Ovid Therapeutics (OVID) - 2025 Q1 - Quarterly Report
2025-05-13 12:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________ FORM 10-Q _______________________________________________________ (Mark One) x 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 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ____ ...
a Therapeutics(COYA) - 2025 Q1 - Quarterly Results
2025-05-13 12:07
Coya Therapeutics Reports First Quarter Financial Results and Provides a Corporate Update Houston, TX, May 13, 2025 -- Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the quarter ended March 31, 2025. Recent Corporate Highlights Upcoming Expected Catalysts for 2025 • Announced positive interim results of an in ...
VerifyMe(VRME) - 2025 Q1 - Quarterly Results
2025-05-13 12:05
(2) Adjusted EBITDA is a non-GAAP financial measure. See "Use of Non-GAAP Financial Measures" below for information about this non-GAAP measure. A reconciliation to the most directly comparable GAAP measure, net loss, is included as a schedule to this release. 1 _________ Exhibit 99.1 VerifyMe Reports First Quarter 2025 Financial Results Lake Mary, FL – May 13, 2025 – PRNewswire — VerifyMe, Inc. (NASDAQ: VRME) ("VerifyMe," "we," "our," or the "Company") provides brand owners time and temperature sensitive l ...
MeiraGTx(MGTX) - 2025 Q1 - Quarterly Results
2025-05-13 12:05
Exhibit 99.1 MeiraGTx Reports First Quarter 2025 Financial and Operational Results - Announced strategic collaboration with Hologen AI, including a $200 million cash upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in capital committed to initially focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson's disease - U.S. Food and Drug Administration (FDA) Granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...
Quince Therapeutics(QNCX) - 2025 Q1 - Quarterly Results
2025-05-13 12:01
Financial Performance - Quince Therapeutics reported cash, cash equivalents, and short-term investments of $31.6 million for Q1 2025, sufficient to fund operations through early 2026[6]. - The company reported a net loss of $15.0 million for Q1 2025, equating to a net loss of $0.34 per share, with 43.9 million shares outstanding[6]. - Total operating expenses for Q1 2025 were $14.9 million, compared to $11.2 million in Q1 2024, reflecting increased R&D costs[13]. - Quince's total assets decreased from $114.5 million at the end of 2024 to $107.1 million by March 31, 2025[11]. Research and Development - Research and development expenses for Q1 2025 were $8.1 million, primarily related to the Phase 3 NEAT clinical trial[6]. - A total of 63 participants have been enrolled in the Phase 3 NEAT clinical trial, with an early enrollment conclusion potentially by the end of June 2025[4]. - The NEAT trial aims to achieve approximately 80% power to determine a statistically significant difference in the primary endpoint if enrollment concludes early[3]. - The company experienced slower than anticipated enrollment due to a challenging academic site environment, but expects increased screening and randomization activities soon[4]. Future Plans - Quince plans to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application (MAA) in Europe in the second half of 2026, assuming positive trial results[4]. - The company has activated all 19 study sites for the NEAT trial, including new sites in the U.K. and Europe[4].
TME(TME) - 2025 Q1 - Quarterly Results
2025-05-13 12:01
Revenue Growth - Total revenues for Q1 2025 were RMB7.36 billion (US$1.01 billion), an 8.7% year-over-year increase, driven by growth in online music services[3] - Revenues from music subscriptions reached RMB4.22 billion (US$581 million), representing a 16.6% year-over-year growth, with paying users increasing by 8.3% to 122.9 million[3] - Revenues from online music services increased by 15.9% year-over-year to RMB5.80 billion (US$800 million), driven by subscription and advertising revenue growth[15] - Total revenues for the three months ended March 31, 2025, increased to RMB 7,356 million, up 8.7% from RMB 6,768 million in the same period of 2024[31] - Online music services revenue rose to RMB 5,804 million, representing a 15.9% increase compared to RMB 5,007 million in the prior year[31] Profitability - Net profit attributable to equity holders was RMB4.29 billion (US$591 million), a 201.8% year-over-year increase, while non-IFRS net profit was RMB2.12 billion (US$293 million), up 24.6% year-over-year[3] - Gross margin improved to 44.1% from 40.9% in the same period of 2024, primarily due to strong growth in music subscription revenues[13] - Gross profit for the period was RMB 3,242 million, reflecting a gross margin of 44.1%, compared to RMB 2,771 million and a margin of 41.0% in the previous year[31] - Operating profit surged to RMB 4,836 million, a significant increase of 146.5% from RMB 1,959 million in the same quarter of 2024[31] - Non-IFRS net profit for the period was RMB 2,226 million, up 22.9% from RMB 1,812 million year-over-year[32] - Basic earnings per share increased to RMB 1.40, compared to RMB 0.46 in the same period last year, marking a growth of 204.3%[31] Cash and Investments - Total cash and short-term investments as of March 31, 2025, amounted to RMB37.67 billion (US$5.19 billion), slightly up from RMB37.58 billion at the end of 2024[20] - Cash and cash equivalents at the end of the period were RMB 12,022 million, an increase from RMB 10,218 million at the end of the previous quarter[38] - The company reported a net cash used in investing activities of RMB 3,221 million for the quarter, down from RMB 5,498 million in the same period last year[38] Shareholder Returns - The company declared a cash dividend of US$0.09 per ordinary share, totaling US$275 million, paid in April 2025[22] - The company repurchased 5.9 million ADSs for approximately US$64.5 million at an average price of US$10.8 per ADS during Q1 2025[21] Assets and Equity - Total assets as of March 31, 2025, reached RMB 98,084 million, up from RMB 90,444 million at the end of December 2024[36] - The company’s equity attributable to equity holders increased to RMB 73,237 million, compared to RMB 67,863 million at the end of the previous year[36] Social Entertainment Services - Revenues from social entertainment services decreased by 11.9% to RMB1.55 billion (US$214 million), attributed to adjustments in live-streaming functions[15] User Engagement - Monthly ARPPU for online music grew to RMB11.4 from RMB10.6 in Q1 2024, reflecting a 7.5% increase[5]
NeuroOne Medical Technologies (NMTC) - 2025 Q2 - Quarterly Report
2025-05-13 12:01
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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ NeuroOne Medical Technologies Corporation (Exact name of Registrant as specified in its charter) Delaware 27-0863354 Commission File Number ...
Monopar Therapeutics(MNPR) - 2025 Q1 - Quarterly Report
2025-05-13 12:00
Financial Position - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled $54.6 million, expected to last through at least December 31, 2026[146]. - The company sold 1,181,540 shares at $16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[148]. - A subsequent offering on December 23, 2024, sold 798,655 shares at $23.79 per share, along with pre-funded warrants, generating approximately $37.4 million in net proceeds[149]. - The accumulated deficit as of March 31, 2025, was approximately $78.4 million, with expectations of continued losses in the foreseeable future[178]. - The company anticipates that available funds as of April 30, 2025, will support operations at least through December 31, 2026[178]. - Net cash used in operating activities for Q1 2025 was $5,663,000, an increase of $4,008,000 from $1,655,000 in Q1 2024[181]. Research and Development - The pivotal Phase 3 trial for ALXN1840 demonstrated three times greater copper mobilization compared to standard-of-care, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[154]. - In the same trial, 45% of patients on ALXN1840 showed improved neurological symptoms compared to 20% on standard-of-care[155]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[158]. - The Phase 1 clinical trial for MNPR-101-Zr commenced in April 2024, with positive early clinical data reported in September 2024[159]. - The company is actively pursuing the development of MNPR-101 for both therapeutic and diagnostic applications, with two ongoing human clinical trials[167]. Financial Performance - Research and development (R&D) expenses for Q1 2025 were $1,643,000, an increase of $677,000 from $966,000 in Q1 2024[174]. - General and administrative (G&A) expenses for Q1 2025 were $1,578,000, up $821,000 from $757,000 in Q1 2024[175]. - Net loss for Q1 2025 was $2,625,000, compared to a net loss of $1,641,000 in Q1 2024, reflecting an increase of $984,000[173]. - Interest income for Q1 2025 increased by $515,000 to $597,000, attributed to higher bank balances and interest on U.S. Treasury securities[176]. - The company has not generated any approved drugs and has not generated any revenues to date, focusing on drug development and collaboration agreements[165]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for drug candidates[185]. Agreements and Obligations - A License Agreement with Alexion was executed on October 23, 2024, granting an exclusive worldwide license for ALXN1840, with an upfront cash payment of $4 million[194]. - Future capital requirements will depend on the progress of drug candidates, including ALXN1840 and MNPR-101, and the need for substantial additional funding for commercialization efforts[187]. - The company is obligated to make milestone payments of up to $94.0 million for regulatory approval and sales-related milestones[195]. - A long-term, non-exclusive master supply agreement was entered into with NorthStar for the supply of actinium-225 (Ac-225) for therapeutic use[196]. - The company has taken a non-exclusive license to XOMA's humanization technology, with potential milestone payments totaling up to $14.925 million[197]. - As of April 30, 2025, no milestone payments have been made to XOMA, and the first payment is due upon the first dosing of a human patient in a Phase 2 clinical trial[197]. Management and Operations - The management team has extensive experience, having co-founded companies that achieved four drug approvals and a sale of a biopharmaceutical company for $800 million[163]. - The company has entered into a 36-month lease for its executive headquarters at a monthly rate of $3,580, along with additional month-to-month leases[199]. - A lease for a small wet laboratory space has been established at a rate of $1,000 per month, cancellable after 6 months[199]. - The company has acquired full ownership of the MNPR-101 radiopharmaceutical platform and jointly shares ownership of a filed patent application related to Ac-225[196]. - The company has not been a party to any adverse material legal proceedings to date[201]. - There are indemnification obligations to officers and non-employee directors, with no claims made to date[203].
Monopar Therapeutics(MNPR) - 2025 Q1 - Quarterly Results
2025-05-13 12:00
Financial Results - Monopar Therapeutics Inc. reported its financial results for Q1 2025, ending March 31, 2025[6] - The company issued a press release on May 13, 2025, detailing its operational performance[6] - Specific financial metrics and user data were not provided in the available content[6] - Future outlook and performance guidance were not disclosed in the provided documents[6] Product Development and Strategy - Information regarding new product development or technological advancements was not included[6] - Market expansion strategies or potential mergers and acquisitions were not mentioned[6] - Other strategic initiatives were not detailed in the available content[6]
Mereo BioPharma(MREO) - 2025 Q1 - Quarterly Report
2025-05-13 11:57
Financial Performance - Total operating expenses for Q1 2025 were $11.2 million, an increase of $1.3 million from $9.9 million in Q1 2024[104] - Net loss before income tax for Q1 2025 was $12.9 million, compared to $9.0 million in Q1 2024, reflecting a $4.2 million increase[104] - The accumulated deficit as of March 31, 2025, was $472.0 million, with expectations of continued significant operating losses[128] - Cash used in operating activities increased to $8.3 million in Q1 2025 from $8.0 million in Q1 2024[123] - The net foreign exchange loss for Q1 2025 was $2.8 million, compared to a gain of $0.6 million in Q1 2024, due to currency fluctuations[113] Expenses - Research and development (R&D) expenses decreased by $0.1 million to $3.9 million in Q1 2025, primarily due to a $1.2 million decrease in expenses for alvelestat[106][107] - General and administrative expenses increased by $1.4 million to $7.3 million in Q1 2025, mainly due to a prior reimbursement reduction[109] Funding and Capital Requirements - The company anticipates needing additional external funding to complete development plans and potentially commercialize selected rare disease products[116][117] - The company expects existing cash and cash equivalents to fund clinical trials, operating expenses, and capital expenditures into 2027[130] - Future capital requirements will depend on factors such as developing additional product candidates and seeking regulatory approvals[131] - The company may need to obtain substantial additional funds to achieve business objectives, which may not be available on acceptable terms[133] - Future debt or preferred equity financing may involve agreements that limit the company's actions and could dilute shareholder ownership[134] Revenue and Business Objectives - Revenues will be derived from development milestones or sales of successfully developed and approved product candidates[132] Regulatory and Accounting Considerations - The costs and timing of regulatory reviews and potential commercialization activities are uncertain and could impact financial performance[138] - The company currently has no commitments or agreements for acquiring new product candidates or entering into licensing arrangements[138] - The company has no critical accounting estimates that significantly affect its financial statements[137] - There have been no significant changes to critical accounting estimates from the previous annual report[139] - The company is classified as a "smaller reporting company" and is not required to provide certain market risk information[141] Interest and Other Income - Interest income increased to $0.7 million in Q1 2025 from $0.6 million in Q1 2024, attributed to a higher cash balance[110] - Net cash provided by financing activities was $0.4 million in Q1 2025, compared to less than $0.1 million in Q1 2024, mainly from warrant exercises[127]