# EDGAR Filing Document

**Accession Number:** 0001479419
**File Stem:** 0001829126-25-010045
**Filing Date:** 2025-12
**Character Count:** 6722
**Document Hash:** 18d2f4fe6803c7dcd7a94981e6430d7d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001829126-25-010045.hdr.sgml**: 20251216

**ACCESSION NUMBER**: 0001829126-25-010045

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20251215

**ITEM INFORMATION**: Changes in Registrant's Certifying Accountant

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251216

**DATE AS OF CHANGE**: 20251216

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** KALA BIO, Inc.
- **CENTRAL INDEX KEY:** 0001479419
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 270604595
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38150
- **FILM NUMBER:** 251574388

**BUSINESS ADDRESS:**
- **STREET 1:** 1167 MASSACHUSETTS AVENUE
- **CITY:** ARLINGTON
- **STATE:** MA
- **ZIP:** 02476
- **BUSINESS PHONE:** 781-996-5252

**MAIL ADDRESS:**
- **STREET 1:** 1167 MASSACHUSETTS AVENUE
- **CITY:** ARLINGTON
- **STATE:** MA
- **ZIP:** 02476

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Kala Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20091223

?xml version='1.0' encoding='ASCII'?

**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<br> of Incorporation) | (Commission <br> File Number) | (IRS Employer<br> 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** | **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.

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| | |
|:---|:---|
| **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.](kalabio_ex16-1.htm) <br> 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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

---

## Exhibit 16.1

**Exhibit 16.1**

December 16, 2025

Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549-7561

Dear Sirs/Madams:

We have read Item 4.01 of KALA BIO Inc.'s Form 8-K dated December 16, 2025, and have the following comments:

&nbsp;&nbsp;&nbsp;&nbsp;1. We agree with the statements made in the first four paragraphs therein.

&nbsp;&nbsp;&nbsp;&nbsp;2. We have no basis on which to agree or disagree with the statement made in the fifth paragraph therein.

Yours truly,

/s/ Deloitte & Touche LLP