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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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: 001-39409 KALARIS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) | Dela ...

[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]

Financial Performance - Legacy Kalaris reported net losses of $69.2 million and $14.7 million for the years ended December 31, 2024, and 2023, respectively[6]. - As of December 31, 2024, Legacy Kalaris had cash and cash equivalents of $1.6 million and an accumulated deficit of $116.6 million[6]. - The company has never generated revenue from product sales and may never achieve or maintain profitability[12]. - The company anticipates needing substantial additional funding to support its operations and product development efforts[17]. - Legacy Kalaris has federal and state net operating losses (NOLs) of $34.9 million and $4.2 million, respectively, as of December 31, 2024[30]. - The company anticipates continuing to incur significant losses in the foreseeable future[30]. - Legacy Kalaris has a limited operating history since its incorporation in 2019, which may affect the evaluation of its future viability[22]. Clinical Trials and Product Development - The lead product candidate, TH103, received investigational new drug clearance in June 2024 and the first patient was treated in August 2024 during a Phase 1 clinical trial[7]. - The first patient was treated in the Phase 1 clinical trial of TH103 for patients with nAMD in August 2024[32]. - The Phase 1 clinical trial of TH103 is currently open for enrollment, with the first patient treated in August 2024[50]. - The company may face delays in obtaining marketing approvals due to difficulties in patient enrollment for clinical trials[51]. - There is a high failure rate for product candidates in clinical trials, which could materially harm the company's business and results of operations[47]. - The success of TH103 and other product candidates will depend on various factors, including successful completion of clinical trials and obtaining marketing approvals[34]. - The company may need to abandon or limit the development of TH103 if dose limiting toxicities or serious adverse events are identified during trials[52]. Regulatory and Compliance Risks - The acceptance of foreign clinical trial data by the FDA is subject to specific conditions, and failure to meet these could necessitate additional costly trials[44]. - The company may incur unplanned costs and face delays in obtaining marketing approvals due to various regulatory requirements[59]. - Regulatory authorities may impose additional post-marketing testing requirements, affecting the commercialization of TH103[59]. - The company must navigate varying regulatory requirements in different countries, which can complicate the approval process[179]. - The approval process may require the product to be approved for reimbursement in many countries before it can be sold[190]. - Non-compliance with regulatory requirements could lead to significant time and resource expenditure in government investigations, negatively affecting commercialization efforts[198]. - Continued regulatory compliance efforts will be necessary post-approval, impacting the company's financial condition and profitability[199]. Competition and Market Dynamics - The biopharmaceutical industry is characterized by intense competition, particularly in the market for retinal disease treatments, with major competitors including Novartis, Regeneron, AbbVie, and Roche[70]. - Several companies have received FDA approval for biosimilars to treat nAMD, which may provide cost-effective treatment options and increase market competition[71]. - Emerging biopharmaceutical companies are advancing therapeutic candidates for nAMD, with ongoing clinical trials for various product candidates[72]. - Market acceptance of TH103, if approved, may be limited due to the established competition in the anti-VEGF therapy market[61]. - The company’s ability to compete may be affected by insurers encouraging the use of generic and biosimilar products, potentially reducing market share[73]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trademarks, and trade secrets to protect its intellectual property, which is crucial for its product candidates[105]. - There is uncertainty regarding the ability to obtain and maintain patent protection for current and future product candidates, which could adversely affect commercialization efforts[110]. - The patent application process is expensive and time-consuming, and there is no guarantee that pending applications will result in issued patents[109]. - The company may face challenges in integrating acquired technologies and personnel, which could divert management attention and increase expenses[102]. - The company may face expensive and time-consuming lawsuits to protect its patents, which could result in patents being found invalid or unenforceable[136]. - The company may not be able to effectively prevent competitors from commercializing similar products if patent protection is inadequate[116]. - The company may face significant problems in protecting trade secrets and proprietary know-how, especially in countries with weaker protections[151]. Manufacturing and Supply Chain Risks - The company relies on third-party contract development and manufacturing organizations (CDMOs) for the manufacture of both drug substance and finished drug products, increasing the risk of insufficient quantities or quality, which could delay commercialization efforts[89]. - Manufacturing biologics is complex, and the company may experience production issues that could delay the development or commercialization of product candidates[85]. - The company currently relies on single-source suppliers for certain materials, exposing it to risks such as supply disruptions and price increases[94]. - Any contamination during the manufacturing process could materially harm the company's ability to produce product candidates on schedule, affecting operational results and reputation[86]. - The ability to scale manufacturing while maintaining quality and efficiency has yet to be tested, posing risks to supply for clinical trials or commercial needs[88]. Mergers and Acquisitions - The company may face challenges in integrating the businesses of AlloVir and Kalaris and realizing the anticipated benefits of the merger[8]. - Acquisitions or in-licensing transactions could disrupt the business and may lead to dilution of stockholder value[102]. - The company may pursue in-licensing or acquisition of complementary technologies and product candidates, but faces competition from established companies in this area[77]. Financial Controls and Governance - Legacy Kalaris identified material weaknesses in its internal control over financial reporting as of December 31, 2024 and 2023[25]. - The company plans to engage financial consultants and recruit additional accounting personnel to address identified material weaknesses[27].

Core Points - AlloVir stockholders approved all proposals at a Special Meeting, including the merger with Kalaris Therapeutics [1] - The merger is expected to close soon, with the combined company to be renamed Kalaris Therapeutics, Inc. and trade under the ticker "KLRS" on Nasdaq [2] - Kalaris focuses on developing treatments for retinal diseases, particularly TH103, an investigational therapy for neovascular Age-related Macular Degeneration [2] - AlloVir specializes in allogeneic T cell immunotherapy aimed at restoring immunity against viral diseases in immunocompromised patients [3] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to retinal disease treatments [2] - TH103 is a novel anti-VEGF therapy developed by Dr. Napoleone Ferrara, designed for improved VEGF inhibition and longer retention in the retina [2] - Kalaris is currently conducting a Phase 1 clinical trial for TH103, with plans to expand its application to other retinal diseases like Diabetic Macular Edema and Retinal Vein Occlusion [2] Industry Context - The merger between Kalaris and AlloVir represents a strategic consolidation in the biopharmaceutical sector, particularly in the field of immunotherapy and retinal disease treatment [1][2] - The focus on retinal diseases highlights a growing market demand for innovative therapies addressing prevalent conditions affecting vision [2]