Candel Therapeutics Inc

Previous wording

An open-label phase 2 clinical trial in the United States evaluating CAN-2409 plus valacyclovir in combination with continued PD-(L)1 checkpoint inhibitors in approximately 80 patients with stage III/IV NSCLC who have inadequate response to front line PD-(L)1 checkpoint inhibitor treatments. In April 2023, we announced that the FDA granted fast track designation for CAN-2409 plus valacyclovir in combination with pembrolizumab in order to improve survival or delay progression in patients with stage III (not candidates for curative intent) or stage IV NSCLC, who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy. These patients historically have had an expected median overall survival (mOS) of <12 months (Reckamp K et al. J Clin Onc 2022;40:2295-2306). The aim of the CAN-2409 immunotherapy antitumor strategy is to raise the tail on the survival curve by increasing the number of long survivors beyond 10-14 months in patients treated with two CAN-2409 injections.

Current wording

An open-label phase 2 clinical trial in the United States evaluating CAN-2409 plus valacyclovir in combination with continued PD-(L)1 checkpoint inhibitors in patients with stage III/IV NSCLC who have inadequate response to front line PD-(L)1 checkpoint inhibitor treatments. In April 2023, we announced that the FDA granted fast track designation for CAN-2409 plus valacyclovir in combination with pembrolizumab in order to improve survival or delay progression in patients with stage III (not candidates for curative intent) or stage IV NSCLC, who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy. These patients historically have had an expected median overall survival (mOS) of <12 months (Reckamp K et al. J Clin Onc 2022;40:2295-2306). The aim of the CAN-2409 immunotherapy antitumor strategy is to raise the tail on the survival curve by increasing the number of long survivors beyond 14 months in patients treated with two CAN-2409 injections.

Previous wording

We have initiated a randomized phase 2 clinical trial in the United States and Mexico evaluating the activity of CAN-2409 in borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC). Initial positive phase 2 data revealed notable clinical improvements in patients with borderline resectable PDAC following CAN-2409 plus prodrug together with SoC chemoradiation. In March 2023, in connection with our cost management and dynamic portfolio management initiatives, we elected to pause new enrollment in this randomized phase 2 clinical trial, subject to additional funding. Despite the pause in new patient enrollment, we presented initial positive interim overall survival and immunological biomarker clinical data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in the fourth quarter of 2023. In December 2023, we announced that the FDA granted fast track designation for CAN-2409 plus valacyclovir for the treatment of patients with PDAC to improve overall survival. In April 2024, we announced updated positive overall survival data and also announced that the FDA has granted orphan drug designation for CAN-2409 for the treatment of pancreatic cancer.

Current wording

We have initiated a randomized phase 2 clinical trial in the United States and Mexico evaluating the activity of CAN-2409 in borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC). Initial positive phase 2 data revealed notable clinical improvements in patients with borderline resectable PDAC following CAN-2409 plus prodrug together with standard of care (SoC) chemoradiation. In March 2023, in connection with our cost management and dynamic portfolio management initiatives, we elected to pause new enrollment in this randomized phase 2 clinical trial, subject to additional funding. Despite the pause in new patient enrollment, we presented initial positive interim overall survival and immunological biomarker clinical data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in the fourth quarter of 2023. In December 2023, we announced that the FDA granted fast track designation for CAN-2409 plus valacyclovir for the treatment of patients with PDAC to improve overall survival. In April 2024, we announced updated positive overall survival data and also announced that the FDA has granted orphan drug designation for CAN-2409 for the treatment of pancreatic cancer.

Previous wording

We are conducting an extension of the clinical trial known as arm C, in which patients with recurrent HGG will receive a repeat dosing regimen of CAN-3110 (up to six injections over four months). Clinical data from arm C will help evaluate whether multiple injections can increase mOS. This clinical trial extension is supported by the Break Through Cancer foundation. In June 2024, a poster presentation at the ASCO Annual Meeting showed additional detail from the arm C portion of the study, which incorporates two sub-cohorts of six patients each. To date, we have dosed six patients with multiple injections of CAN-3110 (up to six injections over a period of four months), completing cohort 1 of arm C. No dose-limiting toxicities or severe adverse events were observed. More than 300 core biopsies were obtained from all six patients, across the planned dose ranging time points, which were processed for “-omic” analysis, including single-cell RNA sequencing and cell profiling. Updated phase 1b data from the patients in cohort 1/arm C for CAN-3110 in recurrent HGG is expected in the second half of 2024.

Current wording

We are conducting an extension of the clinical trial known as arm C, in which patients with recurrent HGG will receive a repeat dosing regimen of CAN-3110 (up to six injections over four months). Clinical data from arm C will help evaluate whether multiple injections can increase mOS. This clinical trial extension is supported by the Break Through Cancer foundation. To date, we have dosed six patients with multiple injections of CAN-3110 (up to six injections over a period of four months), completing cohort 1 of arm C. In June 2024, a poster presentation at the ASCO Annual Meeting demonstrated that multiple intratumoral injections of CAN-3110 were feasible and well tolerated with no dose-limiting toxicities or severe adverse events observed in the first six patients treated in arm C. More than 300 core biopsies were obtained from these patients, across the planned dose ranging time points, which were processed for “-omic” analysis, including single-cell RNA sequencing and cell profiling. In October 2024, during the 16th Annual International Oncolytic Virotherapy Conference (IOVC), we announced clinical activity and biomarker data for arm C. The principal investigator of the study reported ongoing improved survival compared to historical controls in patients treated with multiple injections of CAN-3110, with 3 out of 6 patients with rHGG (recurrent glioblastoma) still alive more than one year (12.2, 13.0, and 18.7 months, respectively) after initiation of experimental treatment with CAN-3110. The data also showed discrepancies between imaging and histologic findings. Post treatment longitudinal biopsies demonstrated near absence of tumor cells alongside dense lymphocyte infiltrates especially in patients with enhancement on post-treatment MRI scans, suggesting the presence of radiologic pseudo-progression after treatment with CAN-3110. This data cautions the evaluation of progression by imaging, restating the importance of survival as the primary endpoint for viral immunotherapy trials.

Previous wording

Our cash and cash equivalents were $21.5 million as of June 30, 2024. In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), 205-40, Presentation of Financial Statements - Going Concern, we are required to assess our ability to continue as a going concern for the one-year look forward period following the date that the condensed consolidated financial statements are issued. Based on our current operating plan and existing cash and cash equivalents, we determined that substantial doubt exists regarding our ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, we will require additional funding. We expect to finance our cash needs through a combination of public or private equity or debt financings, government grants, and other sources, which may include collaborations, strategic alliances and licensing arrangements with third parties. There is no assurance that we will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect our business prospects or our ability to continue as a going concern.

Current wording

Our cash and cash equivalents were $16.6 million as of September 30, 2024. In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), 205-40, Presentation of Financial Statements - Going Concern, we are required to assess our ability to continue as a going concern for the one-year look forward period following the date that the condensed consolidated financial statements are issued. Based on our current operating plan and existing cash and cash equivalents, we determined that substantial doubt exists regarding our ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, we will require additional funding. We expect to finance our cash needs through a combination of public or private equity or debt financings, government grants, and other sources, which may include collaborations, strategic alliances and licensing arrangements with third parties. There is no assurance that we will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect our business prospects or our ability to continue as a going concern or could force us to initiate steps to cease operations.

Previous wording

Interest income consists of amounts earned on investment of cash equivalents.

Current wording

Interest income primarily consists of amounts earned on investment of cash equivalents.

Previous wording

Interest expense consists of interest expense on our debt under our Loan Agreement with Silicon Valley Bank (SVB).

Current wording

Interest expense primarily consists of interest expense on our debt under our Loan Agreement with SVB.

Previous wording

In connection with the November 13, 2018 issuance of Series B preferred stock we issued warrants to the purchasers of the Series B preferred stock, to purchase up to 7,344,968 shares of our common stock with an exercise price of $6.81 per share. We also issued a warrant to the NC Incorporated Ohio Trust, an irrevocable trust funded by us, to purchase 162,740 shares of our common stock, $0.01 par value, at an exercise price of $1.46 per share, subject to adjustments as specified in the warrant agreement (the NC Ohio Warrants). Certain of those warrants are recorded as a liability on our balance sheet. The warrants recorded as a liability are remeasured to their fair value at each reporting date with changes in the fair value recognized as a component of other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. We will continue to recognize changes in the fair value of the warrants until they are exercised, expire or qualify for equity classification. The fair value of the warrants is determined based on significant inputs not observable in the market. The fair value of the warrants uses various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants. The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods. Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, and the remaining contractual term of the warrants. Therefore, the fair value may not be appropriately captured by simple models.

Current wording

We will continue to recognize changes in the fair value of the warrants until they are exercised, expire or qualify for equity classification. The fair value of the warrants is determined based on significant inputs not observable in the market. The fair value of the warrants uses various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants. The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods. Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, and the remaining contractual term of the warrants.

Previous wording

Research and development expenses decreased $0.9 million from $5.9 million for the three months ended June 30, 2023 to $5.0 million for the three months ended June 30, 2024. The decrease was primarily attributable to a $0.9 million decrease in clinical development costs driven by decreased regulatory, manufacturing and clinical trial costs for CAN-2409 programs and a $0.1 million decrease in recruiting costs. These decreases were partially offset by a $0.1 million increase in employee-related costs driven by an increase of $1.0 million in stock based compensation costs, which was partially offset by a $0.9 million decrease in payroll related costs.

Current wording

Research and development expenses decreased $0.4 million from $5.8 million for the three months ended September 30, 2023 to $5.4 million for the three months ended September 30, 2024. The decrease was primarily attributable to a $0.5 million decrease in employee-related expenses due to the corporate restructuring in the fourth quarter of 2023 and a $0.2 million decrease in depreciation, impairment, and loss on the sale of fixed assets. These decreases were partially offset by a $0.4 million increase in clinical development costs driven by increased manufacturing costs for CAN-2409 programs.

Previous wording

General and administrative expenses were $3.6 million for each of the three months ended June 30, 2024 and 2023. The small decrease was primarily attributable to a $0.1 million decrease in the cost of directors and officers insurance and a $0.1 million decrease in recruiting expenses. These decreases were partially offset by a $0.2 million increase in professional and consulting fees.

Current wording

General and administrative expenses increased $0.3 million from $3.0 million for the three months ended September 30, 2023 to $3.3 million for the three months ended September 30, 2024. The increase was primarily attributable to a $0.5 million increase in professional and consulting fees. The increase was partially offset by a $0.1 million decrease in the cost of directors and officers insurance.

Previous wording

Interest income was $0.2 million for the three months ended June 30, 2024, compared to interest income of $0.5 million for the three months ended June 30, 2023, and represents earnings on our cash equivalents. The decrease in interest income is the result of interest being generated on a lower cash equivalents balance for the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

Current wording

Interest income was $0.2 million and $0.5 million for the three months ended September 30, 2024 and 2023, respectively, and primarily represents earnings on our cash equivalents. The decrease in interest income is the result of interest being generated on a lower cash equivalents balance for the three months ended September 30, 2024 compared to the three months ended September 30, 2023.

Previous wording

Interest expense was $1.2 million and $1.3 million for the six months ended June 30, 2024 and 2023, respectively, and represents interest expense on our outstanding debt obligations.

Current wording

Interest expense was $0.5 million and $0.7 million for the three months ended September 30, 2024 and 2023, respectively, and represents interest expense on our outstanding debt obligations.

Previous wording

The change in fair value of our warrant liability was an increase of $13.3 million for the three months ended June 30, 2024, compared to a decrease of $0.1 million for the three months ended June 30, 2023. The change in fair value of the warrant liability is primarily driven by changes in the underlying value of our stock price.

Current wording

The change in fair value of our warrant liability was an increase of $1.6 million for the three months ended September 30, 2024, compared to a decrease of $0.6 million for the three months ended September 30, 2023. The change in fair value of the warrant liability is primarily driven by changes in the underlying value of our stock price.

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

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

Current wording

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

Previous wording

Research and development expenses decreased $2.3 million from $11.4 million for the six months ended June 30, 2023 to $9.1 million for the six months ended June 30, 2024. The decrease was primarily attributable to a $1.5 million decrease in clinical development costs driven by decreased regulatory, manufacturing and clinical trial costs for CAN-2409 programs and a $0.6 million decrease in employee-related expenses due to the corporate restructuring in the fourth quarter of 2023. The $0.6 million decrease in employee-related costs was driven by a decrease of $1.8 million in payroll related costs, which was partially offset by a $1.2 million increase in stock based compensation expense.

Current wording

Research and development expenses decreased $2.7 million from $17.2 million for the nine months ended September 30, 2023 to $14.5 million for the nine months ended September 30, 2024. The decrease was primarily attributable to a $1.1 million decrease in employee-related expenses due to the corporate restructuring in the fourth quarter of 2023, a $1.1 million decrease in clinical development costs driven by decreased regulatory and clinical trial costs for CAN-2409 programs, a $0.3 million decrease in recruiting costs, a $0.2 million decrease in depreciation, impairment, and loss on the sale of fixed assets and a $0.2 million decrease in pre-clinical research costs.

Previous wording

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

Current wording

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

Previous wording

General and administrative expenses decreased $0.4 million from $7.8 million for the six months ended June 30, 2023 to $7.4 million for the six months ended June 30, 2024. The decrease was primarily attributable to a $0.6 million decrease in employee-related expenses due to the corporate restructuring in the fourth quarter of 2023 and a $0.3 million decrease in the cost of directors and officers insurance. These decreases were partially offset by a $0.7 million increase in professional and consulting fees.

Current wording

General and administrative expenses decreased $0.1 million from $10.8 million for the nine months ended September 30, 2023 to $10.7 million for the nine months ended September 30, 2024. The decrease was primarily attributable to a $0.6 million decrease in employee-related expenses due to the corporate restructuring in the fourth quarter of 2023, a $0.4 million decrease in the cost of directors and officers insurance and a $0.2 million decrease in recruiting costs. These decreases were partially offset by a $1.2 million increase in professional and consulting fees.

Previous wording

Grant income was zero and $24,000 for the six months ended June 30, 2024 and 2023, respectively. Grant income for the six months ended June 30, 2023 relates to the recognition of income from a grant from the Massachusetts Life Sciences Center.

Current wording

Grant income was zero and $36,000 for the nine months ended September 30, 2024 and 2023, respectively. Grant income for the nine months ended September 30, 2023 relates to the recognition of income from a grant from the Massachusetts Life Sciences Center.

Previous wording

Interest income was $0.6 million for the six months ended June 30, 2024, compared to interest income of $1.2 million for the six months ended June 30, 2023, and represents earnings on our cash equivalents. The decrease in interest income is the result of interest being generated on a lower cash equivalents balance for the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

Current wording

Interest income was $0.8 million and $1.7 million for the nine months ended September 30, 2024 and 2023, respectively, and primarily represents earnings on our cash equivalents. The decrease in interest income is the result of interest being generated on a lower cash equivalents balance for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

Previous wording

Interest expense was $0.6 million for each of the six months ended June 30, 2024 and 2023, and represents interest expense on our outstanding debt obligations.

Current wording

Interest expense was $1.7 million and $1.9 million for the nine months ended September 30, 2024 and 2023, respectively, and represents interest expense on our outstanding debt obligations.

Previous wording

The change in fair value of our warrant liability was an increase of $13.3 million for the six months ended June 30, 2024, compared to a decrease of $0.9 million for the six months ended June 30, 2023. The change in fair value of the warrant liability is primarily driven by changes in the underlying value of our stock price.

Current wording

The change in fair value of our warrant liability was an increase of $15.0 million for the nine months ended September 30, 2024, compared to a decrease of $1.4 million for the nine months ended September 30, 2023. The change in fair value of the warrant liability is primarily driven by changes in the underlying value of our stock price.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials for our product candidates, developing our manufacturing capabilities which may include the cost of establishing a relationship with contract manufacturers to support commercial launch of our product candidate CAN-2409 and costs associated with equipping our laboratory and manufacturing facility to support clinical trials and commercialization and providing general and administrative support for our operations, including the cost associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. Based on current plans and assumptions, we expect that our existing cash and cash equivalents will be sufficient to fund our current operating plan into the first quarter of 2025.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials for our product candidates, developing our manufacturing capabilities which may include the cost of establishing a relationship with contract manufacturers to support commercial launch of our product candidate CAN-2409 and costs associated with equipping our laboratory and manufacturing facility to support clinical trials and commercialization and providing general and administrative support for our operations, including the cost associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. Based on current plans and assumptions, we expect that our existing cash and cash equivalents will be sufficient to fund our current operating plan to the end of the first quarter of 2025.

Previous wording

We do not currently have any approved products and have never generated any revenue from product sales. We have financed our operations primarily through proceeds from government grants and proceeds from the sale of convertible notes, common stock, and our convertible preferred stock. As of June 30, 2024, we have raised approximately $165.7 million, including $15.6 million of government grants, $66.1 million from the sale of convertible preferred stock, $82.7 million from the sale of our common stock, and $1.3 million from stock option exercises. Our cash and cash equivalents totaled $21.5 million as of June 30, 2024. We had $17.3 million of debt as of June 30, 2024. As of June 30, 2024, we have raised $3.6 million under our ATM Program (as defined below). Subsequent to June 30, 2024 and through August 5, 2024, we have raised an additional $4.1 million of net proceeds under our ATM Program.

Current wording

We do not currently have any approved products and have never generated any revenue from product sales. We have financed our operations primarily through proceeds from government grants and proceeds from the sale of convertible notes, common stock, and our convertible preferred stock. As of September 30, 2024, we have raised approximately $169.9 million, including $15.6 million of government grants, $66.1 million from the sale of convertible preferred stock, $86.8 million from the sale of our common stock, and $1.4 million from stock option exercises. Our cash and cash equivalents totaled $16.6 million as of

Previous wording

On February 24, 2022, we entered into a loan and security agreement Loan Agreement with SVB pursuant to which SVB agreed to provide term loans to us in an aggregate principal amount of $20.0 million. We borrowed $20.0 million upon entering into the Loan Agreement. We could have borrowed up to an additional aggregate principal amount not to exceed $5.0 million, at any time on or prior to December 31, 2022, upon the achievement of all of the following milestones, inclusively: (a) positive phase 2 clinical activity data from our CAN-2409 NSCLC clinical trial, (b) dosing of our first patient in our phase 3 CAN-2409 high-grade glioma clinical trial; and (c) receipt on or prior to December 31, 2022, of net cash proceeds in an amount equal to at least $75.0 million from the issuance and sale of equity securities to investors acceptable to SVB. We did not borrow any of the additional aggregate principal amount on or prior to December 31, 2022. The term loans are secured by substantially all of our properties, rights and assets, except for our intellectual property, which is subject to a negative pledge under the Loan Agreement.

Current wording

On February 24, 2022, we entered into a Loan Agreement with SVB pursuant to which SVB agreed to provide term loans to us in an aggregate principal amount of $20.0 million. We borrowed $20.0 million upon entering into the Loan Agreement. We could have borrowed up to an additional aggregate principal amount not to exceed $5.0 million, at any time on or prior to December 31, 2022, upon the achievement of all of the following milestones, inclusively: (a) positive phase 2 clinical activity data from our CAN-2409 NSCLC clinical trial, (b) dosing of our first patient in our phase 3 CAN-2409 high-grade glioma clinical trial; and (c) receipt on or prior to December 31, 2022, of net cash proceeds in an amount equal to at least $75.0 million from the issuance and sale of equity securities to investors acceptable to SVB. We did not borrow any of the additional aggregate principal amount on or prior to December 31, 2022. The term loans are secured by substantially all of our properties, rights and assets, except for our intellectual property, which is subject to a negative pledge under the Loan Agreement.

Previous wording

On August 5, 2022, we filed a shelf registration statement on Form S-3 (as amended, the Shelf) with the SEC, which covers the offering, issuance and sale by us of up to an aggregate of $200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf (the ATM Program). The Shelf was declared effective by the SEC on August 12, 2022. As of August 5, 2024, we have sold and issued 1,268,741 shares of common stock under the ATM Program, with total net proceeds of $7.7 million.

Current wording

On August 5, 2022, we filed a shelf registration statement on Form S-3 (as amended, the Shelf) with the SEC, which covers the offering, issuance and sale by us of up to an aggregate of $200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf (the ATM Program). The Shelf was declared effective by the SEC on August 12, 2022. As of November 4, 2024, we have sold and issued 1,619,142 shares of common stock under the ATM Program, with total net proceeds of $9.7 million.

Previous wording

As of June 30, 2024, we had an accumulated deficit of $167.5 million and have not generated any product sales. We do not know when, or if, we will generate revenue from product sales. We will not generate significant revenue from product sales unless and until we obtain regulatory approval and commercialize one of our current or future product candidates. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical and contract manufacturing costs, legal and other regulatory expenses, and general overhead costs. We expect that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to risks in the development of our products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We will require substantial additional financing to fund our operations and to continue to execute our strategy, and we will pursue a range of options to secure additional capital.

Current wording

As of September 30, 2024, we had an accumulated deficit of $178.1 million and have not generated any product sales. We do not know when, or if, we will generate revenue from product sales. We will not generate significant revenue from product sales unless and until we obtain regulatory approval and commercialize one of our current or future product candidates. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical and contract manufacturing costs, legal and other regulatory expenses, and general overhead costs. We expect that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to risks in the development of our products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We will require substantial additional financing to fund our operations and to continue to execute our strategy, and we will pursue a range of options to secure additional capital.

Previous wording

Cash Flows for the six months ended June 30, 2024 and 2023

Current wording

Cash Flows for the nine months ended September 30, 2024 and 2023

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $14.6 million, primarily consisting of a net loss of $30.5 million as we incurred expenses associated with our clinical programs and incurred costs associated with operating as a public company. We had non-cash charges of $17.1 million primarily related to the $13.3 million change in the fair value of our warrant liability and non-cash stock compensation. Net cash used in operating activities was also impacted by $1.2 million in changes in operating assets and liabilities, primarily driven by a decrease of $1.1 million in accrued expenses.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $21.2 million, primarily consisting of a net loss of $41.1 million as we incurred expenses associated with our clinical programs and incurred costs associated with operating as a public company. We had non-cash charges of $20.3 million primarily related to the $15.0 million change in the fair value of our warrant liability and non-cash stock compensation. Net cash used in operating activities was also impacted by $0.4 million in changes in operating assets and liabilities, primarily driven by a decrease of $0.4 million in lease liability.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2023 was $18.0 million, primarily consisting of a net loss of $18.4 million as we incurred expenses associated with our clinical programs, increased our headcount and incurred costs associated with operating as a public company. In addition, we had non-cash income of $0.9 million as a result of the change in the fair value of our warrant liability. Non-cash income was offset by $2.3 million in non-cash charges primarily related to non-cash stock compensation and depreciation expense. Net cash used in operating activities was also impacted by $1.1 million in changes in operating assets and liabilities, primarily driven by a decrease of $1.2 million in accrued expenses.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2023 was $26.8 million, primarily consisting of a net loss of $26.8 million as we incurred expenses associated with our clinical programs, increased our headcount and incurred costs associated with operating as a public company. In addition, we had non-cash income of $1.4 million as a result of the change in the fair value of our warrant liability. Non-cash income was offset by $3.6 million in non-cash charges primarily related to depreciation and non-cash stock compensation expense. Net cash used in operating activities was also impacted by $2.1 million in changes in operating assets and liabilities, primarily driven by a decrease of $1.2 million in accrued expenses.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2024 was $13,000 and consisted of the purchase of fixed assets.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024 was $13,000 and consisted of the purchase of fixed assets.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2023 was $0.2 million and consisted of the purchase of fixed assets, which was partially offset by proceeds from the sale of fixed assets.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2023 was $0.3 million and consisted of the purchase of fixed assets, which was partially offset by proceeds from the sale of fixed assets.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 was $0.7 million and consisted of $1.2 million of proceeds from option exercises and $3.6 million of net proceeds from the issuance of common stock under our ATM Program, partially offset by $4.2 million of principal payments on our term loan with SVB.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $2.4 million and consisted of $1.3 million of proceeds from option exercises and $7.7 million of net proceeds from the issuance of common stock under our ATM Program, partially offset by $6.7 million of principal payments on our term loan with SVB.

Previous wording

There were no financing activities for the six months ended June 30, 2023.

Current wording

There were no financing activities for the nine months ended September 30, 2023.

Previous wording

We believe that our existing cash and cash equivalents as of June 30, 2024, will enable us to fund our operating expenses and capital expense requirements into the first quarter of 2025. We have based this estimate on assumptions that may prove to be incorrect, and we could utilize our available capital resources sooner than we currently expect.

Current wording

We believe that our existing cash and cash equivalents as of September 30, 2024, will enable us to fund our operating expenses and capital expense requirements to the end of the first quarter of 2025. We have based this estimate on assumptions that may prove to be incorrect, and we could utilize our available capital resources sooner than we currently expect.

Previous wording

During the three and six months ended June 30, 2024, there were no material changes to our critical accounting estimates as reported in our Annual Report on Form 10-K for the year ended December 31, 2023. For a full discussion of these estimates, see “Critical Accounting Estimates” within “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.

Current wording

During the three and nine months ended September 30, 2024, there were no material changes to our critical accounting estimates as reported in our Annual Report on Form 10-K for the year ended December 31, 2023. For a full discussion of these estimates, see “Critical Accounting Estimates” within “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.