ORIC-944 / ORIC Pharma - LARVOL DELTA

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

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 (AACR 2024) - P1 | "RNA-seq analysis of transcriptional changes induced by ORIC-944 provided mechanistic insight into the role of PRC2 in prostate cancer lineage plasticity and combination response.These results position ORIC-944 as a best-in-class PRC2 inhibitor for evaluation in combination with ARPI in patients with metastatic prostate cancer. A phase 1b trial of ORIC-944 is ongoing (NCT05413421)."

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

ORIC Pharmaceuticals Presents Preclinical Data on Two Programs at the 2024 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "ORIC-944, a potent and selective allosteric PRC2 inhibitor with potential best-in-class properties, demonstrates combination synergy with AR pathway inhibitors in prostate cancer models....Results from combinations with an AR inhibitor in an in vivo prostate model shows ORIC-944 provides better activity than PF-06821497....These results position ORIC-944 as a potential best-in-class PRC2 inhibitor for combination with AR inhibitors in patients with prostate cancer."

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

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Updates (GlobeNewswire) - "Fourth Quarter 2023 and Other Recent Highlights: (i) ORIC-114:...Expect to initiate dose expansion of Phase 1b trial in multiple cohorts in the first half of 2024 and expect to report updated Phase 1b data in the first half of 2025; (ii) ORIC-944:...Expect to initiate combination study with AR inhibitor(s) in the first half of 2024 and provide a program update in mid-2024; (iii) ORIC-533:...Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024..."

New P1 trial • New trial • Trial status • Multiple Myeloma • Solid Tumor

ORIC Pharmaceuticals Announces Multiple Presentations at the 2024 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "ORIC Pharmaceuticals, Inc...today announced that multiple abstracts have been accepted for presentation, including two oral presentations on ORIC-944, a potent and selective allosteric inhibitor of PRC2, at the 2024 American Association for Cancer Research (AACR) Annual Meeting taking place April 5-10, 2024, in San Diego, CA."

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

Cantor Fitzgerald bullish on ORIC Pharmaceuticals, stock initiated with overweight rating (Investing.com) - "On Friday, Cantor Fitzgerald initiated coverage on ORIC Pharmaceuticals...assigning an Overweight rating to the clinical-stage oncology-focused biotech company. The firm's optimistic stance is primarily influenced by the potential of ORIC's key drug candidates in the oncology space...The firm's analyst believes ORIC-114, an oral EGFR/HER2 exon 20 inhibitor, has a high chance of becoming a leading drug in its category, particularly for lung cancer treatment. This drug's ability to penetrate the brain and its differentiation in the market are seen as strong points that justify the company's current valuation...Additionally, ORIC-944, an oral PRC2 inhibitor, is perceived to have a favorable risk/reward profile within the large prostate cancer market....the initial public offering (IPO) of ArriVent provided a valuation comparison that favored ORIC-114 in the Ex20 lung cancer space."

Commercial • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor