ARLINGTON, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), (“KALA” or the “Company”) today announced the successful completion of its loan settlement with Oxford Finance, LLC (“Oxford”), marking a transformational milestone for the Company. The completion of the settlement resolves critical debt obligations. As previously disclosed in the Company’s Current Report on Form 8-K filed on November 25, 2025, KALA and its subsidiary Combangio, Inc., entered into a Loan Settlement Agreement w ...

ARLINGTON, Mass., Dec. 05, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) (“KALA” or the “Company”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase of an aggregate of 10,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.00 per share (or pre-funded warrant in lieu thereof). H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The ag ...

ARLINGTON, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) (“KALA” or the “Company”), today announced that it has entered into definitive agreements for the purchase of an aggregate of 10,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.00 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about December 5, ...

Core Insights - KALA BIO, Inc. has entered into a $6 million securities purchase agreement with private investor David E. Lazar for non-voting convertible preferred stock, with an initial investment of $1.8 million received [1][3] - Following the investment, David E. Lazar has been appointed as the new Chief Executive Officer and Chairman of the Board, while former CEO Todd Bazemore remains on the Board [1][3] - KALA plans to continue the evaluation and redevelopment of its product candidates, particularly KPI-012, despite previous setbacks in clinical trials [2][3] Investment and Financials - The investment agreement includes a second closing contingent on stockholder approval, which is expected in the first quarter of 2026, involving an additional $4.2 million investment [3] - KALA has issued new shares of non-voting convertible Series AA preferred stock in exchange for the initial investment [3] Clinical Development - KALA's KPI-012 did not meet the primary endpoint in its Phase 2b clinical trial for treating persistent corneal epithelial defect, leading to a temporary halt in its development [2] - The company aims to explore strategic options and continue evaluating its therapeutic candidates for potential standalone uses or in combination with other products [2] Company Overview - KALA BIO, Inc. focuses on innovative therapies for rare and severe eye diseases, utilizing its proprietary mesenchymal stem cell secretome platform [4] - KPI-012 has received Orphan Drug and Fast Track designations from the FDA for treating persistent corneal epithelial defect [4]

Core Points - KALA BIO Inc. experienced a significant stock price increase of 37.87% to $0.88 in after-hours trading, following a regular session close at $0.64, which was a 3.45% increase [1][6] Financing and Agreements - KALA BIO entered into a Securities Purchase Agreement with investor David Lazar to raise up to $6 million through a private placement, as disclosed in an SEC Form 8-K filing [2] - The first closing raised $1.8 million from the sale of 900,000 Series AA Preferred Shares at $2 each, while a second closing is expected to raise $4.2 million through 2.1 million Series AAA Preferred Shares at $2 each, pending stockholder approval [3] Loan Settlement - KALA BIO reached a loan settlement agreement with Oxford Finance LLC, which requires a $2 million cash payment and the issuance of 1.62 million common stock shares [4] - Upon completion of an initial $1 million payment by January 15, 2026, or the stockholder meeting date, and stock issuance, the Loan Agreement balance will be reduced by $7 million [4] Leadership Changes - David Lazar was appointed as Chief Executive Officer and Principal Executive Officer by the Board, effective from the first closing of the financing [5] - Lazar previously served as CEO of Novabay Pharmaceuticals Inc. from August to November [5] Stock Performance - KALA BIO's stock has declined 91.72% year to date, with a 52-week range of $0.61 to $20.58 and a market capitalization of $5.21 million [6] - Benzinga's Edge Stock Rankings indicate a negative price trend for KALA stock across all time frames [6]

Financial Performance - The company reported a net loss of $7.6 million and $27.7 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $695.6 million as of the same date[158]. - The company has incurred significant operating losses since inception and has financed operations primarily through various funding sources, including the sale of its Commercial Business to Alcon[203]. - The company reported a net cash used in operating activities of $27.4 million for the nine months ended September 30, 2025, compared to $24.8 million for the same period in 2024, reflecting a decrease of $2.7 million[233]. - The company experienced a net cash decrease of $30.1 million for the nine months ended September 30, 2025, compared to a decrease of $1.7 million for the same period in 2024[232]. - The net loss for the nine months ended September 30, 2025 was $27.7 million, an improvement of $2.7 million compared to a net loss of $30.3 million in 2024[194]. Research and Development - The CHASE trial for KPI-012 did not meet its primary endpoint, leading to the decision to cease development of KPI-012 and the MSC-S platform, resulting in a workforce reduction of approximately 51%[141]. - Prior to ceasing R&D activities, the company was evaluating KPI-012 for additional rare diseases and had initiated preclinical studies for KPI-014 targeting inherited retinal degenerative diseases[154]. - The company expects a substantial increase in general and administrative expenses due to commercialization efforts for product candidates KPI-012 and KPI-014[241]. - The company does not expect to generate revenue from KPI-012, KPI-014, or any other product candidates in the foreseeable future[244]. - The company may need to raise additional capital to resume research and development activities, with potential adverse effects on financial condition if unable to do so[248]. Financing and Obligations - As of the Default Notice on September 29, 2025, the total obligations under the Loan Agreement with Oxford Finance were accelerated to $29.1 million, which was later reduced to approximately $9.6 million after cash sweeps[143][148]. - A Convertible Loan Agreement was entered into on November 9, 2025, providing a loan of $375,000 at a 15% annual interest rate, intended for negotiation of additional financing[149][150]. - The company has financed operations through various means, including the sale of its Commercial Business, IPO proceeds, and a recent private placement resulting in gross proceeds of approximately $10.8 million[160]. - The company is eligible to receive up to $325.0 million in milestone payments from Alcon based on sales of EYSUVIS and INVELTYS, but timing and amounts are uncertain[162]. - The company has a total potential maximum payout of $40.0 million for milestone payments and an additional $65.0 million for future sales-based milestone payments related to the Combangio acquisition[228]. Expenses and Cash Flow - General and administrative expenses for Q3 2025 were $4.5 million, an increase of $0.1 million compared to $4.4 million in Q3 2024[185]. - Research and development expenses for Q3 2025 were $6.1 million, up from $5.2 million in Q3 2024, primarily due to a $0.9 million increase in employee-related costs[186]. - Total operating expenses for the nine months ended September 30, 2025 were $28.9 million, down from $31.5 million in 2024, reflecting a decrease of $2.6 million[194]. - Interest income decreased to $0.3 million in Q3 2025 from $0.6 million in Q3 2024, attributed to lower interest rates and changes in investment mix[189]. - Interest expense decreased to $3.1 million for the nine months ended September 30, 2025, down from $4.4 million in 2024, a decrease of $1.3 million[200]. Strategic Options and Future Outlook - The company plans to explore strategic options, including potential sales, licenses, or mergers, contingent on obtaining additional funding[155]. - The company anticipates that its cash and cash equivalents will not be sufficient to fund operations through November 2025, raising substantial doubt about its ability to continue as a going concern[237]. - The financial statements are prepared on a going concern basis, indicating uncertainty regarding asset recoverability and liability classification[243]. - The company has limited experience in product commercialization, which may hinder future product launches and market expectations[245]. - The company may seek financing through equity offerings, debt financings, and strategic alliances, which could dilute existing ownership interests[247]. Workforce and Operational Changes - The company incurred costs of approximately $1.6 million related to workforce reductions, with $0.4 million incurred in the third quarter of 2025 and the remainder expected in the fourth quarter[146]. - The company is restricted from incurring additional debt or making certain capital expenditures under its Loan Agreement[247]. - The company recorded a gain of $4.8 million on fair value remeasurement of contingent consideration for Q3 2025, compared to a loss of $0.4 million in Q3 2024[187]. - The company has incurred $2.6 million in cash and $2.4 million in shares as contingent milestone payments to Combangio equityholders as of September 30, 2025[172]. - The remaining $0.6 million under the CIRM Award will not be received due to the decision to cease clinical development of KPI-012 for PCED[179].

Core Insights - KALA BIO's shares have plummeted 88.3% in a month following the announcement of the failure of its mid-stage study for KPI-012, aimed at treating persistent corneal epithelial defect (PCED) [1] Study Results - The phase IIb CHASE study evaluated the safety and efficacy of two doses of KPI-012 compared to a vehicle control, with 79 patients randomized to receive either treatment [2] - The study did not meet its primary endpoint of complete PCED healing and failed to achieve statistical significance for key secondary efficacy endpoints [3][4] - No significant difference was observed between the KPI-012 treatment group and the placebo group, although the therapy maintained a favorable safety profile [4] Strategic Decisions - Following the study's failure, KALA BIO will discontinue the development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform [5][7] - The company plans to implement cost-control measures, including workforce reductions, and will explore strategic alternatives with its secured lender [7][8] - This decision effectively reverts KALA BIO to the preclinical stage, delaying its product advancement and revenue generation prospects [8] Impact on Future Development - The discontinuation of the MSC-S platform will halt preclinical efforts on KPI-012 for limbal stem cell deficiency and other corneal disorders, as well as the development of KPI-014 for rare inherited retinal diseases [9]

Company Performance - MoonLake Immunotherapeutics (NASDAQ:MLTX) experiences a drastic decrease in its stock price to $6.24, about 89.93% [1][6] - KALA BIO, Inc. (NASDAQ:KALA) sees its stock decline sharply to $2.13, translating to an 88.82% decrease [2][6] - IO Biotech, Inc. (NASDAQ:IOBT) experiences a 77.31% decrease in its stock price, falling to $0.35 [3][6] - Maris-Tech Ltd. (NASDAQ:MTEKW) sees its stock price decrease to $0.22, a 71.16% drop [4] Industry Insights - The recent market movements highlight the volatile nature of the stock market, where companies across various sectors can experience significant fluctuations [5] - Factors such as market sentiment, industry trends, and company-specific developments play crucial roles in influencing stock prices [5]

Core Points - Kala Bio Inc. has halted the development of its experimental treatment KPI-012 for persistent corneal epithelial defect (PCED) after the CHASE Phase 2b trial did not meet its primary endpoint of complete healing [2][4] - The trial also failed to achieve statistical significance for key secondary efficacy endpoints, showing no meaningful difference between the treatment and placebo arms [3] - Following the trial results, the company plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform, while evaluating strategic options and engaging with its secured lender [4] Financial Summary - As of June 30, Kala Bio had cash and cash equivalents of $31.9 million, which is expected to fund operations into the first quarter of 2026 [5] - The company's stock price has dropped significantly, down 91.44% to $1.63 [5]

Core Insights - KALA BIO, Inc. announced that its Phase 2b clinical trial of KPI-012 for treating persistent corneal epithelial defect (PCED) did not meet its primary endpoint of complete healing at Week 8, nor did it achieve statistical significance for secondary endpoints [1][2] - The company plans to cease the development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform, while exploring strategic options and preserving cash through workforce reduction and cost-saving measures [2][3] Clinical Trial Details - The CHASE Phase 2b trial was a multicenter, randomized, double-masked, vehicle-controlled study involving 79 patients across 37 sites in the U.S. and Latin America, evaluating two doses of KPI-012 (3 U/mL and 1 U/mL) [4] - The primary endpoint was complete healing of PCED, assessed by corneal fluorescein staining photographs analyzed by a masked central reading center [4] Company Background - KALA BIO is a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases, utilizing its proprietary MSC-S platform [5] - KPI-012, the lead product candidate, is a human MSC-S containing various biofactors and has received Orphan Drug and Fast Track designations from the FDA for treating PCED [5]