Full Press Release Details
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 India
Expansion of team with key leadership appointments in regulatory and clinical
Filing of an investigational new drug (IND) application for Auxora in acute kidney injury (AKI) expected by year-end 2023
LA JOLLA, CA, August 10, 2023 CalciMedica Inc. ( CalciMedica ) (Nasdaq:
CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for
the second quarter ended June 30, 2023.
Following the completion of our reverse merger in March 2023, CalciMedica has taken critical steps to
accelerate clinical activities with our lead compound, Auxora, said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. We undertook the international expansion of our Phase 2b CARPO study in acute pancreatitis with systemic
inflammatory response syndrome and enrolled our first patient in India. Also, our collaborators at St. Jude Children s Research Hospital are expanding our Phase 1/2 CRSPA study in asparaginase-induced pancreatic toxicity to additional sites.
Further, we expect to file our IND application for Auxora in acute kidney injury by year-end.
Dr. Leheny continued, On the corporate side, we appointed a new Chief Regulatory Officer, Raven Jaeger, M.S., as well as a Senior Vice President of
Clinical Development, Andrew Cunningham, M.D., MRCPI. Raven and Andrew have proved to be wonderful additions to our team and are providing leadership in the execution of our clinical and regulatory plans. Finally, due to the diligent work of our
entire team, we were able to relist our common stock on the Nasdaq Capital Market in June, and we are pleased to be trading on that exchange.
Clinical and Pre-Clinical Updates and Anticipated Milestones:
Financial Results for the Three and Six Months Ended June 30, 2023:
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. CalciMedica is also exploring the potential of Auxora treatment for other acute indications including acute kidney injury and acute
respiratory distress syndrome.
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 the United States, of which approximately 40% present with SIRS, which can compromise the function of other tissues or organs, especially the lungs. Organ failure is responsible for much of the mortality seen in
AP. There is currently no approved therapy for AP. Details of the CARPO trial are available on clinicaltrials.gov (NCT04681066).
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. CalciMedica believes that the CRSPA trial has defined an optimal pediatric dose for Auxora in this setting and the trial is currently being expanded to additional sites.
Details of the CRSPA trial are available on clinicaltrials.gov (NCT04195347).
CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic
diseases. CalciMedica s proprietary technology targets the inhibition of CRAC channels designed to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening
inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica s lead product candidate Auxora , a proprietary, intravenous-formulated CRAC
channel inhibitor, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. Auxora is in development for AP with SIRS and AIPT. CalciMedica was founded by scientists from Torrey Pines Therapeutics and
the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.
Forward-Looking Statements
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.
CalciMedica Contact:
Sarah Sutton/Kevin Murphy
Selected Financial Information
Condensed Consolidated Balance Sheets
(In thousands, except par value and share amounts)
| June 30, 2023 | December 31, 2022 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| 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 | |||||||
| Other assets | 1 | 1,424 | ||||||
| Total assets | $ | 20,245 | $ | 3,349 | ||||
| Liabilities and Stockholders Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,743 | $ | 2,866 | ||||
| Accrued clinical trial costs | $ | 1,207 | $ | 1,143 | ||||
| Accrued other | 1,074 | 572 | ||||||
| Other current liabilities | 199 | |||||||
| Total current liabilities | 4,024 | 4,780 | ||||||
| Long-term liabilities | ||||||||
| Warrant liability | 2,645 | |||||||
| Convertible promissory notes | 5,157 | |||||||
| Total liabilities | 4,024 | 12,582 | ||||||
| Commitments and contingencies (Note 8) | ||||||||
| Preferred stock | 62,071 | |||||||
| Stockholders equity (deficit) | ||||||||
| Common stock | 1 | 3 | ||||||
| Additional paid-in capital | 153,519 | 40,400 | ||||||
| Accumulated deficit | (137,299 | ) | (111,707 | ) | ||||
| 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| 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 | 5,661,933 | 82,923 | 3,255,868 | 80,812 |