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Elevation Oncology(ELEV) - 2025 Q1 - Quarterly Results
2025-05-15 11:45
Boston, Mass. May 15, 2025 – Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced financial results for the quarter ended March 31, 2025, and provided recent business updates. "We recently presented preclinical proof-of-concept data for EO-1022, reaffirming its potential as a differentiated HER3 ADC, and supporting ou ...
Pyxis Oncology(PYXS) - 2025 Q1 - Quarterly Report
2025-05-15 11:41
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 Commission File Number: 001-40881 Pyxis Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1160910 | | --- | --- | | (State or other jurisdiction of | (I.R. ...
Abeona Therapeutics(ABEO) - 2025 Q1 - Quarterly Report
2025-05-15 11:35
Financial Performance - Net loss for the three months ended March 31, 2025, was $12,029 thousand, compared to a net loss of $31,578 thousand for the same period in 2024, representing a 61.9% improvement[15] - The company experienced a net cash used in operating activities of $18,402 thousand for the three months ended March 31, 2025, compared to $14,538 thousand for the same period in 2024, indicating a 26.5% increase in cash outflow[21] - Abeona Therapeutics reported net losses of $12.0 million and $31.6 million for the three months ended March 31, 2025, and 2024, respectively, with an accumulated deficit of approximately $825.3 million as of March 31, 2025[27] - Total expenses for the three months ended March 31, 2025, were $19,727 thousand, compared to $14,330 thousand for the same period in 2024, reflecting a 37.5% increase[15] Assets and Liabilities - Total current assets decreased from $100,853 thousand as of December 31, 2024, to $88,121 thousand as of March 31, 2025, a decline of approximately 12.7%[13] - Total liabilities decreased from $64,900 thousand as of December 31, 2024, to $57,968 thousand as of March 31, 2025, a reduction of about 10.7%[13] - The company’s total stockholders' equity decreased from $44,031 thousand as of December 31, 2024, to $41,396 thousand as of March 31, 2025, a decrease of about 6.0%[13] - Cash and cash equivalents decreased from $23,357 thousand as of December 31, 2024, to $15,936 thousand as of March 31, 2025, a decline of approximately 31.7%[13] Research and Development - Research and development expenses increased to $9,941 thousand for the three months ended March 31, 2025, up from $7,207 thousand in the same period of 2024, an increase of 38.1%[15] - For the three months ended March 31, 2025, total research and development costs amounted to $9.941 million, an increase of 38.1% from $7.207 million in the same period of 2024[106] Financing and Capital Structure - The Company raised $75 million gross from the sale of 12,285,056 shares of common stock and pre-funded warrants on May 7, 2024, with net proceeds of $70.2 million[75] - Under the ATM Agreement, the Company sold 1,312,283 shares of common stock during the three months ended March 31, 2025, resulting in net proceeds of $6.8 million[77] - The Company has a financial covenant requiring it to maintain at least $5 million in unrestricted cash at all times[67] - The Company has a total of 16,028,297 potential dilutive securities that could affect future net loss per share calculations[37] Debt and Obligations - The Company has a total long-term debt of $19,286,000 as of March 31, 2025, with current maturities of $8,148,000[63] - The Company has a total principal payment obligation of $20 million, with $5.926 million due in 2025, $8.889 million in 2026, and $5.185 million in 2027[71] - The effective interest rate on the Company's loans as of March 31, 2025, was 22.09%[65] Revenue and Milestones - The Company has not recognized any significant revenues to date and may continue to incur operating losses until ZEVASKYN™ can provide sufficient revenue[27] - The Company has not recognized any revenue during the three months ended March 31, 2025, from event-based milestone payments related to the sublicense agreements[95] - The Company is subject to remaining milestone payments totaling approximately $0.2 million due upon FDA approval of ZEVASKYN™ on April 28, 2025[89] Stock and Equity - The weighted average number of common shares outstanding increased from 27,315,537 for the three months ended March 31, 2024, to 49,778,801 for the same period in 2025, an increase of 82.3%[15] - Total stock-based compensation expense for the three months ended March 31, 2025, was $2,701,000, a 74.5% increase from $1,546,000 in the same period of 2024[85] - As of March 31, 2025, there were 5,250,307 restricted stock awards outstanding, with a grant date fair value per unit of $4.79[88] Regulatory and Approvals - On April 28, 2025, the FDA approved ZEVASKYN™ as the first and only autologous cell-based gene therapy for treating wounds in patients with RDEB[108] - The Company entered into an exclusive license agreement with Ultragenyx for AAV gene therapy ABO-102, with potential royalties ranging from mid-single-digit percentages up to 10% on net sales and up to $30 million in commercial milestone payments[100]
Precision BioSciences(DTIL) - 2025 Q1 - Quarterly Report
2025-05-15 11:34
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: 001-38841 Precision BioSciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 20-4206017 (State o ...
MEDTECH ACQUISIT(MTAC) - 2025 Q1 - Quarterly Results
2025-05-15 11:34
Share Issuance and Compliance - The Company agrees to sell shares of its common stock at a price of $4.00 per share[54] - The total purchase amount for each Investor is specified in Exhibit A attached to the Agreement[54] - The Closing Date for the sale of shares will occur no earlier than one business day and no later than five business days after the date of the Agreement[55] - The Company will issue the shares in book-entry form, free and clear of all restrictive legends at the Closing[55] - The Company represents that its capitalization disclosure in SEC Reports was accurate in all material respects as of the indicated date[58] - All issued and outstanding shares of Common Stock are fully paid and non-assessable[58] - The Company is not currently under any obligation to register any of its outstanding securities under the Securities Act, except as disclosed in the SEC Reports[59] - The Company has duly authorized the issuance and sale of Shares, ensuring compliance with applicable securities laws[60] - The Shares will be fully paid and non-assessable, issued free of any liens or restrictions, and holders will have all rights accorded to Common Stock[62] - The Company has filed all required forms and reports with the SEC, ensuring compliance with the Exchange Act[66] - The Company is not subject to any disqualification events under Rule 506(d)(1) of Regulation D[92] - The Company will file a Current Report on Form 8-K by 9:00 a.m. New York City time on the first business day following the agreement date, disclosing all material terms of the transactions and non-public information concerning the Company[124] - The Company will not issue shares of Common Stock or Common Stock Equivalents for 60 days post-closing without prior consent from the Investor Majority[137] - The Company will ensure that no conflicting agreements interfere with its obligations to the Investors under the Transaction Agreements[132] - The Company must ensure compliance with all listing requirements for the Common Stock on a National Exchange[147] Financial Performance and Projections - The Company reported a significant increase in revenue, achieving $150 million in Q3 2023, representing a 25% year-over-year growth[1] - User data showed a 40% increase in active users, reaching 2 million by the end of Q3 2023[2] - The Company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a growth rate of 20% to 30% compared to Q4 2022[3] - New product launches are anticipated to contribute an additional $20 million in revenue in the next quarter[4] Strategic Initiatives and Investments - The Company is investing $10 million in R&D for new technologies aimed at enhancing user experience and product efficiency[5] - Market expansion efforts include entering three new international markets, projected to increase user base by 15%[6] - The Company is exploring potential acquisitions to bolster its market position, with a budget of $50 million allocated for this purpose[7] - A strategic partnership was announced, expected to enhance distribution channels and increase sales by 10% over the next year[8] Operational Compliance and Risk Management - The Company has filed all required tax returns and paid all necessary taxes, with no material tax assessments pending[75] - The Company is in compliance with all applicable Environmental Laws and has received all necessary permits, with no material adverse effects expected from any noncompliance[76] - The Company maintains good and marketable title to all material personal property, free of liens and encumbrances[78] - The Company carries adequate insurance customary for its business, with no notices of cancellation or denial of coverage received since January 1, 2024[79] - The Company has conducted clinical trials in accordance with regulatory protocols, with no notices of required termination or suspension from Regulatory Agencies[83] - The Company is in compliance with all applicable Health Care Laws and has not received any claims or actions alleging violations[84] - The Company maintains a system of internal control over financial reporting designed to ensure reliability and compliance with GAAP[86] - The Company has not engaged in any actions to stabilize or manipulate the price of its Common Stock[87] - The Company must ensure that all representations and warranties are true and correct in all material respects as of the Closing Date[139] - The Company is required to perform all obligations and conditions prior to the Closing Date[140] - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the transaction to proceed[141] - No event should occur that would reasonably be expected to have a Material Adverse Effect since the date of the Agreement[142] - The Company must ensure that no stop order or suspension of trading has been imposed by regulatory bodies regarding the Common Stock[147] - The Company must provide a lock-up agreement executed by its officers and directors to the Placement Agent[151] - The Company must execute and deliver the Registration Rights Agreement to the Investors[146] Investor Relations and Support - The Company has entered into Support Agreements with holders of more than 50% of its outstanding Preferred Stock, indicating strong support from key investors[100] - The Company will indemnify and hold harmless each Investor from losses or claims resulting from breaches of representations or warranties made under the Transaction Agreements[133] - The Company will use commercially reasonable efforts to satisfy obligations set forth in the Support Agreements[136] - The Company acknowledges that Investors have relied on independent investigations and SEC Reports in making investment decisions[118] - The Company will not disclose the names of any Investors or their affiliates without prior written consent, except as required by law[124] Corporate Governance and Compliance - The Company has been in compliance with the Sarbanes-Oxley Act of 2002 since January 1, 2024[81] - The Company and its subsidiaries have all necessary governmental authorizations for their operations, with no violations that would have a Material Adverse Effect[71] - The Company owns or has rights to all necessary intellectual property for its business operations, with no known infringements[72] - The Company is in material compliance with all applicable data privacy laws, including HIPAA and GDPR, and has maintained accurate privacy statements to customers and employees[98] Sustainability and Long-term Goals - The Company emphasized its commitment to sustainability, planning to reduce operational costs by 5% through energy-efficient practices[9] - The management team expressed confidence in achieving long-term growth targets, aiming for a 50% increase in overall market share by 2025[10]
TriSalus Life Sciences(TLSI) - 2025 Q1 - Quarterly Results
2025-05-15 11:34
NOW THEREFORE, in consideration of the mutual agreements, representations, warranties and covenants herein contained, the Company and each Investor, severally and not jointly, agree as follows: 1. Definitions. As used in this Agreement, the following terms shall have the following respective meanings: Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this "Agreement") is dated as of April 30, 2025, by and among TriSalus Life Sciences, Inc., a Delaware corporation (the "Company") ...
Acuren Corp(TIC) - 2025 Q1 - Quarterly Report
2025-05-15 11:32
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 Commission file number 001-42524 Acuren Corporation (Exact name of registrant as specified in its charter) | Delaware | 66-1076867 | | -- ...
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].