ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC) is a clinical-stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. The company's pipeline includes several promising product candidates that target various mechanisms of therapeutic resistance, positioning it as a key player in the oncology space.
Financials
For the fiscal year ended December 31, 2023, ORIC reported an annual net loss of $100,697,000 and no revenue. The company's annual operating cash flow was -$85,915,000, and its annual free cash flow was -$86,764,000. These financial results reflect ORIC's ongoing investment in research and development to advance its pipeline of oncology treatments.
In the first quarter of 2024, ORIC reported a net loss of $25,011,000 and no revenue. The company's operating cash flow for the quarter was -$30,186,000, and its free cash flow was -$30,404,000. These quarterly results demonstrate ORIC's continued focus on clinical development and the associated cash burn as the company progresses its product candidates through the pipeline.
Business Overview
ORIC Pharmaceuticals was founded in 2014 and is headquartered in South San Francisco, California, with an additional office in San Diego. The company's mission is to develop innovative therapies that overcome resistance mechanisms in cancer, addressing a significant unmet medical need.
ORIC's clinical-stage product candidates include:
1. ORIC-114: A brain-penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 is being developed across multiple genetically defined cancers.
2. ORIC-944: A potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer.
3. ORIC-533: An orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma.
Beyond these lead candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms.
Recent Developments
In the first quarter of 2024, ORIC made significant progress in advancing its pipeline. The company reported initial Phase 1b data for ORIC-114 at the European Society for Medical Oncology (ESMO) Congress in October 2023, which demonstrated both systemic and intracranial activity across multiple dose levels in a heavily pre-treated patient population.
Additionally, ORIC announced the selection of two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or atypical EGFR mutations.
ORIC also reported initial Phase 1b data for ORIC-944 in January 2024, demonstrating potential best-in-class drug properties, including an approximate 20-hour clinical half-life, robust target engagement, and a favorable safety profile. The company is proceeding with a combination study of ORIC-944 with AR inhibitor(s) in metastatic prostate cancer and plans to provide a program update in mid-2024.
Regarding ORIC-533, the company is completing a Phase 1b trial in patients with relapsed/refractory multiple myeloma and plans to evaluate strategic partnerships to develop ORIC-533 in combination with other immune-based antimyeloma therapies.
Liquidity
As of March 31, 2024, ORIC had $331,500,000 in cash, cash equivalents, and investments. The company believes this cash position will be sufficient to fund its current operating plan into late 2026.
In January 2024, ORIC raised $125,000,000 through a private placement of common stock with new and existing healthcare specialist funds. This additional funding strengthens the company's balance sheet and supports the continued development of its pipeline.
Risks and Challenges
ORIC operates in a highly competitive oncology market, with several companies developing inhibitors targeting EGFR and HER2 exon 20 mutations, PRC2 inhibitors, and CD73 inhibitors. Key competitors include Johnson & Johnson, Bayer, Dizal Pharmaceuticals, Cullinan Oncology, Boehringer Ingelheim, and Arcus Biosciences, among others.
Risks facing ORIC include the inherent challenges of drug development, such as the potential for clinical trial failures, regulatory hurdles, and competition from other therapies. The company also faces risks related to its reliance on third-party manufacturers and contract research organizations, as well as potential intellectual property disputes.
Outlook
ORIC's management has provided guidance on several key milestones expected in 2024 and 2025:
- Reporting updated Phase 1b data for ORIC-114 in the first half of 2025 - Providing a program update for the ORIC-944 combination study in metastatic prostate cancer in mid-2024 - Evaluating strategic partnerships to develop ORIC-533 in combination with other immune-based antimyeloma therapies
These upcoming data readouts and program updates represent important catalysts that could drive further progress for ORIC's pipeline and potentially unlock additional value for shareholders.
Conclusion
ORIC Pharmaceuticals is a promising clinical-stage oncology company focused on developing innovative therapies that address mechanisms of therapeutic resistance in cancer. With a diversified pipeline of product candidates, including ORIC-114, ORIC-944, and ORIC-533, the company is well-positioned to make meaningful contributions to the treatment of various cancer types. While the company faces the inherent risks of drug development, its strong cash position and upcoming milestones suggest that ORIC could emerge as a key player in the oncology space in the years to come.