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BEAM GLEQ.WARRT(BEEMW) - 2025 Q1 - Quarterly Report
2025-05-15 21:10
Table of Contents 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 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 001-38868 Beam Global (Exact name of Registrant as specified in its charter) Nevada 26-1342810 (Stat ...
Brainstorm Cell Therapeutics(BCLI) - 2025 Q1 - Quarterly Report
2025-05-15 21:10
Clinical Trials and Regulatory Status - NurOwn® has completed Phase 3 ALS and Phase 2 PMS clinical trials, with top-line data announced on November 17, 2020, and March 24, 2021, respectively[83]. - The FDA granted Fast Track designation and Orphan Drug status for NurOwn® for ALS, enhancing its regulatory profile[85]. - On September 27, 2023, the Advisory Committee voted 17 no, 1 yes, and 1 abstention, indicating that NurOwn® did not demonstrate substantial evidence of effectiveness for mild to moderate ALS[83]. - The BLA for NurOwn® was withdrawn on November 3, 2023, in coordination with the FDA, viewed as a withdrawal without prejudice[83]. - The company plans to submit a Special Protocol Assessment request to the FDA for a Phase 3b trial of NurOwn® for ALS[83]. - A productive meeting with the FDA on December 6, 2023, focused on plans for a Special Protocol Assessment (SPA) for a Phase 3b trial of NurOwn®[97]. - The FDA granted a meeting to discuss the regulatory path forward for NurOwn® on November 20, 2023, following the withdrawal of the BLA[97]. - The company submitted a BLA to the FDA for NurOwn® for ALS treatment on September 9, 2022, but received a RTF letter on November 10, 2022, indicating the BLA was not sufficiently complete for review[115]. - The FDA granted a Type A meeting on January 11, 2023, where the company was presented with options to return the BLA to regulatory review, including filing over protest[116]. - The BLA was re-filed on February 7, 2023, after the company requested the FDA to file the NurOwn® BLA for ALS over protest[116]. - An amendment to the BLA was submitted on March 7, 2023, addressing the majority of items in the RTF letter, and the FDA confirmed an ADCOM for the BLA on March 22, 2023[117]. - The Advisory Committee voted on September 27, 2023, with 17 voting no, one voting yes, and one abstention, indicating that NurOwn® did not demonstrate substantial evidence of effectiveness for mild to moderate ALS[117]. - The company announced the withdrawal of the BLA for NurOwn® on November 3, 2023, coordinated with the FDA and viewed as a withdrawal without prejudice[117]. - A meeting with the FDA on December 6, 2023, focused on discussing plans for a SPA for a planned Phase 3b registrational trial for NurOwn®[117]. - The SPA request for the Phase 3b clinical trial was submitted on February 23, 2024, and written agreement from the FDA was received on April 9, 2024[118]. Clinical Trial Results - The Phase 2 trial showed that 32.6% of NurOwn® participants met the primary endpoint compared to 27.7% for placebo, but did not reach statistical significance (p=0.453)[112]. - In a pre-specified subgroup with ALSFRS-R baseline scores of 35 or greater, NurOwn® demonstrated a 2.09 point improvement over placebo (p=0.050)[112]. - The Phase 3 trial enrolled rapidly progressing ALS patients but did not achieve statistically significant results, with a responder analysis showing 34.7% for NurOwn® versus 20.5% for placebo (p=0.053)[112]. - The company has completed two Phase 1/2 open-label trials and a Phase 2 double-blind trial, demonstrating tolerability and preliminary signs of activity for NurOwn®[98][99]. - The Phase 2 trial published in JAMA Neurology indicated a slower rate of disease progression in ALS patients treated with NurOwn®[100]. - Key findings from the PMS trial included a 10% mean improvement in the timed 25-foot walk (T25FW) and a 4.8% improvement in the 9-hole peg test (9-HPT) for NurOwn® treated patients compared to historical controls[145]. Financial Overview and Capital Needs - The company aims to raise $2.5 million in stockholders' equity to regain compliance with Nasdaq Listing Rule 5550[87]. - The company reported a net loss of $2,864,000 for the quarter ended March 31, 2025, compared to a net loss of $3,401,000 for the same quarter in 2024, resulting in a net loss per share of $0.45[176]. - Research and development expenditures for the quarter ended March 31, 2025, were $1,304,000, an increase of 35.7% from $961,000 in the same quarter of 2024[172]. - General and administrative expenses increased to $1,785,000 for the quarter ended March 31, 2025, up from $1,513,000 in the prior year, reflecting a rise of 17.9%[174]. - The company had cash, cash equivalents, and restricted cash of $1,826,000 as of March 31, 2025[182]. - Net cash used in operating activities for the quarter ended March 31, 2025, was $1,631,000, primarily due to clinical trial costs and payroll expenses[183]. - The company generated $3,086,000 in net cash from financing activities during the quarter ended March 31, 2025, from sales of common stock and warrants exercise[184]. - The Company anticipates continued losses from clinical development and regulatory activities, necessitating additional capital raises for future trials and commercialization efforts[196]. - Future capital requirements will depend on various factors, including clinical trial costs, regulatory approvals, and commercialization expenses[202]. - The Company expects to incur additional financing needs, potentially through debt or equity, which may dilute existing stockholders[198]. Manufacturing and Production - The NurOwn® manufacturing process is compliant with Good Manufacturing Practice, ensuring quality and safety in production[92]. - The company has developed a validated cryopreservation process for MSC, allowing multiple doses of NurOwn® from a single bone marrow harvest[120]. - The company has contracted with City of Hope and Dana Farber Cancer Institute for the manufacturing of NurOwn® for clinical studies, enhancing production capabilities[121]. - The company has improved the efficiency and stability of NurOwn® production, allowing centralized manufacturing for clinical trials[168]. Intellectual Property and Grants - The company has a comprehensive intellectual property portfolio for NurOwn®, with exclusive commercialization rights held by its Israeli subsidiary[85]. - The Company holds approximately 30 granted patents and is expanding its portfolio to include exosome-based technologies, with a recent patent expected to provide protection until April 10, 2039[150][151]. - The Company was awarded a total of $15,912,390 in grants from the California Institute for Regenerative Medicine to fund the pivotal Phase 3 study of NurOwn® for ALS[147]. Stock and Equity Transactions - The Company entered into a New Distribution Agreement allowing the sale of up to $100 million in Common Stock, with gross proceeds of approximately $706 from 388,059 shares sold under this agreement as of March 31, 2025[191]. - On July 17, 2023, the Company sold 270,270 shares of Common Stock at $27.75 per share, generating gross proceeds of approximately $7.5 million[193]. - A subsequent offering on June 27, 2024, involved the sale of 527,918 registered shares and warrants, yielding gross proceeds of approximately $4.0 million at a purchase price of $5.4 per share[194]. - The Company issued a common warrant to purchase up to 2,762,766 shares of Common Stock on April 1, 2025, subject to stockholder approval[195]. - The exercise price for the Common Warrants from the July 2023 offering is set at $30.00 per share, expiring five years after issuance[193].
Onfolio (ONFO) - 2025 Q1 - Quarterly Report
2025-05-15 21:09
☐ 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: 001-41466 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 ONFOLIO HOLDINGS INC. (Exact Name of Registrant as Specified in its Charter) Delaware 37-1978697 (Stat ...
Concorde International Group Ltd-A(CIGL) - 2024 Q4 - Annual Report
2025-05-15 21:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(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 EXCHANGE ACT OF ...
T Stamp (IDAI) - 2025 Q1 - Quarterly Results
2025-05-15 21:08
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 T STAMP INC. (State or other jurisdiction of incorporation) (Commission File Number) Delaware 001-41252 81-3777260 (I.R.S. Employer Identification Number) 3017 Bolling Way NE, Floors 1 and 2, Atlanta, Georgia 30305 (Address of principal executive offices, including zip code) Regist ...
Wrap Technologies(WRAP) - 2025 Q1 - Quarterly Report
2025-05-15 21:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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: 000-55838 Wrap Technologies, Inc. Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...
American Rebel(AREB) - 2025 Q1 - Quarterly Report
2025-05-15 21:07
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 001-41267 AMERICAN REBEL HOLDINGS, INC. (Exact name of registrant as specified in its charter) | Nevada | 47-3892903 | | --- ...
Sidus Space(SIDU) - 2025 Q1 - Quarterly Results
2025-05-15 21:07
Exhibit 99.1 SIDUS SPACE REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Cape Canaveral, FL – May 15, 2025 – Sidus Space (NASDAQ: SIDU) (the "Company" or "Sidus"), an innovative, agile space mission enabler, today announced its financial results for the first quarter ended March 31, 2025, and provided a business update. The Company is scheduled to host a conference call and webcast today, Thursday, May 15, at 5:00 p.m. ET. "Q1 was a pivotal quarter for Sidus as we launched LizzieSa ...
Brainstorm Cell Therapeutics(BCLI) - 2025 Q1 - Quarterly Results
2025-05-15 21:07
Financial Performance - As of March 31, 2025, cash, cash equivalents, and restricted cash totaled approximately $1.8 million[7] - Research and development expenditures for Q1 2025 were $1.3 million, up from $1.0 million in Q1 2024, representing a 30% increase[7] - General and administrative expenses for Q1 2025 were approximately $1.8 million, compared to approximately $1.5 million in Q1 2024, reflecting a 20% increase[7] - The net loss for Q1 2025 was approximately $2.9 million, an improvement from a net loss of approximately $3.4 million in Q1 2024, indicating a 15% reduction in losses[7] - Net loss per share for Q1 2025 was $0.45, compared to $0.75 for Q1 2024, showing a 40% improvement[7] Clinical Trials and Research - The planned Phase 3b clinical trial for NurOwn is designed to enroll approximately 200 early-stage ALS participants[3] - An IND amendment for NurOwn has been submitted to the FDA, marking a significant milestone for the upcoming Phase 3b trial[3] - NurOwn data was selected for presentation at the ISCT 2025 Meeting, highlighting the impact of the UNC13A genotype on clinical outcomes for ALS patients[3] Assets and Liabilities - Total assets as of March 31, 2025, were $3.571 million, compared to $1.832 million as of December 31, 2024, indicating a significant increase[15] - Total liabilities as of March 31, 2025, were $11.028 million, up from $9.596 million as of December 31, 2024[15]
Murano Global Investments PLC(MRNO) - 2024 Q4 - Annual Report
2025-05-15 21:06
Financial Position - As of June 30, 2023, total assets amounted to $19,364,203,757, with total current assets at $334,054,275 and total non-current assets at $19,030,149,482[24]. - Total current liabilities were reported at $3,940,346,398, while total non-current liabilities reached $7,013,873,839, resulting in total liabilities of $10,954,220,237[26]. - The equity of the company stood at $8,409,983,520, which includes common stock valued at $2,958,456,458 and accumulated losses of $(3,537,549,796)[26]. Shareholder Information - As of March 21, 2024, the company had 79,242,873 ordinary shares outstanding, with Elias Sacal Cababie holding 87.2% of the shares[46]. - The company has a significant concentration of ownership, with the top two shareholders holding a combined 98.2% of the ordinary shares[46]. Company Structure and Governance - The company was incorporated on July 27, 2023, and transitioned to a public limited company on March 1, 2024[29]. - The principal executive office of the company is located at 25 Berkeley Square, London W1J 6HN[29]. - The independent registered public accounting firm for the company is KPMG Cárdenas Dosál, S.C.[22]. - The Chief Financial Officer, David Galan, has signed the report, reflecting corporate governance and accountability[81]. Financial Reporting and Compliance - The company is subject to certain informational filing requirements of the Exchange Act as a foreign private issuer[31]. - Murano's audited combined financial statements for the years ended December 31, 2021 and 2022 are incorporated by reference, showing significant financial performance[73]. - Unaudited interim condensed combined financial statements for the six months ended June 30, 2023, indicate a comparison with the same period in 2022[73]. - The company is subject to the informational filing requirements of the Exchange Act as a foreign private issuer, impacting its reporting frequency[65]. - Murano's financial statements are audited by an independent accounting firm, ensuring compliance and accuracy in financial reporting[73]. - The registrant confirms compliance with all requirements for filing on Form 20-F, indicating adherence to regulatory standards[80]. Market Presence - The company’s ordinary shares and warrants are listed on Nasdaq under the symbols "MRNO" and "MRNOW" respectively[52]. - Murano's ordinary shares and warrants are quoted on Nasdaq, providing liquidity and market visibility[66]. - The company maintains a website for additional information, although it is not incorporated into the official reports[66]. Financial Agreements and Partnerships - The company has entered into various loan agreements, including a U.S. dollar-denominated syndicated secured mortgage loan agreement dated October 4, 2019[76]. - The company has executed a third amendment to a peso-denominated loan agreement with Banco Nacional de Comercio Exterior, dated December 11, 2023[78]. - A memorandum of understanding was established on March 30, 2023, involving multiple hotel operators, indicating potential collaboration or strategic partnerships[78]. - The company has made several amendments to counter guarantees, with the latest being executed on August 22, 2023, suggesting ongoing financial restructuring or support mechanisms[78]. - The company has undergone business combination agreements, indicating strategic growth initiatives and potential market expansion[76]. Financial Projections - The unaudited pro forma condensed combined financial statements of Murano are attached as Exhibit 15.1, providing insights into financial projections[75].