1. NEWARK, Calif., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced a clinical supply agreement with Roche ((SIX: RO, ROG, OTCQX:RHHBY) for the supply of the anti-Programmed Death Ligand-1 (PD-L1) monoclonal antibody, atezolizumab.

    Clinical trials are planned to evaluate milademetan, an oral mouse double minute 2 (MDM2) inhibitor, in combination with atezolizumab for the treatment of patients in genetically selected populations. Under this agreement, Rain is the sponsor of the anticipated clinical trials, and Roche will supply atezolizumab.

    An initial Phase 1 clinical trial is planned to evaluate the safety, tolerability and…

    NEWARK, Calif., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced a clinical supply agreement with Roche ((SIX: RO, ROG, OTCQX:RHHBY) for the supply of the anti-Programmed Death Ligand-1 (PD-L1) monoclonal antibody, atezolizumab.

    Clinical trials are planned to evaluate milademetan, an oral mouse double minute 2 (MDM2) inhibitor, in combination with atezolizumab for the treatment of patients in genetically selected populations. Under this agreement, Rain is the sponsor of the anticipated clinical trials, and Roche will supply atezolizumab.

    An initial Phase 1 clinical trial is planned to evaluate the safety, tolerability and efficacy of milademetan in combination with atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors. CDKN2A encodes for the tumor suppressor p14ARF, an inhibitor of MDM2, and the loss of CDKN2A may lead to MDM2-dependent cancers. Rain anticipates the start of the Phase 1 clinical trial in the second half of 2022. Subsequent Phase 2 clinical trials evaluating the combination of milademetan and atezolizumab may span various additional tumor types.

    "We are excited to evaluate the combination of MDM2 inhibition and cancer immunotherapy with milademetan and atezolizumab, and believe it presents a strong mechanistic rationale," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We believe the therapeutic index afforded by milademetan will enable synergistic combination with PD-L1 checkpoint inhibition and are excited about the potential for favorable results from the Phase 1 study to support moving into subsequent studies across various MDM2-dependent cancers."

    About Milademetan

    Milademetan is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supporting 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), as well as a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2). Rain also anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with Merkel cell carcinoma who are polyoma virus-positive and refractory to immune checkpoint inhibition (ICI), in mid-2022. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for patients with LPS.

    About Rain Therapeutics Inc.

    Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.

    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 studies for milademetan, including the planned Phase 1 clinical trial and potential Phase 2 clinical trials for milademetan in combination with atezolizumab, the timing of the planned Phase 1 clinical trial and the potential results of the planned Phase 1 clinical trial. 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, difficulty enrolling patients in our clinical trials given the relatively small LPS patient population, Rain's reliance on third parties to conduct and support its preclinical studies and clinical trials, and the other risks described in Rain's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  2. NEWARK, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that Avanish Vellanki, co-founder, chairman and chief executive officer of Rain, will provide a corporate overview at the JP Morgan Chase 40th Annual Healthcare Conference and at the H.C. Wainwright Bioconnect Conference, both conferences being held virtually January 10-13, 2022.

    Additional details can be found below:

    Conference: JP Morgan Chase 40th Annual Healthcare Conference
    Date and Time: Thursday, January 13, 2022 at 11:15 a.m. ET
    Location: Webcast Link or at the company's website (click here)

    Conference: H.C. Wainwright Bioconnect Conference
    Date and Time:

    NEWARK, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that Avanish Vellanki, co-founder, chairman and chief executive officer of Rain, will provide a corporate overview at the JP Morgan Chase 40th Annual Healthcare Conference and at the H.C. Wainwright Bioconnect Conference, both conferences being held virtually January 10-13, 2022.

    Additional details can be found below:

    Conference: JP Morgan Chase 40th Annual Healthcare Conference

    Date and Time: Thursday, January 13, 2022 at 11:15 a.m. ET

    Location: Webcast Link or at the company's website (click here)

    Conference: H.C. Wainwright Bioconnect Conference

    Date and Time: Prerecorded presentation will be available beginning Monday, January 10, 2022 at 7:00 a.m. ET

    Location: Webcast Link or at the company's website (click here)

    Replay of the corporate overview presentation will be available by visiting the "Events & Presentations" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

    About Rain Therapeutics Inc.

    Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.

    Media Contact

    Jordyn Temperato

    LifeSci Communications

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    +1.646.597.6989



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  3. NEWARK, Calif., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced it will be added to the NASDAQ Biotechnology Index (NASDAQ:NBI), effective as of market open on Monday, December 20, 2021.

    The NBI is made up of NASDAQ-listed companies classified as Biotechnology & Pharmaceuticals by the Industry Classification Benchmark (ICB), designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®), and is widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. To be selected for addition to the NBI, a company must have a minimum…

    NEWARK, Calif., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced it will be added to the NASDAQ Biotechnology Index (NASDAQ:NBI), effective as of market open on Monday, December 20, 2021.

    The NBI is made up of NASDAQ-listed companies classified as Biotechnology & Pharmaceuticals by the Industry Classification Benchmark (ICB), designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®), and is widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. To be selected for addition to the NBI, a company must have a minimum market capitalization of $200 million; demonstrate an average daily trading volume of at least 100,000 shares; and must be Nasdaq-listed. The index is modified market capitalization-weighted such that constituents are capped at 8% (for the top 5) and at 4% (for the remaining) at each quarterly index rebalance; the entire index is reviewed and reconstituted annually in December.

    For more information about the NASDAQ Biotechnology Index visit www.nasdaq.com.

    About Rain Therapeutics Inc.

    Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    +1.646.597.6989



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  4. NEWARK, Calif., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that Avanish Vellanki, co-founder, chairman and chief executive officer of Rain, will participate in a fireside chat at the Piper Sandler 33rd Annual Healthcare Conference being held virtually November 29-December 2, 2021 and at the Evercore ISI 4th Annual Health CONx Virtual Conference being held virtually November 30-December 2, 2021.

    Additional details can be found below:

    Conference: Piper Sandler 33rd Annual Healthcare Conference
    Date and Time: Prerecorded presentation will be available in advance beginning today, November 22, 2021, at 10:00 a.m. ET
    Location:

    NEWARK, Calif., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that Avanish Vellanki, co-founder, chairman and chief executive officer of Rain, will participate in a fireside chat at the Piper Sandler 33rd Annual Healthcare Conference being held virtually November 29-December 2, 2021 and at the Evercore ISI 4th Annual Health CONx Virtual Conference being held virtually November 30-December 2, 2021.

    Additional details can be found below:

    Conference: Piper Sandler 33rd Annual Healthcare Conference

    Date and Time: Prerecorded presentation will be available in advance beginning today, November 22, 2021, at 10:00 a.m. ET

    Location: Webcast Link - or at the company's website (click here)

    Conference: Evercore ISI 4th Annual Health CONx Virtual Conference

    Date: Thursday, December 2, 2021

    Time: 3:00 p.m. ET

    Location: Webcast Link - or at the company's website (click here)

    Replay of the presentations will be available by visiting the "Events & Presentations" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

    About Rain Therapeutics Inc.

    Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.

    Media Contact

    Jordyn Temperato

    LifeSci Communications

    +1.646.876.5196

    Investor Contact:

    Bob Yedid

    LifeSci Advisors

    +1.646.597.6989



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  5. NEWARK, Calif., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that the first patient has been dosed in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors.

    "The Rain team has worked extraordinarily hard to now commence our second clinical trial for milademetan," said Avanish Vellanki, chief executive officer of Rain Therapeutics. "The MANTRA-2 study reflects our precision oncology focus to base our development strategy on the underlying biological drivers in cancer, now across a tumor-agnostic…

    NEWARK, Calif., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NASDAQ:RAIN), ("Rain"), a late-stage company developing precision oncology therapeutics, today announced that the first patient has been dosed in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors.

    "The Rain team has worked extraordinarily hard to now commence our second clinical trial for milademetan," said Avanish Vellanki, chief executive officer of Rain Therapeutics. "The MANTRA-2 study reflects our precision oncology focus to base our development strategy on the underlying biological drivers in cancer, now across a tumor-agnostic clinical trial. We have also identified a level of gene amplification of MDM2 that we believe will select for patients most likely to benefit."

    Richard Bryce, MBChB, chief medical officer of Rain Therapeutics continued, "the opening of our Phase 2 basket trial is a significant step forward in leveraging the safety profile of milademetan for patients with advanced tumors that exhibit wild-type p53 and amplified MDM2 who do not respond, or stop responding, to standard-of-care therapy."

    The MANTRA-2 trial is designed to evaluate the safety and efficacy of milademetan 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. The primary endpoint of the trial is objective response rate as measured by RECIST criteria. Secondary endpoints include duration of response, disease control rate progression-free survival by investigator assessment, overall survival and, and growth modulation index. An interim analysis from MANTRA-2 is anticipated in the second half of 2022.

    About Milademetan

    Milademetan is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supporting 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), as well as a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2). Rain Therapeutics also anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with Merkel cell carcinoma who are polyoma virus-positive and 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.

    About Rain Therapeutics Inc.

    Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.

    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 studies for milademetan. 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, difficulty enrolling patients in our clinical trials, Rain's reliance on third parties to conduct and support its preclinical studies and clinical trials, the results of Rain's clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities, and the other risks described in Rain's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Media Contact

    Jordyn Temperato

    LifeSci Communications

    +1.646.876.5196

    Investor Contact:

    Bob Yedid

    LifeSci Advisors

    +1.646.597.6989



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