CalciMedica Reports First Quarter 2024 Financial Results and Provides Clinical & Corporate Updates

Rhea-AI Summary

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.

Positive

• 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.

Negative

• 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

Financial Analyst

CalciMedica's financial results for Q1 2024 reflect a net income of $0.1 million, primarily due to a non-cash gain from the fair value adjustment of the warrant liability amounting to $5.6 million. This suggests that the company's operational activities are currently not profitable, as the total loss from operations was $5.8 million. However, their strong cash position, bolstered by the recent private placement of up to $54 million, is expected to sustain operations into the second half of 2025. This indicates solid financial planning, but investors should be cautious of the company's ongoing operational losses.

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.

Medical Research Analyst

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.

Market Research Analyst

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

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
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 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 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, 2024		December 31, 2023
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

 

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SOURCE CalciMedica, Inc.

FAQ

What are the key clinical updates from CalciMedica's Q1 2024 financial results?

CalciMedica completed enrollment for the Phase 2b CARPO trial for Auxora in AP and plans to start patient enrollment for the Phase 2 KOURAGE trial for Auxora in severe AKI in 2Q 2024.

When will CalciMedica release topline data for the CARPO trial?

Topline data for the Phase 2b CARPO trial of Auxora in acute pancreatitis is expected in 2Q 2024.

How is CalciMedica's cash position expected to support its operations?

CalciMedica has $25.7 million in cash and equivalents, expected to fund operations into the second half of 2025.

What financial milestones did CalciMedica achieve in Q1 2024?

CalciMedica completed a $54 million private placement, received $20.4 million upfront, and reported a net income of $0.1 million due to a $5.6 million gain from warrant liability adjustment.

What are the upcoming presentations related to CalciMedica's research?

An abstract on Auxora's potential benefits in AP will be presented at Digestive Disease Week (DDW) 2024 on May 18th.

What is the status of CalciMedica's KOURAGE trial for severe AKI?

The KOURAGE Phase 2 trial for severe acute kidney injury (AKI) is set to initiate patient enrollment in 2Q 2024, with data expected in 2025.

How did CalciMedica perform financially in Q1 2024?

CalciMedica reported a net income of $0.1 million in Q1 2024, supported by a $5.6 million gain from warrant liability adjustment, despite operating losses of $5.8 million.