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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): November 9, 2026
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 2.02 | Results of Operations and Financial Condition. |
On
November 9, 2026, KALA BIO Inc. issued a press release announcing its certain preliminary financial results for the quarter ended September
30, 2026. The press release is furnished as Exhibit 99.1.
The
information in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished pursuant to Item 2.02 and shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general
incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release of KALA BIO, Inc., dated November 9, 2026. |
| 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: November 9,
2026 |
By: |
/s/ Avi Minkowitz |
| |
|
Avi Minkowitz |
| |
|
Chief
Executive Officer |
Exhibit 99.1
KALA
BIO Provides CEO Update and Preliminary Third Quarter 2026 Financial Results
New
York, November 9, 2026 – KALA BIO, Inc. (Nasdaq: KALA) today announced preliminary unaudited financial results for the quarter
ended September 30, 2026.
Preliminary
Third Quarter 2026 Results
| ● | Net
loss of approximately $0.8 million for the third quarter of 2026, compared to $7.6 million
for the third quarter of 2025. |
| ● | Net
loss of approximately $4.0 million for the nine months ended September 30, 2026, compared
to $27.7 million for the same period in 2025. |
| ● | Cash,
cash equivalents and short-term investments of approximately $7.0 million as of September
30, 2026, with no debt. |
“We
reduced our quarterly net loss by approximately 90% year over year and continue to develop the initiatives we have put in motion. We
thank our stockholders who attended our Annual Meeting on November 3, 2026, and for their continued support,” said Avi Minkowitz,
Chief Executive Officer and Chief Financial Officer.
KALA
expects to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 with the SEC on or about November 16, 2026.
Preliminary
Results
The results above are preliminary, unaudited and subject to completion of the Company’s financial close procedures and review by
its independent registered public accounting firm. Final results, to be included in the Form 10-Q, may differ.
About
Kala Bio, Inc. (NASDAQ: KALA)
KALA
BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology
industry. The Company’s dual strategy combines a proprietary biologics pipeline—including its mesenchymal stem cell secretome
(MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates—with a scalable AI platform-as-a-service business
that deploys secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.
Through
its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure
partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data
without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai,
a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The
Company’s focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation
in the life sciences AI sector.
Kala
believes the future of biomedical innovation is in agentic systems.
For
more information, visit www.kalarx.com and Researgency.ai
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including
statements regarding the Company’s preliminary unaudited financial results for the three and nine months ended September 30, 2026
and the expected timing of the filing of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.
The
preliminary financial results set forth in this press release are based on management’s current estimates and information available
as of the date of this release. They are unaudited and remain subject to the completion of the Company’s financial closing procedures,
final adjustments, and review by the Company’s independent registered public accounting firm. The Company’s actual results
may differ materially from these preliminary results, and these preliminary results should not be viewed as a substitute for the full
interim financial statements to be included in the Form 10-Q.
Important
factors that could cause actual results or events to differ materially from those expressed or implied by these forward-looking statements
include, but are not limited to: adjustments arising from the completion of the Company’s financial closing procedures or the review
of its interim financial statements; the identification of subsequent events or additional information prior to the filing of the Form
10-Q; delays in the completion or filing of the Form 10-Q; and other risks detailed in the “Risk Factors” section of the
Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as may be updated in the Company’s Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.
Forward-looking
statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Avi
Minkowitz
Chief Executive Officer, KALA BIO, Inc.
am@kalarx.com
www.kalarx.com | www.Researgency.ai
