Financial Performance - Reported revenue for full year 2025 totaled $791.0 million, a decline of 9.4% year-over-year[6] - Combined pro forma revenue for full year 2025 was $879.6 million, a decline of 13.6% year-over-year[6] - GAAP net income for 2025 was $1.1 billion, compared to a net loss of $215.2 million in the prior year[6] - Pro forma normalized EBITDA for full year 2025 was $90.2 million, a decrease of 13.7% year-over-year[6] - Fourth quarter revenue totaled $207.0 million, a decline of 15.1% year-over-year on a pro forma basis[6] - Reported revenue for FY 2025 was $791,042, a decrease of 9.3% from FY 2024's $872,690[39] - Pro forma revenue for FY 2025 adjusted to $879,600, down 13.6% from FY 2024's $1,017,618[39] - Reported gross profit for FY 2025 was $171,670, a decline of 9.1% compared to FY 2024's $188,766[39] - Pro forma normalized EBITDA for FY 2025 was $90,167, down 13.6% from FY 2024's $104,442[41] Contract Value and Growth Initiatives - Closed total contract value (TCV) of $297.8 million, including $163.8 million of new TCV[6] - New TCV closed in the fourth quarter was $60.2 million, a 53.2% increase year-over-year[6] - The company has strategically invested in sales leadership and AI initiatives to drive growth and operational efficiency[5] - XBP Global aims to stabilize its portfolio and return to growth following the acquisition of Exela Technologies BPA[4] Assets and Liabilities - Total assets increased to $902.097 million as of December 31, 2025, up from $390.421 million in the previous year[31] - Current liabilities totaled $322.043 million, significantly reduced from $1.790206 billion in the previous period[31] - The total stockholder's equity was $87.339 million, a significant improvement from a deficit of $1.456788 billion in the previous year[31] Cash Flow and Expenses - Net cash provided by operating activities for the period was $18,232, compared to a net cash used of $(159,942) in the previous period[37] - Net cash used in investing activities was $(6,336), an increase from $(2,690) in the prior period[37] - Net cash provided by financing activities was $13,109, a significant decrease from $145,264 in the previous period[37] - Selling, general and administrative expenses were $49.669 million, slightly down from $53.946 million in the previous period[34] - Interest expense for the period was $24.237 million, a decrease from $75.226 million in the previous period[34] Impairment and Deficits - The impairment of goodwill was recorded at $320.292 million, indicating a significant write-down[34] - The company reported a net loss of $351.123 million for the same period, compared to a net profit of $1.454658 billion in the previous period[34] - The company’s accumulated deficit reached $351.123 million as of December 31, 2025[31]

Revenue Performance - Reported revenue for full year 2025 totaled $791.0 million, a decline of 9.4% year-over-year[6] - Combined pro forma revenue for full year 2025 was $879.6 million, a decline of 13.6% year-over-year[6] - Fourth quarter revenue totaled $207.0 million, a decline of 15.1% year-over-year on a pro forma basis[6] - The applied workflow automation segment reported revenue of $723.2 million for FY 2025, down 11.4% from FY 2024[7] - The technology segment reported revenue of $67.8 million for FY 2025, an increase of 20.6% from FY 2024[7] - Reported revenue for FY 2025 was $791,042,000, a decrease of 9.3% from $872,690,000 in FY 2024[39] - Pro forma revenue for FY 2025 adjusted to $879,600,000, down 13.6% from $1,017,618,000 in FY 2024[39] Profitability Metrics - GAAP net income for 2025 was $1.1 billion, compared to a net loss of $215.2 million in the prior year[6] - Pro forma normalized EBITDA for 2025 was $90.2 million, a decrease of 13.7% year-over-year[6] - Reported gross profit for FY 2025 was $171,670,000, a decline of 9.1% compared to $188,766,000 in FY 2024[39] - Pro forma gross profit for FY 2025 was $192,335,000, down 12.7% from $220,298,000 in FY 2024[39] - Pro forma net income for FY 2025 was $1,090,175,000, a significant recovery from a loss of $227,294,000 in FY 2024[41] - Net loss for the three months ended December 31, 2025, was $45,286,000, compared to a loss of $134,987,000 for the same period in 2024[41] Cash Flow and Expenses - Cash provided by operating activities for the period was $18,232,000, a recovery from cash used of $159,942,000 in the previous period[37] - Net cash used in investing activities was $6,336,000, compared to $2,690,000 in FY 2024[37] - Net cash provided by financing activities was $13,109,000, a decrease from $145,264,000 in FY 2024[37] - Selling, general and administrative expenses were $49.669 million, slightly down from $53.946 million[34] - The company incurred interest expenses of $24.237 million, down from $75.226 million in the previous period[34] Balance Sheet Highlights - Total assets increased to $902.097 million as of December 31, 2025, up from $390.421 million in the previous year[31] - Current liabilities totaled $322.043 million, significantly reduced from $1.790206 billion in the previous period[31] - The company’s total liabilities decreased to $814.758 million from $1.847209 billion[31] - The impairment of goodwill was recorded at $320.292 million, indicating a significant write-down[34] - Cash and cash equivalents rose to $37.113 million, compared to $11.635 million in the previous period[31] Strategic Focus - The company is focused on stabilizing its portfolio and laying the groundwork for a return to growth through strategic investments in sales leadership and AI initiatives[5] - Closed total contract value (TCV) of $297.8 million, including $163.8 million of new TCV[6]

Clinical Trials and Enrollment - Enrollment completed in two pivotal trials of VDPHL01 for male patients, with topline data expected from Study 302 in 1H 2026 and Study 304 in 2H 2026[1] - Over 1,000 male participants enrolled in Studies 302 and 304, representing one of the largest registration-directed programs for pattern hair loss (PHL) to date[4] - Enrollment ongoing in Study 306, the first Phase 2/3 trial of an oral treatment for female pattern hair loss, expected to enroll over 500 female patients[4] Financial Performance - Cash, cash equivalents, and marketable securities totaled $141.9 million as of December 31, 2025, with an upsized IPO raising approximately $294.8 million completed in February 2026[6][7] - Net loss for the fourth quarter of 2025 was $21.8 million, compared to a net loss of $5.7 million for the same period in 2024[11] - Net loss for the year ended December 31, 2025, was $69,995,000, up from a net loss of $26,488,000 in 2024, reflecting a 164% increase[18] - Total other income, net, for the year ended December 31, 2025, was $2,352,000, compared to $290,000 in 2024, reflecting a significant increase[18] Expenses - Research and development (R&D) expenses increased to $62.1 million for the year ended December 31, 2025, compared to $23.3 million for the previous year[11] - General and administrative (G&A) expenses rose to $10.3 million for the year ended December 31, 2025, compared to $3.5 million for the previous year[11] - Research and development expenses increased to $18,192,000 in Q4 2025 from $4,950,000 in Q4 2024, representing a 267% increase[18] - Total operating expenses rose to $23,011,000 in Q4 2025 compared to $5,971,000 in Q4 2024, marking a 285% increase[18] - Loss from operations for the year ended December 31, 2025, was $72,347,000, compared to $26,778,000 in 2024, a 170% increase[18] Assets and Liabilities - Cash, cash equivalents, and marketable securities increased significantly to $141,862,000 in 2025 from $53,084,000 in 2024, a growth of 167%[20] - Total assets grew to $152,619,000 in 2025, up from $55,535,000 in 2024, indicating a 174% increase[20] - Total liabilities increased to $9,156,000 in 2025 from $4,718,000 in 2024, a rise of 94%[20] - Total stockholders' equity and redeemable convertible preferred stock reached $143,463,000 in 2025, compared to $50,817,000 in 2024, representing a 182% increase[20] Leadership Changes - Mark Neumann appointed as Chief Commercial and Strategy Officer, bringing over 30 years of biopharmaceutical experience[7] Product Development - VDPHL01 is an investigational, orally available non-hormonal drug in Phase 3 development for PHL, with a proprietary extended-release formulation designed to improve efficacy and safety[9] - Anticipated milestones for 2026 include two Phase 3 readouts for men and progress towards a planned NDA submission for VDPHL01[2]

Acquisition and Strategic Partnerships - The company completed the acquisition of dual-targeting CAR-T programs, issuing 8,268,495 shares of common stock as part of the transaction[18]. - The strategic acquisition includes rights to TPST-2003, TPST-2206, TPST-3003, and TPST-3206, enhancing the company's oncology pipeline[19]. - The company entered into a license agreement with Novatim, with potential milestone payments totaling up to $1.32 billion[112]. - The company entered into a collaboration agreement with Roche in February 2021 to accelerate the development of amezalpat, which is currently being evaluated in a Phase 1b/2 clinical study[121]. Clinical Development and Trials - Amezalpat (TPST-1120) is Phase 3-ready for first-line hepatocellular carcinoma (HCC), with positive Phase 2 data showing a six-month improvement in median overall survival[30]. - The company plans to initiate a Phase 2 study for TPST-1495 in familial adenomatous polyposis (FAP) in 2026, funded by the National Cancer Institute[34]. - TPST-2003, the lead CAR-T therapy, is currently in a Phase 1/2a clinical trial for relapsed or refractory multiple myeloma (rrMM) and aims to initiate a registrational Phase 2b trial in China by the end of 2026[36]. - The planned Phase 3 trial for amezalpat will compare its efficacy with standard care, with a primary endpoint of overall survival[31]. - TPST-3003, an allogeneic dual-targeting CAR-T product, is planned for evaluation in patients with relapsed/refractory multiple myeloma (rrMM) with enrollment potentially beginning in Q3 2026[67]. - TPST-4003, an in vivo dual-targeting CAR-T product, is being developed for lupus, with enrollment in a strategic partner-sponsored trial potentially starting in Q2 2026[70]. - TPST-2206, an autologous dual-targeting CAR-T product for renal cell carcinoma (RCC), is planned for a Phase 1 clinical trial starting in Q2 2026[72]. - The Phase 1 trial of TPST-1495 showed tumor shrinkage and prolonged stable disease in a treatment-refractory patient population, with a tolerable safety profile[108]. Product Efficacy and Outcomes - TPST-2003 demonstrated a complete response (CR) rate of 100% (6/6) among evaluable patients in the REDEEM-1 trial as of January 31, 2026[57]. - Overall response rate (ORR) was 100% (25/25) among 25 evaluable patients with measurable disease at baseline across both studies[58]. - Amezalpat demonstrated a 53% clinical benefit rate in late-line, treatment-refractory cancers, with 21% of patients experiencing tumor shrinkage[82]. - In the ongoing global randomized Phase 1b/2 trial for advanced HCC, the median overall survival (OS) in the amezalpat arm reached 21 months, a 6-month improvement over the 15-month OS in the control arm[90]. - The confirmed overall response rate (ORR) for the amezalpat arm was 30%, compared to 13.3% in the control arm, with a notable 43% ORR in patients with β-catenin mutations[92][93]. - In the combination therapy portion of the trial, 50% of evaluable RCC patients achieved an objective response rate (ORR) of 50%[84]. - A patient in the amezalpat arm converted from a partial response (PR) to a complete response (CR) with at least an 80% reduction in tumor burden[92]. Regulatory Designations and Compliance - The company received Orphan Drug Designation and Fast Track Designation from the FDA for amezalpat, which may provide regulatory benefits[32]. - The company plans to submit an Investigational New Drug (IND) application to the FDA and may initiate a U.S. registrational study in 2026 based on current data[64]. - The FDA requires extensive data demonstrating quality, safety, and efficacy before a new pharmaceutical product can be marketed[149]. - The FDA review process for NDAs typically takes about 10 months for standard reviews and 6 months for priority reviews[164]. - Orphan drug designation can provide a seven-year exclusive marketing period in the U.S. for products that receive the first FDA approval for a rare disease, with additional benefits such as tax credits for research[173]. - Fast track designation allows for expedited review of products intended to treat serious conditions, with the FDA required to determine qualification within 60 days of request[175]. - Breakthrough therapy designation may be granted for products showing substantial improvement over existing therapies, allowing for increased interaction with the FDA during development[176]. - The company must comply with Good Manufacturing Practices (cGMP) to ensure consistent production of its products[167]. Intellectual Property and Patent Strategy - The company has filed patents for amezalpat, expected to expire between December 2033 and November 2043, and for TPST-1495, expected to expire between April 2038 and April 2039[100][110]. - As of February 28, 2026, the company holds one pending U.S. patent application and nine pending patent applications for TPST-2003, with expected patent expiration in March 2044[136]. - The patent portfolio for amezalpat includes ten issued U.S. patents and 68 issued patents in various markets outside the U.S., with expected expiration in December 2033[140][141]. - The company intends to pursue patent protection for its product candidates, including compositions, methods of use, and manufacturing processes[144]. - The patent positions of the company are uncertain, with no consistent policy regarding the scope of claims allowable in oncology patents in the U.S.[147]. - The company faces risks that third parties may have blocking patents, which could hinder commercialization of its product candidates[148]. Market and Competitive Landscape - The company is aware of intense competition in the biopharmaceutical industry, particularly for cancer treatments, with competitors including Merck, Roche, and AstraZeneca[128][130]. - The company faces potential limitations in commercial opportunities if competitors develop more effective or safer products[134]. - Coverage and reimbursement decisions for pharmaceutical products are critical and can vary significantly among third-party payors, impacting product acceptance[191]. - Third-party payors increasingly require discounts and challenge pricing, which can delay coverage and reimbursement for newly approved drugs[193]. - The commercialization of therapeutics outside the U.S. is subject to extensive governmental price controls, impacting pricing and usage[194]. Company Operations and Workforce - As of March 1, 2026, the company had four employees, all full-time, with three holding advanced degrees[210]. - The company aims to attract and retain talent by offering competitive salaries, bonuses, and equity ownership opportunities[211]. - The company emphasizes diversity and inclusion in its workforce, encouraging applications from underrepresented groups in the biotech industry[212]. - The company is committed to maintaining compliance with healthcare laws and regulations, which involves substantial costs and risks[204]. - The current administration's policies may lead to reduced drug prices and increased operational costs for manufacturers[208]. - The company is focused on developing internal expertise in cellular biology and clinical development to enhance its product pipeline[210]. - The company has established a code of business conduct and ethics to ensure appropriate behavior among employees[212]. - The company’s headquarters is located in Brisbane, California, and it was incorporated in Delaware in April 2011[213].

Financial Performance and Condition - The company had cash and cash equivalents totaling $5.4 million as of December 31, 2025, primarily invested in money market funds[586]. - The company had no variable rate debt outstanding as of December 31, 2025, indicating a stable debt profile[587]. - The cash out value of the company's convertible notes is $42.9 million as of December 31, 2025, which exceeds the cash available to the company[437]. - The fair value of the liability associated with the Public Warrants decreased from $13.8 million at the time of the Business Combination to $0.2 million by December 31, 2025[457]. - The fair value of the liability associated with the Earn-Out Shares was initially valued at $53.0 million but dropped to less than $0.1 million by December 31, 2025[458]. Stock and Shareholder Impact - The share price of the company experienced significant volatility in 2025, ranging from a high of $10.43 to a low of $1.13, with daily trading volumes fluctuating between approximately 8,300 and 74,451,700 shares[404]. - Future sales of common stock may lead to dilution of existing shareholders' ownership and could negatively impact the share price[410]. - The issuance of a substantial number of shares of common stock could lead to increased volatility and a decline in the market price of the company's common stock[444]. - In February 2025, the company issued 900,000 shares of common stock and accompanying warrants at an offering price of $5.23 per share, raising approximately $4.7 million[446]. - In November 2025, the company sold 2,994,012 shares of common stock and accompanying warrants at an offering price of $1.67 per share[448]. - As of March 17, 2026, the last quoted sale price for the company's common stock was $0.60 per share, indicating potential negative returns for public securityholders[450]. - As of March 17, 2026, there were 13,206,720 Public Warrants outstanding with an exercise price of $202.50 per share, which are currently "out of the money"[452]. Regulatory and Compliance Issues - The company faces increased costs and demands on management due to compliance with public company regulations, which may adversely affect its financial condition[411]. - The company may face increased legal and financial compliance costs due to changing laws and regulations, impacting its operational efficiency[413]. - The company is classified as an "emerging growth company," allowing it to take advantage of certain exemptions from disclosure requirements, potentially making its securities less attractive to investors[419]. - The company is classified as a "smaller reporting company," allowing it to take advantage of certain exemptions from disclosure requirements until its market value exceeds $250 million or annual revenue exceeds $100 million[422]. - The company has identified material weaknesses in its internal control over financial reporting, including insufficient segregation of duties and lack of experienced staff, which could affect the accuracy of financial results[424][425]. - The company is currently working to remediate these material weaknesses by hiring experienced staff and upgrading its enterprise resource planning system to SAP[426]. Capital and Funding Challenges - The company needs to raise additional capital to execute its business plan, which may not be available on favorable terms due to current market conditions[429]. - The company's public float is below $75 million, limiting its ability to raise capital through primary public offerings under the "baby shelf" rules[430][431]. - Trading of the company's securities on the NYSE was suspended due to failure to meet market capitalization standards, which could adversely impact investor perception and liquidity[432][436]. - The company has received delisting notices from the NYSE and is appealing these determinations, which could result in permanent delisting if unsuccessful[433][435]. Foreign Currency Risks - The company is exposed to foreign currency risks from transactions in currencies other than its functional currency, which may impact operating expenses[588]. - A 10% increase or decrease in current exchange rates could materially impact the company's business, financial condition, or results of operations[589]. - The primary exposure to foreign currency is in Europe, with additional exposure in the Middle East and Asia-Pacific regions[589]. - The company has not engaged in any foreign currency hedging activities to date[590]. - An immediate 10% adverse change in foreign exchange rates during the year ended December 31, 2025, would have impacted revenues by approximately 4% and expenses by 3%, affecting net loss by 2%[590]. - For the year ended December 31, 2024, a similar adverse change would have impacted revenues by approximately 6% and expenses by 3%, also affecting net loss by 2%[590]. Restructuring and Operational Challenges - The company implemented a strategic restructuring in August 2025, incurring costs of approximately $1.8 million primarily for one-time severance benefits[401]. - The company expects to incur unforeseen difficulties and costs from its restructuring efforts, which may disrupt operations and affect financial results[401].

Financial Performance - Tempest reported a net loss of $26.3 million for the year ended December 31, 2025, compared to a net loss of $41.8 million in 2024, representing a 37% improvement[9] - Research and development expenses decreased to $12.6 million in 2025 from $28.5 million in 2024, a reduction of 56%[9] - The company ended 2025 with $7.7 million in cash and cash equivalents, down from $30.3 million at the end of 2024[9] - General and administrative expenses increased slightly to $14.0 million in 2025 from $13.6 million in 2024[10] Clinical Trials and Developments - The ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 showed a 100% complete response rate among six efficacy evaluable patients as of January 31, 2026[6] - TPST-2003 is a dual-targeting CAR-T therapy with a biologics license application (BLA) filing planned in China for 2027[6] - The median progression-free survival (PFS) in a prior investigator-initiated trial reached 23.1 months for patients with extramedullary disease[6] - Tempest plans to initiate a U.S. registrational study of TPST-2003 in patients with relapsed/refractory multiple myeloma later in 2026[3] Strategic Actions - Tempest completed a strategic acquisition of dual-targeting CAR-T assets from Factor Bioscience Inc. in an all-stock transaction[6] - The company announced a registered direct offering of up to $8.35 million in November 2025 and a private placement of up to $6 million in March 2026[6]

Manufacturing and Facilities - The company operates two viral vector production facilities in London and Shannon, with a total capacity of 179,000 square feet, designed to meet GMP requirements for clinical and commercial production[26][27]. - The London facility was re-certified by the MHRA in Q2 2024, ensuring compliance with global regulatory standards[26]. - The London manufacturing facility spans 29,000 square feet and is designed to meet multiple regulatory standards, enabling the production of various product candidates in parallel[143]. - The Shannon facility, operational since 2022, encompasses 150,000 square feet and includes capabilities for viral vector production, plasmid DNA manufacturing, and advanced quality control testing[146]. - The manufacturing capabilities are expected to support both clinical and commercial production, ensuring sufficient capacity for future product approvals[147]. - The internal manufacturing capacity is expected to minimize dependence on third-party contract manufacturers, significantly reducing the cost of goods sold[149]. - Significant investment in internal manufacturing capacity provides better control over process development timelines, costs, product quality, and intellectual property[151]. - The company has over 190 highly trained multidisciplinary staff in manufacturing, quality, and supply teams to expedite gene therapy product delivery[148]. Financial Agreements and Collaborations - In December 2023, the company received a non-refundable upfront cash payment of $65 million from Johnson & Johnson Innovative Medicine as part of an asset purchase agreement[34]. - Future contingent consideration from Johnson & Johnson could total up to $350 million, including milestone payments for the initiation of clinical trials and commercial sales of the RPGR Product[34]. - The collaboration with Hologen Limited includes an upfront cash payment of $200 million and potential additional funding of up to $230 million for the development of gene therapies[35]. - The strategic collaboration with Hologen includes a Framework Agreement for the development and commercialization of gene therapies for Parkinson's disease and other conditions[37]. - The Lilly Collaboration Agreement includes an upfront payment of $75 million and potential milestone payments exceeding $400 million[46]. - Hologen has an exclusive option to purchase additional shares in MeiraGTx Manufacturing, potentially owning 40% of the issued share capital[43]. Clinical Development and Trials - The company has produced GMP clinical trial material for eight different indications using multiple AAV serotypes, demonstrating its manufacturing capabilities[29]. - The company aims to develop vectors for treating neurodegenerative diseases, starting with Parkinson's disease, which affects nearly 1 million Americans[65]. - AAV-GAD gene therapy demonstrated a significant decrease in UPDRS scores by 8.1 points (23.1%) in the treatment group compared to a 4.7 points (12.7%) decrease in the sham group at the six-month endpoint[67]. - The high dose AAV-GAD group showed an 18-point average improvement in UPDRS Part 3 "off" medication score at Week 26 (p=0.03), while no significant change was observed in the sham or low dose groups[72]. - The PDQ-39 score improved by 8 points (p=0.02) in the high dose group and by 6 points (p=0.04) in the low dose group, with 100% of high dose participants reporting improvement[75]. - AAV-GAD was well-tolerated with no significant adverse events related to the therapy reported during the trials[68]. - The Phase 1 bridging study for AAV-GAD included 14 subjects, with doses of 7.0×10^10 vg for low dose and 21×10^10 vg for high dose[71]. - AAV-hAQP1 for treating radiation-induced xerostomia has shown saliva flow increases of 60% to 540% in clinical trials[57]. - The FDA granted orphan drug designation and Breakthrough Therapy Designation to AAV-hAQP1 for treating grade 2 and 3 xerostomia[62]. - MeiraGTx is conducting IND-enabling studies for AAV-hAQP1 targeting xerostomia caused by Sjogren's syndrome[63]. - AAV-UPF1 is being developed to address motor neuron death in ALS, showing reduced motor neuron death in preclinical studies[78]. - AAV-AIPL1 has been manufactured for compassionate use to treat 11 children with LCA4, showing improved visual acuity and functional vision without serious adverse effects[92]. - The first cohort of 4 children treated with rAAV8.hRKp.AIPL1 showed a mean visual acuity improvement from 2.7 LogMAR to 0.9 LogMAR after a mean follow-up of 3.5 years[94]. - All 11 children treated with rAAV8.hRKp.AIPL1 have shown meaningful visual acuity responses, with improvements observed 4 or more weeks post-treatment[95]. - AAV-RPE65, developed for RPE65-associated retinal dystrophy, has an estimated prevalence of 6,000 patients across the U.S., Japan, and several European countries[102]. - AAV-CNGB3 and AAV-CNGA3 are designed to treat achromatopsia, with approximately 12,000 patients estimated in the U.S. and Europe, and about 125 new cases diagnosed annually[106]. - AAV-BBS10 has been manufactured for compassionate use under an MHRA specials license to treat BBS patients, with plans to use data for future clinical development[114]. - AAV-RDH12 received orphan drug designation and rare pediatric disease designation from the FDA for treating RDH12-associated retinal dystrophy[118]. - AAV-RetGC received rare pediatric disease designation from the FDA for treating LCA1 due to GUCY2D mutations in January 2025[119]. - The company is developing gene therapy candidates targeting wet AMD and dry AMD, including a partnership with ZipBio for AI-designed complement inhibitors[121]. - The company has a robust and diverse clinical and preclinical pipeline focusing on gene therapy for ocular disorders, salivary gland disorders, and neurodegenerative diseases[122]. Intellectual Property and Regulatory Matters - The company holds 530 issued or allowed patents and 351 pending patent applications as of December 31, 2025[157]. - The company owns ten patent families related to gene regulation platform technologies, with a total of 180 issued patents and 73 pending applications[159]. - The company has licensed patent families from UCLB, Brandeis University, and NIDCR, enhancing its intellectual property portfolio[171]. - The company anticipates facing intense competition as new drugs enter the market, impacting the commercialization of its treatments[155]. - The company sold rights to a patent family related to the RPGR Product to Johnson & Johnson Innovative Medicine on December 20, 2023[178]. - The company’s patent families related to gene therapy programs are expected to expire between 2033 and 2047, depending on jurisdictional patent term adjustments[177][180]. - The second patent family includes 18 pending applications across multiple jurisdictions, with patents expected to expire on August 4, 2042[183]. - Under the Third UCLB License Agreement, an initial upfront payment of £6,994 was made, along with £100,000 in ordinary shares issued to UCLB[185]. - Sales milestone payments of up to £39.8 million are required under the Stand-Alone UCLB Agreements, along with an annual management fee of £50,000 until certain royalty payments are made[187]. - An upfront payment of £1.5 million and £1.5 million in ordinary shares were paid to UCLB for the CNGB3-related Stand-Alone UCLB Agreement[187]. - Low single-digit percentage royalty payments on net sales of licensed products will commence upon the first commercial sale under each Stand-Alone UCLB Agreement[188]. - The Brandeis Agreement includes developmental and regulatory milestone payments of up to $1.0 million and annual license maintenance fees ranging from $15,000 to $100,000[194]. - The Brandeis Agreement mandates low single-digit percentage royalty payments on net sales of licensed products and mid-teen percentages of sublicensing revenues[194]. FDA Regulations and Compliance - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the safety and efficacy of a biological product[205]. - The FDA recommends observing subjects for potential gene therapy-related delayed adverse events for a 15-year period post-approval[205]. - The FDA requires extensive monitoring and auditing of clinical activities, with annual progress reports and IND safety reports to be submitted promptly[206]. - Phase 1 trials focus on safety in healthy subjects, while Phase 2 evaluates efficacy and safety in a limited patient population, and Phase 3 assesses overall risk/benefit in a larger group[208]. - The FDA aims to complete the review of standard BLAs within ten months and priority reviews within six months after acceptance for filing[215]. - A complete response letter may be issued by the FDA if the BLA does not meet regulatory criteria, detailing specific deficiencies that need to be addressed[218]. - Orphan drug designation can provide financial incentives, including grant funding and user-fee waivers, and grants exclusivity for seven years under certain conditions[223]. - The FDA's Fast Track program expedites the review process for candidates addressing serious conditions and unmet medical needs, allowing for more frequent interactions with the review team[224]. - The manufacturing process must comply with cGMP requirements to ensure consistent production and quality of the biological product candidate[210]. - The FDA may require post-market studies to monitor safety and effectiveness after commercialization, which can affect further marketing of the product[221]. - The sponsor must submit a Pediatric Study Plan within sixty days after an end-of-Phase 2 meeting for products with new indications or active ingredients[212]. - The FDA may withdraw product approval if compliance with pre- and post-marketing requirements is not maintained[220]. Technology and Innovation - The company has developed a proprietary riboswitch platform that allows for precise control of gene expression via orally delivered small molecules, enhancing the delivery of biologic therapeutics[30]. - The proprietary riboswitch technology platform allows for precise, dose-responsive control of gene expression, potentially transforming gene therapy applications[130]. - The riboswitch platform enables the expression of any mRNA and protein via oral dosing, opening new therapeutic targets in metabolism[141]. - The company aims to advance its first riboswitch program for metabolic disease, targeting leptin deficiency with a one-time intramuscular delivery system[137]. - Over 40 gene therapies have received regulatory approval in recent years, indicating a growing acceptance of gene therapy technology[123]. - The company has established relationships with leading institutions to enhance development strategies and facilitate patient enrollment for clinical trials[122]. - The company is pursuing strategic collaborations with biotechnology and pharmaceutical companies to leverage its capabilities and technology[126].

Financial Performance - PAVmed completed a $30 million Series D preferred stock offering and a $15 million senior secured note financing, eliminating all previously outstanding convertible securities[8] - Lucid Diagnostics recognized $1.5 million in EsoGuard Esophageal DNA Test revenue for Q4 2025 and processed 3,664 EsoGuard tests[8] - Operating expenses for Q4 2025 were approximately $6.9 million, including stock-based compensation expenses of $0.3 million[8] - GAAP net loss attributable to common stockholders for Q4 2025 was approximately $1.8 million, or $(2.05) per common share on a diluted basis[8] - Non-GAAP adjusted loss for Q4 2025 was approximately $0.9 million, or $(1.05) per common share[8] - PAVmed had cash and cash equivalents of $1.5 million as of December 31, 2025, compared to $1.2 million as of December 31, 2024[10] Product Development and Regulatory Progress - Veris Health is progressing its implantable physiological monitor toward a planned late 2026 FDA 510(k) submission[8] - PAVmed relaunched its medical device portfolio under new leadership, appointing Joseph Virgilio as Chief Business Officer of Medical Devices[8] - Veris Health's strategic engagement with The Ohio State University's James Cancer Hospital is well underway, with full integration into the hospital's electronic health record system now complete[8] Market and Operational Risks - PAVmed and Lucid's management acknowledges risks and uncertainties that could impact future results, including stock price volatility and market conditions[19] - The companies are focused on advancing their products through regulatory submission, which involves significant costs and time[19] - There is uncertainty regarding whether regulatory authorities will approve PAVmed and Lucid's products based on clinical and preclinical study results[19] - Market acceptance of PAVmed and Lucid's products post-approval is a critical factor for future success[19] - The ability to raise additional funding is essential for PAVmed and Lucid to support their operations and product development[19] - New risks and uncertainties may emerge, making it challenging to predict future outcomes[19] Strategic Partnerships - Lucid Diagnostics was awarded a U.S. Department of Veterans Affairs contract for EsoGuard, expanding access to approximately nine million veterans[8]

Market Projections - Ondas projects North American spending in the Counter-UAS market to reach $6.8 billion by 2028, with European spending growing at a 41.8% CAGR[44]. - The global UGV market is expected to reach approximately $2.48 billion in 2024, expanding at a 6.3% CAGR, with U.S. defense budget for small unmanned systems nearing $748 million for FY2026[46]. - The company targets Tier 1 countries for C-UAS and UGV markets, aggregating over $5.5 billion in combined spending for 2025[44]. - The total addressable market (TAM) for Ondas' Optimus System is estimated to exceed $100 billion, encompassing the global defense, civil UAV, and drone services markets[86]. - The drone market is projected to grow from $83.7 billion in 2025 to $160.6 billion by 2030, with a compound annual growth rate (CAGR) of 14%[87]. - The C-UAS technology market is valued at $3.1 billion in 2025 and is expected to grow at a CAGR of 27.2%, reaching $10.6 billion by 2030[88]. - The North American rail network spans 180,000 miles of track, with an estimated addressable market of approximately $1.3 billion for private railroad networks[90]. Technology and Product Development - Ondas Networks' FullMAX platform is designed to upgrade legacy systems, significantly increasing throughput and supporting modern Internet-Protocol-based communications[52]. - Ondas Networks maintains a leadership role in the evolution of IEEE 802.16 standards, which are critical for mission-critical customers and partners[51]. - The FullMAX platform is designed to optimize performance in underutilized VHF/UHF low frequencies, enhancing broadband network capacity through patented algorithms[84]. - The company’s software-defined radio architecture allows for continuous improvements and over-the-air upgrades, enhancing customer loyalty and network longevity[83]. - Ondas Networks is developing new wireless connectivity solutions for critical infrastructure, targeting sectors such as public safety and transportation[66]. - Ondas Networks is developing technology compatible with the IEEE 802.16t wireless broadband standard, which is expected to enhance market competitiveness if a large customer base develops[133]. - OAS offers integrated autonomous mission solutions, including the Optimus System™ and Iron Drone Raider™, designed for various defense and security applications[73]. Strategic Growth and Partnerships - Ondas Capital aims to enhance long-term value creation through targeted investments and strategic partnerships, particularly focusing on strengthening OAS[55]. - Ondas Capital aims to enhance growth through minority investments and strategic partnerships to support its operating businesses[56]. - The company plans to scale its Strategic Growth program through targeted acquisitions, enhancing mission performance and broadening market coverage[60]. - The company’s growth strategy includes attracting new customers and expanding the range of products and services offered[130]. - The company is closely monitoring the impact of military operations in Israel on its operations, with potential risks to production and delivery capabilities[180]. Financial Performance and Risks - As of December 31, 2025, the company had an accumulated deficit of approximately $368.4 million, up from $236.4 million in 2024[120]. - The company expects operating expenses to increase significantly as it pursues growth strategies, including substantial investments in research, development, and marketing[121]. - Two customers accounted for approximately 55% and 11% of revenue during the year ended December 31, 2025, indicating significant dependence on a small number of customers[129]. - The company has incurred significant operating losses since inception and cannot assure that it will achieve or sustain profitability in the future[120]. - Material delays or defaults in customer payments could adversely affect the company's ability to cover project expenditures[143]. - The lengthy sales cycle for products can lead to cancellations or changes in customer plans, impacting revenue expectations[145]. - The company faces risks related to the volatile nature of certain components, which could lead to production delays and adversely affect financial results[155]. - The company may face difficulties in integrating acquired businesses, which could adversely affect revenues and earnings due to potential issues with infrastructure and technology systems[175]. Regulatory and Compliance Issues - The company believes it is in material compliance with all applicable regulatory requirements, which is crucial for its operations[107]. - The company is subject to various government regulations, and failure to comply could result in sanctions that negatively impact business operations[195]. - Changes in the regulatory environment for small UAS could restrict the expansion of drone solutions to industrial and government customers in the U.S.[190]. - The company is subject to evolving regulations regarding product safety and consumer protection, which may increase compliance costs and penalties for non-compliance[196]. - New laws and regulations concerning privacy and data protection, such as the California Consumer Privacy Act, may impose operational requirements and increase costs[199]. Supply Chain and Operational Risks - The company maintains multiple contract manufacturers to mitigate supply chain risks and ensure competitive pricing[91]. - The reliance on a small number of manufacturers exposes the company to risks related to quality assurance and supply chain disruptions[139]. - The company relies on a limited group of suppliers for critical components, which poses risks of supply shortages and price fluctuations[171]. - There is a global shortage of semiconductors affecting the market for electronic components, creating uncertainty in the supply chain[172]. - The company does not have long-term supply contracts with guaranteed pricing, exposing it to fluctuations in raw material and component prices[173]. - The company may face increased costs from tariffs on imported components used in its products, potentially leading to supply chain disruptions[209]. Intellectual Property and Competitive Risks - The company holds a total of 21 issued patents in the U.S. and 31 international patents, with expiration dates ranging from 2026 to 2042[208]. - The company’s ability to protect its intellectual property is uncertain, with risks of competitors circumventing patents or developing comparable products[210]. - Enforcement of intellectual property rights may be costly and time-consuming, with potential litigation risks impacting management focus[213]. - The company has not received any claims regarding intellectual property infringement to date, but future claims could adversely impact revenue and earnings[215]. - The company relies on unpatented technology and trade secrets, which may be at risk of misappropriation, potentially harming its competitive position[216]. Employee Relations - The company has approximately 459 full-time employees and 36 part-time employees as of December 31, 2025[111]. - The company has a good relationship with its employees, with no employees covered by collective bargaining agreements[111].

Acquisition and Divestitures - On July 25, 2024, the company acquired Scienture LLC, a specialty pharmaceutical company focused on cardiovascular and central nervous system diseases, which launched its first product for hypertension and is commercializing a second product for opioid overdose [406]. - The company completed the acquisition of Superlatus on July 31, 2023, with shareholders receiving an aggregate value of $225,000,169 at the time of closing [413]. - The company divested several subsidiaries, including Community Specialty Pharmacy and Alliance Pharma Solutions, to streamline operations and focus on high-growth opportunities in the branded and specialty pharma markets [422]. Financial Performance - As of December 31, 2025, the company had cash and cash equivalents of $6,662,008 and positive working capital of approximately $5,181,000, an improvement of approximately $6,782,000 from a working capital deficit of $(1,601,416) as of December 31, 2024 [427]. - Revenues for the year ended December 31, 2025, were $431,609, an increase of $294,966 or approximately 216% compared to $136,643 in 2024, driven by initial sales of ARBLI™ [435]. - Net cash used in operating activities from continuing operations for the year ended December 31, 2025 was $13,382,482, compared to $13,286,163 for the year ended December 31, 2024, with a net loss of $43,507,142 being the primary driver [430]. - The company reported a net cash provided by financing activities from continuing operations of $19,733,595 for the year ended December 31, 2025, compared to a net cash used of approximately $12,980,000 for 2024 [432]. - The company had an accumulated deficit of $80,551,237 as of December 31, 2025, indicating ongoing financial challenges despite improvements in working capital [427]. - For the year ended December 31, 2025, adjusted EBITDA was $(5,384,274), a significant decrease from $17,820,898 in 2024 [449]. - The net loss for 2025 was $(41,512,264), compared to a net income of $9,065,798 in 2024 [449]. Operating Expenses and Costs - Total operating expenses increased to $42,922,324 in 2025 from $14,707,020 in 2024, primarily due to non-cash impairment charges of $26,346,050 recognized in 2025 [436]. - Professional fees rose by $949,490 to $2,407,822 in 2025, mainly due to higher external consulting costs related to commercialization activities [436]. - Interest expense increased to $4,083,206 in 2025 from $1,335,631 in 2024, reflecting a full year of amortization of debt discount and interest on convertible notes [437]. - The company recognized non-cash impairment charges of $26,346,050 in 2025, impacting adjusted EBITDA [449]. - Depreciation and amortization expenses increased to $491,781 in 2025 from $53,361 in 2024 [449]. - Stock-based compensation (non-cash) increased to $6,378,981 in 2025 from $4,623,878 in 2024 [449]. Product Development and Sales - The company commenced sales of ARBLI™ in the third quarter of 2025 following FDA approval in March 2025, marking a significant milestone in its product offerings [435]. - The company expects to fund operations for at least the next twelve months from its existing cash balance and revenues generated from the commercialization of ARBLI™, which commenced in Q3 2025, and REZENOPY, anticipated to start in Q2 2026 [424]. - The company anticipates revenue growth from ARBLI™ and REZENOPY in 2026, contributing to its liquidity outlook [428]. Tax and Regulatory Matters - The company recognized an income tax benefit of $1,994,878 in 2025, reflecting changes in deferred tax liabilities attributable to the impairment charges [437]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures [452]. - The company did not have any off-balance sheet arrangements during the reported periods [450].