KALA (KALA) Hits Enrollment Milestone; KPI-012 Data Expected Q3 2025

Rhea-AI Filing Summary

KALA Bio (Nasdaq: KALA) has finished enrolling all 79 patients in its CHASE Phase 2b trial of KPI-012, a human mesenchymal stem-cell secretome therapy for persistent corneal epithelial defect (PCED). The multicenter, randomized, double-masked study is comparing two doses (3 U/mL and 1 U/mL) of KPI-012 to vehicle, dosed topically four times daily for 56 days across 37 sites in the United States and Latin America.

Key trial design highlights

• Primary endpoint: complete healing of PCED assessed via fluorescein staining reviewed by a masked central reading center.
• Next catalyst: topline safety and efficacy data expected in Q3 2025.
• Regulatory pathway: management believes positive results could allow CHASE to serve as the first of two pivotal trials supporting a Biologics License Application (BLA) with the U.S. FDA.

The 8-K filing contains forward-looking statements outlining typical clinical, regulatory and market risks but provides no financial metrics or changes to guidance.

Investment view: Completion of enrollment de-risks timeline execution and sets a near-term data read-out, yet clinical success and regulatory approval remain the primary value-drivers.

Insights

Biotech Equity Analyst

TL;DR: Milestone hit; data in Q3 2025 could be pivotal if efficacy holds.

Completion of patient enrollment removes a key operational risk and signals good site activation across 37 centers. The 79-patient sample, while modest, is in line with orphan ophthalmology precedents. If KPI-012 shows statistically significant epithelial healing versus vehicle, management’s plan to treat CHASE as the first pivotal study is credible and could accelerate time-to-market. Near-term value inflection thus shifts to Q3 2025 read-out. Absent efficacy, however, the program would need redesign, which could materially erode enterprise value.

Clinical Trial Risk Analyst

TL;DR: Positive operational step but outcome risk remains high.

While enrollment closure is encouraging, KPI-012’s mechanism has limited late-stage validation, and ophthalmic secretome therapeutics face manufacturing and regulatory scrutiny. The study’s two-month treatment window and binary healing endpoint add execution complexity. Investors should temper enthusiasm until blinded data clarify safety and efficacy; failure rates in PCED studies can exceed 40%. Overall impact is neutral until results emerge.

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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): July 9, 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 8.01. Other Events.

On July 9, 2025, KALA BIO, Inc. (the “Company”) announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome, for the treatment of persistent corneal epithelial defect (“PCED”).

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.

The Company expects to report topline data from the CHASE trial in the third quarter of 2025. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE trial could potentially serve as a pivotal trial required to support the submission of a Biologics License Application (“BLA”) to U.S. Food and Drug Administration (“FDA”).

Forward-Looking Statements

This Current Report on Form 8-K 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 Form 8-K about the Company’s future expectations, plans and prospects, including but not limited to statements about the Company’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; the Company’s belief that the CHASE Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; the Company’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” 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: market conditions; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission. These forward-looking statements represent the Company’s views as of the date of this Form 8-K and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company 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.

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: July 9, 2025	By:	/s/ Mary Reumuth
		Mary Reumuth
		Chief Financial Officer and Corporate Secretary