CalciMedica, Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
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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.
Jun 30, 2026 · Filed Aug 11, 2026
CALC$1.36+4.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219426
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-344689
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 127 previous paragraphs and 136 current paragraphs.
91 unchanged; 26 reworded; 16 added; 9 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 4 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 (16)
Current report
Our pipeline includes Auxora, a potent and selective small-molecule CRAC channel inhibitor formulated for intravenous administration whose active compound is zegocractin (formerly CM4620), and CM5480, a proprietary, selective oral small-molecule CRAC channel inhibitor. Auxora has been evaluated in multiple Phase 2 clinical trials in acute and critical-care settings, including acute pancreatitis (“AP”), severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity, and acute kidney injury (“AKI”). Following feedback from the FDA in July 2026, we are advancing preparations for a potential Phase 2b clinical trial evaluating Auxora in AP, which is intended to inform the design of a potential Phase 3 development program. We also plan to evaluate Auxora in a Phase 1b proof-of-concept study in patients with pulmonary arterial hypertension (“PAH”), with data expected in mid-2027.
Current report
CM5480 is being developed as a potential chronic oral therapy for pulmonary hypertension, including pulmonary arterial hypertension and combined pre- and post-capillary pulmonary hypertension associated with heart failure with preserved ejection fraction. We expect to submit an investigational new drug application for CM5480 in mid-2027. Through our pulmonary hypertension program, we aim to establish CRAC channel inhibition as a differentiated therapeutic approach targeting both pulmonary vascular remodeling and right ventricular dysfunction.
Current report
In July 2026, following a Type C focused meeting with the U.S. Food and Drug Administration (“FDA”), we announced that we and FDA had aligned on certain design features of the next clinical trial in our planned development program for Auxora in AP. FDA aligned on new-onset severe respiratory failure as the primary endpoint for the planned Phase 2b trial, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. FDA also aligned on a strategy to prospectively evaluate elevated lactate dehydrogenase (“LDH”) as a potential enrichment marker for identifying patients at increased risk of new-onset severe respiratory failure. The planned Phase 2b trial is intended to confirm patient selection criteria and inform the endpoints and other design features for a potential Phase 3 program. Additional Phase 3 program design features remain subject to future discussions with FDA. We are advancing preparations for the Phase 2b trial, including engaging with a contract research organization and holding discussions with potential clinical sites. Initiation of the Phase 2b trial is subject to our ability to obtain additional financing.
Current report
We may also continue selective research activities to evaluate CRAC channel inhibition in other inflammatory, immunologic and cardiopulmonary indications.
Current report
In March 2026, we submitted an amendment to the KOURAGE protocol to address design issues, including refinements to patient inclusion criteria and changes to the stratification methodology. The submission also included a comprehensive safety assessment of the 107 patients who had been dosed prior to the pause in enrollment, including cause-of-death information for all deaths and an analysis of serious adverse events (“SAEs”). Based on our review, the observed SAEs were consistent with previous clinical experience with Auxora and did not appear to be drug related. Following the applicable review period, the FDA notified us that it had no comments or questions regarding the submission and issued no clinical hold communication. Accordingly, dosing may resume under the amended protocol. We are evaluating the future development of Auxora in AKI but have no current plans to resume dosing in the KOURAGE trial as we prioritize other development programs, including our planned pulmonary hypertension program for Auxora and CM5480.
Current report
On June 23, 2026, we amended the Loan Agreement to extend the interest-only period by one year through September 30, 2027 and extend the maturity date to September 1, 2029. The amendment also modified certain conversion features and increased the final payment fee payable at maturity or repayment. Management believes the amendment provides additional financial flexibility by deferring scheduled principal repayments while maintaining access to the existing debt financing.
Current report
On June 25, 2026, we completed a PIPE Financing pursuant to a Securities Purchase Agreement dated June 23, 2026 with certain new and existing institutional and accredited investors. Gross proceeds from the financing were approximately $15.0 million before deducting placement agent fees and other offering expenses. At the closing of the PIPE Financing, we issued an aggregate of 18,673,429 units at a purchase price of $0.8033 per unit (or $0.8032 per unit for units including a pre-funded warrant). Each unit consisted of (a) one share of our common stock or, at the election of the investor, one pre-funded warrant to purchase one share of common stock, (b) and a contractual right to receive one Series A and Series B warrant upon receipt of the required stockholder approval under Nasdaq Listing Rule 5635. We issued 14,938,370 shares of common stock and 3,735,059 pre-funded warrants at the closing of the financing. The pre-funded warrants have an exercise price of $0.0001 per share, are immediately exercisable, do not expire and are exercisable for cash or, under certain circumstances, on a cashless basis. The pre-funded warrants contain customary anti-dilution adjustments for stock splits, stock dividends and similar recapitalization events and include beneficial ownership limitations that prohibit exercise if the holder would beneficially own more than a specified percentage of our outstanding common stock, unless such limitation is waived in accordance with the terms of the warrants.
Current report
Other Income (Expense)
Current report
Other Income (Expense)
Current report
Other income (expense) for the three months ended June 30, 2026 was $3.6 million of expense compared to $0.7 million of income for the three months ended June 30, 2025. The decrease of $4.3 million was due to a $3.6 million loss from fair value adjustments to our financial instruments for the three months ended June 30, 2026, compared to a $0.5 million gain in the three months ended June 30, 2025 and a decrease in interest income of $0.2 million driven by the balances of our short term investments and cash equivalents.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
Research and development expenses were $5.6 million for six months ended June 30, 2026, compared to $8.3 million for the six months ended June 30, 2025. The decrease of $2.7 million was due primarily to a decrease of $1.9 million in preclinical and clinical trial related activities related to Auxora and the end of our clinical trial for AKI, a decrease of $0.3 million in chemistry, manufacturing and control activities in regard to our Phase 2 clinical trials of Auxora and consultants and other costs and personnel of $0.5 million.
Current report
General and administrative expenses were $4.0 million for the six months ended June 30, 2026, compared to $4.8 million for the six months ended June 30, 2025. The decrease of $0.8 million was primarily related to a decrease in personnel and consultants and other costs of $0.8 million and facilities of $0.1 million. These costs were partially offset by an increase in professional services of $0.1 million.
Current report
On June 23, 2026, we amended the Loan Agreement to extend the interest-only period by one year through September 30, 2027 and extend the maturity date to September 1, 2029. The amendment also modified certain conversion features and increased the final payment fee payable at maturity or repayment. Management believes the amendment provides additional financial flexibility by deferring scheduled principal repayments while maintaining access to the existing debt financing.
Current report
On June 25, 2026, we completed a PIPE Financing pursuant to a Securities Purchase Agreement dated June 23, 2026 with certain new and existing institutional and accredited investors. Gross proceeds from the financing were approximately $15.0 million before deducting placement agent fees and other offering expenses. At the closing of the PIPE Financing, we issued an aggregate of 18,673,429 units at a purchase price of $0.8033 per unit (or $0.8032 per unit for units including a pre-funded warrant). Each unit consisted of (a) one share of our common stock or, at the election of the investor, one pre-funded warrant to purchase one share of common stock, (b) and a contractual right to receive one Series A and Series B warrant upon receipt of the required stockholder approval under Nasdaq Listing Rule 5635. We issued 14,938,370 shares of common stock and 3,735,059 pre-funded warrants at the closing of the financing. The pre-funded warrants have an exercise price of $0.0001 per share, are immediately exercisable, do not expire and are exercisable for cash or, under certain circumstances, on a cashless basis. The pre-funded warrants contain customary anti-dilution adjustments for stock splits, stock dividends and similar recapitalization events and include beneficial ownership limitations that prohibit exercise if the holder would beneficially own more than a specified percentage of our outstanding common stock, unless such limitation is waived in accordance with the terms of the warrants.
Current report
Cash provided by financing activities for the six months ended June 30, 2026 was $15.0 million and comprised of the PIPE financing and issuance of common stock of $12.0 million and the issuance of pre-funded warrants of $3.0 million.
Removed paragraphs (9)
Previous report
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 report
We are continuing development activities in AP and have engaged with the U.S. Food and Drug Administration (“FDA”) regarding the design of a potential pivotal program in AP, with FDA feedback on program design expected in the second quarter of 2026.
Previous report
In parallel, we have generated preclinical data supporting the potential application of CRAC channel inhibition in both chronic and acute inflammatory and immunologic diseases. These efforts include animal model data suggesting potential relevance in pulmonary arterial hypertension (“PAH”), chronic pancreatitis, rheumatoid arthritis, ulcerative colitis, allergic asthma, and traumatic brain injury. Our current nonclinical development efforts are focused on CM5480, an oral CRAC channel inhibitor being advanced for the treatment of pulmonary hypertension, including PAH and other forms of pulmonary hypertension associated with cardiopulmonary disease, with submission of an Investigational New Drug application (“IND”) currently anticipated in 2027,subject to raising additional funds. We also expect to continue selective research activities to further evaluate CRAC channel inhibition across other inflammatory and immunologic indications.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income
Previous report
Cash provided by financing activities for the three months ended March 31, 2026 was nil and comprised of an immaterial exercise of pre-funded warrants.
Reworded paragraphs (26)
Previous 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.
Current wording
We are a clinical-stage biopharmaceutical company focused on developing therapeutics for serious acute and chronic inflammatory, immunologic and cardiopulmonary diseases. Our product candidates target calcium release-activated calcium (“CRAC”) channels and, if approved, would represent a new class of therapeutics.
Previous wording
Clinical and preclinical data suggest that inhibition of CRAC channels may have therapeutic potential through a dual mechanism involving modulation of inflammatory signaling and protection of tissue cells from calcium-mediated injury. Dysregulated CRAC channel signaling has been implicated in a range of acute and chronic diseases characterized by immune activation, inflammation, and cellular injury. We seek to leverage our CRAC channel inhibitor platform to develop therapies for indications in which these pathways are clinically relevant.
Current wording
Clinical and preclinical data suggest that inhibition of CRAC channels may have therapeutic potential through a dual mechanism involving modulation of inflammatory signaling and protection of tissue cells from calcium-mediated injury. Dysregulated CRAC channel signaling has been implicated in a range of acute and chronic diseases characterized by immune activation, inflammation, vascular dysfunction, fibrosis, remodeling, and cellular injury. We seek to leverage our CRAC channel inhibitor platform to develop therapies for indications in which these pathways are clinically relevant.
Previous wording
In January 2026, following a recommendation from the Independent Data Monitoring Committee (“IDMC”), we paused enrollment in the KOURAGE Phase 2 clinical trial evaluating Auxora in patients with AKI and AHRF due to a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and our comprehensive review, performed in conjunction with external experts, reached the same conclusion. Imbalances in the patients’ severity of disease at baseline may have contributed to the observed safety concern. We expect feedback from the FDA regarding potential future development of Auxora in AKI in the second quarter of 2026.
Current wording
In January 2026, following a recommendation from the Independent Data Monitoring Committee (“IDMC”), we paused enrollment in the KOURAGE Phase 2 clinical trial evaluating Auxora in patients with AKI and AHRF due to a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and our comprehensive review, performed in conjunction with external experts, reached the same conclusion. Our review also identified imbalances in patients’ baseline disease severity that informed revisions to the protocol design.
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”) 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.
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 June 30, 2026, we sold an aggregate of 2,080,943 shares of common stock for net proceeds of approximately $5.8 million after deducting $294,000 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. 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.
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 June 30, 2026, approximately $6.2 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, 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”).
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 our 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. 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.
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 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.
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 June 30, 2026, our operations have been funded primarily by aggregate net proceeds of $207.6 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 loss was $2.7 million for the six months ended June 30, 2026. Included in the net loss for the six months ended June 30, 2026 were total operating expenses of $9.6 million, interest expense of $0.6 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $7.2 million, interest income of $0.2 million and other income of $0.2 million. As of June 30, 2026, we had an accumulated deficit of $192.0 million and $18.6 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 second half of 2027. 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 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.
Current wording
Our other income (expense) 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 $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.
Current wording
Research and development expenses were $2.1 million for the three months ended June 30, 2026, compared to $4.1 million for the three months ended June 30, 2025. The decrease of $2.0 million was due primarily to a decrease of $1.4 million in preclinical activities relating to Auxora and the pause in enrollment in our clinical trial for AKI and a decrease of $0.6 million in personnel and consultants and other costs.
Previous 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.
Current wording
General and administrative expenses were $1.9 million for the three months ended June 30, 2026, compared to $2.6 million for the three months ended June 30, 2025. The decrease of $0.7 million was primarily related to a decrease in personnel and consultants and other costs of $0.8 million partially offset by an increase in professional services of $0.1 million.
Previous 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.
Current wording
Other income for the six months ended June 30, 2026 was $6.9 million, compared to other income of $2.1 million for the six months ended June 30, 2025. The increase of $4.8 million was due to the fair value adjustments to our financial instruments which resulted in a net gain of $7.2 million compared to a $2.2 million gain for the six months ended June 30, 2026 and 2025, respectively. Additionally there was a decrease in interest expense associated with our promissory note of $0.1 million. These were both offset by a decrease in interest income of $0.3 million driven by the balances of our cash equivalents and short-term investments.
Previous wording
As of March 31, 2026 we had cash and cash equivalents of $8.2 million.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $18.6 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. 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.
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. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales under the ATM Facility to $9.7 million. During the six months ended June 30, 2026 there were 49,115 shares sold under the ATM Facility for net proceeds of $0.03 million, after deducting negligible commissions and settlement expenses. As of June 30, 2026, our remaining capacity for sales of common stock under the ATM Facility was $6.2 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 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.
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 a period of one year following the issuance of the accompanying financial statements. Specifically, we expect that our cash and cash equivalents will allow us to fund our current operating plan into the second half of 2027. 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
the progress, costs and results of our ongoing clinical trials of Auxora and our planned trials for our other product candidates;
Current wording
the progress, costs and results of our ongoing and planned clinical trials of Auxora and our ongoing and planned preclinical studies and clinical trials for our other product candidates, including CM5480;
Previous wording
the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our product candidates, including our ongoing clinical trials of Auxora;
Current wording
the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our product candidates, including our ongoing and planned clinical trials of Auxora and our ongoing and planned preclinical studies and clinical trials of CM5480;
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 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.
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 June 30, 2026, we sold an aggregate of 2,080,943 shares of common stock for net proceeds of approximately $5.8 million, after deducting $294,000 of commissions and settlement expenses paid under the ATM Facility. As of June 30, 2026, our remaining capacity for sales of common stock under the ATM Facility was $6.2 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. Our ability to make sales under the ATM Facility is dependent on a number of factors as set forth in the ATM Facility, and in connection with the PIPE Financing, we agreed to refrain from making sales of equity securities, including under our ATM Facility, for a certain period of time following the effectiveness of a registration statement on Form S-3 to register the resale of shares purchased by investors in the PIPE Financing.
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 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,
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, Tranche 2 and Tranche 3 are no longer available to the Company. 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.
Previous 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.
Current wording
Our operations through June 30, 2026, have been funded primarily by aggregate net proceeds of $207.6 million from the issuance of convertible preferred stock, convertible notes, promissory notes, warrants, common stock, and the Merger. Since inception, we have had significant net losses, except for the three month period ended March 31, 2026 and 2024. Our net loss for the six months ended June 30, 2026 was $2.7 million and consisted of total operating expenses of $9.6 million, interest expense of $0.6 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $7.2 million, interest income of $0.2 million and other income of $0.2 million. As of June 30, 2026, we had an accumulated deficit of $192.0 million and $18.6 million in cash and cash equivalents. During the six months ended June 30, 2026, cash used in operations was $9.5 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.
Previous 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.
Current wording
Cash used in operating activities of $9.5 million during the six months ended June 30, 2026 was attributable to our net loss of $2.7 million, non-cash items of $6.1 million and a net change in our operating assets and liabilities of $0.7 million. Non-cash items consisted primarily of $6.7 million and $0.5 million due to a change in our warrant and promissory note liabilities offset by $1.1 million of stock-based compensation.
Previous 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.
Current 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 debt issuance costs of $0.4 million as result of the debt financing in the first quarter of 2025.
Previous 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.
Current wording
Investing activities of $1.5 million for the six months ended June 30, 2026 consisted of the maturing of our short-term investments.
Previous 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.
Current wording
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.
Previous 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.
Current wording
Cash provided by financing activities for the six months ended June 30, 2025 was $10.6 million and comprised of the debt financing of $9.6 million and $1.0 million as a result of our ATM Facility.
Previous 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.
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 8 months, we expect cash requirements for our lease obligation to be approximately $35,000.
Previous wording
Pursuant to the terms of the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P., we will make interest only payments until the 18 month anniversary of the Closing Date and we will be required to make principal payments beginning in October 2026. The maturity date of the Loan is September 2028.
Current wording
Pursuant to the terms of the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P., as amended, we will make interest only payments through September 2027 and we will be required to make principal payments beginning in October 2027. The maturity date of the Loan is September 2029.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The following sets forth our results of operations (in thousands):
Current report — wording carried from elsewhere
Research and development expenses comprised (in thousands):
Current report — wording carried from elsewhere
General and administrative expenses to support our business activities comprised (in thousands):
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Tranche 2 and Tranche 3 are no longer available to the Company. 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.