GRAY Graybug Vision Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 28, 2024

 

 

CalciMedica, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-39538	45-2120079
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
505 Coast Boulevard South, Suite 307
La Jolla, California				92037
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (858) 952-5500

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		CALC		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02. Results of Operations and Financial Condition.

 

On March 28, 2024, CalciMedica, Inc. issued a press release announcing its financial results for the year ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release dated March 28, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			CalciMedica, Inc.
Date:	March 28, 2024	By:	/s/ A. Rachel Leheny, Ph. D.
		Name: Title:	A. Rachel Leheny, Ph. D. Chief Executive Officer

 

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Exhibit 99.1

 

 

CalciMedica Reports 2023 Financial Results and Provides Clinical & Corporate Updates

 

Enrollment in CARPO, Phase 2b trial of Auxora™ in acute pancreatitis (AP), on track with topline data expected in 2Q 2024

 

Auxora granted Investigational New Drug clearance by the FDA for Phase 2 trial in severe acute kidney injury (AKI); KOURAGE initiating in 2Q 2024

 

CRSPA Phase 1/2 trial of Auxora in asparaginase-induced pancreatic toxicity (AIPT) expanded and progressing to Phase 2 following initial patient cohort results presented at ASH 2023

 

Following a private placement financing in January, Company’s cash position is expected to fund operations into 2H 2025

 

LA JOLLA, CA, March 28, 2024 – 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 year ended December 31, 2023.

 

“Over the course of 2023 and into this year, we have continued to build upon CalciMedica’s clinical and financial strength, which has culminated in several recent achievements and has positioned us to execute on key milestones in 2024 including presenting topline data from our ongoing CARPO trial in acute pancreatitis in the second quarter,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Importantly, the support from leading life science investors in our recent private placement financing allows us to initiate KOURAGE, our Phase 2 trial of Auxora in severe AKI patients, and to continue to progress other key programs in our pipeline.”

 

Recent Clinical and Preclinical Updates and Anticipated Milestones:

 

 

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2023 Financial Results and Corporate Updates:

 

About Auxora™

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

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immunologic illnesses. CRAC channels are found on many cell types, including immune system cells, endothelium cells and pancreatic acinar 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 acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS), called CARPO, (ii) a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), called KOURAGE, expected to initiate in the second quarter of 2024 and (iii) an investigator-sponsored Phase 1/2 trial, called CRSPA, being conducted in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase. There are currently no approved therapies to treat either AP, AKI 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 respiratory distress syndrome.

 

About CARPO and AP

CARPO is an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish Auxora’s dose-response and 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).

 

About KOURAGE and AKI

KOURAGE is a randomized, double-blind, placebo-controlled study that will evaluate 150 patients with Stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (IMV). AKI denotes a sudden reduction in kidney function, or the organ's ability to clean and filter the blood. AKI can result as a complication of other serious illnesses such as sepsis, respiratory infections and failure, acute pancreatitis, trauma, surgery and burns. There are approximately 3.7 million hospitalized with AKI in the United States each year with approximately 1.1 million of these patients advancing to Stage 2 and Stage 3 AKI, over half of whom have associated AHRF. The risk of serious morbidities and mortality is significant for advanced Stage 2 and Stage 3 AKI patients. There are currently no approved therapies for AKI.

 

About CRSPA and AIPT

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 (such as Oncaspar and Rylaze). 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 and is expected to enroll 24 patients. Approximately 3,000 pediatric patients are treated for ALL in the United States each year and treatment with asparaginase triggers the development of AIPT in 7-10% of these patients, with approximately half developing pancreatic necrosis and/or pseudocysts. There are currently no approved therapies for AIPT. Details of the CRSPA trial are available on clinicaltrials.gov (NCT04195347).

 

About CalciMedica

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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 its Phase 2 study (called KOURAGE) 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, statements regarding CalciMedica’s expected cash, cash equivalents and short-term investments as of the end of the first quarter of 2024; CalciMedica’s expected use of proceeds from the private placement; CalciMedica's expected cash runway; CalciMedica's business strategy; 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 planned Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF, its ongoing Phase 2b CARPO trial of Auxora for AP with accompanying SIRS and its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; the potential benefits of Auxora for the treatment of AKI, AP and AIPT; the estimated patient populations in the United States for AKI, AIPT and AP; the potential of Auxora for the treatment of other acute indications including acute respiratory distress syndrome; 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-K for the year ended December 31, 2023 being filed with the Securities and Exchange Commission (SEC) later today and elsewhere in CalciMedica's subsequent reports

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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

 

 

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CALCIMEDICA, INC.

Consolidated Balance Sheets

(in thousands, except par value and share amounts)

 

		December 31, 2023				December 31, 2022
Assets
Current assets
Cash and cash equivalents		$	5,530			$	1,327
Restricted cash			—				149
Short-term investments			5,708				—
Prepaid expenses and other current assets			367				254
Total current assets			11,605				1,730
Property and equipment, net			167				147
Right-of-use asset, net			—				48
Other assets			413				1,424
Total assets		$	12,185			$	3,349
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities
Accounts payable		$	1,419			$	2,866
Accrued clinical trial costs			1,141				1,143
Accrued other			1,468				572
Other current liabilities			—				199
Total current liabilities			4,028				4,780
Long-term liabilities
Warrant liability			—				2,645
Convertible promissory notes			—				5,157
Total liabilities			4,028				12,582
Commitments and contingencies (Note 9)
Convertible preferred stock
Series A convertible preferred stock, $0.001 par value; no shares and 25,751,716 authorized, issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				19,107
Series B convertible preferred stock, $0.001 par value; no shares and 11,235,460 authorized at December 31, 2023 and December 31, 2022, respectively; no shares and 10,667,279 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				8,224
Series C-1 convertible preferred stock, $0.001 par value; no shares and 8,016,886 shares authorized, issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				5,683
Series C-2 convertible preferred stock, $0.001 par value; no shares and 16,291,526 authorized at December 31, 2023 and December 31, 2022, respectively; no shares and 13,504,959 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				9,563
Series D convertible preferred stock, $0.001 par value; no shares and 88,875,077 authorized at December 31, 2023 and December 31, 2022, respectively; no shares and 26,880,040 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				19,494
Stockholders’ equity (deficit)
Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at December 31, 2023 and December 31, 2022, respectively; no shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively			—				—
Common stock, $0.0001 par value; 500,000,000 and 5,694,626 shares authorized at December 31, 2023 and December 31, 2022, respectively; 5,754,505 and 84,165 issued and outstanding at December 31, 2023 and December 31, 2022, respectively			1				1
Additional paid-in capital			154,218				40,402
Accumulated deficit			(146,064	)			(111,707	)
Accumulated other comprehensive income (loss)			2
Total stockholders’ equity (deficit)			8,157				(71,304	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	12,185			$	3,349

 

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CALCIMEDICA, INC.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

 

		Year Ended December 31,
		2023				2022
Operating expenses:
Research and development		$	15,859			$	8,350
General and administrative			22,216				5,843
Total operating expenses			38,075				14,193
Loss from operations			(38,075	)			(14,193	)
Other income (expense)
Change in fair value of warrant liability			1,146				3,784
Change in fair value of convertible promissory notes			2,022				2,745
Interest on convertible promissory notes payable			(110	)			(132	)
Other income (expense), net			660				(28	)
Total other income (expense), net			3,718				6,369
Net loss			(34,357	)			(7,824	)
Deemed distribution to convertible promissory note holders			—				(1,318	)
Net loss attributable to common stockholders		$	(34,357	)		$	(9,142	)
Net loss per share—basic and diluted		$	(7.66	)		$	(111.16	)
Weighted-average number of shares outstanding used in    computing net loss per share—basic and diluted			4,486,258				82,245

 

 

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v3.24.1

Document And Entity Information	Mar. 28, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 28, 2024
Entity Registrant Name	CalciMedica, Inc.
Entity Central Index Key	0001534133
Entity Emerging Growth Company	true
Entity File Number	001-39538
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-2120079
Entity Address, Address Line One	505 Coast Boulevard South, Suite 307
Entity Address, City or Town	La Jolla
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92037
City Area Code	(858)
Local Phone Number	952-5500
Entity Information, Former Legal or Registered Name	Not Applicable
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	CALC
Security Exchange Name	NONE

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