8-K

Date: November 2, 2023

CalciMedica, Inc.

/s/ A. Rachel Leheny, Ph.D.

A. Rachel Leheny, Ph.D.

Chief Executive Officer

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

November 2, 2023

Date of Report (Date of earliest event reported)

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 obligations of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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, $0.0001 par value 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. ☐

Item 2.02.

Results of Operations and Financial Condition.

Based on current estimates, as of September 30, 2023, CalciMedica, Inc. (the “Company”) had cash, cash equivalents and short-term investments of $14.6 million. Based on the Company’s current operating plan, the Company believes its existing resources will be sufficient to fund its operations through the third quarter of 2024.

These estimates are preliminary, unaudited and are subject to change upon completion of the Company’s financial statement closing procedures. The review of the Company’s financial statements for the three and nine months ended September 30, 2023 is ongoing and could result in changes to these amounts.

The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to these preliminary results and, accordingly, does not express an opinion or any other form of assurance about them.

The Company expects to file its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023 on or about November 9, 2023.

Item 8.01.

Other Events.

On November 2, 2023, the Company announced that its collaborator, St. Jude Children’s Research Hospital, will present data from the initial cohort of the CRSPA study of Auxora^™ (zegocractin) in asparaginase-induced pancreatic toxicity in an oral presentation at the 65th Annual American Society of Hematology Meeting & Exposition being held December 9-12, 2023 in San Diego, California. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements which include, but are not limited to, statements regarding the Company’s preliminary financial estimates and cash runway, the expected timing of the Company’s Quarterly Report on Form 10-Q, the Company’s preliminary analysis, assessment and conclusions of the results of the first cohort of the CRSPA study, the design and potential benefits of Auxora, the Company’s plans and expected timing for developing its product candidates and potential benefits of its product candidates, the Company’s ongoing and planned clinical trials, the development and outcomes of CARPO and CRSPA trial programs, including the milestones, data announcements, expected enrollment and any other potential results related thereto. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company’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 Company’s need to obtain substantial additional funding to complete the development and any commercialization of its product candidates; the Company’s ability to continue as a going concern; the impact of fluctuations in global financial markets on the Company’s business and the actions the Company may take in response thereto; the Company’s ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; the results that may be observed in the future in comparison to the results from clinical trials; 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 Company’s business generally; the Company’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” and elsewhere in the Company’s most recent filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time.

The forward-looking statements included in this Current Report on Form 8-K are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Description

99.1		Press release, dated November 2, 2023

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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

SEC Form 8-K filed by Graybug Vision Inc.