Kala Bio (NASDAQ: KALA) halts KPI-012 after failed trial and slashes staff

Rhea-AI Filing Summary

KALA BIO, Inc. reported that its CHASE Phase 2b clinical trial of KPI-012 for treating persistent corneal epithelial defect did not meet its primary endpoint of complete healing and also failed to show statistically significant benefits on key secondary measures, with no meaningful difference versus placebo. Based on these results, the company plans to cease development of KPI-012 and its mesenchymal stem cell secretome platform. To preserve cash while it evaluates strategic options, KALA’s board approved a workforce reduction of approximately 19 employees, or about 51%, expected to be substantially completed in the fourth quarter of 2025. The company has not yet determined the related accounting charges and plans to amend this report after it estimates them. KALA also plans to discuss its situation with its secured lender as part of its strategic review.

Positive

• None.

Negative

• KPI-012 Phase 2b failure in PCED, with no meaningful benefit over placebo on primary or key secondary endpoints, leading to termination of the program and platform.
• Workforce reduction of approximately 51% (about 19 employees) approved to preserve cash, indicating a significant downsizing of operations tied to the program failure.

Insights

Biotech & Restructuring Analyst

Failed KPI-012 trial drives program shutdown and deep workforce cuts.

KALA BIO disclosed that the CHASE Phase 2b trial of KPI-012 in persistent corneal epithelial defect did not meet its primary endpoint and showed no meaningful difference from placebo on key secondary measures. This removes a key clinical asset and leads the company to halt development of KPI-012 and its mesenchymal stem cell secretome platform.

In response, the board approved a workforce reduction of about 19 employees, or roughly 51%, expected to be substantially completed in Q4 2025, as part of broader efforts to preserve cash. Management also plans to evaluate strategic options and engage in discussions with its secured lender, signaling a reassessment of the company’s path forward.

The financial impact includes future charges associated with the reduction, which the company has not yet estimated under generally accepted accounting principles and intends to disclose via an amendment. Subsequent updates will likely clarify remaining operating capacity, cash preservation from the cuts, and any outcomes from strategic review and lender discussions.

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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): September 28, 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 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 (Corneal Healing After SEcretome 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	Press Release of KALA BIO, Inc. dated September 29, 2025
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.
Date: September 29, 2025	By:	/s/ Mary Reumuth
		Mary Reumuth
		Chief Financial Officer and Corporate Secretary

FAQ

What did Kala Bio (KALA) announce about the KPI-012 CHASE trial?

KALA BIO announced that its CHASE Phase 2b clinical trial of KPI-012 for persistent corneal epithelial defect did not meet the primary endpoint of complete healing and failed to achieve statistical significance on key secondary efficacy endpoints, with no meaningful difference versus placebo.

How is Kala Bio (KALA) responding to the KPI-012 trial results?

Based on the CHASE trial results, KALA BIO plans to cease development of KPI-012 and its mesenchymal stem cell secretome platform, evaluate strategic options, and engage in discussions with its secured lender while taking steps to preserve cash.

What workforce changes did Kala Bio (KALA) disclose in this 8-K?

The board approved a workforce reduction of approximately 19 employees, representing about 51% of the company’s workforce, with the reduction expected to be substantially completed in the fourth quarter of 2025.

Will Kala Bio (KALA) incur charges related to the workforce reduction?

KALA BIO stated it cannot yet estimate the charges it will incur under generally accepted accounting principles as a result of the reduction and plans to file an amendment after determining the estimated charges.

What strategic steps is Kala Bio (KALA) considering after ending KPI-012 development?

The company plans to evaluate its strategic options, which includes engaging in discussions with its secured lender and implementing the workforce reduction and other cost-saving measures to preserve cash.

Did Kala Bio (KALA) provide any additional materials with this disclosure?

Yes. A press release dated September 29, 2025, describing the CHASE trial results and related decisions, was filed as Exhibit 99.1 and incorporated by reference.