Kala Bio removes Deloitte as independent auditor, cites no disputes

KALA BIO dismissed Deloitte & Touche LLP as its independent registered public accounting firm effective December 15, 2025.

Rhea-AI Filing Summary

KALA BIO dismissed Deloitte & Touche LLP as its independent registered public accounting firm effective December 15, 2025. Deloitte had audited the company’s consolidated financial statements for the fiscal years ended December 31, 2024 and 2023.

The company states that Deloitte’s prior audit reports did not include adverse or disclaimed opinions and were not qualified or modified for uncertainty, scope, or principles. KALA BIO reports no disagreements with Deloitte and no reportable events during those periods and through December 15, 2025. The company has not yet appointed a new independent auditor.

Insights

Equity Governance Analyst

KALA BIO replaced Deloitte as auditor, reporting no disputes or issues.

KALA BIO has ended its engagement with Deloitte & Touche LLP as independent registered public accounting firm effective December 15, 2025. Deloitte’s audit reports on the company’s consolidated financial statements for the years ended December 31, 2024 and December 31, 2023 were clean, with no adverse or disclaimed opinions and no qualifications related to uncertainty, audit scope, or accounting principles.

The company further states that during those two fiscal years and the subsequent interim period through December 15, 2025 there were no disagreements with Deloitte on accounting principles, disclosure, or audit procedures, and no reportable events under Item 304 of Regulation S‑K. Deloitte provided a letter to the SEC, filed as Exhibit 16.1, indicating its position on these disclosures. KALA BIO has not yet named a successor auditor, so future disclosures may clarify the selection and timing of the next firm.

8-K Event Classification

2 items: 4.01, 9.01

2 items

Item 4.01 Changes in Registrant's Certifying Accountant Governance

The company changed its independent auditing firm, which may involve disagreements on accounting matters.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What auditor change did KALA BIO (KALA) disclose?

KALA BIO disclosed that its Audit Committee approved the dismissal of Deloitte & Touche LLP as the company’s independent registered public accounting firm, effective December 15, 2025.

Did Deloitte issue any adverse opinions on KALA BIOs 2023 or 2024 financial statements?

No. The company states that Deloittes audit reports on KALA BIOs consolidated financial statements for the years ended December 31, 2024 and December 31, 2023 did not contain adverse opinions, disclaimers of opinion, or qualifications related to uncertainty, scope, or accounting principles.

Were there any disagreements between KALA BIO and Deloitte before the dismissal?

KALA BIO reports that during its two most recent fiscal years and the interim period through December 15, 2025 there were no disagreements with Deloitte on accounting principles, financial statement disclosure, or auditing scope or procedures, and no reportable events under Regulation S‑K Item 304.

Has KALA BIO (KALA) appointed a new independent auditor?

As of the date of the report, KALA BIO states that it has not appointed a new independent registered public accounting firm to replace Deloitte.

What document did Deloitte provide in connection with KALA BIOs disclosure?

Deloitte furnished a letter to the U.S. Securities and Exchange Commission, dated December 16, 2025, regarding KALA BIOs statements. This letter is filed as Exhibit 16.1.

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Accepted by SEC EDGAR 12/16/2025 - 01:28 PM Learn about SEC filing dates

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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): December 15, 2025

KALA BIO, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-38150		27-0604595
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1167 Massachusetts Avenue

Arlington, MA 02476

(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (781) 996-5252

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 (see General Instruction A.2. below):

☐	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, $0.001 par value per share		KALA		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 4.01. Changes in Registrant’s Certifying Accountant

On December 15, 2025, the Audit Committee of the Board of Directors of KALA BIO, Inc. (the “Company”) approved the dismissal of Deloitte & Touche LLP (“Deloitte”) as the Company’s independent registered public accounting firm, effective as of December 15, 2025.

The audit reports of Deloitte on the Company’s consolidated financial statements as of and for the fiscal years ended December 31, 2024 and 2023 did not contain an adverse opinion or a disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles.

During the Company’s two most recent fiscal years ended December 31, 2024 and 2023, and the subsequent interim periods through December 15, 2025, (i) there were no disagreements (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) with Deloitte on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to Deloitte’s satisfaction, would have caused Deloitte to make reference to the subject matter of the disagreement in connection with its reports on the Company’s financial statements, and (ii) there were no “reportable events” (as defined in Item 304(a)(1)(v) of Regulation S-K).

The Company provided Deloitte with a copy of the disclosures set forth in this Item 4.01 prior to the filing of this Current Report on Form 8-K and requested that Deloitte furnish the Company with a letter addressed to the U.S. Securities and Exchange Commission stating whether it agrees with the statements made herein and, if not, stating the respects in which it does not agree. A copy of Deloitte’s letter, dated December 16, 2025, is filed as Exhibit 16.1 to this Current Report on Form 8-K.

The Company has not appointed a new independent registered public accounting firm as of the date of this filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

16.1	Letter from Deloitte & Touche LLP to the U.S. Securities and Exchange Commission, dated December 16, 2025.
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.

	KALA BIO, INC.
Date: December 16, 2025	By:	/s/ David Lazar
		David Lazar
		Chief Executive Officer

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