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CG Oncology Inc.’s latest research effort to treat bladder cancer is impressing investors.
The Irvine-based biopharmaceutical company on April 26 reported a 75.5% remission rate in patients with high-risk non-muscle invasive bladder cancer in its Phase 3 BOND-003 clinical trial.
Of the 110 patients, 51 maintained remission after one year and 34 after two years. Notably, 91.6% of participants were able to preserve their bladder.
“We continue to see strong safety and efficacy, as well as best-in-disease durability and tolerability,” Dr. Gary Steinberg, a professor at the Department of Urology at Rush University Medical Center, said in a statement issued by the company.
CG presented the data at this year’s American Urological Association (AUA) Annual Meeting in Las Vegas, which took place April 26-29.
The data suggests that CG’s treatment “will represent an important advancement for people suffering with bladder cancer, and we are working diligently to bring it forward to patients,” CG Oncology Chief Operating Officer and President Ambaw Bellete said in the statement.
Shares responded positively to the news, jumping 25% to $27.97 and a $2.1 billion market cap on the first trading day following the announcement (Nasdaq: CGON).
The company’s therapy received both Fast Track and Breakthrough Therapy designations from the Food and Drug Administration last year. CG said that the next step for the company is to submit a Biologics License Applications (BLA) to the FDA in the second half of this year, which would allow the company to distribute its therapy across state lines.
A Race for the Cure
The American Cancer Society estimates that in 2025, more than 85,000 people will be diagnosed with bladder cancer and that the disease will result in nearly 17,500 deaths. An estimated 730,044 people in the U.S. are currently living with the disease, making it the sixth most prevalent cancer in the country. About 74% of patients are over 65 years old.
CG is one of the latest players to join the non-muscle invasive bladder cancer space, which is gaining traction as more and more new therapies come out.
The market is made up of industry giants including Merck & Co. and Ferring Pharmaceuticals. Another is Johnson & Johnson, which has an investigational drug dubbed TAR-200 that received breakthrough therapy designation from the FDA in 2023.
A notable competitor is Los Angeles-based ImmunityBio Inc., whose executive chairman and global chief medical and scientific officer is billionaire Patrick Soon-Shiong.
ImmunityBio, founded in 2014, received FDA approval for its immunotherapy drug Anktiva last year. Analysts are expecting the company’s sales to jump 610% to $104.7 million this year and another 161% to $273.7 million in 2026.
The company also presented at AUA last month, showing its data from a clinical trial for a new indication of Anktiva in papillary disease, which ImmunityBio estimates to be six to 10 times more common than bladder cancer carcinoma in situ (CIS).
“We are pleased with these unmatched long-term follow up results which further illustrate Anktiva’s potential to improve outcomes and quality of life for patients with non-muscle invasive bladder cancer in both indications of CIS, as well as papillary disease without CIS,” Soon-Shiong said in a statement.
Unlike CG, ImmunityBio’s shares were relatively unchanged last week at $2.45 each and a $2.2 billion market cap (Nasdaq: IBRX).
The Game Changer
Bladder disease is highly recurrent, with an estimated 15% to 61% of high-risk patients suffering a relapse within a year.
Patient have limited options. Either the bladder must be removed or repaired, which has a high fatality rate, or medications are administered. Medications often have problems because the bladder, as would be expected, urinates out the anti-cancer drugs.
CG has positioned itself with a treatment that it calls “a game changer” for bladder cancer.
CG’s namesake therapy’s called cretostimogene grenadenorepvec. It uses genetically modified viruses to target tumors in the bladder.
By comparison, Johnson & Johnson’s TAR-200 is a small plastic tube inserted via catheter that releases chemotherapy called gemcitabine into the bladder.
CG’s results demonstrate “emerging best-in-class durability signals,” RBC Capital Markets analyst Gregory Renza said in a report last week.
Cantor Fitzgerald reiterated its overweight rating with a price target of $75, which is triple its current price.
Plenty of Cash
The company went public a year ago with its stock topping $50 each at one point.
CG on March 28 announced its loss from operation in 2024 doubled to $114.7 million. The company missed analysts’ expectations and the shares dropped by a third to as low as $14.80 in subsequent days.
Last December, CG raised an oversubscribed $238 million in a public offering by selling 9.2 million shares of its common stock at $28 apiece. It currently has $742 million in cash and equivalents, enough to fund operations until the first half of 2028.
It is currently in the early stages of building in-house sales and marketing ahead of commercial launch in the U.S.
“We made substantial progress in the fourth quarter of 2024,” Arthur Kuan, chairman and chief executive of CG Oncology, said in a statement.