CG Oncology, Inc. Stock Price, News & Analysis

SUO-CTC and CG Oncology (NASDAQ: CGON) have announced their first annual Non-Muscle Invasive Bladder Cancer (NMIBC) Research Fellowship Award. The fellowship aims to support outstanding clinical cancer research investigators committed to advancing NMIBC treatment and understanding. Applications are due by February 28, 2025, with the award starting in May 2025. The recipient will present their research findings at the SUO Meeting at AUA in April/May 2026.

Eligible candidates may work in basic, translational, and clinical research fields, and must have access to a research environment capable of supporting transformational NMIBC research. Applications will be evaluated based on the proposed research plan quality and available resources.

CG Oncology (NASDAQ: CGON) announced topline data from Phase 3 BOND-003 trial for cretostimogene in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients unresponsive to BCG treatment. Key findings show 74.5% of patients (82 out of 110) achieved complete response, with median duration of response exceeding 27 months. The study demonstrated 63.5% of patients maintained response at 12 months and 56.6% at 24 months. Notably, 97.3% of patients remained free from progression to Muscle Invasive Bladder Cancer at 12 months.

The treatment showed favorable safety profile with no Grade 3 or greater treatment-related adverse events, no deaths, and no treatment discontinuations. Common side effects included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

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.