RAIN Oncology (Therapeutics) – Does it rain money? (Q2)

  • Rain Oncology 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.
  • Rain changed its name to Rain Oncology, effective Dec. 30, to better reflect the company’s focus on addressing unmet needs for cancer patients through precision oncology.
  • Rain’s cash position is good, now providing a cash runway well into 2025

Upcoming Catalyst: Read out in Q1 or 1st half of the year of the Phase 3 MNATRA Trial.

The MANTRA trial, a randomized, multicenter, open-label, Phase 3 registrational study, is designed to evaluate the safety and efficacy of RAIN-32 compared to trabectedin, a current standard of care, in patients with unresectable or metastatic DD LPS with or without a well-differentiated (WD) LPS component that has progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. Approximately 160 patients are expected to be randomized in a 1:1 ratio to receive milademetan or trabectedin. The primary objective of the trial is to compare progression-free survival (PFS) by blinded independent review between the milademetan treatment arm and the trabectedin control arm. Secondary endpoints include overall survival, PFS by investigator assessment, objective response rate, duration of response, disease control rate, safety and patient reported outcomes.

Endpoints and Population

  • Primary / Secondary Endpoints: PFS, OS, DCR, ORR, DoR
  • Unresectable / metastatic DD LPS ± WD component
  • Progression following at least 1 prior chemotherapy including anthracycline therapy
  • PFS analysis at 105 events
  • Disease progression within 6 months of screening

In the last earnings call RAIN commented the following on the trial:

First and foremost, we’re getting closer to the release of results from our pivotal MANTRA trial, the registrational Phase 3 study of mila in patients with specific subtypes of liposarcoma. We completed enrollment with 175 patients in July of this year, and we can now refine our guidance for top-line data to the first quarter of 2023 or next quarter from the prior guidance of the first half of 2023.

The key element here is that the trial is vs. the standard of care, so the results will define the future paths, almost a binary event. Beside the standard of care (trabectedin/Yondelis) there is only one other approved therapy:

Other ongoing clinical research (Phase 1/2):

Position: JUN23 10C

Learn more about the Science behind it


The trial targeted an enrollment of 160 patients and completed enrollment five months ahead of schedule with 175 patients. :+1:

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I remember reading your initial post and thought it sounds like an amazing way to treat cancer and was going to follow up on some additional research on the company. Thank you for the reminder, I looked into it more today and am torn between shares or options (the latter being pricey).

From everything I’ve read on their website and by some analysts, it’s all very positive with initial PT at $16-18 and late PT at near $30. The CEO is going to take part in the Citi Virtual Oncology Leadership Summit next week (Feb 21) and I tried to see if there’s any pattern of the stock price movement from when he takes part in these types of conferences, but unfortunately, it’s all over the map.

I checked into the recent insider buying and the last reported was in November, but insiders own 29%, which I think is good.

Thanks again for the detailed write up, now I need to decide how to best invest.


Key Take aways:

  • Read-out is most likely pushed to Q2 as they want to see 105 progression events, when they looked on Jan 30, they didn’t achieve the numbers of events
  • The standard of care (SoC) for liposarcoma patients is rather poor with median progression-free survival (PFS) of around 2 months, basically the same PFS result you see within the placebo arm of a study. This is important to understand while understanding the data that will be released. On a first view the data will look impressive, but the question is how will it look like compare to other treatments for other cancer types.
  • Pre-clinical data demonstrates median progression-free survival of 7.2 months across 53 patients

PFS = The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse** . In a clinical trial, measuring the PFS is one way to see how well a new treatment works. Also called progression-free survival.

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@Fllwoman highlighted as well the MANTRA-4 study which is focused on Solid tumors and it is combo treatment with Atezolizumab (Roche), which is an well established PD-L1 treatment. Hence the partnership with Roche which is currently focused on a pure supply agreement. In the long-term this is the bigger opportunity for the RAIN, in fact its a 45.000 patients opportunity just in the US.

MANTRA-4 is a Phase 1/2 initially to set up the safety profile (simplified: how many milligrams of Product A and how many from Product B) for the combination and define the optimal treatment cycles. They didn’t see any toxicity with the first 3 patients at a full dose, so they will begin to expand with additional 27 patients (total 30). They start the trial at full scale middle of the year, so do not expect any results in Q2 or Q3.

They run this study only in combination with Atezolizumab, no other PD-L1 treatments.

Position: Given the additional long-term opportunity I started a Shares Position as well.

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Rain Oncology Inc. (NASDAQ:RAIN), (“Rain”), …, today announced it will report financial results for the fourth quarter and full year ended December 31, 2022 and highlights of recent progress on Thursday, March 9, 2023. On that day, management will host a conference call and webcast at 2:00 pm PT (5:00 pm ET) to discuss the Company’s business and financial results.

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Nothing new, the following have been confirmed:

  • Year-end cash position of $130.5 million provides runway to complete all ongoing and planned clinical trials of milademetan, including the Phase 3 MANTRA trial in liposarcoma, Phase 2 MANTRA-2 basket trial, and planned Phase 1/2 MANTRA-4 basket trial
  • Topline data for Phase 3 pivotal MANTRA trial expected in second quarter of 2023
  • Phase 2 MANTRA-2 trial continues to enroll
  • Phase 1/2 MANTRA-4 trial anticipated to commence in mid-2023

Key take aways:

  • Company is not planning to disclosing whether or not they have hit the number of events (see previous comments for additional explanation)
    Company believes that the response rate probably needs to be in the range of around 30%, obviously, with reasonable durability, for an FDA approval
  • Quarter-end cash position of $110 million provides runway to complete all ongoing and planned clinical trials
  • Required number of progression events achieved in the Phase 3 pivotal MANTRA trial to trigger the primary analysis of progression free survival (PFS) in patients with dedifferentiated liposarcoma (DDLPS)
  • Topline data for the MANTRA trial expected this quarter
  • Phase 2 MANTRA-2 trial continues to enroll across MDM2-amplified advanced solid tumor types
  • Phase 1/2 MANTRA-4 trial in advanced solid tumors exhibiting loss of the CDKN2A gene on track to commence in mid-2023

So, in 1 1/2 months we know if i hate myself or not.


Testing auto-import

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Any news on why RAIN is halted this morning?

Rain Oncology Announces Topline Results from Phase 3 MANTRA Trial of Milademetan for the Treatment of Dedifferentiated Liposarcoma.

– The Phase 3 MANTRA trial did not meet the primary endpoint of PFS vs. standard of care