Pieris Pharmaceuticals(PIRS) - 2025 Q1 - Quarterly Results
2025-05-15 11:31
Exhibit 99.1 Palvella Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026 Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cu ...
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
Drug Development - The company is developing innovative medicines for serious chronic diseases, with lead drug candidates IHL-42X, PSX-001, and IHL-675A currently in Phase 2/3 and Phase 2 clinical developments [109]. - The company is focused on addressing significant unmet medical needs with its drug candidates targeting conditions with limited treatment options [109]. - The company expects substantial increases in R&D expenses as it moves drug candidates into later stages of development [126]. Financial Agreements - An equity line of credit Purchase Agreement was entered into on September 6, 2024, allowing for the purchase of up to $50 million of common stock at a price of 96% of the daily volume weighted average price [110]. - The company issued secured convertible debentures under a Purchase Agreement with a total principal amount of up to $10 million, with a 10% original issue discount [111]. - The first tranche of the convertible debenture was completed on October 17, 2024, for a principal amount of $3,333,333, with net proceeds of $2,877,588 after expenses [115][116]. - A Facility Agreement was established on October 9, 2024, providing a term loan facility of up to $4.7 million, with an initial drawdown of approximately $4.6 million [118]. - The Loan Facility has a term of 12 months and an interest rate of 14.5% per annum, payable monthly [118]. - The company issued a five-year warrant for 585,000 shares of common stock with an exercise price of $1.66 per share as part of the equity line of credit agreement [110]. Financial Performance - Revenue from customers for the three months ended March 31, 2025, was $86,000, representing a 100% increase compared to the same period in 2024 [121]. - Research and development expenses decreased by $0.5 million (17%) for the three months ended March 31, 2025, compared to the same period in 2024 [124]. - General and administrative expenses decreased by $1.9 million (45%) for the three months ended March 31, 2025, compared to the same period in 2024 [131]. - Total operating expenses decreased by $2.4 million (33%) for the three months ended March 31, 2025, compared to the same period in 2024 [121]. - The benefit from R&D tax incentive decreased by $0.9 million (68%) for the three months ended March 31, 2025, compared to the same period in 2024 [136]. - Comprehensive loss for the three months ended March 31, 2025, was $4.1 million, a decrease of $2.8 million (41%) compared to the same period in 2024 [144]. - Total comprehensive losses for the nine months ended March 31, 2025, were $16.2 million, compared to $12.4 million for the same period in 2024 [144]. - As of March 31, 2025, the accumulated deficit was $126.0 million [145]. - Cash and cash equivalents as of March 31, 2025, were $6.7 million [145]. - For the nine months ended March 31, 2025, net cash used in operating activities was $11.0 million, a decrease of $1.2 million compared to the same period in 2024 [146]. - As of March 31, 2025, cash and cash equivalents increased to $6.7 million from $5.9 million as of June 30, 2024, representing an increase of $0.8 million [146]. - Current assets exceeded current liabilities by $8.2 million as of March 31, 2025, a decrease of $2.4 million compared to $10.6 million as of June 30, 2024 [146]. - Net cash provided by financing activities was $11.8 million for the nine months ended March 31, 2025, compared to no cash provided in the same period in 2024 [150]. - Cash used in investing activities decreased by $0.3 million for the nine months ended March 31, 2025, due to reduced spending on property, plant, and equipment [149]. Research and Development - Research and development costs are expensed as incurred, including salaries, benefits, and clinical trial costs [154]. - The company recognizes R&D tax credits in Australia as other income once compliance with grant conditions is met [158]. - The difference between accrued costs and actual costs incurred for R&D activities has not been material [157]. - The company did not have any off-balance sheet arrangements during the periods presented [147]. - Management's estimates and assumptions are based on historical experience and known trends, which may differ from actual results under different conditions [151].
Abeona Therapeutics(ABEO) - 2025 Q1 - Quarterly Results
2025-05-15 11:30
FDA Approval and Product Launch - Abeona Therapeutics received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1] - The U.S. launch of ZEVASKYN is underway with the activation of the first Qualified Treatment Center (QTC) at Lurie Children's Hospital, expecting to treat the first patient in Q3 2025 [4] Financial Performance - Cash, cash equivalents, restricted cash, and short-term investments totaled $84.5 million as of March 31, 2025, down from $98.1 million as of December 31, 2024 [7] - The net loss for Q1 2025 was $12.0 million, or $0.24 loss per share, significantly improved from a net loss of $31.6 million, or $1.16 loss per share, in Q1 2024 [9] - Abeona's total assets decreased to $99.4 million as of March 31, 2025, from $108.9 million as of December 31, 2024 [18] Research and Development Expenses - Research and development expenses increased to $9.9 million for Q1 2025, compared to $7.2 million for the same period in 2024, primarily due to increased headcount for ZEVASKYN's commercial launch [8] - General and administrative expenses rose to $9.8 million in Q1 2025 from $7.1 million in Q1 2024, reflecting increased staffing for the ZEVASKYN launch [8] Sales and Market Access - Abeona entered into a sales agreement for a priority review voucher (PRV) for gross proceeds of $155 million, which will fund operations for over two years [6] - Abeona has executed value-based agreements with commercial payer groups covering approximately 100 million commercially-insured lives to ensure broad access to ZEVASKYN [5] - The company is actively discussing further access expansion for ZEVASKYN with multiple commercial and government payers [5]
MiNK Therapeutics(INKT) - 2025 Q1 - Quarterly Results
2025-05-15 11:30
Financial Performance - MiNK Therapeutics reported a cash balance of $3.2 million at the end of Q1 2025, down from $4.6 million at the end of Q4 2024[10] - Cash used in operations for Q1 2025 was $1.3 million, a decrease of 48% compared to $2.5 million in Q1 2024[8] - The net loss for Q1 2025 was $2.8 million, or $0.70 per share, compared to a net loss of $3.8 million, or $1.10 per share, in Q1 2024[8] - Research and development expenses decreased to $1.3 million in Q1 2025 from $2.6 million in Q1 2024, reflecting a reduction of 50%[14] Clinical Development - MiNK is actively enrolling patients in a Phase 2 trial for gastric cancer, with new data showing promising results in PD-1–resistant tumors[6] - The company is pursuing broader patient access through clinical trials and compassionate use programs for its iNKT therapy in ARDS[6] - A peer-reviewed publication is expected in the first half of 2025 detailing a complete remission case in a patient with metastatic testicular cancer treated with agenT-797[6] Strategic Initiatives - MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in GvHD, with a formal award expected by June 2025[6] - The company is engaged in advanced discussions for strategic partnerships in oncology, immune-mediated diseases, and next-generation engineered cell therapies[3] - MiNK's iNKT platform is positioned to deliver off-the-shelf therapies to patients with urgency, focus, and scale, leveraging clinical advances and expanded access to non-dilutive capital[2]
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
Financial Performance - As of March 31, 2025, the company reported an accumulated deficit of $321.3 million, up from $308.9 million as of December 31, 2024[199]. - Revenues for the three months ended March 31, 2025, were $13.6 million, a decrease of 22.3% compared to $17.5 million for the same period in 2024[232]. - The net loss attributable to the company for the three months ended March 31, 2025, was $12.4 million, compared to a net loss of $9.8 million in the same period of 2024[232]. - Adjusted EBITDA loss for the three months ended March 31, 2025, was $8.3 million, an increase from a loss of $5.1 million in the same period of 2024[232]. - Total revenue decreased by $3.8 million, or 21.9%, to $13.6 million for the three months ended March 31, 2025, from $17.5 million for the same period in 2024[274]. - Gross profit for the three months ended March 31, 2025, was $8.8 million, down from $11.6 million in 2024, reflecting a gross profit margin of 64.2% compared to 66.6%[272]. - Loss from operations increased to $9.5 million for the three months ended March 31, 2025, compared to a loss of $7.8 million in 2024[272]. Cash and Financing - The company had cash and cash equivalents of $3.2 million as of March 31, 2025, compared to $4.3 million as of December 31, 2024[199]. - Cash provided by financing activities for the three months ended March 31, 2025, was $5.3 million, primarily from short-term bridge financing[315]. - The company expects to use proceeds from various financing activities for general working capital purposes[301]. - The company entered into a Loan and Security Agreement on April 23, 2024, providing for a term loan of $2.2 million and additional delayed draw term loans of up to $2.8 million[216]. - The company generated gross proceeds of $6.7 million from the 2022 Private Placement, completed on November 18, 2022[206]. - The company completed multiple placements under the 2023 Multi-Tranche Private Placement, raising a total of $5.0 million through various transactions[209][210][211]. - The company may issue up to $9.0 million in shares of Senior Preferred Stock under the 2023 Multi-Tranche Private Placement, with the initial placement generating $2.0 million from the sale of 280,899 shares[298]. Operational Challenges - The company has incurred recurring net operating losses and negative cash flows from operations, indicating ongoing financial challenges[199]. - The company anticipates supply challenges during 2025 due to geopolitical disruptions and inflationary pressures affecting production lead times[245]. - The U.S. Federal administration has increased tariffs on goods imported from Israel to 10%, impacting the company's cost of goods and potentially leading to margin erosion[243][245]. - The company has ceased direct sales operations in 14 countries since June 2020, focusing on the U.S. market to improve profitability[239]. - The decline in lease program revenues in the first three months of 2025 was attributed to a strategy prioritizing cash deals and economic uncertainty impacting customers' financing capabilities[252]. Sales and Revenue Sources - Approximately 25% of the company's aesthetic system revenues were derived from internal lease programs in the three months ended March 31, 2025, consistent with the same period in 2024[226]. - Approximately 68% of total system revenues for the three months ended March 31, 2025, were derived from traditional sales, compared to 62% for the same period in 2024[253]. - Revenues from internal financing programs accounted for approximately 25% of total system revenues for both the three months ended March 31, 2025, and 2024[252]. - Revenues from distributor sales decreased to approximately 7% of total system revenues for the three months ended March 31, 2025, down from 13% in 2024[256]. - A total of 196 systems were delivered in the three months ended March 31, 2025, down from 314 systems delivered in the same period of 2024, representing a decline of 37.5%[238]. - The company sold 196 systems in Q1 2025, a decrease of 37.5% from 314 systems sold in Q1 2024, with systems revenue from internal lease programs remaining at approximately 25%[275]. Expenses and Cost Management - Operating expenses totaled $18.3 million for the three months ended March 31, 2025, compared to $19.4 million in 2024, with selling and marketing expenses at $7.0 million[272]. - Total operating expenses were $18.3 million in Q1 2025, a decrease of $1.1 million, or 5.8%, compared to $19.4 million in Q1 2024[279]. - Selling and marketing expenses decreased by $0.4 million, or 5.2%, in Q1 2025, but as a percentage of total revenues, they increased from 42.2% to 51.2%[280]. - General and administrative expenses decreased by $0.5 million, or 5.0%, in Q1 2025, but increased as a percentage of total revenues from 58.6% to 71.4%[281]. - Research and development expenses are expected to increase in absolute dollars as the company continues to invest in new products and technologies[265]. - Research and development expenses decreased by $0.2 million, or 12.8%, in Q1 2025, with an increase in percentage of total revenues from 10.2% to 11.4%[282]. Regulatory and Compliance - The company has received regulatory clearance for twelve novel aesthetic technology platforms, including ARTAS and NeoGraft systems, enhancing its product offerings[229]. - The allowance for expected credit losses as of March 31, 2025, was $3.1 million, representing approximately 11% of gross outstanding accounts receivable, down from $5.3 million or 13% as of March 31, 2024[241][248]. - The allowance for expected credit losses is based on customer account collectability assessments and aging of invoices, reflecting the company's best estimate of probable credit losses[327]. - Warranty accruals are recorded at the time of sale, based on historical costs and management estimates, with a one-year warranty period for systems sold[328]. - Stock-based compensation costs are recognized based on fair values, using the Black-Scholes option-pricing model for estimating stock options[329][330]. Market and Economic Conditions - The company operates directly in 11 international markets through 9 offices, including the United States, Canada, and China[231]. - The company expects a shift in the ratio of lease program sales to traditional sales to approximately 30:70 for the remainder of 2025 and beyond[286]. - The company anticipates that inventory levels will remain relatively flat in the short term but will increase at a lower rate than revenue growth over the longer term[286]. - The company is restricted by covenants in its loan agreements, which may limit its ability to incur additional indebtedness[306]. Accounting and Reporting - Revenue is recognized based on ASC 606, which includes five steps for contract identification and performance obligation satisfaction[323]. - Long-term receivables are related to internal lease programs with payment terms exceeding one year, discounted at implicit interest rates between 8% and 10%[325]. - Recent accounting pronouncements are detailed in the quarterly report, affecting financial statement presentation and recognition[333]. - As a smaller reporting company, the company is not required to provide disclosures about market risk[334].
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 ...