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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-39538

CalciMedica, Inc.

(Exact name of Registrant as specified in its Charter)

 

 

Delaware

45-2120079

(State or other jurisdiction

of incorporation or organization)

(I.R.S. Employer

Identification No.)

 

505 Coast Boulevard South, Suite 307

La Jolla, CA 92037

(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (858) 952-5500

 

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: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes NO

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes NO

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

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.

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES NO

The number of shares of the Registrant’s common stock outstanding as of November 6, 2023 was 5,684,873.

 

 

 


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements, other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. These forward-looking statements include, but are not limited to, statements concerning the following:

the success, cost and timing of our development activities, non-clinical studies and clinical trials;
the timing and outcome of our current and future clinical trials, and the reporting of data from those trials;
the potential of our technologies and our ability to execute on our corporate strategy;
our ability to attract and retain key scientific, medical, commercial and management personnel;
our ability to fund our working capital needs;
the strength and breadth of our patent portfolio;
the therapeutic potential of Auxora and our other product candidates;
the ability to obtain funding for our operations, including funding necessary to develop and commercialize our product candidates, subject to regulatory approvals:
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
our reliance on third parties to manufacture and conduct preclinical studies and clinical trials of our product candidates;
the success of competing therapies that are or may become available;
our ability to develop and maintain our corporate infrastructure, including our ability to design and maintain an effective system of internal controls;
existing regulations and regulatory developments in the United States and other regulations;
potential claims relating to our intellectual property;
our financial performance;
our ability to obtain and adequately protect intellectual property rights for our product candidates;
our ability to obtain regulatory approval for our product candidates and any related restrictions, limitations and/or warnings in the label of any approved product candidate;
our ability to extend our operating capital;
our ability to continue to satisfy the Nasdaq listing requirements and have our stock continue to trade on Nasdaq; and
the effects of the ongoing conflicts between the Ukraine and Russia and in the Middle East and the recent and potential future bank failures or other geopolitical events.

These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in greater detail under the heading “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. You should not rely upon forward-looking statements as predictions of future events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, after the date of this report, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.

We obtained industry, market and competitive position data in this report from our own internal estimates and research as well as from industry and general publications and research surveys and studies conducted by third parties. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information or estimates.

i


 

EXPLANATORY NOTE

On March 20, 2023, the Delaware corporation formerly known as “Graybug Vision, Inc.” completed its previously announced merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of November 21, 2022, as amended on February 10, 2023 (the “Merger Agreement”), by and among Graybug Vision, Inc. (“Graybug”), Camaro Merger Sub, Inc., a wholly owned subsidiary of Graybug (“Merger Sub”), and CalciMedica, Inc. (“Private CalciMedica”), pursuant to which Merger Sub merged with and into Private CalciMedica, with Private CalciMedica surviving the merger as a wholly owned subsidiary of Graybug (the “Merger”). Additionally, on March 20, 2023, the Company changed its name from “Graybug Vision, Inc.” to “CalciMedica, Inc.” (the “Company”).

On March 17, 2023, in connection with the transactions contemplated by the Merger Agreement, Graybug filed an Amended and Restated Certificate of Incorporation effecting a reverse stock split of Graybug’s common stock at a ratio of 14:1 (the “Reverse Stock Split”). As a result of the Reverse Stock Split, the number of issued and outstanding shares of Graybug’s common stock immediately prior to the Reverse Stock Split was reduced into a smaller number of shares, such that every 14 shares of Graybug’s common stock held by a stockholder immediately prior to the Reverse Stock Split were combined and reclassified into one share of common stock after the Reverse Stock Split. The information in this Quarterly Report on Form 10-Q as of and for the periods prior to the effective date of the Merger gives effect to the Reverse Stock Split.

Since Private CalciMedica was determined to be the accounting acquirer in connection with the Merger, for periods prior to the Merger, the condensed consolidated financial statements were prepared on a stand-alone basis for Private CalciMedica and did not include the combined entities’ activity or financial position. Subsequent to the Merger, the condensed consolidated financial statements as of and for the nine months ended September 30, 2023 include Graybug’s activity from March 21, 2023 through September 30, 2023, and assets and liabilities at their acquisition date fair value. Historical share and per share figures of Private CalciMedica have been retroactively restated based on the exchange ratio of 0.0288.

In this Quarterly Report on Form 10-Q, unless the context indicates otherwise, the terms “Company,” “we,” “us,” and “our” refer to (i) Graybug Vision, Inc., for periods prior to the effectiveness of the Merger and (ii) CalciMedica, Inc. (as a combined company) for periods following the effectiveness of the Merger.

This report contains references to trademarks belonging to other entities, which are the property of their respective holders. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

ii


 

Table of Contents

 

 

 

 

 

Page

 

PART I—FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

2

 

 

Condensed Consolidated Balance Sheets

2

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

3

 

 

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

4

 

 

Condensed Consolidated Statements of Cash Flows

6

 

 

Notes to the Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

 

 

PART II—OTHER INFORMATION

 

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

77

Item 3.

Defaults Upon Senior Securities

77

Item 4.

Mine Safety Disclosures

77

Item 5.

Other Information

77

Item 6.

Exhibits

78

SIGNATURES

80

 

1


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CALCIMEDICA, INC.

Condensed Consolidated Balance Sheets

(in thousands, except par value and share amounts)

 

 

September 30,
2023

 

 

December 31,
2022

 

 

 

(unaudited)

 

 

(See Note 2)

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

11,644

 

 

$

1,327

 

Restricted cash

 

 

 

 

 

149

 

Short-term investments

 

 

2,947

 

 

 

 

Prepaid expenses and other current assets

 

 

682

 

 

 

254

 

Total current assets

 

 

15,273

 

 

 

1,730

 

Property and equipment, net

 

 

187

 

 

 

147

 

Right-of-use asset, net

 

 

 

 

 

48

 

Other assets

 

 

385

 

 

 

1,424

 

Total assets

 

$

15,845

 

 

$

3,349

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

1,417

 

 

$

2,866

 

Accrued clinical trial costs

 

 

860

 

 

 

1,143

 

Accrued other

 

 

1,409

 

 

 

572

 

Other current liabilities

 

 

 

 

 

199

 

Total current liabilities

 

 

3,686

 

 

 

4,780

 

Long-term liabilities

 

 

 

 

 

 

Warrant liability

 

 

 

 

 

2,645

 

Convertible promissory notes

 

 

 

 

 

5,157

 

Total liabilities

 

 

3,686

 

 

 

12,582

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Convertible preferred stock

 

 

 

 

 

 

Series A convertible preferred stock, $0.001 par value; no shares and 25,751,716 authorized, issued and outstanding at September 30, 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 September 30, 2023 and December 31, 2022, respectively; no shares and 10,667,279 shares issued and outstanding at September 30, 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 September 30, 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 September 30, 2023 and December 31, 2022, respectively; no shares and 13,504,959 shares issued and outstanding at September 30, 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 September 30, 2023 and December 31, 2022, respectively; no shares and 26,880,040 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

19,494

 

Stockholders’ equity (deficit) (1)

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at September 30, 2023 and December 31, 2022, respectively; no shares issues issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 and 5,694,626 shares authorized at September 30, 2023 and December 31, 2022, respectively; 5,684,873 and 84,165 issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

154,076

 

 

 

40,402

 

Accumulated deficit

 

 

(141,918

)

 

 

(111,707

)

Total stockholders’ equity (deficit)

 

 

12,159

 

 

 

(71,304

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

$

15,845

 

 

$

3,349

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

(1) Retroactively restated for the reverse recapitalization as described in Note 2.

2


 

CALCIMEDICA, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

2,772

 

 

$

1,244

 

 

$

13,077

 

 

$

6,428

 

General and administrative

 

 

2,061

 

 

 

2,044

 

 

 

20,679

 

 

 

4,660

 

Total operating expenses

 

 

4,833

 

 

 

3,288

 

 

 

33,756

 

 

 

11,088

 

Loss from operations

 

 

(4,833

)

 

 

(3,288

)

 

 

(33,756

)

 

 

(11,088

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

214

 

 

 

(49

)

 

 

377

 

 

 

(78

)

Change in fair value of financial instruments

 

 

 

 

 

756

 

 

 

3,168

 

 

 

1,925

 

Total other income (expense), net

 

 

214

 

 

 

707

 

 

 

3,545

 

 

 

1,847

 

Net loss and comprehensive loss

 

$

(4,619

)

 

$

(2,581

)

 

$

(30,211

)

 

$

(9,241

)

Net loss per share—basic and diluted

 

$

(0.82

)

 

$

(31.04

)

 

$

(7.43

)

 

$

(113.24

)

Weighted-average number of shares outstanding used in
   computing net loss per share—basic and diluted

 

 

5,667,343

 

 

 

83,154

 

 

 

4,068,526

 

 

 

81,601

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

3


 

CALCIMEDICA, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

(Unaudited)

 

 

Convertible Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance—December 31, 2022 (1)

 

 

84,820,880

 

 

$

62,071

 

 

 

84,165

 

 

$

1

 

 

$

40,402

 

 

$

(111,707

)

 

$

(71,304

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,126

 

 

 

 

 

 

11,126

 

Conversion of preferred stock to common stock as a result of Merger

 

 

(84,820,880

)

 

 

(62,071

)

 

 

2,442,852

 

 

 

 

 

 

62,071

 

 

 

 

 

 

62,071

 

Issuance of common stock to Graybug stockholders as a result of Merger and reset to par of $0.0001

 

 

 

 

 

 

 

 

1,571,433

 

 

 

 

 

 

29,218

 

 

 

 

 

 

29,218

 

Issuance of common shares from private placement, net

 

 

 

 

 

 

 

 

596,363

 

 

 

 

 

 

10,340

 

 

 

 

 

 

10,340

 

Conversion of promissory notes into common stock

 

 

 

 

 

 

 

 

590,031

 

 

 

 

 

 

3,245

 

 

 

 

 

 

3,245

 

Conversion of Series C-2 Warrants into common stock

 

 

 

 

 

 

 

 

80,254

 

 

 

 

 

 

442

 

 

 

 

 

 

442

 

Conversion of promissory note warrants into common stock

 

 

 

 

 

 

 

 

152,875

 

 

 

 

 

 

841

 

 

 

 

 

 

841

 

Merger transaction costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,591

)

 

 

 

 

 

(4,591

)

Restricted stock units net settlement

 

 

 

 

 

 

 

 

143,960

 

 

 

 

 

 

(297

)

 

 

 

 

 

(297

)

Reclassification of warrant liability to equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

216

 

 

 

 

 

 

216

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(19,288

)

 

 

(19,288

)

Balance—March 31, 2023

 

 

 

 

 

 

 

 

5,661,933

 

 

 

1

 

 

 

153,013

 

 

 

(130,995

)

 

 

22,019

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

463

 

 

 

 

 

 

463

 

Adjustment to purchase accounting

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Merger transaction costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

40

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,304

)

 

 

(6,304

)

Balance—June 30, 2023

 

 

 

 

 

 

 

 

5,661,933

 

 

 

1

 

 

 

153,519

 

 

 

(137,299

)

 

 

16,221

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

482

 

 

 

 

 

 

482

 

Adjustment to purchase accounting

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Issuance of common stock (net of issuance costs)

 

 

 

 

 

 

 

 

22,940

 

 

 

 

 

 

72

 

 

 

 

 

 

72

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,619

)

 

 

(4,619

)

Balance—September 30, 2023

 

 

 

 

 

 

 

 

5,684,873

 

 

$

1

 

 

$

154,076

 

 

$

(141,918

)

 

$

12,159

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

(1) Retroactively restated for the reverse recapitalization as described in Note 2.

4


 

CALCIMEDICA, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) (1)

(in thousands, except share amounts)

(Unaudited)

 

 

 

Convertible Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance—December 31, 2021

 

 

84,820,880

 

 

 

62,071

 

 

 

78,527

 

 

$

1

 

 

$

39,895

 

 

$

(103,883

)

 

$

 

 

$

(63,987

)

Stock issued on exercise of stock
   options

 

 

 

 

 

 

 

 

180

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

335

 

 

 

 

 

 

 

 

 

335

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,630

)

 

 

 

 

 

(3,630

)

Balance—March 31, 2022

 

 

84,820,880

 

 

 

62,071

 

 

 

78,707

 

 

 

1

 

 

 

40,231

 

 

 

(107,513

)

 

 

 

 

 

(67,281

)

Stock issued on exercise of stock
   options

 

 

 

 

 

 

 

 

4,320

 

 

 

 

 

 

17

 

 

 

 

 

 

 

 

 

17

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

321

 

 

 

 

 

 

 

 

 

321

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,030

)

 

 

 

 

 

(3,030

)

Balance—June 30, 2022

 

 

84,820,880

 

 

 

62,071

 

 

 

83,027

 

 

 

1

 

 

 

40,569

 

 

 

(110,543

)

 

 

 

 

 

(69,973

)

Stock issued on exercise of stock
   options

 

 

 

 

 

 

 

 

1,138

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

8

 

Issuance of common stock upon
   vesting of restricted stock units

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

757

 

 

 

 

 

 

 

 

 

757

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,581

)

 

 

 

 

 

(2,581

)

Balance—September 30, 2022

 

 

84,820,880

 

 

 

62,071

 

 

 

84,165

 

 

$

1

 

 

$

41,334

 

 

$

(113,124

)

 

$

 

 

$

(71,789

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

(1) Retroactively restated for the reverse recapitalization as described in Note 2.

5


 

CALCIMEDICA, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(30,211

)

 

$

(9,241

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

12,071

 

 

 

1,055

 

Depreciation and amortization

 

 

39

 

 

 

39

 

Change in the fair value of warrant liability

 

 

(1,146

)

 

 

(2,077

)

Change in the fair value of convertible promissory notes

 

 

(2,022

)

 

 

152

 

Non-cash interest expense

 

 

110

 

 

 

44

 

Accretion of discount on short-term investment

 

 

(61

)

 

 

 

Common stock issued for services

 

 

 

 

 

8

 

Changes in operating assets and liabilities: