CG Oncology, Inc. Stock Price, News & Analysis

CG Oncology (NASDAQ: CGON) has scheduled a conference call and webcast for December 5, 2024, at 7 am CST to discuss results from their Phase 3 BOND-003 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The call will feature Dr. Mark Tyson, II, urologic oncologist at Mayo Clinic and lead investigator of the BOND-003 study, who will present the results as a late-breaking abstract at the Society of Urologic Oncology (SUO) 25th Annual Meeting in Dallas at 11:45 am CST. The webcast will be accessible through the company's Investor Relations website, with an archive available after the call.

CG Oncology (NASDAQ: CGON) announced multiple presentations featuring cretostimogene at the Society of Urologic Oncology (SUO) 25th Annual Meeting from December 4-6, 2024, in Dallas. The presentations include a late-breaking abstract on the Phase 3 BOND-003 trial results, examining cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC, presented by Dr. Mark D. Tyson.

Additionally, four Trials in Progress posters will be presented, covering: BOND-003 Cohort P for papillary NMIBC, PIVOT-006 Phase 3 study for intermediate-risk NMIBC, CORE-008 Phase 2 multi-arm study, and the Expanded Access Program. These presentations demonstrate the company's comprehensive development program for cretostimogene as a potential bladder-sparing therapeutic.

CG Oncology reported Q3 2024 financial results with a net loss of $20.4 million ($0.30 per share), compared to $17.5 million ($4.00 per share) in Q3 2023. Cash position stood at $540.7 million as of September 30, 2024. R&D expenses increased to $19.6 million from $11.7 million year-over-year, while G&A expenses rose to $8.7 million from $2.3 million. The company's late-breaking abstract on Phase 3 BOND-003 trial results for cretostimogene monotherapy in BCG-Unresponsive NMIBC was accepted at the SUO 25th Annual Meeting. Current cash reserves are expected to fund operations through 2027.

CG Oncology announced the publication of Phase 1b study results in Nature Medicine, evaluating cretostimogene grenadenorepvec combined with nivolumab in muscle-invasive bladder cancer (MIBC). The results were also presented at the Society for Immunotherapy of Cancer 2024. This marks the second Nature Medicine publication for cretostimogene this year, following June 2024's publication of CORE-001 phase 2 study results. The drug shows potential as a bladder-sparing therapeutic, featuring a dual mechanism that selectively targets cancer cells while boosting immune response against bladder tumors. The company expects to share topline results from their BOND-003 registrational study in High-Risk Non-Muscle Invasive Bladder Cancer later this year.

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. Arthur Kuan, the company's Chairman & CEO, is scheduled for a fireside chat on September 6, 2024, at 10:45 am ET in New York, NY.

CG Oncology focuses on developing a potential backbone bladder-sparing therapeutic for bladder cancer patients. Interested parties can access the live audio webcast of the presentation from the Investor Relations section of the company's website at www.cgoncology.com. A replay of the webcast will be available for approximately 90 days after the live presentation concludes.

CG Oncology (NASDAQ: CGON) reported Q2 2024 financial results and business updates. Key highlights:

1. CORE-001 study: 54% complete response (CR) rate at 24 months in BCG-Unresponsive NMIBC with cretostimogene + pembrolizumab.

2. BOND-003 study: 75.2% CR rate in High-Risk, BCG-Unresponsive NMIBC with cretostimogene monotherapy.

3. Initiated Expanded Access Program for cretostimogene grenadenorepvec.

4. Financial highlights: Cash position of $552.9 million as of June 30, 2024. Q2 R&D expenses: $18.5 million. Q2 G&A expenses: $7.5 million. Net loss: $18.9 million ($0.28 per share).

5. Cash runway expected through 2027.

CG Oncology has launched an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The first patient has been dosed, and enrollment is ongoing. This move aims to provide more treatment options for NMIBC patients, reflecting CG Oncology's commitment to addressing this recurrent cancer. Key figures in the bladder cancer community, such as Andrea Maddox-Smith from the Bladder Cancer Advocacy Network, emphasize the hope that EAPs represent for patients who have exhausted all approved treatments.

CG Oncology (NASDAQ: CGON) has published final results from its Phase 2 CORE-001 trial of cretostimogene and pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) in Nature Medicine and presented them at ASCO 2024.

The trial met its primary endpoint with a 54% complete response (CR) rate at 24 months in the intention-to-treat (ITT) population. The 12-month CR was 57%, with 95% of these patients maintaining CR for an additional 12 months.

Progression-free survival (PFS) at 24 months was 100%, with no patients advancing to muscle invasive or metastatic disease. Cystectomy-free survival (CFS) at 24 months was 80%, and 100% for patients in CR. Treatment-related adverse events were consistent with those of the individual agents.

The combination received FDA Breakthrough Therapy Designation in May 2023, and cretostimogene monotherapy also received Fast Track and Breakthrough Therapy Designations in December 2023. Topline data from the Phase 3 BOND-003 trial is expected by the end of 2024.

CG Oncology (NASDAQ: CGON) has announced final results from its Phase 2 CORE-001 trial of cretostimogene in combination with pembrolizumab for treating BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC). The trial achieved a 54% complete response (CR) rate at 24 months, meeting its primary endpoint. The data will be presented at the ASCO 2024 Annual Meeting. Results show significant efficacy with 83% CR rate at any time and 77.3% at 12 months. Moreover, 95% of patients in CR at 12 months remained in CR for another 12 months. Progression-free survival at 24 months is 100%, with no progression to muscle-invasive or metastatic disease. The Kaplan-Meier estimates for CR rate at 24 months are 69.6%. Treatment-related adverse events were consistent with individual agents. The combination therapy has received FDA Breakthrough Therapy Designation, and CG Oncology plans to incorporate these findings into a future CORE-008 trial.