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CALC

CalciMedica, Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
1.23
+0.08 +6.96%
USD · close Oct 23

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How CALC rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
34%
of sentences unchanged
Added
309
new sentences
Dropped
333
sentences removed
Length
−1,601
words, now 24,839

New in FY2025

  • Our corporate headquarters are located in La Jolla, California, where we lease approximately 2,538 square feet of office space.
  • The existing lease is currently month-to-month through March 1, 2026.
  • We exercised the option to extend our lease for another 12 month term through February 28, 2027 and will be relocating to smaller premises of approximately 691 square feet with a new monthly rent amount of $4,375.
  • For a discussion of legal matters as of December 31, 2025, please refer to Note 8, Commitments and Contingencies, which is incorporated into this item by reference.
  • There are currently no other claims or actions pending against us, the ultimate disposition of which we believe could have a material adverse effect on our results of operations.
  • Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
  • Market Information Our common stock trades on The Nasdaq Capital Market under the symbol “CALC.” Holders of Record As of February 25, 2026, there were approximately 67 holders of record of our common stock.
  • Recent Sales of Unregistered Securities None.
  • You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and the related notes and other consolidated financial information included elsewhere in this Annual Report on Form 10-K.
  • In addition to historical consolidated financial information, this discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties.
  • Overview 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.
  • 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.
  • 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, and 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.
  • 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.
  • We expect to finalize the pivotal program design in the first half of 2026.
  • In January 2026, following a recommendation from the Independent Data Monitoring Committee (“IDMC”), we discontinued 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 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 plan to discuss the KOURAGE data and potential future development in AKI with the FDA in the second quarter of 2026.
  • 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, a CRAC channel inhibitor being advanced for the treatment of PAH, with submission of an Investigational New Drug application (“IND”) currently anticipated in 2027.
  • We also expect to continue selective research activities to further evaluate CRAC channel inhibition across other inflammatory and immunologic indications.
  • 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 December 31, 2025, 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.
  • 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 December 31, 2025 , 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.
  • 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).
  • In connection with the discontinuation of 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 is secured by a lien upon and security interest in all of our assets, including intellectual property, subject to agreed exceptions.
  • Through December 31, 2025, our operations have been funded primarily by aggregate net proceeds of $193.9 million from the issuance of convertible preferred stock, convertible notes, warrants, common stock and the Merger.
  • Our net loss was $29.6 million for the year ended December 31, 2025.

and 269 more.

Gone since FY2024

  • Our corporate headquarters are located in La Jolla, California, where we lease approximately 2,850 square feet of office space.
  • The existing lease will expire on December 31, 2025.
  • The ultimate outcome of any litigation is uncertain and unfavorable outcomes could have a negative impact on our results of operations and financial condition.
  • Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm, and other factors.
  • We currently believe there is no litigation pending that could, individually or in the aggregate, have a material adverse effect on our results of operations or financial condition.
  • Market Information Our common stock trades on The Nasdaq Capital Market under the symbol “CALC.” Holders of Record As of March 21, 2025, there were approximately 70 holders of record of our common stock.
  • Recent Sales of Unregistered Securities On May 17, 2024, in connection with services provided under a consulting agreement (the “Danforth Consulting Agreement”) with Danforth Advisors, LLC (“Danforth”), a company affiliated with Dan Geffken, our former Interim Chief Financial Officer, we granted to SG Dan Equity Holdings, LLC, a company affiliated with Mr.
  • Geffken (“SG Dan Equity”), a warrant (“SG 2024 Warrant”) to purchase 10,000 shares of our common stock at an exercise price of $5.45 per share (subject to adjustment as provided therein), which vest in equal monthly installments over a period of one year from the grant date and which are subject to accelerated vesting if the Danforth Consulting Agreement is terminated prior to May 17, 2025 .
  • The SG 2024 Warrant is exercisable until May 24, 2034, unless earlier terminated.
  • The SG 2024 Warrant shall terminate in the event of certain change of control transactions or asset transfers (as provided therein) unless exercised immediately prior to any such transaction.
  • The issuance of securities described above was deemed to be exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act as a transaction by an issuer not involving a public offering.
  • The recipient of the securities in such transaction represented that it was an accredited investor as defined in Regulation D promulgated under the Securities Act and of its intention to acquire the securities for its own account for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the electronic records representing such securities in such transaction.
  • The recipient received adequate information about us.
  • You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and the related notes and other financial information included elsewhere in this Annual Report on Form 10-K.
  • In addition to historical financial information, this discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties.
  • Overview We are a clinical-stage biopharmaceutical company focused on developing therapeutics that treat serious illnesses driven by inflammatory and immunologic processes and direct cellular damage.
  • Our product candidates act upon calcium release-activated calcium (“CRAC”) channels and would constitute a new class of drugs.
  • Clinical and preclinical data have demonstrated that the inhibition of CRAC channels may have a therapeutic effect based on a dual mechanism involving both anti-inflammatory and tissue cell protective activities.
  • Our work has shown compelling evidence of the involvement of CRAC channels in a broad spectrum of both acute critical illnesses and chronic diseases that have the common thread of inflammation or immunologic activity in their pathogenesis.
  • We intend to leverage our CRAC channel inhibitor platform to develop therapeutics for indications where this dual mechanism of action has the potential for clinical benefit.
  • Our lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys.
  • Multiple Phase 2 clinical trials with Auxora have been conducted: an open-label Phase 2a trial in acute pancreatitis (“AP”) with accompanying systematic inflammatory response syndrome (“SIRS”), an international, randomized, double-blind placebo-controlled Phase 2b trial in AP with SIRS (which we refer to as “CARPO”), an investigator led open-label Phase 1/2 trial in asparaginase-induced pancreatic toxicity (“AIPT”) (which we also refer to as “CRSPA”) in which the first cohort of patients has been completed, a placebo-controlled double-blind Phase 2 trial in severe COVID-19 pneumonia (which we also refer to as “CARDEA”) and an investigator led open-label Phase 2a trial in COVID-19 pneumonia patients with acute respiratory distress syndrome (“ARDS”).
  • We observed in all of these trials that patients treated with Auxora experienced a reduction of organ damage and reduced time to recovery.
  • We believe the consistency of the results we observed from these trials in two different acute critical care conditions are mutually supportive and reinforce our plans to further pursue the use of Auxora in several additional acute critical illnesses, including acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure (“AHRF”), in which we are currently conducting a Phase 2 trial (which we also refer to as “KOURAGE”) with data expected around the end of 2025.
  • Additionally, we have compiled additional preclinical data supporting the potential to use CRAC channel inhibition for both chronic and acute inflammatory and immunologic diseases.
  • We have animal model data suggesting CRAC channel inhibition may be useful in treating chronic pancreatitis, rheumatoid arthritis, ulcerative colitis, allergic asthma, and traumatic brain injury.
  • We have several available product candidates that may be suitable for potential oral dosing.
  • Pending additional funding, we have paused IND enabling preclinical work on these compounds to focus resources on our clinical programs.
  • We expect to continue certain research activities to validate CRAC channel inhibition as a potential mechanism in other promising inflammatory and immunologic diseases.
  • We filed a prospectus supplement (the “Current 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 December 31, 2024, we sold an aggregate of 101,522 shares of common stock for net proceeds of $319,000 after deducting $13,000 of commissions paid under the ATM Facility and approximately $4.5 million remains available for sale under the ATM Facility.
  • As of December 31, 2024, $89.5 million remained available for sale under the Shelf Registration Statement.
  • On February 28, 2025 (the “Closing Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund II, L.P.
  • (“Lender”) and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $ 32,500,000 (the “Loan”), with (i) $ 10,000,000 funded on the Closing Date (“Tranche 1”), (ii) up to $ 7,500,000 to be made available to the Company between September 1, 2025 and March 31, 2026, subject to, among other things, the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials (“Tranche 2”) and (iii) up to $ 15,000,000 to be made available to the Company between October 1, 2025 and March 31, 2026, subject to, among other things, (a) the Company’s achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of the Company and the Lender (upon its investment committee approval).
  • Through December 31, 2024, our operations have been funded primarily by aggregate net proceeds of $178.7 million from the issuance of convertible preferred stock, convertible notes, warrants, common stock and the Merger.
  • Our net loss was $13.7 million for the year ended December 31, 2024.
  • Included in the net loss for the year ended December 31, 2024 were total operating expenses of $24.2 million, offset by a gain from the fair value adjustment to our warrant liability of $9.5 million and interest income of $1.0 million.
  • As of December 31, 2024, we had an accumulated deficit of $159.8 million and $18.7 million in cash, cash equivalents and short-term investments.
  • We may elect to discontinue, delay or modify future clinical trials of some product candidates or focus on others.
  • 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.

and 293 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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