CalciMedica Reports First Quarter 2024 Financial Results and Provides Clinical & Corporate Updates
CalciMedica reported a significant quarter ending March 31, 2024, marked by the completion of enrollment for the Phase 2b CARPO trial for Auxora™ in acute pancreatitis (AP), with topline data expected in 2Q 2024.
Additionally, the KOURAGE Phase 2 trial for severe acute kidney injury (AKI) will start patient enrollment in 2Q 2024, with data expected in 2025. A related abstract will be presented at Digestive Disease Week (DDW) 2024.
Financially, the company completed a $54 million private placement, with $20.4 million received upfront and $33.1 million pending from warrant exercises. With $25.7 million in cash and equivalents, operations are funded into the second half of 2025. Total operating losses were $5.8 million for Q1, offset by a $5.6 million gain from warrant liability adjustment, resulting in a $0.1 million net income.
- Completion of Phase 2b CARPO trial enrollment for Auxora in AP with topline data expected in 2Q 2024.
- Initiation of Phase 2 KOURAGE trial for Auxora in severe AKI on track to begin patient enrollment in 2Q 2024.
- Abstract presentation on Auxora's potential benefits in AP at DDW 2024.
- $54 million private placement with $20.4 million upfront investment and $33.1 million potential from warrants.
- Cash position of $25.7 million expected to fund operations into 2H 2025.
- Net income of $0.1 million for Q1 2024 due to a $5.6 million gain from warrant liability adjustment.
- Total operating losses of $5.8 million for Q1 2024.
- Dependency on warrant exercises for an additional $33.1 million in funding.
- No revenue generation reported for Q1 2024, indicating reliance on future clinical success for financial stability.
Insights
CalciMedica's financial results for Q1 2024 reflect a net income of
For retail investors, it's essential to note that while the company has a healthy cash runway, the operational losses highlight the risks associated with investing in clinical-stage biotech firms. The potential for future profitability hinges on the successful outcomes of their ongoing clinical trials.
The completion of patient enrollment in the Phase 2b CARPO trial for Auxora™ in acute pancreatitis (AP) is a significant milestone. The anticipation of topline data in Q2 2024 will be a critical event for CalciMedica, as positive results could accelerate the company's path to regulatory approval and commercialization. Additionally, the initiation of the Phase 2 KOURAGE trial in severe acute kidney injury (AKI) marks progress in diversifying the therapeutic potential of Auxora™.
Retail investors should understand that the outcomes of these trials will be pivotal. Success in these trials could substantially enhance the company's valuation, given the unmet medical needs in AP and AKI. However, clinical trials carry inherent risks and negative results could adversely impact the stock price.
The upcoming poster presentation at Digestive Disease Week (DDW) 2024 and preclinical data presented at the AKI & CRRT conference may bolster CalciMedica's visibility in the scientific community. The abstract from Cedars-Sinai supports the potential benefits of Auxora™ in AP, drawing parallels to its efficacy in COVID-19 pneumonia, which could generate further interest and credibility in their ongoing clinical efforts.
For retail investors, these presentations could serve as catalysts that attract attention from both the scientific community and potential investors. They enhance the company's profile, which could positively influence investor sentiment and potentially drive the stock price up in the short term.
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
"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
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 18th 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) inSan 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 $20.4 million $33.1 million - As of March 31, 2024, CalciMedica had approximately
$25.7 million - Total loss from operations for the three months ended March 31, 2024, was approximately
$5.8 million $5.6 million $0.3 million - With the impact of a
$5.6 million $0.1 million $0.01
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™, a proprietary, intravenous-formulated CRAC channel inhibitor, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica is currently conducting a Phase 2b trial (called CARPO – 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
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected use of proceeds from the private placement; any additional gross proceeds that may be received by CalciMedica upon exercise, if any, of the accompanying warrants issued in the private placement; CalciMedica's expected cash runway; CalciMedica's business strategy; the potential for multiple value-creating milestones on the horizon; 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 2b CARPO trial of Auxora for AP with accompanying SIRS, its ongoing Phase ½ CRSPA trial of Auxora in pediatric patients with AIPT and its planned Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AP, AIPT and AKI; 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; 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 Annual Report on Form 10-Q for the quarter ended March 31, 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
calcimedica@argotpartners.com
(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, | — | — | |||
Common stock, | 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 | |||||
View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-first-quarter-2024-financial-results-and-provides-clinical--corporate-updates-302143887.html
SOURCE CalciMedica, Inc.
FAQ
What are the key clinical updates from CalciMedica's Q1 2024 financial results?
When will CalciMedica release topline data for the CARPO trial?
How is CalciMedica's cash position expected to support its operations?
What financial milestones did CalciMedica achieve in Q1 2024?
What are the upcoming presentations related to CalciMedica's research?
What is the status of CalciMedica's KOURAGE trial for severe AKI?
How did CalciMedica perform financially in Q1 2024?
