Candel Therapeutics, Inc.

Previous wording

In December 2024, we announced positive topline data from our phase 3 clinical trial (DeWeese TL et al. Lancet Oncology (In press)). This randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled 745 patients (intent to treat population (ITT)) to evaluate the effectiveness and safety of aglatimagene plus prodrug (valacyclovir) viral immunotherapy in combination with SoC external beam radiation therapy to improve DFS in patients with intermediate- to high-risk (single high-risk feature), localized prostate cancer. Patients were randomized 2:1 (496 in aglatimagene+prodrug and 249 in placebo + prodrug). Both arms received standard-of-care external beam radiation therapy (EBRT) +/- short course androgen deprivation therapy (ADT) (≤6 months) and were stratified by NCCN risk group and ADT use. Three intraprostatic injections of aglatimagene (5x1011 vp/2mL) or placebo were administered, each followed by 14 days of prodrug.

Current wording

In December 2024, we announced positive topline data from our phase 3 clinical trial (DeWeese TL et al. Lancet Oncology 2026;27:673–685). This randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled 745 patients (intent to treat population (ITT)) to evaluate the effectiveness and safety of aglatimagene plus prodrug (valacyclovir) viral immunotherapy in combination with SoC external beam radiation therapy to improve DFS in patients with intermediate- to high-risk (single high-risk feature), localized prostate cancer. Patients were randomized 2:1 (496 in aglatimagene+prodrug and 249 in placebo + prodrug). Both arms received standard-of-care external beam radiation therapy (EBRT) +/- short course androgen deprivation therapy (ADT) (≤6 months) and were stratified by NCCN risk group and ADT use. Three intraprostatic injections of aglatimagene (5x1011 vp/2mL) or placebo were administered, each followed by 14 days of prodrug.

Previous wording

The median follow-up time for the recruited population was 50.3 months. The primary outcome measure, DFS, included the evaluation of post-treatment biopsies, performed at two years from the end of radiation, for the microscopic presence of tumor recurrence. Local or systemic recurrence and death from any cause were also part of the primary endpoint.

Current wording

The median follow-up time for the recruited population was 50.3 months. The primary outcome measure, DFS, included the evaluation of post-treatment biopsies, performed at two years from the end of radiation therapy, for the microscopic presence of tumor recurrence. Local or systemic recurrence and death from any cause were also part of the primary endpoint.

Previous wording

Statistically significant increase in the proportion of patients with a pathological complete response in 2-year post-treatment biopsies (80.4% in the aglatimagene arm vs. 63.6% in the control arm; p=0.0015)

Current wording

Statistically significant increase in the proportion of patients with a pathological complete response in 2-year post-treatment biopsies (80% in the aglatimagene arm vs. 63% in the control arm; p=0.0018)

Previous wording

We expect to announce supportive data on prostate cancer-specific outcomes (prostate cancer-specific DFS, time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy) after extended follow-up during a plenary oral presentation at the American Urological Association (AUA) 2026 Annual Meeting (Garzotto MG et al.) in May 2026.

Current wording

In May 2026, we announced updated clinical data on prostate cancer-specific outcomes (prostate cancer-specific DFS, time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy) from extended follow-up (data cutoff March 15, 2026) of the phase 3 trial during a plenary oral presentation at the American Urological Association (AUA) 2026 Annual Meeting (Garzotto MG et al.).

Previous wording

In addition, in the third quarter of 2026, we expect to present novel immunological biomarker data in patients with localized prostate cancer.

Current wording

In addition, in the third quarter of 2026, we will present novel immunological biomarker data in patients with localized prostate cancer at the 2026 ASTRO Annual Meeting.

Previous wording

We have initiated a phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution and shedding of aglatimagene plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive EBRT. The study aims to recruit up to 45 patients (30 in the treatment arm and 15 in the control arm treated with EBRT alone). Biosamples (blood, urine, semen) will be collected at specified timepoints. We anticipate that this data will be submitted as part of the BLA filing in the fourth quarter of 2026.

Current wording

We have initiated a phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution and shedding of aglatimagene plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive EBRT +/- short-term ADT. The study aims to recruit up to 45 patients (30 in the treatment arm and 15 in the control arm treated with EBRT+/-ADT alone). Biosamples (blood, urine, semen) will be collected at specified timepoints. We anticipate that the data generated during this clinical trial will be submitted as part of the BLA filing.

Previous wording

Based on these positive findings, we plan to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous NSCLC progressing on ICI treatment in the second quarter of 2026. Following an end-of-phase 2 meeting, the FDA acknowledged that this trial could serve as a registrational study for potential approval of aglatimagene in NSCLC.

Current wording

In June 2026, we activated our first trial site and opened enrollment for our pivotal phase 3 clinical trial (AURORA) of aglatimagene in patients with metastatic, non-squamous NSCLC progressing on ICI treatment. Following an end-of-phase 2 meeting, the FDA acknowledged that this trial could serve as a registrational study for potential approval of aglatimagene in NSCLC.

Previous wording

Our lead HSV-based product candidate, linoserpaturev (referred to previously as CAN-3110), is currently being evaluated in an ongoing investigator-sponsored phase 1b clinical trial in the initial target indication of recurrent high-grade glioma (HGG). Patients recruited in this study have previously failed SoC treatment and have a poor prognosis (expected overall survival < 6-9 months).

Current wording

Our lead HSV-based product candidate, linoserpaturev (referred to previously as CAN-3110), is currently being evaluated in an ongoing investigator-sponsored phase 1b clinical trial in the initial target indication of recurrent high-grade glioma (HGG).

Previous wording

We are conducting an extension of the clinical trial (arm C), in which patients with recurrent glioblastoma receive a repeat dosing regimen of linoserpaturev (up to six injections over four months). Clinical data from arm C will help evaluate whether multiple injections could further improve survival. This clinical trial extension is supported by the Break Through Cancer foundation. In October 2024, at the 16th Annual International Oncolytic Virotherapy Conference (IOVC), we presented initial clinical and biomarker data from Arm C of the linoserpaturev trial. The principal investigator reported improved survival compared to historical controls in patients who received multiple injections of linoserpaturev. Post-treatment longitudinal biopsies showed a near absence of tumor cells with dense lymphocyte infiltration, particularly in patients with post-treatment MRI enhancement, consistent with radiologic pseudo-progression. These findings were reported in a Science Translational Medicine manuscript published in October 2025, which followed two patients from Arm C through 97 serial tumor biopsies. Serial brain biopsy samples showed extensive immune-mediated remodeling of the tumor microenvironment after linoserpaturev administration, characterized by dense lymphocyte infiltration and extensive tumor cell death. One patient achieved a complete pathological response, with clearance of tumor cells from post-treatment biopsies. In contrast, MRI scans for both patients showed apparent tumor enlargement (pseudo-progression), underscoring that conventional imaging criteria may underestimate linoserpaturev’s anti-tumor activity. These results illustrate the limitations of conventional imaging in evaluating the response to viral immunotherapy in glioblastoma and highlight the importance of overall survival data, supported by histology, in this indication.

Current wording

We completed enrollment for the extension cohort of the clinical trial (arm C), in which patients with recurrent glioblastoma receive a repeat dosing regimen of linoserpaturev (up to six injections over four months). Clinical data from arm C will help evaluate whether multiple injections could further improve survival. This clinical trial extension is supported by the Break Through Cancer foundation. In October 2024, at the 16th Annual International Oncolytic Virotherapy Conference (IOVC), we presented initial clinical and biomarker data from Arm C of the linoserpaturev trial. The principal investigator reported improved survival compared to historical controls in patients who received multiple injections of linoserpaturev. Post-treatment longitudinal biopsies showed a near absence of tumor cells with dense lymphocyte infiltration, particularly in patients with post-treatment MRI enhancement, consistent with radiologic pseudo-progression. These findings were reported in a Science Translational Medicine manuscript published in October 2025, which followed two patients from Arm C through 97 serial tumor biopsies. Serial brain biopsy samples showed extensive immune-mediated remodeling of the tumor microenvironment after linoserpaturev administration, characterized by dense lymphocyte infiltration and extensive tumor cell death. One patient achieved a complete pathological response, with clearance of tumor cells from post-treatment biopsies. In contrast, MRI scans for both patients showed apparent tumor enlargement (pseudo-progression), underscoring that conventional imaging criteria may underestimate linoserpaturev’s anti-tumor activity. These results illustrate the limitations of conventional imaging in evaluating the response to viral immunotherapy in glioblastoma and highlight the importance of overall survival data, supported by histology, in this indication.

Previous wording

We have recently completed enrollment in arm C and expect to present mature mOS data and an update on long-term survivors in the fourth quarter of 2026.

Current wording

We expect to present data on potential long-term survivors in the fourth quarter of 2026.

Previous wording

In January 2026, we received clearance from the FDA for an IND that will support enabling work for a potential future randomized controlled phase 2 dose regimen finding study of linoserpaturev in recurrent glioblastoma.

Current wording

In January 2026, we received clearance from the FDA for an IND that supports enabling work for a potential future randomized controlled phase 2 dose regimen finding study of linoserpaturev in recurrent glioblastoma.

Previous wording

We were incorporated in Delaware in June 2003 as Advantagene, Inc. (Advantagene). In December 2019, Advantagene licensed substantially all the assets of Periphagen, a company focused on engineering HSV as a gene therapy vector, and in

Current wording

We were incorporated in Delaware in June 2003 as Advantagene, Inc. (Advantagene). In December 2019, Advantagene licensed substantially all the assets of Periphagen, a company focused on engineering HSV as a gene therapy vector, and in September 2020, licensed linoserpaturev from Mass General Brigham (MGB). In December 2020, we formally changed our name from Advantagene to Candel Therapeutics, Inc. We completed our initial public offering in July 2021.

Previous wording

On August 5, 2022, we filed a shelf registration statement on Form S-3 (as amended to date, the 2022 Shelf) with the U.S. Securities and Exchange Commission (SEC), which covered 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 2022 Shelf (the 2022 ATM Program). The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025. As of August 12, 2025, we had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, with total net proceeds of $20.9 million.

Current wording

On August 5, 2022, we filed a shelf registration statement on Form S-3 (as amended to date, the 2022 Shelf) with the U.S. Securities and Exchange Commission (SEC), which covered 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 2022 Shelf (the 2022 ATM Program). The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025. As of August 12, 2025, we had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, for total net proceeds of $20.9 million.

Previous wording

On August 14, 2025, we filed a shelf registration statement on Form S-3 (the 2025 Shelf) with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 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 $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf (the 2025 ATM Program). The 2025 Shelf was declared effective by the SEC on August 22, 2025. As of March 31, 2026 and through May 7, 2026, we have not sold any shares of common stock under the 2025 ATM Program.

Current wording

On August 14, 2025, we filed a shelf registration statement on Form S-3 (the 2025 Shelf) with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 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 $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf (the 2025 ATM Program). The 2025 Shelf was declared effective by the SEC on August 22, 2025. As of June 30, 2026, the Company has sold and issued 2,838,894 shares of common stock under the 2025 ATM Program, for total net proceeds of $24.2 million. Subsequent to June 30, 2026 and through August 11, 2026, the Company has sold and issued 617,345 additional shares of common stock under the 2025 ATM Program, for total net proceeds of $6.3 million.

Previous wording

Our cash and cash equivalents were $194.8 million as of March 31, 2026. We believe our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2028.

Current wording

Our cash and cash equivalents were $201.6 million as of June 30, 2026. We believe our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2028.

Previous wording

We expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our continued clinical development and manufacturing activities and to meet the requirements of a public company. We expect to incur increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Current wording

We expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our continued clinical development and manufacturing activities. We expect to continue to incur increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Previous wording

In connection with the October 14, 2025 Trinity LSA, we issued warrants to the Lenders to purchase up to 254,642 shares of our common stock, $0.01 pay value, at an exercise price of $5.89 per share. In connection with the drawdown of any Tranche under the Trinity LSA, the Company is required to issue to the Lenders warrants (the Lender Warrants) to purchase shares of the Company’s common stock, $0.01 par value per share. The exercise price for the Lender Warrants is equal to $5.89 per share. The number of shares of common stock for which each Lender Warrant is exercisable is equal to 3.0% of the applicable drawn down amount, divided by the exercise price. The Lender Warrants shall have a term of ten years from the date of issuance and shall permit cashless net exercise, all in accordance with their terms. 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 consolidated statements of operations. 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 is determined using a hybrid Monte Carlo simulation and Black-Scholes methodology, which incorporates assumptions and estimates to value the common stock warrants. Key inputs, estimates, and assumptions impacting the fair value measurement include the Company stock price, risk-free interest rate, expected dividend yield, volatility, remaining contractual term of the warrants, timing of milestone achievements, and expected stock price increases and decreases in success and failure scenarios related to the milestones.

Current wording

In connection with the October 14, 2025 Trinity LSA, we issued warrants to the Lenders to purchase up to 254,642 shares of our common stock, $0.01 par value, at an exercise price of $5.89 per share. In connection with the drawdown of any Tranche under the Trinity LSA, the Company is required to issue to the Lenders warrants (the Lender Warrants) to purchase shares of the Company’s common stock, $0.01 par value per share. The exercise price for the Lender Warrants is equal to $5.89 per share. The number of shares of common stock for which each Lender Warrant is exercisable is equal to 3.0% of the applicable drawn down amount, divided by the exercise price. The Lender Warrants shall have a term of ten years from the date of issuance and shall permit cashless net exercise, all in accordance with their terms. 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 consolidated statements of operations. 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 is determined using a hybrid Monte Carlo simulation and Black-Scholes methodology, which incorporates assumptions and estimates to value the common stock warrants. Key inputs, estimates, and assumptions impacting the fair value measurement include the Company stock price, risk-free interest rate, expected dividend yield, volatility, remaining contractual term of the warrants, timing of milestone achievements, and expected stock price increases and decreases in success and failure scenarios related to the milestones.

Previous wording

As of December 31, 2025, we had federal net operating loss carryforwards (NOLs) of approximately $141.1 million and state NOLs of approximately $131.2 million which may be available to offset future taxable income. Our federal NOLs include $8.8 million available to reduce future taxable income through 2037 and approximately $132.3 million of NOLs that do not expire and are available to reduce future taxable income indefinitely. The state NOLs are available to offset future taxable income through 2045. As of December 31, 2025, we also had federal and state research and development tax credit carryforwards of $5.7 million and $2.6 million, respectively, which are available to offset federal and state tax liabilities through 2045 and 2040, respectively.

Current wording

As of December 31, 2025, we had federal net operating loss carryforwards (NOLs) of approximately $141.1 million and state NOLs of approximately $131.2 million which may be available to offset future taxable income. Our federal NOLs include $8.8 million available to reduce future taxable income through 2037 and approximately $132.3 million of NOLs that do not expire and are available to reduce future taxable income indefinitely. The state NOLs are available to offset future taxable income through

Previous wording

Research and development expenses increased $5.8 million from $4.0 million for the three months ended March 31, 2025 to $9.8 million for the three months ended March 31, 2026. The increase was primarily attributable to a $3.6 million increase in clinical development costs driven by increased clinical trial, manufacturing and regulatory costs for aglatimagene programs, and a $2.0 million increase in employee-related expenses.

Current wording

Research and development expenses increased $12.8 million from $7.0 million for the three months ended June 30, 2025 to $19.8 million for the three months ended June 30, 2026. The increase was primarily attributable to a $10.0 million increase in clinical development costs driven by increased clinical trial, manufacturing and regulatory costs for aglatimagene programs, and a $2.9 million increase in employee-related expenses due to higher headcount and increased stock-based compensation expense.

Previous wording

General and administrative expenses increased $2.3 million from $4.1 million for the three months ended March 31, 2025 to $6.4 million for the three months ended March 31, 2026. The increase was primarily attributable to a $1.2 million increase in commercial readiness costs and a $0.7 million increase in employee-related expenses.

Current wording

General and administrative expenses increased $2.7 million from $4.2 million for the three months ended June 30, 2025 to $6.9 million for the three months ended June 30, 2026. The increase was primarily attributable to a $2.1 million increase in commercial readiness costs due to increased investments in launch preparation insight gathering, stakeholder engagement, and commercial consulting expenses and a $0.7 million increase in employee-related expenses due to higher headcount and increased stock-based compensation expense.

Previous wording

Interest income was $1.3 million and $0.9 million for the three months ended March 31, 2026 and 2025, respectively, and primarily represents earnings on our cash equivalents. The increase in interest income is the result of interest being generated on a higher cash equivalents balance for the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Current wording

Interest income was $1.7 million and $0.9 million for the three months ended June 30, 2026 and 2025, respectively, and represents earnings on our cash equivalents. The increase in interest income is the result of interest being generated on a higher average cash equivalents balance for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

Previous wording

Interest expense was $1.6 million and $0.3 million for the three months ended March 31, 2026 and 2025, respectively, and represents interest expense on our outstanding debt obligations. The increase in interest expense is the result of higher outstanding balance on the term loan payable under the Trinity LSA.

Current wording

Interest expense was $1.6 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively, and represents interest expense on our outstanding debt obligations. The increase in interest expense is primarily the result of higher outstanding balance on the term loan payable under the Trinity LSA.

Previous wording

The change in fair value of our warrant liabilities was a decrease of $7.6 million for the three months ended March 31, 2026, compared to a decrease of $14.9 million for the three months ended March 31, 2025. The change in fair value of the warrant liabilities is primarily driven by changes in the underlying value of our stock price, the remaining contractual term and lower volatility.

Current wording

The change in fair value of our warrant liabilities was an increase of $12.3 million for the three months ended June 30, 2026, compared to a decrease of $5.7 million for the three months ended June 30, 2025. The change in fair value of the warrant liabilities is primarily driven by changes in the underlying value of our stock price, the remaining contractual term and lower volatility.

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 aglatimagene 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. As of March 31, 2026, we had cash and cash equivalents of $194.8 million. 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 2028. We will require additional capital to commercialize aglatimagene in early localized prostate cancer, to advance the phase 3 trial for aglatimagene in NSCLC, and to advance the development of linoserpaturev beyond the current trials.

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 aglatimagene 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. As of June 30, 2026, we had cash and cash equivalents of $201.6 million. Based on current plans and assumptions, including increased planned investment in our clinical development and commercialization readiness activities, we continue to expect that our existing cash and cash equivalents will be sufficient to fund our current operating plan into the first quarter of 2028. We will require additional capital to commercialize aglatimagene in early localized prostate cancer, to support enrollment and conduct the phase 3 trial for aglatimagene in NSCLC, and to advance the development of linoserpaturev beyond the current trials.

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 March 31, 2026, we have raised approximately $385.9 million of gross proceeds from such transactions, including $15.9 million of government grants, $66.1 million from the sale of convertible preferred stock, $301.6 million from the sale of our common stock and accompanying pre-funded warrants, and $2.3 million from stock option exercises. Our cash and cash equivalents totaled $194.8 million as of March 31, 2026. We had $47.5 million of debt as of March 31, 2026.

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 June 30, 2026, we have raised approximately $410.9 million of gross proceeds from such transactions, including $15.9 million of government grants, $66.1 million from the sale of convertible preferred stock, $326.6 million from the sale of our common stock and accompanying pre-funded warrants, and $2.3 million from stock option exercises. Our cash and cash equivalents totaled $201.6 million as of June 30, 2026. We had $47.8 million of debt as of June 30, 2026.

Previous wording

On August 5, 2022, we filed the 2022 Shelf with the SEC, which covered 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 2022 Shelf. The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025. As of August 12, 2025, we had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, with total net proceeds of $20.9 million.

Current wording

On August 5, 2022, we filed the 2022 Shelf with the SEC, which covered 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 2022 Shelf. The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025. As of August 12, 2025, we had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, for total net proceeds of $20.9 million.

Previous wording

On August 14, 2025, we filed the 2025 Shelf with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 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 $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf. The 2025 Shelf was declared effective by the SEC on August 22, 2025. As of March 31, 2026 and through May 7, 2026, we have not sold any shares of common stock under the 2025 ATM Program. As market conditions permit, we may offer and sell securities under the 2025 Shelf, including through the 2025 ATM Program, in order to fund our operations or provide additional liquidity.

Current wording

On August 14, 2025, we filed the 2025 Shelf with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 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 $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf. The 2025 Shelf was declared effective by the SEC on August 22, 2025. As of June 30, 2026, the Company has sold and issued 2,838,894 shares of common stock under the 2025 ATM Program, for total net proceeds of $24.2 million. Subsequent to June 30, 2026 and through August 11, 2026, the Company has sold and issued 617,345 additional shares of common stock under the 2025 ATM Program, for total net proceeds of $6.3 million. As market conditions permit, we may offer and sell securities under the 2025 Shelf, including through the 2025 ATM Program, in order to fund our operations or provide additional liquidity.

Previous wording

As of March 31, 2026, we had an accumulated deficit of $239.2 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 June 30, 2026, we had an accumulated deficit of $278.2 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, launch and commercial readiness costs, 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 three months ended March 31, 2026 and 2025

Current wording

Cash Flows for the six months ended June 30, 2026 and 2025

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was $18.0 million, consisting primarily of net loss of $8.9 million and non-cash charges of $5.6 million, primarily related to the $7.6 million change in the fair value of our warrant liabilities and partially offset by non-cash stock compensation. Net cash used in operating activities was also impacted by $3.6 million in changes in operating assets and liabilities, primarily driven by a decrease of $3.9 million in accrued expenses and an increase of $1.3 million in prepaid expenses, partially offset by an increase of $1.7 million in accounts payable.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was $35.2 million, consisting primarily of net loss of $47.8 million and non-cash charges of $10.2 million, primarily related to the $4.6 million change in the fair value of our warrant liabilities and $4.3 million of non-cash stock compensation. Net cash used in operating activities was also impacted by $2.4 million in changes in operating assets and liabilities, primarily driven by an increase of $4.1 million in accounts payable, partially offset by an increase $1.1 million in prepaid expenses and other current assets.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $8.6 million, primarily consisting of a net income of $7.4 million and non-cash charges of $14.2 million, primarily related to the $14.9 million change in the fair value of our warrant liability and partially offset by non-cash stock compensation. Net cash used in operating activities was also impacted by $1.8 million in changes in operating assets and liabilities, primarily driven by a decrease of $2.4 million in accrued expenses and partially offset by an increase of $0.5 million in accounts payable.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 was $17.5 million, primarily consisting of a net income of $2.6 million and non-cash charges of $18.3 million, primarily related to the $20.6 million change in the fair value of our warrant liability and partially offset by $1.4 million of non-cash stock compensation. Net cash used in operating activities was also impacted by $1.8 million in changes in operating assets and liabilities, primarily driven by a decrease of $1.2 million in accrued expenses and partially offset by an increase of $1.5 million in accounts payable.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2026 was $0.7 million and consisted of the purchase of fixed assets.

Current wording

Net cash used in investing activities for the six months ended June 30, 2026 was $0.7 million and consisted of the purchase of fixed assets.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2025 was $3,000 and consisted of the purchase of fixed assets.

Current wording

Net cash used in investing activities for the six months ended June 30, 2025 was $34,000 and consisted of the purchase of fixed assets.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $93.8 million and consisted primarily of $93.8 million of net proceeds from the issuance of common stock in the 2026 Follow-On Offering.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $117.8 million and consisted primarily of $93.5 million of net proceeds from the issuance of common stock in the 2026 Follow-On Offering and $24.2 million of net proceeds from the issuance of common stock under our 2025 ATM Program.

Previous wording

Net cash used in financing activities for the three months ended March 31, 2025 was $1.9 million and consisted of $2.5 million of principal payments on our term loan with SVB, partially offset by $0.2 million of proceeds from option exercises and $0.4 million of net proceeds from the issuance of common stock under our 2022 ATM Program.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $15.6 million and consisted of $15.0 million of proceeds from the issuance of common stock in the Registered Direct Offering, before deducting expenses payable by us, $5.0 million of net proceeds from the issuance of common stock under our 2022 ATM Program, and $0.5 million of proceeds from option exercises, partially offset by $5.0 million of principal payments on our term loan with SVB.

Previous wording

We expect our operating expenses to increase substantially in the future in connection with our ongoing activities, particularly as we advance aglatimagene and linoserpaturev through research and development, clinical trials, and develop our manufacturing capabilities, as we research and as we prepare for potential marketing approval and potential commercialization. We also expect to incur additional costs associated with operating as a public company.

Current wording

We expect our operating expenses to increase substantially in the future in connection with our ongoing activities, particularly as we advance aglatimagene and linoserpaturev through research and development, clinical trials, and develop our manufacturing capabilities, as we research and as we prepare for potential marketing approval and potential commercialization. We also expect to continue to incur additional costs associated with operating as a public company.

Previous wording

We also enter into contracts in the normal course of business with hospitals, clinics, universities, and other third parties for clinical trials and testing and with construction contractors and process developers for the construction of our manufacturing facility. These contracts do not contain minimum purchase commitments and are cancelable by us upon prior written notice. Payments due upon cancelation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancelation. These payments are not included in the table above as the amount and timing of such payments are not known.

Current wording

We also enter into contracts in the normal course of business with contract research organizations, contract manufacturing organizations, and other third parties to assist in the performance of our research and development, manufacturing, and commercial activities. These contracts generally do not contain minimum purchase commitments and are cancelable by us upon prior written notice, subject in certain cases to required notice periods, binding purchase orders, or cancellation fees that we may be obligated to pay. Payments due upon cancelation consist of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancelation, and in certain cases may include cancellation fees. These payments are not included in the table above as the amount and timing of such payments are not known.

Previous wording

During the three months ended March 31, 2026, 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, 2025. 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, 2025.

Current wording

During the three and six months ended June 30, 2026, 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, 2025. 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, 2025.