Financial Performance - Revenue recognized from the License and Collaboration Agreement with Biogen for the three months ended March 31, 2025 was $152.4 million, compared to no revenue for the same period in 2024[7] - Net income for the three months ended March 31, 2025 was $112.9 million, or $1.90 per diluted share, compared to a net loss of $26.4 million, or $0.57 per share for the same period in 2024[7] - Total revenue for the first quarter of 2025 was $158.6 million, compared to $4.2 million for the same period in 2024[16] Expenses - Research and development expenses for the three months ended March 31, 2025 were $32.7 million, compared to $22.4 million for the same period in 2024, including a one-time $8.2 million sublicense fee associated with the Biogen agreement[7] - General and administrative expenses for the three months ended March 31, 2025 were $14.7 million, compared to $10.2 million for the same period in 2024[7] Cash Position - As of March 31, 2025, the company had $380.3 million in cash, cash equivalents, and marketable securities, expected to fund operations beyond the second half of 2027 and into launch readiness projected for mid-2028[1] Collaboration with Biogen - The collaboration with Biogen includes an upfront payment of $165 million, with potential milestone payments of up to $385 million and tiered royalties on net sales[3] - The company retains exclusive rights for zorevunersen in the United States, Canada, and Mexico, while Biogen has exclusive commercialization rights for the rest of the world[3] Clinical Trials - The company plans to initiate the Phase 3 EMPEROR study in the second quarter of 2025, with an expected data readout in the second half of 2027[3] - The Phase 3 study will evaluate two loading doses of 70mg followed by two maintenance doses of 45mg over 52 weeks in children and adolescents with Dravet syndrome[4]

Financial Position - Altimmune reported cash, cash equivalents, and short-term investments totaling $150 million as of March 31, 2025[10]. - The company secured a $100 million credit facility with Hercules Capital to enhance financial flexibility and support pemvidutide development[5]. Research and Development - Research and development expenses for Q1 2025 were $15.8 million, down from $21.5 million in Q1 2024, reflecting a decrease in clinical trial costs[10]. - Phase 2 trials for Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are set to initiate in Q2 and Q3 2025, respectively[2]. - Top-line data from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) is expected in Q2 2025[1]. - A total of 212 participants were randomized in the IMPACT Phase 2b trial, exceeding the original plan of 190 participants[6]. - The proportion of participants achieving MASHResInd responses exceeded 90% after 24 weeks of treatment in the Phase 1b trial, indicating potential high rates of MASH resolution[6]. - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH, with top-line results from the ongoing IMPACT Phase 2b trial expected in late June 2025[9]. Expenses and Losses - General and administrative expenses increased to $6.0 million in Q1 2025 from $5.3 million in Q1 2024, primarily due to a $0.5 million rise in stock compensation and labor-related expenses[10]. - Net loss for Q1 2025 was $19.6 million, or $0.26 per share, compared to a net loss of $24.4 million, or $0.34 per share, in the same period in 2024[10].

Financial Performance - First quarter 2025 net revenues reached $221.0 million, a 19.1% increase from $185.6 million in the prior year period[4] - The net loss for the first quarter 2025 was $9.8 million, reflecting a 54.2% improvement compared to a net loss of $21.3 million in the prior year period[4] - Adjusted EBITDA for the first quarter 2025 was $42.1 million, a 56.4% increase from $26.9 million in the prior year period[4] - Net revenues for Q1 2025 reached $220,972,000, a 19.1% increase from $185,600,000 in Q1 2024[19] - The company reported a net loss of $9,786,000 for Q1 2025, an improvement of 54.2% compared to a net loss of $21,346,000 in Q1 2024[19] - Adjusted EBITDA for Q1 2025 was $42,060,000, compared to $26,894,000 in Q1 2024, reflecting a significant increase[20] - The net income (loss) margin improved to (4.4)% in Q1 2025, compared to (11.5)% in Q1 2024[20] Operational Metrics - Submissions in the first quarter 2025 totaled 303,026, marking a 40.2% increase from 216,148 submissions in the prior year period[4] - The number of submissions increased by 40.2%, reaching 303,026 in Q1 2025, compared to 216,148 in Q1 2024[24] - Sales per submission decreased to $724 in Q1 2025, down 15.4% from $856 in Q1 2024[24] - Direct operating cost per submission improved to $522, an 18.4% decrease from $640 in the prior year period[4] - Direct operating cost per submission improved to $522 in Q1 2025, a reduction of 18.4% from $640 in Q1 2024[24] Revenue Sources - The company experienced a significant increase in commission revenue, which rose to $167,109,000 from $79,733,000 year-over-year[22] - Commissions receivable - current decreased to $207,443,000 as of March 31, 2025, down from $320,399,000 at the end of 2024[23] Strategic Initiatives - GoHealth launched GoHealth Protect, expanding its product offerings into guaranteed acceptance life insurance[4] - The company aims to enhance cash flow generation and reduce acquisition costs through the scaling of the new life insurance offering[3] - Investments in high-return initiatives are expected to drive continued momentum in future quarters[3] - The company is focused on refining its platform and technology to improve consumer experience and outcomes[3] - GoHealth's proprietary technology platform leverages machine-learning algorithms to match health plans to consumer needs[7]

Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a major response rate (MRR) of 58.2%, exceeding the FDA's statistical hurdle of 20%[102] - The overall response rate (ORR) in evaluable patients was 83.6%, with 98.2% of patients experiencing disease control[102] - Iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[102] - The CLOVER-WaM study reported a median duration of response not reached with 11.4 months of follow-up, and 76% of patients remained progression-free at a median follow-up of eight months[102] - The CLOVER-2 Phase 1a pediatric study for iopofosine has been conducted internationally at seven leading pediatric cancer centers[103] - The Phase 2a study reported a 100% ORR in six WM patients, with an average treatment-free survival of 330 days[128] - The Phase 2 study in triple class refractory MM patients showed a 40% ORR, with patients receiving >60 mCi typically exhibiting greater responses[129] - The Phase 1a pediatric study determined the maximum tolerated dose of iopofosine to be greater than 60 mCi/m²[118] - The CLOVER-2 Phase 1b study is evaluating two different doses of iopofosine in r/r pediatric patients with high-grade gliomas[118] - In the ongoing CLOVER-1 Phase 2 clinical study, approximately 91% of patients experienced a reduction in tumor markers, with about 73% experiencing a reduction greater than 37%[138] - In the Phase 1 study for pediatric patients, initial data showed disease control in heavily pretreated patients with ependymomas, confirming that iopofosine crosses the blood-brain barrier[140] - In the Phase 1 study of iopofosine in combination with external beam radiation therapy (EBRT) for head and neck cancer, complete remission was achieved in 64% of patients, with an ORR of 73%[143] - The overall survival rate at 12 months in the head and neck cancer study was 67%, with a progression-free survival rate of 42%[143] Financial Performance - Research and development expenses for Q1 2025 were approximately $3.43 million, a decrease of 52% from $7.09 million in Q1 2024[148] - General and administrative expenses for Q1 2025 were approximately $2.97 million, down 39% from $4.91 million in Q1 2024[149] - The company reported a net loss of approximately $6.6 million for the three months ended March 31, 2025[151] - Cash used for operations during Q1 2025 was approximately $9.4 million, with a consolidated cash balance of approximately $13.9 million as of March 31, 2025[151] - Other income (expense), net, for Q1 2025 was an expense of approximately $340,000, significantly reduced from $14.96 million in Q1 2024[150] - The company plans to secure additional capital through equity and/or debt securities to improve liquidity[151] - The company has raised substantial doubt about its ability to continue as a going concern due to ongoing operating losses[152] Strategic Initiatives - The company plans to initiate a Phase 1 imaging and dose escalation safety study for CLR 121225 in the second half of 2025, subject to financing[99] - CLR 121125 is prepared for a Phase 1b dose-finding study in the second half of 2025, also contingent on obtaining additional financing[101] - The company is exploring a full range of strategic alternatives, including mergers, acquisitions, and partnerships, to advance its platform and drug development pipeline[98] - The company is evaluating other alpha-emitting isotopes in preclinical studies and has ongoing collaborations to enhance its product pipeline[106][107] - Management is considering strategic alternatives, including mergers and acquisitions, to address liquidity concerns[151] Regulatory Designations - The company has received Fast Track Designation from the FDA for iopofosine in multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[104] - The FDA granted multiple designations for iopofosine, including Fast Track and Orphan Drug Designation (ODD) for various malignancies[119] - The FDA granted Fast Track Designation for iopofosine in WM for patients who have received two or more prior treatment regimens[134] Adverse Events - The most common grade ≥3 adverse events at the highest dose (75 mCi TBD) included thrombocytopenia (65%), neutropenia (41%), and leukopenia (30%), with no patients experiencing cardiotoxicities or neurological toxicities[133]

Financial Performance - The company reported an accumulated deficit of approximately $399.1 million as of March 31, 2025, compared to $395.4 million as of December 31, 2024[76]. - For the three months ended March 31, 2025, the company recorded a net loss of $3.8 million, a decrease from a net loss of $8.6 million for the same period in 2024, representing a reduction of approximately 56%[76]. - Net cash used in operating activities was approximately $4.1 million for the three months ended March 31, 2025, compared to $6.1 million for the same period in 2024[107][109]. - The net loss for the three months ended March 31, 2025, was $3.8 million, down from a net loss of $8.6 million in the same period of 2024[108][109]. Expenses - Research and development expenses decreased to $1.4 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024, a decrease of approximately 67%[90]. - General and administrative expenses remained constant at $2.5 million for both the three months ended March 31, 2025, and 2024[91]. - Investment income decreased to $158 thousand for the three months ended March 31, 2025, down from $358 thousand in the same period of 2024, a decrease of approximately 44%[93]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials as it seeks regulatory approval for product candidates[104]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates, as none have been approved for commercialization[82]. - The company has not generated any revenue from product sales to date, only collaborative revenue from a licensing agreement with Janssen[104]. Cash and Financing - As of March 31, 2025, the company had approximately $17.4 million in cash, cash equivalents, and restricted cash, which is expected to meet operating commitments for the next 12 months[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[105]. - The company believes its existing cash and equivalents will be sufficient to meet cash commitments for at least the next 12 months[105]. - A $60 million payment from Royalty Pharma for the sale of royalty interests in seltorexant is recorded as a liability related to future royalties[104]. Regulatory and Operational Outlook - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing the need for additional studies to support its safety and effectiveness[75]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates and supports its operations as a public company[96]. Company Classification and Accounting Policies - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures under the Securities Exchange Act[114]. - Critical accounting policies include research and development costs, goodwill, and liabilities related to future royalties[112].

Financial Performance - Broadwind reported a net loss of ($0.4) million, or ($0.02) per diluted share in Q1 2025, compared to net income of $1.5 million, or $0.07 per diluted share in Q1 2024[4]. - Total revenue for Q1 2025 was $36.8 million, a decline of 2.1% year-over-year, primarily due to lower sales in mining, oil & gas, and natural gas turbine markets[5]. - Adjusted EBITDA for Q1 2025 was $2.4 million, representing 6.4% of total revenue, down from $4.2 million in the prior year[4][9]. - Revenues for Q1 2025 were $36,838,000, a decrease of 2.07% compared to $37,616,000 in Q1 2024[28]. - Gross profit for Q1 2025 was $4,326,000, down 34.67% from $6,637,000 in Q1 2024[28]. - Operating income for Q1 2025 was $184,000, a significant decline from $2,078,000 in Q1 2024[29]. - Net loss for Q1 2025 was $370,000, compared to a net income of $1,510,000 in Q1 2024[29]. Orders and Revenue Segments - Total orders increased by 5% year-over-year to $30.5 million, driven by demand for wind repowering adapters and natural gas turbine content[6][9]. - Total orders for Q1 2025 were $30,455,000, an increase of 5.04% from $28,996,000 in Q1 2024[33]. - The Heavy Fabrications segment saw a revenue increase of 14.7% to $25.2 million, primarily due to higher demand for wind repowering adapters[12]. - The Gearing segment experienced a revenue decline of 28.4% to $6.0 million, mainly due to reduced demand in mining and oil & gas markets[14]. - The Industrial Solutions segment's revenue decreased by 29.3% to $5.6 million, attributed to lower shipments of natural gas turbine content[16]. - Adjusted EBITDA for Q1 2025 was $2,368,000, down 43.14% from $4,170,000 in Q1 2024[36]. - Heavy Fabrications segment revenues increased to $25,248,000 in Q1 2025 from $22,016,000 in Q1 2024[33]. Financial Position - As of March 31, 2025, Broadwind had total cash and availability of $22.6 million, with a net debt to trailing twelve-month adjusted EBITDA ratio of 1.4x[7][10]. - Total current liabilities increased to $45,112,000 in Q1 2025 from $43,557,000 in Q4 2024[26]. - Total stockholders' equity decreased slightly to $59,309,000 in Q1 2025 from $59,400,000 in Q4 2024[26]. - Cash at the end of Q1 2025 was $1,204,000, a decrease from $1,073,000 at the end of Q1 2024[30]. Future Outlook - The company reiterated its full-year 2025 revenue guidance, projecting total revenue between $140 million and $160 million[18]. - Management expects steady improvements in order activity across diverse end-markets for the remainder of the year[8].

Treated first FTD-GRN patient with Dose 2 PBFT02 and enrolled second patient; several additional patients being evaluated for trial eligibility Announced presentation of process development data of a high productivity, suspension-based manufacturing process for PBFT02 at American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting Cash runway into 1Q 2027 PHILADELPHIA – May 13, 2025 – Passage Bio, Inc. (Nasdaq: PASG), a clinical stage genetic medicines company focused on improving the lives of pati ...

Table of Contents LEAP THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware State or other jurisdiction of incorporation or organization 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 ...

EX-99.1 2 uamy_ex991.htm PRESS RELEASE EXHIBIT 99.1 United States Antimony Corporation Reports Record First Quarter 2025 DALLAS, TX / ACCESS Newswire / May 8, 2025 – United States Antimony Corporation ("USAC" or the "Company" or "U.S. Antimony Corporation"), (NYSE: UAMY) reported today its first quarter 2025 financial and operational results. Revenues for the first three months of 2025 increased 128% or $3.9 million, to $7 million. This is compared to the first three months of 2024 of $3.1 million in total ...

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 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: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) (State or other jur ...