CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates

- Cretostimogene Monotherapy Demonstrated Sustained, Durable Complete Responses in High-Risk Bacillus Calmette Guérin $(BCG)$-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) -

- Initiated CORE-008 Clinical Trial of Cretostimogene Monotherapy in High-Risk BCG-Naïve (Cohort A) and BCG-Exposed (Cohort B) NMIBC -

- Late-Breaking Clinical and First Translational Data from BOND-003 Cohort C Presented at the 40th Annual European Association of Urology Congress -

- Completed Oversubscribed $238 Million Follow-on Public Equity Offering that Extends Expected Runway into the First Half of 2028 -

IRVINE, Calif., March 28, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. $(CGON)$, a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business updates.

"We made substantial progress in the fourth quarter of 2024, with our announcement at SUO of topline data from the Phase 3 BOND-003 Cohort C trial, as well as a successful follow-on equity offering to expand our clinical development programs and support our commercial readiness activities," said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. "Looking ahead, further readouts are expected from our BOND-003 trial and the anticipated initiation of our Biologics License Application $(BLA.AU)$ submission, as well as the announcement of topline data from CORE-008 Cohort A expected before year-end."

Corporate Highlights

   -- Cretostimogene Monotherapy Demonstrated 74.5% Complete Response Rate at 
      Any Time in High-Risk $(HR)$ BCG-Unresponsive NMIBC with carcinoma in situ 
      (CIS) with or without Ta/T1 disease. On December 5th at the Society of 
      Urologic Oncology (SUO) 25th Annual Meeting, the Company presented 
      groundbreaking data from Cohort C of the Phase 3 BOND-003 clinical trial 
      that showed 74.5% of patients (82 out of 110, 95% confidence interval 
      $(CI)$, 65.4-82.4%) with HR-NMIBC unresponsive to BCG achieved a complete 
      response $(CR)$ at any time, after receiving treatment with cretostimogene 
      as a single agent. The median duration of response (DoR) has not been 
      reached but exceeds 27 months as of the data cutoff of September 30, 
      2024. 
 
   -- Updated Clinical Results from BOND-003 Cohort C Raised CR Rate at Any 
      Time to 75.5%. On March 24th at the 40th Annual European Association of 
      Urology $(EAU.SI)$  Congress, the Company reported that 83 out of 110 patients 
      (75.5%) achieved a CR at any time, with 30 complete responders having 
      reached 24-month timepoint and beyond. The median DoR has not been 
      reached but exceeds 28 months as of the data cutoff of January 20, 2025. 

Also at the EAU Congress, new translational data 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.

   -- Initiated CORE-008 clinical trial of cretostimogene in HR NMIBC. In 
      October, the Company initiated CORE-008 Cohort A clinical trial of 
      cretostimogene in high-risk NMIBC which are naïve to BCG treatment, 
      including patients with CIS and with or without Ta/T1 disease and 
      patients with only Ta/T1 disease. In March 2025, this study was expanded 
      into the BCG-exposed population (Cohort B). 
 
   -- Published in Nature Medicine Phase 1b study results evaluating 
      cretostimogene in combination with nivolumab in muscle-invasive bladder 
      cancer. Encouraging data adds to the body of evidence supporting 
      potential use of cretostimogene as a backbone bladder-sparing therapeutic 
      for bladder cancer. 
 
   -- Completed oversubscribed follow-on public equity offering with full 
      exercise of underwriters' option. Raised $238 million gross proceeds to 
      CG Oncology that extends expected runway into the first half of 2028. 

Anticipated Milestones

   -- Initiation of BLA submission for cretostimogene monotherapy in HR 
      BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease anticipated 
      in the second half of 2025. 
 
   -- BOND-003 Cohort C (HR BCG-unresponsive NMIBC with CIS and with or without 
      Ta/T1 disease): Final data from the Phase 3 clinical trial of 
      cretostimogene monotherapy to be presented at the 120th American 
      Urological Association Annual Meeting. 
 
   -- BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without 
      CIS): Topline data from the Phase 3 clinical trial of cretostimogene 
      monotherapy anticipated in the second half of 2025. 
 
   -- CORE-008 Cohort A (HR BCG-naïve NMIBC): Topline data from the Phase 
      2 clinical trial of cretostimogene monotherapy anticipated in the second 
      half of 2025. 
 
   -- CORE-008 Cohort B (HR BCG-exposed NMIBC) and CX (HR BCG-exposed NMIBC): 
      Initiation anticipated in the first half of 2025. 

Fourth Quarter and Year End Financial Highlights

   -- Cash Position: Cash and cash equivalents and marketable securities as of 
      December 31, 2024, were $742.0 million, compared with $540.7 million as 
      of September 30, 2024. Based on current operating plans, the Company 
      expects its existing cash, cash equivalents and marketable securities 
      will be sufficient to fund operations into the first half of 2028. 
 
   -- Research and Development (R&D) Expenses: R&D expenses were $26.8 million 
      for the fourth quarter of 2024, as compared to $16.3 million for the 
      prior year period. The increase was primarily due to an increase in 
      clinical trial expenses, including CMC costs, an increase in compensation 
      costs due to increased headcount, and higher facilities and other related 
      costs. For the full year 2024, R&D expenses were $82.1 million, which 
      compares to $45.8 million for the full year 2023. 
 
   -- General and Administrative (G&A) Expenses: G&A expenses were $11.7 
      million for the fourth quarter of 2024, as compared to $3.0 million for 
      the prior year period. The increase was primarily attributed to an 
      increase in personnel-related expenses, including compensation costs from 
      increased headcount, an increase in professional and consultant fees 
      related to legal, accounting and consulting fees, and an increase in 
      insurance and marketing-related costs. For the full year 2024, G&A 
      expenses were $33.7 million, which compares to $9.9 million for the full 
      year 2023. 
 
   -- Net Loss: Net loss attributable to common stockholders was $31.8 million, 
      or ($0.46) per share, for the fourth quarter of 2024, as compared to 
      $22.5 million, or ($4.36) per share, for the prior year period. For the 
      full year 2024, net loss attributable to common stockholders was $88.0 
      million, or ($1.41) per share, as compared to $67.8 million, or ($15.65) 
      per share, for the full year 2023. 

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 250 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

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.

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, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; and the timing and likelihood of regulatory filings and approvals for cretostimogene. 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: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve

our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; 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; and other risks described in our filings with the Securities and Exchange Commission $(SEC.UK)$, 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 http://www.sec.gov). 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

VP, Communications and Patient Advocacy

$(508.SI)$ 654-2277

sarah.connors@cgoncology.com

Investor Relations

Chau Cheng

VP, Investor Relations

(949) 342-8939

chau.cheng@cgoncology.com

 
 
                         CG Oncology, Inc. 
 
                    Consolidated Balance Sheets 
         (In thousands, except share and per share amounts) 
 
 
                                                December 31, 
                                            --------------------- 
Assets                                        2024        2023 
                                            ---------   --------- 
Current assets: 
   Cash and cash equivalents                $ 257,068   $   8,266 
   Marketable securities                      484,930     179,408 
   Prepaid expenses and other current 
    assets                                     11,431       6,358 
   Accounts receivable - other                    781          92 
                                             --------    -------- 
     Total current assets                     754,210     194,124 
Property and equipment, net                       272          69 
Operating lease right-of-use assets               221         422 
Other assets                                       94          19 
Deferred offering costs                            --       4,667 
     Total assets                           $ 754,797   $ 199,301 
                                             ========    ======== 
Liabilities, Convertible Preferred Stock 
and Stockholders' Equity (Deficit) 
Current liabilities: 
   Accounts payable                         $   6,517   $   3,242 
   Success fee liability, current portion          --         352 
   Operating lease liabilities, current 
    portion                                       186         217 
   Accrued expenses and other current 
    liabilities                                14,665      10,443 
     Total current liabilities                 21,368      14,254 
                                             --------    -------- 
Success fee liability, non-current                 --          13 
Operating lease liabilities, net of 
 current portion                                   52         244 
     Total liabilities                         21,420      14,511 
                                             --------    -------- 
Commitments and contingencies (Note 5) 
Redeemable convertible preferred stock: 
   Redeemable convertible preferred stock, 
    $0.0001 par value per share; zero and 
    337,928,674 shares authorized, issued 
    and outstanding as of December 31, 
    2024 and December 31, 2023, 
    respectively; liquidation value of $0 
    and $307.890 as of December 31, 2024 
    and December 31, 2023, respectively             -     307,890 
Stockholders' equity (deficit): 
   Common stock, $0.0001 par value per 
   share; 700,000,000 and 493,530,000 
   shares authorized as of December 31, 
   2024 and December 31, 2023, 
   respectively; 76,154,783 and 5,222,283 
   shares issued and outstanding as of 
   December 31, 2024 and December 31, 
   2023, respectively                               8          -- 
   Additional paid-in capital                 951,350       6,842 
   Accumulated deficit                       (217,981)   (129,942) 
                                             --------    -------- 
   Total stockholders' equity (deficit)       733,377    (123,100) 
                                             --------    -------- 
     Total liabilities, redeemable 
      convertible preferred stock and 
      stockholders' equity (deficit)        $ 754,797   $ 199,301 
                                             ========    ======== 
 
 
                          CG Oncology, Inc. 
 
       Consolidated Statements of Operations and Comprehensive 
                                 Loss 
          (In thousands, except share and per share amounts) 
 
 
                                          Year Ended December 31, 
                                        --------------------------- 
                                             2024           2023 
                                        --------------   ---------- 
Revenues 
   License and collaboration revenue     $       1,139   $      204 
Operating expenses 
   Research and development                     82,102       45,752 
   General and administrative                   33,703        9,901 
     Total operating expenses                  115,805       55,653 
                                            ----------    --------- 
Loss from operations                          (114,666)     (55,449) 
Other income (expense), net: 
   Interest income, net                         26,624        6,904 
   Other income (expense), net                       3          (62) 
                                            ----------    --------- 
     Total other income, net                    26,627        6,842 
                                            ----------    --------- 
Net loss and comprehensive loss          $     (88,039)  $  (48,607) 
                                            ==========    ========= 
   Deemed dividend on redeemable 
    convertible preferred stock 
    issuances                                       --         (410) 
   Cumulative redeemable convertible 
    preferred stock dividends                       --      (18,781) 
                                            ----------    --------- 
Net loss attributable to common 
 stockholders                            $     (88,039)  $  (67,798) 
                                            ==========    ========= 
Net loss per share, basic and diluted    $       (1.41)  $   (15.65) 
                                            ==========    ========= 
Weighted average shares of common 
 stock outstanding, basic and diluted       62,496,725    4,330,933 
                                            ==========    ========= 
 

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March 28, 2025 07:00 ET (11:00 GMT)