Operations and Facilities - As of September 30, 2025, Ardent Health operates 30 acute care hospitals and approximately 280 sites of care, employing 1,917 providers, marking a 3.0% increase in affiliated providers compared to the previous year[139]. - The company operates 13 acute care hospital facilities in Texas, with a total of 1,436 licensed beds[160]. - The company generated 35.8% of total revenue from the Texas market, 23.6% from Oklahoma, and 17.1% from New Mexico for the nine months ended September 30, 2025[160][161]. Financial Performance - Total revenue for the three months ended September 30, 2025, increased by $126.9 million, or 8.8%, compared to the same period in the prior year, driven by a 5.8% increase in net patient service revenue per adjusted admission and a 2.9% increase in adjusted admissions[167]. - For the nine months ended September 30, 2025, total revenue increased by $359.5 million, or 8.2%, with net patient service revenue per adjusted admission rising by 5.7%[168]. - Medicare accounted for 38.0% of total revenue for the three months ended September 30, 2025, while Medicaid represented 9.8% and other managed care accounted for 44.5%[171]. - Net income attributable to Ardent Health, Inc. for the nine months ended September 30, 2025 was $90,855, representing 1.9% of total revenue[176]. - For the three months ended September 30, 2025, net income was $1.2 million, a significant decrease from $46.0 million in the same period of 2024[218]. Expenses and Costs - Total operating expenses increased by $186.2 million, representing 95.9% of total revenue for the three months ended September 30, 2025, compared to 96.1% for the same prior year period[183]. - Salaries and benefits for the three months ended September 30, 2025, were $676.962 million, representing 42.9% of total revenue, compared to $635.223 million, or 43.8%, in the prior year[173]. - Other operating expenses increased to 12.6% of total revenue for the three months ended September 30, 2025, compared to 8.2% for the same prior year period[191]. - Interest expense for the nine months ended September 30, 2025 was $42,819, representing 0.9% of total revenue[176]. Debt and Financing - On September 18, 2025, Ardent Health refinanced its Term Loan B Facility, reducing the interest rate by 50 basis points to Term SOFR plus 2.25% and extending the maturity date to September 18, 2032[141]. - The company amended its ABL Credit Agreement on June 26, 2024, increasing the revolving commitment by $100.0 million to $325.0 million and extending the maturity date to June 26, 2029[152]. - As of September 30, 2025, total long-term debt obligations amount to $1,533.2 million, with $24.8 million due within one year[247]. - The Term Loan B Facility has a refinanced balance of $777.5 million, requiring quarterly installment payments of 0.25%[241]. Regulatory and Economic Environment - The OBBBA may reduce federal Medicaid expenditures and tighten eligibility requirements, potentially impacting Ardent Health's financial performance[144]. - Changes in federal tax law under the OBBBA include a return to the EBITDA formula for calculating business interest expense limitations and 100% bonus depreciation for qualifying property, which will reduce current tax liability[146]. - The OBBBA is expected to decrease the number of individuals obtaining health insurance from ACA marketplace exchanges, likely resulting in significant cost increases for ACA plans[148]. - The company is sensitive to regulatory, economic, and competitive conditions in Texas and Oklahoma, where its facilities are heavily concentrated[136]. Capital Expenditures and Investments - Capital expenditures for non-acquisitions were $127.9 million for the nine months ended September 30, 2025, compared to $106.2 million in 2024, reflecting a 20.5% increase[225]. - The company expects to finance future capital expenditures with internally generated and borrowed funds, indicating a strategic focus on maintaining and modernizing facilities[230]. Other Financial Metrics - Adjusted EBITDA for the nine months ended September 30, 2025, was $411.1 million, up 30.2% from $315.9 million in the same period of 2024[218]. - Cash flows provided by operating activities for the nine months ended September 30, 2025, totaled $247.1 million, an increase of 26.4% compared to $195.5 million for the same period in 2024[224]. - Total cash and cash equivalents as of September 30, 2025, were $609.4 million, contributing to available liquidity of $903.8 million[222].

Financial Performance - Revenues for the first nine months of 2025 increased to $26.23 million, a 182% increase from $9.31 million in the same period of 2024[2] - Gross profit for the first nine months of 2025 was $7.22 million, up 219% from $2.26 million in the prior year, with a gross margin increase to 28% from 24%[2] - Antimony sales reached $23.57 million for the first nine months of 2025, a 235% increase compared to the previous year[4] - The company incurred a net loss of $4.05 million for the nine months ended September 30, 2025, compared to a net loss of $847k for the same period in 2024[3] - Operating expenses for the first nine months of 2025 were $11.76 million, an increase of $8.19 million compared to the same period in the prior year[2] - Net loss for the nine months ended September 30, 2025, was $4,052,621, compared to a loss of $847,485 for the same period in 2024[20] Cash and Assets - The company's cash position totaled $38.5 million at September 30, 2025, up from $18.2 million at year-end 2024[6] - Cash and cash equivalents at the end of the period were $18,470,081, up from $13,067,366, reflecting an increase of 42%[20] - Total assets increased to $79,882,341 as of September 30, 2025, compared to $34,642,602 on December 31, 2024, representing a growth of 130%[19] - Current assets rose to $31,797,939, up from $20,678,569, marking an increase of 53%[19] - Total liabilities increased to $8,131,411 from $6,041,929, an increase of 35%[19] - Total stockholders' equity increased to $71,750,930 from $28,600,673, representing a growth of 151%[19] Cash Flow - Net cash used in operating activities was $(6,220,686) for the nine months ended September 30, 2025, compared to $1,042,162 provided in 2024[20] - Cash flows from investing activities showed a net cash outflow of $(35,995,481) for the nine months ended September 30, 2025[20] - Proceeds from issuance of common stock, net of issuance costs, were $38,440,596 during the nine months ended September 30, 2025[20] Contracts and Future Projections - USAC has secured two major sales contracts: a five-year contract with the U.S. Defense Logistics Agency valued at up to $245 million and a commercial supply agreement worth approximately $107 million[9] - The company is narrowing its revenue guidance for fiscal year 2025 to $40 - $43 million and projecting revenues of $125 million for 2026[8] - As of September 30, 2025, the company held an antimony inventory of 230 tons, valued at approximately $9.2 million[7] - The company plans to expand its operating base into other critical minerals, anticipating significant margin expansion from new antimony ore sourced from its recently reopened mine in Montana[9] Share-Based Compensation - Share-based compensation for the nine months ended September 30, 2025, amounted to $4,688,772, significantly higher than $453,566 in 2024[20]

Financial Performance - Net interest income for the three months ended September 30, 2025, was $5,010,000, slightly up from $4,999,000 in the same period of 2024, indicating a marginal increase of 0.2%[17] - The company reported a net loss of $2,657,000 for the three months ended September 30, 2025, compared to a net loss of $26,954,000 in the same period of 2024, reflecting a significant improvement[17] - Non-interest income increased to $2,207,000 for the three months ended September 30, 2025, compared to $2,115,000 in the same period of 2024, marking an increase of approximately 4.3%[17] - Total non-interest expense rose to $10,310,000 for the three months ended September 30, 2025, compared to $8,396,000 in the same period of 2024, an increase of about 22.7%[17] - Basic loss per share improved to $(0.03) for the three months ended September 30, 2025, compared to $(6.78) in the same period of 2024, indicating a significant reduction in losses per share[17] - The total comprehensive loss for the nine months ended September 30, 2025, was $6,675,000, while for the same period in 2024, it was $28,117,000[22] Assets and Liabilities - Total assets decreased to $950,752,000 as of September 30, 2025, down from $1,012,292,000 on December 31, 2024, representing a decline of approximately 6.1%[13] - The company’s accumulated deficit increased to $97,343,000 as of September 30, 2025, compared to $86,908,000 on December 31, 2024[13] - Cash and cash equivalents at the end of the period on September 30, 2025, were $201,530,000, up from $72,772,000 at the end of September 30, 2024[24] - The total financial liabilities were reported at $847.715 million with an estimated fair value of $836.867 million as of September 30, 2025, compared to $1.001165 billion and $1.000091 billion as of December 31, 2024[183] Deposits - Total deposits decreased to $830,855,000 as of September 30, 2025, down from $966,597,000 on December 31, 2024, a decline of about 14.0%[13] - Non-interest bearing deposits fell to $87.766 million from $119.212 million, a decrease of about 26.4%[109] - Interest bearing deposits totaled $743.089 million, down from $847.385 million, reflecting a reduction of approximately 12.3%[109] - Digital Payments Division deposits were approximately $236.9 million as of September 30, 2025, compared to $265.5 million as of December 31, 2024, indicating a decline of about 10.8%[110] Credit Losses - The company experienced a recovery of provision for credit loss expense of $431,000 in Q3 2025, contrasting with a provision expense of $1,026,000 in Q3 2024[17] - The provision for credit losses was $1,826,000 for the nine months ended September 30, 2025, down from $4,776,000 for the same period in 2024[23] - The allowance for credit losses was $7,187,000 as of September 30, 2025, a decrease from $7,305,000 on December 31, 2024[13] - The provision for credit losses for the three months ended September 30, 2025 was $403,000, compared to a provision of $1,084,000 for the same period in 2024[78] Equity and Stock - As of September 30, 2025, the total shareholders' equity was $95,023,000, an increase from $16,386,000 as of September 30, 2024[22] - The company issued common stock resulting in proceeds of $85,572,000 during the nine months ended September 30, 2025[24] - The company granted a total of 1,501,667 restricted stock units (RSUs) during the three months ended September 30, 2025, and 10,254,187 RSUs during the nine months ended September 30, 2025[135] - The Company recognized total share-based compensation expense for RSUs of $1.7 million and $3.1 million for the three and nine months ended September 30, 2025, respectively[124] Lending Activities - The loan portfolio as of September 30, 2025, totaled $588.67 million, down from $707.47 million as of December 31, 2024, with a net allowance for credit losses of $7.19 million[48] - The commercial real estate loan segment decreased to $360.80 million as of September 30, 2025, from $419.49 million at the end of 2024[48] - The company began expanding its lending activities to the greater Los Angeles Metropolitan Statistical Area starting in Q3 2025[49] - The company introduced three new lending programs in Q3 2025, including an unsecured line of credit program with amounts ranging from $250,000 to $5 million[69] Interest and Fees - Interest and fees on loans decreased to $8,565,000 for the three months ended September 30, 2025, down from $11,704,000 in the same period of 2024, a decline of approximately 26.3%[17] - Cash paid for interest decreased to $23,262,000 in 2025 from $25,182,000 in 2024, representing a decline of approximately 7.6%[25] Capital Management - The Bank's common equity tier 1 capital ratio was 17.96% as of September 30, 2025, well above the required minimum of 10.00%[159] - The Bank completed three equity issuances in the nine months ended September 30, 2025, to fulfill obligations under the OCC Agreement[156] - The Company expects to raise approximately $25.6 million from a registered direct offering of 31,985,103 shares of common stock at a price of $1.25 per share[138] - The Company completed a Private Placement in March 2025, crucial for addressing the Capital Plan and Higher Minimums Articles in the OCC Agreement[154]

Financial Performance - Sales for the three months ended September 30, 2025, were $729,394, up 31.4% from $554,908 in the same period of 2024[21] - Net loss for the nine months ended September 30, 2025, was $14.68 million, compared to a net loss of $13.69 million for the same period in 2024, indicating a 7.2% increase in losses[21] - The company reported a net loss per share of $0.10 for the three months ended September 30, 2025, compared to $0.24 for the same period in 2024[21] - For the nine months ended September 30, 2025, total revenue reached $1,479,926, up 41.2% from $1,047,532 in the prior year[54] - U.S. sales for the nine months ended September 30, 2025, were $1,015,168, up from $755,082 in 2024, representing a 34.4% increase[54] - International sales for the nine months ended September 30, 2025, were $464,758, compared to $292,450 in 2024, marking a 58.8% increase[54] - Total sales for the nine months ended September 30, 2025, were $1,479,926, an increase from $1,047,532 in the same period of 2024, reflecting a 41.2% year-over-year growth[100] Assets and Liabilities - Total assets increased to $16.29 million as of September 30, 2025, from $12.45 million as of December 31, 2024, representing a 30.5% growth[16] - Total current liabilities rose to $10.54 million as of September 30, 2025, compared to $8.58 million as of December 31, 2024, reflecting a 22.8% increase[19] - Total stockholders' equity increased to $4.56 million as of September 30, 2025, from $2.30 million as of December 31, 2024, a growth of 97.8%[19] - The accumulated deficit as of September 30, 2025, was $141,875,839, with expectations of continued losses and negative operating cash flows for at least the next twelve months[39] Cash Flow and Financing - Cash and cash equivalents increased to $4.57 million as of September 30, 2025, from $3.45 million as of December 31, 2024, a growth of 32.4%[16] - The company reported a net cash used in operating activities of $14,505,325 for the nine months ended September 30, 2025, compared to $14,369,440 for the same period in 2024, indicating a slight increase in cash outflow of about 0.9%[30] - The company raised $7,998,826 from the issuance of common stock, accompanying warrants, and pre-funded warrants in August 2025 financing[30] - The company generated proceeds of $4,510,001 from the issuance of common stock in June 2025 financing[30] - The company executed a promissory note with AFCO for $367,450 in July 2025, with a monthly installment of $31,672 at an interest rate of 7.44%[58] - The company entered into a definitive agreement for the issuance of senior secured convertible notes in November 2025, with an aggregate principal amount of $12,000,000, convertible into 16,378,563 common shares at a conversion price of $0.73 per share[102] Expenses - Research and development expenses decreased to $5.76 million for the nine months ended September 30, 2025, from $6.05 million in 2024, a reduction of 4.5%[21] - Interest expense for the nine months ended September 30, 2025, was $1.48 million, up from $1.16 million in the same period of 2024, an increase of 27.5%[21] - Share-based compensation expense for the nine months ended September 30, 2025, was $723,722, compared to $310,004 for the same period in 2024, representing an increase of approximately 133.3%[30] - The company reported total operating expenses of $13,876,592 for the nine months ended September 30, 2025, compared to $13,758,269 in 2024, indicating a slight increase of 0.9%[100] Stock and Shareholder Information - The company issued 10,434,586 shares of common stock in connection with August 2025 financing, net of issuance costs, raising approximately $7,068,694[24] - The weighted average number of shares used in computing net loss per share increased to 41,015,196 in 2025 from 22,232,799 in 2024, indicating a significant increase in share dilution[94] - The company granted 1,599,915 stock options during the nine months ended September 30, 2025, with an average exercise price of $1.08[82] - The company issued 49,247 shares under its Employee Stock Purchase Plan (ESPP) for a fair value of $40,875 during the nine months ended September 30, 2025, compared to 12,081 shares for $10,390 in the same period of 2024[88] Regulatory and Market Developments - The company aims to obtain FDA approval for its FemBloc product candidate, which is critical for future commercialization efforts[10] - The company has received regulatory approvals for its products in multiple regions, including the U.S., EU, UK, Canada, and Australia, enhancing its market presence[1] - The company announced strategic distribution partnerships for FemBloc in Spain and the France/Benelux region in March and September 2025, respectively[32] - The company received FDA approval in November 2025 for its investigational device exemption supplement to proceed with the final phase of the pivotal clinical trial for FemBloc[32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 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: 001-40768 O ...

Financial Performance - Third quarter 2025 revenues totaled approximately $384,000, a 280% increase year-over-year from $101,000 in Q3 2024, with a gross margin of 33%[5] - The company reported a net income of $2.4 million, or $0.01 per basic share, compared to a net loss of $5.7 million, or a loss of $0.06 per basic share in the same period last year[5] - Total assets increased to $898.2 million as of September 30, 2025, up from $153.6 million at year-end 2024[5] - Cash and cash equivalents rose by $273.5 million to $352.4 million from year-end 2024, with total investments at $460.6 million[5] - Operating expenses for Q3 2025 were $10.5 million, up from $5.4 million in Q3 2024, reflecting continued investment in R&D and engineering[5] Capital Raising - The company raised gross proceeds of $500 million through a private placement of common stock during the third quarter and an additional $750 million post-quarter[5] Business Development - QCi achieved a purchase order from a top 5 U.S. bank for its quantum security solutions, marking its first commercial sale in this sector[8] - The company is advancing its collaboration with NASA to develop quantum-based techniques for atmospheric sensing using its Dirac-3 quantum optimization machine[8] - QCi's photonic chip foundry in Tempe, Arizona, is stabilizing production processes and ramping up small-batch manufacturing to fulfill early customer orders[8] - The company continues to expand its engineering and operations teams to support long-term growth and execution of its scalable manufacturing roadmap[8]

Clinical Trials - The company is currently enrolling patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial, which combines REQORSA and AstraZeneca's Tagrisso for late-stage NSCLC patients[145] - The recommended Phase 2 dose (RP2D) of REQORSA in the Acclaim-1 trial is determined to be 0.12 mg/kg, which is twice the highest dose level delivered in previous trials[145] - Three patients in the Phase 1 portion of the Acclaim-1 trial experienced prolonged progression-free survival (PFS), with one patient maintaining a partial remission for approximately 39 months[145] - The Acclaim-2 trial, which involved REQORSA and Merck's Keytruda, has been closed due to slow enrollment and competition for eligible patients[148] - The Phase 2 expansion portion of the Acclaim-3 trial is expected to enroll approximately 50 patients, with a primary endpoint of determining the 18-week progression-free survival rate[149] - The FDA has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed on Tagrisso treatment[146] - The Acclaim-3 trial has also received FDA Fast Track Designation and Orphan Drug Designation for the patient population with extensive stage small cell lung cancer[150] - The company is collaborating with MD Anderson to discover and develop biomarkers to select the patient population most likely to respond to REQORSA[144] - The company has experienced delays in clinical trial enrollment due to competition for patients and disruptions caused by the COVID-19 pandemic[194] - The company expects interim enrollment for the Phase 2a expansion of the Acclaim-1 trial and the Phase 2 dose expansion of the Acclaim-3 trial to be completed in the first half of 2026[193] Research and Development - The ONCOPREX Delivery System is designed to deliver tumor suppressor genes to cancer cells, with the potential to combat multiple types of cancer[142] - The company is in early stages of discovery programs to identify other cancer candidates using the ONCOPREX Delivery System[144] - The company has licensed multiple gene therapy technologies for Type 1 and Type 2 diabetes from the University of Pittsburgh, utilizing an adeno-associated virus vector containing the Pdx1 and MafA genes[151] - GPX-002 is being developed for both Type 1 and Type 2 diabetes, with preclinical studies showing decreased insulin requirements and improved glucose tolerance in treated non-human primate models[152] - The company submitted a request to the FDA in December 2023 for guidance on nonclinical studies needed for an Investigational New Drug application, with plans to initiate research in Type 2 diabetes animal models by the end of 2025[151] - The new sponsored research agreement with the University of Pittsburgh includes a revised research plan for Type 1 and Type 2 diabetes, incorporating the latest technologies acquired in 2023[151] - The company is working on regulatory and clinical strategic planning for its diabetes gene therapy products, aiming for IND-enabling studies by the end of 2025[151] Financial Performance - An equity line of credit agreement was established with Lincoln Park Capital Fund, allowing the company to sell up to $12.5 million in common stock over 24 months, with net proceeds of approximately $2.9 million from sales in Q3 2025[153] - A reverse stock split was approved at a ratio of one-for-fifty, effective October 21, 2025, to adjust share prices[155] - The company completed two registered direct offerings in October 2025, raising approximately $2.5 million and $3.1 million in net proceeds, respectively, from the sales of common stock[156][157] - The company has filed a prospectus supplement for up to $11.495 million of common stock under the 2023 ATM Facility, selling 242,537 shares for aggregate net proceeds of $1,006,740 since October 1, 2025[158] - The company has a full valuation allowance on deferred tax assets due to a history of operating losses since inception, with cumulative net operating losses recorded from April 1, 2009, to September 30, 2025[165] - Research and development (R&D) expense for Q3 2025 was $2,192,881, a decrease of $563,200 or 20% compared to Q3 2024[176] - R&D expense for the nine months ended September 30, 2025 was $7,232,370, a decrease of $464,613 or 6% compared to the same period in 2024[177] - General and administrative (G&A) expense for Q3 2025 was $1,153,032, a decrease of $413,053 or 26% compared to Q3 2024[178] - G&A expense for the nine months ended September 30, 2025 was $4,764,617, a decrease of $4,370,608 or 48% compared to the same period in 2024[179] - Net loss for Q3 2025 was $3,799,240, a decrease of $516,747 or 12% compared to Q3 2024[184] - Net loss for the nine months ended September 30, 2025 was $12,438,742, a decrease of $4,341,960 or 26% compared to the same period in 2024[185] - As of September 30, 2025, the accumulated deficit was $167,238,185[187] - The company sold 338,811 shares of common stock for gross proceeds of approximately $7.2 million during the nine months ended September 30, 2025[189] - The company entered into an equity line of credit purchase agreement with Lincoln Park for up to $12.5 million[190] - As of September 30, 2025, the company had $1,103,315 in cash and cash equivalents[192] - The company does not expect to generate revenue from product sales until successful development and regulatory approval of its product candidates, which may take several years[193] - The company anticipates needing to raise additional capital to fund operations, including ongoing clinical trials, with uncertainty regarding its ability to maintain liquidity over the next 12 months[193] - Net cash used in operating activities decreased by $2,840,198, or 20%, from $14,053,136 in 2024 to $11,212,938 in 2025, primarily due to the closure of the Acclaim-2 trial and expense reduction strategies[196] - The company had no net cash provided by investing activities in 2025, compared to $774,645 in 2024, due to timing associated with patent prosecution costs[197] - Net cash provided by financing activities increased by $2,685,450, from $8,029,143 in 2024 to $10,714,593 in 2025, due to higher amounts raised from capital raising activities[198] - The overall headcount of the company reduced from nineteen employees in 2024 to thirteen employees in 2025, contributing to decreased operating expenses[196] - There is substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and the need for additional financing[193]

Financial Performance - Revenues for the nine months ended September 30, 2025, were $42,000, a decrease of 57.6% from $99,000 for the same period in 2024[24] - Operating expenses for the nine months ended September 30, 2025, totaled $8,487,000, an increase of 16.9% from $7,257,000 in the same period of 2024[24] - Net loss for the nine months ended September 30, 2025, was $8,423,000, compared to a net loss of $7,183,000 for the same period in 2024, reflecting an increase of 17.3%[24] - The company reported a loss per share of $0.18 for the nine months ended September 30, 2025, compared to a loss per share of $0.19 for the same period in 2024[24] - For the nine months ended September 30, 2025, the segment net loss was $8,423, compared to a net loss of $7,183 for the same period in 2024, reflecting an increase of approximately 17.3%[66] Assets and Liabilities - Total current assets increased to $17,007,000 as of September 30, 2025, compared to $8,972,000 at December 31, 2024, representing an increase of 89.5%[21] - Total liabilities increased to $2,173,000 as of September 30, 2025, from $1,310,000 at December 31, 2024, marking a rise of 66%[21] - Shareholders' equity rose to $15,234,000 as of September 30, 2025, compared to $8,080,000 at December 31, 2024, indicating an increase of 88.5%[21] - Cash and cash equivalents at the end of the period were $8,574,000, slightly down from $8,660,000 at the end of 2024[21] Cash Flow and Financing - Cash flows from financing activities for the nine months ended September 30, 2025, amounted to $13,536,000, significantly higher than $1,259,000 for the same period in 2024[31] - The company has not anticipated paying any cash dividends in the foreseeable future, focusing on capital appreciation as the sole source of gain for shareholders[16] - The Company has agreed to use the proceeds from the sale of ordinary shares solely to fund its development cost obligations under the 2025 Collaboration Agreement[61] - In October and November 2025, 192,736 warrants were exercised for a total consideration of $155,249[68] Research and Development - Entera's most advanced product candidate, EB613, met primary and secondary endpoints in a Phase 2 study involving 161 post-menopausal women with low bone mineral density and osteoporosis[34] - Entera Bio Ltd. plans to conduct a Phase 3 study for EB613, with a primary endpoint evaluating change in total hip bone mineral density[34] - The company is developing the first oral oxyntomodulin for obesity treatment under a collaboration agreement with OPKO Health, Inc., signed in 2025[36] - As of September 30, 2025, Entera's management believes available funds will support operations through the middle of the third quarter of 2026, assuming ongoing capital use for research and development[36] - The Company completed the first stage of research services under a material transfer and research project agreement in Q1 2025, recognizing $42 in revenues for the nine months ended September 30, 2025[55] Collaboration Agreements - Under the 2025 Collaboration Agreement with OPKO, the Company will retain 40% of all proceeds from the program, while OPKO will retain 60%[58] - The company issued 3,685,226 ordinary shares to OPKO for a total purchase price of $8 million, at approximately $2.17 per share, as part of a collaboration agreement[49] - The Company recognized net expenses of $190 related to the 2025 Collaboration Agreement for the nine months ended September 30, 2025[65] - The Company incurred net expenses of $1,544 related to subcontractors and consulting for the nine months ended September 30, 2025, up from $934 in the same period of 2024, representing an increase of approximately 65.3%[66] Going Concern - The company incurred negative cash flows from operating activities since its inception in 2009, raising substantial doubt about its ability to continue as a going concern[37]

Revenue and Profit - Revenue for the three months ended September 30, 2025, was approximately $191 thousand, a decrease of 54% compared to $412 thousand for the same period in 2024[130] - Gross profit for the three months ended September 30, 2025, was $99 thousand, down 50% from $198 thousand in the prior year[130] - Revenue for the six months ended September 30, 2025, was approximately $519 thousand, a decrease of 24% from $684 thousand in the same period in 2024[135] - Cost of revenue for the six months ended September 30, 2025, was approximately $266 thousand, resulting in gross margins of 49%, down from 53% in the same period of 2024[136] Expenses - Research and development expenses increased by 73% to approximately $1.6 million for the three months ended September 30, 2025, compared to $917 thousand in the same period in 2024[133] - Selling, general, and administrative expenses for the three months ended September 30, 2025, increased by 35% to approximately $1.4 million[132] - SG&A expenses decreased by approximately $93 thousand or 3% to approximately $2.6 million for the six months ended September 30, 2025, due to operational efficiency efforts[137] - R&D expenses increased by approximately $633 thousand or 35% to approximately $2.4 million during the six months ended September 30, 2025, primarily due to Phase 2 trials on IGC-AD1[138] Other Income - Other net income surged by 2,407% to approximately $1.1 million for the three months ended September 30, 2025, compared to $43 thousand in the prior year[134] - Other net income increased by approximately $1.3 million or 2,170% to approximately $1.4 million for the six months ended September 30, 2025, attributed to a tax credit and asset disposition profits[139] Cash Flow and Assets - Cash and cash equivalents increased by approximately $700 thousand to $1.1 million, representing a 173% increase from $405 thousand as of March 31, 2025[149] - Net cash used in operating activities was approximately $3.5 million for the six months ended September 30, 2025, compared to $2.7 million in the same period of 2024[151] - Net cash provided by financing activities was approximately $3.9 million for the six months ended September 30, 2025, an increase from $3.3 million in the same period of 2024[156] - The Company sold assets associated with its Vancouver facility for approximately $2.7 million, eliminating a recurring cash loss of approximately $600 thousand annually[144] Clinical Trials and Development - The company successfully enrolled over 50% of patients in the ongoing Phase 2 CALMA clinical trial for IGC-AD1, targeting agitation in Alzheimer's disease[127] - IGC-AD1 is expected to potentially act within two weeks, significantly faster than traditional medications that can take 6 to 12 weeks[118] - The company is developing MINT-AD, a diagnostic tool aimed at reducing false negatives and delayed diagnoses of Alzheimer's disease[119] Investments - The Company invested approximately $25 thousand in a U.S.-listed digital asset through an ETP during the three-month quarter ended September 30, 2025[145] Working Capital - Working capital decreased by approximately $149 thousand or 23% to $490 thousand as of September 30, 2025, from $639 thousand as of March 31, 2025[148]

Financial Performance - For the three months ended September 30, 2025, net sales decreased to $737,000 from $4,038,000 in the same period of 2024, representing an 81.8% decline[162]. - Gross profit for the three months ended September 30, 2025, was a loss of $5,103,000 compared to a profit of $3,027,000 in 2024, indicating a significant deterioration in profitability[162]. - The total net sales for the nine months ended September 30, 2025, were $2,994,000, down from $11,616,000 in 2024, reflecting a 74.2% decrease[162]. - As of September 30, 2025, accounts receivable decreased to $4,138,000 from $4,262,000 as of December 31, 2024, showing a slight decline[162]. - For the three months ended September 30, 2025, the net loss attributable to Class A common stockholders was $8.93 million, resulting in a basic and diluted net loss per share of $6.44[142]. Liquidity and Capital Management - The Company aims to improve liquidity and profitability through cost reduction, new product introductions, and customer acquisition[36]. - The Company raised $6.5 million through a securities purchase agreement on August 12, 2024, issuing 3,152 units consisting of common stock and warrants[38]. - A note of $3,237,269 was issued on August 7, 2024, with a 20% original issue discount, convertible into common stock after maturity[37]. - The Company entered into definitive agreements for a $25.0 million offering of Class A common stock on February 18, 2025[40]. - The Company received approximately $24.3 million in cash and $19.0 million in USDT and USDC from a private placement closed on October 23, 2025[163]. - The Company plans to use the majority of the proceeds from the private placement to acquire BERA and establish digital asset treasury operations, with $3.0 million allocated for legacy operations[164]. Inventory Management - As of September 30, 2025, total gross inventory was approximately $23.0 million, with reserves of approximately $17.0 million, resulting in a net carrying value of approximately $6.0 million[66]. - The Company recorded a $5.0 million increase to its reserve for slow-moving and obsolete inventory during the three months ended September 30, 2025[66]. - A 10 percentage point reduction in expected recovery rates would increase the reserve by approximately $0.6 million based on balances as of September 30, 2025[66]. - An Inventory Monetization Project was initiated to accelerate the disposition of aged inventory after September 30, 2025[171]. Debt Management - An Exchange Agreement on October 29, 2024, reduced outstanding debt by approximately $617,000, with new Senior Subordinated Notes of $4,000,000 issued[39]. - The Exchange Note of $4.0 million was paid off in full during the nine months ended September 30, 2025[94]. - The Company extinguished the Secured Bridge Loan, resulting in a gain of $2.1 million recorded in the consolidated statement of operations for the year ended December 31, 2024[102]. - The principal balance with Synergy decreased from $5.1 million to $2.7 million as part of the debt modification[102]. - The Company utilized $4.0 million from the 2025 Offering proceeds to pay off a Note in full during the nine months ended September 30, 2025[99]. Operational Focus - Management is focusing on cost controls and monetizing legacy assets to minimize losses and working capital needs[54]. - New distribution agreements were established in Q2 2025 to enhance the vaporizer product category[57]. - The Company has successfully renegotiated vendor and supplier partnership terms to improve working capital arrangements[59]. - The Company continues to run operations related to the EU subsidiary purchase agreement, but sales were not material for the three and nine months ended September 30, 2025[80]. - The Board began evaluating strategic alternatives for the legacy distribution business after September 30, 2025[170]. Legal and Compliance - The Company is currently involved in various legal proceedings but does not believe any will have a material adverse effect on its business[105]. Stock and Equity - Class A common stock has voting and economic interests, with all Class B shares converted to Class A as of December 2022[129]. - A one-for-750 reverse stock split was completed on June 25, 2025, converting every 750 shares into one share of Common Stock[130]. - The weighted average shares of Class A common stock outstanding for the three months ended September 30, 2025, were 1,386,551[142]. - As of September 30, 2025, the company had 31,552 warrants to purchase common stock excluded from the diluted net loss per share calculation due to anti-dilution effects[147]. - The Company recognized no equity-based compensation expense for the nine months ended September 30, 2025, compared to $86,000 in 2024[149]. Taxation - The operating company's tax status changed from a partnership to a disregarded entity effective December 31, 2022, impacting tax reporting starting in 2023[151]. - As of September 30, 2025, the company established a full valuation allowance against deferred tax assets, reflecting a carrying balance of $0[152]. Digital Asset Strategy - The Company established a digital-asset treasury and expects to begin holding crypto assets in the fourth quarter of 2025[166]. - The Company incurred costs related to evaluating digital-asset alternatives and transitioning to a crypto-treasury operating model during the three and nine months ended September 30, 2025[76]. - The Company is exposed to market risk from changes in the fair value of BERA and other digital assets acquired after quarter end, with no crypto assets held as of September 30, 2025[274].