ORIC Pharmaceuticals Inc ( ORIC ). released preliminary efficacy and safety data on Wednesday from its ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).

Preliminary activity analysis:

59% of patients (10/17) achieved a PSA50 response and nearly all patients with a PSA50 response were confirmed one month later, for a confirmed PSA50 response rate of 47% (8/17), which does not include one additional PSA response pending confirmation.

24% of patients (4/17) achieved a PSA90 response, all of which were subsequently confirmed.

PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or darolutamide.

The majority of patients are still ongoing, with multiple patients approaching one year or more on therapy. Further dose exploration is ongoing.

Preliminary safety analysis:

ORIC-944 combined with apalutamide or with darolutamide has been generally well tolerated to date. The majority of adverse events (AEs) are Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.

Following completion of the Phase 1b dose exploration portion of the trial expected in mid-2025, the company plans to evaluate two candidate RP2Ds for each combination in the dose optimization portion of the trial in 2H 2025.

Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the company’s first global Phase 3 registrational trial in mCRPC, which it expects to initiate in 1H 2026.

The company announced a concurrent $125 million private placement financing that it expects will extend the cash runway into the second half of 2027 and through the anticipated primary endpoint readout from the first ORIC-944 Phase 3 registrational trial in mCRPC.

The company will sell approximately 19.2 million shares in a private placement at $6.50 per share (or $6.4999 per pre-funded warrant). 

Price Action: At the last check on Thursday, ORIC stock was up 24.7% at $7.44 during the premarket session.

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