Financial Performance - The company reported net losses of $33.4 million and $47.1 million for the nine months ended September 30, 2025 and 2024, respectively[156]. - Negative cash flows from operations were $31.3 million and $12.8 million for the nine months ended September 30, 2025 and 2024, respectively[156]. - As of September 30, 2025, the company had an accumulated deficit of $150.0 million[156]. - The net loss for the nine months ended September 30, 2025, was $33.4 million, offset by non-cash charges of $1.6 million, while for the same period in 2024, the net loss was $47.1 million with non-cash charges of $35.4 million[220][221]. - Other income increased to $1.9 million for the nine months ended September 30, 2025, compared to $0.1 million in 2024[210]. - The loss on issuance of convertible promissory notes decreased from $2.1 million in 2024 to $0.2 million in 2025[209]. Cash and Investments - The company had $77.0 million in cash, cash equivalents, and short-term investments as of September 30, 2025, expected to fund operations into 2027[157]. - Net cash used in operating activities was $31.3 million for the nine months ended September 30, 2025, compared to $12.8 million for the same period in 2024, indicating a significant increase in cash outflow[219]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $34.7 million, primarily from purchases of short-term investments[222]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $107.3 million, significantly higher than $11.6 million for the same period in 2024[223][224]. Research and Development - The company is developing TH103, a novel anti-VEGF drug, with initial clinical data expected by the end of 2025 and further data from a Phase 1b/2 trial anticipated in the second half of 2026[155]. - The company plans to expand TH103's development into other retinal diseases, including Diabetic Macular Edema, diabetic retinopathy, and Retinal Vein Occlusion[155]. - Research and development expenses decreased by $26.9 million, from $36.0 million for the three months ended September 30, 2024, to $9.1 million for the same period in 2025[192]. - The company anticipates a substantial increase in research and development expenses as it advances its product candidate through clinical trials and pursues regulatory approval[183]. - The company incurred $7.4 million in external costs related to CDMO, CRO, and other third-party preclinical studies and clinical trials for the three months ended September 30, 2025[192]. - Research and development expenses decreased by $17.6 million, from $41.2 million in 2024 to $23.6 million in 2025[201]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $12.7 million, a decrease of $25.1 million from $37.8 million in the same period of 2024[191]. - The company expects general and administrative expenses to increase due to higher personnel costs and additional expenses associated with being a public company[185]. - General and administrative expenses rose by $1.8 million, primarily due to increases in legal, accounting, and other professional services following the Merger[196]. - General and administrative expenses increased by $8.4 million, from $3.4 million in 2024 to $11.8 million in 2025[205]. - Personnel-related costs increased by $0.9 million due to hiring in the research and development organization[195]. Merger and Corporate Structure - The merger with AlloVir was completed on March 18, 2025, with Legacy Kalaris becoming a wholly-owned subsidiary of AlloVir[166]. - Following the merger, stockholders of Legacy Kalaris owned approximately 74.47% of the outstanding common stock of the combined company on a fully diluted basis[169]. Obligations and Liabilities - The company recorded $32.1 million as a long-term liability related to future royalty payments to Samsara under the Royalty Agreement[176]. - The company recognized an initial royalty liability of $32.1 million under the Royalty Agreement, which is based on its estimated fair value[227]. - The company is obligated to pay up to $4.6 million upon achieving various development and regulatory milestones under the UCSD Agreement[170]. - The company incurred a royalty obligation expense of $32.0 million in connection with the Royalty Agreement during the nine months ended September 30, 2024[221]. - The company has no non-cancellable obligations under its agreements as of September 30, 2025, indicating flexibility in its operational commitments[225]. Licensing and Agreements - The company entered into a license agreement with UCSD, paying $0.2 million initially and agreeing to issue shares equal to 5% of fully diluted outstanding securities until $5.0 million in gross proceeds from equity sales is raised[170]. - The company is required to pay milestone payments contingent upon specific development and regulatory events, with $0.1 million recognized related to the UCSD Agreement as of September 30, 2025[226]. - The company recognized $0.1 million and $0.2 million in patent reimbursement costs for the three and nine months ended September 30, 2025, respectively[174]. Cash Flow and Asset Management - Cash flows from operating activities were impacted by changes in net operating assets and liabilities, with a decrease in prepaid expenses and other current assets of $1.5 million for the nine months ended September 30, 2025[220]. - The company made a payment of $0.1 million related to the first development milestone in August 2024, recorded as research and development expense[174]. - The company entered into an operating lease agreement for office space in Berkeley Heights, New Jersey, with total remaining undiscounted payments of approximately $2.2 million[228].

Financial Position - As of September 30, 2025, Kalaris had cash, cash equivalents, and short-term investments of $77.0 million, a significant increase from $1.6 million as of December 31, 2024, primarily due to the merger with AlloVir in Q1 2025[4] - Kalaris expects its cash resources will be sufficient to fund operations into 2027[4] - The total assets of Kalaris as of September 30, 2025, were $81.2 million, with total liabilities of $39.3 million[16] Research and Development - Research and development expenses for Q3 2025 were $9.1 million, down from $36.0 million in Q3 2024, mainly due to a $32.0 million royalty obligation expense in the previous year[5] - Kalaris is currently enrolling patients in a Phase 1b/2 multiple ascending dose trial of TH103, with initial clinical data from the Phase 1a trial expected by year-end 2025[2] - The newly initiated Phase 1b/2 trial aims to evaluate multiple dose levels of TH103 in up to 80 patients with neovascular age-related macular degeneration (nAMD)[3] - Kalaris has selected KBI Biopharma as its Contract Development and Manufacturing Organization (CDMO) for clinical supply manufacturing of TH103[10] General and Administrative Expenses - General and administrative expenses increased to $3.6 million in Q3 2025 from $1.8 million in Q3 2024, attributed to higher insurance, legal, and professional fees[6] Net Loss - The net loss for Q3 2025 was $11.9 million, compared to a net loss of $38.1 million in Q3 2024, with a total of 18,702,418 shares outstanding[7] Corporate Developments - The company opened a new corporate headquarters in Berkeley Heights, New Jersey, and appointed Matthew Gall as Chief Financial Officer[10]

Core Points - Bragar Eagel & Squire, P.C. is investigating potential claims against AlloVir, Inc. on behalf of long-term stockholders following a class action complaint filed on March 19, 2024, concerning the period from March 22, 2022 to December 21, 2023 [2][7] - The investigation focuses on whether AlloVir's board of directors breached their fiduciary duties to the company [2] - The complaint alleges that AlloVir made materially false and misleading statements regarding its business and operations, particularly concerning the posoleucel Phase 3 studies [7] Company Details - AlloVir announced on December 22, 2023, that it would discontinue the posoleucel Phase 3 studies due to efficacy concerns, stating that pre-planned analyses indicated they would not meet their primary endpoints [7] - Following this announcement, AlloVir's stock price fell by $1.57 per share, or 67.38%, closing at $0.76 per share on December 22, 2023 [7]

Financial Performance - The company reported net losses of $21.5 million and $9.1 million for the six months ended June 30, 2025 and 2024, respectively, with negative cash flows from operations of $20.0 million and $8.5 million for the same periods [153]. - The net loss for Q2 2025 was $11.4 million, compared to a net loss of $5.7 million in Q2 2024 [189]. - The net loss for the six months ended June 30, 2025, was $21.5 million, compared to a net loss of $9.1 million in 2024, reflecting an increase of $12.5 million [198]. - The accumulated deficit as of June 30, 2025, was $138.1 million, indicating significant ongoing financial challenges [210]. Cash Flow and Financing - Cash and cash equivalents as of June 30, 2025, totaled $88.4 million, with gross proceeds of $67.5 million from sales of redeemable convertible preferred stock and convertible promissory notes since inception [208]. - Net cash used in operating activities was $20.0 million for the six months ended June 30, 2025, compared to $8.5 million in 2024 [216]. - Net cash provided by financing activities for the six months ended June 30, 2025, was $107.3 million, including $102.1 million from the Merger and $7.5 million from a convertible promissory note [219]. - Cash provided by financing activities for the six months ended June 30, 2024, was $11.6 million, consisting of $10.0 million from convertible promissory notes and $1.6 million from redeemable convertible preferred stock [220]. Research and Development - The company is developing TH103, a novel anti-VEGF drug, and is currently enrolling patients in a Phase 1 clinical trial for neovascular Age-related Macular Degeneration (nAMD), with initial clinical data expected in Q4 2025 [152]. - The company plans to expand TH103's development into other VEGF-mediated retinal diseases, including Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO) [152]. - Research and development expenses increased by $5.2 million, from $3.2 million in Q2 2024 to $8.4 million in Q2 2025 [190]. - The company expects substantial increases in research and development expenses as it advances its product candidate through clinical trials [179]. - Research and development expenses increased by $9.3 million, from $5.2 million in 2024 to $14.5 million in 2025, primarily due to costs associated with the Phase 1 clinical trial of TH103 [199]. Operating Expenses - Total operating expenses for Q2 2025 were $12.3 million, compared to $4.2 million in Q2 2024, reflecting an increase of $8.1 million [189]. - General and administrative expenses rose by $2.8 million, from $1.0 million in Q2 2024 to $3.8 million in Q2 2025 [192]. - General and administrative expenses rose by $6.5 million, from $1.6 million in 2024 to $8.1 million in 2025, driven by increased legal, accounting, and professional services costs [201]. - External research and development costs accounted for $6.9 million in Q2 2025, up from $2.4 million in Q2 2024, an increase of $4.6 million [190]. Merger and Licensing - The merger with AlloVir was completed on March 18, 2025, resulting in Legacy Kalaris becoming a wholly-owned subsidiary of AlloVir, with stockholders of Legacy Kalaris owning approximately 74.47% of the combined company [163][165]. - The company has entered into a license agreement with UCSD, which includes obligations to pay $0.2 million and issue shares equal to 5% of fully diluted securities until $5.0 million in gross proceeds from equity sales is raised [166]. Liabilities and Future Obligations - The company recorded $32.1 million as a long-term liability related to future royalty payments under the Royalty Agreement with Samsara [174]. - The company has an initial royalty liability of $32.1 million under the Royalty Agreement with Samsara, which is not currently deemed probable and estimable [224]. Economic and Operational Risks - The company is subject to macroeconomic risks, including inflation and trade restrictions, which may impact its capital access and overall financial position [159]. - Management's estimates for financial statements are based on historical experience and various factors, with potential material changes in estimates affecting reported results [227]. - There have been no material changes to critical accounting estimates since the last report filed on March 18, 2025 [228].

[Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) 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](index=1&type=chunk)[2](index=2&type=chunk) Cash and Cash Equivalents | Metric | Amount (June 30, 2025) | | :----- | :--------------------- | | Cash and Cash Equivalents | $88.4M | [Business Updates (Operational)](index=1&type=section&id=Business%20Updates%20(Operational)) Kalaris progresses TH103 Phase 1 trial for nAMD and strengthens its leadership team with a key clinical hire [TH103 Clinical Trial Progress](index=1&type=section&id=TH103%20Clinical%20Trial%20Progress) 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](index=2&type=chunk) - TH103 is engineered to potentially provide **longer-lasting and increased anti-VEGF activity**, with initial clinical data expected in **Q4 2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) [Leadership Team Expansion](index=1&type=section&id=Leadership%20Team%20Expansion) 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](index=6&type=chunk) [Financial Highlights (Summary)](index=1&type=section&id=Financial%20Highlights%20(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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=2&type=section&id=Company%20Overview%20and%20TH103%20Program) 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](index=8&type=chunk) - 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](index=8&type=chunk) - 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](index=8&type=chunk) [Disclaimer and Risk Factors](index=2&type=section&id=Disclaimer%20and%20Risk%20Factors) 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](index=9&type=chunk) - Forward-looking statements are subject to **substantial risks and uncertainties**, including those related to clinical development, regulatory approval, capital needs, and potential litigation[9](index=9&type=chunk)[10](index=10&type=chunk) - Kalaris does not assume any obligation to update forward-looking statements, except as required by applicable law[10](index=10&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) 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](index=11&type=chunk)

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against AlloVir, Inc. due to a class action complaint alleging that the company's board may have breached their fiduciary duties to shareholders during the specified class period [1][2]. Group 1: Allegations and Company Performance - The class action complaint alleges that AlloVir made materially false and misleading statements regarding its business operations and prospects, particularly concerning the posoleucel Phase 3 studies [2]. - It is claimed that the defendants failed to disclose that the posoleucel Phase 3 studies were unlikely to meet their primary endpoints, leading to an overstatement of the drug's efficacy and commercial prospects [2]. - Following the announcement on December 22, 2023, that AlloVir would discontinue the posoleucel Phase 3 studies due to efficacy concerns, the company's stock price plummeted by $1.57 per share, or 67.38%, closing at $0.76 per share [3]. Group 2: Legal and Contact Information - Long-term stockholders of AlloVir are encouraged to contact Bragar Eagel & Squire for discussions regarding their legal rights and potential claims [1][4]. - The law firm specializes in representing individual and institutional investors in complex litigation, indicating a focus on shareholder rights [5].

Market Overview - The global branded anti-VEGF market for retinal neovascular/exudative diseases is approximately $14 billion in 2023 and is projected to grow to approximately $18 billion by 2029[8, 16, 24] - Branded anti-VEGF therapies accounted for approximately 70% of the global anti-VEGF units in retinal disease in 2023, while compounded bevacizumab accounted for approximately 30%[25] TH103 Development - TH103 is a fusion protein targeting VEGF, engineered for longer-lasting and increased anti-VEGF activity, invented by VEGF pioneer Dr Napoleone Ferrara[6, 8, 38] - Preclinical studies demonstrated TH103 achieved 100% inhibition of VEGF-induced endothelial cell proliferation in vitro, compared to 80% by aflibercept[57] - TH103 demonstrated increased retention in the retina compared to aflibercept at two weeks in rabbit retina cross-sections[64] - In a mouse laser CNV model, TH103 demonstrated increased duration of action in reducing mean CNV area after administration at Day -14 compared to aflibercept[72] Clinical Program & Intellectual Property - Kalaris received IND clearance from the FDA in June 2024 for a Phase 1 clinical trial of TH103 for nAMD[84] - Initial clinical data from the Phase 1 trial of TH103 for nAMD is expected in Q4 2025[8, 84, 86] - Kalaris holds US exclusivity for TH103 compositions of matter through the early 2040s[92]

Core Points - The United States District Court for the District of Massachusetts has approved a proposed class action settlement for purchasers of AlloVir, Inc. securities, amounting to $1,000,000 [2][3] Group 1: Settlement Details - The settlement benefits individuals or entities who purchased AlloVir securities from January 11, 2023, to December 21, 2023 [1] - The proposed settlement includes a hearing scheduled for July 30, 2025, to determine its fairness and adequacy [3] - Lead Counsel may request attorneys' fees of up to 33.33% of the settlement fund and reimbursement of litigation expenses up to $100,000 [3] Group 2: Claim Process - Settlement Class Members must submit a Claim Form by August 19, 2025, to be eligible for distribution from the Net Settlement Fund [6] - Instructions for submitting the Claim Form and obtaining transaction data from brokerages are available on the case website [6] - Members wishing to exclude themselves from the Settlement Class must submit a written request by July 9, 2025 [7] Group 3: Objections and Inquiries - Any objections to the proposed settlement or related motions must be filed with the Court by July 9, 2025 [8] - Inquiries regarding the settlement can be directed to Lead Counsel or the Claims Administrator [5][6]

Financial Performance - The company reported net losses of $10.2 million and $3.4 million for the three months ended March 31, 2025, and 2024, respectively, with an accumulated deficit of $126.8 million as of March 31, 2025[180]. - The net loss for the three months ended March 31, 2025, was $10.2 million, compared to a net loss of $3.4 million for the same period in 2024, reflecting an increase of $6.8 million[216]. - Operating expenses totaled $10.4 million for the three months ended March 31, 2025, compared to $2.6 million for the same period in 2024, indicating a significant increase of $7.8 million[216]. - Net cash used in operating activities was $7.4 million for the three months ended March 31, 2025, compared to $4.5 million for the same period in 2024[232]. - The company reported net cash provided by financing activities of $107.3 million for the three months ended March 31, 2025, primarily from the merger with AlloVir, compared to $6.6 million in the same period of 2024[237][238]. Cash and Funding - The company has $101.0 million in cash and cash equivalents as of March 31, 2025, which is expected to fund operations into the fourth quarter of 2026[181]. - The company anticipates needing substantial additional funds to achieve its business objectives, particularly for the development and potential commercialization of TH103[230]. - The company entered into a convertible note purchase agreement to issue up to $25.0 million in convertible promissory notes, receiving $10.0 million from initial closings[189]. - The company received gross proceeds of $67.5 million from sales of redeemable convertible preferred stock and convertible promissory notes since inception, along with approximately $102.1 million in cash and cash equivalents from the AlloVir merger[226]. Research and Development - The company has not generated any revenue from product sales and anticipates incurring substantial losses for the foreseeable future[182]. - The company is conducting a Phase 1 clinical trial of TH103 for neovascular Age-related Macular Degeneration (nAMD), with initial clinical data expected in Q4 2025[179]. - The company plans to expand TH103's development into other retinal diseases, including Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)[179]. - Research and development expenses increased by $4.1 million, from $2.0 million for the three months ended March 31, 2024, to $6.0 million for the same period in 2025[217]. - The increase in research and development expenses was primarily due to a $3.3 million rise in costs associated with CDMO, CRO, and other third-party preclinical studies and clinical trials, from $1.5 million in Q1 2024 to $4.8 million in Q1 2025[217]. - The company anticipates substantial increases in research and development expenses as it advances its product candidate through clinical trials and pursues regulatory approval[206]. - Research and development expenses are expected to increase significantly as the company advances its lead product candidate, TH103, and expands corporate infrastructure[227]. General and Administrative Expenses - General and administrative expenses rose by $3.7 million, from $0.6 million for the three months ended March 31, 2024, to $4.3 million for the same period in 2025[219]. - The company expects general and administrative expenses to increase due to higher personnel costs and additional expenses associated with being a public company[210]. Merger and Ownership - The merger with AlloVir was completed on March 18, 2025, with Legacy Kalaris becoming a wholly-owned subsidiary of AlloVir[190]. - Following the merger, stockholders of Legacy Kalaris owned approximately 74.47% of the outstanding common stock of the combined company on a fully diluted basis[192]. Licensing and Obligations - The company has a license agreement with UCSD, which includes obligations to pay up to $4.6 million upon achieving various milestones and low single-digit royalties on net sales of licensed products[193]. - The company is required to make annual license maintenance payments of $10,000 for the first four anniversaries and $15,000 on the fifth and subsequent anniversaries of the effective date of the UCSD Agreement[193]. - A royalty obligation to Samsara was established with a fair value of $32,000, requiring low single-digit royalty payments on future net product sales[253]. - As of March 31, 2025, no royalty payments to Samsara were deemed probable and estimable, resulting in no interest expense recognized for the royalty liability during the period[202]. Liabilities and Fair Value - The fair value of the royalty obligation to Samsara was estimated at $32.1 million, recorded as a long-term liability related to future royalty payments[199]. - The company recognized a $0.4 million gain related to changes in the fair value of tranche liability for the three months ended March 31, 2025[220]. - The company recognized $1.2 million related to changes in the fair value of derivative liabilities for the three months ended March 31, 2025[221]. - The intrinsic value of all outstanding stock options as of March 31, 2025, was approximately $44.7 million, with $14.1 million related to vested options and $30.6 million related to unvested options[258]. Company Classification - The company is classified as an emerging growth company (EGC) and intends to rely on exemptions from various public company disclosure requirements until certain thresholds are met[260]. - The company is also classified as a smaller reporting company, with a market value of stock held by non-affiliates below $700.0 million and annual revenue below $100.0 million during the most recently completed fiscal year[261].

Financial Performance - As of March 31, 2025, Kalaris had cash and cash equivalents of $101.0 million, a significant increase from $1.6 million as of December 31, 2024, primarily due to the merger with AlloVir[5] - The net loss for Q1 2025 was $10.2 million, or $2.52 per share, compared to a net loss of $3.4 million, or $2.60 per share, in Q1 2024[8] - Total operating expenses for Q1 2025 were $10.4 million, significantly higher than $2.6 million in Q1 2024[15] - General and administrative expenses rose to $4.3 million in Q1 2025 from $0.6 million in Q1 2024, driven by a one-time charge for AlloVir's insurance and increased professional fees[7] - Research and development expenses for Q1 2025 were $6.0 million, up from $2.0 million in Q1 2024, reflecting increased costs related to manufacturing and clinical trials[6] Operational Developments - The merger with AlloVir was completed in March 2025, expanding Kalaris' operational capabilities[4] - Kalaris is currently enrolling patients in a Phase 1 trial for TH103, with initial clinical data expected in Q4 2025[4] - Kalaris plans to develop TH103 for additional retinal diseases beyond neovascular Age-related Macular Degeneration (nAMD)[9] Shareholder Information - The total number of shares outstanding as of March 31, 2025, was 18,702,418[8] - Kalaris' total assets as of March 31, 2025, were $103.1 million, compared to $6.2 million as of December 31, 2024[17]