FitLife Brands(FTLF) - 2025 Q1 - Quarterly Report
2025-05-15 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT For the transition period from N/A to N/A Commission File No. 000-52369 FITLIFE BRANDS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (IRS Employer Id ...
Incannex(IXHL) - 2025 Q3 - Quarterly Report
2025-05-15 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) ha ...
Abeona Therapeutics(ABEO) - 2025 Q1 - Quarterly Results
2025-05-15 11:30
Exhibit 99.1 Abeona Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates - Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priorit ...
MiNK Therapeutics(INKT) - 2025 Q1 - Quarterly Results
2025-05-15 11:30
At AACR IO and ASCO GI, MiNK presented new data showing that agenT-797, in combination with checkpoint inhibitors and chemotherapy, drives rapid tumor infiltration, CD8+ T cell activation, and immune reprogramming in PD-1–resistant gastroesophageal cancers—a population with limited therapeutic options. A Phase 2 trial (NCT06251973), led by Memorial Sloan Kettering Cancer Center, is actively enrolling in second-line gastric cancer. A peer-reviewed publication expected in the first half of 2025 will detail a ...
Dt Cloud Acquisition Corporation(DYCQU) - 2025 Q1 - Quarterly Report
2025-05-15 11:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to ______ Commission File Number 001-41967 DT Cloud Acquisition Corporation (Exact name of registrant as specified in its charter) Cayman Islands n/a (St ...
Dt Cloud Acquisition Corporation(DYCQ) - 2025 Q1 - Quarterly Report
2025-05-15 11:25
Washington, D.C. 20549 FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to ______ Commission File Number 001-41967 DT Cloud Acquisition Corporation (Exact name of registrant as specified in its charter) Cayman Islands n/a (St ...
Zenas BioPharma, Inc.(ZBIO) - 2025 Q1 - Quarterly Report
2025-05-15 11:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-42270 Zenas BioPharma, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...
Venus cept (VERO) - 2025 Q1 - Quarterly Report
2025-05-15 11:21
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-38238 Venus Concept Inc. Securities registered pursuant to Section 12(b) of the Act: ...
Acuren Corp(TIC) - 2025 Q1 - Quarterly Results
2025-05-15 11:18
- Reiterates 2025 outlook - TOMBALL, Texas -- (BUSINESS WIRE) -- Acuren Corporation (NYSE American: TIC) ("Acuren" or the "Company"), a leading provider of critical asset integrity services, today reported its financial results for the three months ended March 31, 2025. Exhibit 99.1 - Revenue of $234.2 million, up 5.0% driven by deeper service line penetration with recurring customers and market share Acuren Corporation Announces Results for the First Quarter 2025 gains - Capital Resources and Liquidity At ...
Adagio(IVVD) - 2025 Q1 - Quarterly Report
2025-05-15 11:16
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].