CG Oncology(CGON) - 2025 Q1 - Quarterly Report
2025-05-13 12:30
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 Commission File Number: 001-41925 CG Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 37-1611499 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Artelo Biosciences(ARTL) - 2025 Q1 - Quarterly Report
2025-05-13 12:22
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 PERSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38951 ARTELO BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other ...
Verb(VERB) - 2025 Q1 - Quarterly Report
2025-05-13 12:20
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 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: 001-38834 Verb Technology Company, Inc. (Exact name of registrant as specified in its charter) | Nevada | 90-1118043 | | --- ...
NeuroOne Medical Technologies (NMTC) - 2025 Q2 - Quarterly Results
2025-05-13 12:15
Exhibit 99.1 NeuroOne Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6% Filed 510(k)Submission with FDA for OneRF Trigeminal Nerve Ablation System to Treat Facial Pain Ahead of Schedule Company Fully Funded Through at Least Fiscal Year 2026 Following Oversubscribed $8.2 Million Capital Raise EDEN PRAIRIE, Minn., May 13, 2025 -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicat ...
Atossa Therapeutics(ATOS) - 2025 Q1 - Quarterly Report
2025-05-13 12:15
Drug Development - The company is developing (Z)-endoxifen for breast cancer treatment, with a focus on metastatic breast cancer, aiming for a streamlined regulatory pathway[85] - The FDA has authorized the Investigational New Drug (IND) application for (Z)-endoxifen, with a Phase 2 study enrolling approximately 190 patients planned[98] - The ongoing Phase 2 DCIS study aims to evaluate (Z)-endoxifen's suitability for long-term active surveillance in women with ductal carcinoma in situ, with approximately 100 patients expected to be treated[96] - The treatment cohort for the neoadjuvant study of (Z)-endoxifen was initiated in April 2025, comparing it to exemestane plus OFS[100] - The company plans to conduct additional studies to assess (Z)-endoxifen's correlation with breast cancer risk reduction, as advised by the FDA[94] - (Z)-endoxifen achieved a primary endpoint with 95% of patients receiving over 75% of planned treatment, showing a 69% reduction in Ki-67 and a 30.4% reduction in functional tumor volume after three weeks[102] - The company has completed four Phase 1 and two Phase 2 clinical studies for (Z)-endoxifen, demonstrating its potential in treating breast cancer and reducing breast density[89] Financial Performance - Total operating expenses increased to $7.4 million for the three months ended March 31, 2025, up from $7.0 million in the same period in 2024, reflecting a $0.4 million increase[110] - Research and Development (R&D) expenses totaled $4.2 million for the three months ended March 31, 2025, an 11% increase from $3.7 million in 2024[111] - Compensation expenses within R&D rose by 41% to $0.9 million, while professional fees increased by 123% to $0.5 million for the same period[111] - Interest income decreased to $0.7 million for the three months ended March 31, 2025, down from $1.1 million in 2024, due to a lower balance in the money market account[112] - Net cash used in operating activities was $5.96 million for the three months ended March 31, 2025, compared to $4.70 million in 2024, reflecting a $1.3 million increase[115] - As of March 31, 2025, the company had $65.1 million in cash and cash equivalents, sufficient to fund projected operating requirements for at least the next 12 months[115] - The company has an estimated non-cancellable commitment of $9.4 million for clinical trial service providers as of March 31, 2025[122] - The company is not currently generating revenue and does not anticipate doing so until pharmaceutical programs are developed and launched[104] Intellectual Property - The company has been granted six U.S. and ten international patents for (Z)-endoxifen, with protection extending through at least November 17, 2038[83] Corporate Strategy - The company aims to opportunistically add programs in areas of high unmet medical need through acquisition or collaboration[84] - The company is focused on advancing its clinical studies and successfully commercializing new therapeutics[82] Compliance and Regulatory Issues - The company received a letter from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline to regain compliance by August 20, 2025[121]
Candel Therapeutics(CADL) - 2025 Q1 - Quarterly Results
2025-05-13 12:15
Exhibit 99.1 Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights Dr. Tak continued, "CAN-2409, Candel's most advanced multimodal biological immunotherapy candidate, continues to demonstrate meaningful overall survival benefits in patients with advanced NSCLC, non-responsive to immune checkpoint inhibitors, as well as in patients with borderline resectable PDAC. The totality of data showing notable extension of survival based on both phase 2a clinical trials in NS ...
CG Oncology(CGON) - 2025 Q1 - Quarterly Results
2025-05-13 12:15
Corporate Highlights Exhibit 99.1 | CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates - Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of 42.3% by K-M - - Promising early signal in Cohort P with 90.5% high-grade recurrence free survival at 3 and 9 months by K-M - - New enrollment completion date for Phase 3 PIVOT-006 in intermediate-risk non-muscle invasive blad ...
a Therapeutics(COYA) - 2025 Q1 - Quarterly Report
2025-05-13 12:14
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: 001-41583 Coya Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4017781 | | --- ...
BK Technologies(BKTI) - 2025 Q1 - Quarterly Results
2025-05-13 12:13
Exhibit 99.1 BK Technologies Announces First Quarter 2025 Results WEST MELBOURNE, FL May 13, 2025 / BK Technologies Corporation (NYSE American: BKTI) (the "Company," "BK Technologies") today announced financial and operating results for the first quarter ended March 31, 2025. The Company will host a conference call today, May 13, 2025, at 9:00 a.m. Eastern Time. First Quarter 2025 Financial and Operational Update 1 Represents a non-GAAP financial measure. Refer to the section entitled "Use of Non-GAAP Finan ...
MeiraGTx(MGTX) - 2025 Q1 - Quarterly Report
2025-05-13 12:09
Table of Contents ☒ 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: 001-38520 MeiraGTx Holdings plc UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 ...