On May 11, 2023 Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, reported its financial results for the first quarter ended March 31, 2023, along with an update on the Company’s key corporate highlights and upcoming milestones (Press release, Rain Oncology, MAY 11, 2023, View Source [SID1234631532]).
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"We remain excited for MANTRA’s topline data readout, which we continue to anticipate in the second quarter. We are hopeful these data will support a potential new therapeutic option for patients with dedifferentiated liposarcoma, and also assert the importance of p53’s role in the regulation of cancer," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We continue to maintain strong fiscal prudence with tightly controlled cash burn on top of continued enrollment in MANTRA-2, and the anticipated, imminent start of the MANTRA-4 clinical trial."
First Quarter 2023 Key Research and Development (R&D) Highlights and Upcoming Milestones
· Phase 3 Dedifferentiated Liposarcoma (DDLPS) Trial (MANTRA)
o Trial achieved required number of at least 105 progression events
o Company expects to announce topline data in the second quarter of 2023
o Company anticipates filing regulatory applications in the United States and other regions globally, subject to supportive clinical topline data readout
· Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors (n=65)
o Clinical trial continues to enroll across solid tumors with MDM2 copy number greater than or equal to 8
· Phase 1/2 Basket Trial (MANTRA-4) in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene
o Company expects to commence trial in mid-2023, which will evaluate the combination of milademetan with Roche’s FDA-approved immune-oncology therapy, atezolizumab in 30 patients who have previously failed or progressed on immunotherapy
Our updated corporate presentation is available at the "Corporate Presentation" section of the Rain website.
First Quarter 2023 Financial Results
For the three months ended March 31, 2023, Rain reported a net loss of $20.5 million, as compared to a net loss of $17.4 million for the same period in 2022. Net loss per share for the three months ended March 31, 2023, was $0.56, as compared to a net loss per share of $0.66 for the same period in 2022.
Research and development (R&D) expenses were $16.7 million for the three months ended March 31, 2023, as compared to $13.6 million for the same period in 2022. The increase was 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 $1.1 million in the three months ended March 31, 2023, as compared to $0.9 million in the same period in 2022.
General and administrative (G&A) expenses were $5.1 million for the three months ended March 31, 2023, as compared to $3.9 million for the same period in 2022. The increase was primarily due to higher professional services costs and legal costs, as well as higher payroll-related costs. Non-cash stock-based compensation expense included in G&A expenses was approximately $0.4 million for each of the three months ended March 31, 2023 and 2022.
Total non-cash stock-based compensation expenses were approximately $1.6 million for the three months ended March 31, 2023, as compared to $1.2 million for the same period in 2022.
As of March 31, 2023, Rain had $109.8 million in cash, cash equivalents and short-term investments. Consistent with the prior quarter, Rain will not provide guidance on cash runway at this time. Rain will continue to assess its cash runway and provide further guidance in the next quarter, if appropriate, after the release of MANTRA topline results in this quarter.
As of March 31, 2023, Rain had approximately 36.4 million shares of common stock outstanding.
First Quarter 2023 Results Conference Call and Webcast Details
The management of Rain Oncology will host a conference call and webcast for the investment community today, May 11, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here: View Source;tp_key=22d79acd4c. The conference call can be accessed by dialing (877) 704-4453 (domestic) or (201) 389-0920 (international). The passcode for the conference call is 13738120.
Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.
About Milademetan
Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of inhibition of the p53-MDM2 complex. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS and anticipates topline data this quarter. In addition, milademetan is being evaluated in a Phase 2 tumor-agnostic basket trial in certain solid tumors with MDM2 amplification (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in mid-2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.