AlloVir(ALVR) - 2025 Q2 - Quarterly Results

Q2 2025 Highlights Kalaris announced Q2 2025 financial results, highlighting continued TH103 Phase 1 trial enrollment and $88.4 million cash balance - TH103 Phase 1 trial for nAMD continues enrollment, with initial clinical data expected in Q4 2025[1][2] Cash and Cash Equivalents | Metric | Amount (June 30, 2025) | | :----- | :--------------------- | | Cash and Cash Equivalents | $88.4M | Business Updates (Operational) Kalaris progresses TH103 Phase 1 trial for nAMD and strengthens its leadership team with a key clinical hire TH103 Clinical Trial Progress Enrollment continues for TH103 Phase 1 trial in nAMD patients, with initial data expected in Q4 2025 - Continued enrollment of treatment-naïve nAMD patients in Phase 1 clinical trial of TH103[2] - TH103 is engineered to potentially provide longer-lasting and increased anti-VEGF activity, with initial clinical data expected in Q4 2025[1][2][6] Leadership Team Expansion Kalaris expanded its leadership team by hiring Kristine Curtiss as SVP of Clinical, enhancing ophthalmology expertise - Kristine Curtiss hired as Senior Vice President of Clinical, bringing over 25 years of experience in ophthalmology biotech[6] Financial Highlights (Summary) Kalaris reported increased cash to $88.4M due to merger, higher R&D and G&A expenses, and a net loss of $11.4M for Q2 2025 Key Financial Highlights | Metric | Value (June 30, 2025) | Value (June 30, 2024) | Change (YoY) | Primary Reason | | :-------------------------- | :-------------------- | :-------------------- | :----------- | :------------- | | Cash and Cash Equivalents (period end) | $88.4M | $1.6M (Dec 31, 2024) | +$86.8M (vs Dec 31, 2024) | Merger with AlloVir | | R&D Expenses (Q2) | $8.4M | $3.2M | +$5.2M | Phase 1 clinical trial initiation | | G&A Expenses (Q2) | $3.8M | $1.0M | +$2.8M | Public company operating costs | | Net Loss (Q2) | $11.4M | $5.7M | +$5.7M | Increased expenses | | Net Loss per Share (Q2) | $0.61 | $4.26 | -$3.65 (due to share count increase) | | Condensed Consolidated Statements of Operations Q2 2025 net loss was $11.4M ($0.61/share) due to increased R&D and G&A expenses, with H1 2025 net loss at $21.5M Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Operating Expenses | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :-------------------------------- | :--------------------- | :--------------------- | | Research and development | $8,440 | $3,211 | | General and administrative | $3,816 | $976 | | Total operating expenses | $12,256 | $4,187 | | Loss from operations | $(12,256) | $(4,187) | | Total other income (expense), net | $906 | $(1,463) | | Net loss | $(11,350) | $(5,650) | | Net loss per share, basic and diluted | $(0.61) | $(4.26) | | Weighted-average shares outstanding | 18,701,286 | 1,325,706 | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Operating Expenses | H1 2025 (in thousands) | H1 2024 (in thousands) | | :-------------------------------- | :--------------------- | :--------------------- | | Research and development | $14,470 | $5,172 | | General and administrative | $8,140 | $1,578 | | Total operating expenses | $22,610 | $6,750 | | Loss from operations | $(22,610) | $(6,750) | | Total other income (expense), net | $1,064 | $(2,307) | | Net loss | $(21,546) | $(9,057) | | Net loss per share, basic and diluted | $(1.89) | $(6.87) | | Weighted-average shares outstanding | 11,417,677 | 1,319,129 | Condensed Consolidated Balance Sheets Total assets increased to $92.8M as of June 30, 2025, driven by cash, while liabilities decreased and equity turned positive Condensed Consolidated Balance Sheets | Asset/Liability/Equity | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------------ | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $88,426 | $1,639 | | Total current assets | $91,651 | $2,606 | | Total assets | $92,842 | $6,162 | | Total liabilities | $39,727 | $56,779 | | Redeemable convertible preferred stock | — | $45,999 | | Total stockholders' equity (deficit) | $53,115 | $(96,616) | Company Overview and TH103 Program Kalaris is a clinical-stage biopharmaceutical company developing TH103, a novel anti-VEGF therapy for retinal diseases - Kalaris is a clinical-stage biopharmaceutical company developing treatments for prevalent retinal diseases[8] - TH103 is a novel, differentiated anti-VEGF investigational therapy, a fully humanized recombinant fusion protein engineered for improved VEGF inhibition and longer retention in the retina[8] - TH103 is currently in Phase 1 clinical trial for nAMD, with plans to develop it for Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)[8] Disclaimer and Risk Factors This section outlines forward-looking statements regarding Kalaris's operations, development, and finances, subject to substantial risks and uncertainties - Press release contains forward-looking statements regarding strategy, future operations, TH103 therapeutic potential, clinical data timelines, and cash sufficiency[9] - Forward-looking statements are subject to substantial risks and uncertainties, including those related to clinical development, regulatory approval, capital needs, and potential litigation[9][10] - Kalaris does not assume any obligation to update forward-looking statements, except as required by applicable law[10] Contact Information Investor inquiries for Kalaris Therapeutics can be directed to Corey Davis, Ph.D. at LifeSci Advisors, LLC - Investor contact information provided for Corey Davis, Ph.D. at LifeSci Advisors, LLC[11]