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Lazydays Holdings(GORV) - 2025 Q1 - Quarterly Results
2025-05-15 11:13
Total revenue for the first quarter 2025 was $165.8 million compared to $270.1 million for the same period in 2024. Loss from operations for the first quarter 2025 was $2.3 million compared to $16.6 million for the same period in 2024. We recognized impairment charges of $2.9 million related to indefinite-lived intangible assets during the first quarter 2025. First quarter 2025 net loss was $9.5 million compared to net loss of $22.0 million for the same period in 2024. First quarter 2025 Adjusted EBITDA, a ...
Lazydays (LAZY) - 2025 Q1 - Quarterly Results
2025-05-15 11:13
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 ...
Cabaletta Bio(CABA) - 2025 Q1 - Quarterly Report
2025-05-15 11:10
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 $15,000[59].
Sintx Technologies(SINT) - 2025 Q1 - Quarterly Results
2025-05-15 11:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware 001-33624 84-1375299 (State or other jurisdiction of incorporation) Registrant's telephone number, including area code: (801) 839-3500 (Former name or former address, if changed since last repo ...
Lithium Americas (LAC) - 2025 Q1 - Quarterly Results
2025-05-15 11:10
Exhibit 99.1 NEWS RELEASE TSX: LAC ● NYSE: LAC www.lithiumamericas.com Lithium Americas Reports First Quarter 2025 Results (All amounts in US$ 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 ...
Mersana Therapeutics(MRSN) - 2025 Q1 - Quarterly Results
2025-05-15 11:09
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. ...
TCTM Kids(TCTM) - 2024 Q4 - Annual Report
2025-05-15 11:08
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 ...
Tarena(TEDU) - 2024 Q4 - Annual Report
2025-05-15 11:08
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 ...
Adagio(IVVD) - 2025 Q1 - Quarterly Results
2025-05-15 11:06
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 ...
Nauticus Robotics(KITT) - 2025 Q1 - Quarterly Results
2025-05-15 11:05
Financial Results - Nauticus Robotics, Inc. reported its financial results for the quarter and year ended December 31, 2024, along with amended quarterly results for Q1, Q2, and Q3 of 2024[4] Conference Call - The company will hold a conference call to discuss its operating results following the press release issued on April 15, 2025[4] Press Release - The press release is incorporated as Exhibit 99.1 in the Current Report on Form 8-K[4]