costs for milademetan, higher payroll-related costs for our R&D personnel, and various other R&D costs for milademetan. Non-cash stock-based compensation expenses included in R&D expenses were approximately $1.0 million and $3.8 million in the three months and year ended December 31, 2022, respectively, as compared to $1.1 million and $2.5 million in the same periods in 2021, respectively. General and administrative (G&A) expenses were $4.5 million and $15.7 million for the three months and year ended December 31, 2022, respectively, as compared to $3.4 million and $10.7 million for the same periods in 2021, respectively. The increases were primarily due to higher payroll-related costs for Rain’s G&A personnel, outside consulting, legal costs and various third-party G&A costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.3 million and $1.1 million for the three months and year ended December 31, 2022, respectively, as compared to $0.2 million and $0.6 million for the same periods in 2021, respectively. Total non-cash stock-based compensation expenses were approximately $1.3 million and $4.9 million for the three months and year ended December 31, 2022, respectively, as compared to $1.3 million and $3.1 million for the same periods in 2021, respectively. As of December 31, 2022, Rain had $130.5 million in cash, cash equivalents and short-term investments. Rain will not provide guidance on cash runway at this time. Rain will continue to assess its cash runway and provide further guidance, if appropriate, after the release of MANTRA topline results in the second quarter of this year. As of December 31, 2022, Rain had approximately 36.3 million shares of common stock outstanding.
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