CG Oncology, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
CGON$75.99+17.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0000950170-24-124642
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0000950170-25-069831
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 117 previous paragraphs and 118 current paragraphs.
78 unchanged; 26 reworded; 14 added; 10 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
In anticipation of potential FDA approval, we are actively building our commercial operations, marketing, market access and patient access and field force capabilities. This includes pre-launch activities currently being executed, including scientific communication activities and engagements by our field medical organization. We are also implementing strategic initiatives to build seamless product distribution and patient support. Our efforts are focused on ensuring that we are fully prepared to launch and deliver cretostimogene to patients and healthcare providers, if approved. We are evaluating the safety and efficacy of cretostimogene as a monotherapy in BOND-003 Cohort C, our ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC with carcinomain situ(CIS) and with or without Ta/T1 disease. We have completed enrollment for this cohort and reported interim data at the American Urological Association’s (AUA) 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 March 2025, and at the 2025 AUA Annual Meeting in April 2025. We believe that this trial could serve as the basis for a BLA submission to the U.S. FDA, which we expect to initiate in the second half of 2025. Cretostimogene has received both Fast Track and Breakthrough Therapy designations from the FDA for the treatment of High-Risk BCG-unresponsive NMIBC with CIS with or without Ta or T1 tumors.
Current report
In April 2024, we initiated BOND-003 Cohort P, an exploratory study evaluating cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with only Ta/T1 disease. Initial data from this Cohort was reported at the 2025 AUA Annual Meeting, with updated data expected in the second half of 2025. In October 2024, we initiated CORE-008 Cohort A, our 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 and patients with only Ta/T1 disease. In March 2025, we expanded CORE-008 into the high-risk BCG-exposed population (Cohort B). In addition, in April 2025, we initiated a third Cohort (Cohort CX), evaluating cretostimogene in combination with gemcitabine in the high-risk BCG-exposed population. We have completed and published the results for CORE-001, our Phase 2 clinical trial of cretostimogene in combination with pembrolizumab in high-risk BCG-unresponsive NMIBC patients that have CIS. Additionally, in NMIBC that is not categorized as high-risk, we have launched our second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT). We believe cretostimogene, if approved in intermediate-risk NMIBC, has the potential to serve as backbone therapy, thereby alleviating the current need to prioritize treatment recipients and ration administration of BCG given its significant market shortage.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income (Expense), Net
Current report
Other Income (Expense)
Current report
License and Collaboration Revenue
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income (Expense), Net
Current report
At-the-Market Offering
Current report
On March 28, 2025, we entered into an Open Market Sale Agreement SM (Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, up to $250 million of shares of our common stock. On the same day, we filed a shelf registration statement on Form S-3ASR with the SEC, which contains a base prospectus, covering an unlimited amount of our common stock, preferred stock, debt securities and warrants to purchase any of such securities, and a sales agreement prospectus, covering the offering, issuance and sale of up to a maximum aggregate offering price of $250 million of our common stock that may be issued and sold from time to time under the Jefferies Sales Agreement. As of the filing of this Quarterly Report, no sales have been made under the shelf registration statement or the Jefferies Sales Agreement.
Current report
During the three months ended March 31, 2025, net cash provided by financing activities was $0.5 million, consisting primarily of proceeds from exercise of options of $0.7 million, partially offset by deferred offering costs of $0.2 million.
Removed paragraphs (10)
Previous report
In January 2024, we completed our initial public offering of 23,000,000 common shares at a price of $19.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 3,000,000 shares of common stock. We received net proceeds of $399.6 million, after deducting discounts and commissions and offering expenses. In addition, as a result of our initial public offering, our redeemable convertible preferred stock converted into common stock concurrently with the initial public offering.
Previous report
Other (Expense) Income
Previous report
Research and Collaboration Revenue
Previous report
Research and collaboration revenue was less than $0.1 million for the three months ended September 30, 2024 and 2023. We recorded $43.0 thousand in revenue related to the Kissei License Agreement for the three months ended September 30, 2024, as compared to $9.0 thousand in revenue related to the Lepu License Agreement during the prior year period.
Previous report
R&D expenses were $19.6 million for the three months ended September 30, 2024 compared to $11.7 million for the three months ended September 30, 2023. The increase of $7.9 million in R&D expenses for the three months ended September 30, 2024 was primarily due to an increase of $5.6 million in external clinical trial expenses, including an increase of $1.9 million of chemistry, manufacturing and control (CMC) costs, and an increase of $2.1 million in compensation costs due to increased headcount.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Research and Collaboration Revenue
Previous report
The following table summarizes our R&D expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous report
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous report
During the nine months ended September 30, 2023, net cash used in financing activities was $89.9 million, consisting of net proceeds from the issuance of Series F redeemable convertible preferred stock of $104.6 million and the exercise of common stock options of $1.8 million, partially offset by payments of long-term debt of $16.3 million.
Reworded paragraphs (26)
Previous wording
The following discussion and analysis and the unaudited interim financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2023 (the 2023 Annual Report).
Current wording
The following discussion and analysis and the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2024 (the 2024 Annual Report).
Previous wording
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” or “will” or the negative of these terms or other similar expressions. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial and other trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties, and assumptions, including, without limitation, the risk factors described in Part II, Item 1A, “Risk Factors” of this Quarterly Report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. 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.
Current wording
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” or “will” or the negative of these terms or other similar expressions. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial and other trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties, and assumptions, including, without limitation, the risk factors described in Part I, Item 1A, “Risk Factors” of the 2024 Annual Report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. 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.
Previous wording
We are a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. Our product candidate, cretostimogene, is in clinical development for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care for high-risk NMIBC. There is significant unmet need for treatments in these patients given the limitations of currently approved therapies and patient reluctance to undergo radical cystectomy, or the complete removal of the bladder. We are evaluating the safety and efficacy of cretostimogene as monotherapy in BOND-003 Cohort C, our ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC patients with CIS and with or without high-grade Ta/T1 papillary disease. We have completed enrollment for this trial and reported interim data in May 2024. In September 2024, we submitted a late-breaking abstract reporting data from BOND-003 to the Society of Urologic Oncology that was accepted for an oral presentation at its Annual Scientific Meeting in Urologic Oncology scheduled for December 2024. If successful, we believe that this trial could serve as the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). In April 2024, we initiated BOND-003 Cohort P evaluating cretostimogene in high-risk BCG-unresponsive NMIBC patients with high-grade Ta/T1 papillary disease. The first patient has been dosed in BOND-003 Cohort P. In addition, in our CORE-001 Phase 2 clinical trial, we evaluated the use of cretostimogene when administered to the BOND-003 Cohort C population in combination with FDA-approved pembrolizumab, and reported positive final results from the CORE-001 trial in May 2024. Moreover, we intend to assess the safety and efficacy of cretostimogene in treating a range of other bladder cancer indications as an alternative to BCG therapy and in patients who are not categorized as high-risk BCG-unresponsive, including our second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in up to 364 intermediate-risk NMIBC patients following transurethral resection of the bladder tumor (TURBT). In June 2024, we 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. We believe 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.
Current wording
We are a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. Our goal is to develop cretostimogene grenadenorepvec (cretostimogene), our 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. Given the limitations of currently approved therapies, the next course of treatment for these BCG-unresponsive patients is radical cystectomy, or the complete removal of the bladder, which is associated with significant social, functional and emotional burden. As such, there is a significant unmet need for effective treatments in these patients.
Previous wording
We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $56.2 million and $32.1 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $186.2 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and, to a lesser extent, from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses in the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize cretostimogene and potentially seek to discover and develop additional product candidates, utilize third parties to manufacture cretostimogene, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. If we obtain regulatory approval for cretostimogene, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we do not become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce or terminate our operations.
Current wording
We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $34.5 million and $16.9 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $252.4 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and, to a lesser extent, from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses in the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize cretostimogene and potentially seek to discover and develop additional product candidates, utilize third parties to manufacture cretostimogene, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. If we obtain regulatory approval for cretostimogene, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we do not become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce or terminate our operations.
Previous wording
To date, we have primarily funded our operations with proceeds from the sale of common shares from our IPO, our redeemable convertible preferred stock and previously outstanding term debt. From inception through September 30, 2024, we have received aggregate gross proceeds of approximately $749.8 million from the sale of common shares from our IPO and sales of redeemable convertible preferred stock. In addition, from inception through September 30, 2024, we have recognized $25.7 million in research and collaboration revenue pursuant to our license and collaboration agreements. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $540.7 million. Our ability to generate any product revenue and, in particular, our ability to generate product revenue sufficient to achieve profitability, will depend on the successful development and eventual commercialization of cretostimogene and any future product candidates.
Current wording
To date, we have primarily funded our operations with proceeds from the sale of shares of our common stock through public offerings and our redeemable convertible preferred stock, as well as through previously outstanding term debt. From inception through March 31, 2025, we have received aggregate gross proceeds of approximately $982.9 million from the sale of shares of our common stock from our IPO, a follow-on offering in December 2024, and sales of redeemable convertible preferred stock. In addition, from inception through March 31, 2025, we have recognized $26.2 million in license and collaboration revenue pursuant to our license and collaboration agreements. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $688.4 million. Our ability to generate any product revenue and, in particular, our ability to generate product revenue sufficient to achieve profitability, will depend on the successful development and eventual commercialization of cretostimogene and any future product candidates.
Previous wording
Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, will be sufficient to fund our projected operating expenses and capital expenditure requirements through 2027. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Current wording
Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operations into the first half of 2028. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Previous wording
In March 2019, we entered into a development and license agreement (the Lepu License Agreement) with Lepu, under which we granted an exclusive license to Lepu to develop, manufacture and commercialize cretostimogene and/or DDM to treat and/or prevent cancer in the Lepu Territory. Lepu paid to us a one-time upfront payment of $4.5 million and is obligated to make regulatory milestone payments of up to $2.5 million and commercial milestone payments of up to $57.5 million. We are entitled to receive a high single-digit royalty on net sales of cretostimogene and/or DDM sold in the Lepu Territory, subject to a specified reduction. During the three months ended September 30, 2024 and 2023, zero and less than $0.1 million in research and collaboration revenue was recorded related to the Lepu License Agreement. During the nine months ended September 30, 2024 and 2023, $0.5 million and less than $0.1 million in research and collaboration revenue was recorded related to the Lepu License Agreement, respectively.
Current wording
In March 2019, we entered into a development and license agreement (the Lepu License Agreement) with Lepu, under which we granted an exclusive license to Lepu to develop, manufacture and commercialize cretostimogene and/or DDM to treat and/or prevent cancer in the Lepu Territory. Lepu paid to us a one-time upfront payment of $4.5 million and is obligated to make regulatory milestone payments of up to $2.5 million and commercial milestone payments of up to $57.5 million. We are entitled to receive a high single-digit royalty on net sales of cretostimogene and/or DDM sold in the Lepu Territory, subject to a specified reduction. During the three months ended March 31, 2025 and 2024, zero and $0.5 million in license and collaboration revenue was recorded related to the Lepu License Agreement, respectively.
Previous wording
In March 2020, and as amended September 2022, we entered into a license and collaboration agreement (the Kissei License Agreement) with Kissei, under which we 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. Kissei paid to us a one-time upfront payment of $10.0 million under the agreement. Kissei is obligated to pay development milestone payments of up to $33.0 million and commercial milestone payments of up to $67.0 million. We have also agreed to pay Kissei a royalty on net sales of Licensed Product outside the Kissei Territory and outside the Lepu Territory, including on any U.S. sales, in a low-single digit percentage, subject to certain capped reductions. We are entitled to receive a royalty on net sales of Licensed Product in the Kissei Territory in the mid-twenties percentage, subject to certain capped reductions and offset rights. We are obligated to supply and Kissei will exclusively purchase its clinical and commercial requirements of Licensed Product from us. During the three months ended September 30, 2024, all research and collaboration revenue recorded was related to the Kissei License Agreement, with no research and collaboration revenue related to the Kissei License Agreement recorded during the three months ended September 30, 2023. During the nine months ended September 30, 2024 and 2023, $0.2 million and $0.2 million in research and collaboration revenue was recorded related to the Kissei License Agreement, respectively.
Current wording
In March 2020, and as amended September 2022, we entered into a license and collaboration agreement (the Kissei License Agreement) with Kissei, under which we 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. Kissei paid to us a one-time upfront payment of $10.0 million under the agreement. Kissei is obligated to pay development milestone payments of up to $33.0 million and commercial milestone payments of up to $67.0 million. We have also agreed to pay Kissei a royalty on net sales of Licensed Product outside the Kissei Territory and outside the Lepu Territory, including on any U.S. sales, in a low-single digit percentage, subject to certain capped reductions. We are entitled to receive a royalty on net sales of Licensed Product in the Kissei Territory in the mid-twenties percentage, subject to certain capped reductions and offset rights. We are obligated to supply and Kissei will exclusively purchase its clinical and commercial requirements of Licensed Product from us. During the three months ended March 31, 2025, all license and collaboration revenue recorded was related to the Kissei License Agreement, with no license and collaboration revenue related to the Kissei License Agreement recorded during the three months ended March 31, 2024.
Previous wording
From inception through September 30, 2024, we have recognized $25.7 million in research and collaboration revenue through our license and collaboration agreements. We have not generated any revenue from the sale of products, however, and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all. If our or our collaborators’ development efforts for cretostimogene and any future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales, payments from existing or potential future collaboration or license agreements with third parties, or any combination thereof.
Current wording
From inception through March 31, 2025, we have recognized $26.2 million in license and collaboration revenue through our license and collaboration agreements. We have not generated any revenue from the sale of products, however, and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all. If our or our collaborators’ development efforts for cretostimogene and any future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales, payments from existing or potential future collaboration or license agreements with third parties, or any combination thereof.
Previous wording
Other (expense) income consists of miscellaneous items, such as success fees and final payment amortization and other items not related to our core operations.
Current wording
Other income (expense) consists of miscellaneous items, such as success fees and final payment amortization and other items not related to our core operations.
Previous wording
Research and collaboration revenue was $0.7 million for the nine months ended September 30, 2024 compared to $0.2 million for the nine months ended September 30, 2023. We recorded $0.5 million and less than $0.1 million in revenue for the nine months ended September 30, 2024 and 2023, respectively, related to the Lepu License Agreement, and we recorded $0.2 million and $0.2 million in revenue related to the Kissei License Agreement for the nine months ended September 30, 2024 and 2023, respectively.
Current wording
License and collaboration revenue was $0.1 million for the three months ended March 31, 2025 compared to $0.5 million for the three months ended March 31, 2024. We recorded zero and $0.5 million in revenue for the three months ended March 31, 2025 and 2024, respectively, related to the Lepu License Agreement, and $0.1 million and zero in revenue related to the Kissei License Agreement for the three months ended March 31, 2025 and 2024, respectively.
Previous wording
R&D expenses were $55.3 million for the nine months ended September 30, 2024 compared to $29.4 million for the nine months ended September 30, 2023. The increase of $25.9 million in R&D expenses for the nine months ended September 30, 2024 was primarily due to an increase of $19.8 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, including an $9.9 million increase in CMC costs, as well as an increase of $4.9 million in compensation costs due to increased headcount, including a $1.8 million increase in stock-based compensation.
Current wording
R&D expenses were $27.5 million for the three months ended March 31, 2025 compared to $17.2 million for the three months ended March 31, 2024. The increase of $10.3 million in R&D expenses for the three months ended March 31, 2025 was primarily due to an increase of $5.6 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, as well as an increase of $3.6 million in compensation costs due to increased headcount, including a $1.1 million increase in stock-based compensation, and an increase in other fees and costs of $1.1 million.
Previous wording
General and administrative expenses were $22.0 million for the nine months ended September 30, 2024 compared to $6.9 million for the nine months ended September 30, 2023. The increase of $15.1 million in general and administrative expenses for the nine months ended September 30, 2024 was primarily due to an increase in compensation costs of $9.0 million due to increased headcount, including a $3.9 million increase in stock-based compensation, as well as increased professional and consultant fees of $2.9 million related to legal, accounting and consulting fees, an increase in marketing-related costs of $1.2 million, and an increase in insurance costs of $1.0 million.
Current wording
General and administrative expenses were $14.8 million for the three months ended March 31, 2025 compared to $5.8 million for the three months ended March 31, 2024. The increase of $9.0 million in general and administrative expenses for the three months ended March 31, 2025 was primarily due to an increase in compensation costs of $5.3 million due to increased headcount, including a $2.5 million increase in stock-based compensation, as well as increased professional and consultant fees of $1.4 million related to legal, accounting and consulting fees, an increase in marketing-related costs of $1.1 million, and an increase in insurance, fees, and other costs of $1.2 million.
Previous wording
Other income (expense), net, for the three months ended September 30, 2024 was an other income, net of $7.9 million compared to an other income, net of $2.3 million for the three months ended September 30, 2023 and primarily consisted interest income related to marketable securities balances in each period.
Current wording
Other income (expense), net, for the three months ended March 31, 2025 was an other income, net of $7.8 million compared to an other income, net of $5.5 million for the three months ended March 31, 2024. For the three months ended March 31, 2025 and 2024, other income (expense), net primarily consisted of $7.7 million and $5.5 million, respectively, in interest income related to marketable securities balances.
Previous wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses in the foreseeable future as we advance the clinical development of cretostimogene and any future product candidates. To date, we have primarily funded our operations with proceeds from the sale of shares of our common stock in our initial public offering, the sale of shares of our redeemable convertible preferred stock and previously outstanding term debt. Through September 30, 2024, we have received aggregate gross proceeds of $749.8 million from the sale of common stock in our IPO and sale of redeemable convertible preferred stock. In addition, through September 30, 2024, we have recognized $25.7 million in research and collaboration revenue through our license and collaboration agreements. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $540.7 million. On January 29, 2024, we closed our initial public offering of common stock for aggregate net proceeds of $399.6 million, after deducting discounts and commissions and offering expenses.
Current wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses in the foreseeable future as we advance the clinical development of cretostimogene and any future product candidates. To date, we have primarily funded our operations with proceeds from the sale of shares of our common stock through public offerings and our redeemable convertible preferred stock, as well as through previously outstanding term debt. Through March 31, 2025, we have received aggregate gross proceeds of $982.9 million from the sale of shares of our common stock through our public offerings and our redeemable convertible preferred stock. In addition, through March 31, 2025, we have recognized $26.2 million in license and collaboration revenue through our license and collaboration agreements. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $688.4 million. On January 29, 2024, we closed our initial public offering of common stock for aggregate net proceeds of $399.6 million, after deducting discounts and commissions and other offering expenses. In December 2024, we closed a follow-on public offering of common stock for aggregated net proceeds of $223.1 million, after deducting discounts and commissions and other offering expenses.
Previous wording
Based upon our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, will be sufficient to fund our projected operating expenses and capital expenditure requirements through 2027. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Current wording
Based upon our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operations into the first half of 2028. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Previous wording
During the three and nine months ended September 30, 2024, there have been no material changes outside of the ordinary course of business in the composition to the material contractual obligations or commitments discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Material Cash Requirements for Known Contractual and Other Obligations” included in the 2023 Annual Report.
Current wording
During the three months ended March 31, 2025, there have been no material changes outside of the ordinary course of business in the composition to the material contractual obligations or commitments discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Material Cash Requirements for Known Contractual and Other Obligations” included in the 2024 Annual Report.
Previous wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
Current wording
The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
Previous wording
During the nine months ended September 30, 2023, operating activities used $31.0 million of cash, primarily resulting from our net loss of $32.1 million and accretion of the discount on short-term investments of $1.4 million, partially offset by $1.5 million of non-cash charges, which includes stock-based compensation expense and amortization associated with the term loan final payoff and success fees, and net cash used in changes in our operating assets and liabilities of $0.9 million.
Current wording
During the three months ended March 31, 2025, operating activities used $29.3 million of cash, primarily resulting from our net loss of $34.5 million, as well as accretion of the discount on short-term investments of $0.3 million, partially offset by non-cash stock-based compensation charges of $5.2 million and net cash provided by changes in our operating assets and liabilities of $0.5 million.
Previous wording
During the nine months ended September 30, 2024, operating activities used $58.1 million of cash, primarily resulting from our net loss of $56.2 million, as well as accretion of the discount on short-term investments of $6.2 million and net cash used in changes in our operating assets and liabilities of $2.0 million, partially offset by non-cash stock-based compensation charges of $6.4 million.
Current wording
During the three months ended March 31, 2024, operating activities used $26.0 million of cash, primarily resulting from our net loss of $16.9 million, accretion of the discount on short-term investments of $2.2 million, and net cash used in changes in our operating assets and liabilities of $8.4 million, partially offset by $1.5 million of non-cash stock-based compensation charges.
Previous wording
During the nine months ended September 30, 2023, net cash used in investing activities was $136.7 million, primarily due to purchases of marketable securities offset by proceeds from sales and maturities of short-term investments.
Current wording
During the three months ended March 31, 2025, net cash used in investing activities was $186.8 million, primarily due to purchases of marketable securities offset by proceeds from sales and maturities of short-term investments and the issuance of a note receivable through a convertible promissory note in the principal amount of $25.0 million to provide SP Healthcare SPV I, LLC with proceeds to make an investment in Biovire, Inc. for the purpose of Biovire’s acquisition of substantially all of the assets of a contract manufacturing organization that provides clinical supply of cretostimogene to us.
Previous wording
During the nine months ended September 30, 2024, net cash used in investing activities was $311.7 million, primarily due to purchases of marketable securities offset by proceeds from sales and maturities of short-term investments.
Current wording
During the three months ended March 31, 2024, net cash used in investing activities was $307.4 million, primarily due to purchases of marketable securities offset by proceeds from sales and maturities of short-term investments.
Previous wording
During the nine months ended September 30, 2024, net cash provided by financing activities was $404.9 million, consisting primarily of net proceeds from the initial public offering, net of issuance costs and deferred offering costs of $403.0 million, partially offset by the long-term debt success fee payoff of $0.4 million.
Current wording
During the three months ended March 31, 2024, net cash provided by financing activities was $402.7 million, consisting primarily of net proceeds from the initial public offering, net of issuance costs and deferred offering costs of $403.0 million, partially offset by the long-term debt success fee payoff of $0.4 million.
Previous wording
Our condensed financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed financial statements. We base our estimates on historical experience, known trends and events, and various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Current wording
Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Previous wording
As part of the process of preparing our condensed financial statements, we are required to estimate our R&D expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our R&D expenses as of each balance sheet date based on facts and circumstances known to us at that time. The significant estimates in our R&D expenses include the costs incurred for services performed by our vendors in connection with services for which we have not yet been invoiced. We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct R&D on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows.
Current wording
As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our R&D expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our R&D expenses as of each balance sheet date based on facts and circumstances known to us at that time. The significant estimates in our R&D expenses include the costs incurred for services performed by our vendors in connection with services for which we have not yet been invoiced. We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct R&D on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows.
Previous wording
A description of recently issued accounting standards that may potentially impact our financial position, results of operations and cash flows is included in Note 2 to our condensed financial statements included elsewhere in this Quarterly Report.
Current wording
A description of recently issued accounting standards that may potentially impact our financial position, results of operations and cash flows is included in Note 2 to our condensed consolidated financial statements included elsewhere in this Quarterly Report.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
General and administrative expenses were $8.7 million for the three months ended September 30, 2024 compared to $2.3 million for the three months ended September 30, 2023. The increase of $6.4 million in general and administrative expenses for the three months ended September 30, 2024 was primarily due to an increase in personnel-related expenses, including an increase in compensation costs of $4.0 million due to increased headcount, an increase in professional and consultant fees of $1.4 million related to legal, accounting and consulting fees, and an increase in insurance and marketing-related costs of $0.7 million.
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous report — wording carried elsewhere
Other income (expense), net, for the nine months ended September 30, 2024 was an other income, net of $20.4 million compared to an other income, net of $4.0 million for the nine months ended September 30, 2023. For the nine months ended September 30, 2024, other income (expense), net primarily consisted of $20.4 million in interest income related to marketable securities balances, and for the nine months ended September 30, 2023, other income (expense), net primarily consisted of interest income of $4.1 million related to marketable securities balances.