CG Oncology, Inc.

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 I, Item 1A, “Risk Factors” of the 2024 Annual Report, as supplemented 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, as supplemented in Part II, Item 1A, “Risk Factors” of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. 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

In anticipation of potential U.S. Food and Drug Administration (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 fourth quarter 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 wording

In anticipation of potential U.S. Food and Drug Administration (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. In September 2025, we reported topline data from Cohort C of the BOND-003 Phase 3 clinical trial. These updated data showed 12 additional patients with NMIBC were in complete response (CR) at 24 months. The 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that we announced at the 2025 AUA Annual Meeting in April 2025. The study reported 75.5% CR at any time and 41.8% at 24 months with 46 confirmed CRs as of the cutoff date of June 23, 2025. The estimated 12- and 24-month duration of response (DOR) rates are 64.1% and 58.3%, respectively. Median DOR is 28 months and is ongoing.

Previous wording

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 fourth quarter 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 wording

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 fourth quarter 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), with enrollment completed in the third quarter of 2025. 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.

Previous wording

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $75.9 million and $35.8 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $293.9 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 $119.7 million and $56.2 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $337.7 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 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 June 30, 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 June 30, 2025, we have recognized $26.2 million in license and collaboration revenue pursuant to our license and collaboration agreements. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $661.1 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 September 30, 2025, we have received aggregate gross proceeds of approximately $1,032.9 million from the sale of shares of our common stock from our IPO, our follow-on offering in December 2024, and our at-the-market facility, and sales of redeemable convertible preferred stock. In addition, from inception through September 30, 2025, we have recognized $26.3 million in license and collaboration revenue pursuant to our license and collaboration agreements. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $680.3 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

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for cretostimogene or any future product candidates, which we expect will take a number of years and may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements or arrangements as, and when needed, we may delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

Current wording

We will not generate revenue from product sales of cretostimogene or any future product candidates unless and until we successfully complete clinical development and obtain regulatory approval, which we expect will take a number of years and may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements or arrangements as, and when needed, we may delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

Previous wording

In March 2019, we entered into a development and license agreement (the Lepu License Agreement) with Lepu Biotech Co., Ltd. (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 and six months ended June 30, 2025, the Company did not recognize any license and collaboration revenue related to the Lepu License Agreement. During the three and six months ended June 30, 2024, the Company recognized zero and $0.5 million, respectively, in license and collaboration revenue related to the Lepu License Agreement.

Current wording

In March 2019, we entered into a development and license agreement (the Lepu License Agreement) with Lepu Biotech Co., Ltd. (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 and nine months ended September 30, 2025, the Company did not recognize any license and collaboration revenue related to the Lepu License Agreement. During the three and nine months ended September 30, 2024, the Company recognized zero and $0.5 million, respectively, in license and collaboration revenue related to the Lepu License Agreement.

Previous wording

In March 2020, and as amended September 2022, we entered into a license and collaboration agreement (the Kissei License Agreement) with Kissei Pharmaceutical Co., Ltd. (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 and six months ended June 30, 2025, zero and less than $0.1 million in license and collaboration revenue was recorded related to the Kissei License Agreement, respectively. During the three and six months ended June 30, 2024, $0.1 million in license and collaboration revenue was recorded related to the Kissei License Agreement.

Current wording

In March 2020, and as amended September 2022, we entered into a license and collaboration agreement (the Kissei License Agreement) with Kissei Pharmaceutical Co., Ltd. (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 and nine months ended September 30, 2025, $0.2 million in license and collaboration revenue was recorded related to the Kissei License Agreement, respectively. During the three and nine months ended September 30, 2024, less than $0.1 million and $0.2 million in license and collaboration revenue was recorded related to the Kissei License Agreement, respectively.

Previous wording

From inception through June 30, 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.

Current wording

From inception through September 30, 2025, we have recognized $26.3 million in license and collaboration revenue through our license and collaboration agreements. We have not generated any revenue from the sale of our cretostimogene products, however, and do not expect to generate any revenue from the sale of our cretostimogene 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

Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.

Current wording

Our operating costs and expenses consist of (i) cost of sales, (ii) research and development expenses and (ii) general and administrative expenses.

Previous 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.

Current wording

Other income (expense) consists of miscellaneous items, such as success fees and final payment amortization, interest expense, and other items not related to our core operations.

Previous wording

License and collaboration revenue was zero for the three months ended June 30, 2025 compared to $0.1 million for the three months ended June 30, 2024. All revenue recognized during the three months ended June 30, 2024 was related to the Kissei License Agreement.

Current wording

License and collaboration revenue was $0.2 million for the three months ended September 30, 2025 compared to less $0.1 million for the three months ended September 30, 2024. All revenue recognized during the three months ended September 30, 2025 and 2024 was related to the Kissei License Agreement.

Previous wording

R&D expenses were $31.3 million for the three months ended June 30, 2025 compared to $18.5 million for the three months ended June 30, 2024. The increase of $12.9 million in R&D expenses for the three months ended June 30, 2025 was primarily due to an increase of $7.9 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, as well as an increase of $3.9 million in compensation costs due to increased headcount, including a $1.5 million increase in stock-based compensation, and an increase in other fees and costs of $1.1 million.

Current wording

R&D expenses were $27.9 million for the three months ended September 30, 2025 compared to $19.6 million for the three months ended September 30, 2024. The increase of $8.3 million in R&D expenses for the three months ended September 30, 2025 was primarily due to an increase of $4.2 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, as well as an increase of $2.9 million in compensation costs due to increased headcount, including a $1.6 million increase in stock-based compensation, and an increase in other research and development costs of $1.2 million.

Previous wording

General and administrative expenses were $17.4 million for the three months ended June 30, 2025 compared to $7.5 million for the three months ended June 30, 2024. The increase of $9.9 million in general and administrative expenses for the three months ended June 30, 2025 was primarily due to an increase in compensation costs of $5.4 million due to increased headcount, including a $3.2 million increase in stock-based compensation, as well as increased professional and consultant fees of $3.3 million, including a $3.0 million increase in legal fees, an increase in marketing-related costs of $0.4 million, and an increase in insurance, fees, and other costs of $0.8 million.

Current wording

General and administrative expenses were $23.3 million for the three months ended September 30, 2025 compared to $8.7 million for the three months ended September 30, 2024. The increase of $14.6 million in general and administrative expenses for the three months ended September 30, 2025 was primarily due to an increase in professional and consultant fees of $7.5 million, including a $4.1 million increase in legal fees, an increase in compensation costs of $4.7 million due to increased headcount, including a $3.1 million increase in stock-based compensation, an increase in marketing-related costs of $0.7 million, and an increase in insurance, fees, and other costs of $1.7 million.

Previous wording

Other income (expense), net, for the three months ended June 30, 2025 was $7.3 million compared to $7.0 million for the three months ended June 30, 2024. The $0.4 million increase was driven by higher interest income earned related to cash equivalents and marketable securities balances.

Current wording

Other income, net, for the three months ended September 30, 2025 was $7.3 million compared to $7.9 million for the three months ended September 30, 2024. The $0.6 million decrease was driven by a decrease in interest income earned related to cash equivalents and marketable securities balances and interest expense related to debt acquired through SPV and Biovire, with no corresponding interest expense in the prior period.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

License and collaboration revenue was less than $0.1 million for the six months ended June 30, 2025 compared to $0.6 million for the six months ended June 30, 2024. During the six months ended June 30, 2025 we recognized less than $0.1 million in license and collaboration revenue related to the Kissei License Agreement. During the six months ended June 30, 2024, we recognized $0.5 million in license and collaboration revenue related to the Lepu License Agreement and $0.1 million in license and collaboration revenue related to the Kissei License Agreement.

Current wording

License and collaboration revenue was $0.2 million for the nine months ended September 30, 2025 compared to $0.7 million for the nine months ended September 30, 2024. During the nine months ended September 30, 2025 we recognized $0.2 million in license and collaboration revenue related to the Kissei License Agreement. During the nine months ended September 30, 2024, we recognized $0.5 million in license and collaboration revenue related to the Lepu License Agreement and $0.2 million in license and collaboration revenue related to the Kissei License Agreement.

Previous wording

R&D expenses were $58.8 million for the six months ended June 30, 2025 compared to $35.7 million for the six months ended June 30, 2024. The increase of $23.1 million in R&D expenses for the six months ended June 30, 2025 was primarily due to an increase of $13.4 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, as well as an increase of $7.4 million in compensation costs due to increased headcount, including a $2.6 million increase in stock-based compensation, and an increase in other fees and costs of $2.3 million.

Current wording

R&D expenses were $86.7 million for the nine months ended September 30, 2025 compared to $55.3 million for the nine months ended September 30, 2024. The increase of $31.4 million in R&D expenses for the nine months ended September 30, 2025 was primarily due to an increase of $17.7 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, as well as an increase of $10.3 million in compensation costs due to increased headcount, including a $4.2 million increase in stock-based compensation, and an increase in other research and development costs of $3.4 million.

Previous wording

General and administrative expenses were $32.2 million for the six months ended June 30, 2025 compared to $13.3 million for the six months ended June 30, 2024. The increase of $18.9 million in general and administrative expenses for the six months ended June 30, 2025 was primarily due to an increase in compensation costs of $10.7 million due to increased headcount, including a $5.8 million increase in stock-based compensation, as well as increased professional and consultant fees of $4.8 million related to legal, accounting and consulting fees, an increase in marketing-related costs of $1.5 million, and an increase in insurance, fees, and other costs of $2.0 million.

Current wording

General and administrative expenses were $55.5 million for the nine months ended September 30, 2025 compared to $22.0 million for the nine months ended September 30, 2024. The increase of $33.5 million in general and administrative expenses for the nine months ended September 30, 2025 was primarily due to an increase in compensation costs of $15.4 million due to increased headcount, including a $8.9 million increase in stock-based compensation, and increased professional and consultant fees of $12.3 million, which includes a $8.3 million increase in legal fees, as well as an increase in marketing-related costs of $2.2 million and an increase in insurance, fees, and other costs of $3.6 million.

Previous wording

Other income (expense), net, for the six months ended June 30, 2025 was $15.1 million compared to $12.5 million for the six months ended June 30, 2024. The $2.6 million increase was driven by higher interest income earned related to cash equivalents and marketable securities balances.

Current wording

Other income, net, for the nine months ended September 30, 2025 was $22.4 million compared to $20.4 million for the nine months ended September 30, 2024. The $2.0 million increase was driven by higher interest income earned related to cash equivalents and marketable securities balances, partially offset by $0.1 million of interest expense related to debt acquired through SPV and Biovire, with no corresponding interest expense in the prior period.

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 through public offerings and our redeemable convertible preferred stock, as well as through previously outstanding term debt. From inception through June 30, 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 June 30, 2025, we have recognized $26.2 million in license and collaboration revenue through our license and collaboration agreements. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $661.1 million.

Current wording

Since our inception, we have not generated any revenue from product sales of cretostimogene 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. From inception through September 30, 2025, we have received aggregate gross proceeds of $1,032.9 million from the sale of shares of our common stock through our public offerings and our redeemable convertible preferred stock. In addition, through September 30, 2025, we have recognized $26.3 million in license and collaboration revenue through our license and collaboration agreements. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $680.3 million.

Previous wording

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 June 30, 2025, no sales have been made under the shelf registration statement or the Jefferies Sales Agreement.

Current wording

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. During the three months ended September 30, 2025, 1,515,151 shares were sold under the Jefferies Sales Agreement, at a price of $33.00 per share. The Company received net proceeds of $48.7 million, after deducting discounts and commissions and other offering expenses.

Previous wording

During the three and six months ended June 30, 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.

Current wording

During the three and nine months ended September 30, 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 six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

During the six months ended June 30, 2025, operating activities used $57.2 million of cash, primarily resulting from our net loss of $75.9 million, as well as accretion of the discount on short-term investments of $2.2 million, partially offset by non-cash stock-based compensation charges of $12.2 million and net cash provided by changes in our operating assets and liabilities of $9.1 million.

Current wording

During the nine months ended September 30, 2025, operating activities used $96.1 million of cash, primarily resulting from our net loss of $119.7 million, as well as accretion of the discount on short-term investments of $2.0 million, partially offset by non-cash stock-based compensation charges of $19.5 million and net cash provided by changes in our operating assets and liabilities of $6.3 million.

Previous wording

During the six months ended June 30, 2024, operating activities used $42.1 million of cash, primarily resulting from our net loss of $35.8 million, accretion of the discount on short-term investments of $4.7 million, and net cash used in changes in our operating assets and liabilities of $5.4 million, partially offset by $3.8 million of non-cash stock-based compensation charges.

Current 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, 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 $6.4 million of non-cash stock-based compensation charges.

Previous wording

During the six months ended June 30, 2025, net cash used in investing activities was $185.4 million, primarily due to purchases of marketable securities and the issuance of a note receivable through a convertible promissory note in the principal amount of $26.0 million, partially offset by proceeds from sales and maturities of short-term investments.

Current wording

During the nine months ended September 30, 2025, net cash used in investing activities was $170.3 million, primarily due to $770.1 million of purchases of marketable securities and $22.0 million, net of cash acquired, for the acquisition of SPV and Biovire through the Conversion Event, partially offset by proceeds from sales and maturities of short-term investments.

Previous wording

During the six months ended June 30, 2024, net cash used in investing activities was $343.7 million, primarily due to purchases of marketable securities offset by proceeds from sales and maturities of short-term investments.

Current 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.

Previous wording

During the six months ended June 30, 2025, net cash provided by financing activities was $0.2 million, consisting primarily of proceeds from exercise of options of $0.7 million, partially offset by deferred offering costs of $0.5 million.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities was $54.5 million, consisting primarily of proceeds of $49.0 million from the sale of our common stock pursuant to the Jefferies Sales Agreement, net of issuance costs, and proceeds from exercise of options of $5.8 million, partially offset by deferred offering costs of $0.3 million.

Previous wording

During the six months ended June 30, 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.

Current 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.

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 consolidated 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 unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.