- Co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital -

- Proceeds to accelerate clinical programs across bladder cancer including in the first-line setting, positioning CG Oncology as the leading urologic oncology company -

- Brian Liu, M.D., Principal, Longitude Capital to join board of directors -

CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced the close of an oversubscribed $120 million Series E financing round, co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital. The company has secured a total of over $200 million in funding to date. In connection with the financing, Brian Liu, M.D., Principal from Longitude Capital, will join the company’s board of directors.

The proceeds from the Series E financing will be used to advance the company’s lead clinical programs in bladder cancer towards FDA approval as well as broaden the scope of its pipeline to address unmet medical needs in urologic cancer, such as the first-line setting in Bacillus Calmette-Guérin (BCG)-naïve, intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients.

“We are delighted by the support from leading global investors to help us accomplish our mission of developing innovative therapeutics for patients suffering from urologic cancers,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “Our continued clinical progress in bladder cancer is a testament to our lead candidate CG0070 in both monotherapy and combination therapy studies, setting the stage to further expand development across additional urologic oncology indications.”

CG0070 is an intravesically delivered oncolytic immunotherapy agent in an ongoing Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a fully enrolled combination Phase 2 study (CORE1) of CG0070 with anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) in the same indication. CG Oncology has a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of CG0070 with pembrolizumab in CORE1. Interim Phase 2 data for CORE1 announced at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting on November 10, 2022, continue to show both strong anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.

“We have strong conviction in CG Oncology which continues to generate compelling data to develop potential bladder-sparing innovative therapeutics for patients suffering from bladder cancer,” said Simone Song, Founder and Senior Partner of ORI Capital. “We’ve been strong supporters of the CG Oncology team from an early stage by leading the Series C round, and we are particularly proud to co-lead this round with Longitude Capital and Decheng Capital, as we see tremendous potential for CG0070 to be a game changer for patients with NMIBC.”

“In advanced clinical studies CG0070 has continued to demonstrate potentially transformational results in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,” said Brian Liu, M.D., Principal, Longitude Capital. “I am excited to join CG Oncology’s board of directors during this significant expansion trajectory for the company and am looking forward to working with the leadership team to bring this therapy to patients in need.”

CG0070 has been administered to over 200 patients for the treatment of bladder cancer. The investigational therapy has exhibited potential best-in-class efficacy and safety in monotherapy as well as strong response rates when combined with checkpoint inhibitors. Given CG0070’s combination results with strong complete response rates in heavily pre-treated BCG-unresponsive, high-risk NMIBC patients, there has been significant demand within the urologic community for CG0070 to also be investigated in the BCG-naïve NMIBC setting, where limited treatment options have been exacerbated by the global BCG shortage impacting both providers and patients. In response, CG Oncology has decided to investigate the activity of CG0070 as a first-line treatment of BCG-naïve, intermediate-risk NMIBC in a Phase 2 study to expand clinical development for additional patients with bladder cancer.

About CG0070

Our lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA^® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO^® (nivolumab).

About CG Oncology

CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. At CG Oncology, we see a world where urologic cancer patients can benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, visit www.cgoncology.com. Follow us on Twitter @cgoncology.

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