– End of third quarter cash position of
– Phase 3 pivotal MANTRA trial topline data now anticipated in first quarter of 2023 –
– Phase 2 MANTRA-2 trial preliminary interim data demonstrates encouraging monotherapy signal in ten evaluable patients; MANTRA-2 continues to enroll –
– Phase 2 MANTRA-3 trial deprioritized to rationalize use of financial resources –
– Phase 1/2 MANTRA-4 trial anticipated to commence in first quarter 2023 –
– Management to host conference call and webcast today at
“Rain continues to execute on our milademetan franchise with encouraging early interim data from our Phase 2 MANTRA-2 trial and anticipated near-term topline data from our Phase 3 registrational MANTRA trial next quarter,” said
Dr.
Dr.
Key Corporate Updates and Upcoming Milestones
$50.0 Million Registered Offering of Common Stock- Completed a
$50.0 million registered offering of common stock and non-voting common stock onNovember 8, 2022 - End of third quarter cash balance of
$90.7 million excludes the$50.0 million registered offering
- Completed a
- Phase 3 MANTRA Trial of Milademetan in Dedifferentiated Liposarcoma
- Topline data now anticipated in the first quarter of 2023
- Phase 2 Preliminary Interim Data for the MANTRA-2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors
- As of
October 26, 2022 , ten patients were efficacy-evaluable with CN ≥8 by central testing- Two unconfirmed PRs were observed with tumor regression of 34% and 30% (pancreatic and lung cancer, respectively)
- The patient with pancreatic cancer is pending response confirmation and ongoing treatment
- The patient with lung cancer is deceased due to COVID-19
- Two patients exhibited promising activity with tumor regression of 29% and 27% (biliary tract and breast cancer, respectively) and the patients are continuing with the investigational therapy
- Two unconfirmed PRs were observed with tumor regression of 34% and 30% (pancreatic and lung cancer, respectively)
- Observed rapid anti-tumor effect of milademetan in heavily pretreated, refractory patients, with a median of four prior therapies
- Safety profile to date is preliminarily consistent with prior Phase 1 milademetan trial
- As of
- Phase 2 MANTRA-3 Trial in Merkel Cell Carcinoma Deprioritized
- MANTRA-3 is deprioritized to rationalize use of financial and personnel resources
- Phase 1/2 MANTRA-4 Basket Trial in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene
- Commencement of MANTRA-4, the trial to evaluate the combination of milademetan with Roche’s FDA-approved IO therapy, atezolizumab, planned for first quarter of 2023
- Recent addition to our
Scientific Advisory Board ,Nicholas A. Saccomano , Ph.D. inSeptember 2022 Dr. Saccomano is the former Chief Scientific Officer ofArray Biopharma , and a seasoned leader and mentor with over 30 years of experience in pharmaceutical and biotechnology research and development
Our updated corporate presentation includes details of the preliminary interim data for MANTRA-2 and is available at the “Corporate Presentation” section of the Rain website.
Third Quarter Financial Results
For the three and nine months ended
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Total non-cash stock-based compensation expense were approximately
As of
As of
Third Quarter 2022 Results Conference Call and Webcast Details
The management of
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 MANTRA-2
The MANTRA-2 trial is designed to evaluate the safety and efficacy of milademetan monotherapy in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy and that exhibit wild-type p53 and a prespecified minimum MDM2 gene copy number. Approximately 65 patients are anticipated to be enrolled to receive milademetan. As of the latest data cutoff on
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 MDM2 inhibition. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS, and is evaluating milademetan in a Phase 2 tumor-agnostic basket trial in certain solid tumors (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 the first quarter of 2023. Milademetan has received Orphan Drug Designation from the
About
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Rain’s ongoing and planned trials for milademetan, including expected timing for the commencement of MANTRA-4, the efficacy and safety profile of milademetan, expected trial design, expected timing for topline data in MANTRA trial and the relationship between the results from the interim data from trial and results of future or ongoing clinical studies. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will”, “anticipates,” “goal,” “potential,” “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain’s business in general and limited operating history, Rain’s ability to execute on its strategy, Rain’s reliance on third parties to conduct and support its preclinical studies and clinical trials, positive results from a clinical trial, or interim data from an ongoing clinical trial, may not necessarily be predictive of the results of future or ongoing clinical studies, the effect of the COVID-19 pandemic on Rain’s clinical trials and business operations, the impact of general economic, health, industrial or political conditions in
Investor Contact
617-430-7576
daniel@lifesciadvisors.com
Media Contact
jtemperato@lifescicomms.com
CONDENSED STATEMENTS OF OPERATIONS | |||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 14,510 | $ | 15,284 | $ | 42,322 | $ | 26,101 | |||||||
General and administrative | 3,901 | 3,154 | 11,257 | 7,334 | |||||||||||
Total operating expenses | 18,411 | 18,438 | 53,579 | 33,435 | |||||||||||
Loss from operations | (18,411 | ) | (18,438 | ) | (53,579 | ) | (33,435 | ) | |||||||
Other income: | |||||||||||||||
Interest income | 370 | 11 | 533 | 25 | |||||||||||
Other income | — | 1 | — | 1 | |||||||||||
Total other income, net | 370 | 12 | 533 | 26 | |||||||||||
Net loss | $ | (18,041 | ) | $ | (18,426 | ) | $ | (53,046 | ) | $ | (33,409 | ) | |||
Net loss per share, basic and diluted | $ | (0.68 | ) | $ | (0.70 | ) | $ | (2.00 | ) | $ | (1.96 | ) | |||
Weighted-average shares used to compute net loss per share, basic and diluted | 26,564,615 | 26,466,746 | 26,535,474 | 17,025,032 | |||||||||||
SUMMARY BALANCE SHEET DATA | |||||
(in thousands) | |||||
2022 | 2021(1) | ||||
(unaudited) | |||||
Cash, cash equivalents and short-term investments | $ | 90,708 | $ | 140,218 | |
Total assets | 94,635 | 147,140 | |||
Stockholders’ equity | 81,409 | 130,504 | |||
(1) Derived from audited financial statements |
Source:
2022 GlobeNewswire, Inc., source