UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| 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.
| Date: November 2, 2023 | CalciMedica, Inc. | |||||
| By: | /s/ A. Rachel Leheny, Ph.D. | |||||
| Name: | A. Rachel Leheny, Ph.D. | |||||
| Title: | Chief Executive Officer | |||||