KALA

ARLINGTON, Mass. (AP) — ARLINGTON, Mass. (AP) — KALA BIO, Inc. (KALA) on Friday reported a loss of $1.6 million in its first quarter. On a per-share basis, the Arlington, Massachusetts-based company said it had a loss of 14 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on KALA at https://www.zacks.com/ap/KALA

ARLINGTON, Mass. (AP) — ARLINGTON, Mass. (AP) — KALA BIO, Inc. (KALA) on Wednesday reported net income of $686,000 in its fourth quarter. The Arlington, Massachusetts-based company said it had net income of 86 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on KALA at https://www.zacks.com/ap/KALA

ARLINGTON, Mass. (AP) — ARLINGTON, Mass. (AP) — KALA BIO, Inc. (KALA) on Wednesday reported a loss of $7.6 million in its third quarter. On a per-share basis, the Arlington, Massachusetts-based company said it had a loss of $1.07. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on KALA at https://www.zacks.com/ap/KALA

-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance -- -- KPI-012 was well-tolerated with no treatment-related serious adverse events observed -- -- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options -- ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining. The CHASE trial also failed to achieve statistical significance for key secondary efficacy endpoints and did not show any meaningful difference between either KPI-012 treatment arm and the placebo arm. Based on the CHASE trial results, KALA plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. KALA plans to evaluate its strategic options and as part of its evaluation to engage in discussions with its secured lender. In the interim, the company plans to take steps to preserve cash, including by conducting a reduction in workforce and other cost-saving measures. “We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the Phase 1b study. KPI-012 continued to be well-tolerated and demonstrated a favorable safety profile but did not demonstrate the efficacy results that would warrant advancing the program for treatment of front-of-the-eye diseases,” said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of Kala BIO. “We would like to thank all of the patients and investigators who participated in in the CHASE trial.” About CHASE (Corneal Healing After SEcretome therapy) Phase 2b Trial 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 a...

-- Completed patient enrollment in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED); topline data expected at the end of September 2025 -- -- Cash resources of $31.9 million as of June 30, 2025, expected to fund operations into 1Q 2026 -- ARLINGTON, Mass., Aug. 08, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the second quarter ended June 30, 2025 and provided a corporate update. “The second quarter of 2025 was a pivotal period for KALA, marked by the completion of patient enrollment in our Phase 2b CHASE trial of KPI-012 in PCED and the continued execution of our clinical and corporate strategy,” said Todd Bazemore, interim Chief Executive Officer of KALA BIO. “We are well-positioned heading into our key readout of the CHASE trial, which we believe has the potential to serve as a pivotal trial required to support a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), contingent on positive results and subject to discussions with regulatory authorities. We are now focused on finalizing study activities and remain on track to report topline results at the end of September of this year.” Mr. Bazemore continued, “In July, we hosted a virtual KOL event featuring leading cornea specialists who underscored the high unmet need for patients with PCED and highlighted the potential of KPI-012’s multifactorial mechanism of action to address all underlying etiologies of this debilitating and clinically burdensome condition. With no FDA-approved products covering all underlying etiologies of PCED, we believe KPI-012 has the potential to dramatically improve the treatment paradigm for the estimated 100,000 patients with PCED in the United States.” Second Quarter and Recent Business Highlights: KALA’s innovative pipeline is based on its proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA believes the multifactorial mechanism of action of its MSC-S platform technology may enable it to generate product candidates for a range of rare, ocular diseases and is evaluating the potential development of this technology for multiple rare, front- and back-of-the-eye diseases. KALA’s lead product ca...

ARLINGTON, Mass. (AP) — ARLINGTON, Mass. (AP) — KALA BIO, Inc. (KALA) on Friday reported a loss of $11.2 million in its second quarter. On a per-share basis, the Arlington, Massachusetts-based company said it had a loss of $1.71. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on KALA at https://www.zacks.com/ap/KALA

-- Ongoing patient enrollment in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED); topline data anticipated in 3Q 2025 -- -- Cash resources of $42.2 million as of March 31, 2025, expected to fund operations into 1Q 2026 -- ARLINGTON, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the first quarter ended March 31, 2025 and provided a corporate update. “This year, our top priority is advancing the development of KPI-012 towards key milestones,” said Todd Bazemore, interim Chief Executive Officer of KALA BIO. "We are targeting to report topline results from the Phase 2b CHASE trial of KPI-012 in the third quarter of this year, which, if successful could serve as the first of two pivotal trials needed to support a BLA submission. KPI-012 has potential to be the first therapy that can address all underlying etiologies of PCED, through a multifactorial mechanism of action that addresses the multiple impaired corneal healing processes that can cause PCED. We look forward to delivering on our near-term data readout and unlocking the full potential of the MSC-S platform technology for the treatment of rare and severe ocular diseases.” First Quarter and Recent Business Highlights: KALA’s innovative pipeline is based on its proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA believes the multifactorial mechanism of action of its MSC-S platform technology may enable it to generate product candidates for a range of rare, ocular diseases and is evaluating the potential development of this technology for multiple rare, front- and back-of-the-eye diseases. KALA’s lead product candidate, KPI-012, contains growth factors, protease inhibitors, matrix proteins and neurotrophic factors to potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KALA is initially developing KPI-012 for the treatment of Persistent Corneal Epithelial Defect (PCED), a persistent, non-healing corneal defect or wound that is refractory to conventional treatments which, if left untreated, can lead to significant complications, including infection, corneal perforation/scarring...

-- Randomized 87 patients to date in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED) -- -- Continuing enrollment into 2Q25; currently targeting topline data in 3Q25 -- -- Raised $10.75 million in private placement financing with participation from SR One, Cormorant Asset Management, Woodline Partners and another life sciences-focused investor -- -- Cash resources of $51.2 million as of December 31, 2024, expected to fund operations into 1Q 2026 -- ARLINGTON, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a corporate update. “We are well-positioned this year to execute our clinical and strategic priorities, with KPI-012 at the center of our efforts,” said Todd Bazemore, interim Chief Executive Officer of KALA BIO. “We are encouraged by the potential of KPI-012 to address all underlying etiologies of PCED and significantly improve patient outcomes. With the recent uptick in enrollment in the Phase 2b CHASE trial, we have now randomized 87 patients. Upon review of only the masked screening and baseline data, we have decided to extend enrollment to account for 13 patients who were enrolled and treated based on the investigators’ determination of the presence of a PCED which was subsequently not verified by the central reading center. We now plan to report topline results in the third quarter of 2025. If successful the CHASE trial could serve as the first of two pivotal trials required to support a BLA submission, bringing us one step closer to potentially delivering the first FDA-approved treatment option for all patients with PCED regardless of etiology.” Mr. Bazemore continued, “Additionally, we recently completed a $10.75 million private placement financing, which has strengthened our balance sheet and extended our cash runway into the first quarter of 2026. We look forward to reporting topline clinical data in the third quarter and continuing to advance our MSC-S platform technology for the treatment of rare and severe ocular diseases.” Fourth Quarter and Recent Business Highlights: KALA’s innovative pipeline is based on its proprie...