Cretostimogene Grenadenorepvec

– Final positive CORE-001 safety and efficacy findings were published simultaneously online by Nature Medicine and featured at ASCO 2024 – – 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint of the phase 2 study – IRVINE, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced the publication in Nature Medicine of final results from the Company’s CORE-001 Phase 2 trial of cretostimogene plus pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NIMBC). The article, titled “Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial” is now available online and will be published in a future print issue of Nature Medicine. The most recent data cut as of May 17, 2024, was also featured as a poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. “The CORE-001 trial results published in Nature Medicine clearly demonstrate the potential for cretostimogene to be used as a bladder-sparing backbone therapy for NMIBC,” said Vijay Kasturi, MD, Chief Medical Officer, CG Oncology. “We are honored that Nature Medicine and ASCO are publishing our compelling safety and efficacy phase 2 study results, which showed a class-leading complete response (CR) and duration of response (DoR) compared to existing FDA-approved therapies and other investigational candidates.” “As a principal investigator on both the BOND-003 Phase 3 monotherapy clinical trial as well as the CORE-001 Phase 2 combination trial it is especially gratifying to see the studies culminating in such strong results,” said Roger Li, M.D., urologic oncologist at Moffitt Cancer Center. “These data highlight the promise of cretostimogene’s novel mechanism of action, providing both direct tumor cell kill while activating an anti-tumor immune response. I believe cretostimogene as an oncolytic immunotherapy has the potential to act as the backbone to multiple treatment strategies in the new bladder sparing paradigm in bladder cancer management.” As previously shared in the Company’s May 24th press release, the CORE-001 Final Results are as follows: As of the data cutoff on February 5, 2024, the CR rate in the intention-to-treat (ITT) population at 12-months and any time, was 57% (20/35) [95% confidence interval (CI), 40-73%] and 83% (29/35) (95% CI, 70-95%), respectively. As of May 17, 2024, the CR rate in the ITT population at 24 months was 54% (19/35) (95% CI, 37-71%). Of the patients in a CR at 12 months, 95% of patients (19/20) maintained a CR for another 12 months. Median DoR has not been reached but exceeds 21 months. Additionally, the Kaplan-Meier estimates for CR rate at 12- and 24 months were 77.3% (95% CI, 58.1-88.5%) and 69.6% (95% CI, 49.4-83.0%), respectively. Progression-free survival (PFS) at 24 months is 100% with no patients progressing to muscle invasive cancer or metastatic disease; Cystectomy-free survival (CFS) at 24 months was 80%; for patients in CR, CFS at 24 months was 100%. Treatment-related adverse events (TRAEs) were consistent with the individual agents and demonstrate no synergistic toxicity. Results to be presented are an update from previously reported data in the abstract. The Phase 2 CORE-001 trial was conducted in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The combination of cretostimogene and pembrolizumab received FDA Breakthrough Therapy Designation in May 2023. Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, HR-NMIBC with CIS in December 2023. CG Oncology recently presented data from the Phase 3 BOND-003 trial at the 2024 American Urological Association Annual Meeting which showed sustained durable responses over 12 months and a 75.2% complete response rate at any time. Topline data from BOND-003 is expected by the end of 2024, and the Company is on track for a regulatory approval submission. To learn more about the results from BOND-003 you may read the Company’s press release issued on May 3, 2024. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About the CORE-001 Study CORE-001 was a Phase 2 single-arm, open-label clinical trial of cretostimogene administered in 35 patients with high-risk, BCG-unresponsive NMIBC that have carcinoma in situ-containing tumors, in combination with pembrolizumab, following disease resection. CORE-001 was conducted pursuant to a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). More information about the study, CORE-001 (NCT04387461), along with other studies sponsored by CG Oncology, can be found at or . About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: . Forward Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene in combination with pembrolizumab for high-risk NMIBC patients and the importance of the data as they relate to addressing bladder cancer and supporting further investigation in combination with checkpoint inhibitors; the anticipated timing of BOND-003 final data; and the Company’s expectations on a regulatory approval submission. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene in combination with pembrolizumab that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at ). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology (508) 654-2277 sarah.connors@cgoncology.com Investor Relations Laurence Watts New Street IR (619) 916-7620 IR@cgoncology.com

Pictured: Pair of hands framing graph of upward-trending numbers/Nicole Bean for BioSpace At the end of 2023, PwC predicted a “gradual uptick” in IPOs, with the market expected to favor those companies with “strong clinical data.” Roel van den Akker, pharmaceutical and life sciences deals leader at PwC, said that current market activity aligns with the firm’s predictions. “I do think that we’ve seen somewhat of an uptick in public offerings going into January, February, March. It’s definitely picked up," van den Akker said. “We’ve seen some pretty critical ones in the first and second quarter of FY24, which we didn’t really see in FY23 and FY22.” Lorenzo Paoletti, head of biotech investment banking at Truist Securities, agreed that the first half of 2024 is looking good compared with late 2023. Through May 10, his firm calculated that the biotech sector has seen $23 billion of issuance—including IPOs, secondary offerings, convertible debt, PIPEs and registered directs—compared with $15 billion in the second half of 2023. A month-to-month look at the year so far reveals a downward trend, however, with $7 billion generated from IPOs in January, $9 billion in February, $4 billion in March and $2 billion in April. As of May 29, 11 companies have launched IPOs this year. Five of those companies—Alto Neuroscience, ArriVent Biopharma, CG Oncology, Kyverna Therapeutics and Metagenomi—entered the market in January alone. The most recent, Rapport Therapeutics and Telix Pharma, each filed on May 17. Van den Akker said it is hard to predict the future of the public market “given the geopolitical backdrop that we’re facing in the United States and abroad,” but this year so far has given the firm reasons to be optimistic about its continued strong performance. Paoletti told BioSpace that we’re in a volatile time right now, largely due to the high interest rates. He added that he expects we’ll see a pause in IPOs as we get close to November’s presidential election, as investors will want to know the outcome before making bets on future returns. “As a banker, I would certainly recommend my clients to not launch an IPO close to elections,” he said, adding that some companies now waiting to go public may pull the trigger right after the election or in Q1 2025. Here are this year’s IPOs so far: 1. CG Oncology Date: Jan. 26-29 Value: $380 million CG Oncology announced it was going public in January. The company initially anticipated $180 million in gross proceeds but later announced an upsized IPO. Its late-stage product cretostimogene grenadenorepvec infiltrates and kills cancer cells and is undergoing Phase III trials for non-muscle invasive bladder cancer. 2. Kyverna Therapeutics Date: Feb. 8-11 Value: $366.9 million Kyverna initially aimed for $182 million, pulled in $319 million on the first day of sales and closed at nearly $370 million. The company focuses on cell therapies for autoimmune diseases such as progressive multiple sclerosis. It published results of first use of its product KYV-101 at the end of March. 3. ArriVent Biopharma Date: Jan. 26-29 Value: $175 million ArriVent initially anticipated netting between $135.7 million and $156.7 million with its IPO, but ended up upsizing to $175 million. The company, which is developing drugs for non-small cell lung cancer, said the IPO will help fund development but it expects to need to raise “substantial additional capital” in the future. 4. Alto Neuroscience Date: Feb. 2-6 Value: $147.9 million Alto, a precision medicine company focused on psychiatric drug development, predicted closing with $128.6 million but ended with $147.9 million in gross proceeds. Alto recently saw positive results in a Phase I trial for ALTO-101, a PDE4 inhibitor for patients experiencing cognitive impairment with schizophrenia. 5. Contineum Therapeutics Date: April 5-9 Value: $110 million Contineum, originally called Pipeline, aimed to raise between $140.8 million and $158.4 million, but reduced the number of shares it expected to sell, dropping proceeds to about $110 million. Contineum, focused on treatments for neurologic, inflammatory and immune diseases, is developing two clinical-phase candidates: PIPE-307 for relapse-remitting multiple sclerosis and PIPE-791 for idiopathic pulmonary fibrosis. 6. Boundless Bio Date: March 28-April 2 Value: $100 million Boundless Bio went public in March, pulling in goal proceeds of $100 million. The company intends to use the funding for development of its extrachromosomal DNA programs for cancer, including products BBI-355 and BBI-825. It also plans to fund an extrachromosomal DNA diagnostic test called ECHO. 7. Fractyl Health Date: Feb. 2-6 Value: $100 million Fractyl, a company developing treatments for type 2 diabetes and obesity, initially set its sights on $99 million in its IPO, before raising its goal to $110 million. Its gross proceeds were ultimately $100 million. Fractyl's main therapies are Revita, a device for inserting fluid into the small intestine to remodel the duodenal lining, and Rejuva PGTx, a pancreatic gene therapy. 8. Metagenomi Date: Feb 9-13 Value: $93.75 million Metagenomi went public in February, touting its metagenomics genome editing tools. It initially planned to raise $86.9 million, but the IPO closed with nearly $94 million despite share prices falling during its debut. The company has multiple preclinical and discovery-stage assets and had early support from companies such as Moderna, which exited its gene-editing deal with Metagenomi in May but remains a shareholder. 9. Telomir Pharmaceuticals Date: Feb 9-13 Value: $7 million Telomir went public in February, with gross proceeds meeting its $7 million prediction. The company is developing Telomir-1, a small molecule drug that aims to lengthen telomeres at the ends of chromosomes to prolong cell division and slow aging. 10. Rapport Therapeutics Date: Announced May 17 Value: Undisclosed Rapport is developing RAP-219, a tablet that targets a neuronal receptor–associated protein for the AMPA receptor to treat epilepsy and eventually psychiatric conditions. The company is also developing a long-acting injectable form of RAP-219 and treatments that target nicotinic acetylcholine receptors for pain, hearing disorders and psychiatric conditions. 11. Telix Pharma Date: Announced May 17 Value: Undisclosed The company’s prostate cancer PET scan agent Illuccix was approved by the FDA in 2021 and received an expanded label in 2023. It’s hoping to further expand Illuccix’s label and develop other late-stage products. Nadia Bey is a freelance reporter from North Carolina. Her work and contact information can be found at nadiabey.com. Reporting contributed by Jef Akst, managing editor of BioSpace.