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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) |
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| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ |
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.
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KALA BIO, INC. |
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| Date: September 29, 2025 |
By: |
/s/ Mary Reumuth |
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Mary Reumuth |
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Chief Financial Officer and Corporate Secretary |
