Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents [156]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024 [181]. Financial Performance - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, with an accumulated deficit of $918.3 million as of the same date [165]. - Product revenue, net was $11.3 million for the three months ended March 31, 2025, compared to $0 for the same period in 2024, reflecting sales from the launch of PEMGARDA [191]. - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, a decrease from a net loss of $43.5 million in the same period of 2024 [206][207]. - Other income decreased to $0.6 million for the three months ended March 31, 2025, from $2.6 million in 2024, primarily due to interest earned on invested cash balances [197]. - The company incurred a net cash used in operating activities of $21.1 million for the three months ended March 31, 2025, compared to $50.2 million for the same period in 2024, indicating a 58.1% improvement [205][207]. - The company reported a net decrease in cash and cash equivalents of $21.3 million for the three months ended March 31, 2025, compared to a decrease of $11.3 million in the same period of 2024 [205]. Research and Development - The ongoing Phase 1 clinical trial of VYD2311 is evaluating safety, tolerability, pharmacokinetics, and immunogenicity, with positive clinical data reported for both safety and pharmacokinetics [157]. - The company aims to develop monoclonal antibodies (mAbs) for serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications [158]. - The company expects research and development expenses to increase as it advances VYD2311 through clinical development and seeks regulatory approval for its product candidates [177]. - Research and development expenses decreased by $20.5 million to $10.6 million for the three months ended March 31, 2025, from $31.2 million in 2024 [196]. - Acquired in-process research and development expenses consist primarily of costs related to acquiring rights to Adimab's antibodies for COVID-19 and SARS [182]. Commercialization and Expenses - Invivyd, Inc. has incurred significant commercialization expenses related to product manufacturing, marketing, sales, and distribution of PEMGARDA [166]. - The company anticipates ongoing expenses related to the commercialization of PEMGARDA and the development of other product candidates, which may lead to continued operating losses [198]. - Selling, general and administrative expenses increased by $1.8 million to $16.8 million for the three months ended March 31, 2025, compared to $14.9 million in 2024 [196]. - Cost of product revenue was $0.8 million for the three months ended March 31, 2025, with no cost recorded for the same period in 2024 [192]. - The company has committed to noncancelable purchase obligations of $27.4 million related to commercial drug substance and drug product manufacturing, expected to be paid in 2025 [214]. Funding and Liquidity - Invivyd, Inc. has financed operations primarily with net proceeds of $464.7 million from preferred stock sales and $327.5 million from its IPO [164]. - The company expects to require additional funding to support ongoing operations and growth strategy, with substantial doubt about its ability to continue as a going concern without securing additional funds [169]. - The company entered into a Loan Agreement providing for a senior secured term loan facility of up to $30 million, with terms including a repayment period starting March 1, 2029 [203][204]. - The company raised $39.3 million from the sale of 9,000,000 shares of common stock at an average price of $4.50 per share under a Sales Agreement in February 2024 [202]. - The company expects to finance operations through a combination of revenue contributions, equity offerings, and debt financing, indicating a focus on maintaining liquidity [213]. - The company has substantial doubt about its ability to continue as a going concern, as it may not have sufficient cash to fund operations beyond one year from the issuance of its financial statements [212]. Inventory and Manufacturing - The company has capitalized inventory costs since March 2024, which would have resulted in reported margins approaching 80% if pre-EUA manufacturing costs had been capitalized [193]. - The company is actively monitoring SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA against variants KP.3.1.1 and LB.1 [161]. - The company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles [162]. Accounting and Compliance - The JOBS Act allows emerging growth companies to delay the adoption of new accounting standards until they apply to private companies [220]. - Companies are exempt from compliance with the auditor attestation requirement for internal control over financial reporting [221]. - Reduced disclosure obligations regarding executive compensation are available for smaller reporting companies [221]. - Exemptions from non-binding advisory votes on executive compensation and stockholder approval of golden parachute payments are provided [221]. - Companies are not required to disclose quantitative and qualitative information about market risk as they qualify as smaller reporting companies [222].

Financial Performance - Net sales for the three months ended March 31, 2025, were $12.1 million, a 13.7% decrease from $14.1 million in the same period of 2024[2] - Gross profit increased by $100,000 or 6.7% to $2.0 million, with gross profit as a percentage of sales rising to 16.8%, an increase of 320 basis points from 13.6% in 2024[2] - Operating expenses increased by $615,000 or 28.4%, primarily due to a $412,000 increase in non-cash stock compensation expense[2] - Operating loss was $746,000, compared to an operating loss of $259,000 in 2024[2] - Net loss for the first quarter of 2025 increased by $282,000 to $988,000[2] - Adjusted EBITDA improved to $576,000, representing a 59.1% increase over 2024[4] Operational Metrics - The Book-to-Bill ratio was 1.34 to 1.00 at the end of the first quarter of 2025, nearly a 20% improvement from the prior year[4] - Funded backlog of firm customer orders increased by $2.7 million or 2.3%, while total backlog continues to exceed a quarter of a billion dollars[9] Future Outlook - The company reaffirms belief that full-year 2025 results will exceed those of 2024[9] - Operating loss increased primarily due to higher non-cash stock compensation expenses, which accounted for 67% of the increase in operating expenses[4]

Financial Performance - Total revenue for Q1 2025 was $13.6 million, down 22% year-over-year from $17.5 million in Q1 2024[6] - U.S. revenue decreased by $1.7 million, or 16.5%, to $8.4 million, while international revenue decreased by $2.2 million, or 29.3%, to $5.2 million[7] - Gross profit for Q1 2025 decreased by $2.9 million, or 25%, to $8.8 million, with a gross margin of 64.2% compared to 66.6% in Q1 2024[8] - Revenue for the three months ended March 31, 2025, was $13,643 million, a decrease of 22.3% compared to $17,479 million in the same period of 2024[22] - Net loss for the three months ended March 31, 2025, was $12,366 million, compared to a net loss of $9,789 million in the same period of 2024, representing a 26.1% increase in losses[22] - Adjusted EBITDA for the three months ended March 31, 2025, was $(8,344) million, compared to $(5,118) million in the same period of 2024, indicating a worsening operational performance[27] Operating Expenses - Operating expenses for Q1 2025 decreased by $1.1 million, or 6%, to $18.3 million, reflecting cost containment efforts[9] - Total operating expenses for the three months ended March 31, 2025, were $18,283 million, down from $19,407 million in the same period of 2024, a decrease of 5.8%[22] - Cash used in operating activities for the three months ended March 31, 2025, was $(6,310) million, compared to $(2,878) million in the same period of 2024, reflecting increased cash outflows[24] Cash and Debt - Cash and cash equivalents as of March 31, 2025, were $3.2 million, down from $4.3 million at the end of 2024[12] - Total debt obligations decreased to approximately $35.5 million from $39.7 million as of December 31, 2024[12] - Cash and cash equivalents and restricted cash at the end of the period were $3,199 million, down from $5,087 million at the end of the same period in 2024[24] Shareholder Impact - The net loss attributable to stockholders for Q1 2025 was $12.4 million, or $17.44 per share, compared to a net loss of $9.8 million, or $16.91 per share in Q1 2024[11] - The weighted-average number of shares used in the basic and diluted loss per share calculation increased to 709 million in 2025 from 579 million in 2024[22] Strategic Actions - The company is not providing full-year 2025 financial guidance due to ongoing evaluations of strategic alternatives and potential trade disruptions[13] - The company completed a registered direct offering, raising approximately $1.1 million and $1.57 million from two separate transactions in April 2025[6] - The company intends to challenge the Canada Revenue Agency's assessment regarding the denial of CEWS claims, which could impact future cash flows[29] Foreign Exchange - The company experienced a foreign exchange gain of $(119) million for the three months ended March 31, 2025, compared to a loss of $324 million in the same period of 2024[27] Loss on Debt - The company reported a loss on debt extinguishment of $1,049 million for the three months ended March 31, 2025[27] Revenue Sources - The percentage of total systems revenue derived from the company's internal lease programs was approximately 25% in Q1 2025, consistent with the prior year[7]

- Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 - Exhibit 99.1 Zenas BioPharma Reports First Quarter 2025 Financial Results and Provides Corporate Updates - Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 - - Phase 2 MoonStone trial in Relapsing Multiple Sclerosis enrollment concluding; topline results expected early in the fourth quarter 20 ...

Financial Performance - Total revenue for Q1 2025 was $165.8 million, a decrease of 38.5% compared to $270.1 million in Q1 2024[2] - Net loss for Q1 2025 was $9.5 million, improved from a net loss of $22.0 million in Q1 2024[2] - Adjusted EBITDA for Q1 2025 was $(4.0) million, compared to $(18.2) million in Q1 2024[2] - The company reported a net loss of $9,533,000 for the three months ended March 31, 2025, compared to a net loss of $21,980,000 in the same period of 2024, indicating an improvement in financial performance[14] - Adjusted EBITDA for the three months ended March 31, 2025, was $(4,025,000), an improvement from $(18,161,000) in Q1 2024, highlighting a positive trend in core operating results[18] Profitability Metrics - Gross profit increased to $43.8 million in Q1 2025, with a total gross profit margin of 26.4%, up from 14.0% in Q1 2024[11][12] - New vehicle retail gross profit margin improved to 11.1% in Q1 2025, compared to 3.7% in Q1 2024[12] Sales and Units - Retail units sold decreased to 2,148 in Q1 2025 from 3,521 in Q1 2024[12] - Average selling price for new vehicles increased to $85,318 in Q1 2025, up from $74,263 in Q1 2024[12] Debt and Liabilities - The company repaid approximately $145 million in debt during the quarter, significantly de-leveraging its balance sheet[2] - Total liabilities decreased to $429.1 million as of March 31, 2025, down from $586.2 million at the end of 2024[13] Cash Flow and Liquidity - Net cash provided by operating activities was $26,032,000 for Q1 2025, a decrease from $80,240,000 in Q1 2024, reflecting changes in working capital[14] - Total cash at the end of the period was $19,727,000, down from $39,350,000 at the end of Q1 2024, indicating a decrease in liquidity[14] - The company’s cash flow from financing activities showed a net outflow of $144,939,000 in Q1 2025, compared to a net outflow of $90,210,000 in Q1 2024, indicating increased financing pressures[14] Expenses - The company incurred $10,759,000 in interest expense for the three months ended March 31, 2025, compared to $12,199,000 in the same period of 2024[18] - Depreciation and amortization expenses totaled $4,582,000 for Q1 2025, down from $5,461,000 in Q1 2024, suggesting improved asset utilization[18] Inventory and Asset Management - The company reported a significant increase in inventories, with a change of $32,346,000 for the three months ended March 31, 2025, compared to $109,442,000 in the same period of 2024[14] - The company experienced a loss on the sale of businesses, property, and equipment amounting to $459,000 in Q1 2025, while there were no such losses reported in Q1 2024[18] - The company generated $113,947,000 in net proceeds from the sale of businesses, property, and equipment during the three months ended March 31, 2025[14]

Exhibit 99.1 Lazydays has been a prominent player in the RV industry since our inception in 1976, earning a stellar reputation for delivering exceptional RV sales, service, and ownership experiences. Our commitment to excellence has led to enduring relationships with RVers and their families who rely on us for all of their RV needs. Our wide selection of RV brands from top manufacturers, state-of-the-art service facilities, and an extensive range of accessories and parts ensure that Lazydays is the go-to de ...

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. ...