Kala Pharmaceuticals(KALA) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Corporate Update Key Achievements and Corporate Update KALA BIO completed patient enrollment for the KPI-012 Phase 2b CHASE trial for PCED in Q2 2025, with top-line data expected by late September 2025, and has sufficient cash to fund operations into Q1 2026 - KALA BIO has completed patient enrollment for the KPI-012 Phase 2b CHASE trial for PCED, with top-line data expected by late September 2025[1][2] - As of June 30, 2025, the company's cash resources were $31.9 million, projected to support operations until Q1 2026[1] Business Highlights and Pipeline Update KPI-012 for Persistent Corneal Epithelial Defect (PCED) KPI-012, KALA's lead product for PCED, has FDA Orphan Drug and Fast Track designations, with its Phase 2b CHASE trial fully enrolled and top-line data expected by late September 2025, potentially serving as a pivotal trial for BLA submission - KPI-012 has received FDA Orphan Drug and Fast Track designations for PCED, a condition affecting approximately 100,000 patients in the US with significant market potential[5] - The CHASE Phase 2b clinical trial has completed enrollment of 79 patients, with top-line data anticipated by late September 2025, potentially serving as a pivotal trial to support a BLA[5] Other Pipeline Candidates and Platform Technology KALA's MSC-S platform technology offers a multifactorial mechanism for developing therapies for various rare ocular diseases, with KPI-014 as a preclinical program for inherited retinal degenerative diseases and KPI-012 exploring potential for Limbal Stem Cell Deficiency (LSCD) - KALA's proprietary Mesenchymal Stem Cell Secretome (MSC-S) platform technology features a multifactorial mechanism of action, enabling the development of product candidates for various rare ocular diseases[3][4] - KPI-014 is a preclinical program targeting inherited retinal degenerative diseases, such as retinitis pigmentosa and Stargardt disease, utilizing a gene-agnostic approach[6] - The company is exploring the potential of KPI-012 to treat other rare anterior segment diseases, including Limbal Stem Cell Deficiency (LSCD), which is estimated to affect 100,000 patients in the US[10] Key Opinion Leader (KOL) Event KALA hosted a KOL webinar in July 2025, where experts highlighted the unmet needs of PCED patients and the potential of KPI-012's multifactorial mechanism of action - In July 2025, KALA hosted a KOL webinar where leading corneal experts emphasized the unmet needs of PCED patients and the potential of KPI-012's multifactorial mechanism of action[2][10] Financial Results Cash Position and Financial Runway As of June 30, 2025, KALA's cash and cash equivalents were $31.9 million, a decrease from $42.2 million on March 31, primarily due to operations and debt repayment, with existing cash expected to fund operations into Q1 2026 | Metric | June 30, 2025 (USD Millions) | March 31, 2025 (USD Millions) | Change (USD Millions) | | :--- | :---: | :---: | :---: | | Cash and Cash Equivalents | 31.9 | 42.2 | -10.3 | - The cash decrease was primarily due to cash used in operations and a $2.5 million prepayment of debt principal and fees[7] - Cash resources as of June 30, 2025, are projected to support operations until Q1 2026[7] Financial Results for the Three Months Ended June 30, 2025 In Q2 2025, KALA experienced increases in both G&A and R&D expenses, leading to expanded operating and net losses | Metric (USD Thousands) | Q2 2025 | Q2 2024 | Year-over-Year Change | | :--- | :---: | :---: | :---: | | G&A Expenses | 4,643 | 4,317 | +7.55% | | R&D Expenses | 6,232 | 5,317 | +17.21% | | Loss (Gain) on Fair Value Remeasurement of Contingent Consideration | 153 (Loss) | (29) (Gain) | Significant Change | | Operating Loss | (11,028) | (9,605) | +14.81% | | Net Loss | (11,155) | (9,579) | +16.45% | | Net Loss Per Share (Diluted) | (1.71) | (3.16) | -45.89% | | Weighted Average Shares Outstanding | 6,513,108 | 3,030,213 | +115% | - G&A expenses increased primarily due to higher stock-based compensation expense, while R&D expenses rose due to increased personnel-related costs and KPI-012 development costs[11] Financial Results for the Six Months Ended June 30, 2025 In H1 2025, KALA saw a slight decrease in G&A expenses, an increase in R&D expenses, stable operating loss year-over-year, and a narrowed net loss | Metric (USD Thousands) | H1 2025 | H1 2024 | Year-over-Year Change | | :--- | :---: | :---: | :---: | | G&A Expenses | 9,236 | 9,739 | -5.27% | | R&D Expenses | 12,287 | 11,668 | +5.30% | | Loss on Fair Value Remeasurement of Contingent Consideration | 174 (Loss) | 129 (Loss) | +34.88% | | Operating Loss | (21,697) | (21,536) | +0.75% | | Net Loss | (20,102) | (21,386) | -6.00% | | Net Loss Per Share (Diluted) | (3.13) | (7.32) | -57.24% | | Weighted Average Shares Outstanding | 6,429,950 | 2,921,712 | +120% | - H1 G&A expenses decreased primarily due to lower personnel-related costs, while R&D expenses increased due to higher personnel-related costs and KPI-012 development costs[9][14] Balance Sheet Data As of June 30, 2025, KALA reported $31.942 million in cash and cash equivalents, $36.053 million in total assets, and a negative $3.206 million in total stockholders' equity | Metric (USD Thousands) | June 30, 2025 | December 31, 2024 | Change | | :--- | :---: | :---: | :---: | | Cash and Cash Equivalents | 31,942 | 51,181 | -19,239 | | Total Assets | 36,053 | 55,483 | -19,430 | | Working Capital | 17,647 | 35,841 | -18,194 | | Current Portion of Long-Term Debt | 9,511 | 10,336 | -825 | | Long-Term Debt, Net of Discount | 18,786 | 20,102 | -1,316 | | Other Long-Term Liabilities | 4,457 | 6,093 | -1,636 | | Total Stockholders' (Deficit) Equity | (3,206) | 12,332 | -15,538 | - As of June 30, 2025, the company's stockholders' equity turned into a deficit, reflecting a decrease in assets and relatively stable liabilities[17] Consolidated Statement of Operations This section details KALA's operating expenses, profit and loss, and net loss per share for Q2 and H1 2025 | Metric (USD Thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :---: | :---: | :---: | :---: | | G&A Expenses | 4,643 | 4,317 | 9,236 | 9,739 | | R&D Expenses | 6,232 | 5,317 | 12,287 | 11,668 | | Loss (Gain) on Fair Value Remeasurement of Contingent Consideration | 153 | (29) | 174 | 129 | | Total Operating Expenses | 11,028 | 9,605 | 21,697 | 21,536 | | Operating Loss | (11,028) | (9,605) | (21,697) | (21,536) | | Interest Income | 407 | 504 | 870 | 1,008 | | Interest Expense | (1,081) | (1,458) | (2,172) | (2,913) | | Grant Income | 547 | 980 | 2,897 | 2,055 | | Total Other Income (Expense) | (127) | 26 | 1,595 | 150 | | Net Loss | (11,155) | (9,579) | (20,102) | (21,386) | | Net Loss Per Share (Diluted) | (1.71) | (3.16) | (3.13) | (7.32) | | Weighted Average Shares Outstanding | 6,513,108 | 3,030,213 | 6,429,950 | 2,921,712 | About KALA BIO, Inc. KALA BIO is a clinical-stage biopharmaceutical company focused on rare and severe ocular diseases, developing biologic therapies using its proprietary Mesenchymal Stem Cell Secretome (MSC-S) platform - KALA BIO is a clinical-stage biopharmaceutical company focused on rare and severe ocular diseases, developing biologic therapies using its proprietary Mesenchymal Stem Cell Secretome (MSC-S) platform[12] - The company's lead product candidate, KPI-012, a human MSC-S, is in clinical development for PCED and has received FDA Orphan Drug and Fast Track designations[12] - KALA is also exploring KPI-012's potential for Limbal Stem Cell Deficiency and other rare corneal diseases, and has initiated preclinical studies for its MSC-S platform in retinal degenerative diseases[12] Forward-Looking Statements This press release contains forward-looking statements regarding KALA's future expectations, plans, and prospects, including KPI-012's potential benefits, CHASE trial timelines, BLA submission likelihood, other indication development, and cash runway sufficiency - This press release contains forward-looking statements regarding KALA's future expectations, plans, and prospects, including KPI-012's potential benefits, CHASE trial timelines, BLA submission likelihood, other indication development, and cash runway sufficiency[13] - Actual results may differ materially from forward-looking statements due to various important factors such as clinical trial uncertainties, regulatory approvals, key personnel retention, and financing needs[13] - KALA undertakes no obligation to update any forward-looking statements, except as required by law[15]