Financial Performance - As of March 31, 2025, Cabaletta Bio, Inc. reported total assets of $165,141,000, a decrease of 10.8% from $185,046,000 on December 31, 2024[15]. - The company incurred a net loss of $35,943,000 for the three months ended March 31, 2025, compared to a net loss of $25,047,000 for the same period in 2024, representing a 43.5% increase in losses year-over-year[18]. - The net loss per share for the three months ended March 31, 2025, was $0.71, compared to $0.51 for the same period in 2024[18]. - The accumulated deficit as of March 31, 2025, reached $385,044,000, an increase from $349,101,000 at the end of 2024[15]. - The total stock-based compensation for the three months ended March 31, 2025, was $5.16 million, compared to $3.79 million for the same period in 2024, reflecting a 36% increase[91]. - The net loss for Q1 2025 was reported at $35,943,000, compared to a net loss of $25,047,000 in Q1 2024, indicating increased operational expenditures[71]. - For the three months ended March 31, 2025, total operating expenses increased to $37.1 million from $28.0 million in the same period of 2024, representing a change of $9.1 million[144]. - Cash used in operating activities was $30.8 million for Q1 2025, compared to $24.0 million in Q1 2024, indicating an increase of $6.8 million[161]. - As of March 31, 2025, the company had $131.8 million in cash and cash equivalents, which is expected to fund operations into the first half of 2026[149]. Research and Development - Research and development expenses increased to $29,018,000 for the three months ended March 31, 2025, up 32.3% from $21,954,000 in the prior year[18]. - Research and development expenses for Q1 2025 totaled $28,973,000, a significant increase from $18,000,000 in Q1 2024, reflecting a rise in personnel and clinical trial costs[71]. - Research and development expenses rose to $29.0 million in Q1 2025, up from $22.0 million in Q1 2024, marking an increase of $7.1 million[145]. - The company anticipates continued increases in research and development and general administrative expenses, with a need for additional funding to support operations[153]. - The company plans to raise additional capital through equity offerings, debt financings, and strategic alliances to fund its operations[32]. - The company expects to incur additional losses in the future as it continues its research and development efforts and will need to raise additional capital[32]. Clinical Trials and Product Development - The FDA granted clearance for the rese-cel IND application for systemic lupus erythematosus (SLE) treatment, affecting an estimated 320,000 patients in the U.S. and 150,000 in Europe, with approximately 40% of SLE patients experiencing lupus nephritis (LN)[103]. - The RESET-SLE Phase 1/2 clinical trial is designed to treat 12 patients, with a single weight-based dose of 1.0 x 10^6 cells/kg, and is open for enrollment across multiple sites in the U.S. and one in the EU[103]. - The FDA granted Fast Track Designation for rese-cel for SLE and LN, and the RESET-Myositis trial is actively enrolling patients with three myositis subtypes, affecting approximately 70,000 patients in the U.S. and 85,000 in Europe[104]. - The RESET-SSc trial for systemic sclerosis (SSc) is designed to treat 12 patients, with SSc affecting approximately 90,000 patients in the U.S. and 60,000 in Europe[105]. - The RESET-MG trial for generalized myasthenia gravis (gMG) is open for enrollment, targeting approximately 55,000 patients in the U.S. and 100,000 in Europe[107]. - As of May 9, 2025, 44 patients are enrolled and 23 patients have been dosed across multiple Phase 1/2 disease cohorts in the RESET clinical development program[118]. - The company is collaborating with Cellares Corp. to evaluate an automated manufacturing platform, with successful integration of the Cell Shuttle™ into the manufacturing strategy for rese-cel[120]. - The company plans to implement two registrational cohorts in the RESET-Myositis trial, each evaluating approximately 15 patients, with a focus on achieving a broad label for myositis treatment[116]. Financial Position and Liabilities - Total current liabilities rose to $33,989,000 as of March 31, 2025, compared to $27,086,000 on December 31, 2024, indicating a 25.4% increase[15]. - The company has an accumulated deficit of $385.0 million as of March 31, 2025, indicating ongoing financial challenges[152]. - Future lease payments under non-cancelable leases as of March 31, 2025, total $25,444,000 for finance leases and $5,939,000 for operating leases[79]. - The company has no off-balance sheet risks, such as foreign exchange contracts or other hedging arrangements, ensuring a straightforward financial position[37]. - The company has not recorded any income tax benefits for the three months ended March 31, 2025, due to the likelihood of not recognizing deferred tax benefits[95]. Risks and Challenges - The company has not yet established sales and marketing capabilities, which will be crucial upon obtaining regulatory approval to gain market acceptance[192]. - The regulatory approval process for the company's novel product candidates is complex and may take longer than expected, with potential delays in commercialization[190]. - Patients receiving T cell-based immunotherapies may experience serious adverse events, which could negatively affect the clinical development and commercial potential of the company's product candidates[193]. - The company faces inherent product liability risks during clinical testing, which could lead to substantial liabilities and limit commercialization efforts[209]. - The company currently does not hold product liability insurance for commercialization, which could inhibit the ability to market products if claims arise[210]. - Adverse events from CAR T cell therapies have resulted in patient deaths, indicating significant risks associated with current and future product candidates[213]. - The company is early in its development efforts and may face significant delays in clinical trials if suitable doses are not identified[188]. - The company must navigate variability in T cell quality and quantity, which could affect the reliability of manufacturing its product candidates[186]. Agreements and Collaborations - The Company is committed to pay up to $2,250,000 under the CARTA Services Agreement for cell processing manufacturing through December 31, 2025[54]. - The IASO Agreement includes an upfront payment of $2.5 million and potential total consideration of up to $162 million based on milestone achievements[123]. - The Company entered into a License and Supply Agreement with Oxford Biomedica, which includes an upfront fee and potential regulatory and sales milestone payments in the low tens of millions[124]. - The Company has entered into a Development and Manufacturing Services Agreement with Lonza for a term of 12 months, with the ability to extend, focusing on the CAR-T cell therapy product rese-cel[62]. - An Option and License Agreement with Autolus was established, requiring an upfront license fee of $1,200, with potential regulatory milestones of up to $12,000 for each licensed target and sales milestones totaling up to $15,000[59].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware 001-33624 84-1375299 (State or other jurisdiction of incorporation) Registrant's telephone number, including area code: (801) 839-3500 (Former name or former address, if changed since last repo ...

Exhibit 99.1 NEWS RELEASE TSX: LAC ● NYSE: LAC www.lithiumamericas.com Lithium Americas Reports First Quarter 2025 Results (All amounts in US$ unless otherwise indicated) May 15, 2025 – Vancouver, Canada: Lithium Americas Corp. (TSX: LAC) (NYSE: LAC) ("Lithium Americas" or the "Company") announced that it has filed its Quarterly Report on Form 10-Q, which includes the Company's consolidated interim financial statements ("Financials") for the three months ended March 31, 2025 ("Q1 2025"), and provided an upd ...

Emiltatug Ledadotin (Emi-Le; XMT-1660) Mersana has continued to advance the development of Emi-Le, the company's B7-H4-directed Dolasynthen ADC. Updated Clinical Data Presented at ESMO Breast Cancer 2025 Today: Earlier this morning at the European Society for Medical Oncology Breast Cancer 2025 Annual Congress (ESMO Breast Cancer 2025) in Munich, Germany, updated clinical data as of a March 8, 2025 data cutoff from Emi-Le's Phase 1 dose escalation and backfill cohorts were presented in a mini oral session. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

Exhibit 99.1 Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights WALTHAM, Mass., May 15, 2025 – Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended March 31, 2025, and provided recent business highlights. "To drive long-term topline growth, we made a strategic decision to internalize our sales force at the beginning of 2025," said Bill Duke, Chief Financial Officer of Invivyd. "Although this shift created a short-term headwind, we're now seein ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 CABALETTA BIO, INC. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) Delaware 001-39103 82-1685768 (Commission File Number) (IRS Employer 2929 Arch Street Suite 600 Philadelphia, Pennsylvania 19104 (Address of Principal Executive ...

Financial Performance - Net sales for Q4 FY2025 decreased by $38.1 million, or 5.8%, to $615.8 million compared to $653.8 million in the prior year quarter[3] - For FY2025, net sales increased by $29.8 million, or 1.0%, to $2,904.2 million, driven by growth in the Infiltrator business and Allied products portfolio[8] - Net sales for the three months ended March 31, 2025, were $615,761,000, a decrease of 5.8% compared to $653,840,000 for the same period in 2024[24] Profitability - Adjusted EBITDA for Q4 FY2025 decreased by $14.5 million, or 7.6%, to $176.7 million, representing 28.7% of net sales compared to 29.2% in the prior year[7] - Gross profit for FY2025 decreased by $51.7 million, or 4.5%, to $1,094.2 million, primarily due to unfavorable pricing and material costs[9] - Net income attributable to ADS for the three months ended March 31, 2025, was $77,157,000, a decline of 18.7% from $94,822,000 in the prior year[24] - Adjusted EBITDA for the three months ended March 31, 2025, was $176,695, down from $191,178 in the same period of 2024[38] - Net income for the fiscal year ended March 31, 2025, was $452,573, down from $513,291 in 2024, a decline of 11.8%[38] Cash Flow and Debt - Free cash flow for FY2025 decreased by $165.6 million to $368.5 million, compared to $534.1 million in the prior year[13] - The company reported a net cash provided by operating activities of $581,491,000 for the fiscal year ended March 31, 2025, down from $717,928,000 in 2024, a decrease of 19.0%[28] - As of March 31, 2025, the company's net debt was $962.3 million, an increase of $101.4 million from the previous year[13] - Long-term debt obligations, net, were $1,251,589,000 as of March 31, 2025, compared to $1,259,522,000 in 2024, showing a slight decrease of 0.6%[26] Expenses - Selling, general and administrative expenses for FY2025 increased by $9.7 million, or 2.6%, to $380.4 million, representing 13.1% of sales[10] - Operating expenses for the fiscal year ended March 31, 2025, were $380,378,000, slightly higher than $370,714,000 in 2024, reflecting an increase of 2.0%[24] - Interest expense for the fiscal year ended March 31, 2025, was $91,803, slightly up from $88,862 in 2024[38] Capital Expenditures - Capital expenditures for the fiscal year ended March 31, 2025, were $212,944,000, compared to $183,812,000 in 2024, an increase of 15.9%[28] - Capital expenditures for the fiscal year ended March 31, 2025, were $212,944, an increase from $183,812 in 2024[40] Dividends and Shareholder Returns - The company declared cash dividends of $0.16 per share for the three months ended March 31, 2025, up from $0.14 per share in the same period of 2024[24] Acquisition - The company completed the acquisition of Orenco on October 1, 2024, which is expected to enhance its Infiltrator segment[14] Assets - Total assets increased to $3,690,360,000 as of March 31, 2025, compared to $3,268,913,000 as of March 31, 2024, representing a growth of 12.9%[26] - Cash and restricted cash at the end of the fiscal year was $469,271,000, down from $495,848,000 in the previous year, indicating a decrease of 5.4%[28] Earnings Per Share - Diluted earnings per share for the three months ended March 31, 2025, was $0.99, down from $1.21 in 2024, reflecting a decline of 18.2%[42] - Adjusted earnings per share for the fiscal year ended March 31, 2025, was $5.89, compared to $6.39 in 2024, representing a decrease of 7.8%[42]

Financial Performance - Total revenues decreased by approximately $4.4 million, or 13.0%, to approximately $29.8 million for the year ended December 31, 2024, compared to approximately $34.2 million for the same period in 2023[324]. - Revenues from sewage treatment systems installations decreased by approximately $3.9 million, or 11.9%, to approximately $28.4 million for the year ended December 31, 2024[326]. - Gross profit decreased by approximately $0.1 million, or 1.2%, to approximately $11.2 million for the year ended December 31, 2024[332]. - Total operating expenses increased by approximately $6.5 million, or 233.5%, to approximately $9.2 million for the year ended December 31, 2024[334]. - Net income decreased by approximately $5.6 million, or 80.0%, to approximately $1.4 million for the year ended December 31, 2024, from approximately $7.0 million for the same period in 2023[340]. - Total revenues increased by approximately $5.4 million, or 18.6%, to approximately $34.2 million for the year ended December 31, 2023, compared to approximately $28.8 million for the same period in 2022[342]. - Revenues from sewage treatment systems increased by approximately $5.7 million, or 21.5%, to approximately $32.3 million for the year ended December 31, 2023[344]. - Gross profit increased by approximately $1.1 million, or 11.0%, to approximately $11.4 million for the year ended December 31, 2023[349]. - Total operating expenses decreased by approximately $1.1 million, or 28.9%, to approximately $2.8 million for the year ended December 31, 2023[351]. Cash Flow and Working Capital - Net cash used in operating activities was approximately $1.99 million for the year ended December 31, 2024, a decrease from $3.13 million in 2023[361]. - Working capital as of December 31, 2024, was approximately $26.0 million, with current assets of approximately $77.7 million and current liabilities of approximately $51.6 million[358]. - Net cash provided by investing activities was $545,167 in 2024, an increase from $243,586 in 2023[361]. - Net cash provided by financing activities was approximately $1.0 million for the year ended December 31, 2024, consisting of $2.5 million from loans and $4.3 million from net IPO proceeds[387]. Accounts Receivable and Credit Losses - Accounts receivable increased by approximately $23.1 million in 2024, primarily due to a longer collection cycle caused by delays in government billing approvals[366]. - Days sales outstanding (DSO) increased to 455 days by December 31, 2024, reflecting prolonged delays in the government payment approval process amid economic downturn[368]. - The allowance for doubtful accounts was 14.2% of total accounts receivable as of December 31, 2024[372]. - The allowance for credit loss against accounts receivable was $9,267,851, $3,009,363, and $3,189,642 as of December 31 for the years 2024, 2023, and 2022, representing 17.0%, 9.4%, and 13.7% of gross accounts receivable respectively[400]. Contract Assets and Liabilities - Contract assets increased by approximately $1.4 million, $13.6 million, and $12.2 million for the years ended December 31, 2024, 2023, and 2022, respectively[377]. - As of December 31, 2024, contract assets totaled approximately $40.0 million, with $29.3 million aged over 720 days[380]. - Accounts payable increased by approximately $13.0 million, $9.2 million, and $5.6 million for the years ended December 31, 2024, 2023, and 2022, respectively, primarily due to raw material purchases[384]. - Total contractual obligations as of December 31, 2024, amounted to $5,660,179, with $5,446,210 due within one year[421]. Tax and Other Expenses - Income tax expense decreased by approximately $0.9 million to approximately $0.5 million for the year ended December 31, 2024[339]. - Other expenses, net, amounted to approximately $0.2 million for the year ended December 31, 2023, compared to other income of approximately $41,000 for the same period in 2022[354]. - Income tax expense increased by approximately $0.2 million to approximately $1.4 million for the year ended December 31, 2023[355]. Research and Development - Research and development expenses were $61,786 for the year ended December 31, 2024, $80,948 for 2023, and $112,668 for 2022, indicating a continued investment in R&D to enhance market position[409]. - The company is focused on improving the efficiency of microorganisms in sewage treatment systems and exploring new technologies to enhance water treatment[408]. Company Outlook and Strategy - The company anticipates that current cash resources will be insufficient to execute its business plan for the next twelve months, raising concerns about its ability to operate as a going concern[361]. - The company plans to invest in rural sewage treatments, including building sewage treatment equipment, and explore potential mergers and acquisitions[362]. - The company has enforceable rights to payments for work performed under sewage treatment service contracts, with revenue recognized based on labor costs incurred[398]. - Provisions for estimated losses on uncompleted contracts are recorded in the period when such losses are determined, ensuring accurate financial reporting[401]. - The company has a long history of sewage treatment services, allowing for reasonable estimates of service hours and progress towards completion on fixed-price contracts[399]. - The company has elected to take advantage of the extended transition period for complying with new or revised accounting standards under the JOBS Act[419].