Welcome to our dedicated page for Kala Pharmaceuticals SEC filings (Ticker: KALA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The KALA BIO, Inc. (NASDAQ: KALA) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. These documents offer detailed insight into KALA’s clinical-stage biopharmaceutical business focused on rare and severe eye diseases, its mesenchymal stem cell secretome (MSC-S) platform, and its evolving financial and strategic position.
Through KALA’s annual reports on Form 10-K and quarterly reports on Form 10-Q, investors can review information on research and development activities, pipeline programs such as KPI-012 and KPI-014, risk factors, liquidity and capital resources. Current Reports on Form 8-K highlight material events, including the CHASE Phase 2b trial results for KPI-012, decisions to cease development of KPI-012 and the MSC-S platform, workforce reductions, financing agreements, loan defaults and settlements with Oxford Finance LLC, and Nasdaq listing deficiency notices.
KALA’s filings also include transaction-related documents, such as the Securities Purchase Agreement for Series AA and Series AAA convertible preferred stock, the Convertible Loan Agreement with an investor, and the Oxford Loan Settlement Agreement. These records explain how the company has structured recent financings, addressed debt obligations and framed its exploration of strategic alternatives. Notifications like Form 12b-25 describe timing of periodic reports when delays occur.
On Stock Titan, KALA filings are updated in near real time as they appear on EDGAR. AI-powered summaries help interpret lengthy 10-K and 10-Q reports, breaking down key sections on clinical programs, cash runway, going-concern language and risk disclosures. For Form 4 and other insider-related filings, users can quickly see reported insider transactions in KALA stock. This combination of raw filings and AI-generated explanations allows readers to understand what each document means for KALA’s business, capital structure and potential strategic direction without having to parse every page manually.
KALA BIO, Inc. reported that its lender, Oxford Finance LLC, has delivered a written notice declaring an event of default under the companies’ Loan and Security Agreement. The notice states that the event of default is based on a contractual “Material Adverse Change” provision and alleges that additional defaults may exist.
As a result, Oxford has declared all obligations under the loan immediately due and payable and has started charging interest at the contractual default rate. The company reports that obligations accelerated and declared payable under the loan total $29.1 million, plus additional interest at the default rate and any expenses owed under the agreement.
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.
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 (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.
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