On November 10, 2021 Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology therapeutics, reported financial results for the third quarter and nine months ended September 30, 2021, along with an update on the company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, NOV 10, 2021, View Source [SID1234595086]).

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"Rain has had a number of important recent accomplishments including data presentations at various medical conferences and announcement of plans to progress our lead candidate, milademetan, into a Phase 2 trial for patients with Merkel cell carcinoma," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We continue to view milademetan as having a differentiated therapeutic index and will remain focused on strategies to further enhance its value for patients with MDM2-dependent cancers."

Key Developments and Operational Updates

Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors
Rain anticipates enrolling the first patient in its multicenter, open-label Phase 2 basket trial (MANTRA-2) this quarter, evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor for the treatment of MDM2-amplified advanced solid tumors.
Non-Clinical Data on Milademetan Presented at IASLC 2021 (Sept. 8-14, 2021) and AACR (Free AACR Whitepaper)-NCI-EORTC ("Triple Cancer Conference") 2021 (Oct. 7-10, 2021)
Rain, in collaboration with certain research partners, presented non-clinical data on milademetan in MDM2-amplified tumors, Merkel cell carcinoma, GATA3-mutant ER+ breast cancer, and mesothelioma models.
Rain Highlights Plans for Phase 2 Trial for Milademetan in Merkel Cell Carcinoma (MANTRA-3)
On the strength of recent non-clinical data from the Dana-Farber Cancer Institute presented at the Triple Cancer Conference, Rain is now prioritizing a Phase 2 clinical trial of milademetan as monotherapy in MCC patients failing first-line checkpoint inhibitors, with a trial start anticipated in mid-2022. The Phase 2 MCC clinical trial will replace the previously planned Phase 2 clinical trial of milademetan in intimal sarcoma.
Research and Development (R&D) Day
Rain hosted a R&D Day webinar on November 9, 2021 which featured several key opinion leaders in oncology, along with members of Rain’s management team, who discussed the Company’s R&D program, as well as select clinical and preclinical data. A replay of the event is archived on the Company’s corporate website here.
Anticipated Near-term Milestones

Milademetan MDM2-Amplified Phase 2 Basket Trial (MANTRA-2)
Phase 2 trial anticipated to commence enrollment this quarter
Interim data anticipated in the second half of 2022
Milademetan MCC Phase 2 Trial (MANTRA-3)
Phase 2 trial anticipated to commence in mid-2022
Milademetan Dedifferentiated Liposarcoma Phase 3 Trial (MANTRA)
Data anticipated in 2023
RAD52 Research Program
Lead candidate selection anticipated in 2022
Third Quarter Financial Results
For the three and nine months ended September 30, 2021, Rain reported a net loss of $18.4 million and $33.4 million, respectively, as compared to a net loss of $10.4 million and $15.6 million for the same periods in 2020, respectively. Net loss per share for the three and nine months ended September 30, 2021, was $0.70 and $1.96, respectively, as compared to a net loss per share of $3.05 and $4.73 for the same periods in 2020, respectively.

R&D expenses were $15.3 million and $26.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $7.9 million and $11.2 million for the same periods in 2020, respectively. The increases were primarily driven by development milestone fees to Daiichi Sankyo Co., Ltd, R&D costs for Rain’s lead candidate, milademetan, mainly for its on-going Phase 3 pivotal trial in dedifferentiated liposarcoma, as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.7 million and $1.4 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.2 million and $0.4 million in the same periods in 2020, respectively.

General and administrative (G&A) expenses were $3.2 million and $7.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $0.6 million and $2.3 million for the same periods in 2020, respectively. The increases were primarily due to increases in various third-party G&A costs, including legal costs, outside consulting fees and accounting and audit fees associated with maintaining compliance with exchange listing and SEC requirements as a public company, as well as personnel costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.1 million and $0.4 million for the three and nine months ended September 30, 2021, respectively as compared to $0.1 million and $0.2 million for the same periods in 2020, respectively.

Total non-cash stock-based compensation expenses were approximately $0.8 million and $1.8 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.3 million and $0.6 million for the same periods in 2020, respectively.

As of September 30, 2021, Rain had $150.1 million in cash, cash equivalents and short-term investments. Rain expects that its quarter-end cash position will provide runway to continue advancing its R&D pipeline and complete all three planned clinical trials of milademetan.

As of September 30, 2021, Rain had approximately 26.5 million shares of common stock outstanding.

The Company continues to expect its full year 2021 net cash used in operating activities to be approximately $50 million to $60 million and a projected year end cash balance of approximately $137 million to $147 million in cash, cash equivalents and short-term investments.

Third Quarter 2021 Results Conference Call and Webcast Details
The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2021, at 1:30 p.m. PT (4:30 p.m. ET). The conference call can be accessed by dialing 1 (833) 562-0127 (U.S. Toll Free) / 1 (661) 567-1105 (U.S. Toll). The passcode for the conference call is 1985710. A live webcast may be accessed by visiting the "Investors" section of the Rain Therapeutics’ website at www.rainthera.com. The call will be recorded and available for replay on the Company’s website for approximately 30 days after the call.

About Milademetan

Milademetan is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, validating a rationally-designed dosing schedule to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition. Milademetan is being evaluated in an ongoing Phase 3 clinical trial in patients with LPS (MANTRA) with a planned Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2) anticipated to start in the fourth quarter of 2021. Rain Therapeutics also anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with Merkel cell carcinoma refractory to immune checkpoint inhibition (ICI), in mid-2022. Milademetan has received U.S. Food and Drug Administration Orphan Drug Designation for patients with LPS.