KALA BIO (KALA) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 Go ahead and start. Welcome, everyone. First of all, I wanted to thank the Jefferies team for inviting us to provide an ups oh, I need to find the way. An update on Kala and remind everyone there will be likely some forward looking statements. So, Kala is a leader, in the emerging field of mesenchymal stem cell secretomes, and our focus is on rare ophthalmic diseases. We have an ongoing pivotal trial with our lead product, KPI o one two, for ...

ARLINGTON, Mass., May 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 members of management will present at the Jefferies Global Healthcare Conference being held in New York, NY on Thursday, June 5, 2025 at 1:25 p.m. ET. Management will also be available for one-on-one meetings on Thursday, June 5, 2025. To ac ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA BIO, Inc. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other jurisdict ...

Financial Performance - As of March 31, 2025, KALA BIO reported cash and cash equivalents of $42.2 million, down from $51.2 million as of December 31, 2024, reflecting cash used in operations[7]. - KALA's net loss for the first quarter of 2025 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[11]. - KALA's total operating expenses for Q1 2025 were $10.7 million, compared to $11.9 million for the same period in 2024[11]. - KALA's total stockholders' equity decreased to $5.7 million as of March 31, 2025, from $12.3 million as of December 31, 2024[14]. Expenses - General and administrative expenses decreased to $4.6 million in Q1 2025 from $5.4 million in Q1 2024, primarily due to reduced employee-related costs[11]. - Research and development expenses for Q1 2025 were $6.1 million, down from $6.4 million in Q1 2024, mainly due to decreased medical affairs-related costs for KPI-012[11]. Clinical Trials and Development - KALA is currently enrolling patients in the Phase 2b CHASE trial for KPI-012, targeting topline data in the third quarter of 2025[5]. - The company activated clinical trial sites in Latin America for the CHASE trial, contingent on positive results[5]. Market Opportunity - KPI-012 addresses Persistent Corneal Epithelial Defect (PCED), which has an estimated incidence of approximately 100,000 patients in the U.S., representing a significant market opportunity[5]. - KALA is exploring the potential of KPI-012 for additional rare ocular diseases, including Limbal Stem Cell Deficiency (LSCD), which also has an estimated incidence of 100,000 patients in the U.S.[5].

Financial Performance - The company incurred net losses of $38.5 million and $42.2 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $667.9 million as of December 31, 2024[285]. - The company expects to continue incurring significant operating losses and expenses for the foreseeable future, with net losses potentially fluctuating significantly[291]. - Cash and cash equivalents were $51.2 million as of December 31, 2024, expected to fund operations into the first quarter of 2026, but insufficient for completing clinical development of KPI-012[294]. - The company anticipates needing substantial additional funding to support ongoing and planned activities, particularly for clinical trials and commercialization efforts[292]. - The company has substantial debt obligations that may limit cash flow available for operations and could lead to default if covenants under the Loan Agreement are not met[303]. Research and Development - The company expects significant increases in research and development expenses as it advances the clinical development of KPI-012 and conducts preclinical studies for other product candidates[286]. - The company is substantially dependent on the success of its product candidate, KPI-012, and intends to allocate significant resources to its development[315]. - The company may need to conduct additional clinical trials for KPI-012, which could delay marketing approval or lead to restrictions on its use[320]. - The company experienced delays in clinical trials which could increase product development costs and impair commercialization efforts[322]. - KPI-012 is being developed for PCED, a rare condition with an estimated incidence of 100,000 cases per year in the United States, leading to potential challenges in patient enrollment for clinical trials[325]. Market and Commercialization Challenges - The company has limited experience in commercializing products, which may hinder its ability to successfully launch and market new products[290]. - Market acceptance of KPI-012 may be limited due to the rarity of PCED and potential underestimation of the patient population[337]. - The company may face challenges in obtaining adequate reimbursement for KPI-012, which could adversely affect its market success[342]. - Delays in obtaining coverage and reimbursement for newly approved products may limit market access and profitability[343]. - The company expects KPI-012 to compete with Oxervate®, the only approved product in the PCED space, which could impact market entry and revenue potential[358]. Regulatory and Compliance Issues - The company is subject to significant regulatory scrutiny, which may delay or prevent the commercialization of product candidates[454]. - The FDA's strict manufacturing requirements necessitate thorough testing and compliance, and any failure could result in regulatory actions that disrupt supply chains[376][378]. - The marketing approval process is expensive, time-consuming, and uncertain, with no guarantee of obtaining necessary approvals for product candidates like KPI-012[441]. - The company faces heightened risks in obtaining marketing authorization in the UK due to Brexit, with new procedures potentially complicating the approval process[457]. - The company must navigate complex FDA regulations to ensure compliance and avoid significant liabilities[464]. Intellectual Property Risks - The company faces significant uncertainty regarding the issuance, scope, and enforceability of its patent rights, which could impair its ability to commercialize its technology[399]. - The potential for litigation could increase as the company's product candidates approach commercialization, impacting its resources[416]. - The company may not obtain patent term extensions under the Hatch-Waxman Act, which could shorten the exclusivity period for its products[407]. - Non-compliance with intellectual property agreements could lead to termination and loss of rights to market products[421]. - Intellectual property litigation could divert resources and distract management, potentially impacting financial performance[437]. Funding and Financial Obligations - The company has received gross proceeds of approximately $8.6 million, $12.5 million, and $10.8 million from private placements in March, June, and December 2024, respectively[285]. - The company is restricted from paying dividends and incurring additional debt beyond $1.0 million without lender consent under its Loan Agreement[298]. - The company holds $10 million in product liability insurance, which may not be sufficient to cover potential liabilities arising from product commercialization[367]. - The company may enter collaborations for the development and commercialization of product candidates, but these arrangements carry risks such as limited control over resources and potential termination of agreements[390][391]. - The company may need to seek additional patent approvals and licenses for product candidates outside the United States, complicating international commercialization efforts[356].

Financial Performance - The net loss for Q4 2024 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[12]. - For the full year 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 2023[15]. - Total costs and expenses for Q4 2024 were $9,459 million, a slight decrease from $9,619 million in Q4 2023[20]. - Total costs and expenses for the year ended December 31, 2024 were $40,983 million, compared to $39,663 million for the year ended December 31, 2023, an increase of 3.3%[20]. - Net loss for the year ended December 31, 2024 was $38,511 million, an improvement from a net loss of $42,199 million in the previous year, reflecting a decrease of 8.0%[20]. Cash and Financing - The company raised $10.75 million in a private placement financing, strengthening its balance sheet and extending cash runway into Q1 2026[1][2][7]. - As of December 31, 2024, KALA had cash and cash equivalents of $51.2 million, up from $49.2 million as of September 30, 2024[8]. - KALA's total stockholders' equity increased to $12.3 million as of December 31, 2024, compared to $7.5 million in 2023[18]. Expenses - General and administrative (G&A) expenses for Q4 2024 were $4.2 million, a decrease from $4.6 million in Q4 2023[11]. - Research and development (R&D) expenses for Q4 2024 increased to $5.3 million from $4.7 million in Q4 2023, primarily due to KPI-012 development costs[11]. - Research and development expenses increased to $5,258 million in Q4 2024 from $4,718 million in Q4 2023, representing an increase of 11.5%[20]. Clinical Trials and Product Development - KALA BIO has randomized 87 patients to date in the Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED), with topline data expected in Q3 2025[1][2]. - The company plans to report topline clinical data in Q3 2025 and believes the CHASE trial could serve as the first of two pivotal studies for a Biologics License Application (BLA) submission to the FDA[10][16]. - KALA is exploring KPI-012 for additional rare front-of-the-eye diseases, including Limbal Stem Cell Deficiency (LSCD), which has an estimated incidence of 100,000 patients in the U.S.[10]. Income and Shares - Total other income for Q4 2024 was $1,284 million, an increase from $992 million in Q4 2023, reflecting a growth of 29.4%[20]. - Interest income decreased to $478 million in Q4 2024 from $610 million in Q4 2023, a decline of 21.6%[20]. - Grant income increased to $2,198 million in Q4 2024, up from $1,855 million in Q4 2023, representing a growth of 18.5%[20]. - Weighted average shares outstanding for basic and diluted shares increased to 4,694,611 in Q4 2024 from 2,712,475 in Q4 2023[20].

Core Insights - KALA BIO, Inc. is advancing its clinical development of KPI-012 for Persistent Corneal Epithelial Defect (PCED) and has randomized 87 patients in the Phase 2b CHASE trial, with topline data expected in Q3 2025 [1][2] - The company raised $10.75 million through private placement financing, enhancing its financial position and extending its cash runway into Q1 2026 [2][8] - KALA's cash and cash equivalents stood at $51.2 million as of December 31, 2024, reflecting an increase from $49.2 million as of September 30, 2024 [9] Clinical Development - KPI-012 is being developed to address the underlying causes of PCED, which affects approximately 100,000 patients in the U.S. and currently lacks FDA-approved treatments [5][14] - The CHASE trial could serve as the first of two pivotal studies needed for a Biologics License Application (BLA) submission to the FDA [5][2] - KALA is also exploring KPI-012 for other ocular diseases, including Limbal Stem Cell Deficiency (LSCD), which has a similar estimated incidence of 100,000 patients in the U.S. [6][5] Financial Performance - For Q4 2024, KALA reported a net loss of $8.2 million, or $1.74 per share, an improvement from a net loss of $8.6 million, or $3.18 per share, in Q4 2023 [12][22] - Full-year 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, in 2023 [16][22] - General and administrative expenses decreased to $4.2 million in Q4 2024 from $4.6 million in Q4 2023, while research and development expenses increased to $5.3 million from $4.7 million in the same period [12][21] Corporate Updates - KALA's innovative pipeline is based on its proprietary mesenchymal stem cell secretome (MSC-S) platform, which is believed to have a multifactorial mechanism of action for treating various ocular orphan diseases [3][14] - The company has activated clinical trial sites in Latin America for the CHASE trial [5] - KALA's lead product candidate, KPI-012, contains various biofactors aimed at correcting impaired corneal healing associated with severe ocular diseases [4][14]

Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases [3] - The company utilizes a proprietary mesenchymal stem cell secretome (MSC-S) platform for its investigational therapies [3] Product Development - KALA's lead product candidate, KPI-012, is designed to address impaired corneal healing, specifically for persistent corneal epithelial defect (PCED) [3] - KPI-012 has received Orphan Drug and Fast Track designations from the U.S. FDA, indicating its potential significance in treating rare diseases [3] - The company is also exploring KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision [3] - Preclinical studies are underway to evaluate the MSC-S platform's potential for treating retinal degenerative diseases, including Retinitis Pigmentosa and Stargardt Disease [3] Upcoming Events - KALA management will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. ET [1] - One-on-one meetings with management will also be available on the same day [1]

Core Viewpoint - KALA BIO, Inc. announces the resignation of CEO Mark Iwicki and the appointment of Todd Bazemore as interim CEO, effective immediately, while Iwicki will remain as Chair of the Board [1][2] Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare and severe eye diseases [3] - The company utilizes its proprietary mesenchymal stem cell secretome (MSC-S) platform for its investigational therapies [3] Leadership Transition - Mark Iwicki has been with KALA and is proud of the work done utilizing the MSC-S platform, particularly regarding the lead product candidate KPI-012 for treating persistent corneal epithelial defect (PCED) [2] - Todd Bazemore, who has over 30 years of experience in the pharmaceutical industry, has been with KALA since November 2017 and will lead the company during this transition [2][3] Product Development - KALA's lead product candidate, KPI-012, is in clinical development for PCED and has received Orphan Drug and Fast Track designations from the U.S. FDA [3] - The company is also exploring the potential of KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases, as well as preclinical studies for retinal degenerative diseases [3]

Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare and severe eye diseases [10] - The company's lead product candidate, KPI-012, is designed to treat persistent corneal epithelial defect (PCED) and has received Orphan Drug and Fast Track designations from the U.S. FDA [10] Private Placement Details - KALA has entered into a securities purchase agreement for a private placement, raising approximately $10.75 million before expenses [1] - The company will sell 1,340,603 shares of common stock at $6.44 per share and 3,286 shares of Series I Preferred Stock at $644.00 per share [2] - The private placement is expected to close on or about December 31, 2024, pending customary closing conditions [2] Use of Proceeds - The net proceeds from the private placement will be used to advance the clinical development of KPI-012 and for general corporate purposes [8] - KALA anticipates that the funds will support operations into the first quarter of 2026 [8] Clinical Development and Trials - KALA is actively recruiting patients for the ongoing Phase 2b CHASE trial of KPI-012, with over 40 clinical trial sites open and enrolling [8] - The company expects to report topline data from the CHASE trial in the second quarter of 2025, which may serve as the first of two pivotal trials required for a Biologics License Application (BLA) submission [8] Investor Participation - The private placement included participation from both new and existing investors, such as SR One, Cormorant Asset Management, and Woodline Partners [7]