Rain Oncology receives Buy rating from Roth

Roth Capital Partners renewed coverage of Rain Oncology (Rain Oncology Stock Quote, Charts, News, Analysts, Financials NASDAQ:RAIN) on Tuesday, with Roth analyst Kumaraguru Raja saying there’s a favourable risk-reward on the stock heading into a data readout during the present quarter.

Newark, CA-based Rain Oncology is a development stage precision oncology company targeting drivers of tumour through a tumour-agnostic approach to treat patients with genetically-defined solid tumour indications. The company’s lead product candidate is milademetan (RAIN-32), a small molecule oral inhibitor of mouse double minute 2 (MDM2) protein interaction with TP53, which may be oncogenic in a number of cancers. 

Currently, milademetan is being evaluated in an ongoing Phase 3 MANTRA clinical trial in patients with liposarcoma. The trial completed enrolment in Q3 2022 and topline results are expected in Q1 2023.

Raja said he’s modelling a 70 per cent probability of success in the Phase 3 trial and he’s expecting milademetan to beat chemotherapy drug trabectedin in the trial.

“Yondelis (trabectedin) and Halaven (eribulin) treatment in second-line WD/ DD LPS have shown progression-free survival of 2.2 months and 2.0 months, respectively. With intermittent dosing of milademetan WD/DD LPS patients experienced a median progression-free survival of 7.4 months in Phase 1 trial,” Raja said. 

“The primary endpoint of the MANTRA trial is progression-free survival. If the results from the MANTRA data are supportive, Rain will submit an NDA with the FDA in early 2024. We expect Rain to find a partner for similar submissions in Europe and possibly additional jurisdictions,” he said.

On Rain Oncology’s other efforts, Raja said an interim update for milademetan’s second indication for MDM2-amplified solid tumours, currently in a Phase 2 basket trial, showed partial response in two patients out of nine efficacy evaluable patients. Elsewhere, Raja said milademetan has potential in CDKN2A loss, where a Phase 1/2 trial will evaluate patients having solid tumours with CDKN2A loss and wild-type p53.

Further, Raja said there’s a substantial opportunity for milademetan, for which Rain has global rights in all indications, beyond oncology.

“MDM2 has noncarcinogenic roles and is involved in inflammatory and autoimmune diseases, dementia and neurodegenerative diseases, heart failure and cardiovascular diseases, nephropathy, diabetes, obesity, and sterility. Based on preclinical data, targeting MDM2 may have therapeutic benefits in these indications,” he wrote.

Raja has set a “Buy” rating and $21.00 target price on RAIN, which at press time represented a projected one-year return of 117 per cent.