# EDGAR Filing Document

**Accession Number:** 0001479419
**File Stem:** 0001104659-25-094125
**Filing Date:** 2025-9
**Character Count:** 14411
**Document Hash:** 31613b7b1091f76c0154e37b6f5b777e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-094125.hdr.sgml**: 20250929

**ACCESSION NUMBER**: 0001104659-25-094125

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250928

**ITEM INFORMATION**: Cost Associated with Exit or Disposal Activities

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250929

**DATE AS OF CHANGE**: 20250929

**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:** 251352341

**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): **September 28, 2025**

**KALA BIO, Inc.**

(Exact Name of Registrant as Specified in its Charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-38150** | **27-0604595** |
| (State or Other Jurisdiction of<br> 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):

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| |
|:---|
| 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:

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| | |
|:---|:---|
| **Title of each class** | **Name of each exchange on which <br> 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 2.05. Costs Associated with Exit or Disposal Activities.**

On September 28, 2025, the board of directors (the "Board") of KALA BIO, Inc. (the "Company") determined to cease development of KPI-012 and its mesenchymal stem cell secretome platform and to take steps to preserve cash as the Company explores its strategic options. In connection with such decisions, the Board approved a reduction in the Company's workforce by approximately 19 employees, or approximately 51% (the "Reduction").

The Company expects to substantially complete the Reduction in the fourth quarter of 2025. As of the filing of this Current Report on Form 8-K, the Company cannot estimate the charges it will incur under generally accepted accounting principles as a result of the Reduction. The Company will file an amendment to this Current Report on Form 8-K within four business days after it determines the amount of the estimated charges.

**Item 8.01. Other Events.**

On September 29, 2025, the Company issued a press release announcing that its CHASE (**C**orneal **H**ealing **A**fter **SE**cretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect ("PCED") did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining. The CHASE trial also failed to achieve statistical significance for key secondary efficacy endpoints and did not show any meaningful difference between either KPI-012 treatment arm and the placebo arm.

Based on the results of the CHASE trial, the Company plans to cease development of KPI-012 and its mesenchymal stem cell secretome platform. The Company plans to evaluate its strategic options and, as part of its evaluation, to engage in discussions with its secured lender. In the interim, the Company plans to take steps to preserve cash, including by implementing the Reduction and other cost-saving measures.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

**Cautionary Note Regarding Forward Looking Statements**

Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the Company's plans to evaluate its strategic options, engage in discussions with its secured lender, preserve cash and implement the Reduction. Any forward-looking statements in this Current Report are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, uncertainty regarding what, if any, actions the Company's secured lender may take to recover amounts owed by the Company; the Company's ability to successfully identify and pursue a strategic option on attractive terms, or at all; uncertainty as to the costs and charges related to the Reduction; uncertainty as to whether the Reduction will result in the anticipated savings and be completed when anticipated; and those other risks and uncertainties set forth in the Company's filings with the Securities and Exchange Commission ("SEC"), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and in subsequent filings the Company may make with the SEC. All forward-looking statements contained in this Current Report speak only as of the date of this Current Report. The Company anticipates that subsequent events and developments will cause its views to change. However, the Company undertakes no obligation to update such forward-looking statements to reflect events that occur or circumstances that exist after the date of this Current Report, except as required by law.

**Item 9.01. Financial Statements and Exhibits.**

**(d) Exhibits.**

[99.1](tm2527340d1_ex99-1.htm) [Press Release of KALA BIO, Inc. dated September 29, 2025](tm2527340d1_ex99-1.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: September 29, 2025 | By: | /s/ Mary Reumuth |
|  |  | Mary Reumuth |
|  |  | Chief Financial Officer and Corporate Secretary |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm2527340d1_ex99-1img01.jpg)

**KALA BIO Announces Topline Results from CHASE Phase 2b Clinical Trial Evaluating KPI-012 for the Treatment of<br> Persistent Corneal Epithelial Defect (PCED) Did Not Meet Primary Endpoint**

*-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance --*

 

*-- KPI-012 was well-tolerated with no treatment-related serious adverse events observed --*

 

*-- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options --*

 

**ARLINGTON, Mass., September 29, 2025 -** KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that its CHASE (**C**orneal **H**ealing **A**fter **SE**cretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining. The CHASE trial also failed to achieve statistical significance for key secondary efficacy endpoints and did not show any meaningful difference between either KPI-012 treatment arm and the placebo arm.

Based on the CHASE trial results, KALA plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. KALA plans to evaluate its strategic options and as part of its evaluation to engage in discussions with its secured lender. In the interim, the company plans to take steps to preserve cash, including by conducting a reduction in workforce and other cost-saving measures.

"We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the Phase 1b study. KPI-012 continued to be well-tolerated and demonstrated a favorable safety profile but did not demonstrate the efficacy results that would warrant advancing the program for treatment of front-of-the-eye diseases," said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of Kala BIO. "We would like to thank all of the patients and investigators who participated in in the CHASE trial."

**About CHASE** (**C**orneal **H**ealing **A**fter **SE**cretome therapy) **Phase 2b Trial**

The CHASE Phase 2b trial is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed topically QID for 56 days. The CHASE trial randomized 79 patients across 37 sites in the United States and Latin America with verified PCEDs at baseline that will be eligible for inclusion in the primary efficacy analysis. The primary endpoint is complete healing of PCED as measured by corneal fluorescein staining photographs analyzed by a masked central reading center.

**About KALA BIO, Inc.**

KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA's biologics-based investigational therapies utilize KALA's proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA's lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors. KPI-012 received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing.

**Cautionary Note Regarding Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA's future expectations, plans and prospects, including but not limited to statements about KALA's plans to evaluate its strategic options, engage in discussions with its secured lender, preserve cash, conduct a reduction in workforce and other cost-saving measures and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainty regarding what, if any, actions KALA's secured lender may take to recover amounts owed by KALA; KALA's ability to successfully identify and pursue strategic options on attractive terms, or at all; uncertainty as to whether the reduction in workforce and other cost-saving measures will result in the anticipated savings and be completed when anticipated; and other important factors, any of which could cause KALA's actual results to differ from those contained in the forward-looking statements, discussed in the "Risk Factors" section of KALA's Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA's views as of the date of this press release and should not be relied upon as representing KALA's views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

**Investor Contact:**

Taylor Steiner

taylor.steiner@precisionaq.com

212-362-1200