Business Combinations - The Company entered into a Business Combination Agreement with AUM Biosciences Pte. Ltd. on October 19, 2022, which was later terminated on June 8, 2023[187][188]. - The Company entered into a non-binding term sheet with CUBEBIO Co., Ltd. for a proposed business combination on May 2, 2024[197]. - The Company entered into a Business Combination Agreement with CUBEBIO Co., Ltd. on August 29, 2024, with a closing expected by May 15, 2025[209]. - The Company has until November 16, 2026, to consummate a proposed Business Combination, raising concerns about its ability to continue as a going concern[238]. Financial Performance - As of September 30, 2025, the Company had a net loss of $358,431, with operating costs of $388,221 and interest income of $36,656[217]. - For the nine months ended September 30, 2024, the Company had a net loss of $220,998, with general and administrative expenses of $431,169[218]. - The Company incurred transaction costs of $5,090,361 related to its Initial Public Offering, including $1,380,000 in underwriting fees[221]. Capital and Funding - The Company issued an unsecured promissory note of up to $400,000 to the Sponsor on October 30, 2023, for working capital purposes[190]. - The Company issued an unsecured promissory note of up to $500,000 to the Sponsor on August 14, 2024, for working capital purposes[201]. - The Company issued an unsecured promissory note of up to $500,000 on April 25, 2025, with $270,000 outstanding as of September 30, 2025[208]. - The Company issued an unsecured promissory note for up to $300,000 on April 3, 2024, with similar terms as the 2023 Note[231]. - The August 2024 Note issued for up to $500,000 had an outstanding amount of $500,000 as of September 30, 2025[235]. - The Company held cash of $41,172 outside the Trust Account for general working capital purposes as of September 30, 2025[226]. - The Company plans to use funds in the Trust Account to complete its Business Combination and for working capital for the target business[225]. Compliance and Regulatory Matters - The Company received approval from Nasdaq to transfer its listing from The Nasdaq Global Market to The Nasdaq Capital Market, effective October 27, 2023[189]. - The Company regained compliance with Nasdaq's $35,000,000 market value of listed securities requirement on June 5, 2024[199]. - The Company has successfully regained compliance with Nasdaq's Listing Rule after filing required reports[202][203][204]. - The Company received a notice from Nasdaq on November 14, 2024, regarding non-compliance with IM-5101-2, leading to delisting of its securities[206]. Trust Account and Investments - As of September 30, 2025, the Trust Account held investments totaling $1,193,968, including $126,805 of interest income[224]. - The underwriters are entitled to a deferred fee of $2,070,000, payable only if the Company completes a Business Combination[241]. Notes and Agreements - The Company entered into a note conversion agreement to convert a Note into 75,000 shares of Common Stock[229]. - On October 30, 2023, the Company issued an unsecured promissory note for up to $400,000, due upon the consummation of a Business Combination or liquidation[230]. - As of September 30, 2025, there was $300,000 outstanding under the April 2024 Note[234]. - The Company has no off-balance sheet financing arrangements as of September 30, 2025[239]. - The Company does not have any long-term debt or capital lease obligations, only a monthly payment agreement of up to $10,000[240]. Meeting and Shareholder Actions - The Company held an annual meeting on November 8, 2024, where stockholders approved an amendment to the Company's Charter, with 418,217 shares tendered for redemption[205]. - The Company has extended the Combination Period multiple times, with the latest extension to November 16, 2024[198].

Business Combination Agreements - The Company entered into a Business Combination Agreement with AUM Biosciences Pte. Ltd. on October 19, 2022, which was later terminated on June 8, 2023[187][188]. - The Company entered into a non-binding term sheet with CUBEBIO Co., Ltd. for a proposed business combination on May 2, 2024[197]. - The Business Combination Agreement with CUBEBIO Co., Ltd. was entered into on August 29, 2024, with a closing expected no later than May 15, 2025[209]. - The Company has until November 16, 2026, to consummate a proposed Business Combination, raising concerns about its ability to continue as a going concern[238]. Financial Performance - As of September 30, 2025, the Company had a net loss of $358,431, with operating costs of $388,221 and interest income of $36,656 from investments held in the Trust Account[217]. - The Company had a net loss of $220,998 for the nine months ended September 30, 2024, with general and administrative expenses of $431,169[218]. Cash and Investments - The Company had cash of $41,172 held outside the Trust Account for general working capital purposes as of September 30, 2025[226]. - As of September 30, 2025, the Company had investments held in the Trust Account totaling $1,193,968, including $126,805 of interest income[224]. - The Company plans to use substantially all funds in the Trust Account to complete its Business Combination[225]. Promissory Notes - The Company issued an unsecured promissory note of up to $400,000 to the Sponsor on October 30, 2023, for working capital purposes[190]. - The Company issued an unsecured promissory note of up to $500,000 to the Sponsor on August 14, 2024, for working capital purposes[201]. - The Company issued an unsecured promissory note for up to $500,000 on April 25, 2025, with $270,000 outstanding as of September 30, 2025[236]. - The Company issued an unsecured promissory note for up to $300,000 on April 3, 2024, with similar terms as the 2023 Note[231]. - On October 30, 2023, the Company issued an unsecured promissory note for up to $400,000, due upon consummation of a Business Combination or liquidation[230]. - The August 2024 Note issued for up to $500,000 had an outstanding amount of $500,000 as of September 30, 2025[235]. - As of September 30, 2025, there was $300,000 outstanding under the April 2024 Note[234]. Compliance and Listing - The Company received approval from Nasdaq to transfer its listing from The Nasdaq Global Market to The Nasdaq Capital Market, effective October 27, 2023[189]. - The Company submitted a plan to regain compliance with Nasdaq's listing rules by September 16, 2024, and successfully regained compliance by October 30, 2024[203][204]. - The Company did not complete its initial business combination by November 12, 2024, leading to delisting from Nasdaq and suspension of trading on November 21, 2024[206]. - The Company regained compliance with the $35,000,000 market value of listed securities requirement on June 5, 2024[199]. Initial Public Offering - The Company generated gross proceeds of $60,000,000 from its Initial Public Offering of 6,000,000 Units at $10.00 per Unit on November 16, 2021[219]. - The Company incurred transaction costs of $5,090,361 related to its Initial Public Offering, including $1,380,000 in underwriting fees[221]. - The underwriters are entitled to a deferred fee of $2,070,000, payable only if the Company completes a Business Combination[241]. Other Financial Obligations - The Company does not have any long-term debt or capital lease obligations, with a monthly obligation of up to $10,000 for office-related expenses[240]. - The Company has no off-balance sheet financing arrangements as of September 30, 2025[239].

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]