CalciMedica, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-107334
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277617
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 122 previous paragraphs and 125 current paragraphs.
93 unchanged; 25 reworded; 7 added; 3 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
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 report
Other Income
Current report
Other Income (Expense)
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
Other Income (Expense)
Current report
Net Cash Provided by Investing Activities
Current report
Valuation of Common Warrants
Removed paragraphs (3)
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
Net Cash Used in Investing Activities
Previous report
Valuation of Warrants
Reworded paragraphs (25)
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 early 2026. Additionally, we have conducted a productive initial meeting with the FDA to present the findings from the Phase 2b CARPO trial and discuss the design of a pivotal trial in AP. Additional meetings with the FDA are anticipated in the second half of 2025, with alignment on the trial design anticipated around the end of the year.
Current 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.
Previous wording
Additionally, we have compiled additional preclinical data supporting the potential to use CRAC channel inhibition for both chronic and acute inflammatory and immunologic diseases. We have animal model data suggesting CRAC channel inhibition may be useful in treating chronic pancreatitis, rheumatoid arthritis, ulcerative colitis, allergic asthma, and traumatic brain injury. We have several available product candidates that may be suitable for potential oral dosing. Pending additional funding, we have paused IND enabling preclinical work on these compounds to focus resources on our clinical programs. We expect to continue certain research activities to validate CRAC channel inhibition as a potential mechanism in other promising inflammatory and immunologic diseases.
Current wording
Additionally, we have compiled additional preclinical data supporting the potential to use CRAC channel inhibition for both chronic and acute inflammatory and immunologic diseases. We have animal model data suggesting CRAC channel inhibition may be useful in treating pulmonary arterial hypertension, chronic pancreatitis, rheumatoid arthritis, ulcerative colitis, allergic asthma, and traumatic brain injury. We have several available product candidates that may be suitable for potential oral dosing. Pending additional funding, we have paused IND enabling preclinical work on these compounds to focus resources on our clinical programs. We expect to continue certain research activities to validate CRAC channel inhibition as a potential mechanism in other promising inflammatory and immunologic diseases.
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 “December Prospectus Supplement”) with the SEC on December 20, 2024 for an aggregate gross sales price of up to $4.45 million of shares of common stock to be sold pursuant to the ATM Facility. As of June 30, 2025, we sold an aggregate of 591,595 shares of common stock for net proceeds of $1.3 million after deducting $45,000 of commissions paid under the ATM Facility. As of June 30, 2025, the Company’s remaining capacity for sales of common stock pursuant to the December Prospectus Supplement was $3.45 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 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.
Previous wording
On February 28, 2025 (the “Closing Date”), the Company 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 the Company 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 the Company between October 1, 2025 and March 31, 2026, subject to, among other things, (a) the Company’s 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). The Company will make interest only payments until the 18 month anniversary of the Closing Date, subject to a 6-month extension upon the Company’s 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 the Company’s 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, 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”).
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 June 30, 2025, our operations have been funded primarily by aggregate net proceeds of $189.4 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 $11.0 million for the six months ended June 30, 2025. Included in the net loss for the six months ended June 30, 2025 were total operating expenses of $13.1 million and interest expense of $0.8 million, offset by a gain from the fair value adjustment to our warrant liability and promissory note of $2.2 million, interest income of $0.4 million and other income of $0.3 million. As of June 30, 2025, we had an accumulated deficit of $170.8 million and $18.0 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 middle 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 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.
Previous wording
Our other income includes (i) interest income and expense and changes in the fair value of the promissory note; (ii) changes in the fair value of our warrant liabilities; and (iii) other non-operating income.
Current wording
Our other income includes (i) interest income and expense and non-cash changes in the fair value of the promissory note; (ii) non-cash changes in the fair value of our warrant liabilities; and (iii) other non-operating income.
Previous wording
Research and development expenses were $4.1 million for the three months ended June 30, 2025, compared to $4.2 million for the three months ended June 30, 2024. The decrease of $0.1 million was due primarily to a decrease of $0.9 million in chemistry, manufacturing and control activities offset by an increase of $0.4 million in preclinical activities relating to Auxora and our oral compound, an increase of $0.2 million in personnel and consultants and other costs of $0.1 million.
Current wording
Research and development expenses were $3.9 million for the three months ended September 30, 2025, compared to $3.6 million for the three months ended September 30, 2024. The increase of $0.3 million was due primarily to an increase of $0.5 million in clinical trial and preclinical activities, offset by a decrease of $0.2 million in consultants and other costs.
Previous wording
General and administrative expenses were $2.6 million for the three months ended June 30, 2025, compared to $2.4 million for the three months ended June 30, 2024. The increase of $0.2 million was primarily related to an increase in personnel costs of $0.6 million partially offset by a decrease in professional services of $0.4 million.
Current 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.
Previous wording
Other income for the three months ended June 30, 2025 was income of $0.7 million, compared to $2.6 million for the three months ended June 30, 2024. The decrease of $1.9 million was due to a $1.8 million decrease in fair value adjustments to our financial instruments for the three months ended June 30, 2025, an increase in interest expense associated with our promissory note of $0.3 million and a decrease of $0.1 million of interest income as of June 30, 2025. These were offset by miscellaneous income of $0.3 million for the three months ended June 30, 2025.
Current 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.
Previous wording
Research and development expenses were $8.3 million for the six months ended June 30, 2025, compared to $7.1 million for the six months ended June 30, 2024. The increase of $1.2 million was due primarily to an increase of $1.0 million in preclinical and clinical trial related activities relating to Auxora and our oral compound, an increase of $0.3 million in consultants and other costs, and personnel of $0.2 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 $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.
Previous wording
General and administrative expenses were $4.8 million for the six months ended June 30, 2025, compared to $5.2 million for the six months ended June 30, 2024. The decrease of $0.4 million was primarily related to a decrease in consultants and other costs of $0.9 million driven by transactions costs associated with the 2024 Private Placement as of the six months ended June 30, 2024 and professional services of $0.4 million. These costs were partially offset by an increase in personnel costs of $0.9 million driven by increased headcount for the six months ended June 30, 2025.
Current wording
General and administrative expenses were $6.6 million for the nine months ended September 30, 2025, compared to $7.4 million for the nine months ended September 30, 2024. The decrease of $0.8 million was primarily related to a decrease in consultants and other costs of $1.1 million driven by transactions costs associated with the 2024 Private Placement as of the nine months ended September 30, 2024 and professional services of $0.7 million. These costs were partially offset by an increase in personnel costs of $1.0 million driven by non-cash stock based compensation of $0.5 million for the nine months ended September 30, 2025.
Previous wording
Other income for the six months ended June 30, 2025 was income of $2.1 million, compared to $8.5 million for the six months ended June 30, 2024. The decrease of $6.4 million was due to the fair value adjustments to our financial instruments which resulted in a net gain of $2.2 million compared to a $7.9 million gain for the six months ended June 30, 2025 and 2024, respectively. Additionally we had an increase in interest expense associated with our promissory note issued pursuant to the Loan Agreement of $0.8 million and a decrease in interest income of $0.2 million driven by the balances of our cash equivalents and short-term investments. These decreases were offset by miscellaneous income of $0.3 million for the six months ended June 30, 2025.
Current wording
Other income (expense) for the nine months ended September 30, 2025 was expense of $0.1 million, compared to other income of $8.6 million for the nine months ended September 30, 2024. The increase of $8.7 million in expenses was due to the non-cash fair value adjustments to our financial instruments which resulted in a net gain of $0.2 million compared to a $7.8 million gain for the nine months ended September 30, 2025 and 2024, respectively. Additionally, we had an increase in interest expense associated with our promissory note issued pursuant to the Loan Agreement of $1.1 million and a decrease in interest income of $0.2 million driven by the balances of our cash equivalents and short-term investments. These decreases were offset by miscellaneous income of $0.2 million for the nine months ended September 30, 2025.
Previous wording
As of June 30, 2025 we had cash, cash equivalents and short-term investments of $18.0 million.
Current wording
As of September 30, 2025 we had cash, cash equivalents and short-term investments of $14.1 million.
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. In March 2025, we sold an aggregate of 490,073 shares of common stock for net proceeds of $968,000 after deducting $32,000 of commissions and settlement expenses paid under the ATM Facility.
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 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.
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 middle 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, 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.
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 December Prospectus Supplement with the SEC on December 20, 2024 for an aggregate gross sales price of up to $4.45 million of shares of common stock to be sold pursuant to the ATM Facility. As of June 30, 2025, we sold an aggregate of 591,595 shares of common stock for net proceeds of $1.3 million after deducting $45,000 of commissions paid under the ATM Facility. As of June 30, 2025, the Company’s remaining capacity for sales of common stock pursuant to the December Prospectus Supplement was $3.45 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 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.
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)
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 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.
Previous wording
Our operations through June 30, 2025, have been funded primarily by aggregate net proceeds of $189.4 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 six months ended June 30, 2025 was $11.0 million and consisted of total operating expenses of $13.1 million and interest expense of $0.8 million offset by a gain from the fair value adjustment to our warrant liability and the promissory note of $2.2 million, interest income of $0.4 million and other income of $0.3 million. For the six months ended June 30, 2024, our net loss was $3.8 million consisting of $12.3 million of operating expenses offset by a gain from the fair value adjustment to our warrant liability of $7.9 million and interest income of $0.6 million. As of June 30, 2025, we had an accumulated deficit of $170.8 million and $18.0 million in cash, cash equivalents and short-term investments. During the six months ended June 30, 2025, cash used in operations was $11.5 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 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.
Previous wording
Cash used in operating activities of $11.5 million during the six months ended June 30, 2025 was attributable to our net loss of $11.0 million, non-cash items of $0.3 million and a net change in our operating assets and liabilities of $0.2 million. Non-cash items consisted primarily of $1.8 million and $0.4 million due to a change in our warrant liabilities and promissory note and accretion on our short term investments of $0.2 million offset by $1.7 million of stock-based compensation and promissory note issuance costs of $0.4 million as result of the debt financing in the first quarter of 2025.
Current 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.
Previous wording
Cash used in operating activities of $11.5 million during the six months ended June 30, 2024 was attributable to our net loss of $3.8 million, non-cash items of $6.6 million and a net change in our operating assets and liabilities of $1.1 million. Non-cash items consisted primarily of $7.9 million due to a change in our warrant liability as result of the 2024 Private Placement in the first quarter of 2024 and accretion on our short term investments of $0.4 million, offset by $0.8 million of transaction costs allocated to warrants and $0.9 million of stock-based compensation.
Current 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.
Previous wording
Cash used in investing activities of $1.1 million for the six months ended June 30, 2025 consisted of purchases of short-term investments of $14.0 million offset by the maturing of short-term investments of $12.9 million.
Current 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.
Previous wording
Cash used in investing activities of $8.0 million for the six months ended June 30, 2024 consisted of the purchase of short-term investments of $17.9 million, offset by maturing of short-term investments of $9.9 million.
Current 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.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2025 was $10.6 million comprised of the debt financing of $9.6 million and $1.0 million as a result of our ATM.
Current 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.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2024 was $19.1 million comprised of the sale and issuance of common stock of $20.4 million in the 2024 Private Placement and $0.1 million as a result of our ATM Facility, offset by transaction costs of $1.4 million.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2024 was $19.1 million comprised of the sale and issuance of common stock of $20.4 million in the 2024 Private Placement and $0.1 million as a result of our ATM Facility, offset by transaction costs of $1.4 million.
Previous wording
Our material cash requirements from known contractual obligations consisted 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 six months, we expect cash requirements for our lease obligation to be approximately $63,000.
Current 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.