- Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
- First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk NMIBC (IR-NMIBC)
- Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC will be presented at ASCO 2024
- Completed Oversubscribed and Upsized
$437 Million Initial Public Offering that Extends Expected Runway Through 2027
- Completed Oversubscribed and Upsized
“2024 is a transformative year for
Corporate Highlights
- Completed Oversubscribed and Upsized Initial Public Offering that extends expected runway through 2027.
- Cretostimogene Monotherapy Demonstrated 75.2% CR Rate at Any Time in BCG-Unresponsive HR-NMIBC. On
May 3 rd at AUA in the paradigm-shifting, practice-changing clinical trials in urology session, the Company announced data from the BOND-003 Phase 3, single arm, open label, registrational study evaluating the efficacy and safety of cretostimogene monotherapy in patients with HR-NMIBC unresponsive to BCG, showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a CR at any time, as of the cutoff date ofApril 1, 2024 . - First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in IR-NMIBC. In February, the Company announced the first patient was dosed in PIVOT-006, a Phase 3, open-label, two-arm trial enrolling up to 364 IR-NMIBC patients, one arm to be administered cretostimogene following the standard of care TURBT with the second arm receiving the standard of care TURBT only. The primary endpoint of this trial is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival.
- Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.
Anticipated Next Milestones
- BOND-003 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 3 clinical trial of cretostimogene monotherapy by the end of 2024.
- CORE-001 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 2 clinical trial of crestostimogene in combination with pembrolizumab in
June 2024 at the 2024 ASCO Annual Meeting.
First Quarter 2024 Financial Highlights
- Cash Position: Cash and cash equivalents and marketable securities as of
March 31, 2024 , were$566.5 million , compared with$187.7 million as ofDecember 31 , 2023. Based on cash, cash equivalents and marketable securities, as ofMarch 31, 2024 , and current operating plans, the Company expects its cash runway to be sufficient to fund operations through 2027. - Research and Development (R&D) Expenses: R&D expenses for the first quarter ended
March 31, 2024 were$17.2 million compared with$7.8 million for the first quarter endedMarch 31, 2023 due to the progression of and increase in clinical trials expense supporting the development of cretostimogene in multiple indications. - General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended
March 31, 2024 were$5.8 million compared with$2.1 million for the first quarter endedMarch 31, 2023 . The increase in G&A is primarily attributed to an increase in headcount in the company’s general and administrative functions to support the business as a public company. - Net Loss: Net loss attributable to common stockholders was
$16.9 million , or ($0.36 ) per share, for the first quarter endedMarch 31, 2024 , compared to$12.4 million , or ($3.22 ) per share, for the first quarter endedMarch 31, 2023 .
About
Forward-Looking Statements
Contacts
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New Street IR
(619) 916-7620
IR@cgoncology.com
Media
(917) 291-5744
kimberly.ha@kkhadvisors.com
Source:
2024 GlobeNewswire, Inc., source