CG Oncology, Inc.

Previous wording

We are a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene), an investigational oncolytic immunotherapy with a dual mechanism of action designed both to eliminate cancer cells directly by selective replication and indirectly by activating an anti-tumor immune response, as a potential backbone therapy in a broad range of patients afflicted with bladder cancer. Cretostimogene is currently in clinical development for the treatment of patients with high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), which potentially represents up to 150,000 addressable patients.

Current wording

We are a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene), an investigational oncolytic immunotherapy with a dual mechanism of action designed both to eliminate cancer cells directly by selective replication and indirectly by activating an anti-tumor immune response, as a potential backbone therapy in a broad range of patients afflicted with bladder cancer. Cretostimogene is currently in clinical development for the treatment of patients with high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), which potentially represents up to 150,000 addressable patients (US).

Previous wording

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 Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease. Given the limitations of currently approved therapies, the next course of treatment for these patients with BCG-unresponsive tumors is radical cystectomy, which is the complete removal of the bladder. This surgery carries a significant social, functional and emotional burden for patients. As such, there is a significant unmet need for effective bladder-sparing treatments. We have completed enrollment for this cohort and reported potentially best-in-disease data in September 2025. This trial served as the basis for our Biologics License Application (BLA) submission for our initial indication to the U.S. Food and Drug Administration (FDA), which we initiated in the fourth quarter of 2025 and expect to complete in the fourth quarter of 2026. 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 papillary tumors. Additionally, 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 potentially best-in-disease data reported at the Society of Urologic Oncology (SUO) 26th Annual Meeting in December 2025. Based on internal research derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program’s (NIH SEER) database, secondary claims data analytics and management assumptions, the high-risk BCG-unresponsive NMIBC segment may represent up to 25,000 addressable patients.

Current wording

We are evaluating the safety and efficacy of cretostimogene monotherapy in BOND-003 Cohort C, our ongoing Phase 3 clinical trial in high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease. Given the limitations of currently approved therapies, the next course of treatment for these patients with BCG-unresponsive tumors is radical cystectomy, which is the complete removal of the bladder. This surgery carries a significant social, functional and emotional burden for patients. As such, there is a significant unmet need for effective bladder-sparing treatments. We reported potentially best-in-disease data in September 2025, and results were subsequently updated and published in The Lancet Oncology in July 2026. These results included a 75.5% complete response (CR) at any time, after receiving cretostimogene as monotherapy, with 12- and 24-month duration of response (DOR) rates of 64.2% and 60.1%, respectively and a favorable safety and tolerability profile. This trial served as the basis for our Biologics License Application (BLA) submission for our initial indication to the U.S. Food and Drug Administration (FDA), which we expect to complete in the fourth quarter of 2026. 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 papillary tumors. Additionally, 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. Based on internal research derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program’s (NIH SEER) database, secondary claims data analytics and management assumptions, the high-risk BCG-unresponsive NMIBC segment may represent up to 25,000 addressable patients.

Previous wording

We are also conducting a Phase 3 clinical trial, PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC assessing adjuvant cretostimogene following transurethral resection of the bladder tumor (TURBT), with enrollment completed in the third quarter of 2025. These patients with intermediate-risk NMIBC are encumbered by frequent tumor recurrence that requires repeat resection of the bladder tumors. Moreover, intravesical BCG is no longer recommended by guidelines for this patient population due to the continuous BCG shortage. We believe cretostimogene, if approved in intermediate-risk NMIBC, has the potential to serve as a first-in-class backbone therapy in this frontline adjuvant setting, for which there are currently no U.S. FDA approved options. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the intermediate-risk NMIBC segment may represent up to 50,000 addressable patients.

Current wording

We are also conducting a Phase 3 clinical trial, PIVOT-006, the first randomized registrational trial to evaluate an investigational adjuvant therapy in intermediate-risk NMIBC assessing cretostimogene following transurethral resection of the bladder tumor (TURBT), with enrollment completed in the third quarter of 2025. These patients with intermediate-risk NMIBC are encumbered by frequent tumor recurrence that requires repeat resection of the bladder tumors. Moreover, intravesical BCG is no longer recommended by guidelines for this patient population due to the continuous BCG shortage. We believe cretostimogene, if approved in intermediate-risk NMIBC, has the potential to serve as a first-in-class backbone therapy in this frontline adjuvant setting, for which there are currently no U.S. FDA approved options. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the intermediate-risk NMIBC segment may represent up to 50,000 addressable patients.

Previous wording

Additionally, we have multiple ongoing Phase 2 trials designed to generate data in high-risk BCG-exposed and BCG-naïve patients. In October 2024, we initiated CORE-008 Cohort A, a 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. Initial data from this Cohort were reported at the SUO Annual Meeting in December 2025. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the high-risk BCG-naïve NMIBC segment may represent up to 25,000 addressable patients. In March 2025, we expanded CORE-008 evaluating cretostimogene as a monotherapy in 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 both the high-risk BCG-exposed and BCG-unresponsive population. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the high-risk BCG-exposed NMIBC segment may represent up to 50,000 addressable patients. Notably, cretostimogene’s potential for combination with other therapies was assessed in a Phase 2 CORE-001 clinical trial evaluating cretostimogene in combination with the checkpoint inhibitor (CPI) pembrolizumab in high-risk BCG-unresponsive NMIBC patients.

Current wording

Additionally, we have multiple ongoing Phase 2 trials designed to generate data in high-risk BCG-exposed and BCG-naïve patients. In October 2024, we initiated CORE-008 Cohort A, a 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. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the high-risk BCG-naïve NMIBC segment may represent up to 25,000 addressable patients. In March 2025, we expanded CORE-008 evaluating cretostimogene monotherapy in 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 both the high-risk BCG-exposed and BCG-unresponsive population. Notably, cretostimogene’s potential for combination with other therapies was assessed in a Phase 2 CORE-001 clinical trial evaluating cretostimogene in combination with the checkpoint inhibitor (CPI) pembrolizumab in high-risk BCG-unresponsive NMIBC patients. In May 2026, first results from CORE-008 Cohort CX data were presented at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting. As of the March 13, 2026 cut off, the data included a favorable safety and tolerability profile and an overall high-grade event-free survival (HG-EFS) of 96.0% at 3 months and 89.5% at 6 months, with a a median follow-up of 6.6 months, in the overall intent-to-treat (ITT) population. There were no statistically significant differences in HG-EFS across concurrent and sequential treatment arms. High CR rates at any time were observed in the CIS-containing population with 85.7% and 92.3% in the ITT and Efficacy Evaluable population, respectively. Based on internal research derived from NIH SEER database, secondary claims data analytics and management assumptions, the high-risk BCG-exposed NMIBC segment may represent up to 50,000 addressable patients.

Previous wording

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $60.2 million and $34.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $439.2 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 $139.3 million and $75.9 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $518.2 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.

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. 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, commissions and other offering expenses. In addition, as a result of our initial public offering, our convertible preferred stock converted into common stock concurrently with the initial public offering. In December 2024, we completed a follow-on offering of 8,500,000 common shares at a price of $28.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,200,000 shares of common stock. We received net proceeds of $223.1 million, after deducting discounts, commissions and other offering expenses. 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, 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, which we subsequently amended on January 13, 2026, covering the offering, issuance and sale of up to a maximum aggregate offering of $550 million of our common stock that may be issued and sold from time to time under the Jefferies Sales Agreement. As of March 31, 2026, we have completed the Jefferies Sales Agreement and have received gross proceeds of $550.0 million and net aggregate proceeds of $538.5 million under the Jefferies Sales Agreement, after deducting discounts and commissions and other offering expenses.

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.

Previous wording

Through March 31, 2026, we have received aggregate gross proceeds of approximately $1,532.9 million from the sale of shares of our common stock from our initial public offering, our follow-on offering in December 2024, and our at-the-market facility, and sales of redeemable convertible preferred stock. In addition, through March 31, 2026, we have recognized $26.9 million in license and collaboration revenue pursuant to our license and collaboration agreements. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $1,076.2 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

Through June 30, 2026, we have received aggregate gross proceeds of approximately $1,532.9 million from the sale of shares of our common stock from our initial public offering, our follow-on offering in December 2024, and our at-the-market facility, and sales of redeemable convertible preferred stock. In addition, through June 30, 2026, we have recognized $26.9 million in license and collaboration revenue pursuant to our license and collaboration agreements. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $1,028.3 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 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.

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. For example, we may seek to raise additional capital through our Open Market Sale Agreement SM (Jefferies Sales Agreement) with Jefferies LLC, pursuant to which we may issue and sell up to an additional $500.0 million shares of our common stock. 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 months ended March 31, 2026 and 2025, we did not recognize any 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 six months ended June 30, 2026 and 2025, we did not recognize any 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 each of the three months ended March 31, 2026 and 2025, less than $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 each of the three and six months ended June 30, 2026 and the six months ended June 30, 2025, less than $0.1 million in license and collaboration revenue was recorded related to the Kissei License Agreement. We did not recognize any license and collaboration revenue related to the Kissei License Agreement during the three months ended June 30, 2025.

Previous wording

Other income (expense), net consists primarily of interest income related to interest earned on our invested cash equivalents and marketable securities balances. It also includes other miscellaneous items, such as interest expense and other items not related to our core operations. We expect our interest income will increase as we invest the cash received from the net proceeds from our public offerings.

Current wording

Other income (expense), net consists primarily of interest income related to interest earned on our invested cash equivalents and marketable securities balances. It also includes other miscellaneous items, such as interest expense and other items not related to our core operations.

Previous wording

License and collaboration revenue was less than $0.1 million for the three months ended March 31, 2026 and the three months ended March 31, 2025. All revenue recognized during both periods was related to the Kissei License Agreement.

Current wording

License and collaboration revenue was less than $0.1 million for the three months ended June 30, 2026 compared to zero the three months ended June 30, 2025. All revenue recognized was related to the Kissei License Agreement.

Previous wording

Cost of sales was $3.0 million for the three months ended March 31, 2026 compared to zero for the three months ended March 31, 2025. As the Conversion Event occurred in July 2025, there was no corresponding costs in the prior period.

Current wording

Cost of sales was $3.9 million for the three months ended June 30, 2026 compared to zero for the three months ended June 30, 2025. As the Conversion Event occurred in July 2025, there was no corresponding costs in the prior period.

Previous wording

R&D expenses were $43.7 million for the three months ended March 31, 2026 compared to $27.5 million for the three months ended March 31, 2025. The increase of $16.3 million in R&D expenses for the three months ended March 31, 2026 was primarily due to an increase of $14.5 million in external clinical trial expenses related to higher Chemistry, Manufacturing, and Controls (CMC) costs, as well as an increase of $2.1 million in compensation costs due to increased headcount, including a $0.9 million increase in stock-based compensation, partially offset by a decrease in other research and development costs of $0.3 million.

Current wording

R&D expenses were $54.7 million for the three months ended June 30, 2026 compared to $31.3 million for the three months ended June 30, 2025. The increase of $23.3 million in R&D expenses for the three months ended June 30, 2026 was primarily due to an increase of $21.3 million in external clinical trial expenses related to higher Chemistry, Manufacturing, and Controls (CMC) costs, as well as an increase of $2.7 million in compensation costs due to increased headcount, including a $0.8 million increase in stock-based compensation, partially offset by a decrease in other research and development costs of $0.6 million.

Previous wording

General and administrative expenses were $20.8 million for the three months ended March 31, 2026 compared to $14.8 million for the three months ended March 31, 2025. The increase of $6.0 million in general and administrative expenses for the three months ended March 31, 2026 was primarily due to an increase in compensation costs of $2.7 million due to increased headcount, including a $0.4 million increase in stock-based compensation, an increase in professional and consultant fees of $2.5 million, and an increase in other general fees and costs of $1.1 million, partially offset by a decrease in marketing-related costs of $0.4 million.

Current wording

General and administrative expenses were $49.8 million for the six months ended June 30, 2026 compared to $32.2 million for the six months ended June 30, 2025. The increase of $17.6 million in general and administrative expenses for the six months ended June 30, 2026 was primarily due to an increase in compensation costs of $13.6 million due to increased headcount, including a $7.0 million increase in stock-based compensation, an increase in other general fees and costs of $2.7 million, and an increase in professional and consultant fees of $1.2 million, partially offset by a decrease in marketing-related costs of $0.3 million.

Previous wording

Other income, net, for the three months ended March 31, 2026 was an other income, net of $6.2 million compared to an other income, net of $7.8 million for the three months ended March 31, 2025. The $1.6 million decrease was driven primarily by a decrease in interest income earned related to cash equivalents and marketable securities balances, as well as interest expense in the current period related to debt acquired through SPV and Biovire, with no corresponding interest expense in the prior period.

Current wording

Other income (expense), net, for the six months ended June 30, 2026 was an other income, net of $13.5 million compared to $15.1 million for the six months ended June 30, 2025. The $1.5 million decrease was primarily due to a decrease in interest income earned related to cash equivalents and marketable securities balances, as well as interest expense in the current period 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 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. Through March 31, 2026, we have received aggregate gross proceeds of $1,532.9 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, 2026, we have recognized $26.9 million in license and collaboration revenue through our license and collaboration agreements. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $1,076.2 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. Through June 30, 2026, we have received aggregate gross proceeds of $1,532.9 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, 2026, we have recognized $26.9 million in license and collaboration revenue through our license and collaboration agreements. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $1,028.3 million.

Previous wording

On March 28, 2025, we entered into the Jefferies Sales Agreement with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, 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, which we subsequently amended on January 13, 2026, covering the offering, issuance and sale of up to a maximum aggregate offering of $550 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 March 31, 2026, 6,941,407 shares were sold under the Jefferies Sales Agreement, at a weighted-average price of $57.56 per share, and the Company received net proceeds of $391.4 million, after deducting discounts and commissions and other offering expenses.

Current wording

On March 28, 2025, we entered into the Jefferies Sales Agreement with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, 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, which we subsequently amended on January 13, 2026 and on August 6, 2026, covering the offering, issuance and sale of up to a maximum aggregate offering of $1.05 million of our common stock that may be issued and sold from time to time under the Jefferies Sales Agreement. As of June 30, 2026, we have received gross proceeds of $550.0 million and net aggregate proceeds of $538.5 million under the Jefferies Sales Agreement, after deducting discounts and commissions and other offering expenses. During the six months ended June 30, 2026, 6,941,407 shares were sold under the Jefferies Sales Agreement, at a weighted-average price of $57.56 per share, and the Company received net proceeds of $391.4 million, after deducting discounts and commissions and other offering expenses.

Previous wording

During the three months ended March 31, 2026, 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 – Contractual Obligations and Other Commitments” included in the 2025 Annual Report.

Current wording

During the three and six months ended June 30, 2026, 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 – Contractual Obligations and Other Commitments” included in the 2025 Annual Report.

Previous wording

The following table provides information regarding our cash flows for the three months ended March 31, 2026 and 2025 (in thousands):

Current wording

The following table provides information regarding our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

During the three months ended March 31, 2026, operating activities used $56.9 million of cash, primarily resulting from our net loss of $60.2 million, as well as net cash used by changes in our operating assets and liabilities of $5.8 million, partially offset by non-cash stock-based compensation charges of $6.5 million and other non-cash operating adjustments of $2.6 million.

Current wording

During the six months ended June 30, 2026, operating activities used $103.4 million of cash, primarily resulting from our net loss of $139.3 million, as well as net cash used by changes in our operating assets and liabilities of $8.6 million, partially offset by non-cash stock-based compensation charges of $20.8 million and other non-cash operating adjustments of $6.5 million.

Previous 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, accretion of the discount on short-term investments of $0.3 million, partially offset by $5.2 million of non-cash stock-based compensation charges and net cash used in changes in our operating assets and liabilities of $0.5 million.

Current 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, accretion of the discount on short-term investments of $2.2 million, partially offset by $12.2 million of non-cash stock-based compensation charges and net cash used in changes in our operating assets and liabilities of $9.1 million.

Previous wording

During the three months ended March 31, 2026, net cash used in investing activities was $334.8 million, primarily due to $587.4 million of purchases of marketable securities, partially offset by proceeds from sales and maturities of short-term investments.

Current wording

During the six months ended June 30, 2026, net cash used in investing activities was $304.4 million, primarily due to $783.4 million of purchases of marketable securities, partially offset by proceeds from sales and maturities of short-term investments.

Previous 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.

Current 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 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 $26.0 million.

Previous wording

During the three months ended March 31, 2026, net cash provided by financing activities was $393.0 million, consisting primarily of proceeds of $391.4 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 $1.7 million.

Current wording

During the six months ended June 30, 2026, net cash provided by financing activities was $394.9 million, consisting primarily of proceeds of $391.4 million from the sale of our common stock pursuant to the Jefferies Sales Agreement, net of issuance costs, and net proceeds from exercise of options of $3.6 million.

Previous wording

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.

Current 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 stock issuance costs of $0.5 million.