CG Oncology, Inc., a late-stage clinical biopharmaceutical company, focuses on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer.
The company’s goal is to develop cretostimogene grenadenorepvec (cretostimogene), its product candidate, as an alternative to Bacillus Calmette-Guérin (BCG) in treating a broad range of bladder cancer indications. Cretostimogene is in clinical development for the treatment of patients with high-...
CG Oncology, Inc., a late-stage clinical biopharmaceutical company, focuses on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer.
The company’s goal is to develop cretostimogene grenadenorepvec (cretostimogene), its product candidate, as an alternative to Bacillus Calmette-Guérin (BCG) in treating a broad range of bladder cancer indications. Cretostimogene is in clinical development for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to BCG therapy, the current standard-of-care for high-risk NMIBC.
The company is actively building its commercial operations, marketing, market access, and patient access and field force capabilities. This includes pre-launch activities currently being executed, such as scientific communication activities and engagements by the company’s field medical organization. The company is also implementing strategic initiatives to build product distribution and patient support. It is evaluating the safety and efficacy of cretostimogene as a monotherapy in BOND-003 Cohort C, the company’s ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) and with or without Ta/T1 disease. The company has completed enrollment for this cohort and reported interim data at the American Urological Association's 2024 Annual Meeting in May 2024, and topline data at the 2024 Society of Urologic Oncology (SUO) Annual Meeting in December 2024, which was updated at the 40th Annual European Association of Urology (EAU) Congress.
In April 2024, the company initiated BOND-003 Cohort P, an exploratory study evaluating cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with only Ta/T1 disease, and expects to report topline data from this cohort in the second half of 2025. In October 2024, the company initiated CORE-008 Cohort A, its Phase 2 clinical trial in high-risk NMIBC patients who are naïve to BCG treatment, including patients with CIS and with or without Ta/T1 disease, as well as patients with only Ta/T1 disease. The company intends to expand CORE-008 into the high-risk BCG-exposed population, evaluating cretostimogene as a monotherapy and in a combination therapy. It has recently completed and published the results for CORE-001, its Phase 2 clinical trial of cretostimogene in combination with pembrolizumab in patients with high-risk BCG-unresponsive NMIBC that have CIS. Additionally, the company has launched its second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in Intermediate-Risk NMIBC following transurethral resection of the bladder tumor (TURBT).
Cretostimogene, as both a monotherapy and in combination with other therapies, has shown a potential best-in-class target product profile. Topline data from the Phase 3 BOND-003 Cohort C trial, which was presented as a late-breaking abstract at the 2024 SUO Annual Meeting, showed that cretostimogene, as a monotherapy in patients with high-risk BCG-unresponsive NMIBC, achieved a 74.5% complete response (CR) rate at any time, as of the data cutoff date on September 30, 2024. Additionally, as of the data cutoff of September 30, 2024, the Kaplan-Meier estimated CR rates at 12 and 24 months were 50% (95% confidence interval (CI), 39.6-58.9%) and 41% (95% CI, 30.4-50.8%), respectively. Progression-free survival (PFS) at 12 months was 97.3%, with no patients progressing to muscle invasive cancer, and cystectomy-free survival at 12 months was 90.0%. The estimated duration of response (DoR) probability at 12 months and 24 months was 63.5% (95% CI, 51.2-73.4%) and 56.6% (95% CI, 43.3-67.8%), respectively. The median DoR was not reached but, as of the cutoff date, was greater than 27 months. There were no Grade 3 or higher treatment-related adverse events (TRAEs) or deaths reported. The most common TRAEs (=10%) were bladder spasm, pollakiuria, dysuria, micturition urgency, and hematuria. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all protocol-defined treatments, demonstrating favorable patient adherence and compliance. The study was updated in a late-breaking abstract at the 40th Annual EAU Congress, showing the CR rate at any time improved to 75.5%, with the median DoR not reached but exceeding 28 months as of the data cutoff of January 20, 2025. In addition, final results from the open-label Phase 2 CORE-001 clinical trial of intravesical cretostimogene in combination with pembrolizumab in high-risk BCG-unresponsive NMIBC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in Nature Medicine. As of the May 17, 2024 data cutoff, 29 of the 35 (82.9%; 95% CI, 70.4-95.3%) patients achieved a CR at any time, with 57.1% (n=20/35, 95% CI, 39.5-73.2%) of patients maintaining a CR at 12 months, and 54.3% (n=19/35, 95% CI, 36.9-70.8%) of patients maintaining a CR at 24 months, indicating that 95.1% of patients in CR at 12 months remain in CR at 24 months. The safety profile was favorable, with no overlapping or synergistic toxicity observed. Adverse events attributed to cretostimogene were Grade 1 or Grade 2 and self-limited. The company has presented the CI for CR at any time above and elsewhere in this Annual Report. CI is a range of values in which, statistically, there is a specified level of confidence where the result lies. It is conventional to set the CI at 95%, which means 95 of 100 times, the CI will contain the true value. The lower bound of the 95% CI around the observed CR rate provides support that such rate may be clinically meaningful. Interim results from these trials may differ from future results of the trials as more patient data become available. Based on these encouraging data, the company is working toward the submission of a BLA for cretostimogene as a treatment for patients with high-risk BCG-unresponsive NMIBC, which it expects to initiate in the second half of 2025. The company intends to evaluate cretostimogene for use in a broad range of bladder cancer indications.
Beyond the company’s ongoing clinical trials in NMIBC, it also initiated CORE-008, an open-label, multi-arm, multi-cohort Phase 2 clinical trial designed to assess the safety and efficacy of cretostimogene when administered as monotherapy in high-risk BCG-exposed and BCG-naïve NMIBC patients.
In addition to NMIBC, the company has evaluated cretostimogene as a potential therapeutic to treat patients with MIBC. MIBC is a more aggressive form of bladder cancer than NMIBC and is associated with significantly higher mortality. In CORE-002, a single-arm, exploratory investigator-sponsored clinical trial, intravesical cretostimogene was evaluated in combination with the CPI nivolumab in patients with MIBC ineligible for cisplatin chemotherapy prior to radical cystectomy.
Strategy
Key elements of the company’s strategy are to pursue FDA approval of cretostimogene as monotherapy in high-risk BCG-unresponsive NMIBC; expand the development of cretostimogene monotherapy as a potential backbone therapy across NMIBC indications; continue to evaluate cretostimogene in combination with other therapies, such as checkpoint inhibitors, to potentially further enhance its clinical utility across various stages of bladder cancer; commercialize cretostimogene; and leverage the company’s chemistry, manufacturing, and controls expertise and relationships to scale commercialization efforts.
Cretostimogene: The company’s Product Candidate for Intermediate- and High-Risk NMIBC
Cretostimogene is an investigational oncolytic immunotherapy with a dual mechanism of action designed both to eliminate cancer cells directly by selective replication and indirectly activating an anti-tumor immune response. The company’s ongoing open-label Phase 3 clinical trial, BOND-003, is designed to assess the safety and efficacy of cretostimogene in high-risk BCG-unresponsive NMIBC when administered as a monotherapy. The company has completed enrolling patients with high-risk NMIBC with CIS and with or without Ta/T1 disease who are unresponsive to BCG in the BOND-003 Cohort C trial and reported topline data in December 2024, which was updated in March 2025.
Cretostimogene, as both a monotherapy and in combination with other therapies, has shown a potential best-in-class target product profile. Topline data from the Phase 3 BOND-003 Cohort C trial, which was presented as a late-breaking abstract at the 2024 SUO Annual Meeting, showed that cretostimogene, as a single agent, achieved a 74.5% CR at any time in high-risk BCG-unresponsive NMIBC. As of the data cutoff of September 30, 2024, the Kaplan-Meier estimated that 63.5% and 56.6% of patients remained in response at 12 months or greater and at 24 months or greater, respectively, while the median DoR was not reached and exceeds 27 months. There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. The most common TRAEs (=10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The study was updated in a late-breaking abstract at the 40th Annual EAU Congress, showing the CR rate at any time improved to 75.5%, with the median DoR not reached but exceeding 28 months as of the data cutoff of January 20, 2025.
The company is also evaluating the tolerability and efficacy of cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with only Ta/T1 disease in BOND-003 Cohort P and has initiated CORE-008 Cohort A, the company’s Phase 2 clinical trial in high-risk NMIBC which are naïve to BCG treatment, including patients with CIS and with or without Ta/T1 disease, as well as patients with only Ta/T1 disease. The company recently expanded CORE-008 into the BCG-exposed population (Cohort B), evaluating cretostimogene as a monotherapy and intends to add a third cohort (Cohort CX) in a combination approach. In intermediate-risk NMIBC, the company initiated PIVOT-006 in November 2023, which is a randomized Phase 3 clinical trial designed to assess the safety and efficacy of adjuvant cretostimogene in NMIBC following TURBT.
Cretostimogene Grenadenorepvec
Cretostimogene is an investigational oncolytic immunotherapy that has been designed to selectively replicate in retinoblastoma (Rb)-E2F gene pathway-altered cells present in the majority of UCs and trigger an anti-tumor immune response. Cretostimogene enters the tumor by binding to Coxsackievirus and Adenovirus Receptors (CAR) present in specialized intracellular junctions and tight junctions of polarized epithelial cells.
There are two modifications made to cretostimogene for tumor selectivity and potency. The first modification is the insertion of an E2F-1 promoter in cretostimogene, which acts as a safety mechanism to selectively replicate and lyse Rb-E2F altered tumor cells rather than healthy cells that have intact Rb pathways. The second modification is the insertion of the gene for the cytokine granulocyte-macrophage colony stimulation factor (GM-CSF). GM-CSF is widely recognized as a potent stimulator of longer-term anti-tumor activity.
Cretostimogene Clinical Development
Cretostimogene Monotherapy for High-risk CIS-containing NMIBC after BCG Failure
BOND-002 Trial Design
The BOND-002 trial was a Phase 2, open-label, single-arm clinical trial of cretostimogene in patients with high-risk NMIBC after BCG failure. Cretostimogene was administered intravesically at 1x10^12 viral particles (VPs) per milliliter to patients who had refused radical cystectomy and with high-risk CIS-containing NMIBC, with or without Ta/T1 tumors, and a cohort of Ta/T1 only tumors, that had failed BCG therapy. The trial included a heterogeneous mixture of BCG-exposed and BCG-unresponsive NMIBC.
A total of 65 patients were enrolled, which included 46 CIS patients, with or without Ta/T1 disease, and 19 patients with Ta/T1 disease. Patients received an initial induction course of six weekly administrations. Patients who achieved a CR at month six received six weekly maintenance doses of cretostimogene using the same concentration. Patients whose disease did not respond to the first induction course received accelerated maintenance at month three to four, which involved early administration of the maintenance normally provided at six months. Six weekly follow-up doses were then administered at months 12 and 18. In this trial, CR rates were evaluated at various timepoints throughout the study.
Response Data in BOND-002 Trial
Among the 40 (61.5%) patients achieving a CR at any timepoint, the median DoR had yet to be reached after 18 months, with 21 patients (52.5%) without disease progression at 18 months. In most patients, responses occurred early in the treatment course. Specifically, in the 46 patients with high-risk CIS-containing NMIBC, 30 (65.2%; 95% CI, 49.7-78.2%) patients displayed a CR at any time subsequent to the administration of cretostimogene. Four out of 10 (40.0%) patients who did not achieve CR at three months, and who were subsequently re-dosed with cretostimogene at three months, demonstrated CR at six months.
In addition to the 65 patients enrolled per the trial protocol, the safety results above included three additional patients, two who were dosed with cretostimogene for compassionate, single-use patient INDs, and one more determined not to have baseline NMIBC retrospectively. Cretostimogene was generally well-tolerated, and most TRAEs were limited to Grade 1 to 2, only two Grade 3 TRAEs involving dysuria and hypotension (both of which were resolved), and no Grade 4 or 5 TRAEs. Furthermore, eight SAEs were reported but were determined not related to cretostimogene. Adverse events are generally classified as SAEs if they are fatal or life-threatening, result in inpatient hospitalization or prolongation of an existing hospitalization, or result in persistent or significant disability or incapacity, as well as other medically significant events that may jeopardize the patient or require medical or surgical intervention. Regardless of grade, a TRAE can be classified as an SAE if it meets the aforementioned criteria.
BOND-003 Trial Design
BOND-003 is a global, open-label, single-arm Phase 3 clinical trial designed to evaluate the safety and efficacy of cretostimogene as monotherapy in the treatment of patients that have received adequate BCG therapy with high-risk BCG-unresponsive, CIS-containing NMIBC and BCG-unresponsive Ta or T1 papillary tumors. The company designed this trial in light of the 2018 FDA guidance, and the revised draft guidance in August 2024, which defines BCG-unresponsive disease states and states that single-arm trials that assess CR rate as the primary endpoint, taking DoR into account, may be appropriate for full approval.
The initial induction course of therapy is six weekly doses of cretostimogene containing 1x10^12 VPs per milliliter. Patients who achieve a CR at month three receive maintenance treatments, involving three weekly cretostimogene doses administered at the same concentration every three months for the first 12 months and every six months for the next 24 months. Patients who do not achieve a CR after the first induction course may receive a second induction course of six weekly cretostimogene treatments at month 3, rather than the maintenance course involving three weekly treatments. The primary endpoint of the BOND-003 trial is CR at any time subsequent to induction. The company has completed enrollment for this trial and reported topline data in December 2024, which was updated in March 2025.
Enrollment of Additional Cohort in BOND-003 Trial
The company added a cohort of up to 75 patients to evaluate the safety and efficacy of cretostimogene as a monotherapy in the treatment of patients with high-risk BCG-unresponsive NMIBC, Ta or T1 without CIS that have received adequate BCG therapy. The primary endpoint of this cohort is overall event-free survival, with secondary endpoints including safety, high-grade recurrence-free survival (RFS), low-grade RFS, PFS, cystectomy-free survival, and bladder cancer-specific survival. The company expects to report topline data in the second half of 2025.
Topline Data from BOND-003 Cohort C Trial
Topline data from the Phase 3 BOND-003 Cohort C that was presented as a late-breaking abstract at the 2024 SUO Annual Meeting showed that cretostimogene, as a single agent, achieved a 74.5% complete response (CR) at any time in high-risk BCG-unresponsive NMIBC. As of the data cutoff of September 30, 2024, by Kaplan-Meier estimated, 63.5% and 56.6% of patients remained in response at 12 months or greater and at 24 months or greater, respectively, while the median DoR was not reached but exceeds 27 months. The study was updated in a late-breaking abstract at the 40th Annual EAU Congress, showing the CR rate at any time improved to 75.5%, with 63.7% and 58.7% of patients remaining in response at 12 months or greater and at 24 months or greater, respectively, while the median DoR was not reached but exceeds 28 months as of the data cutoff of January 20, 2025.
Interim Safety Data from BOND-003 Trial
Cretostimogene was generally well-tolerated in this trial as of the January 20, 2025, safety data cutoff, with mostly Grade 1 or Grade 2 adverse events reported and no Grade 3 or higher treatment-related adverse events (TRAEs) or deaths reported. The median time to TRAE resolution was one day. There were no treatment discontinuations due to TRAEs, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. Two patients (1.8%) had serious adverse events (SAEs), including Grade 2 noninfective cystitis, and Grade 2 clot retention, both of which resolved.
Translational Data from BOND-003 Trial
Translational data shared at the EAU Congress showed the level of cretostimogene peaked immediately after instillation, which was sustained locally for 4-5 days. Furthermore, intravesical delivery of cretostimogene reduces anti-drug antibody neutralization, thereby preserving therapeutic efficacy. There was no systemic exposure, with cretostimogene levels remaining below the limit of detection, providing evidence that post-cretostimogene treatment close contact precautions are not needed. This information supports the current dosing schedule.
Combination of Cretostimogene Plus Pembrolizumab for High-Risk BCG-unresponsive CIS-containing NMIBC
CORE-001 Trial Design
CORE-001 was a Phase 2 single-arm, open-label clinical trial of cretostimogene administered in up to 35 patients with high-risk BCG-unresponsive NMIBC that have CIS-containing tumors, in combination with pembrolizumab, following disease resection. Patients that demonstrate a CR after an initial six-week induction phase of weekly cretostimogene administrations, dosed at a concentration of 1x10^12 VP per milliliter, who also receive two, 400 mg doses of pembrolizumab over three months, are given a maintenance course of three weekly doses of cretostimogene at an equivalent VP concentration, along with two doses of pembrolizumab for three months. Trial participants that do not respond to an initial induction course are eligible to receive a second induction course of six weekly administrations over the following three-month period. During the following six months, patients are provided three weekly doses of cretostimogene every three months for six months, in addition to pembrolizumab every six weeks, with longer-term follow-up administration of three weekly doses every six months for 12 months, along with pembrolizumab every six weeks. The primary endpoint of the CORE-001 trial is CR at 12 months, with secondary endpoints including CR at any time, DoR, and PFS. The company entered into a clinical trial collaboration and supply agreement with Merck, providing at no-cost supply of pembrolizumab for use in CORE-001 (which agreement also provides for the joint ownership of clinical trial data but has no additional financial obligations and terminates upon conclusion of the trial).
The dosing schedule of intravesical cretostimogene in CORE-001 is similar to BOND-003, while pembrolizumab is administered pursuant to its approved dosing schedule.
Final Clinical Results in the Company’s Ongoing CORE-001 Trial
Final results from CORE-001 demonstrated that, as of the May 17, 2024, data cutoff, 29 of the 35 (82.9%; 95% CI, 70.4-95.3%) evaluable patients displayed a CR at any time subsequent to completion of induction therapy. Moreover, administration of cretostimogene had also resulted in durable responses, with 81.8% (n=27/33) of the evaluable patients maintaining a CR at six months and 68.0% (n=17/25) of evaluable patients maintaining a CR at 12 months, each as of the cutoff date.
Safety Data from the CORE-001 Trial
As of the May 17, 2024, data cutoff, 29 of the 35 (82.9%; 95% CI, 70.4-95.3%) patients achieved a CR at any time, with 57.1% (n=20/35, 95% CI, 39.5-73.2%) of patients maintaining a CR at 12 months, and 54.3% (n=19/35, 95% CI, 36.9-70.8%) of patients maintaining a CR at 24 months, indicating that 95.1% of patients in CR at 12 months remain in CR at 24 months. The safety profile was favorable, with no overlapping or synergistic toxicity observed. Adverse events attributed to cretostimogene were Grade 1 or Grade 2 and self-limited.
Additional, Ongoing Clinical Trials
Cretostimogene Monotherapy for Intermediate-Risk NMIBC Following TURBT
Phase 3 PIVOT-006 Clinical Trial
The company initiated PIVOT-006 in November 2023, which is a randomized Phase 3 trial intended to assess the safety and efficacy of adjuvant cretostimogene when administered as monotherapy to patients with intermediate-risk NMIBC (IR-NMIBC) following TURBT. This is a two-arm trial enrolling up to 364 patients with IR-NMIBC, one arm to be administered cretostimogene following the standard of care TURBT, with the second arm receiving the standard of care TURBT only. If IR-NMIBC recurrence is noted in the surveillance arm, patients will be eligible to receive intravesical cretostimogene. The initial induction course is six weekly doses of cretostimogene containing 1x10^12 VPs per milliliter. The company expects that patients who are recurrence-free at month three will receive a maintenance course involving three weekly cretostimogene doses administered at the same concentration, in months 3 and 6, followed by single weekly doses in months 9 and 12. The primary endpoint of this trial is overall RFS, with secondary endpoints, including RFS at 12 and 24 months, and PFS. RFS is based on time to last cystoscopic evaluation or time to disease relapse where relapse is defined as any grade bladder cancer recurrence. The first patient was dosed in February 2024. The company expects to complete enrollment for this trial in the first half of 2026.
Cretostimogene Monotherapy for High-Risk NMIBC
Phase 2 CORE-008 Clinical Trial
The study is an open-label multi-cohort Phase 2 trial intended to assess the safety and clinical outcomes of cretostimogene in treating patients with high-risk NMIBC, including BCG-exposed and BCG-naïve NMIBC. Each cohort is expected to enroll at least 60 patients. BCG-exposed patients are classified as those with NMIBC with persistent, recurrent, or progressive disease after BCG treatment but do not meet the specific disease classification criteria to be designated BCG-unresponsive. BCG-naïve patients are classified as those patients with NMIBC who have not received any prior BCG therapy. After an induction course of therapy of six weekly doses of cretostimogene containing 1x10^12 VPs per milliliter, the company expects that patients who achieve a CR will receive a maintenance course at the same concentration every three months until disease recurrence. The company expects that patients who do not achieve a CR after the initial induction course will receive a second induction course at the same concentration followed by the same maintenance course if they achieve a CR. The targeted efficacy endpoints of this trial are expected to include CR at any time following induction, CR at 12 months, DoR, and PFS. The company initiated Cohort A in BCG-naïve patients in the second half of 2024, with topline data expected in the second half of 2025. The company also initiated Cohort B in BCG-exposed patients in the first half of 2025. Topline data from Cohort B is expected to be available in 2026.
Completed Clinical Trial Evaluations in MIBC
MIBC is associated with significantly higher mortality than NMIBC, with the five-year mortality rate for patients with MIBC ranging from approximately 66% to 95% depending on disease stage. As such, the delay of disease progression is of particular significance to the estimated 20% to 25% of newly diagnosed bladder cancer patients with MIBC, as well as those patients with high-risk NMIBC that progresses to MIBC. Moreover, the annual cost of care for patients with MIBC is estimated to be approximately 2.5 times the annual cost of care for patients with NMIBC.
Systemic administration of cisplatin is often used as neoadjuvant chemotherapy in the treatment of MIBC. However, as many as 50% of patients are ineligible to receive cisplatin because of existing co-morbidities, such as decreased renal function or neuropathy, in which case CPIs are the default standard of care. The company evaluated the use of intravesical cretostimogene in combination with the CPI nivolumab as a treatment for MIBC, including by the company’s support of CORE-002, a single-arm exploratory investigator-sponsored clinical trial of 21 cisplatin-ineligible patients with no evidence of distant metastases prior to radical cystectomy. Intravesical cretostimogene induction therapy is accompanied by IV nivolumab dosed week 2 and week 6, followed by TURBT or cystectomy. The primary endpoint in this trial is safety; secondary endpoints include evaluations of pathological CR (pCR), RFS, and changes in inflammatory status of tumors after combination therapy.
Among the 21 evaluable patients, the combination of cretostimogene and nivolumab produced a pathologic complete response (pCR) in 42.1% (n=19/21; 95% CI, 20-64%). Cretostimogene was well-tolerated among trial participants. There were no dose-limiting toxicities or Grade 3 or higher treatment-related or immune-related adverse events. Additionally, 95% of participants completed all study treatments. There was no delay in time to radical cystectomy and no unexpected surgical complications from treatment. Importantly, investigators found that treatment response was not correlated with pre-treatment PD-L1 levels, and that the majority of PD-L1 negative patients had CRs. Additionally, the formation and maturation of tertiary lymphoid structures (TLS) in responders were observed, suggesting the mechanistic onset of anti-tumor humoral memory. TLS are special structures that form in areas of chronic inflammation and assist the immune system to fight cancer. These final clinical and translational results were published in Nature Medicine online in November 2024.
Commercialization
As the company prepares for potential FDA approval of cretostimogene for high-risk NMIBC patients unresponsive to BCG, it has established a seasoned executive leadership team and commercial leadership organization with a proven track record for successfully bringing urology and bladder cancer products to market. Additionally, the company continues to build its commercial capabilities and commercial infrastructure to ensure market development and commercial launch readiness.
License and Collaboration Agreements
Kissei Pharmaceutical Co., Ltd. License and Collaboration Agreement
In March 2020, and as amended in September 2022, the company entered into a license and collaboration agreement (the Kissei Agreement) with Kissei Pharmaceutical Co., Ltd. (Kissei), under which it granted to Kissei an exclusive license to certain intellectual property rights in Bangladesh, Bhutan, Brunei, Cambodia, India, Indonesia, Japan, South Korea, Laos, Malaysia, Myanmar, Nepal, Pakistan, Palau, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, and Vietnam (the Kissei Territory), for Kissei to develop and commercialize, but not manufacture, cretostimogene in combination with DDM (the Licensed Product) for all uses in oncology indications for which marketing approval is being sought.
Lepu Biotech Co., Ltd. Development and License Agreement
In March 2019, the company entered into a development and license agreement (the Lepu Agreement) with Lepu Biotech Co., Ltd. (Lepu), under which it granted an exclusive license to Lepu to develop, manufacture, and commercialize cretostimogene and/or DDM to treat and/or prevent cancer in mainland China, including Hong Kong and Macau (the Lepu Territory).
Intellectual Property
As of March 27, 2025, the company owned seven patent families comprising four issued U.S. patents, nine issued foreign patents in Australia, China, Europe (Unitary Patent), Japan, Singapore, Spain, and the United Kingdom, two pending U.S. non-provisional patent applications, three pending U.S. provisional patent applications, and twelve pending patent applications in jurisdictions outside of the United States.
With regard to cretostimogene, the company owns four issued U.S. patents and nine issued patents in Australia, China, Europe (Unitary Patent), Japan, Singapore, Spain, and the United Kingdom with claims covering methods of use using cretostimogene, including claims covering treatment schedules and combination therapy. These issued patents are expected to expire between 2036 and 2038, without accounting for potentially available patent term adjustments or extensions. The company also owns two pending U.S. applications and eleven related pending applications with claims covering methods of use using cretostimogene (including claims covering treatment schedules and combination therapy) in Australia, New Zealand, Japan, South Korea, China, Singapore, Hong Kong, and before the European Patent Office, and three pending U.S. provisional patent applications, and any patents that issue from these applications are expected to expire between 2036 and 2045, without accounting for potentially available patent term adjustments or extensions.
Research and Development
The company’s research and development expenses were $82.1 million for the year ended December 31, 2024.
History
The company was founded in 2010. The company was incorporated in 2010. The company was formerly known as Cold Genesys, Inc. and changed its name to CG Oncology, Inc. in 2020.
