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BK Technologies(BKTI) - 2025 Q2 - Quarterly Results
2025-08-14 11:04
[Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) This section provides an overview of the company's strong Q2 2025 performance, including CEO commentary and key financial highlights [CEO Commentary and Business Update](index=1&type=section&id=CEO%20Commentary%20and%20Business%20Update) The CEO highlighted strong Q2 2025 operational execution, achieving higher-than-expected gross margins and improved profitability - Delivered strong operational performance in Q2 2025, with gross margins reaching **47.4%**[3](index=3&type=chunk) - Federal order activity increased significantly after the quarter, highlighted by **$12.9 million** in purchase orders from the USDA Forest Service, suggesting a strong outlook for the second half of the year[3](index=3&type=chunk)[5](index=5&type=chunk) - Launched RelayONE, a new rapid deployment portable repeater kit, and received the first purchase order from the Latimer County Sheriff's Office in Colorado[3](index=3&type=chunk) [Q2 2025 Financial Highlights](index=1&type=section&id=Q2%202025%20Financial%20Highlights) BK Technologies reported strong Q2 2025 financial results, with revenue at **$21.2 million** and gross margin significantly improving to **47.4%** Q2 2025 Key Financial Metrics vs. Q2 2024 | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Revenue | $21.2 million | $20.3 million | | Gross Margin | 47.4% | 37.3% | | GAAP Diluted EPS | $0.96 | $0.47 | | Non-GAAP Adj. Diluted EPS | $1.30 | $0.55 | [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) This section analyzes the company's Q2 and first-half 2025 financial performance, including balance sheet insights [Second Quarter 2025 Financial Review](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Review) Q2 2025 revenue increased **4.5%** to **$21.2 million**, with gross margin expanding to **47.4%** Q2 2025 vs. Q2 2024 Performance | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $21.2M | $20.3M | +4.5% | | Gross Margin | 47.4% | 37.3% | +10.1 p.p. | | Operating Income | $4.0M | $2.0M | +100% | | Net Income | $3.7M | $1.7M | +117.6% | - The improvement in gross margin was driven by a favorable product mix and ongoing cost savings from operational efficiencies and outsourced manufacturing[7](index=7&type=chunk) - Selling, General & Administrative (SG&A) expenses rose to **$6.0 million** from **$5.5 million** year-over-year, reflecting continued investments in sales, marketing, and engineering[8](index=8&type=chunk) [Six Months 2025 Financial Review](index=3&type=section&id=Six%20Months%202025%20Financial%20Review) First-half 2025 revenue grew **4.5%** to **$40.2 million**, with gross margin improving to **47.2%** First Half 2025 vs. First Half 2024 Performance | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $40.2M | $38.5M | +4.5% | | Gross Margin | 47.2% | 35.9% | +11.3 p.p. | | Operating Income | $6.9M | $3.0M | +130% | | Net Income | $5.9M | $2.3M | +157.4% | [Balance Sheet and Working Capital](index=3&type=section&id=Balance%20Sheet%20and%20Working%20Capital) As of June 30, 2025, working capital increased to **$28.9 million**, driven by higher cash and receivables - Working capital totaled approximately **$28.9 million** at June 30, 2025, an increase from **$23.0 million** at December 31, 2024[11](index=11&type=chunk) - Cash, cash equivalents, and trade receivables grew to **$23.4 million**, up from **$14.4 million** at the end of 2024[11](index=11&type=chunk) Key Balance Sheet Items (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,853 | $7,075 | | Total current assets | $44,833 | $36,941 | | Total liabilities | $23,663 | $21,668 | | Total stockholders' equity | $36,763 | $29,831 | [Full Year 2025 Outlook](index=2&type=section&id=Full%20Year%202025%20Outlook) BK Technologies has raised its full-year 2025 financial guidance due to strong year-to-date performance and robust demand Updated Full Year 2025 Guidance | Metric | New Guidance | Prior Guidance | | :--- | :--- | :--- | | Revenue Growth | High single digits | Single-digit growth | | Gross Margin | > 47% | > 42% | | GAAP Diluted EPS | $3.15 | $2.40 | | Non-GAAP Adj. Diluted EPS | $3.80 | $2.80 | - The upward revision is attributed to strong demand, leverage in the business model, and confidence in sustaining higher performance levels[6](index=6&type=chunk) [Appendix](index=5&type=section&id=Appendix) This section provides supplementary information, including non-GAAP financial measures and detailed financial statements [Use of Non-GAAP Measures](index=5&type=section&id=Use%20of%20Non-GAAP%20Measures) The company uses non-GAAP financial measures to supplement GAAP statements, offering clearer insight into core operational performance - Adjusted EBITDA is used to help investors understand operational factors by excluding interest, taxes, depreciation, amortization, stock-based compensation, and other infrequent charges[21](index=21&type=chunk) - Adjusted EPS adjusts GAAP EPS for items that management does not see as reflective of core operating performance, such as stock-based compensation and one-time charges related to manufacturing transition and tax provisions[22](index=22&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section provides unaudited condensed consolidated financial statements for Q2 and H1 2025, including key financial statements and non-GAAP reconciliations [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 income statement shows net sales of **$21.2 million** and net income of **$3.7 million** Q2 & H1 2025 Income Statement Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Sales, net | $21,165 | $20,254 | $40,219 | $38,485 | | Operating income | $3,997 | $2,025 | $6,913 | $3,008 | | Net income | $3,741 | $1,664 | $5,873 | $2,345 | | Diluted EPS | $0.96 | $0.47 | $1.51 | $0.66 | [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the balance sheet indicates total assets of **$60.4 million** Balance Sheet Summary (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Total current assets | $44,833 | $36,941 | | Total assets | $60,426 | $51,499 | | Total liabilities | $23,663 | $21,668 | | Total stockholders' equity | $36,763 | $29,831 | [Reconciliation of Non-GAAP Financial Measures](index=10&type=section&id=Reconciliation%20of%20Non-GAAP%20Financial%20Measures) This table reconciles GAAP Net Income to non-GAAP Adjusted EBITDA and Adjusted Earnings for Q2 2025 Q2 2025 GAAP to Non-GAAP Reconciliation (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Income (GAAP) | $3,741 | $1,664 | | Adjusted EBITDA (Non-GAAP) | $4,417 | $2,489 | | Adjusted Earnings (Non-GAAP) | $5,055 | $1,974 | | Adjusted EPS - diluted (Non-GAAP) | $1.30 | $0.55 |
ABVC BioPharma(ABVC) - 2025 Q2 - Quarterly Results
2025-08-14 11:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 193 ...
Larimar Therapeutics(LRMR) - 2025 Q2 - Quarterly Results
2025-08-14 11:02
Exhibit 99.1 study. • Strengthened Balance Sheet With $65.1 Million Public Offering: In July 2025, Larimar announced a public offering of common stock with net proceeds of $65.1 million supported by existing and new leading healthcare investors that extends its projected cash runway into the fourth quarter of 2026. Larimar Therapeutics Reports Second Quarter 2025 Financial Results *Pro forma cash, cash equivalents, and marketable securities of $203.6 million reflects $138.5 million of cash, cash equivalents ...
Onconova Therapeutics(ONTX) - 2025 Q2 - Quarterly Results
2025-08-14 11:01
Exhibit 99.1 Traws Pharma Reports Second Quarter 2025 Results and Business Highlights Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation ...
Traws Pharma, Inc.(TRAW) - 2025 Q2 - Quarterly Results
2025-08-14 11:01
[Executive Summary & Business Highlights](index=1&type=section&id=executive_summary_business_highlights) [Company Overview and Strategic Focus](index=1&type=section&id=company_overview_strategic_focus) Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including SARS-CoV-2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM), with a strategic shift towards antivirals as both therapeutic and prophylactic agents - Traws Pharma is a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, including SARS-CoV-2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM)[3](index=3&type=chunk) - Antivirals are emphasized for their dual therapeutic (eliminating viral infections) and prophylactic (preventing viral infections or spreading) benefits, unlike vaccines[3](index=3&type=chunk) [CEO's Strategic Reprioritization](index=1&type=section&id=ceo_strategic_reprioritization) The Interim CEO, Iain D. Dukes, announced a reprioritization of clinical trial plans to enhance short and medium-term shareholder value, focusing on advancing ratutrelvir for COVID-19 (including PAXLOVID-ineligible patients and Long COVID) and engaging BARDA for TXM's inclusion in influenza drug stockpiling - Traws has reprioritized clinical trial plans to reflect potential short and medium-term shareholder value[4](index=4&type=chunk) - For the COVID program, a Phase 2 study of ratutrelvir (ritonavir-free) has been submitted to HREC to evaluate safety and efficacy against PAXLOVID in newly diagnosed COVID patients, and separately, in PAXLOVID-ineligible patients, with results expected by year-end 2025[4](index=4&type=chunk) - For the influenza program, constructive discussions with BARDA are ongoing regarding the inclusion of TXM in the drug stockpiling initiative, which represents the major short-to-medium-term commercial potential[4](index=4&type=chunk) PAXLOVID Sales Performance (Q2 2025) | Metric | Q2 2025 Sales | | :----- | :------------ | | PAXLOVID | $427 million | | YoY Increase | 70% | [CMO & CSO Perspectives on Public Health Needs](index=2&type=section&id=cmo_cso_perspectives_public_health_needs) The CMO and CSO highlighted the ongoing public health challenges posed by COVID and influenza, emphasizing the limitations of current treatments (drug-drug interactions, rebound infections, Long COVID risk), believing Traws' ritonavir-free COVID and once-daily flu candidates can overcome these shortcomings - COVID and influenza continue to mutate and pose critical threats, with close to **one million hospitalizations** and **tens of thousands of deaths** reported in the 2024-2025 virus season[5](index=5&type=chunk) - Current COVID treatments like PAXLOVID are often contraindicated in vulnerable populations due to ritonavir-based drug-drug interactions and can result in rebound infections and long-term viral syndromes[5](index=5&type=chunk) - Traws' ritonavir-free COVID (ratutrelvir) and once-daily flu (TXM) candidates are believed to have the potential to overcome current treatment shortcomings and become the new standard of care[5](index=5&type=chunk) - Ratutrelvir's emerging profile, based on broad activity against resistant strains and good overall tolerability for once-daily dosing, could position it for wide adoption, especially in vulnerable individuals, and potentially reduce rebound and Long COVID risk[5](index=5&type=chunk) [Recent Highlights and Anticipated Milestones](index=3&type=section&id=recent_highlights_anticipated_milestones) [Ratutrelvir (COVID Program)](index=3&type=section&id=ratutrelvir_covid_program) Ratutrelvir is an investigational ritonavir-independent oral Mpro inhibitor for acute COVID infection, with potential to reduce rebound and Long COVID, including in PAXLOVID-ineligible patients; Phase 1 data showed sustained plasma levels and no adverse events, supporting its best-in-class potential, with a Phase 2 non-inferiority study against PAXLOVID planned to start soon in Australia - Ratutrelvir is a ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed for potential once-daily, 10-day dosing for acute COVID infection[6](index=6&type=chunk)[8](index=8&type=chunk) - It is intended for acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVID, including in PAXLOVID-ineligible patients[8](index=8&type=chunk) - The U.S. market opportunity for COVID treatment is estimated to be a **multi-billion dollar market**[8](index=8&type=chunk) - Phase 1 studies showed ratutrelvir maintained plasma drug levels **four times above the EC90** over a 10-day treatment period in healthy volunteers, with no drug-induced metabolism or treatment-related adverse events, suggesting a novel, best-in-class therapy[8](index=8&type=chunk) - Next steps include initiating dosing in a Phase 2 non-inferiority study in Australia comparing ratutrelvir to PAXLOVID in newly diagnosed COVID patients, and a single-arm study for PAXLOVID-ineligible patients[8](index=8&type=chunk) [Tivoxavir Marboxil (Influenza Program)](index=3&type=section&id=tivoxavir_marboxil_influenza_program) Tivoxavir Marboxil (TXM) is a single-dose investigational CAP-dependent endonuclease inhibitor for bird flu and seasonal flu, with a multi-billion dollar U.S. market opportunity, largely driven by stockpiling initiatives; Phase 1 data showed sustained plasma levels and good tolerability, and preclinical studies demonstrated compelling protection against mortality and disease in multiple animal models against H5N1 virus, with discussions with BARDA for stockpiling advancing - TXM is a single-dose, investigational CAP-dependent endonuclease inhibitor for the treatment or prevention of H5N1 bird flu and seasonal flu[6](index=6&type=chunk)[8](index=8&type=chunk) - The U.S. market opportunity is estimated to be a **multi-billion dollar market**, including potential for stockpiling in the short- to medium-term[8](index=8&type=chunk) - Phase 1 data showed TXM maintained plasma blood levels above the EC90 for approximately **three weeks** after a single oral dose with good overall tolerability[8](index=8&type=chunk) - TXM demonstrated compelling protection against mortality and disease in three well-accepted flu models (mice, ferrets, non-human primates) using H5N1 virus, reducing viral burden and increasing survival[8](index=8&type=chunk) - Next steps include advancing discussions with BARDA and other regulatory agencies regarding TXM's inclusion in drug stockpiling initiatives for pandemic preparedness[8](index=8&type=chunk) [Legacy Oncology Programs](index=3&type=section&id=legacy_oncology_programs) Traws' strategic objective for its legacy oncology assets, rigosertib and narazaciclib, is to establish additional partnerships for further development; rigosertib, intended for RDEB SCC, showed a compelling overall response rate of 80% (50% complete responses) in clinical efficacy data published in the British Journal of Dermatology, highlighting its potential for an ultra-rare disease with substantial unmet need - Traws' strategic objective for its legacy oncology assets (rigosertib and narazaciclib) is to establish additional partnerships for further development[6](index=6&type=chunk)[22](index=22&type=chunk) - Rigosertib is intended for the treatment of recessive dystrophic epidermolysis bullosa associated locally advanced or metastatic squamous cell carcinoma (RDEB SCC), an ultra-rare, complicated monogenic disease with a substantial unmet need and no approved therapies[7](index=7&type=chunk)[13](index=13&type=chunk) - Key clinical efficacy data for rigosertib in RDEB SCC showed a compelling **overall response rate of 80%**, with **complete responses in 50%** of evaluable patients and good overall tolerability[13](index=13&type=chunk) - Traws is actively seeking partnership opportunities to support further development of rigosertib[13](index=13&type=chunk) [Corporate Updates](index=5&type=section&id=corporate_updates) [Management Updates](index=5&type=section&id=management_updates) Traws Pharma announced several management changes, including Jack Stover being named Chairman of the Board and Charles Parker appointed Interim Chief Financial Officer, while Iain D. Dukes transitioned to Board Member with expanded responsibilities as Interim CEO - Jack Stover was named Chairman of the Board on April 15, 2025[13](index=13&type=chunk) - Iain D. Dukes transitioned to Board Member, with expanded responsibilities as Interim Chief Executive Officer (announced March 31, 2025)[13](index=13&type=chunk) - Charles Parker was named Interim Chief Financial Officer (CFO) on July 5, 2025[13](index=13&type=chunk) [Conference Call and Webcast Information](index=5&type=section&id=conference_call_webcast_information) Traws hosted a conference call on August 14, 2025, at 8:30 AM ET to discuss Q2 results and pipeline progress, with a replay available on the Investors section of their website - Traws hosted a conference call on August 14, 2025, at 8:30 AM ET to discuss its Q2 results and pipeline progress[9](index=9&type=chunk) - A replay of the webcast is available on the Investors section of the Traws website[10](index=10&type=chunk) [Financial Results](index=5&type=section&id=financial_results) [Q2 2025 Financial Highlights](index=5&type=section&id=q2_2025_financial_highlights) Traws Pharma reported a significant increase in Q2 2025 revenue to $2.7 million, primarily from deferred revenue recognition, a substantial reduction in net loss to $0.9 million due to the absence of a prior year's one-time charge for acquired in-process R&D, and reductions in cash, R&D, and G&A expenses [Cash, Cash Equivalents and Short-Term Investments](index=5&type=section&id=cash_cash_equivalents_short_term_investments) As of June 30, 2025, Traws Pharma reported approximately $13.1 million in cash, cash equivalents, and short-term investments, a decrease from $21.3 million as of December 31, 2024 Cash, Cash Equivalents and Short-Term Investments | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash, cash equivalents, and short-term investments | $13.1 million | $21.3 million | -$8.2 million | [Revenue](index=5&type=section&id=revenue) Revenue for Q2 2025 significantly increased to $2.7 million from $57 thousand in Q2 2024, primarily due to the recognition of deferred revenue from the mutual termination of a legacy oncology licensing agreement Revenue (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------- | :-------- | :-------- | :----- | | Revenue | $2,733,000 | $57,000 | +$2,676,000 | - The increase in Q2 2025 revenue was attributable to **$2.7 million** in deferred revenue recognized from the mutual termination of a licensing agreement associated with a legacy oncology program[12](index=12&type=chunk) [Operating Expenses](index=6&type=section&id=operating_expenses) Total operating expenses for Q2 2025 decreased significantly to $3.98 million from $123.41 million in Q2 2024, primarily due to the absence of a large one-time charge for acquired in-process R&D from the prior year, with R&D and G&A expenses also seeing reductions Total Operating Expenses (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :---------- | :----- | | Total Operating Expenses | $3,982,000 | $123,405,000 | -$119,423,000 | [Research and Development (R&D) Expense](index=6&type=section&id=research_development_expense) R&D expense for Q2 2025 decreased by $1.7 million to $2.3 million compared to $4.0 million in Q2 2024, mainly due to reduced oncology program and personnel expenses, partially offset by increased virology program expenses Research and Development Expense (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :---------------------- | :-------- | :-------- | :----- | | Research and Development | $2,291,000 | $3,964,000 | -$1,673,000 | - The decrease was primarily related to a decrease in expenses for the oncology program and personnel expenses, partially offset by an increase in expenses for virology programs[14](index=14&type=chunk) [General and Administrative (G&A) Expense](index=6&type=section&id=general_administrative_expense) G&A expense for Q2 2025 decreased by $0.3 million to $1.7 million from $2.0 million in Q2 2024, mainly due to lower personnel-related expenses and stock-based compensation, partially offset by higher professional and consulting fees General and Administrative Expense (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------------ | :-------- | :-------- | :----- | | General and Administrative | $1,691,000 | $1,977,000 | -$286,000 | - The decrease was primarily attributable to a decrease in personnel-related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees[15](index=15&type=chunk) [Net Income (Loss)](index=6&type=section&id=net_income_loss) Traws Pharma reported a net loss of $0.9 million ($0.11 per share) for Q2 2025, a substantial improvement from a net loss of $123.1 million ($20.52 per share) in Q2 2024, which included a one-time charge of $117.5 million for acquired in-process R&D Net Income (Loss) (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------------------------ | :-------- | :---------- | :----- | | Net (loss) income | $(915,000) | $(123,143,000) | +$122,228,000 | | Net (loss) income per share, basic | $(0.11) | $(20.52) | +$20.41 | - The significant improvement in net loss was due to the inclusion of a one-time charge of **$117.5 million** for acquired in-process research and development in the comparable period of 2024[15](index=15&type=chunk) [Shares Outstanding](index=6&type=section&id=shares_outstanding) As of August 13, 2025, Traws had 7,063,829 shares of common stock outstanding Shares Outstanding | Metric | As of August 13, 2025 | | :---------------------- | :-------------------- | | Common Stock Outstanding | 7,063,829 shares | [Condensed Consolidated Balance Sheets](index=9&type=section&id=condensed_consolidated_balance_sheets) As of June 30, 2025, total assets were $15.62 million, down from $24.96 million at December 31, 2024, primarily driven by a decrease in cash and cash equivalents; total liabilities also decreased significantly to $7.36 million from $56.59 million, largely due to the reduction in warrant liabilities and deferred revenue, while stockholders' equity turned positive to $8.26 million from a deficit of $31.63 million Condensed Consolidated Balance Sheets Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------ | :------------ | :---------------- | :----- | | Total assets | $15,622,000 | $24,962,000 | -$9,340,000 | | Cash and cash equivalents | $13,081,000 | $21,338,000 | -$8,257,000 | | Total current assets | $15,370,000 | $24,951,000 | -$9,581,000 | | Total liabilities | $7,360,000 | $56,592,000 | -$49,232,000 | | Warrant liabilities | $8,000 | $42,494,000 | -$42,486,000 | | Deferred revenue (current & non-current) | $0 | $2,791,000 | -$2,791,000 | | Total stockholders' equity (deficit) | $8,262,000 | $(31,630,000) | +$39,892,000 | [Condensed Consolidated Statements of Operations](index=10&type=section&id=condensed_consolidated_statements_of_operations) For the six months ended June 30, 2025, Traws reported a net income of $20.58 million, a significant turnaround from a net loss of $128.13 million in the prior year period, driven by a substantial increase in revenue and a large positive change in the fair value of warrant liability, alongside the absence of the prior year's acquired in-process R&D charge Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 6 Months 2025 | 6 Months 2024 | Change | | :------------------------------------ | :------------ | :------------ | :----- | | Revenue | $2,790,000 | $113,000 | +$2,677,000 | | Acquired in-process R&D | $0 | $117,464,000 | -$117,464,000 | | Total operating expenses | $9,242,000 | $128,673,000 | -$119,431,000 | | Net (loss) income | $20,575,000 | $(128,126,000) | +$148,701,000 | | Net (loss) income per share, basic | $2.02 | $(37.45) | +$39.47 | | Change in fair value of warrant liability | $26,659,000 | $0 | +$26,659,000 | [Product Information](index=6&type=section&id=product_information) [About Ratutrelvir](index=6&type=section&id=about_ratutrelvir) Ratutrelvir is an investigational oral, small molecule Mpro inhibitor for SARS-CoV-2/COVID-19, designed to be ritonavir-independent to avoid drug-drug interactions and enable wider patient use; Phase 1 data showed sustained target blood plasma levels, potentially reducing clinical rebound and Long COVID risk, with the COVID treatment market representing a potential multi-billion dollar opportunity - Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed as a broadly acting, ritonavir-independent treatment for SARS-CoV-2/COVID-19[17](index=17&type=chunk) - It aims to avoid ritonavir-associated drug-drug interactions, potentially enabling wider patient use, and has demonstrated in vitro activity against a range of virus strains[17](index=17&type=chunk) - Phase 1 data showed maintenance of target blood plasma levels approximately **13 times above the EC50**, which may reduce the likelihood of clinical rebound and the risk for Long COVID[17](index=17&type=chunk) - The COVID treatment market represents a potential **multi-billion dollar opportunity**[17](index=17&type=chunk) [About Tivoxavir Marboxil](index=6&type=section&id=about_tivoxavir_marboxil) Tivoxavir marboxil (TXM) is an investigational oral, single-dose CAP-dependent endonuclease inhibitor for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains, including H5N1, and consistent positive preclinical data across three animal species demonstrating therapeutic effect against H5N1 bird flu; the seasonal influenza antiviral market is a multi-billion dollar opportunity, with additional upside from potential pandemic outbreaks and stockpiling initiatives - Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza[18](index=18&type=chunk) - It has shown potent in vitro activity against a range of influenza strains, including a human isolate of the highly pathogenic avian flu H5N1[18](index=18&type=chunk) - Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu[18](index=18&type=chunk) - The seasonal influenza antiviral market is an estimated **multi-billion dollar opportunity**, largely driven by global health organizations, practice guidelines, government tenders, and inclusion in drug stockpiling initiatives, with upside potential from pandemic flu outbreaks[18](index=18&type=chunk) [About Traws Pharma, Inc.](index=7&type=section&id=about_traws_pharma_inc) Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel oral small molecule antiviral agents for critical respiratory viral diseases like COVID-19/Long COVID (Ratutrelvir, Mpro inhibitor) and bird flu/seasonal influenza (Tivoxavir marboxil, CEN inhibitor), also seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib - Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases[21](index=21&type=chunk) - The company is advancing novel investigational oral small molecule antiviral agents: Ratutrelvir (ritonavir-independent COVID treatment, Mpro inhibitor) and Tivoxavir marboxil (single-dose bird flu and seasonal influenza treatment, CEN inhibitor)[21](index=21&type=chunk) - Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib[22](index=22&type=chunk) [Additional Information](index=8&type=section&id=additional_information) [Forward-Looking Statements](index=8&type=section&id=forward_looking_statements) The release contains forward-looking statements regarding Traws' business, product candidates, market opportunities, clinical and regulatory plans, and legacy programs; these statements involve known and unknown risks and uncertainties, including clinical trial success, regulatory interactions, market conditions, and the ability to raise capital, with Traws undertaking no obligation to update these statements except as required by law - The release contains forward-looking statements regarding the Company, its business and product candidates, including potential opportunity, market size, benefits, effectiveness, safety, and clinical/regulatory plans[25](index=25&type=chunk) - These statements involve known and unknown risks, uncertainties, and other factors, including the success and timing of clinical trials, interactions with regulatory bodies (FDA, BARDA), market conditions, and the ability to raise additional capital[25](index=25&type=chunk) - Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law[25](index=25&type=chunk) [Contact Information](index=8&type=section&id=contact_information) Contact information for Traws Pharma (Charles Parker) and Investor Relations (John Fraunces of LifeSci Advisors, LLC) is provided for inquiries - Contact information for Traws Pharma (Charles Parker) and Investor Contact (John Fraunces, LifeSci Advisors, LLC) is provided[26](index=26&type=chunk)
Biotricity (BTCY) - 2026 Q1 - Quarterly Report
2025-08-14 11:01
Part I – Financial Information [Condensed Consolidated Interim Financial Statements](index=3&type=section&id=Item%201%20%E2%80%93%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Presents Biotricity's unaudited interim financial statements, detailing balance sheets, operations, cash flows, and notes [Condensed Consolidated Interim Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) Total assets increased to $6.04 million, liabilities grew to $36.84 million, and stockholders' deficiency widened to $32.80 million Condensed Consolidated Balance Sheet Highlights (in USD) | Balance Sheet Item | June 30, 2025 (Unaudited) | March 31, 2025 (Audited) | | :--- | :--- | :--- | | **Total Current Assets** | $5,144,540 | $4,639,292 | | **Total Assets** | $6,037,319 | $5,640,954 | | **Total Current Liabilities** | $21,806,321 | $20,636,148 | | **Total Liabilities** | $36,835,946 | $35,655,054 | | **Total Stockholders' Deficiency** | ($32,798,917) | ($32,014,390) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue increased to **$3.87 million**, gross profit rose to **$3.12 million**, and profit from operations reached **$281,945** Statement of Operations Summary (in USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Revenue** | $3,873,993 | $3,201,743 | | **Gross Profit** | $3,116,800 | $2,363,168 | | **(Loss) Profit from Operations** | $281,945 | ($1,116,846) | | **Net Loss Attributable to Common Stockholders** | ($754,293) | ($6,948,292) | | **Loss Per Share, Basic and Diluted** | ($0.029) | ($0.490) | [Condensed Consolidated Interim Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Net cash used in operating activities reduced to **$373,389**, with a net increase in cash of **$62,316**, ending with **$391,292** Cash Flow Summary (in USD) | Cash Flow Activity | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($373,389) | ($1,494,240) | | **Net cash provided by (used in) financing activities** | $435,705 | $868,180 | | **Net decrease in cash during the period** | $62,316 | ($626,060) | | **Cash, end of period** | $391,292 | $100,731 | [Notes to the Condensed Consolidated Interim Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Details accounting policies, going concern, revenue, convertible notes, derivatives, and equity changes - The company has incurred recurring losses, resulting in an accumulated deficit of **$140,196,078** and a working capital deficiency of **$16,661,781** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern[20](index=20&type=chunk) Revenue Breakdown (in USD) | Revenue Source | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Technology fees | $3,371,392 | $3,016,250 | | Device sales | $502,601 | $185,493 | | **Total** | **$3,873,993** | **$3,201,743** | - During the quarter ended June 30, 2025, the company issued **$850,000** in unsecured convertible promissory notes to private investors and repaid a **$100,000** note from the prior fiscal year[123](index=123&type=chunk) - Subsequent to the quarter end, between July 1 and August 14, 2025, the company issued an additional **$694,197** in convertible notes and used the proceeds to redeem **$500,000** of other convertible notes[213](index=213&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202%20%E2%80%93%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, highlighting positive profit from operations, revenue growth, and going concern [Company Overview](index=44&type=section&id=Company%20Overview) Biotricity is a medical technology company focused on cardiac diagnostics, offering biometric monitoring and AI tools - The company's business model focuses on earning utilization-based recurring technology fee revenue by placing devices with clinically focused, repeat users[219](index=219&type=chunk) - Biotricity is expanding its AI technology development in remote cardiac care, using proprietary AI to create predictive monitoring tools for new disease profiling and improved patient management[231](index=231&type=chunk) - The company has monitored over **two billion heartbeats**, benefiting over **28,000 patients** diagnosed with atrial fibrillation (afib), a leading cause of strokes[230](index=230&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Achieved first-ever profit from operations of **$281,945**, revenue up **21%** to **$3.9 million**, and gross margin at **80.5%** - The company reported its first-ever positive profit from operations and positive EBITDA for the quarter ended June 30, 2025[237](index=237&type=chunk)[250](index=250&type=chunk) Key Operational Results (in USD) | Metric | Q1 FY2026 (ended June 30, 2025) | Q1 FY2025 (ended June 30, 2024) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $3,873,993 | $3,201,743 | +21.0% | | **Gross Profit** | $3,116,800 | $2,363,168 | +31.9% | | **Gross Margin** | 80.5% | 73.8% | +6.7 pts | | **Profit (Loss) from Operations** | $281,945 | ($1,116,846) | +$1,398,791 | | **Net Loss before Dividends** | ($671,977) | ($3,694,520) | +$3,022,543 | EBITDA and Adjusted EBITDA (in USD) | Metric | 3 months ended June 30, 2025 | 3 months ended June 30, 2024 | | :--- | :--- | :--- | | **EBITDA** | $333,337 | ($1,779,631) | | **Adjusted EBITDA** | $289,368 | ($1,056,380) | [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) Substantial doubt about going concern due to losses and working capital deficit, despite positive Free Cash Flow - Management has noted the existence of substantial doubt about the company's ability to continue as a going concern, and its independent auditor included an explanatory paragraph in its report[257](index=257&type=chunk) - The company had a cash balance of approximately **$0.4 million** as of June 30, 2025[269](index=269&type=chunk) Free Cash Flow (in USD) | Metric | 3 months ended June 30, 2025 | 3 months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($373,389) | ($1,494,240) | | Add: Interest expense | $850,254 | $768,673 | | **Free Cash Flows** | **$476,865** | **($725,567)** | [Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203%20%E2%80%93%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Disclosure not required as Biotricity Inc. qualifies as a smaller reporting company - Not required for a smaller reporting company[282](index=282&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes to internal controls - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[284](index=284&type=chunk) - There were no changes in the Company's internal controls over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[285](index=285&type=chunk) Part II – Other Information [Legal Proceedings](index=55&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[288](index=288&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=55&type=section&id=Item%202%20%E2%80%93%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[290](index=290&type=chunk) [Other Information](index=55&type=section&id=Item%205%20%E2%80%93%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the quarter ended June 30, 2025[294](index=294&type=chunk) [Exhibits](index=55&type=section&id=Item%206%20%E2%80%93%20Exhibits) Lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL financial data - The report includes the following exhibits: - Certifications pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002 - Inline XBRL Document Set for the financial statements[296](index=296&type=chunk)
Sacks Parente Golf(SPGC) - 2025 Q2 - Quarterly Report
2025-08-14 11:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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: 001-41701 NEWTON GOLF COMPANY, INC. (Exact name of registrant as specified in its charter) | Large, accelerated f ...
FitLife Brands(FTLF) - 2025 Q2 - Quarterly Report
2025-08-14 11:00
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 June 30, 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. | | | Name of each exchange on which | | --- | --- | --- | | Title of each class | Trading Symbol(s) | registered | | C ...
Evoke Pharma(EVOK) - 2025 Q2 - Quarterly Report
2025-08-14 11:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 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 June 30, 2025 OR EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-8447886 (State or other jurisdiction of incorporation) (IRS Employer Id ...
Predictive Oncology (POAI) - 2025 Q2 - Quarterly Results
2025-08-14 11:00
PITTSBURGH, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), a science- driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended June 30, 2025, and provided a corporate update. The Company reported a loss from continuing operations of approximately ...