CalciMedica, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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, 2026 · Filed Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-455490
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 136 previous paragraphs and 139 current paragraphs.
82 unchanged; 48 reworded; 8 added; 6 removed; 0 previous and 1 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 (8)
Current report
At the 2026 Annual Meeting of Stockholders held on August 19, 2026, our stockholders approved, among other things, (a) the issuance of Series A Warrants to purchase up to an aggregate of 3,734,678 shares of common stock and Series B Warrants to purchase up to an aggregate of 3,734,678 shares of common stock pursuant to the Securities Purchase Agreement, including issuances to certain directors and officers of the Company, and (b) the issuance of shares of common stock upon exercise of such Series A Warrants and Series B Warrants, or in lieu thereof, pre-funded warrants to purchase shares of common stock and the shares of common stock issuable upon exercise thereof, in each case, pursuant to Nasdaq Listing Rule 5635(d). Following receipt of such stockholder approval, we issued (a) Series A Warrants to purchase up to 3,734,678 shares of common stock (or pre-funded warrants in lieu thereof), with an exercise price of $4.0165 per share, and (b) Series B Warrants to purchase up to 3,734,678 shares of common stock (or pre-funded warrants in lieu thereof), with an exercise price of $5.00 per share. The Series A Warrants and Series B Warrants became exercisable upon issuance and are subject to customary anti-dilution adjustments, beneficial ownership limitations and other customary terms contained in the respective warrant agreements. The Series A Warrants will expire on the earlier of (i) December 25, 2027 and (ii) 30 days following our public announcement of the clearance of our Investigational New Drug Application by the U.S. Food and Drug Administration for CM5480. The Series B Warrants will expire on June 25, 2031.
Current report
We filed the 2026 Prospectus Supplement to the 2026 Shelf Registration Statement with the SEC on September 30, 2026 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross offering price of up to $25.0 million.
Current report
On August 27, 2026, we filed a Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a 1-for-5 reverse stock split of our issued and outstanding common stock (the "Reverse Stock Split") and a reduction in the total number of authorized shares of our common stock from 500,000,000 to 100,000,000. The Reverse Stock Split became effective at 5:00 p.m. Eastern Time on August 28, 2026, and our common stock began trading on the Nasdaq Capital Market on a post-Reverse Stock Split basis when the market opened on August 31, 2026. Except as otherwise noted or the context otherwise requires, all share and per share amounts in this Quarterly Report on Form 10-Q give retroactive effect to the Reverse Stock Split.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $13.8 million.
Current report
Continued losses or declines in stockholders’ equity could require us to raise capital sooner than anticipated to maintain compliance with Nasdaq’s listing standards. Failure to maintain compliance could result in delisting, reduce the liquidity of our common stock and further impair our ability to raise capital. See Part II, Item 1A, “Risk Factors.”
Current report
At the 2026 Annual Meeting of Stockholders held on August 19, 2026, our stockholders approved, among other things, (a) the issuance of Series A Warrants to purchase up to an aggregate of 3,734,678 shares of common stock and Series B Warrants to purchase up to an aggregate of 3,734,678 shares of common stock pursuant to the Securities Purchase Agreement, including issuances to certain directors and officers of the Company, and (b) the issuance of shares of common stock upon exercise of such Series A Warrants and Series B Warrants, or in lieu thereof, pre-funded warrants to purchase shares of common stock and the shares of common stock issuable upon exercise thereof, in each case, pursuant to Nasdaq Listing Rule 5635(d). Following receipt of such stockholder approval, we issued (a) Series A Warrants to purchase up to 3,734,678 shares of common stock (or pre-funded warrants in lieu thereof), with an exercise price of $4.0165 per share, and (b) Series B Warrants to purchase up to 3,734,678 shares of common stock (or pre-funded warrants in lieu thereof), with an exercise price of $5.00 per share. The Series A Warrants and Series B Warrants became exercisable upon issuance and are subject to customary anti-dilution adjustments, beneficial ownership limitations and other customary terms contained in the respective warrant agreements. The Series A Warrants will expire on the earlier of (i) December 25, 2027 and (ii) 30 days following our public announcement of the clearance of our Investigational New Drug Application by the U.S. Food and Drug Administration for CM5480. The Series B Warrants will expire on June 25, 2031.
Current report
We filed the 2026 Prospectus Supplement to the 2026 Shelf Registration Statement with the SEC on September 30, 2026 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross offering price of up to $25.0 million.
Removed paragraphs (6)
Previous 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. 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 report
Other Income (Expense)
Previous report
Other Income (Expense)
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Other Income
Previous report
As of June 30, 2026, we had cash and cash equivalents of $18.6 million.
Reworded paragraphs (48)
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, 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.
Current wording
Clinical and nonclinical 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
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 wording
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 (“AIPT”), 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 hypertension (“PH”). Details on this trial and the target patient population are expected by year-end 2026, with data anticipated in mid-2027.
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. Our review also identified imbalances in patients’ baseline disease severity that informed revisions to the protocol design.
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 acute hypoxemic respiratory failure (“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 January 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors, in which we sold the following securities to the accredited investors in a private placement transaction (the “2024 Private Placement”): (i) an aggregate of 4,985,610 shares of our common stock; (ii) to certain investors, in lieu of shares, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 306,506 shares of our common stock; (iii) Tranche A Common Warrants (the “Tranche A Common Warrants”) to purchase an aggregate of up to 2,646,058 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants); and (iv) Tranche B Common Warrants (the “Tranche B Common Warrants” and together with the Tranche A Common Warrants, the “Common Warrants”) to purchase an aggregate of up to 2,646,058 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants). The purchase price per share and accompanying Common Warrants was $3.827 (or $4.3915 for directors, employees or consultants participating in the 2024 Private Placement) (or $3.8269 per Pre-Funded Warrant and accompanying Common Warrants, which represented the price of $3.827 per share and accompanying Common Warrants minus the $0.0001 per share exercise price of each such Pre-Funded Warrant).
Current wording
In January 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors, in which we sold the following securities to the accredited investors in a private placement transaction (the “2024 Private Placement”): (i) an aggregate of 997,122 shares of our common stock; (ii) to certain investors, in lieu of shares, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 61,301 shares of our common stock; (iii) Tranche A Common Warrants (the “Tranche A Common Warrants”) to purchase an aggregate of up to 529,211 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants); and (iv) Tranche B Common Warrants (the “Tranche B Common Warrants” and together with the Tranche A Common Warrants, the “Common Warrants”) to purchase an aggregate of up to 529,211 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants). The purchase price per share and accompanying Common Warrants was $19.135 (or $21.9575 for directors, employees or consultants participating in the 2024 Private Placement) (or $19.1345 per Pre-Funded Warrant and accompanying Common Warrants, which represented the price of $19.135 per share and accompanying Common Warrants minus the $0.0005 per share exercise price of each such Pre-Funded Warrant).
Previous wording
On November 1, 2024, we closed an underwritten public offering of 2,720,000 shares of our common stock at a price to the public of $3.75 per share pursuant to the Shelf Registration Statement (the “2024 Follow-On”). The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were $10.2 million.
Current wording
On November 1, 2024, we closed an underwritten public offering of 544,000 shares of our common stock at a price to the public of $18.75 per share pursuant to the Shelf Registration Statement (the “2024 Follow-On”). The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were $10.2 million.
Previous wording
In August 2023, we filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”), which contains two prospectuses, a base prospectus and an at the market offering prospectus, as supplemented on March 29, 2024 (as supplemented, the “Original Prospectus Supplement”) that covered the offering, issuance and sale of up to $17.3 million of common stock pursuant to an at the market offering agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) acting as sales agent (the “ATM Facility”). The Shelf Registration Statement permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing.
Current wording
In August 2023, we filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”), which contained two prospectuses, a base prospectus and an at-the-market offering prospectus, as supplemented on March 29, 2024 (as supplemented, the “Original Prospectus Supplement”) that covered the offering, issuance and sale of up to $17.3 million of common stock pursuant to an at the market offering agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) acting as sales agent (the “ATM Facility”). The Shelf Registration Statement permitted the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing.
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 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.
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. On November 6, 2025, we filed the 2025 Prospectus Supplement which increased our capacity for sales of common stock under the ATM Facility to an aggregate gross sales price of up to $9.7 million. During the three and nine months ended September 30, 2026, there were 9,822 shares sold under the ATM Facility for net proceeds of $0.03 million, after deducting negligible commissions and settlement expenses. As of September 30, 2026, we sold an aggregate of 416,188 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. On August 18, 2026, the Shelf Registration Statement expired.
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 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.
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 March 3, 2025 (“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 our 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
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 wording
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 on the outstanding loan. Tranche 2 and Tranche 3 are no longer available to us.
Previous wording
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 wording
Financing, we issued an aggregate of 3,734,678 units at a purchase price of $4.0165 per unit (or $4.016 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; and (b) a contractual right to receive one Series A warrant and one Series B warrant upon receipt of the required stockholder approval under Nasdaq Listing Rule 5635. We issued 2,987,667 shares of common stock and 747,011 pre-funded warrants at the closing of the financing. The pre-funded warrants have an exercise price of $0.0005 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.
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, 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.
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, 2026, our operations have been funded primarily by aggregate net proceeds of $207.5 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 net losses, except for the three-month periods ended March 31, 2026 and March 31, 2024. Our net loss was $4.4 million for the nine months ended September 30, 2026. Included in the net loss for the nine months ended September 30, 2026 were total operating expenses of $14.4 million, interest expense of $1.0 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $10.5 million, interest income of $0.3 million and other income of $0.2 million. As of September 30, 2026, we had an accumulated deficit of $193.7 million and $13.8 million in cash, cash equivalents and short-term investments. Specifically, we expect that our cash, cash equivalents and short-term investments will allow us to fund our current operating plan into the second half of 2027 through the anticipated data readout of our planned Phase 1b proof-of-concept study of Auxora in patients with PH and our planned submission of an IND for CM5480 in PH. As a result, there is substantial doubt about our 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 initiate and complete our planned Phase 2b clinical trial of Auxora in AP, nor will they be sufficient to pursue additional indications for Auxora or CM5480 beyond our current operating plan, nor will it be sufficient to fund work on other product candidates in our portfolio aside from Auxora and CM5480, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.
Previous wording
expenses incurred under agreements with consultants, third-party contract organizations that conduct research and development activities on our behalf;
Current wording
expenses incurred under agreements with consultants and third-party contract organizations that conduct research and development activities on our behalf;
Previous wording
costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers;
Current wording
costs related to production of nonclinical and clinical materials, including fees paid to contract manufacturers;
Previous wording
laboratory and vendor expenses related to the execution of preclinical studies and previously planned and ongoing clinical trials;
Current wording
laboratory and vendor expenses related to the execution of nonclinical studies and previously planned and ongoing clinical trials;
Previous wording
Most of our historical research and development expenses have been related to the preclinical and clinical development of Auxora. We have not reported program costs since inception because we have not tracked or recorded our research and development expenses on a program-by-program basis historically due to the fact that these costs do not necessarily correlate to the overall research and development efforts attributable to such programs and these costs can vary significantly from period to period. We have historically used our personnel and infrastructure resources across the breadth of our research and development activities, which are directed toward identifying and developing product candidates.
Current wording
Most of our historical research and development expenses have been related to the nonclinical and clinical development of Auxora. We have not reported program costs since inception because we have not tracked or recorded our research and development expenses on a program-by-program basis historically due to the fact that these costs do not necessarily correlate to the overall research and development efforts attributable to such programs and these costs can vary significantly from period to period. We have historically used our personnel and infrastructure resources across the breadth of our research and development activities, which are directed toward identifying and developing product candidates.
Previous wording
Because of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion costs of the current or future preclinical studies and clinical trials or if, when, or to what extent we will generate revenues from the commercialization and sale of our product candidates or if we even continue to pursue such product development, commercialization or sales. We may never succeed in achieving regulatory approval for our product candidates. The duration, costs and timing of preclinical studies and clinical trials and development of our remaining product candidates, to the extent we continue to pursue such activities, will depend on a variety of factors, including:
Current wording
Because of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion costs of the current or future nonclinical studies and clinical trials or if, when, or to what extent we will generate revenues from the commercialization and sale of our product candidates or if we even continue to pursue such product development, commercialization or sales. We may never succeed in achieving regulatory approval for our product candidates. The duration, costs and timing of nonclinical studies and clinical trials and development of our remaining product candidates, to the extent we continue to pursue such activities, will depend on a variety of factors, including:
Previous wording
successful completion of preclinical studies and initiation of clinical trials for Auxora, our other current product candidates and any future product candidates;
Current wording
successful completion of nonclinical studies and initiation of clinical trials for Auxora, our other current product candidates and any future product candidates;
Previous wording
We may never succeed in achieving regulatory approval for any of our remaining product candidates. We may obtain unexpected results from our preclinical studies and subsequent clinical trials, if any. We may elect to discontinue, delay or modify future clinical trials or preclinical activities of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current preclinical product candidates. For example, if the FDA, or another regulatory authority, were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or future clinical trials, if any, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development.
Current wording
We may never succeed in achieving regulatory approval for any of our remaining product candidates. We may obtain unexpected results from our nonclinical studies and subsequent clinical trials, if any. We may elect to discontinue, delay or modify future clinical trials or nonclinical activities of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current nonclinical product candidates. For example, if the FDA, or another regulatory authority, were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our nonclinical studies or future clinical trials, if any, we could be required to expend significant additional financial resources and time on the completion of nonclinical and clinical development.
Previous 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.
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 (expense).
Previous 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.
Current wording
Research and development expenses were $2.3 million for the three months ended September 30, 2026, compared to $3.9 million for the three months ended September 30, 2025. The decrease of $1.5 million was due primarily to a decrease of $1.4 million in nonclinical activities relating to Auxora and the pause of our clinical trial for AKI and a decrease of $0.3 million in chemistry, manufacturing and controls also due to our clinical trial for AKI pausing, partially offset by an increase of $0.2 million in personnel inclusive of severance, consultants and other costs.
Previous wording
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 wording
General and administrative expenses were $2.4 million for the three months ended September 30, 2026, compared to $1.8 million for the three months ended September 30, 2025. The increase of $0.7 million was primarily related to an increase of $0.4 million in professional services and $0.3 million in consultants and other costs.
Previous wording
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 wording
Other income for the three months ended September 30, 2026 was $3.1 million, compared with other expense of $2.2 million for the three months ended September 30, 2025. The increase of $5.3 million was due to a $3.3 million gain compared to a $2.0 million loss from fair value adjustments to our financial instruments for the three months ended September 30, 2026 and September 30, 2025, respectively.
Previous wording
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 wording
Research and development expenses were $7.9 million for the nine months ended September 30, 2026, compared to $12.1 million for the nine months ended September 30, 2025. The decrease of $4.2 million was due primarily to a decrease of $3.3 million in nonclinical studies and clinical trial activities for Auxora, including its AKI program, a decrease of $0.7 million in consultants and other costs and a decrease of $0.6 million in chemistry, manufacturing and controls activities for our Phase 2 clinical trials of Auxora. These decreases were partially offset by an increase of $0.4 million in personnel costs inclusive of severance.
Previous 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.
Current wording
General and administrative expenses were $6.5 million for the nine months ended September 30, 2026, compared to $6.6 million for the nine months ended September 30, 2025. The decrease of $0.1 million was primarily related to a decrease in personnel and facilities of $0.7 million offset by an increase of $0.6 million in professional services, consultants and other costs.
Previous 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.
Current wording
Other income (expense) for the nine months ended September 30, 2026 was $10.0 million, compared to other expense of $0.1 million for the nine months ended September 30, 2025. The increase of $10.1 million was due to the fair value adjustments to our financial instruments which resulted in a net gain of $10.5 million compared to a $0.2 million gain for the nine months ended September 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 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.
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. We filed the 2026 Prospectus Supplement to the 2026 Shelf Registration Statement with the SEC on September 30, 2026 providing for the sale of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $25.0 million. As of September 30, 2026, our remaining capacity for sales of common stock under the ATM Facility was $25.0 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 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.
Current wording
The accompanying unaudited condensed consolidated financial statements have been prepared on a basis which assumes we are a going concern and do 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 a period of 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 our current operating plan into the second half of 2027 through the anticipated data readout of our planned Phase 1b proof-of-concept study of Auxora in patients with PH and our planned submission of an IND for CM5480 in PH. 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 initiate and complete our planned Phase 2b clinical trial of Auxora in AP, nor will they be sufficient to pursue additional indications for Auxora or CM5480 beyond our current operating plan, nor will it be sufficient to fund work on other product candidates in our portfolio aside from Auxora and CM5480, 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 and planned clinical trials of Auxora and our ongoing and planned preclinical studies and clinical trials for our other product candidates, including CM5480;
Current wording
the progress, costs and results of our ongoing and planned clinical trials of Auxora and our ongoing and planned nonclinical 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 and planned clinical trials of Auxora and our ongoing and planned preclinical studies and clinical trials of CM5480;
Current wording
the scope, progress, results and costs of discovery research, nonclinical development, laboratory testing and clinical trials for our product candidates, including our ongoing and planned clinical trials of Auxora and our ongoing and planned nonclinical studies and clinical trials of CM5480;
Previous wording
Since we commenced operations in October 2006, we have primarily financed our operations through private placements of our preferred stock, convertible promissory notes, promissory notes, warrants, common stock, and through the Merger. We have used substantial amounts of cash to fund our operations and expect our expenses to increase substantially for the foreseeable future. The development of drug product candidates is highly capital intensive. As our product candidates enter and advance through preclinical studies and clinical trials, we will need substantial additional funds to expand our clinical, regulatory and quality capabilities. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to marketing, sales, manufacturing and distribution. Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts. The global credit and financial markets have experienced extreme volatility, including in liquidity and credit availability, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability. There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive.
Current wording
Since we commenced operations in October 2006, we have primarily financed our operations through private placements of our preferred stock, convertible promissory notes, promissory notes, warrants, common stock, and through the Merger. We have used substantial amounts of cash to fund our operations and expect our expenses to increase substantially for the foreseeable future. The development of drug product candidates is highly capital intensive. As our product candidates enter and advance through nonclinical studies and clinical trials, we will need substantial additional funds to expand our clinical, regulatory and quality capabilities. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to marketing, sales, manufacturing and distribution. Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts. The global credit and financial markets have experienced extreme volatility, including in liquidity and credit availability, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability. There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive.
Previous 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.
Current 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 arrangements 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 August 2023, we filed the Shelf Registration Statement, which contains two prospectuses, a base prospectus and the Original Prospectus Supplement that covered the offering, issuance and sale of up to $17.3 million of common stock pursuant to the ATM Agreement with Wainwright, acting as sales agent. The Shelf Registration Statement permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing.
Current wording
In August 2023, we filed the Shelf Registration Statement, which contains two prospectuses, a base prospectus and the Original Prospectus Supplement that covered the offering, issuance and sale of up to $17.3 million of common stock pursuant to the ATM Agreement with Wainwright, acting as sales agent. The Shelf Registration Statement permitted the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing.
Previous wording
In January 2024, we entered into the Purchase Agreement with certain accredited investors, in which we sold the following securities to the accredited investors the 2024 Private Placement: (i) an aggregate of 4,985,610 shares of our common stock; (ii) to certain investors, in lieu of shares, Pre-Funded Warrants to purchase an aggregate of 306,506 shares of our common stock; (iii) Tranche A Common Warrants to purchase an aggregate of up to 2,646,058 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants); and (iv) Tranche B Common Warrants to purchase an aggregate of up to 2,646,058 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants). The purchase price per share and accompanying Common Warrants was $3.827 (or $4.3915 for directors, employees or consultants participating in the 2024 Private Placement) (or $3.8269 per Pre-Funded Warrant and accompanying Common Warrants, which represented the price of $3.827 per share and accompanying Common Warrants minus the $0.0001 per share exercise price of each such Pre-Funded Warrant).
Current wording
In January 2024, we entered into the Purchase Agreement with certain accredited investors, in which we sold the following securities in the 2024 Private Placement: (i) an aggregate of 997,122 shares of our common stock; (ii) to certain investors, in lieu of shares, Pre-Funded Warrants to purchase an aggregate of 61,301 shares of our common stock; (iii) Tranche A Common Warrants to purchase an aggregate of up to 529,211 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants); and (iv) Tranche B Common Warrants to purchase an aggregate of up to 529,211 shares of our common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of our common stock issuable upon exercise of such Pre-Funded Warrants). The purchase price per share and accompanying Common Warrants was $19.135 (or $21.9575 for directors, employees or consultants participating in the 2024 Private Placement) (or $19.1345 per Pre-Funded Warrant and accompanying Common Warrants, which represented the price of $19.135 per share and accompanying Common Warrants minus the $0.0005 per share exercise price of each such Pre-Funded Warrant).
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 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.
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. On November 6, 2025, we filed the 2025 Prospectus Supplement providing for the sales of shares of common stock under the ATM Facility having an aggregate gross sales price of up to $9.7 million. During the nine months ended September 30, 2026, there were 9,822 shares sold under the ATM Facility for net proceeds of $0.03 million, after deducting negligible commissions and settlement expenses. As of September 30, 2026, we sold an aggregate of 416,188 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. On August 18, 2026, the Shelf Registration Statement expired. 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, 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.
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 March 3, 2025, (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 our 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
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 wording
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 on the outstanding loan. Tranche 2 and Tranche 3 are no longer available to us.
Previous wording
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 wording
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 3,734,678 units at a purchase price of $4.0165 per unit (or $4.016 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; and (b) a contractual right to receive one Series A warrant and one Series B warrant upon receipt of the required stockholder approval under Nasdaq Listing Rule 5635. We issued 2,987,667 shares of common stock and 747,011 pre-funded warrants at the closing of the financing. The pre-funded warrants have an exercise price of $0.0005 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.
Previous 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.
Current wording
Our operations through September 30, 2026, have been funded primarily by aggregate net proceeds of $207.5 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 periods ended March 31, 2026 and 2024. Our net loss for the nine months ended September 30, 2026 was $4.4 million and consisted of total operating expenses of $14.4 million, interest expense of $1.0 million offset by a non-cash gain from the fair value adjustment to our warrant liability and promissory note of $10.5 million, interest income of $0.3 million and other income of $0.2 million. As of September 30, 2026, we had an accumulated deficit of $193.7 million and $13.8 million in cash, cash equivalents and short-term investments. During the nine months ended September 30, 2026, cash used in operations was $13.3 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 $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.
Current wording
Cash used in operating activities of $13.3 million during the nine months ended September 30, 2026 was attributable to our net loss of $4.4 million and non-cash items of $8.9 million. The net change in our operating assets and liabilities was immaterial. Non-cash items consisted primarily of $2.8 million and $7.7 million due to a change in our promissory note and warrant liabilities offset by $1.6 million of stock-based compensation.
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 debt 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 a 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.
Showing the first 40 of 48 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
On June 25, 2026, we completed a private placement (the “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