ORIC Pharmaceuticals Expands Precision Oncology Pipeline with Exclusive License to Brain Penetrant EGFR/HER2 Exon 20 Inhibitor Program

ORIC Pharmaceuticals today announced it has entered into an exclusive license agreement with Voronoi, Inc., an innovative drug discovery company dedicated to advancing novel therapeutics. ORIC secured exclusive rights worldwide excluding the People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC Territory) for the development and commercialization of ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations. ORIC expects to initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers during the second half of 2021.

Jacob Chacko, M.D., president and chief executive officer of ORIC Said: “ORIC-114 is well aligned with our mission of overcoming cancer resistance by leveraging our expertise in precision oncology and key tumor dependencies, and it puts us in position for three INDs or equivalents next year, ORIC-114 fits with our team’s success in developing therapies for tumor-agnostic mutations, including in patients with brain metastases, and will leverage our team’s prior experience in the pioneering development of entrectinib for genetically defined cancers. We believe Voronoi’s highly selective and brain penetrant inhibitors targeting exon 20 insertion mutations may address an area of significant unmet medical need for which no FDA-approved therapies exist today.”

Daekwon Kim, chief executive officer of Voronoi Said: “We are thrilled to be partnering with ORIC to further develop our potential best-in-class EGFR/HER2 exon 20 inhibitor program, With ORIC’s focus on developing targeted cancer therapies and their team’s prior experience in leading efforts for multiple global regulatory approvals for mutant NSCLC and tumor-agnostic indications, ORIC is an ideal partner to further the development of this program.”

Under the terms of the agreement, in exchange for an exclusive license to develop and commercialize Voronoi’s EGFR and HER2 exon 20 inhibitor program in the ORIC Territory, ORIC paid to Voronoi a one-time payment comprising $5 million in cash and $8 million in shares of ORIC common stock. The number of shares issued to Voronoi was based on a price of $28.24 per share, representing a premium of 25% to the 30-day trailing volume-weighted average trading price of ORIC’s common stock. In addition, ORIC will pay Voronoi success-based payments of up to $111 million in development and regulatory milestones and up to $225 million in sales milestones with respect to the first licensed product. If ORIC pursues a second licensed product, ORIC would pay Voronoi up to an additional $272 million in success-based milestones. ORIC will also pay tiered mid-single-digit to low double-digit royalties based on annual net sales in the ORIC Territory. ORIC will be responsible for development activities and expenses in the ORIC Territory.

Webcast and Conference Call

ORIC will host a webcast and conference call today, October 19th, at 4:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID: 8129902. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company's website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.

About ORIC-114 and Exon 20 Insertion Mutations in EGFR and HER2

The ErbB receptor tyrosine kinase family is involved in key cellular functions, including cell growth and survival. Epidermal growth factor receptor (EGFR, or ErbB1) and human epidermal growth factor receptor 2 (HER2, or ErbB2) exon 20 insertion mutations are observed across multiple solid tumors, including NSCLC, breast, gastrointestinal, bladder and other cancers. EGFR exon 20 insertion mutations are observed in approximately 2% of all patients with NSCLC and have a worse prognosis than patients with NSCLC driven by other EGFR mutations. HER2 exon 20 insertion mutations are observed in approximately 1.5% of all patients with NSCLC. Approximately one-third of patients with exon 20 insertion mutations may develop brain metastases, which contributes to poor prognosis.

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated greater brain exposure in preclinical studies compared to other compounds being developed against exon 20 mutations and demonstrates strong anti-tumor activity in an EGFR-driven intracranial lung cancer model. Currently, there are no medicines approved by the FDA to treat tumors with EGFR or HER2 exon 20 insertion mutations. ORIC expects to initiate a global Phase 1/2 tumor-agnostic trial of ORIC-114 in genetically defined cancers in the second half of 2021.

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