LA JOLLA, Calif., Nov. 13, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (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 third quarter ended September 30, 2024 and provided clinical and corporate updates.
"These past few months have been very exciting for CalciMedica, punctuated by our announcement of the full data set and win ratio analysis from our Phase 2b CARPO trial in patients with AP, which was presented by Prof. Sutton at the American College of Gastroenterology Annual Meeting last month," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "With its unique dual mechanism of immunomodulation and direct organ tissue protection, we believe Auxora continues to be a promising candidate for treating not only AP patients, but also critically ill patients suffering from other acute inflammatory diseases, such as AKI. We are committed to working closely with the FDA to design a pivotal program for Auxora in AP, and we continue to make progress in KOURAGE, our Phase 2 trial of Auxora in patients with severe AKI, with enrollment ongoing and topline data expected in 2025."
Recent Clinical Updates and Anticipated Milestones:
The Company is planning an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and expects to be in a position to initiate a Phase 3 program in 2025.
Financial Results and Corporate Updates:
About CalciMedica
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 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™ has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with AP with SIRS and completed a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE – NCT06374797) in patients with AKI with associated AHRF with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA – NCT04195347) in patients with AIPT with data expected in 2025. 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, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF and its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; plans for an end-of-Phase 2 meeting with the FDA for CARPO and to be in a position to initiate a pivotal trial in AP in 2025; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; the potential for additional proceeds from the underwritten public offering if the underwriter exercises its option to purchase additional shares; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases. 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 or preclinical studies 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; the impact of government laws and regulations; and CalciMedica's financial position and need for additional capital. 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 September 30, 2024, being filed with the Securities and Exchange Commission (SEC) later today, 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. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
This email address is being protected from spambots. You need JavaScript enabled to view it.
(212) 600-1902
CALCIMEDICA, INC. Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts) (Unaudited) | ||||||||
September 30, | December 31, | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 9,151 | $ | 5,530 | ||||
Short-term investments | 5,452 | 5,708 | ||||||
Prepaid expenses and other current assets | 1,083 | 367 | ||||||
Total current assets | 15,686 | 11,605 | ||||||
Property and equipment, net | 130 | 167 | ||||||
Other assets | 396 | 413 | ||||||
Total assets | $ | 16,212 | $ | 12,185 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,536 | $ | 1,419 | ||||
Accrued clinical trial costs | 1,103 | 1,141 | ||||||
Accrued expenses | 1,143 | 1,468 | ||||||
Total current liabilities | 3,782 | 4,028 | ||||||
Long-term liabilities | ||||||||
Warrant liability | 3,400 | — | ||||||
Total liabilities | 7,182 | 4,028 | ||||||
Commitments and contingencies (Note 9) | ||||||||
Stockholders' equity | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2024 and | — | — | ||||||
Common stock, $0.0001 par value; 500,000,000 shares authorized at September 30, 2024 and | 3 | 1 | ||||||
Additional paid-in capital | 164,529 | 154,218 | ||||||
Accumulated deficit | (155,506) | (146,064) | ||||||
Accumulated other comprehensive income | 4 | 2 | ||||||
Total stockholders' equity | 9,030 | 8,157 | ||||||
Total liabilities and stockholders' equity | $ | 16,212 | $ | 12,185 | ||||
CALCIMEDICA, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 3,546 | $ | 2,772 | $ | 10,647 | $ | 13,077 | ||||||||
General and administrative | 2,190 | 2,061 | 7,385 | 20,679 | ||||||||||||
Total operating expenses | 5,736 | 4,833 | 18,032 | 33,756 | ||||||||||||
Loss from operations | (5,736) | (4,833) | (18,032) | (33,756) | ||||||||||||
Other income | ||||||||||||||||
Change in fair value of financial instruments | (100) | — | 7,790 | 3,168 | ||||||||||||
Other income | 218 | 214 | 800 | 377 | ||||||||||||
Total other income | 118 | 214 | 8,590 | 3,545 | ||||||||||||
Net loss | $ | (5,618) | $ | (4,619) | $ | (9,442) | $ | (30,211) | ||||||||
Net loss per share - basic and diluted | $ | (0.50) | $ | (0.82) | $ | (0.88) | $ | (7.43) | ||||||||
Weighted-average number of shares outstanding used in | 11,134,964 | 5,667,343 | 10,674,531 | 4,068,526 | ||||||||||||
| Last Trade: | US$3.00 |
| Daily Change: | -0.21 -6.54 |
| Daily Volume: | 9,156 |
| Market Cap: | US$40.440M |
November 20, 2024 October 30, 2024 October 28, 2024 October 16, 2024 | |
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