Company Overview June 2025 1 Forward-Looking Statements & Disclaimer This presentation contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this presentation, including statements regarding the strategy, future operations, future financial position, projected ...

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]

Merger and Acquisition - AlloVir entered into a merger agreement with Kalaris, expected to close in Q1 2025, with AlloVir stockholders owning approximately 24.66% of the combined company[27][28]. - The merger agreement includes conditions such as AlloVir's net cash at closing being no less than $95 million and stockholder approvals[27]. - Kalaris is permitted to raise up to $15 million in financing prior to the merger, with AlloVir contributing up to $7.5 million[32]. - AlloVir's valuation is set at $116 million, subject to adjustments based on net cash at closing, while Kalaris is valued at $347 million[29][31]. - A termination fee of $3.48 million may be payable by AlloVir to Kalaris, or $10.41 million from Kalaris to AlloVir, if the merger agreement is terminated under specified circumstances[195]. - The merger's completion is contingent upon the approval of AlloVir stockholders for the issuance of common stock to Kalaris stockholders[199]. - The combined company will be subject to more stringent reporting requirements due to AlloVir's status as a shell company following the merger[203]. - The combined company will not be eligible to use Form S-3 until 12 full calendar months after the merger closes[206]. - The combined company will need to file a Form 8-K to report its status as a non-shell company after the merger[206]. - Holders of restricted combined company securities will not be able to sell them under Rule 144 until one year after the Form 10 information is filed with the SEC[202]. - The merger may be completed even if adverse changes occur prior to closing, which could negatively impact the market price of the combined company's stock[201]. - AlloVir's directors and executive officers may have interests in the merger that differ from those of other stockholders, potentially influencing their support for the merger[205]. - The merger may lead to significant dilution of ownership interests for both AlloVir and Kalaris stockholders without guaranteed benefits[212]. - AlloVir's stock price is subject to significant fluctuations, particularly if the merger is not completed, which could lead to a decline in market price[210]. - The merger process has resulted in a workforce reduction of approximately 95% at AlloVir, which may impact the ability to complete the merger[221]. - The merger agreement includes provisions that may discourage third parties from submitting competing proposals, potentially limiting strategic options[217]. - AlloVir may incur significant costs related to the merger, including legal and accounting fees, which could reduce available cash for operations[223]. - The combined company may need to raise additional capital, which could further dilute stockholder interests and restrict operations[215]. - There is uncertainty regarding the fair market value of Kalaris' capital stock, complicating the valuation of AlloVir's common stock to be issued to Kalaris stockholders[218]. - Stockholder litigation could delay or prevent the merger, adversely affecting the business and financial condition of both companies[220]. Clinical Trials and Product Development - AlloVir discontinued three Phase 3 trials of posoleucel due to futility analyses indicating the studies were unlikely to meet primary endpoints[25]. - ALVR106, targeting respiratory viruses, has halted development pending strategic review outcomes[41]. - AlloVir's future operations depend heavily on the success of the merger, with potential alternatives including dissolution if the merger fails[35]. - AlloVir's ALVR107 is an allogeneic, off-the-shelf VST therapy aimed at achieving a functional cure for chronic Hepatitis B Virus (HBV) infection, which affects approximately 260 million people globally[44][46]. - The company completed preclinical and IND-enabling studies for ALVR107 in 2022, supporting its advancement into a proof-of-concept study[46]. - AlloVir's proprietary VST manufacturing platform enables rapid generation of virus-specific T cell therapies[36]. - AlloVir's patent portfolio includes ten patent families, with patents expected to expire between 2030 and 2043, covering various VST therapies and methods[53]. - The company has decided to abandon its patent family related to ALVR107 and ALVR108, allowing the PCT application to expire without nationalization[57]. Financial Obligations and Agreements - AlloVir's A&R License Agreement with BCM includes a non-refundable license fee of $250,000 and an annual maintenance fee of $20,000 for the first four anniversaries[66][67]. - Total milestone payments from AlloVir to BCM could exceed $30.0 million if multiple products are successfully developed, launched, and commercialized under the Second License Agreement[73]. - AlloVir has agreed to pay BCM approximately $6.0 million over the term of the Research Collaboration Agreement, which has been extended to December 31, 2025[74]. - Earnout payments to investors from AlloVir will be 10% of net sales of Viralym-M, potentially reduced to a high single-digit percentage under certain conditions[75]. - AlloVir was awarded a CPRIT Grant requiring a share of revenue on sales of commercial products developed using CPRIT funds, equal to low single digits until 400% of the grant award proceeds is paid[76]. - AlloVir is obligated to pay BCM a non-refundable annual license maintenance fee of $20,000 for the first four years and $40,000 starting from the fifth anniversary, with fees fully creditable against royalty revenue due in the applicable year[73]. - AlloVir must use commercially reasonable efforts to develop and commercialize products in certain countries under the Second License Agreement[73]. - The Research Agreement with BCM commenced on January 1, 2021, and was initially for three years, now extended for an additional year[74]. - AlloVir is responsible for all costs related to the patent rights licensed under the Second License Agreement, including legal fees incurred prior to its effective date[72]. Regulatory Environment - The FDA requires extensive monitoring and auditing of all clinical activities, with annual progress reports detailing clinical trial results submitted to the FDA[87]. - The FDA targets ten months for the initial review of a standard Biologics License Application (BLA) and six months for priority review applications[91]. - The FDA may refuse to file any BLA deemed incomplete, requiring resubmission with additional information[90]. - Before approving a BLA, the FDA inspects manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP)[93]. - Orphan Drug Designation is granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[98]. - A product with orphan drug designation may receive exclusivity for seven years if it is the first FDA approval for that active ingredient for the designated disease[99]. - The FDA's breakthrough therapy program allows for expedited development and review for products showing substantial improvement over existing therapies[103]. - Priority review designation aims to review applications in six months, compared to ten months for standard reviews[104]. - Accelerated approval may be granted based on surrogate endpoints that predict clinical benefit, with post-marketing trials required[105]. - The FDA may withdraw approval if post-marketing requirements are not maintained or if safety issues arise after market entry[96]. - The Regenerative Medicine Advanced Therapy (RMAT) designation facilitates expedited development and review of products intended to treat serious diseases, with a 60-day FDA review period for eligibility[106]. - Post-approval requirements include compliance with cGMP regulations, adverse experience reporting, and periodic reporting, ensuring product safety and efficacy[107]. - Manufacturers must comply with FDA advertising and promotion requirements, including restrictions on off-label use and direct-to-consumer advertising[108]. - Non-compliance with FDA regulations can lead to severe sanctions, including product recalls, clinical holds, and potential criminal penalties[111]. - The Biologics Price Competition and Innovation Act (BPCIA) allows for a 12-year exclusivity period for reference biological products, with potential for a 5-year patent term extension[113][115]. - Pediatric market exclusivity can add six months to existing exclusivity periods for biological products based on voluntary completion of pediatric studies[118]. - AlloVir is subject to various international regulations, including anti-corruption laws and trade control laws, which impose strict compliance requirements[120][121]. - The new Clinical Trials Regulation in the EU aims to streamline clinical trial approvals with a single entry point and defined deadlines, expected to be fully functional by January 2023[129]. - Advanced therapy medicinal products (ATMPs) are subject to extensive regulation in the European Economic Area, with AlloVir's products classified as somatic cell therapy medical products[130]. - The EEA provides eight years of data exclusivity and an additional two years of market exclusivity for innovative medicinal products upon receiving marketing authorization[134]. - The maximum timeframe for the evaluation of a marketing authorization application (MAA) for an advanced therapy medicinal product (ATMP) is 210 days, which can be reduced to 150 days in exceptional cases[134]. - Products with orphan designation in the EEA can receive ten years of market exclusivity, which may be extended by two years if a Pediatric Investigation Plan is complied with[137]. - The marketing authorization holder must establish a pharmacovigilance system and report serious adverse reactions[144]. Market and Competitive Landscape - The biopharmaceutical industry presents intense competition, with AlloVir facing challenges from established companies with greater resources[48][49]. - There are currently no FDA-approved cell therapies for the viral diseases AlloVir targets, highlighting a significant market opportunity[50]. - AlloVir's competitors may obtain regulatory approvals faster, potentially establishing a strong market position before AlloVir can enter[49]. - The company emphasizes the importance of protecting its intellectual property through patents and trade secrets to maintain a competitive edge[52][62]. - AlloVir's strategic direction includes focusing on developing proprietary technologies and therapies to address unmet medical needs in viral infections[47]. Compliance and Regulatory Risks - AlloVir's operations are subject to various federal and state regulations, including the federal Anti-Kickback Statute and the False Claims Act, which impose significant compliance costs[156][164]. - The U.S. Department of Health and Human Services (HHS) has removed safe harbor protections for certain price reductions, impacting pricing strategies for pharmaceutical manufacturers[163]. - Increased scrutiny on patient assistance programs may lead to regulatory actions that could adversely affect AlloVir's sales and financial condition[160]. - AlloVir may face significant penalties if found in violation of healthcare laws, including administrative, civil, and criminal penalties[164]. - Compliance with data privacy and security laws, such as HIPAA, is critical, with potential fines for breaches of protected health information[166]. - The Biden Administration's executive order restricts certain personal data transfers, impacting data management strategies for companies[167]. - AlloVir's business arrangements with third parties must comply with complex healthcare laws, increasing operational costs and compliance risks[165]. - The California Consumer Privacy Act (CCPA) may increase AlloVir's compliance costs and potential liability due to evolving privacy legislation[170]. - The CCPA was amended by the California Privacy Rights Act (CPRA), imposing additional obligations on companies effective January 1, 2023[170]. - The NIS 2 Directive aims to ensure a high level of cybersecurity in the EEA, imposing obligations on organizations, including those in healthcare[174]. - Under NIS 2, companies may face administrative fines of up to €10 million or 2% of worldwide turnover for non-compliance[174]. - The Inflation Reduction Act (IRA) includes provisions that could impact AlloVir's business, such as allowing the U.S. government to negotiate drug prices[184]. - Legislative changes may result in additional reductions in Medicare and other healthcare funding, affecting pricing for AlloVir's products[181]. - The regulatory framework governing data privacy is rapidly evolving, potentially increasing compliance costs and legal risks for AlloVir[175]. Employee Relations - AlloVir had 6 full-time employees as of December 31, 2024, with no employees represented by labor unions[186]. - The company considers its relationship with employees to be good, focusing on recruiting, retaining, and incentivizing personnel[187]. - AlloVir's equity incentive plans aim to attract and retain personnel to increase shareholder value and company success[187].

Clinical Trials and Research Activities - The company discontinued three Phase 3 trials of posoleucel in December 2023 due to futility analyses indicating the studies were unlikely to meet primary endpoints[98] - The company paused development of ALVR106 and ALVR107 pending the outcome of strategic alternatives review[101] - Research and development expenses decreased by $34.4 million to $(0.2) million for the three months ended September 30, 2024, compared to $34.2 million for the same period in 2023, primarily due to the discontinuation of clinical trials and research activities[128] - Research and development expenses decreased by $87.7 million to $12.0 million for the nine months ended September 30, 2024, compared to $99.7 million for the same period in 2023, primarily due to the discontinuation of clinical trials and research activities and a $5.6 million gain on lease termination[133] - The company expects research and development expenses to continue to decrease significantly due to the discontinuation of clinical trials and research activities, and will incur costs associated with the proposed Merger with Kalaris[140] - The $29.6 million decrease in cash used in operating activities for the nine months ended September 30, 2024 compared to the same period in 2023 was a result of the discontinuation of the company's three Phase 3 registrational trials[147] - The company expects research and development and general and administrative costs to increase in connection with planned research and development activities[141] Workforce Reduction and Restructuring - The company implemented a workforce reduction plan, cutting approximately 95% of its employees, primarily completed by April 15, 2024[99] - General and administrative expenses decreased by $6.9 million to $5.9 million for the three months ended September 30, 2024, compared to $12.8 million for the same period in 2023, primarily due to workforce reduction and a $1.5 million gain on lease remeasurement[129] - Restructuring costs were $0.1 million for the three months ended September 30, 2024, primarily due to severance and employee termination costs[130] - General and administrative expenses decreased by $14.1 million to $23.7 million for the nine months ended September 30, 2024, compared to $37.8 million for the same period in 2023, primarily due to workforce reduction and a $3.3 million gain on lease remeasurement[134] - Restructuring costs were $10.1 million for the nine months ended September 30, 2024, primarily due to severance and employee termination costs[135] Financial Performance and Cash Flow - The company reported a net loss of $40.5 million for the nine months ended September 30, 2024, with an accumulated deficit of $696.7 million[106] - The company had $121.9 million in cash, cash equivalents, and short-term investments as of September 30, 2024, with a projected runway of at least twelve months[109] - Total other income (loss), net decreased by $1.1 million to $1.6 million for the three months ended September 30, 2024, compared to $2.7 million for the same period in 2023, primarily due to a decrease in accretion of discounts on short-term investments[131] - Total other income (loss), net decreased by $1.2 million to $5.3 million for the nine months ended September 30, 2024, compared to $6.8 million for the same period in 2023, primarily due to a decrease in accretion of discounts on short-term investments[136] - The company has cash, cash equivalents, and short-term investments of $121.9 million as of September 30, 2024, which is expected to fund operations for at least twelve months, but there is substantial doubt about the company's ability to continue as a going concern[139] - Net cash used in operating activities was $64.1 million for the nine months ended September 30, 2024, reflecting a net loss of $40.5 million and a decrease in net operating assets and liabilities of $29.6 million[146] - Net cash provided by investing activities was $90.0 million for the nine months ended September 30, 2024, primarily due to investment maturities[148] - Net cash provided by financing activities was $0.0 million for the nine months ended September 30, 2024, primarily due to proceeds from the issuance of stock under the employee stock purchase plan[149] - Net cash used in operating activities was $93.7 million for the nine months ended September 30, 2023, reflecting a net loss of $130.7 million[146] - Net cash provided by investing activities was $12.8 million for the nine months ended September 30, 2023, due to investment maturities of $128.8 million, partially offset by the purchase of investments of $116.0 million[148] - Net cash provided by financing activities was $70.5 million for the nine months ended September 30, 2023, due to $70.2 million in net proceeds from the issuance of common stock in a public offering[150] Mergers and Acquisitions - The company entered into a merger agreement with Kalaris Therapeutics on November 7, 2024, with Kalaris continuing as a wholly-owned subsidiary[100] Revenue and Product Development - The company has no approved product candidates and has not generated any revenue from product sales[102] Capital Raising Activities - The company raised $292.0 million in net proceeds from its IPO in August 2020[103] - The company raised $126.4 million in net proceeds from a securities purchase agreement in July 2022[104] - The company raised $70.2 million in net proceeds from a public offering in June 2023[105] Contingent Payments and Royalties - The company may incur potential contingent payments upon achievement of clinical, regulatory, and commercial milestones, or be required to make royalty payments under license agreements[151] Regulatory and Reporting Considerations - The company is an emerging growth company and may rely on exemptions and reduced reporting requirements provided by the JOBS Act[154]

Group 1 - Monteverde & Associates PC is investigating AlloVir, Inc. regarding its proposed merger with Kalaris Therapeutics [1] - Under the merger agreement, AlloVir will acquire 100% of Kalaris' outstanding equity interest [1] - Post-merger, AlloVir stockholders are expected to own approximately 25.05% of the combined company, while Kalaris stockholders are expected to own approximately 74.95% [1]

Merger and Transaction Details - AlloVir and Kalaris Therapeutics have entered into a definitive merger agreement in an all-stock transaction, with AlloVir acquiring 100% of Kalaris' equity [1] - Post-merger, AlloVir stockholders are expected to own approximately 25.05% of the combined company, while Kalaris stockholders will own approximately 74.95% [1] - The combined company is expected to have a cash balance of approximately $100 million at closing, anticipated in Q1 2025, providing a cash runway into Q4 2026 [1] - The transaction has been approved by the Boards of Directors of both companies and is subject to customary closing conditions, including stockholder approvals and regulatory clearances [7] TH103 and Clinical Development - TH103, a novel anti-VEGF therapy developed by Dr Napoleone Ferrara, has demonstrated longer-acting and increased anti-VEGF activity in preclinical studies compared to aflibercept [1] - TH103 is currently in a Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD), with initial data expected in Q3 2025 [1][5] - The therapy is designed as a fully humanized, recombinant fusion protein acting as a decoy receptor against VEGF, with improved VEGF inhibition and longer retention in the retina [1][4] - The global branded anti-VEGF retinal market is valued at approximately $14 billion, with TH103 potentially offering a meaningful advance in treatment [1][2] Management and Governance Post-Merger - The combined company will be led by Kalaris' current CEO Andrew Oxtoby, COO Jeffrey Nau, and Medical Lead Matthew Feinsod [6] - The board of directors will be chaired by AlloVir's current Chairman David Hallal, with key members including Kalaris co-founders and industry veterans such as Dr Napoleone Ferrara and Dr Srini Akkaraju [6] - The combined company will operate under the name Kalaris Therapeutics, Inc and trade on Nasdaq under the ticker symbol "KLRS" [1] Market and Therapeutic Potential - TH103 has the potential to disrupt the large anti-VEGF market, with near-term value-inflecting milestones and a well-credentialed management team [2] - The therapy could address unmet medical needs in retinal diseases such as nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [11] - Current anti-VEGF treatments face challenges with real-world patient outcomes due to suboptimal compliance, highlighting the need for longer-acting therapies like TH103 [3] Strategic and Financial Advisors - Leerink Partners is serving as exclusive financial advisor to AlloVir, with Goodwin Procter LLP as legal counsel [8] - Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Kalaris [8]