Company Overview
CG Oncology, Inc. (CGON) is a late-stage clinical biopharmaceutical company that has emerged as a promising player in the battle against bladder cancer. With a relentless focus on developing and commercializing a potential backbone bladder-sparing therapeutic, the company has positioned itself at the forefront of innovative cancer treatments.
Founded in 2010, CG Oncology has steadily built a robust pipeline and established a strong foothold in the industry. The company has focused substantially all of its resources on organizing and staffing, business planning, raising capital, establishing and maintaining its intellectual property portfolio, conducting research, preclinical studies, and clinical trials, establishing arrangements with third parties for the manufacture of its lead product candidate cretostimogene, and providing general and administrative support. Through June 30, 2024, the company has received aggregate gross proceeds of approximately $747.5 million from the sale of its preferred stock and common stock in its initial public offering.
Financials
From inception through June 30, 2024, CG Oncology has recognized $25.6 million in research and collaboration revenue pursuant to its license and collaboration agreements. The company has not generated any revenue from the sale of products. To date, CG Oncology has primarily funded its operations with proceeds from the sale of its redeemable convertible preferred stock.
In the company's most recent financial report, CG Oncology reported a net loss of $35.84 million and a total revenue of $640,000 for the six-month period ended June 30, 2024. This financial performance reflects the company's continued investment in research and development (R&D) efforts, which accounted for $35.68 million of the total expenses during the same period.
For the fiscal year 2023, CG Oncology reported annual revenue of $204,000 and a net loss of $48.61 million. The company's annual operating cash flow and free cash flow for 2023 were both negative $45.68 million.
In the most recent quarter (Q2 2024), the company reported quarterly revenue of $43,000 and a net loss of $20.41 million. As this was the first quarter reported after the company's IPO, year-over-year growth comparisons are not available.
Liquidity
The company's cash, cash equivalents, and marketable securities stood at a robust $552.90 million as of June 30, 2024, providing ample resources to support its ongoing and future endeavors. The cash and cash equivalents component of this total was $25.16 million.
CG Oncology's financial position is further strengthened by its strong liquidity ratios. The company's current ratio and quick ratio are both 35.32, indicating a solid ability to meet short-term obligations. The debt-to-equity ratio is very low at 0.0006, suggesting minimal reliance on debt financing.
Based on its current operating plan, CG Oncology estimates that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its projected operating expenses and capital expenditure requirements through 2027. However, the company may need to raise additional capital through equity offerings, debt financings, or other sources in the future to support its operations and future growth.
Clinical Trials and Research
One of the key highlights of CG Oncology's journey has been the positive data from its Phase 3 BOND-003 trial, which evaluated cretostimogene as a monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. The trial demonstrated that 74.5% of patients achieved a complete response at any time, with a median duration of response exceeding 27 months as of the data cutoff in September 2024. These impressive results have not only bolstered the company's confidence in its lead candidate but have also garnered significant interest from the medical community.
In addition to the BOND-003 trial, CG Oncology has a robust pipeline of ongoing clinical studies evaluating cretostimogene in various bladder cancer indications. This includes the CORE-1 Phase 2 trial, which assessed the use of cretostimogene in combination with pembrolizumab, and the PIVOT-6 Phase 3 trial, which is evaluating the use of cretostimogene as an adjuvant therapy in intermediate-risk NMIBC patients following transurethral resection of the bladder tumor (TURBT).
The company has completed enrollment for the BOND-3 Phase 3 clinical trial, reported interim data in May 2024, and expects to report primary data by the end of 2024. If successful, CG Oncology believes this trial could serve as the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).
In June 2024, CG Oncology initiated an expanded access program (EAP) for cretostimogene in the U.S. for patients with NMIBC who are unresponsive to BCG and meet certain program eligibility criteria. The first patient has been dosed in the EAP and enrollment in the study is ongoing.
Strategic Collaborations
The company's strategic collaborations have also been a key driver of its growth. In 2019, CG Oncology entered into a development and license agreement with Lepu Biotech Co., Ltd., granting the latter an exclusive license to develop, manufacture, and commercialize cretostimogene and/or DDM in mainland China, Hong Kong, and Macau. The agreement has the potential to provide CG Oncology with significant milestone payments and royalties on net sales in the Lepu Territory.
Similarly, in 2020, the company entered into a license and collaboration agreement with Kissei Pharmaceutical Co., Ltd., granting the latter an exclusive license to develop and commercialize, but not manufacture, cretostimogene in combination with DDM in certain Asian countries. This partnership has the potential to generate additional revenue streams for CG Oncology through milestone payments and royalties.
Achievements and Challenges
The company's commitment to innovation and its relentless pursuit of a bladder-sparing therapy have been recognized by the industry. In 2024, CG Oncology completed a successful initial public offering (IPO), raising approximately $399.6 million in net proceeds to further support its research and development efforts.
However, CG Oncology's journey has not been without its challenges. In March 2024, the company was faced with a legal challenge from ANI Pharmaceuticals, Inc., which filed a complaint seeking a declaratory judgment that an assignment and technology transfer agreement between the two companies obligates CG Oncology to pay ANI a royalty on certain net sales of cretostimogene. The company has disputed the allegations and is vigorously defending the matter.
Future Outlook
Looking ahead, CG Oncology remains steadfast in its mission to transform the treatment landscape for patients with bladder cancer. The company's robust pipeline, strong financial position, and strategic collaborations position it well to navigate the complexities of the industry and continue its pioneering work in the development of a potential bladder-sparing therapy.
The company believes cretostimogene, if approved, has the potential to serve as first-line therapy, thereby alleviating the current need to prioritize treatment recipients and ration administration of BCG given its significant market shortage. This could potentially address a significant unmet need in the treatment of bladder cancer.
As CG Oncology continues to navigate the regulatory landscape and advance its clinical trials, investors and the medical community will closely follow the company's progress. The successful commercialization of cretostimogene, if approved, could not only solidify CG Oncology's position as a leader in the field but also provide a much-needed bladder-sparing treatment option for patients battling this devastating disease.