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 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. About KALA BIO, Inc. KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors. KPI-012 received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing. Cautionary Note Regarding Forward-Looking Statements This press release 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 press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s plans to evaluate its strategic options, engage in discussions with its secured lender, preserve cash, conduct a reduction in workforce and other cost-saving measures and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” 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: uncertainty regarding what, if any, actions KALA’s secured lender may take to recover amounts owed by KALA; KALA’s ability to successfully identify and pursue strategic options on attractive terms, or at all; uncertainty as to whether the reduction in workforce and other cost-saving measures will result in the anticipated savings and be completed when anticipated; and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA 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. Investor Contact: Taylor Steiner [email protected] 212-362-1200

-- 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 candidate, KPI-012, contains numerous growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can 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 and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S., representing a potentially sizeable market opportunity as there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication covering all underlying etiologies of PCED. KPI-012 has received both Orphan Drug and Fast Track designations from the FDA for the treatment of PCED. In July 2025, KALA announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED. The 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 Company expects to report topline data from the trial at the end of September of 2025. Contingent on positive results and subject to discussion with regulatory authorities, KALA believes the CHASE Phase 2b trial could potentially serve as a pivotal trial to support the submission of a Biologics License Application (BLA) to the FDA. In July 2025, KALA hosted a webcast event with Key Opinion Leaders (KOLs) to discuss the potential of KPI-012 for the treatment of PCED. The KOLs provided a disease overview of PCED, including the unmet need and patient journey, as well as insights into KALA’s MSC-S technology, KPI-012's multi-factorial mechanism and the CHASE clinical trial design. Company management reviewed the commercial opportunity of KPI-012 and provided an update on upcoming milestones. An archived replay of the event is available under “Presentations” in the Investor section of the Company’s website at www.kalarx.com. KALA is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, including Limbal Stem Cell Deficiency (LSCD). LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, conjunctivalization, inflammation, neovascularization and other sequalae that can lead to significant symptomology and a loss of corneal clarity and vision impairment. Like PCED, LSCD represents a potentially substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S. KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases, such as Retinitis Pigmentosa and Stargardt Disease. Financial Results: Cash Position: As of June 30, 2025, KALA had cash and cash equivalents of $31.9 million, compared to $42.2 million as of March 31, 2025. This decrease reflects cash used in operations and a prepayment of $2.5 million in principal and fees on the Company’s debt facility. Based on its current plans, KALA anticipates that its cash resources as of June 30, 2025, will enable it to fund operations into the first quarter of 2026. Three Months Ended June 30, 2025 Financial Results: G&A Expenses: For the quarter ended June 30, 2025, general and administrative (G&A) expenses were $4.6 million, compared to $4.3 million for the same period in 2024. The increase was primarily due to an increase in stock-based compensation expense. R&D Expenses: For the quarter ended June 30, 2025, research and development (R&D) expenses were $6.2 million, compared to $5.3 million for the same period in 2024. The increase was primarily related to an increase in employee-related costs and KPI-012 development costs. Loss (gain) on Fair Value Remeasurement of Contingent Consideration: For the quarter ended June 30, 2025, the loss on fair value remeasurement of contingent consideration, in connection with the Combangio acquisition, was $0.2 million, compared to a gain of less than $0.1 million for the same period in 2024. Operating Loss: For the quarter ended June 30, 2025, loss from operations was $11.0 million, compared to $9.6 million for the same period in 2024. Net Loss: For the quarter ended June 30, 2025, net loss was $11.2 million, or $1.71 per share, compared to a net loss of $9.6 million, or $3.16 per share, for the same period in 2024. The weighted average number of shares used to calculate net loss per share was 6.5 million for the quarter ended June 30, 2025, and 3.0 million for the quarter ended June 30, 2024. Six Months Ended June 30, 2025 Financial Results: G&A Expenses: For the six months ended June 30, 2025, G&A expenses were $9.2 million, compared to $9.7 million for the same period in 2024. The decrease was primarily due to a decrease in employee-related costs. R&D Expenses: For the six months ended June 30, 2025, R&D expenses were $12.3 million, compared to $11.7 million for the same period in 2024. The increase was primarily related to an increase in employee-related costs and KPI-012 development costs. Loss on Fair Value Remeasurement of Contingent Consideration: For the six months ended June 30, 2025, the loss on fair value remeasurement of contingent consideration, in connection with the Combangio acquisition, was $0.2 million, compared to $0.1 million for the same period in 2024. Operating Loss: For the six months ended June 30, 2025, loss from operations was $21.7 million, compared to $21.5 million for the same period in 2024. Net Loss: For the six months ended June 30, 2025, net loss was $20.1 million, or $3.13 per share, compared to a net loss of $21.4 million, or $7.32 per share, for the same period in 2024. The weighted average number of shares used to calculate net loss per share was 6.4 million for the six months ended June 30, 2025, and 2.9 million for the six months ended June 30, 2024. About KALA BIO, Inc. KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also exploring the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com. Forward Looking Statements: This press release 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 press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’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; KALA’s belief that the CHASE Phase 2b trial could serve as a pivotal trial to support the submission of a BLA to the FDA; KALA’s plans to pursue research and development of KPI-012, KPI-014, and its MSC-S platform for other indications; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” 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: uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; 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 Phase 2b clinical 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; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA 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. Financial Tables: (1) The Company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further information regarding its current assets and current liabilities. Investor Contact: Taylor Steiner [email protected] 212-362-1200

-- 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 and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S., representing a potentially sizeable market opportunity as there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication covering all underlying etiologies of PCED. KALA continues to enroll patients in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and is targeting topline data in the third quarter of 2025. The Company has also activated clinical trial sites in Latin America. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE Phase 2b trial could potentially serve as the first of two pivotal studies required to support the submission of a Biologics License Application (BLA) to the FDA. KALA is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, including Limbal Stem Cell Deficiency (LSCD). LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, conjunctivalization, inflammation, neovascularization and other sequalae that can lead to significant symptomology and a loss of corneal clarity and vision impairment. Like PCED, LSCD represents a potentially substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S. KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases, such as Retinitis Pigmentosa and Stargardt Disease. Financial Results: Cash Position: As of March 31, 2025, KALA had cash and cash equivalents of $42.2 million, compared to $51.2 million as of December 31, 2024. This decrease reflects cash used in operations. Based on its current plans, KALA anticipates that its cash resources as of March 31, 2025, will enable it to fund operations into the first quarter of 2026. First Quarter 2025 Financial Results: G&A Expenses: For the quarter ended March 31, 2025, general and administrative (G&A) expenses were $4.6 million, compared to $5.4 million for the same period in 2024. The decrease was primarily due to a decrease in employee-related costs. R&D Expenses: For the quarter ended March 31, 2025, research and development (R&D) expenses were $6.1 million, compared to $6.4 million for the same period in 2024. The decrease was primarily related to a decrease in medical affairs-related KPI-012 development costs. Loss on Fair Value Remeasurement of Contingent Consideration: For the quarter ended March 31, 2025, the loss on fair value remeasurement of contingent consideration, in connection with the Combangio acquisition, was less than $0.1 million, compared to $0.2 million for the same period in 2024. Operating Loss: For the quarter ended March 31, 2025, loss from operations was $10.7 million, compared to $11.9 million for the same period in 2024. Net Loss: For the quarter ended March 31, 2025, net loss was $8.9 million, or $1.41 per share, compared to a net loss of $11.8 million, or $4.20 per share, for the same period in 2024. The weighted average number of shares used to calculate net loss per share was 6.3 million for the quarter ended March 31, 2025, and 2.8 million for the quarter ended March 31, 2024. About KALA BIO, Inc. KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com. Forward Looking Statements: This press release 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 press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’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; KALA’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; KALA’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; expectations about the potential benefits and future operation of the CIRM award; KALA’s ability to achieve the specified milestones and obtain the full funding under the CIRM award; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” 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: KALA’s ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; 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 Phase 2b clinical 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; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA 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. Financial Tables: (1) The Company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further information regarding its current assets and current liabilities. Investor Contact: Taylor Steiner [email protected] 212-362-1200

-- 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 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 ocular orphan 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 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 and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S., representing a potentially sizeable market opportunity as there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication covering all underlying etiologies of PCED. KALA continues to enroll patients in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and plans to report topline data in the third quarter of 2025. The Company has also activated clinical trial sites in Latin America. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE Phase 2b trial could potentially serve as the first of two pivotal studies required to support the submission of a Biologics License Application (BLA) to the FDA. KALA is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, including Limbal Stem Cell Deficiency (LSCD) and other corneal diseases. LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, conjunctivalization, inflammation, neovascularization and other sequalae that can lead to significant symptomology and a loss of corneal clarity and vision impairment. Like PCED, LSCD represents a potentially substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S. KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases, such as Retinitis Pigmentosa and Stargardt Disease. Corporate Updates: In December 2024, KALA announced the completion of a private placement financing, raising aggregate gross proceeds of $10.75 million. The financing included participation from both new and existing investors, including SR One, Cormorant Asset Management, Woodline Partners and another life sciences-focused investor. In the private placement, KALA sold 1,340,603 shares of its common stock at a price of $6.44 per share and 3,286 shares of its Series I Preferred Stock at a price of $644.00 per share. Financial Results: Cash Position: As of December 31, 2024, KALA had cash and cash equivalents of $51.2 million, compared to $49.2 million as of September 30, 2024. This increase reflects gross proceeds of $10.75 million received from KALA’s December 2024 private placement financing and $2.5 million received under the CIRM award in December 2024, partially offset by a prepayment of $5.0 million in principal and fees on its debt facility as well as cash used in operations. Based on its current plans, KALA anticipates that its cash resources as of December 31, 2024 will enable it to fund operations into the first quarter of 2026. Financial Results for the Three Months Ended December 31, 2024: G&A Expenses: For the quarter ended December 31, 2024, general and administrative (G&A) expenses were $4.2 million, compared to $4.6 million for the same period in 2023. This decrease was primarily due to a decrease in employee-related costs. R&D Expenses: For the quarter ended December 31, 2024, research and development (R&D) expenses were $5.3 million, compared to $4.7 million for the same period in 2023. The increase was primarily due to an increase in KPI-012 development costs, as KALA advances the clinical development of KPI-012, and employee-related costs. Loss on Fair Value Remeasurement of Contingent Consideration: The was no gain or loss on fair value remeasurement of contingent consideration, in connection with the Combangio acquisition, for the quarter ended December 31, 2024. For the quarter ended December 31, 2023, the loss on fair value remeasurement of continent consideration was $0.3 million. Operating Loss: For the quarter ended December 31, 2024 loss from operations was $9.5 million, compared to $9.6 million for the same period in 2023. Net Loss: For the quarter ended December 31, 2024, net loss was $8.2 million, or $1.74 per share, compared to a net loss of $8.6 million, or $3.18 per share, for the same period in 2023. The weighted average number of shares used to calculate net loss per share was 4.7 million for the quarter ended December 31, 2024 and 2.7 million for the quarter ended December 31, 2023. Financial Results for the Full Year Ended December 31, 2024: G&A Expenses: For the full year ended December 31, 2024, G&A expenses were $18.3 million, compared to $20.6 million for the same period in 2023. The decrease was primarily due to a decrease in administrative and professional service fees and a decrease in employee-related costs, partially offset by an increase in stock-based compensation expense. R&D Expenses: For the full year ended December 31, 2024, R&D expenses were $22.1 million, compared to $18.6 million for the same period in 2023. The increase was primarily due to an increase in development costs, as KALA advances the clinical development of KPI-012, and an increase in employee-related costs. Gain on Fair Value Remeasurement of Deferred Purchase Consideration: There was no gain or loss on fair value remeasurement of Deferred Purchase Consideration for the full year ended December 31, 2024 due to the final settlement of the liability in March 2023. For the full year ended December 31, 2023, the gain on fair value remeasurement of deferred purchase consideration was $0.2 million. Loss on Fair Value Remeasurement of Contingent Consideration: For the full year ended December 31, 2024, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.5 million, compared to $0.7 million for the same period in 2023. Operating Loss: For the full year ended December 31, 2024, loss from operations was $41.0 million, compared to $39.7 million for the same period in 2023. Net Loss: For the full year ended December 31, 2024, net loss was $38.5 million, or $10.15 per share, compared to a net loss of $42.2 million, or $17.35 per share, for the same period in 2023. The weighted average number of shares used to calculate net loss per share was 3.8 million for the full year ended December 31, 2024, and 2.4 million for the full year ended December 31, 2023. About KALA BIO, Inc. KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com. Forward Looking Statements: This press release 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 press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’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; KALA’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; KALA’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; expectations about the potential benefits and future operation of the CIRM award; KALA’s ability to achieve the specified milestones and obtain the full funding under the CIRM award; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” 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: KALA’s ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; 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 Phase 2b clinical 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; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA 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. Financial Tables: (1) The Company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further information regarding its current assets and current liabilities. Investor Contact: Taylor Steiner [email protected] 212-362-1200