ORIC-944 / ORIC Pharma - LARVOL DELTA

Anticipated Program Milestones (GlobeNewswire) - "ORIC anticipates the following upcoming data milestones: ORIC-944 (mCRPC): (i)1Q 2026: Combination dose optimization data with AR inhibitor(s)."

P1 data • Prostate Cancer

ORIC Pharmaceuticals Announces Completion of Dose Exploration Portion of ORIC-944 Phase 1b Clinical Trial and Continues to Demonstrate Potential Best-in-Class Efficacy and Safety (GlobeNewswire) - "55% of patients (11/20) achieved a PSA50 response, confirmed in 40% (8/20). 20% of patients (4/20) achieved a PSA90 response (all confirmed)....Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% of patients (13/17) achieving >50% ctDNA reduction....'We look forward to sharing dose optimization data in 1Q 2026 ahead of initiating our first global Phase 3 registrational trial in mCRPC in the first half of next year'."

New P3 trial • P1 data • Trial status • Castration-Resistant Prostate Cancer

PRC2 inhibition enhances KRAS inhibitor response to delay treatment relapse in KRAS-mutant preclinical lung and colorectal cancer models (AACR-NCI-EORTC 2025) - P1 | "The combination of adagrasib, a KRAS G12C inhibitor, and ORIC-944 resulted in greater antitumor efficacy, more tumor regressions, and significantly smaller tumors, in both CRC and NSCLC models. Combining ORIC-944 with KRAS inhibition significantly improved efficacy and PFS in NSCLC and CRC models, demonstrating that PRC2 inhibition can deepen and extend KRAS inhibitor responses to prevent or delay resistance to KRAS inhibition. ORIC-944 is under clinical evaluation in a global Phase 1b study (NCT05413421)."

Preclinical • Breast Cancer • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • KRAS

PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies (AACR-NCI-EORTC 2025) - P1 | "In vivo xenografts were dosed with ORIC-944 or EZH2 inhibitor mevrometostat, darolutamide, or the combinations...Transcriptional effects induced by combining ORIC-944 and ARI were comparable irrespective of ARI (i.e. darolutamide, apalutamide or enzalutamide)... These preclinical results position ORIC-944 as a potential best-in-class PRC2 inhibitor that induces luminal cell fate and restricts lineage TF accessibility in both CRPC and CSPC settings, thereby extending the duration of response to ARI treatment by disabling cellular plasticity and delaying prostate tumor adaptation. ORIC-944 is under clinical evaluation in combination with ARIs in a global Phase 1b study (NCT05413421)."

Preclinical • Tumor cell • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOXA1 • HNF1A • ONECUT2

ORIC Pharmaceuticals Presented Preclinical Data at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics Supporting Best-in-Class Potential of ORIC-944 to Treat Patients With Prostate Cancer and Other Solid Tumors (GlobeNewswire) - "Mechanistically, ORIC-944 in combination with AR inhibition in CSPC was linked to increased luminal cell state, and the restriction of lineage adaptation through reduced chromatin accessibility at binding sites of transcription factors associated with lineage diversification and cell plasticity...ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with KRAS inhibition, significantly improved efficacy and progression-free survival in KRAS G12C mutant non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models."

Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Prostate Cancer

ORIC Pharmaceuticals Expands Leadership Team with the Appointment of Kevin Brodbeck as Chief Technical Officer (GlobeNewswire) - "The creation of the CTO role and Dr. Brodbeck’s appointment reflect the impending advancement of ORIC’s clinical programs into late-stage development with the potential start of Phase 3 trials for ORIC-944 and enozertinib (ORIC-114) in 2026."

New P3 trial • Solid Tumor

ORIC Pharmaceuticals Announces $125 Million Private Placement Financing (GlobeNewswire) - "ORIC Pharmaceuticals...announced that it has agreed to sell approximately 19.2 million shares of its common stock (or pre-funded warrants in lieu thereof) to a select group of institutional and accredited healthcare specialist investors in a private placement, at a price per share of $6.50 (or $6.4999 per pre-funded warrant)....ORIC intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund the current operating plan into the second half of 2027 and through the anticipated primary endpoint readout from the first ORIC-944 Phase 3 registrational trial in prostate cancer."

Financing • Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC (GlobeNewswire) - P1/1b | N=250 | NCT05413421 | Sponsor: ORIC Pharmaceuticals | "Data include 17 patients with mCRPC previously treated with a median of three lines of prior therapy, including abiraterone, up to one prior line of chemotherapy....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)....24% of patients (4/17) achieved a PSA90 response, all of which were subsequently confirmed....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...in the first global Phase 3 registrational trial in mCRPC that the company expects to initiate in 1H 2026."

New P3 trial • P1 data • Trial status • Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals to Present Initial Data from Phase 1b Trial of ORIC-944 in Combination with Androgen Receptor Inhibitors in Patients with mCRPC (GlobeNewswire) - "ORIC Pharmaceuticals, Inc...today announced that the company will present initial data from the Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration resistant prostate cancer (mCRPC) in a conference call and webcast on Wednesday, May 28, 2025, at 4:30 p.m. ET."

P1 data • Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates (GlobeNewswire) - "Announced...plans to initiate first Phase 3 registrational trial for ORIC-944 in mCRPC in 1H 2026....ORIC anticipates the following upcoming milestones: ORIC-944 (mCRPC): (i) 1H 2025: Combination dose escalation data with AR inhibitors(s); (ii) 2H 2025: Updated combination dose escalation data with AR inhibitors(s); (iii) 4Q 2025 / 1Q 2026: Combination dose optimization data with AR inhibitor(s)."

New P3 trial • P1 data • Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals Presents Preclinical Data to Support the Potential of ORIC-944 as a Best-in-Class PRC2 Inhibitor for the Treatment of Prostate Cancer at the 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "ORIC Pharmaceuticals...announced the presentation of a poster at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting preclinical data on ORIC-944....ORIC-944 increased progression-free survival (PFS) when combined with ARPIs in both castration-sensitive and castration-resistant prostate cancer models....In preclinical prostate cancer models, ORIC-944 demonstrated robust inhibition of PRC2, enhanced luminal cell state, and consistently restricted lineage transcription factor accessibility through chromatin remodeling, ​thereby reenforcing the luminal state and preventing access to plasticity programs."

Preclinical • Castration-Resistant Prostate Cancer

ORIC-944, a PRC2 inhibitor with best-in-class properties, restores luminal features and restricts adaptation in prostate cancer models, conferring synergy with AR pathway inhibitors (AACR 2025) - P1 | "These results position ORIC-944 as a potential best-in-class PRC2 inhibitor that blocks prostate tumor adaptation, restores luminal features, and sensitizes tumors to ARPI. A phase 1b trial of ORIC-944 in combination with ARPIs is ongoing in metastatic prostate cancer (NCT05413421)."

Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Embryonic ectoderm development protein (EED) inhibitor APG-5918 exhibits potent antitumor activity and synergizes with androgen receptor (AR) inhibitor enzalutamide in preclinical prostate cancer (PCa) models (AACR 2025) - "APG-5918 appeared to be more potent than two EZH2 inhibitors (tazemetostat, PF-06821497) and EED inhibitor ORIC-944 under the same experimental condition. APG-5918 alone or in combination with enzalutamide exhibited antitumor activity in preclinical PCa models, supporting EED inhibition (± AR antagonists) as a therapeutic strategy for PCa."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CCND1 • CDK4 • DNMT1 • MCL1 • SUZ12 • UHRF1

ORIC Pharmaceuticals Announces ORIC-944 Preclinical Presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "ORIC Pharmaceuticals...announced that a preclinical abstract highlighting the potential of ORIC-944, a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting..."

Preclinical • Prostate Cancer

ORIC-944-01: Study of ORIC-944 in Patients with Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: ORIC Pharmaceuticals | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ORIC Pharmaceuticals Announces Focused Registrational Clinical Development Plans for Lead Programs, Extended Cash Runway, and Updated Corporate Milestones (GlobeNewswire) - "ORIC-944:...Given the recently reported encouraging early safety and efficacy data from an ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) and favorable enrollment trends, ORIC now expects to report dose escalation data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in 1H 2025, followed by an additional update in 2H 2025. Expected timing for the previously communicated milestone of ORIC-944 dose optimization data in combination with AR inhibitor(s) has been accelerated/narrowed to 4Q25 or 1Q26 (previously 4Q25 or 1H 2026). ORIC expects to initiate its first Phase 3 trial for ORIC-944 in mCRPC in 1H 2026."

New P3 trial • P1 data • Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Updates (GlobeNewswire) - "ORIC anticipates the following upcoming data milestones: (1) ORIC-114 (NSCLC): (i) 1H 2025: 2L EGFR exon 20 and 2L+ HER2 exon 20; (ii) 2H 2025: 2L+ EGFR atypical; (iii) 1H 2026: 1L EGFR exon 20; (iv) Mid-2026: 1L EGFR exon 20 combination with SC amivantamab and 1L EGFR atypical; (2) ORIC-944 (mCRPC): 4Q 2025 / 1H 2026: Combination with AR inhibitors."

P1 data • P1/2 data • Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer

ORIC Pharmaceuticals Provides…Anticipated Upcoming Milestones (GlobeNewswire) - "These accomplishments position us well for 2025 and beyond, with seven anticipated data readouts over the next 18 months as we advance toward potentially initiating registrational studies for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026."

New trial • Oncology

ORIC Pharmaceuticals Provides...Anticipated Upcoming Milestones (GlobeNewswire) - "ORIC anticipates the following upcoming data milestones: ORIC-944 (mCRPC): 4Q 2025 / 1H 2026: Combination with AR inhibitors."

P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer

ORIC Pharmaceuticals Provides Early Phase 1b Combination Data for ORIC-944... (GlobeNewswire) - P1/1b | N=250 | NCT05413421 | Sponsor: ORIC Pharmaceuticals | "This initial experience demonstrated: Deep prostate-specific antigen (PSA) decreases across both the 600 mg and 800 mg dose cohorts; 3 of 6 patients achieved confirmed PSA50 responses, of which 2 achieved confirmed PSA90 responses....Well-tolerated safety, with primarily Grade 1 and Grade 2 treatment related adverse events (TRAE), consistent with PRC2 and androgen receptor (AR) inhibition, and one Grade 3 TRAE of fatigue (patient remains on treatment without dose modification)."

P1 data • Genito-urinary Cancer • Prostate Cancer • Solid Tumor

ORIC-944, a potent and selective allosteric PRC2 inhibitor with best-in-class properties, demonstrates combination synergy with AR pathway inhibitors in prostate cancer models (PCF 2024) - P1 | "These results position ORIC-944 as a potential best-in-class PRC2 inhibitor for evaluation in combination with ARPIs in patients with metastatic prostate cancer. A phase 1b trial of ORIC-944 in combination with ARPI is ongoing (NCT05413421)."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • SUZ12

ORIC-944-01: Study of ORIC-944 in Patients with Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: ORIC Pharmaceuticals | N=42 ➔ 250 | Trial completion date: Jun 2024 ➔ Sep 2026 | Trial primary completion date: May 2023 ➔ Dec 2024

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ORIC Shares Rise After Announcing Prostate Cancer Drug Trial Collaborations (Market Watch) - "Shares of ORIC Pharmaceuticals climbed in post-market trading after the company announced an ongoing prostate cancer drug trial, to which Bayer and Johnson & Johnson will contribute. The stock was up 9% to $12.00 on Tuesday. Shares are up more than 19% since the beginning of the year....It also said it has entered two separate clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, a Johnson & Johnson company, to evaluate ORIC-944 in combination with other treatments as part of the study."

Commercial • Oncology • Prostate Cancer • Solid Tumor

ORIC Pharmaceuticals Announces Multiple Clinical Collaborations with Strategic Partners to Support Ongoing Trial Evaluating ORIC-944 in Combination with AR Inhibitors for the Treatment of Prostate Cancer (GlobeNewswire) - "ORIC Pharmaceuticals...announced it initiated dosing of ORIC-944, a potent and selective allosteric inhibitor of PRC2, in combination with darolutamide as well as in combination with apalutamide, in the first half of 2024 as part of the ongoing Phase 1b trial in patients with metastatic prostate cancer....The company also announced that it has entered into clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-944 in combination with NUBEQA, Bayer’s androgen receptor (AR) inhibitor, and ERLEADA, Johnson & Johnson’s AR inhibitor. Under the terms of the collaborations, ORIC will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer and Johnson & Johnson will provide darolutamide and apalutamide, respectively, for the study."

Licensing / partnership • Trial status • Prostate Cancer

Discovery of ORIC-944, a novel inhibitor of PRC2 with best-in-class properties for the treatment of prostate cancer (AACR 2024) - P1 | "Characterization of ORIC-944 revealed superiority to first generation clinical PRC2 inhibitors across a variety of preclinical assessments including potency, solubility, CYP inhibition/induction, PK and oral bioavailability. Together, the preclinical results indicate the desired properties were achieved in ORIC-944 to meet a superior target candidate profile, and the ongoing phase 1b trial (NCT05413421) demonstrates a clinical half-life of approximately 20 hours consistent with once daily dosing and a potential best-in-class profile."

Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Oncology • Prostate Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor