Skip to main content

CG Oncology Inc

For the period ended Sep 30, 2024. Filed Nov 12, 2024.

View on SEC.gov

About 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.

Sep 30, 2024 · Filed Nov 12, 2024

CGON$75.99+17.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0000950170-24-093238

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current 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 Operations

The 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 117 current paragraphs.

90 unchanged; 24 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 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 (3)

Current report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Current report

The following table summarizes our R&D expenses for the nine months ended September 30, 2024 and 2023 (in thousands):

Current report

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Removed paragraphs (3)

Previous report

The following table summarizes our R&D expenses for the six months ended June 30, 2024 and 2023 (in thousands):

Previous report

The following table summarizes our general and administrative expenses for the six months ended June 30, 2024 and 2023 (in thousands):
Reworded paragraphs (24)

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 initially 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, our ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC patients. We have completed enrollment for this trial, reported interim data in May 2024 and expect to report primary data by the end of 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 addition, in our CORE-001 Phase 2 clinical trial, we evaluated the use of cretostimogene when administered to this same patient 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 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 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.

Previous wording

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $35.8 million and $20.3 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $165.8 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 $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.

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 June 30, 2024, we have received aggregate gross proceeds of approximately $747.5 million from the sale of common shares from our IPO and sales of redeemable convertible preferred stock. In addition, from inception through June 30, 2024, we have recognized $25.6 million in research and collaboration revenue pursuant to our license and collaboration agreements. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $552.9 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 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.

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 years ended December 31, 2023 and 2022, less than $0.1 million and zero collaboration revenue, respectively, was recorded related to the Lepu License Agreement. During the three months ended June 30, 2024 and 2023, no collaboration revenue was recorded related to the Lepu License Agreement. During the six months ended June 30, 2024 and 2023, $0.5 million and zero in 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 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.

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 years ended December 31, 2023 and 2022, we recorded $0.2 million and $0.2 million, respectively in development income related to the Kissei License Agreement. During the three months ended June 30, 2024 and 2023, $0.1 million and zero in collaboration revenue was recorded related to the Kissei License Agreement, respectively. During the six months ended June 30, 2024 and 2023, $0.5 million and $0.2 million in 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 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.

Previous wording

From inception through June 30, 2024, we have recognized $25.6 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 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.

Previous wording

Research and collaboration revenue was $0.1 million for the three months ended June 30, 2024 compared to zero for the three months ended June 30, 2023. We recorded $0.1 million in development revenue related to the Kissei License Agreement for the three months ended June 30, 2024, with zero development revenue during the prior year period.

Current wording

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 wording

R&D expenses were $18.5 million for the three months ended June 30, 2024 compared to $9.8 million for the three months ended June 30, 2023. The increase of $8.6 million in R&D expenses for the three months ended June 30, 2024 was primarily due to an increase of $6.4 million in external clinical trial expenses, including an increase of $3.2 million of chemistry, manufacturing and control (CMC) costs, and an increase of $1.7 million in compensation costs due to increased headcount.

Current wording

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 wording

General and administrative expenses were $7.5 million for the three months ended June 30, 2024 compared to $2.5 million for the three months ended June 30, 2023. The increase of $5.0 million in general and administrative expenses for the three months ended June 30, 2024 was primarily due to an increase in personnel-related expenses, including an increase in compensation costs of $3.0 million due to increased headcount, an increase in professional and consultant fees of $0.7 million related to legal, accounting and consulting fees, and an increase of marketing-related costs of $0.6 million.

Current wording

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 wording

Other income (expense), net, for the six months ended June 30, 2024 was an other income, net of $12.5 million compared to an other income, net of $1.8 million for the six months ended June 30, 2023. For the six months ended June 30, 2024, other income (expense), net primarily consisted of $12.5 million in interest income related to marketable securities balances, and for the six months ended June 30, 2023, other income (expense), net primarily consisted of interest income of $1.8 million related to marketable securities balances.

Current 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.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

Research and collaboration revenue was $0.6 million for the six months ended June 30, 2024 compared to $0.2 million for the three months ended June 30, 2023. For development revenue, we recorded $0.5 million and zero for the six months ended June 30, 2024 and 2023, respectively, related to the Lepu License Agreement, and we recorded $0.1 million and $0.2 million related to the Kissei License Agreement for the six months ended June 30, 2024 and 2023, respectively.

Current 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.

Previous wording

R&D expenses were $35.7 million for the six months ended June 30, 2024 compared to $17.7 million for the six months ended June 30, 2023. The increase of $18.0 million in R&D expenses for the six months ended June 30, 2024 was primarily due to an increase of $14.2 million in external clinical trial expenses related to higher CRO fees as patient enrollment increased, including an $8.0 million increase in CMC costs, as well as an increase of $2.8 million in compensation costs due to increased headcount, including a $1.1 million increase in stock-based compensation.

Current 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.

Previous wording

General and administrative expenses were $13.3 million for the six months ended June 30, 2024 compared to $4.6 million for the six months ended June 30, 2023. The increase of $8.7 million in general and administrative expenses for the six months ended June 30, 2024 was primarily due to an increase in compensation costs of $5.0 million due to increased headcount, including a $2.3 million increase in stock-based compensation, as well as increased professional and consultant fees of $1.5 million related to legal, accounting and consulting fees, and an increase in marketing-related costs of $1.0 million.

Current 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.

Previous wording

Other income (expense), net, for the three months ended June 30, 2024 was an other income, net of $7.0 million compared to an other income, net of $0.7 million for the three months ended June 30, 2023. For the three months ended June 30, 2024, other income (expense), net primarily consisted of $6.9 million in interest income related to marketable securities balances, and for the three months ended June 30, 2023, other income (expense), net primarily consisted of interest income of $0.8 million related to marketable securities balances.

Current wording

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.

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 June 30, 2024, we have received aggregate gross proceeds of $747.5 million from the sale of common stock in our IPO and sale of redeemable convertible preferred stock. In addition, through June 30, 2024, we have recognized $25.6 million in research and collaboration revenue through our license and collaboration agreements. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $552.9 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 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.

Previous wording

During the three and six months ended June 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 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.

Previous wording

The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):

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, as well as 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 non-cash stock-based compensation charges of $3.8 million.

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, 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.

Previous wording

During the six months ended June 30, 2023, operating activities used $18.8 million of cash, primarily resulting from our net loss of $20.3 million, partially offset by $1.1 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 $0.7 million.

Current 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.

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, 2023, net cash used in investing activities was $24.7 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, 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.

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

During the six months ended June 30, 2023, net cash used in financing activities was $16.0 million, consisting of payments of long-term debt of $16.2 million partially offset by the exercise of common stock options of $0.2 million.

Current wording

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.