Last patient enrolled in CARPO, Phase 2b trial of Auxora in acute pancreatitis (AP); topline data expected in 2Q 2024
KOURAGE, Phase 2 trial in severe acute kidney injury (AKI) remains on track to initiate patient enrollment in 2Q 2024 with data expected in 2025
Collaborators from Cedars-Sinai to present abstract on human proteomics data supporting the potential benefits of Auxora in AP at Digestive Disease Week (DDW) 2024
Cash position expected to fund operations into 2H 2025
LA JOLLA, Calif., May 13, 2024 /PRNewswire/ -- 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 first quarter ended March 31, 2024.
"This past quarter was transformational for CalciMedica. We completed enrollment in our Phase 2b CARPO trial in AP, we received FDA clearance on our IND application and started work on KOURAGE, our Phase 2 trial in patients with severe AKI, and we continued to progress our other programs, with multiple value-creating milestones on the horizon," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Our progress was further supported by a private placement of up to approximately $54 million including an upfront investment of $20.4 million and a potential additional approximately $33.1 million from accompanying warrants that trigger upon announcement of clinical trial data. We expect our cash, cash equivalents and short-term investments will provide funding into the second half of 2025. We look forward to continuing to advance our programs and to announcing topline data from CARPO later this quarter."
Recent Clinical and Preclinical Updates and Anticipated Milestones:
- Last patient enrolled in Phase 2b CARPO trial and topline data expected in 2Q24: In April 2024, CalciMedica enrolled the last patient in CARPO, the Company's randomized, double-blind, placebo-controlled Phase 2b trial of Auxora in acute pancreatitis (AP) patients, reaching full target enrollment of 216 patients. Topline data from the trial is expected to be announced later this quarter.
- Phase 2 KOURAGE trial initiation underway: In February 2024, CalciMedica received clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for Auxora to be evaluated in a Phase 2 trial in severe acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), which has been named KOURAGE. CalciMedica expects to enroll the first patient in KOURAGE later this quarter, with data expected in 2025.
- Abstract accepted for poster presentation at DDW 2024: CalciMedica collaborator Richard Waldon, Ph.D., of Cedars-Sinai Medical Center will be presenting a poster titled "Serum Proteomics Reveals That the Orai1 Inhibitor Auxora May Provide Benefits in Severe Acute Pancreatitis Similar to Those Seen in COVID-19 Pneumonia" at the upcoming DDW 2024 meeting on Saturday, May 18 th from 12:30-1:30 p.m. ET.
- Preclinical data presented at AKI & CRRT: In March 2024, CalciMedica collaborator David Basile, Ph.D., of Indiana University presented data from preclinical studies of Auxora in AKI at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. The results of the studies indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI through inhibiting the Orai1 channels on Th17 and endothelial cells.
- CRSPA study expanded and continuing to enroll in Phase 2 portion of trial: The CRSPA study in asparaginase-induced pancreatic toxicity (AIPT) has been expanded to additional sites, and the dose used in the initial cohort has been established as the recommended Phase 2 dose and a target total trial enrollment has been set at 24. Data is expected in 2025.
Financial Results for the Three Months Ended March 31, 2024:
- In January 2024, CalciMedica completed a private placement of securities to new and existing investors for up to approximately $54 million in gross proceeds that includes initial upfront funding of $20.4 million and up to an additional approximately $33.1 million upon exercise of accompanying warrants. The upfront net proceeds from the private placement will support the Company's ongoing Phase 2 CARPO trial for Auxora in AP and planned Phase 2 KOURAGE trial for Auxora in AKI.
- As of March 31, 2024, CalciMedica had approximately $25.7 million in cash, cash equivalents and short-term investments, which, based on its current operating plan, CalciMedica expects to be sufficient to fund its operations into the second half of 2025.
- Total loss from operations for the three months ended March 31, 2024, was approximately $5.8 million, which was offset by a gain from the fair value adjustment to the warrant liability of $5.6 million and interest income of $0.3 million.
- With the impact of a $5.6 million non-cash gain from the fair value adjustment of the warrant liability, net income was $0.1 million, or $0.01 per share (basic and diluted) for the three months March 31, 2024.
About CalciMedica
NCT04681066) for AP with SIRS, with topline data expected in the second quarter of 2024, as well as supporting the ongoing Phase 1/2 AIPT study (called CRSPA - NCT04195347), with data expected in 2025. CalciMedica plans to initiate patient enrollment its Phase 2 study (called KOURAGE - NCT06374797) in AKI with associated AHRF in the second quarter of 2024 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
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
[email protected]
(212) 600-1902
CALCIMEDICA, INC. Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts) (Unaudited) | |||||
March 31, | December 31, | ||||
Assets | |||||
Current assets | |||||
Cash and cash equivalents | $ 6,755 | $ 5,530 | |||
Short-term investments | 18,955 | 5,708 | |||
Prepaid expenses and other current assets | 894 | 367 | |||
Total current assets | 26,604 | 11,605 | |||
Property and equipment, net | 153 | 167 | |||
Other assets | 377 | 413 | |||
Total assets | $ 27,134 | $ 12,185 | |||
Liabilities and Stockholders' Equity | |||||
Current liabilities | |||||
Accounts payable | $ 1,535 | $ 1,419 | |||
Accrued clinical trial costs | 1,000 | 1,141 | |||
Accrued other | 1,752 | 1,468 | |||
Total current liabilities | 4,287 | 4,028 | |||
Long-term liabilities | |||||
Warrant liability | 5,600 | - | |||
Total liabilities | 9,887 | 4,028 | |||
Commitments and contingencies (Note 9) | |||||
Stockholders' equity | |||||
Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at March 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | - | - | |||
Common stock, $0.0001 par value; 500,000,000 shares authorized at March 31, 2024 and December 31, 2023; 10,740,115 and 5,754,505 issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 3 | 1 | |||
Additional paid-in capital | 163,195 | 154,218 | |||
Accumulated deficit | (145,934) | (146,064) | |||
Accumulated other comprehensive income (loss) | (17) | 2 | |||
Total stockholders' equity | 17,247 | 8,157 | |||
Total liabilities and stockholders' equity | $ 27,134 | $ 12,185 | |||
CALCIMEDICA, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) | |||||||
Three Months Ended March 31, | |||||||
2024 | 2023 | ||||||
Operating expenses: | |||||||
Research and development | $ | 2,944 | $ | 6,491 | |||
General and administrative | 2,823 | 15,849 | |||||
Total operating expenses | 5,767 | 22,340 | |||||
Loss from operations | (5,767) | (22,340) | |||||
Other income (expense) | |||||||
Change in fair value of financial instruments | 5,590 | 3,168 | |||||
Other income (expense), net | 307 | (116) | |||||
Total other income (expense), net | 5,897 | 3,052 | |||||
Net income (loss) | $ | 130 | $ | (19,288) | |||
Earnings per share | |||||||
Basic | $ | 0.01 | $ | (23.43) | |||
Diluted | $ | 0.01 | $ | (23.43) | |||
Shares used in computing earnings per share | |||||||
Basic | 9,754,517 | 823,069 | |||||
Diluted | 10,047,415 | 823,069 | |||||
SOURCE CalciMedica, Inc.
