KALA BIO, Inc. SEC Filings

KALA BIO, Inc. Schedule 13G reports that Point72-related filers — Point72 Asset Management, Point72 Capital Advisors, Inc., and Steven A. Cohen — jointly disclose beneficial ownership of 469,229 shares of KALA common stock, representing 6.7% of the class as of the close of business on September 10, 2025. The filing states Point72 Asset Management and Point72 Capital Advisors exercise shared voting and dispositive power over these shares through Point72 Associates, an investment fund they manage. The filing includes a Joint Filing Agreement (Exhibit 99.1) and affirms the shares were not acquired to influence control of the issuer.

Perceptive Advisors and related parties report holding 543,745 shares of KALA BIO, Inc., representing 7.7% of the outstanding common stock. The Schedule 13G shows the Master Fund directly holds the shares and that Perceptive Advisors (as investment manager) and Joseph Edelman (managing member) may be deemed to beneficially own those shares. The filing states the position is held passively and not for the purpose of changing or influencing control of the issuer.

KALA BIO, Inc. reporting person Todd Bazemore, identified as a director and officer (President and Chief Executive Officer), was granted a stock option on 08/29/2025 to purchase 180,000 shares of common stock at an exercise price of $11.22 per share. The option vests over four years beginning on the vesting commencement date of 08/29/2025, with 1/48th of the shares vesting at the end of each successive one-month period until 08/29/2029, subject to continued service. The option lists an expiration/exercisable date of 08/28/2035. The Form 4 was signed by an attorney-in-fact on behalf of the reporting person on 09/02/2025.

KALA BIO, Inc. appointed Todd Bazemore as Chief Executive Officer, effective immediately, while he continues as President and leaves the Chief Operating Officer role. He was also elected as a Class II director, serving until the 2025 annual stockholders’ meeting or earlier departure.

The company amended his offer letter to set an annual base salary of $655,000 and a target annual bonus equal to 60% of base salary. Following a qualifying termination within 24 months after a change of control, he may receive 24 months of salary, certain bonus amounts, 24 months of COBRA premiums, and outplacement services. He also received an option to purchase 180,000 shares of common stock at the Effective Date’s closing price, vesting monthly over four years, subject to continued service.

KALA BIO (Nasdaq: KALA) Q2 2025 10-Q highlights

• No commercial revenue after 2022 business sale; the model is now fully R&D-focused on lead candidate KPI-012 for persistent corneal epithelial defects (PCED).
• Losses narrowed modestly. Six-month net loss was $20.1 m vs. $21.4 m YoY; quarterly loss was $11.2 m.
• Cash burn improved: operating cash outflow $16.6 m vs. $20.1 m YoY. However, cash & equivalents fell to $31.9 m from $51.2 m at 12/31/24.
• Runway & going-concern. Management projects liquidity into 1Q 2026 but discloses “substantial doubt” about continuing as a going concern without additional capital.
• Balance sheet deterioration. Shareholders’ equity turned negative (-$3.2 m) from +$12.3 m; accumulated deficit reached $688 m.
• Expenses. 1H 25 R&D $12.3 m (+5% YoY); G&A $9.2 m (-5%). Grant income of $2.9 m from CIRM partially offsets costs.
• Debt. Total Oxford loan balance $28.3 m (current $9.5 m); $2.5 m principal repaid YTD. Compliance depends on maintaining Nasdaq listing.
• Milestone potential. Up to $325 m of sales-based payments from Alcon remain possible but timing uncertain; $4.8 m in Combangio contingent liabilities remain on balance sheet.
• Share count 7.0 m common as of 8/7/25; Series E–I convertible preferred outstanding but carry no dividend or liquidation preference.

Management continues Phase 2b CHASE trial for KPI-012; additional capital raises, partnerships or cost cuts are being evaluated.

KALA BIO announced that it has released its quarterly results for the period ending June 30, 2025 and provided a general business and corporate update. The company has furnished a press release as Exhibit 99.1 to this Form 8-K so investors can read the full update. The filing notes that the information is being furnished (not "filed") under the Exchange Act and therefore is for disclosure rather than subject to certain filing liabilities.

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.

Kala Bio Chief Business Officer Darius Kharabi reported a sale of 4,511 shares of common stock on June 24, 2025, at a weighted average price of $4.01 per share (ranging from $3.87 to $4.12). The transaction was executed under a pre-established 10b5-1 trading plan from November 16, 2021.

Key details of the transaction:

• The sale was specifically made to cover tax withholding obligations related to RSU vesting from a June 22, 2023 grant
• Following the transaction, Kharabi maintains beneficial ownership of 62,566 shares, including 28,878 unvested RSUs
• The transaction was executed as a direct ownership sale
• The Form 4 was filed through an attorney-in-fact on June 26, 2025

This planned sale under Rule 10b5-1 demonstrates standard executive equity management for tax obligations rather than a discretionary trading decision.

Kala Bio CFO Mary Reumuth reported a sale of 3,631 shares of common stock on June 24, 2025, at a weighted average price of $4.01 per share (range: $3.87-$4.12). The transaction was executed under a pre-established 10b5-1 trading plan from November 9, 2020.

Key details of the transaction:

• The sale was specifically made to cover tax withholding obligations related to RSU vesting from a June 22, 2023 grant
• Following the transaction, Reumuth maintains beneficial ownership of 62,100 shares, including 28,906 unvested RSUs
• The transaction was reported via Form 4 within the required filing deadline

This planned sale under Rule 10b5-1 demonstrates standard executive equity management practices for tax obligations and does not indicate a significant change in the CFO's overall position in the company.