CalciMedica Reports Second Quarter 2023 Financial Results and Provides Clinical & Corporate Updates
International expansion of CARPO, a Phase 2b clinical trial of Auxora in acute pancreatitis (AP) patients with accompanying systemic inflammatory response syndrome (SIRS), in
Expansion of team with key leadership appointments in regulatory and clinical development
Filing of an investigational new drug (IND) application for Auxora in acute kidney injury (AKI) expected by year-end 2023
“Following the completion of our reverse merger in
Clinical and Pre-Clinical Updates and Anticipated Milestones:
April 2023, CalciMedicainitiated the international expansion of CARPO, a Phase 2b clinical trial of its lead candidate, Auxora, in AP patients with accompanying SIRS, in Indiaand began enrolling patients there during the third quarter of 2023. CARPO enrollment is expected to be complete by the first quarter of 2024, with topline data available in the first half of 2024.
May 2023, the Independent Data Monitoring Committee for CARPOmet to review data from the first 90 patients enrolled in the trial and determined that the trial should continue without modifications.
- Collaborators at St. Jude Children’s
Research Hospitalare expanding the Phase 1/2 CRSPA trial of Auxora in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT), which has been a single-center study to date. Patient enrollment from additional sites is expected to begin in the fourth quarter of 2023. CalciMedicaexpects to file an IND application for Auxora in AKI by year-end 2023. If allowed, CalciMedicawill then be in a position to initiate clinical trials in this indication in the first half of 2024, pending additional funding.
May 2023, preclinical data from studies in animal models of recurrent acute pancreatitis (RAP) and early chronic pancreatitis (CP) conducted at University of Szegedwere published in The Journal of Clinical Investigation Insight. The data showed that inhibiting Orai1-mediated store-operated Ca2+ entry with a selective CRAC channel inhibitor prevented the progression of RAP and early CP into established CP, thus supporting the initiation of clinical studies assessing Orai1 inhibition in patients with RAP and early CP.
Financial Results for the Three and Six Months Ended
Cash Equivalents and Marketable Securities: As of June 30, 2023, CalciMedicahad $19.1 millionin cash and cash equivalents, which the Company expects to be sufficient to fund operations for at least the next twelve months.
- Total Operating Expenses: Total operating expenses were
$6.6 millionfor the three months ended June 30, 2023. Total operating expenses were $28.9 millionfor the six months ended June 30, 2023, which included $16.2 millionof one-time charges related to accelerated vesting and severance for employees of Graybug Vision, Inc. at the time of the reverse merger with Graybug. The majority of costs stemming from the reverse merger have been expensed including the payment of accrued transaction expenses in the second quarter.
- Net Loss: Net loss was
$6.3 million, or $1.11per share (basic and diluted), and $25.6 million, or $7.86per share (basic and diluted), for the three and six months ended June 30, 2023, respectively.
May 2023, CalciMedicaannounced the appointments of Raven Jaeger, M.S. as Chief Regulatory Officer and Andrew Cunningham, M.D., MRCPI as Senior Vice President of Clinical Development.
June 2023, CalciMedica’s common stock was relisted on the Nasdaq Capital Market. CalciMedicatrades on the Nasdaq Capital Market under the ticker symbol “CALC”.
CalciMedica’s lead clinical compound, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with acute inflammatory and immunologic illnesses. CRAC channels are found on many cell types, including pancreatic acinar cells, lung endothelium cells and immune system cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes. Auxora is currently being evaluated in: (i) a Phase 2b trial for AP with accompanying SIRS, called CARPO, (ii) an investigator-sponsored Phase 1/2 trial called CRSPA being conducted in pediatric patients with AIPT as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase, and (iii) a Phase 2 dose-ranging pharmacodynamic study in critical COVID-19 patients. There are currently no approved therapies to treat either AP or AIPT. In previous trials, patients responded well to Auxora regardless of severity or cause of disease.
CARPO is an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish efficacy in AP with accompanying SIRS. It is expected to enroll 216 patients. AP can be a life-threatening condition where the pancreas becomes inflamed, sometimes leading to pancreatic cell death or necrosis, systemic inflammation, organ failure and death. There are an estimated 275,000 hospitalizations for AP annually in
CRSPA is an investigator-sponsored Phase 1/2 trial being conducted in pediatric acute lymphoblastic leukemia (ALL) patients with AIPT, which is acute pancreatitis toxicity caused by the administration of asparaginase and for which there is no approved therapy. Treatment with asparaginase triggers the development of AIPT in 7-10% of these patients, with approximately half developing pancreatic necrosis and/or pseudocysts.
This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica’s expected cash runway; CalciMedica’s business strategy; the design and potential benefits of Auxora; CalciMedica’s plans and expected timing for developing its product candidates and potential benefits of its product candidates; CalciMedica’s ongoing and planned clinical trials; the development and outcomes of CARPO and CRSPA trial programs, including the milestones, data announcements, expected enrollment and any other potential results related thereto. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica’s business and the actions it may take in response thereto; CalciMedica’s ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in CalciMedica’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and elsewhere in CalciMedica’s subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica’s web page at ir.calcimedica.com/financials-filings/sec-filings.
Investors and Media
|Selected Financial Information
Condensed Consolidated Balance Sheets
(In thousands, except par value and share amounts)
|Cash and cash equivalents||$||19,084||$||1,476|
|Prepaid expenses and other current assets||961||254|
|Total current assets||20,045||1,730|
|Property and equipment, net||199||147|
|Right-of-use asset, net||—||48|
|Liabilities and Stockholders’ Equity (Deficit)|
|Accrued clinical trial costs||$||1,207||$||1,143|
|Other current liabilities||—||199|
|Total current liabilities||4,024||4,780|
|Convertible promissory notes||—||5,157|
|Commitments and contingencies (Note 8)|
|Stockholders’ equity (deficit)|
|Additional paid-in capital||153,519||40,400|
|Total stockholders’ equity (deficit)||16,221||(71,304||)|
|Total liabilities and stockholders’ equity||$||20,245||$||3,349|
|Selected Financial Information
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Three Months Ended
||Six Months Ended
|Research and development||$||3,814||$||2,259||$||10,305||$||5,184|
|General and administrative||2,769||1,330||18,618||2,616|
|Total operating expenses||6,583||3,589||28,923||7,800|
|Loss from operations||(6,583||)||(3,589||)||(28,923||)||(7,800||)|
|Other income (expense)|
|Other income (expense), net||279||(29||)||163||(29||)|
|Change in fair value of financial instruments||—||588||3,168||1,169|
|Total other income (expense), net||279||559||3,331||1,140|
|Net loss and comprehensive loss||$||(6,304||)||$||(3,030||)||$||(25,592||)||$||(6,660||)|
|Net loss per share—basic and diluted||$||(1.11||)||$||(36.55||)||$||(7.86||)||$||(82.42||)|
|Weighted-average number of shares outstanding used in
computing net loss per share—basic and diluted