IPO and Fundraising - On February 2, 2026, the company completed its IPO, selling 5,000,000 units at $10.00 per unit, generating gross proceeds of $50,000,000[23] - The underwriters exercised the Over-Allotment Option in full, resulting in additional proceeds of $7,500,000[23] - A private placement of 186,250 units was completed simultaneously with the IPO, generating total proceeds of $1,862,500[24] - A total of $57,500,000 from the IPO and private placement proceeds was deposited in a trust account for public shareholders[25] - The trust account has an initial amount of $57,500,000, assuming no redemptions, providing flexibility for business combinations and future expansions[97] - The company intends to use cash from the IPO proceeds and private placements for the initial business combination, which may include shares or debt securities[98] - The Initial Public Offering generated gross proceeds of $57,500,000 from the sale of 5,750,000 units at $10.00 per unit[181] Regulatory Risks and Challenges - The company will not conduct an initial business combination with any target company that operates through variable interest entities (VIEs), limiting potential acquisition candidates in China[29] - The company is subject to significant regulatory risks from the PRC government, which may impact its ability to search for and complete a business combination[33] - The PRC government has recently implemented new regulations affecting overseas listings, which could complicate future business combinations[38] - The company believes it is not required to obtain approvals from PRC authorities for its IPO or to search for a target company, but future regulatory changes could impose new requirements[39] - The combined company may face restrictions on paying dividends due to PRC laws, which require at least 10% of after-tax profits to be set aside for statutory reserves[41] - The PRC government has significant authority to influence business operations, which may affect the ability to conduct foreign investments or list on U.S. exchanges[56] - Recent regulatory actions in China could materially impact the operations of any post-business combination company, leading to potential declines in share value[54] - The PCAOB has determined it cannot fully inspect firms in mainland China and Hong Kong, which may affect trading of securities if compliance is not met[44] - The company does not currently have operations in China and believes it is not subject to CSRC regulations for its IPO, as it is incorporated in the British Virgin Islands[59] - The company may face regulatory challenges if the CSRC or other authorities later determine that approval is needed for the IPO or business combination[95] Business Strategy and Target Acquisition - The company aims to target small-cap companies valued between $650 million and $2 billion, focusing on sectors like green business, new energy, and advanced technologies[62][75] - The company plans to leverage its management team's expertise to identify and evaluate potential acquisition targets in emerging markets[70][71] - The company is focused on companies with strong competitive advantages and the capacity to meet high demand in fast-growing markets[72] - The company aims to prioritize acquisitions in high-growth geographic markets and industries, focusing on sectors like green businesses and artificial intelligence[76] - Target businesses will be those exhibiting recent revenue growth and strong expansion prospects, driven by new products and technological advancements[77] - The company seeks to acquire businesses with robust market positions, innovative technologies, and strong brands, emphasizing competitive advantages[79] - Management will focus on creating shareholder value by guiding high-growth companies toward commercialization, with no specific target businesses currently under consideration[83] - The company believes there are numerous potential target businesses at attractive valuations that can benefit from public listing and access to new capital[84] Financial Performance and Projections - As of December 31, 2025, the company had cash of $1,824,242 and a working capital deficit of $3,590,521[158] - The company reported net losses of $140,962 and $221,014 for the years ended December 31, 2024 and 2025, respectively, due to formation and operating expenses[180] - The company expects to incur significant costs related to being a public company and pursuing business combinations[178] - There is substantial doubt about the company's ability to continue as a going concern if it cannot complete a business combination within the specified period[186] - The company has no long-term debt or off-balance sheet arrangements as of December 31, 2025[187] Management and Governance - The management team has extensive experience in public companies and SPACs, which may aid in identifying suitable acquisition targets[47] - Zhen Li appointed as Chief Financial Officer since October 2024, bringing over 10 years of experience in SPACs and financial services[206] - Angela Lee joined as Independent Director in October 2024, with over 20 years in investment banking and M&A, previously leading Macquarie's semiconductor business in Asia[210] - The audit committee consists of independent directors Russelle Kinpui Choi, Angela Lee, and Laurent Patrick André Michelon, ensuring compliance with NASDAQ standards[221] - Russelle Kinpui Choi is recognized as an "audit committee financial expert" under SEC rules, enhancing the board's financial oversight capabilities[222] - The company has established four standing committees: executive, audit, compensation, and nominating and corporate governance, all governed by written charters[220] - The board of directors includes members with extensive experience in corporate strategy, acquisitions, and private equity investment management[216] Shareholder Rights and Redemption - Public shareholders will have the opportunity to redeem their shares at a per-share price initially anticipated to be $10.00 upon consummation of the initial business combination[120] - Redemption rights will be available regardless of whether shareholders vote for or against the proposed business combination[121] - A public shareholder is restricted from seeking redemption rights for 20% or more of the shares sold in the IPO, preventing manipulation of the stock[122] - Initial shareholders and officers have agreed not to redeem any ordinary shares in connection with a shareholder vote for the proposed business combination[118] - The company has set a net tangible asset threshold of $5,000,001 to avoid being subject to Rule 419, which may limit its ability to consummate the initial business combination[117] - The actual per-share redemption amount may be less than $10.00 due to potential claims from creditors against the trust account[144] - The redemption rights for public shares will not apply to rights, which will expire worthless if the business combination is not consummated[143] Timeframe and Extensions for Business Combination - The company has 15 months from the IPO closing to complete an initial business combination, with the possibility of extending this period by up to 6 months for a total of 21 months[139] - To extend the time for consummating a business combination, the sponsor must deposit $500,000 or up to $575,000 if the underwriters' over-allotment option is exercised in full, for each three-month extension[139] - If the initial business combination is not completed, the company will distribute the amount in the trust account, approximately $10.00 per share, to public shareholders[144] - Initial shareholders have agreed to waive their redemption rights for founder shares if the business combination is not completed within the specified period[143] Competitive Landscape - The company may face intense competition from other entities with similar business objectives, which could limit its ability to acquire larger target businesses[151] - The company may face challenges in maintaining or obtaining the quotation or listing of its securities on a national exchange if the number of beneficial holders is reduced[137] - Historical performance of the management team does not guarantee future success in identifying suitable candidates for business combinations[218]

Financial Performance - Net sales decreased from $454.6 million in 2024 to $316.6 million in 2025, a decline of 30.4%[269] - Direct-to-consumer net sales fell by 37.0%, from $319.1 million in 2024 to $200.9 million in 2025[292] - Retail net sales decreased by 14.6%, from $135.5 million in 2024 to $115.6 million in 2025[292] - Gross profit for the year ended December 31, 2025 was $188,080, a decrease of $72,184 or 27.7% compared to 2024[294] - Income (loss) from operations improved to $(113,483) in 2025, a reduction in loss of $61,135 or 35.0% compared to $(174,618) in 2024[301] - Solo Stove net sales fell to $167,220 in 2025, a decrease of $130,159 or 43.8% from $297,379 in 2024[308] - Chubbies net sales increased to $122,943 in 2025, up $10,230 or 9.1% compared to $112,713 in 2024[312] Operational Changes - The company engaged strategic consulting firms in 2025, incurring cash outlays of $7.5 million for operational improvements[285] - The company closed and relocated a distribution center in Mexico to the U.S. in response to tariff changes, impacting inventory and costs of goods sold[273] - The company shifted sourcing from China to Vietnam and Cambodia to mitigate tariff impacts, reducing reliance on Chinese suppliers[273] - The company anticipates additional restructuring activity in 2026 to optimize its operating platform[284] - The company noted a shift in seasonal demand, with retail channel net sales highest in the first and fourth quarters in 2025, indicating a potential long-term change in seasonality[280] Cost Management - Loss from operations decreased from $174.6 million in 2024 to $113.5 million in 2025, primarily due to reduced restructuring and effective management of operating expenses[269] - Operating expenses decreased to $301,563 in 2025, down $133,319 or 30.7% from $434,882 in 2024[297] - Cost of goods sold for Solo Stove decreased to $63,524 in 2025, down $50,453 or 44.3% from $113,977 in 2024[309] - Chubbies cost of goods sold rose to $51,749 in 2025, an increase of $6,042 or 13.2% from $45,707 in 2024[313] - Operating expenses for Chubbies decreased to $48,783 in 2025, down $2,410 or 4.7% from $51,193 in 2024[314] Cash Flow and Financing - The company expects future cash needs to continue for working capital and debt obligations, primarily funded through operating cash flows and borrowings[315] - As of December 31, 2025, the company had cash and cash equivalents of $20,034,000 and a revolving credit facility availability of $54,865,000[319] - The company experienced a significant increase in cash used in operating activities, totaling $46,602,000, which represents a 543.1% increase compared to the previous year[333][334] - Cash provided by financing activities increased by $66,545,000, primarily due to net debt activity related to the 2025 Refinancing Amendment[333][336] - The company refinanced $136.5 million of loans under the 2021 Revolving Credit Facility and $32.5 million of the 2021 Term Loan during the year ended December 31, 2025[328] Debt and Financial Obligations - The company is required to maintain a minimum Consolidated EBITDA of $25 million for the four fiscal quarters ended December 31, 2025, and a maximum Total Leverage Ratio starting from the fiscal quarter ending September 30, 2026[332] - The 2025 Refinancing Amendment resulted in a total principal amount of $240 million for refinancing term loans and $90 million for the revolving credit facility[327] - The company must comply with financial covenants including a minimum liquidity amount of $10 million for the first three months and $20 million for the last nine months of each fiscal year, starting July 31, 2026[332] - The maturity date for the 2025 Revolving Credit Facility and the 2025 Term Loan is set for June 30, 2028[329] - The company had total indebtedness of $253.1 million as of December 31, 2025, with an annualized interest rate of 9.17% under its 2025 Term Loan[363] Tax and Valuation - As of December 31, 2025, the company recorded a valuation allowance of $40.6 million against deferred tax assets due to current losses[346] - The Chubbies reporting unit's fair value exceeded its book value by more than 10% as of December 31, 2025, but a 100 basis point increase in the discount rate could indicate potential impairment[352] - Future changes in judgments and assumptions used in impairment testing could result in significantly different estimates of fair value[350] - The company evaluates the carrying value of definite-lived intangible assets whenever circumstances indicate that the net carrying value may not be recoverable[353] Currency and International Sales - International sales accounted for 7.0% of consolidated revenues for the year ended December 31, 2025[367] - A 100 basis point unfavorable change in foreign currency exchange rates would increase operating expenses by approximately $0.1 million and decrease net sales by approximately $0.2 million for the year ended December 31, 2025[367] Amortization and Interest Rates - The company expects amortization expense to decrease by approximately $8 million annually due to impairment charges related to intangible assets[358] - A 100 basis point increase in SOFR would increase the company's interest expense by approximately $2.5 million annually[363] - The company has not entered into any interest rate swap contracts as of December 31, 2025[363]

Pipeline Development - The company is advancing multiple programs in preclinical and clinical development, including masked multi-specifics, with strategic partnerships established with AbbVie and Gilead[27]. - XTX501, a bispecific PD-1/masked IL-2, is expected to submit an IND application in mid-2026 and initiate a Phase 1 trial in the second half of 2026, targeting metastatic non-small cell lung cancer (NSCLC) initially[38][41]. - The anticipated milestones for the pipeline include initial Phase 1 data for XTX501 in the second half of 2027 and IND submissions for other programs in 2027[36]. - The company plans to advance a multi-specific masked T cell engager targeting PSMA and STEAP1 with co-stimulation, nominating a development candidate by Q2 2026[50]. - Efarindodekin alfa, a masked IL-12, is currently in a Phase 2 clinical trial for advanced solid tumors, with an option data package expected to be delivered to Gilead in the first half of 2027[48][51]. Technology and Innovation - The masking technology allows for localized activity within the tumor microenvironment, minimizing systemic toxicity and enhancing the therapeutic window[32][45]. - The company aims to leverage its clinically-validated masking technology to discover and commercialize masked I-O therapies that overcome limitations of existing agents[34]. - The modular architecture of the masked T cell engagers enables flexibility in design, including the incorporation of co-stimulatory domains to enhance potency[43][49]. - The proprietary engineering platform technology enables the development of masked I-O molecules designed to selectively activate within the tumor microenvironment, reducing severe side effects[70]. Clinical Trial Results - As of September 2, 2025, 62 patients with advanced solid tumors were treated with efarindodekin alfa, with a median age of 66 years and 89% having received two or more prior lines of anti-cancer therapy[54]. - Efarindodekin alfa demonstrated anti-tumor activity with two partial responses, including a 33% decrease in target lesions for a patient with HPV-negative head and neck squamous cell carcinoma and a 55% decrease for a patient with uveal melanoma[54]. - The treatment was generally well-tolerated, with treatment-related adverse events primarily classified as Grade 1 or 2[54]. - In 2023, a co-funded clinical trial collaboration with Roche was initiated to evaluate vilastobart in combination with atezolizumab, showing promising clinical efficacy in heavily pre-treated patients[57]. Partnerships and Collaborations - The collaboration with AbbVie includes a licensed masked antibody program and options for masked T cell engager programs, enhancing the company's development capabilities[37][47]. - The company has received a total of $52.0 million in upfront payments from AbbVie, including a cash payment of $42.0 million and an equity investment of $10.0 million at $32.20 per share[91]. - The company is eligible to receive up to approximately $2.1 billion in additional contingent payments from AbbVie, which includes up to $305.0 million in program nomination fees and up to $1.8 billion in development, regulatory, and sales-based milestones[92]. - The collaboration agreement with AbbVie includes an exclusive option for up to four programs leveraging the company's proprietary masking technology[88]. - The company entered into an exclusive license agreement with Gilead in March 2024 for the development and commercialization of efarindodekin alfa, a masked IL-12 product candidate[96]. Intellectual Property - The company owns 18 patent application families related to its business, including 11 issued U.S. patents and 164 pending foreign applications as of February 28, 2026[69]. - Efarindodekin alfa is part of a patent family that includes two issued U.S. patents and 46 foreign applications, with a statutory expiration date ranging from 2039 to 2047[76]. - As of February 28, 2026, the company owns, co-owns, or exclusively in-licenses three patent families related to masked anti-CTLA-4 antibody constructs, including vilastobart, with expiration dates ranging from 2037 to 2039[77]. - The company has a total of 27 foreign patent applications issued across various countries, including China, Japan, and South Korea[77]. Regulatory Environment - The FDA's regulations ensure the protection of human subjects in non-IND foreign clinical studies and the integrity of resulting data[119]. - Clinical trials must be approved by an IRB, which conducts annual reviews and can suspend trials if safety requirements are not met[120]. - A data monitoring committee (DMC) oversees trials and can halt development if participants face unacceptable health risks[121]. - The FDA requires sponsors to submit a diversity action plan for Phase 3 clinical trials to encourage diverse patient enrollment[124]. - The FDA aims to review 90% of applications for New Molecular Entities (NMEs) within ten months and 90% of priority review applications within six months[147]. Market and Competition - The company faces competition from major pharmaceutical and biotechnology companies, which may have greater financial and technical resources[59]. - The key competitive factors affecting the success of the company's products include efficacy, safety, convenience, price, and availability of reimbursement[63]. - The company is actively seeking a partner to maximize the value of vilastobart, which is believed to have best-in-class potential for use in combination therapies[57]. Financial Obligations and Payments - Xilio Development has received a total of $72.5 million in payments under agreements with Gilead, including a $30.0 million upfront cash payment, $25.0 million from private placements, and a $17.5 million development milestone payment[99]. - The company is eligible for up to $575.0 million in additional contingent payments under the license agreement, which includes a $75.0 million transition fee and up to $500.0 million in development, regulatory, and sales-based milestones[99]. - Xilio Development has made $0.8 million in milestone payments to City of Hope related to its anti-CTLA-4 monoclonal antibody program, with a potential obligation of up to $10.3 million per licensed product[104]. - The company has paid $5.8 million in milestone payments to WuXi Biologics related to its anti-CTLA-4 monoclonal antibody program, with a total obligation of approximately $25.8 million for specified development and regulatory milestones[107]. Employee and Organizational Structure - As of February 28, 2026, the company employed 76 full-time employees, including 30 with advanced degrees, with 54 engaged in research and development[223]. - The company conducts annual performance reviews and employee surveys to assess engagement and satisfaction, aiming to retain and develop talent[224]. - The equity incentive plans are designed to attract and motivate employees through stock-based compensation awards, ensuring competitive total rewards[225]. Compliance and Data Protection - The company is subject to various foreign regulations for clinical trials and product sales, which may differ significantly from U.S. requirements[221]. - The GDPR imposes strict requirements on companies processing personal data, including potential fines of up to €20 million or 4% of annual global revenues for violations[217]. - The rise in privacy-related lawsuits poses potential risks for the company, particularly regarding data practices and compliance with state and federal laws[216].

Product Development and Clinical Trials - The company is focused on developing engineered T cell therapies for autoimmune diseases, utilizing the CABA® platform which aims to reset the immune system[15]. - Rese-cel, the lead product candidate, is designed for deep depletion of B cells with a single infusion, showing potential for durable responses without chronic therapy[16]. - A registrational trial for rese-cel in dermatomyositis and anti-synthetase syndrome was initiated in December 2025, with ongoing trials for systemic lupus erythematosus and other conditions[17]. - The FDA granted Fast Track Designation and Orphan Drug Designation for rese-cel in myositis, with a registrational cohort planned for 17 patients[21][22]. - The RESET-Myositis® trial targets approximately 80,000 patients in the U.S., with an estimated 20% to 25% potentially eligible for treatment[20]. - The RESET-SLE™ trial is designed to treat 12 patients with active lupus nephritis and systemic lupus erythematosus, with complete data expected in the first half of 2026[27]. - Rese-cel has shown significant clinical responses in myositis patients, with major TIS responses observed in the Phase 1/2 cohort[25]. - The company anticipates a Biologics License Application submission for myositis in 2027, based on pooled safety data from the RESET™ clinical trial program[25]. - The RESET-PV® trial is evaluating rese-cel in pemphigus vulgaris patients, with initial results indicating substantial B cell depletion and improvements in disease activity scores[37][40]. - Cabaletta has developed rese-cel, a 4-1BB-containing CD19-CAR T investigational therapy, showing deep and durable clinical responses in all five SLE patients treated, with responses lasting up to 4 years[45]. - In October 2025, all 4 DM/ASyS patients in the myositis registrational cohort achieved immunomodulatory-free TIS responses of moderate or major improvement at week 16[52]. - The company has cleared five IND applications for RESET TM Phase 1/2 clinical trials in SLE, myositis, SSc, gMG, and MS within the routine 30-day period[49]. - 95% of patients in the first 40 dosed with rese-cel experienced either no CRS or Grade 1 CRS, and 95% experienced no ICANS[52]. - Initial clinical data from the RESET-PV® trial indicated substantial B cell depletion in all three patients within the first month post-infusion, with meaningful early clinical responses observed[52]. - The company aims to optimize patient experience by minimizing inpatient stays and innovating manufacturing processes to address scale in autoimmune diseases[52]. - Rese-cel is designed to achieve transient but deep depletion of all B cells following a single infusion, potentially resetting the immune system[62]. - Cabaletta is advancing RESET™ Phase 1/2 clinical trials in systemic lupus erythematosus (SLE), myositis, systemic sclerosis (SSc), generalized myasthenia gravis (gMG), and pemphigus vulgaris (PV), with each cohort expected to comprise 6 patients[74]. Market and Patient Demographics - Approximately 320,000 patients in the U.S. are affected by SLE, with lupus nephritis impacting 30-40% of these patients, leading to a 17% risk of end-stage renal disease and a 12% risk of death within 10 years of diagnosis[68]. - Myositis affects approximately 80,000 patients in the U.S., with many remaining refractory to existing medications despite standard care[70]. - Systemic sclerosis affects around 90,000 patients in the U.S., with an average survival of approximately 12 years following initial diagnosis due to inadequate treatments[71]. - Generalized myasthenia gravis impacts about 100,000 patients in the U.S., with standard therapies requiring chronic administration, increasing the risk of serious long-term side effects[72]. - Pemphigus vulgaris affects approximately 15,000 patients in the U.S. and 20,000 in Europe, with a reported mortality risk 2-3 times higher than the general population[73]. Manufacturing and Scalability - The company announced INDa clearance for rese-cel to be manufactured using the Cell Shuttle™ platform, allowing scalability for thousands of patients annually[18]. - Cabaletta has partnered with Cellares Corporation to incorporate automated manufacturing for rese-cel, enabling scalability to produce for thousands of patients per year with minimal capital investment[52]. - The manufacturing strategy includes a transition to a partially automated and commercially scalable process (Process B) before the first pivotal study in 2026, with initial clinical manufacturing data using Process C expected in 2026[78]. - The company may experience delays in developing a sustainable and scalable manufacturing process, affecting clinical studies and commercialization timelines[213]. - Manufacturing processes for CAR T or CAAR T cells may require improvements, potentially delaying commercial launch and incurring additional expenses[212]. - The company may face challenges in transferring manufacturing processes to commercial partners, impacting timely and profitable commercialization[213]. Regulatory Compliance and Intellectual Property - The company is subject to extensive regulation as a biopharmaceutical entity, requiring compliance with cGMP for biologics and submission of a BLA for marketing authorization[106]. - Regulatory compliance is critical, as failure to meet requirements can lead to significant delays or sanctions, impacting product development and market entry[108]. - The company must submit a Biologics License Application (BLA) to the FDA, which includes results from clinical trials and detailed information on chemistry, manufacturing, and quality controls[113]. - The FDA's goal is to review BLAs within 10 months for standard review or 6 months for priority review, particularly for products intended for serious conditions[121]. - The FDA may impose clinical holds on drug candidates at any time due to safety concerns or non-compliance, which can delay clinical trials[119]. - The company has in-licensed a patent family related to a CD19-specific chimeric antigen receptor, with patents set to expire in 2040, and additional patents expected to expire in 2044 and 2045[93]. - The company has entered into multiple agreements with CDMOs, including Oxford Biomedica and Minaris, to support the clinical development and commercialization of rese-cel[79][80]. - The company relies on know-how and trade secret protection for proprietary information, alongside regulatory protections based on orphan drug exclusivities and data exclusivities[96]. Financial and Market Considerations - Sales of products depend on third-party payor coverage and reimbursement, which are increasingly being reduced[152]. - Conducting pharmacoeconomic studies may be necessary to demonstrate the cost-effectiveness of drug candidates for reimbursement[153]. - Coverage and reimbursement decisions are primarily made by CMS, with significant variability among different payors[154]. - The U.S. government and state legislatures are focusing on drug pricing and cost-containment measures, which could impact revenue[154]. - In the European Union, pricing and reimbursement schemes vary, often resulting in lower prices compared to the U.S.[155]. Employee and Organizational Structure - As of December 31, 2025, the company had 156 employees, with 139 engaged in research and development activities[195]. - The company aims to attract and retain key personnel through equity incentive plans, which are crucial for maintaining competitiveness and innovation[196]. - The company operates as a single reportable segment, with all tangible assets held in the United States[198]. - The company has two subsidiaries located in Switzerland and Germany, indicating a presence in Europe[197]. Challenges and Risks - The company has not yet completed any clinical trials, and its ability to generate product revenues is heavily dependent on successful development and commercialization of product candidates[205]. - The company is early in the clinical development process and cannot predict short-term or long-term effects from treatment with any product candidates[212]. - Adverse events in clinical trials could negatively impact the development of future product candidates based on the CABA® platform[214]. - Unexpected side effects from product candidates could significantly impact the company's business[214]. - The presence of strongly activating soluble antibodies in trial subjects could lead to adverse side effects, distinguishing the company's therapies from previously licensed CAR T therapies[214].

Financial Estimates - As of December 31, 2025, Xilio Therapeutics, Inc. estimates cash and cash equivalents of approximately $137.5 million[4] - The cash balance estimate is based on preliminary, unaudited information and management estimates for the fiscal year ended December 31, 2025[5] Leadership Changes - The company announced the appointment of Sara M. Bonstein as chair of the Board, succeeding Paul Clancy who retired on January 6, 2026[7]

Financial Performance - The net loss for Q4 2025 was $41.9 million, compared to a net loss of $32.6 million in Q4 2024, and the full-year net loss was $167.9 million versus $115.9 million in 2024[14]. - The company reported a revenue of $50 million for Q3 2023, representing a 25% increase year-over-year[17]. - The company provided guidance for Q4 2023, expecting revenue to be between $55 million and $60 million, indicating a potential growth of 10% to 20%[17]. - The company reported a net income of $5 million, a significant improvement from a net loss of $2 million in the same quarter last year[17]. Expenses - Research and development expenses for Q4 2025 were $36.2 million, up from $25.5 million in Q4 2024, and for the full year, they totaled $142.7 million compared to $97.2 million in 2024[9]. - General and administrative expenses for Q4 2025 were $6.4 million, down from $8.3 million in Q4 2024, while for the full year, they increased to $29.6 million from $27.9 million in 2024[9]. Cash Position - As of December 31, 2025, Cabaletta had cash, cash equivalents, and short-term investments of $133.6 million, a decrease from $164.0 million as of December 31, 2024[9]. - The company expects its cash position as of December 31, 2025, along with additional funds raised in Q1 2026, to support operations into Q4 2026[9]. Clinical Development - The registrational dermatomyositis and antisynthetase syndrome cohort is enrolling 17 patients, with a primary endpoint of moderate or major total improvement score response expected in 16 weeks[4]. - Initial clinical experience using the automated Cellares manufacturing platform is anticipated in 1H26, which could enable production for thousands of patients annually with minimal capital investment[4]. - Complete Phase 1/2 data from the RESET-SLE, RESET-SSc, and RESET-MG trials are expected to be presented in 1H26, supporting discussions with the FDA on potential registrational pathways[4]. - The company plans to submit a Biologics License Application (BLA) for rese-cel in myositis in 2027[10]. - Clinical data from the no-preconditioning program in RESET-SLE and RESET-PV are expected in 1H26 and throughout 2026, respectively[4]. Market Strategy - Investment in new product development increased by 15% compared to the previous quarter, focusing on innovative technologies[17]. - The company plans to expand its market presence in Europe, targeting a 20% increase in market share by the end of 2024[17]. - A strategic acquisition was announced, expected to enhance the company's product portfolio and drive future growth[17]. - The company is exploring partnerships with key industry players to accelerate growth and innovation[17]. Customer Metrics - User data showed a growth in active users to 1.2 million, up from 900,000 in the previous quarter, marking a 33% increase[17]. - Customer retention rate increased to 85%, up from 80% in the previous quarter, indicating stronger customer loyalty[17]. Operational Efficiency - The gross margin improved to 60%, up from 55% in the previous quarter, reflecting better cost management[17].

Financial Performance - As of December 31, 2025, Arbutus had cash, cash equivalents, and marketable securities totaling $91.5 million, down from $122.6 million in 2024[6]. - Total revenue for the year ended December 31, 2025, was $14.1 million, a significant increase from $6.2 million in 2024, primarily due to the recognition of previously deferred revenue[7]. - The net loss for the year ended December 31, 2025, was $33.5 million, or a loss of $0.17 per share, compared to a net loss of $69.9 million, or a loss of $0.38 per share, in 2024[10]. Expenses Management - Research and development expenses decreased to $25.2 million in 2025 from $54.0 million in 2024, reflecting cost-saving measures[8]. - General and administrative expenses were reduced to $15.9 million in 2025 from $22.1 million in 2024, driven by cost-cutting efforts[9]. Milestones and Payments - Arbutus received a milestone payment of $0.5 million in December 2025 related to Alnylam's use of its proprietary LNP technology[5]. - The settlement with Moderna includes a $950 million upfront payment and an additional $1.3 billion contingent payment, with Arbutus entitled to 20% of the upfront payment after litigation costs[4]. Clinical Trials and Development - A total of 10 patients have achieved functional cure in Phase 2a clinical trials of imdusiran, with two additional patients achieving this status recently[4]. - Arbutus continues to support Genevant in ongoing patent litigation against Pfizer/BioNTech regarding the use of its patented LNP technology[4]. - Arbutus has made numerous assumptions regarding the effectiveness and timeliness of clinical trials, which are subject to significant uncertainties[22]. - Ongoing and anticipated clinical trials may incur higher costs or take longer than expected, potentially affecting product development[22]. - Regulatory approvals for clinical development of product candidates are uncertain and may not be obtained[22]. Strategic Considerations - The company is evaluating a potential return of capital to shareholders in Q3 2026 following the receipt of the noncontingent payment from Moderna[5]. - Arbutus may change its strategy regarding product candidates and clinical development activities based on market conditions[22]. - Market shifts may necessitate a change in strategic focus for Arbutus[22]. - Workforce reduction plans aim to decrease net cash burn but may not significantly extend the cash runway[22]. Risk Factors - The company faces risks related to the sufficiency of cash resources for foreseeable and unforeseeable operating expenses[22]. - Known risk factors include potential litigation and patent litigation uncertainties[22]. - Economic and market conditions may worsen, impacting overall business performance[22]. - Arbutus disclaims any obligation to revise or update forward-looking statements unless required by law[23].

Drug Development and Clinical Trials - Arbutus Biopharma is developing imdusiran (AB-729) and AB-101 for chronic hepatitis B (cHBV) treatment[26]. - In Phase 2a trials, 47% (49/105) of patients achieved functional cure or remained off nucleos(t)ide analogue therapy after treatment with imdusiran[36]. - Imdusiran has shown meaningful reductions in HBsAg and other viral proteins, leading to functional cure in some patients[34]. - The IM-PROVE I trial showed a functional cure rate of 50% (3/6) in HBeAg negative patients with baseline HBsAg levels <1000 IU/mL[37]. - AB-101 is currently in a Phase 1a/1b clinical trial, showing it was generally well-tolerated with evidence of high receptor occupancy[35]. - In the IM-PROVE I Phase 2a trial, 37% (16/43) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[50]. - The IM-PROVE II trial showed that 25% (3/12) of patients achieved functional cure, with 50% (3/6) of patients having baseline HBsAg <1000 IU/mL achieving this outcome[53]. - The addition of low dose nivolumab in the IM-PROVE II trial increased HBsAg seroclearance rates to 23% (3/13) by week 48[54]. - In the Phase 1b trial for imdusiran, 71% (44/62) of patients achieved HBsAg levels below 100 IU/mL, with 5% (3/62) achieving HBsAg seroclearance[58]. - The treatment with AB-101 was well-tolerated, showing no serious adverse events or liver dysfunction in patients[63]. - The clinical trial process is expensive and time-consuming, with outcomes uncertain, and delays could harm the company's financial condition and prospects[205]. - Regulatory approval processes are time-consuming and unpredictable, and the company may fail to obtain necessary approvals for its product candidates[220]. - The company must demonstrate the safety and efficacy of its product candidates through extensive clinical testing, which requires significant investment and carries inherent risks[208]. - Compliance with GLP and GCP regulations is essential for controlled research and human clinical testing[223]. - Regulatory approval may be delayed or prevented due to clinical trial challenges, impacting financial position[224]. - Difficulties in patient enrollment for clinical trials could delay the testing of product candidates[225]. - Side effects may lead to stronger product warnings and costly post-marketing studies, affecting commercial viability[224]. - Failure to demonstrate safety and efficacy in clinical trials could result in denial of marketing approval[223]. - Inadequacies in third-party manufacturing processes may adversely affect product candidates[223]. - The need for Risk Evaluation and Mitigation Strategy (REMS) could arise from undesirable side effects[224]. - Disagreements with regulatory authorities regarding clinical data interpretation may hinder approval processes[223]. - The commercial viability of approved products may be limited by undesirable side effects[224]. - The timing of clinical trials is dependent on the speed of patient recruitment[225]. Financial and Strategic Partnerships - Moderna will make a $950 million noncontingent payment to Arbutus and Genevant by July 8, 2026, with an additional contingent payment of $1.3 billion possible[28]. - In 2025, Arbutus reduced its workforce by 40% and incurred one-time restructuring charges of $12.9 million[28]. - The company is exploring strategic alliances to accelerate the development of its pipeline programs[44]. - Qilu Pharmaceutical Co., Ltd. made a one-time upfront cash payment of $40 million and agreed to pay up to $245 million upon achieving certain milestones related to imdusiran[65]. - Qilu is responsible for all costs related to the development and commercialization of imdusiran in Greater China and Taiwan, with a joint development committee established to coordinate efforts[66]. - The company recognized all previously deferred revenue in Q2 2025 after mutually agreeing to terminate the Qilu License Agreement, regaining global rights for imdusiran[69]. - Alnylam's ONPATTRO generates tiered royalty payments for the company, ranging from 1.00% to 2.33% on global net sales, with the highest tier applicable to sales above $500 million[71]. - The company received $0.5 million in December 2025 for achieving a contractual milestone related to Alnylam's use of its LNP technology in a new product candidate[73]. - The company is involved in ongoing patent infringement lawsuits against Pfizer/BioNTech and potentially Moderna, requiring substantial resource investment[186]. - The potential additional payments related to the acquisition of Enantigen Therapeutics could reach up to $102.5 million in sales performance milestones, plus a low single-digit royalty on net sales of the first commercialized HBV product[94]. - The company has $91.5 million in cash, cash equivalents, and marketable securities as of December 31, 2025[192]. - The Moderna Settlement Agreement includes a Noncontingent Settlement Payment of $950 million and a Contingent Settlement Payment of up to $1.3 billion, dependent on specific legal outcomes[187]. Regulatory and Compliance Challenges - The company is committed to complying with all applicable laws and regulations, which is crucial for the successful development and commercialization of its products[114]. - The FDA generally provides for action on a New Drug Application (NDA) within 10 months of the 60-day filing date, or within 12 months of the NDA submission[129]. - For product candidates granted priority review designation, the targeted action date can be shortened to 6 months of the 60-day filing date, or 8 months after NDA submission[130]. - The FDA may require post-approval studies to be underway prior to Accelerated Approval or within a specified time from the date of approval[131]. - The maximum period of patent term restoration is five years, and the patent cannot be extended to more than 14 years from the date of FDA approval of the product[137]. - In the European Union, new medicinal products are granted a protection period of eight years of data exclusivity and an additional two years of market exclusivity[138]. - A proposal to reform the EU regulatory data protection system suggests a total of nine years of protection, with the possibility of obtaining up to 11 years under certain circumstances[139]. - Once approved, drug products are subject to ongoing monitoring for safety information and may face regulatory actions if safety problems occur post-market[140]. - The FDA may convene an advisory committee to seek insights and recommendations on issues relevant to the approval of an NDA[132]. - The FDA's interpretation of clinical trial data may differ from the sponsor's, which can affect the approval process[132]. - The FDA can conduct audits to determine if clinical trials were conducted in compliance with Good Clinical Practice (GCP) regulations[132]. - Companies must comply with Good Manufacturing Practices (GMP) to avoid enforcement actions from the FDA, which can include fines and withdrawal of approval[141]. - The European Union's pharmaceutical legislation revision is expected to start applying in mid-2028, impacting regulatory data exclusivity and environmental risk assessments[145]. - Companies must meet numerous regulatory requirements, including adverse event reporting and periodic report submissions, to maintain compliance with approved NDAs[146]. - Non-compliance with federal and state healthcare fraud and abuse laws can lead to significant civil and criminal penalties, including fines and exclusion from government healthcare programs[148]. - The company is subject to scrutiny under the federal Anti-Kickback Law, which prohibits certain financial arrangements that could influence healthcare purchasing decisions[147]. - The company must navigate complex privacy laws that vary by jurisdiction, complicating compliance efforts and increasing operational risks[149]. - The company may incur significant costs related to compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other privacy regulations[152]. - Compliance with GDPR could result in fines up to EUR 20,000,000 or 4% of total worldwide annual turnover for serious offenses[156]. - The EU-U.S. Data Privacy Framework adopted in July 2023 allows for lawful transfer of personal data from the EU to the U.S.[157]. - Compliance with new AI regulations is expected to incur substantial costs in the future[158]. Market and Competitive Landscape - The market opportunity for an HBV curative regimen is significant, with over 250 million people worldwide suffering from cHBV infection[39]. - Current treatment options for chronic HBV infection include IFN and NA therapies, with less than 10% of patients achieving functional cure after treatment[40]. - The company faces competition from established pharmaceutical companies and research-stage companies, which may have greater resources and experience[109]. - The company’s ability to compete depends on successfully completing clinical trials, obtaining regulatory approvals, and effectively marketing approved products[112]. - Coverage and reimbursement for new drug products are uncertain and can vary significantly by country, potentially delaying market launches[159]. - Adverse pricing limitations may hinder the ability to recoup investments in product candidates even after obtaining marketing approval[160]. - Third-party payors may limit coverage to specific products, impacting the demand and pricing of approved drugs[161]. - The Medicaid Drug Rebate Program requires manufacturers to pay rebates for covered outpatient drugs, affecting revenue[164]. - The Inflation Reduction Act of 2022 established a Medicare Part B inflation rebate scheme, imposing penalties for non-compliance[167]. - The drug price negotiation program starting in 2026 may cap prices for certain high-spend drugs, impacting market conditions[169]. - Legislative changes aimed at cost containment could prevent or delay marketing approvals and affect profitability[171]. - Future revenues may be adversely affected by more rigorous coverage criteria and new payment methodologies resulting from healthcare reforms[179]. Financial Health and Future Outlook - The company has incurred an accumulated net deficit of approximately $1.4 billion from inception to December 31, 2025, and anticipates continued operating losses for the foreseeable future[198]. - The company does not expect to achieve operating profits until product sales, milestone payments, and royalty payments generate sufficient revenues to fund ongoing operations[198]. - Significant expenses related to ongoing operations and product candidate development are expected to continue, with potential delays and additional costs due to regulatory decisions and clinical trial challenges[199]. - The company may need to seek collaborators for product candidates at earlier stages or on less favorable terms due to financial constraints[200]. - The company does not anticipate generating significant revenues from product sales for the foreseeable future, if ever, and its ability to generate future revenues depends heavily on successful regulatory approvals[203]. - The company may require substantial additional capital to fund operations and development, with potential dilution to shareholders[192]. - The company faces risks related to compliance with foreign regulations, which could negatively impact operations and market access[180]. - The company may face substantial costs to ensure compliance with evolving privacy and data protection laws, including the GDPR and state-specific regulations[155].

Product Development and Clinical Trials - MICVO, the lead product candidate, is an investigational ADC targeting EDB+FN, which is highly expressed in tumors but minimally in normal tissues[18]. - In the Phase 1 monotherapy study, MICVO showed a 50% confirmed objective response rate (ORR) in heavily pre-treated patients with R/M HNSCC at a dose of 3.6 mg/kg to 5.4 mg/kg[21]. - The ongoing dose expansion phase of the monotherapy study aims to evaluate MICVO at 5.4 mg/kg IV Q3W, with a target enrollment of approximately 40 patients[29]. - Preliminary data from the combination study with KEYTRUDA® indicated a 71% confirmed ORR among seven efficacy-evaluable patients with 1L/2L+ R/M HNSCC[26]. - The disease control rate (DCR) for MICVO monotherapy in R/M HNSCC was reported at 92% among 13 efficacy evaluable patients[23]. - The company plans to report updated clinical data from the monotherapy and combination studies in mid-2026 and the second half of 2026, respectively[28][32]. - The Phase 1/2 combination study with KEYTRUDA® is designed to evaluate safety, tolerability, and preliminary efficacy across multiple tumor types[25]. - MICVO was generally well tolerated, with no Grade 4 or Grade 5 treatment-related adverse events reported, and 89% of patients experienced treatment-related adverse events[24]. - The company is actively exploring dosing modifications to optimize MICVO's benefit-risk profile, particularly for patients with higher body weight[24]. - The confirmed overall response rate (ORR) for MICVO monotherapy in patients with R/M HNSCC was 46% (6/13), with a disease control rate (DCR) of 92% (12/13) as of the November 3, 2025 data cut-off[97]. - Among the seven response-evaluable patients in the combination study with pembrolizumab, the confirmed ORR was 71% (5/7) per RECIST v1.1[128]. - Treatment-related adverse events (TRAEs) were reported in 89% (16/18) of patients treated with MICVO, with 56% (10/18) experiencing Grade 3 or higher TRAEs[102]. - The ongoing study has implemented modified dosing strategies for MICVO, including dose capping and AIBW-based dosing, to improve tolerability in higher body weight patients[106]. - The Phase 1 study of PYX-106 enrolled 45 patients, with 41 evaluable, and was observed to be generally safe and well-tolerated across doses from 0.5 mg/kg to 22.5 mg/kg[138]. - PYX-107 demonstrated a 15.2% partial response rate and a 30.3% stable disease rate in melanoma patients refractory to anti-PD-(L)1 in a Phase II trial[139]. Market Need and Competitive Landscape - Head and neck cancer is projected to reach approximately one million new cases annually by 2030, highlighting the unmet medical need in this area[35]. - The company is prioritizing the development of its lead product candidate, MICVO, for R/M HNSCC, addressing a significant unmet need with an estimated one million new cases globally by 2030[37]. - Approximately 60,000 cases of HNSCC are diagnosed annually in the U.S., with a 13% 5-year survival rate in the R/M setting, highlighting the urgent need for effective therapies[36]. - The median overall survival for patients with 1L R/M HNSCC ranges from 9 months (HPV unrelated) to about 14 months (HPV+)[36]. - The overall incidence of HNSCC is expected to rise by 30% annually by 2030, driven by factors such as tobacco use and HPV infections[36]. - Emerging therapies targeting EDB+FN, such as MICVO, are designed to improve anti-tumor activity and stability compared to conventional ADCs[47]. - Competition includes various companies developing cancer immunotherapies and ADCs, which may impact the company's ability to execute its business plan[150]. - Emerging agents targeting R/M HNSCC, such as Genmab's and Johnson & Johnson's products, pose significant threats to the company's clinical development strategy[154]. Intellectual Property and Licensing - The company aims to maximize value from its intellectual property and technology platforms, including the Flexible Antibody Conjugation Technology (FACT) platform for ADC development[37]. - The company has a patent portfolio comprising 29 different patent families, including patents licensed from the University of Chicago, Pfizer, and Biosion[200]. - The patent family for MICVO includes granted patents and pending applications with expiration dates ranging from 2032 to 2046[202]. - The company has sole ownership of a patent family for dosage and treatment regimens of MICVO, with a pending PCT application expiring in 2045[208]. - The company has joint ownership of a patent family for the combination of MICVO and pembrolizumab, with a term running through 2046[210]. - The company is focused on protecting its intellectual property through patent protection and trade secrets, which are critical to its business[194]. - The company has exclusively licensed a patent family from Pfizer related to cytotoxic pentapeptides and antibody-drug conjugates, with patents granted in multiple countries including the United States, and a 20-year term running through 2032[211]. - A patent family for antibodies and antibody fragments for site-specific conjugation has been exclusively licensed from Pfizer, with a 20-year term running through 2036 and patents granted in several countries including Canada and Australia[212]. - The company has licensed a patent family for engineered antibody constant regions for site-specific conjugation from Pfizer, with patents granted in the United States and a 20-year term running through 2032[213]. - A patent family for PYX-203, an anti-CD123 antibody-drug conjugate, has been exclusively licensed from Pfizer, with patents granted in the United States and a 20-year term running through 2038[214]. - The company has licensed a patent family for PYX-106, an anti-Siglec-15 antibody, from Biosion USA, Inc., with patents granted in the United States and a 20-year term running through 2041[215]. - Through the acquisition of Apexigen, Inc., the company has acquired two patent families for high affinity CD40 agonist monoclonal antibodies, with the first family having a 20-year term running through 2032 and patents granted in the United States[216]. - The second patent family for CD40 agonist antibodies includes patents granted in the United States and a 20-year term running through 2033[216]. Financial and Operational Considerations - The company has entered into multiple licensing agreements, including a $25 million agreement with Pfizer for ADC product candidates, which includes an upfront cash payment of $5 million and shares valued at $20 million[171]. - The company is obligated to pay Pfizer up to $665 million in future contingent payments for the first four licensed ADCs, along with tiered royalties on net sales ranging from low single digits to mid-teens[174]. - Under the Biosion License Agreement, the company paid an upfront fee of $10 million and is obligated to pay up to $217.5 million in future contingent payments for normal approval, with royalties on net sales ranging from low single digits to low teens[178]. - The company currently has no sales, marketing, or commercial product distribution capabilities but plans to build a specialized sales and marketing organization over time[165]. - The company relies on third-party contract development and manufacturing organizations (CDMOs) for the manufacture of its product candidates, limiting direct control over manufacturing capacity and compliance[159]. - The company has established internal personnel and governance processes to oversee CDMOs and manage manufacturing data and regulatory documentation[164]. - The company is obligated to use commercially reasonable efforts to develop and bring licensed products to market, including meeting specific preclinical and clinical development milestones[169]. - The company has no plans to establish its own cGMP-compliant manufacturing facilities and will continue to rely on third-party manufacturers[159]. - The company assessed milestone and royalty events under the University License Agreement and determined that no amounts were required as of December 31, 2025 and 2024[168]. - The company is dependent on the performance and compliance of its CDMOs, and any failure could materially affect development timelines and commercialization efforts[160]. - In August 2023, the company completed the acquisition of Apexigen, which is now a wholly owned subsidiary, and assumed all out-licensing agreements of Apexigen[181]. - The company received a $3 million regulatory approval milestone under the Simcere Agreement upon the approval of suvemcitug by the NMPA in June 2025[186]. - In December 2025, the company relinquished future royalties on net sales of Enzeshu® to Simcere for a one-time payment of $11 million and four semi-annual installments of $175,000 each[187].

Financial Performance - The company recorded net losses of $60.6 million in 2023, $9.2 million in 2024, and $2.0 million in 2025, with an accumulated deficit of $401 million as of December 31, 2025[51]. - As of December 31, 2025, the company held $20.9 million in cash, cash equivalents, and short-term bank deposits, which is projected to meet capital requirements into the first half of 2027[52]. - The company expects to continue incurring significant expenses and net losses for the foreseeable future as it develops GLIX1 and motixafortide in other indications[51]. - The company has generated limited revenues from sales of APHEXDA, and profitability remains uncertain due to reliance on licensees for commercialization[61]. - The company has entered into a secured loan agreement with BlackRock for up to $40 million, with $30 million drawn down as of now, and a repayment plan established[55][56]. Regulatory and Compliance Risks - Management has expressed substantial doubt about the company's ability to continue as a going concern, which could hinder future financing efforts[58]. - Regulatory approval processes for therapeutic candidates are lengthy, expensive, and uncertain, with potential delays impacting commercialization[73]. - Any failure to obtain or maintain regulatory approvals could significantly harm the company's business and revenue generation[78]. - The ongoing regulatory review of approved products may lead to withdrawal from the market if compliance is not maintained[81]. - Regulatory authorities may impose additional restrictions or require further studies, impacting the ability to market products[75]. Market and Competitive Landscape - The life sciences industry is highly competitive, with significant competition from other companies developing products for similar indications, particularly in stem cell mobilization[100]. - The commercial success of therapeutic candidates like GLIX1 and motixafortide is uncertain and may depend on market acceptance, which could be smaller than estimates[64]. - Future revenues from motixafortide will depend on market size, pricing, reimbursement, and commercialization agreements[62]. - The commercial success of therapeutic candidates like GLIX1 and motixafortide will depend on third-party payor coverage and reimbursement practices, which are uncertain[104]. Clinical Development and Trials - Clinical trials are complex and costly, with uncertain outcomes that may not predict future results[79]. - The company relies on third parties for preclinical studies and clinical trials, which may affect control and timelines[85]. - The Phase 1 part of the GLIX1 trial is expected to recruit up to 30 patients, with preliminary efficacy data anticipated in H1 2027[218]. - The ongoing multi-center Phase 1 trial for motixafortide at St. Jude Children's Research Hospital began dosing patients in February 2025, with data expected in 2026[230]. - The pivotal bridging study for motixafortide in China was initiated in November 2025, with data expected approximately 18 months later[225]. Intellectual Property and Licensing - The company has in-licensed rights to therapeutic candidates, including motixafortide and BL-5010, and is obligated to make commercially reasonable efforts to sublicense or commercialize these products[134]. - As of March 8, 2026, the company owns or exclusively licenses 20 patent families, which include 141 granted patents, 3 allowed patent applications, and 97 pending patent applications related to its therapeutic candidates[137]. - Patent protection is uncertain, and the company cannot guarantee that its patents will provide competitive advantages or withstand legal challenges[138]. - The company relies on a combination of patents, trade secrets, and confidentiality agreements to protect its proprietary information, but enforcement can be challenging[142]. Operational and Environmental Risks - The company must comply with environmental, health, and safety laws regarding hazardous materials, which can be costly and may restrict business operations[129]. - The company is subject to scrutiny regarding ESG initiatives, which could increase costs and impact business operations if expectations are not met[115]. - Political and military instability in Israel may adversely affect the company's operations and ability to raise capital[173]. - The company is exposed to currency fluctuation risks, particularly as a significant portion of expenses is in NIS while revenues are primarily in USD[186]. Future Outlook and Strategic Focus - The company aims to in-license additional assets in oncology and rare diseases, focusing on candidates with high therapeutic and commercial success potential[207]. - BioLineRx has refocused its operations on development activities in Israel, significantly reducing its annual cash burn rate following the out-licensing of motixafortide[204]. - The company may need to seek alternative licensees or develop internal sales and marketing capabilities if existing agreements are breached or terminated[90]. - The company has shifted focus from independent commercialization in the U.S. to development activities in Israel, particularly in oncology and rare diseases[72].