On August 10, 2021 Rain Therapeutics Inc., (NasdaqGS: RAIN),. ("Rain"), a late-stage company developing precision oncology therapeutics, reported financial results for the second quarter and six months ended June 30, 2021, along with an update on the company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, AUG 10, 2021, View Source [SID1234586240]).
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"Rain has made strong progress in the second quarter and six months ended 2021," said Avanish Vellanki, co-founder and chief executive officer of Rain. "Patients with dedifferentiated liposarcoma are in desperate need of new therapies, and we are proud to have been able to dose the first patient in a pivotal Phase 3 trial in under 12 months from acquiring the program. As we move forward with the milademetan clinical strategy, we look to commence our second trial, MANTRA-2, in patients with MDM2-amplified solid tumors, in the second half of 2021."
Key Developments and Operational Updates
First Patient Dosed in Phase 3 MANTRA Clinical Trial of Milademetan (RAIN-32) for DD LPS
In July 2021, Rain announced that the first patient was randomized in the multicenter, open-label, Phase 3 registrational trial (MANTRA) evaluating milademetan, an oral mouse double minute 2 ("MDM2") inhibitor, for the treatment of DD LPS.
Rain anticipates data from this trial in 2023.
MDM2-Amplified Phase 2 Basket Trial (MANTRA-2) to commence shortly
Rain anticipates enrolling the first patient in its basket study of patients with MDM2-amplified advanced solid tumors (MANTRA-2) in the second half of 2021. These patients will exhibit a degree of MDM2 amplification that Rain believes is oncogenic and sensitive to MDM2 inhibition.
Rain anticipates interim data in 2H 2022.
Collaborations with Tempus and Caris Life Sciences for the Milademetan MDM2-Amplified Phase 2 Basket Trial (MANTRA-2)
In June 2021, Rain announced an agreement with Tempus, an artificial intelligence and precision medicine company, to use their comprehensive genomic profiling testing platform for the Phase 2, MANTRA-2 basket trial for milademetan. Under the terms of the agreement, Tempus will provide both centralized tumor testing and patient matching services using their Connect & TIME Trial Network.
In June 2021, Rain also announced a patient referral partnership with Caris Life Sciences ("Caris"). Under the terms of the partnership, Caris will provide patient referral services using their molecular intelligence trials platform for MANTRA-2.
Milademetan Non-Clinical Data Abstracts Submitted to Upcoming Conferences
Rain, in collaboration with several research partners, intends to present non-clinical data at upcoming conferences relating to additional clinical opportunities for milademetan in the second half of 2021. Presentations for milademetan have been submitted and accepted to the 2021 World Conference of Lung Cancer (Sept. 8-14, 2021) and the 2021 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) virtual conference (Oct. 7-10, 2021).
Anticipated Near-term Milestones
Milademetan MDM2-Amplified Phase 2 Basket Study (MANTRA-2)
Phase 2 trial expected to commence in the second half of 2021
Rain anticipates interim data in 2H 2022
Milademetan Intimal Sarcoma Phase 2 Study
Phase 2 trial expected to commence by early 2022
Rain anticipates interim data in late 2022
Milademetan DD LPS Phase 3 Study (MANTRA)
Rain anticipates data from this trial in 2023
RAD52 Research Program
Lead candidate selection expected in 2022
Second Quarter Financial Results
For the three and six months ended June 30, 2021, Rain reported a net loss of $8.2 million and $15.0 million, respectively, as compared to a net loss of $2.6 million and $5.2 million for the same periods in 2020, respectively. Net loss per share for the three and six months ended June 30, 2021, were $0.39 and $1.23, respectively, as compared to a net loss per share of $0.78 and $1.60 for the same periods in 2020, respectively.
Research and development ("R&D") expenses were $5.5 million and $10.8 million for the three and six months ended June 30, 2021, respectively, as compared to $1.5 million and $3.2 million for the same periods in 2020, respectively. The increases were primarily driven by the clinical costs for Rain’s lead product candidate, milademetan, as Rain prepared to launch its Phase 3 pivotal trial in DD LPS in July 2021, as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.6 million and $0.8 million in the three and six months ended June 30, 2021, respectively, as compared to $0.1 million and $0.2 million in the same periods in 2020, respectively.
General and administrative ("G&A") expenses were $2.7 million and $4.2 million for the three and six months ended June 30, 2021, respectively, as compared to $1.1 million and $1.8 million for the same periods in 2020, respectively. The increases were primarily due to increases in various third-party G&A costs, including legal, outside consulting, as well as accounting and audit fees. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.2 million in each of the three and six months ended June 30, 2021, 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 $1.0 million in the three and six months ended June 30, 2021, respectively, as compared to $0.2 million and $0.4 million for the same periods in 2020, respectively.
As of June 30, 2021, Rain had $164.6 million in cash, cash equivalents and short-term investments. This included the $121.5 million in net proceeds from Rain’s initial public offering in April 2021. Rain’s quarter-end cash position adequately provides runway through late-2024.
As of June 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 $50.0 million to $60.0 million and a projected year end cash balance of approximately $137.0 million to $147.0 million in cash, cash equivalents and short-term investments.
Second 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, August 10, 2021, at 1:30 p.m. PT (4:30 p.m. ET). The conference call can be accessed by dialing 1 (800) 708-4539 (U.S. Toll Free) / 1 (847) 619-6396 (U.S. Toll). The passcode for the conference call is 50202648. 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 Well-Differentiated/Dedifferentiated Liposarcoma
Liposarcoma ("LPS") is a rare cancer originating from fat cells located in the soft tissues of the body. It is a malignant cancer that can spread to other parts of the body. Well-differentiated ("WD") LPS is less aggressive and tends to present as a large painless mass found in deeper tissues. Dedifferentiated ("DD") LPS is more aggressive, arising from WD LPS, and is usually found in tissue behind the abdominal area (retroperitoneal) or the extremities. WD/DD LPS are the most frequent subtypes of LPS and share common genomic abnormalities, predominately MDM2 gene amplification. The incidence of LPS is estimated at approximately 3,000 patients annually in the U.S., of which two-thirds are of the DD and WD type, and for which there are few effective treatment options.
About MANTRA Trial
The MANTRA trial is a randomized, multicenter, open-label, Phase 3 registrational trial evaluating milademetan, an oral MDM2 inhibitor, for the treatment of DD LPS. The MANTRA trial is designed to evaluate the safety and efficacy of milademetan compared to trabectedin, a current standard of care, in patients with unresectable or metastatic DD LPS that progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. Approximately 160 patients will be randomly assigned in a 1:1 ratio to receive milademetan or trabectedin. The primary objective of the MANTRA trial is to compare progression-free survival as determined by blinded independent review between the milademetan treatment arm and trabectedin control arm, in patients with unresectable or metastatic DD LPS, with or without a well-differentiated LPS component. Overall survival, disease control rate, objective response rate, duration of response, safety and patient reported outcomes will also be evaluated.