CalciMedica, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing therapeutics that treat serious illnesses driven by inflammatory and immunologic processes and direct cellular damage. Our product candidates act upon calcium release-activated calcium (“CRAC”) channels and would constitute a new class of drugs.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing therapeutics for serious illnesses driven by inflammatory and immunologic processes and direct cellular damage. Our product candidates target calcium release-activated calcium (“CRAC”) channels and, if approved, would represent a new class of therapeutics.

Previous wording

Our lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. Multiple Phase 2 clinical trials with Auxora have been conducted: an open-label Phase 2a trial in acute pancreatitis (“AP”) with accompanying systematic inflammatory response syndrome (“SIRS”), an international, randomized, double-blind placebo-controlled Phase 2b trial in AP with SIRS (which we refer to as “CARPO”), an investigator led open-label Phase 1/2 trial in asparaginase-induced pancreatic toxicity (“AIPT”) (which we also refer to as “CRSPA”) in which the first cohort of patients has been completed, a placebo-controlled double-blind Phase 2 trial in severe COVID-19 pneumonia (which we also refer to as “CARDEA”) and an investigator led open-label Phase 2a trial in COVID-19 pneumonia patients with acute respiratory distress syndrome (“ARDS”). We observed in all of these trials that patients treated with Auxora experienced a reduction of organ damage and reduced time to recovery. We believe the consistency of the results we observed from these trials in two different acute critical care conditions are mutually supportive and reinforce our plans to further pursue the use of Auxora in several additional acute critical illnesses, including acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure (“AHRF”), in which we are currently conducting a Phase 2 trial (which we also refer to as “KOURAGE”) with data expected in the first half of 2026. Additionally, we have had positive engagement with the FDA regarding the design of a pivotal trial in AP. We expect to finalize the pivotal trial design in the first half of 2026.

Current wording

Our lead product candidate is Auxora, a potent and selective, intravenously formulated small-molecule CRAC channel inhibitor containing the active compound zegocractin (formerly CM4620). Auxora has been evaluated in multiple Phase 2 clinical trials across acute critical care settings, including acute pancreatitis (“AP”), severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity (“AIPT”), and acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure (“AHRF”). Results from these studies have informed our understanding of the pharmacologic profile of CRAC channel inhibition in acute inflammatory conditions.

Previous wording

In connection with the 2024 Follow-On, on October 30, 2024, we suspended sales of common stock under the ATM Facility pursuant to the Original Prospectus Supplement, and until December 20, 2024, did not offer for sale any shares of common stock pursuant to the ATM Agreement. We filed a prospectus supplement (the “2024 Prospectus Supplement”) to the Shelf Registration Statement with the SEC on December 20, 2024 providing for the sale of shares of common stock pursuant to the ATM Facility having an aggregate gross sales price of up to $4.45 million. As of September 30, 2025, we sold an aggregate of 861,652 shares of common stock for net proceeds of approximately $2.0 million, after deducting $146,000 of commissions and settlement expenses paid under the ATM Facility. As of September 30, 2025, approximately $2.6 million remained available under the ATM Facility for the offer and sale of shares of common stock pursuant to the 2024 Prospectus Supplement.

Current wording

In connection with the 2024 Follow-On, on October 30, 2024, we suspended sales of common stock under the ATM Facility pursuant to the Original Prospectus Supplement, and until December 20, 2024, did not offer for sale any shares of common stock pursuant to the ATM Agreement. We filed a prospectus supplement (the “2024 Prospectus Supplement”) with the SEC on December 20, 2024 for an aggregate gross sales price of up to $4,450,000 of shares of common stock to be sold pursuant to the ATM Facility. As of March 31, 2026, we sold an aggregate of 2,031,828 shares of common stock for net proceeds of approximately $5.8 million after deducting $292,000 of commissions and settlement expenses paid under the ATM Facility.

Previous wording

We filed a prospectus supplement (the “2025 Prospectus Supplement”) to the Shelf Registration Statement with the SEC on November 6, 2025 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $9.7 million.

Current wording

We filed a prospectus supplement (the “2025 Prospectus Supplement”) to the Shelf Registration Statement with the SEC on November 6, 2025 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $9.7 million. As of March 31, 2026, approximately $6.3 million remained available under the ATM Facility for the offer and sale of shares of common stock pursuant to the 2025 Prospectus Supplement.

Previous wording

On February 28, 2025 (the “Closing Date”), we entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund II, L.P. (“Lender”) and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $32,500,000 (the “Loan”), with (i) $10,000,000 funded on the Closing Date (“Tranche 1”), (ii) up to $7,500,000 to be made available to us between September 1, 2025 and March 31, 2026, subject to, among other things, the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials (“Tranche 2”) and (iii) up to $15,000,000 to be made available to us between October 1, 2025 and March 31, 2026, subject to, among other things, (a) our achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of us and the Lender (upon its investment committee approval). We will make interest only payments until the 18 month anniversary of the Closing Date, subject to a 6-month extension upon our achievement of certain milestones with respect to certain of its ongoing clinical trials and funding of the full amount under Tranche 2. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 5.00% plus the prime rate as reported in The Wall Street Journal and (b) 12.75%. The Loan is secured by a lien upon and security interest in all of our assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is September 1, 2028 (the “Maturity Date”).

Current wording

On February 28, 2025 (the “Closing Date”), we entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund II, L.P. (“Lender”) and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $32,500,000 (the “Loan”), with (i) $10,000,000 funded on the Closing Date (“Tranche 1”), (ii) up to $7,500,000 to be made available to us between September 1, 2025 and March 31, 2026, which was subject to, among other things, our achievement of certain milestones with respect to certain of its ongoing clinical trials (“Tranche 2”) and (iii) up to $15,000,000 to be made available to us between October 1, 2025 and March 31, 2026, which was subject to, among other things, (a) our achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of us and the Lender (upon its investment committee approval) (“Tranche 3”). In connection with the pause in enrollment in the KOURAGE trial, Tranche 2 and Tranche 3 are no longer available to us. We will make interest only payments until the 18 month anniversary of the Closing Date. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 5.00% plus the prime rate as reported in The Wall Street Journal and (b) 12.75%. The Loan is secured by a lien upon and security interest in all of our assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is September 1, 2028 (the “Maturity Date”).

Previous wording

Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Through September 30, 2025, our operations have been funded primarily by aggregate net proceeds of $190.2 million from the issuance of convertible preferred stock, convertible promissory notes, promissory notes, common stock, and the Merger. Since inception we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss was $18.8 million for the nine months ended September 30, 2025. Included in the net loss for the nine months ended September 30, 2025 were total operating expenses of $18.7 million and interest expense of $1.1 million, offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $0.2 million, interest income of $0.6 million and other income of $0.3 million. As of September 30, 2025, we had an accumulated deficit of $178.6 million and $14.1 million in cash, cash equivalents and short-term investments. We expect that our cash, cash equivalents and short-term investments will enable us to fund our current operating plan into the second half of 2026. As a result, there is substantial doubt about our ability to continue as a going concern.

Current wording

Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Through March 31, 2026, our operations have been funded primarily by aggregate net proceeds of $193.9 million from the issuance of convertible preferred stock, convertible promissory notes, promissory notes, warrants, common stock, and the Merger. Since inception we have had significant operating losses, except for the three month period ending March 31, 2026 and March 31, 2024. Our net income was $5.0 million for the three months ended March 31, 2026. Included in the net income for the three months ended March 31, 2026 were total operating expenses of $5.6 million and interest expense of $0.3 million, offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $10.8 million and interest income of $0.1 million. As of March 31, 2026, we had an accumulated deficit of $184.4 million and $8.2 million in cash and cash equivalents. We expect that our cash and cash equivalents will enable us to fund our current operating plan into the fourth quarter of 2026. As a result, there is substantial doubt about our ability to continue as a going concern.

Previous wording

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

Current wording

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses from operating activities for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

Previous wording

We have not had any products approved for sale and, therefore, have not generated any product revenue. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.

Current wording

We have not had any products approved for sale and, therefore, have not generated any product revenue. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs, reduce headcount, file for bankruptcy, reorganize, merge with another entity or cease operations.

Previous wording

successful enrollment and completion of our clinical trials for Auxora and any clinical trials for future product candidates;

Current wording

successful enrollment and completion of our clinical trials for our current product candidates or any future product candidates;

Previous wording

Research and development expenses were $12.1 million for the nine months ended September 30, 2025, compared to $10.6 million for the nine months ended September 30, 2024. The increase of $1.5 million was due primarily to an increase of $1.5 million in clinical trial and preclinical activities, an increase of $0.2 million in personnel costs and an increase in consultants and other costs of $0.1 million. These were all offset by a decrease of $0.3 million in chemistry, manufacturing and control activities in regard to our Phase 2 clinical trials of Auxora.

Current wording

Research and development expenses were $3.5 million for the three months ended March 31, 2026, compared to $4.2 million for the three months ended March 31, 2025. The decrease of $0.7 million was due primarily to a decrease of $0.5 million in preclinical and clinical trial activities relating to Auxora and our oral compound, a decrease of $0.3 million in chemistry, manufacturing and control and a decrease in consultants and other costs of $0.1 million offset by an increase of $0.2 million in personnel.

Previous wording

General and administrative expenses were $1.8 million for the three months ended September 30, 2025, compared to $2.2 million for the three months ended September 30, 2024. The decrease of $0.4 million was primarily related a decrease in professional services of $0.2 million and a decrease in consultants and other costs of $0.2 million.

Current wording

General and administrative expenses were $2.1 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily related to a decrease in personnel costs of $0.1 million and immaterial decreases in professional services, consultants and other costs and facilities totaling $0.1 million.

Previous wording

Other income (expense) for the three months ended September 30, 2025 was expense of $2.2 million, compared to other income of $0.1 million for the three months ended September 30, 2024. The increase of $2.3 million in other expenses was due to a non-cash $1.9 million increase in fair value adjustments to our financial instruments, which resulted in net expense of $2.0 million compared to $0.1 million expense for the three months ended September 30, 2025 and 2024, respectively, an increase in interest expense associated with our promissory note of $0.3 million for the three months ended September 30, 2025 and a decrease of $0.1 million of interest income as of September 30, 2025.

Current wording

Other income for the three months ended March 31, 2026 was $10.6 million, compared to $1.5 million for the three months ended March 31, 2025. The increase of $9.1 million was due to a $2.7 million and $6.4 increase in income resulting from a gain due to the fair value adjustments to our promissory note and common stock warrants, respectively, and an offsetting decrease in interest expense associated with our promissory note of $0.1 million and an increase of $0.1 million of interest income.

Previous wording

As further described below, on February 28, 2025, the Company entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P. for an initial $10.0 million of gross proceeds. During the three months ended September 30, 2025, we sold an aggregate of 270,057 shares of common stock for net proceeds of $777,000 after deducting $76,000 of commissions and settlement expenses paid under the ATM Facility. As of September 30, 2025, our remaining capacity for sales of common stock under the ATM Facility was $2.6 million. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales under the ATM Facility to $9.7 million.

Current wording

As further described below, on February 28, 2025, the Company entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P. for an initial $10.0 million of gross proceeds. During the three months ended March 31, 2026, there were no shares sold under the ATM Facility. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales under the ATM Facility to $9.7 million. As of March 31, 2026, our remaining capacity for sales of common stock under the ATM Facility was $6.3 million.

Previous wording

The accompanying unaudited condensed consolidated financial statements have been prepared on a basis which assumes we are a going concern and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to our ability to continue as a going concern. Based on our current operating plans, we believe our cash, cash equivalents and short-term investments may not be sufficient to fund our operations for the period one year following the issuance of the accompanying financial statements. Specifically, we expect that our cash, cash equivalents and short-term investments will allow us to fund the current operating plan into the second half of 2026. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. In addition, our current cash, cash equivalents and short-term investments will not be sufficient to fund any of our product candidates through regulatory approval, nor will it be sufficient to pursue additional indications for Auxora, nor will it be sufficient to fund clinical work on other product candidates in our portfolio aside from Auxora, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.

Current wording

The accompanying unaudited condensed consolidated financial statements have been prepared on a basis which assumes we are a going concern and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to our ability to continue as a going concern. Based on our current operating plans, we believe our cash and cash equivalents may not be sufficient to fund our operations for the period one year following the issuance of the accompanying financial statements. Specifically, we expect that our cash and cash equivalents will allow us to fund the current operating plan into the fourth quarter of 2026. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. In addition, our current cash and cash equivalents will not be sufficient to fund any of our product candidates through regulatory approval, nor will it be sufficient to pursue additional indications for Auxora, nor will it be sufficient to fund clinical work on other product candidates in our portfolio aside from Auxora, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.

Previous wording

We expect to finance our longer-term expected future cash requirements and obligations through a combination of existing cash, cash equivalents and short-term investments and equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. To continue to finance our operations, we will need to raise additional capital, which cannot be assured. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. However, we may be unable to raise additional funds or enter into such other arrangement when needed or on favorable terms, if at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.

Current wording

We expect to finance our longer-term expected future cash requirements and obligations through a combination of existing cash and cash equivalents and equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. To continue to finance our operations, we will need to raise additional capital, which cannot be assured. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. However, we may be unable to raise additional funds or enter into such other arrangement when needed or on favorable terms, if at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs, reduce headcount, file for bankruptcy, reorganize, merge with another entity or cease operations.

Previous wording

In connection with the 2024 Follow-On, on October 30, 2024, we suspended sales of common stock under the ATM Facility pursuant to the Original Prospectus Supplement, and until December 20, 2024, did not offer for sale any shares of common stock. We filed the 2024 Prospectus Supplement with the SEC on December 20, 2024 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $4.45 million of shares of common stock. As of September 30, 2025, we sold an aggregate of 861,652 shares of common stock for net proceeds of approximately $2.0 million, after deducting $146,000 of commissions and settlement expenses paid under the ATM Facility. As of September 30, 2025, our remaining capacity for sales of common stock under the ATM Facility was $2.6 million. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales of common stock under the ATM Facility of up to $9.7 million.

Current wording

In connection with the 2024 Follow-On, on October 30, 2024, we suspended sales of common stock under the ATM Facility pursuant to the Original Prospectus Supplement, and until December 20, 2024, did not offer for sale any shares of common stock. We filed the 2024 Prospectus Supplement with the SEC on December 20, 2024 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $4.45 million of shares of common stock. As of March 31, 2026, we sold an aggregate of 2,031,828 shares of common stock for net proceeds of approximately $5.8 million, after deducting $292,000 of commissions and settlement expenses paid under the ATM Facility. As of March 31, 2026, our remaining capacity for sales of common stock under the ATM Facility was $2.6 million. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales of common stock under the ATM Facility of up to $9.7 million.

Previous wording

On February 28, 2025, we entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $32,500,000, with (i) Tranche 1 for $10,000,000 funded on the Closing Date, (ii) Tranche 2 for up to $7,500,000 to be made available to the Company between September 1, 2025 and March 31, 2026, subject to, among other things, our achievement of certain milestones with respect to certain of its ongoing clinical trials and (iii) Tranche 3 for up to $15,000,000 to be made available to the Company between October 1, 2025 and March 31, 2026, subject to, among other things, (a) our achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of the Company and the Lender (upon its investment committee approval). We will make interest only payments until the 18 month anniversary of the Closing Date, subject to a 6-month extension upon our achievement of certain milestones with respect to certain of its ongoing clinical trials and funding of the full amount under Tranche 2. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 5.00% plus the prime rate as reported in The Wall Street Journal and (b) 12.75%. The Loan is secured by a lien upon and security interest in all of our assets, including intellectual property, subject to agreed exceptions. The Maturity Date of the Loan is September 1, 2028.

Current wording

On February 28, 2025, we entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $32,500,000, with (i) Tranche 1 for $10,000,000 funded on the Closing Date, (ii) Tranche 2 for up to $7,500,000 to be made available to us between September 1, 2025 and March 31, 2026, which was subject to, among other things, our achievement of certain milestones with respect to certain of our ongoing clinical trials and (iii) Tranche 3 for up to $15,000,000 to be made available to the Company between October 1, 2025 and March 31, 2026, which was subject to, among other things, (a) our achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of us and the Lender (upon its investment committee approval). In connection with the pause in enrollment in the KOURAGE trial,

Previous wording

Our operations through September 30, 2025, have been funded primarily by aggregate net proceeds of $190.2 million from the issuance of convertible preferred stock, convertible notes, promissory notes, common stock, and the Merger. Since inception, we have had significant operating losses, except for the three month period ending March 31, 2024. Our net loss for the nine months ended September 30, 2025 was $18.8 million and consisted of total operating expenses of $18.7 million and interest expense of $1.1 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $0.2 million, interest income of $0.6 million and other income of $0.2 million. For the nine months ended September 30, 2024, our net loss was $9.4 million consisting of $18.0 million of operating expenses offset by a non-cash gain from the fair value adjustment to our warrant liability of $7.8 million and interest income of $0.8 million. As of September 30, 2025, we had an accumulated deficit of $178.6 million and $14.1 million in cash, cash equivalents and short-term investments. During the nine months ended September 30, 2025, cash used in operations was $16.3 million, primarily due to cash outlays for operations. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Our operations through March 31, 2026, have been funded primarily by aggregate net proceeds of $193.9 million from the issuance of convertible preferred stock, convertible notes, promissory notes, warrants, common stock, and the Merger. Since inception, we have had significant operating losses, except for the three month period ending March 31, 2026 and 2024. Our net income for the three months ended March 31, 2026 was $5.0 million and consisted of total operating expenses of $5.6 million and interest expense of $0.3 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $10.8 million and interest income of $0.1 million. For the three months ended March 31, 2025, our net loss was $5.0 million consisting of $6.5 million of operating expenses and $0.4 million of interest expense offset by a non-cash gain from the fair value adjustment to our warrant liability of $1.7 million and interest income of $0.2 million. As of March 31, 2026, we had an accumulated deficit of $184.4 million and $8.2 million in cash and cash equivalents. During the three months ended March 31, 2026, cash used in operations was $4.9 million, primarily due to cash outlays for operations. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

Cash used in operating activities of $16.2 million during the nine months ended September 30, 2024 was attributable to our net loss of $9.4 million, non-cash items of $5.8 million and a net change in our operating assets and liabilities of $1.0 million. Non-cash items consisted primarily of $7.8 million due to a change in our warrant liability and accretion on our short term investments of $0.5 million offset by $1.7 million of stock-based compensation and transaction costs of $0.8 million as a result of the 2024 Private Placement in the first quarter of 2024.

Current wording

Cash used in operating activities of $4.9 million during the three months ended March 31, 2026 was attributable to our net income of $5.0 million and a net change in our operating assets and liabilities of $0.4 million offset by non-cash items of $10.3 million. Non-cash items consisted primarily of $10.8 million due to a change in the fair value of our financial instruments offset by $0.5 million of stock-based compensation expense.

Previous wording

Cash used in operating activities of $16.3 million during the nine months ended September 30, 2025 was attributable to our net loss of $18.8 million, offset by non-cash items of $2.2 million and a net change in our operating assets and liabilities of $0.3 million. Non-cash items consisted primarily of $2.3 million of stock-based compensation and debt issuance costs of $0.4 million as result of the debt financing in the first quarter of 2025 offset by $0.2 million due to a change in our warrant liabilities and accretion on our short term investments of $0.3 million.

Current wording

Cash used in operating activities of $4.9 million during the three months ended March 31, 2025 was attributable to our net loss of $5.0 million and non-cash items of $0.9 million offset by a net change in our operating assets and liabilities of $1.0 million. Non-cash items consisted primarily of $1.4 million and $0.3 million due to a change in our warrant liabilities and long term debt and accretion on our short term investments of $0.1 million offset by $0.6 million of stock-based compensation expense and debt costs of $0.3 million as a result of the debt financing in the first quarter of 2025.

Previous wording

Net Cash Provided by Investing Activities

Current wording

Net Cash Provided by (Used In) Investing Activities

Previous wording

Cash provided by investing activities of $0.7 million for the nine months ended September 30, 2024 consisted of the purchase of short-term investments of $18.8 million, offset by maturing of short-term investments of $19.5 million.

Current wording

Cash provided by investing activities of $1.5 million for the three months ended March 31, 2026 consisted of the maturing of short-term investments.

Previous wording

Cash provided by investing activities of $2.4 million for the nine months ended September 30, 2025 consisted of purchases of short-term investments of $17.8 million, offset by the maturing of short-term investments of $15.4 million.

Current wording

Cash used in investing activities of $1.2 million for the three months ended March 31, 2025 consisted of purchases of short-term investments of $6.6 million offset by the maturing of short-term investments of $5.4 million.

Previous wording

Cash provided by financing activities for the nine months ended September 30, 2025 was $11.5 million comprised of the debt financing of $9.7 million and $1.8 million as a result of our ATM.

Current wording

Cash provided by financing activities for the three months ended March 31, 2025 was $10.8 and comprised of the debt financing of $9.8 million and $1.0 million as a result of our ATM Facility.

Previous wording

Our material cash requirements from known contractual obligations consist primarily of our lease obligation. We lease office and laboratory space in La Jolla, California with monthly rent expense of approximately $10,000 pursuant to a 12 month lease agreement that commenced in January 2023 and was amended and renewed in December 2023 for an additional 12 month term with monthly rent expense of approximately $10,000. In December 2024, an amendment was executed for a 12 month term with monthly rent expense of approximately $10,500. Over the next three months, we expect cash requirements for our lease obligation to be approximately $32,000.

Current wording

Our material cash requirements from known contractual obligations consisted primarily of our lease obligation and Loan Agreement. We lease office space in La Jolla, California with monthly rent expense of approximately $4,375 pursuant to a lease agreement that commenced on March 1, 2026 for another 12 month term through February 28, 2027. We also relocated to smaller premises of approximately 691 square feet. Monthly rent expense of approximately $13,300 was paid for each of the first two months of 2026. Over the next 11 months, we expect cash requirements for our lease obligation to be approximately $48,000.

Previous wording

We are also a “smaller reporting company,” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), because both the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of June 30th. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

We are a “smaller reporting company,” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), because both the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of June 30th. As a smaller reporting company, we may rely on exemptions from certain disclosure requirements that are available to smaller reporting companies, including only presenting the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K, simplified executive compensation disclosures and being exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that an independent registered public accounting firm provide an attestation report on the effectiveness of internal control over financial reporting.