Clinical Trials and Development Programs - Certainty has treated six patients in Phase 1 clinical trials for ovarian cancer CAR-T therapy, with two patients showing anecdotal signs of efficacy, including tumor necrosis and one patient being 20 months past initial treatment[17] - The Phase 1 clinical trial for ovarian cancer CAR-T therapy is expected to be completed in two to three years, involving 24 to 48 patients[18] - The breast cancer vaccine Phase 1 trial has shown antigen-specific T cell responses in vaccinated women at all dose levels, with no adverse side effects other than injection site irritation[21] - The company plans to initiate a Phase 2 clinical trial for the breast cancer vaccine in 2025, focusing on the neo-adjuvant setting[21] - The company entered into a Joint Development and Option Agreement with Cleveland Clinic in May 2024 to develop additional cancer vaccines targeting high incidence malignancies in the lung, colon, and prostate[25] - The company is developing a CAR-T therapy for ovarian cancer and vaccines for breast and ovarian cancers[238] - The Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional treatment[93] - The Phase 1a breast cancer vaccine clinical trial is enrolling patients who have undergone standard of care treatment for TNBC[93] - The Phase 1b breast cancer vaccine clinical trial is enrolling healthy women with BRCA1, BRCA2, or PALB2 gene mutations who have elected prophylactic mastectomies[93] Financial Performance and Expenses - Research and development expenses increased by $1.627 million to $6.396 million in fiscal year 2024, driven by CAR-T and breast cancer vaccine programs[172] - General and administrative expenses rose by $1.144 million to $7.435 million in fiscal year 2024, primarily due to investor relations and employee compensation costs[173] - Research and development expenses for cancer vaccines and CAR-T therapeutics were $3.748 million and $2.648 million, respectively, in fiscal year 2024[171] - Research and development expenses increased to $6.4 million in 2024 from $4.8 million in 2023, reflecting a 34.1% year-over-year growth[231] - Net loss attributable to common shareholders widened to $12.6 million in 2024 from $9.8 million in 2023, a 28.0% increase[231] - Total operating costs and expenses increased to $13.8 million in 2024 from $11.2 million in 2023, a 23.3% rise[231] - Net loss per share increased to $0.39 in 2024 from $0.32 in 2023, a 21.9% increase[231] - Net loss for the year ended October 31, 2024, was $12.7 million, compared to $9.9 million in 2023[236] - Net cash used in operating activities for 2024 was $7.3 million, compared to $6.2 million in 2023[236] - Disbursements to acquire short-term investments in 2024 were $63.8 million, compared to $44.4 million in 2023[236] - Proceeds from maturities of short-term investments in 2024 were $68.0 million, compared to $38.8 million in 2023[236] - Net cash provided by financing activities in 2024 was $3.4 million, compared to $0.4 million in 2023[236] - Cash and cash equivalents at the end of 2024 were $1.3 million, compared to $0.9 million in 2023[236] - The company reported a net loss of $12.7 million for the year ended October 31, 2024, with Cancer Vaccines and CAR-T Therapeutics segments contributing $7.39 million and $5.26 million, respectively[307] - The company had no revenue in 2024, compared to $210,000 in 2023, which was solely generated from the Other segment[308] - The company raised approximately $2.96 million through an at-the-market equity offering in 2024 and may sell up to $97 million of common stock under its current equity program[67] - The company believes its existing cash and short-term investments will fund operations for at least the next twelve months, but may require additional funding through equity sales or debt, potentially diluting stockholders[67] - The company had approximately $19,924,000 in cash, cash equivalents, and short-term investments as of October 31, 2024[68] - The company does not generate any revenue from its therapeutics or vaccines and expects no significant revenue in the foreseeable future[68] - The company may need additional funding sooner than anticipated due to rapid resource consumption[68] - Interest income increased to $1,133,000 in fiscal year 2024, up from $1,081,000 in fiscal year 2023, driven by higher interest rates and increased average short-term investment holdings[174] - Cash and cash equivalents rose to $1.3 million in 2024 from $0.9 million in 2023, a 38.9% increase[228] - Short-term investments decreased to $18.7 million in 2024 from $22.9 million in 2023, a 18.6% decline[228] - Total current assets decreased to $21.4 million in 2024 from $25.4 million in 2023, a 15.7% decline[228] - Total liabilities increased to $2.7 million in 2024 from $2.2 million in 2023, a 25.7% rise[228] - Additional paid-in capital grew to $260.4 million in 2024 from $252.2 million in 2023, a 3.3% increase[234] - Accumulated deficit expanded to $240.8 million in 2024 from $228.2 million in 2023, a 5.5% increase[234] Intellectual Property and Licensing - The company relies on licenses from Wistar for CAR-T technology and Cleveland Clinic for cancer vaccine technologies, with potential risks if these licenses are terminated[117] - The company faces risks related to intellectual property disputes, which could impact its ability to commercialize products[116] - The company's revenue recognition policy involves complex judgments, particularly regarding technology licensing and intellectual property transfers[183] - Failure to maintain licenses could result in litigation, damages, and potential product sales restrictions, adversely affecting the company's operations and financial condition[122] - Disclosure or misappropriation of proprietary technology could erode the company's competitive position in the market[123] - Uncertainty regarding the issuance, validity, and enforceability of patents could impact the company's ability to protect its product candidates[124][125] - Delays in clinical trials could reduce the patent-protected marketing period for the company's product candidates[126] - Noncompliance with patent maintenance requirements could result in the loss of patent rights, enabling competitors to enter the market[127] - Changes in U.S. patent law, including recent Supreme Court rulings, could diminish the value of the company's patents and weaken its ability to enforce them[130] - Limited intellectual property rights outside the U.S. may hinder the company's ability to prevent competitors from using its technologies in foreign jurisdictions[131] - Enforcement of patent rights in foreign jurisdictions, particularly in China and developing countries, could be costly and ineffective[132] Equity and Stock Information - The company's common stock had 307 record holders as of January 8, 2025, with a closing price of $2.25 per share[159] - Equity compensation plans approved by security holders include 11,171,094 securities to be issued with a weighted average exercise price of $3.74[161] - The company has issued 13,488,062 shares of common stock with a weighted average exercise price of $3.53, and has the authority to issue an additional 645,000 shares annually, which may dilute stockholders' ownership and exert downward pressure on the stock price[141] - The company's common stock trades under the symbol "ANIX" on the NASDAQ Capital Market[158] - The 2018 Share Incentive Plan allows for the issuance of up to 5,000,000 shares initially, with an annual replenishment of 2,000,000 shares starting January 2019[163] - The 2018 Share Incentive Plan provides for various equity-based awards, including stock options and performance awards, and is administered by the Compensation Committee[163] - Future issuance or sale of shares, including an at-the-market equity offering of up to $97 million, could dilute ownership and reduce the market price of the company's common stock[133] - Fluctuations in quarterly operating results, driven by clinical trial progress and regulatory developments, could cause volatility in the company's stock price[137] - Weighted average fair value of stock options granted in 2024 is $2.94, compared to $3.29 in 2023[275] - Expected volatility for stock options decreased to 76.48% in 2024 from 100.27% in 2023[275] - Risk-free interest rate remained constant at 3.87% for both 2024 and 2023[275] - Excluded from Diluted EPS calculation for 2024 are options to purchase 12,158,062 shares and warrants to purchase 300,000 shares[278] Regulatory and Compliance Risks - The company faces risks of failing to enroll sufficient patients, meet clinical trial endpoints, or secure necessary materials for trials[74] - The company relies on strategic collaborations for manufacturing and commercialization but faces challenges in timing and establishing partnerships[75] - The company's product candidates, including CAR-T therapies and cancer vaccines, face significant development and regulatory challenges[83][84] - The company may incur substantial liabilities from product liability lawsuits, potentially limiting commercialization[76] - The company's biotechnology and pharmaceutical products are in early stages, with no revenue generated and significant uncertainty regarding profitability[79] - The company relies on third parties, including universities and medical institutions, to conduct pre-clinical studies and clinical trials, which may lead to delays and increased costs[88] - Failure to comply with cGCP regulations by third parties could result in unreliable clinical data and require additional trials, delaying regulatory approval[88] - Switching or adding third parties for clinical trials involves substantial costs and can cause delays, impacting development timelines[90] - The company is responsible for ensuring clinical trials comply with legal, regulatory, and scientific standards, despite reliance on third parties[88] - The company faces challenges in obtaining regulatory approval for T cell therapies due to limited regulatory experience with such treatments[87] - Establishing sales and marketing capabilities is crucial for gaining market acceptance of novel therapies post-regulatory approval[87] - The FDA regulatory approval process for the company's product candidates is lengthy, uncertain, and costly, with potential delays due to the novel nature of T cell therapies and cancer vaccines[107] - Clinical trial delays may occur due to financial constraints, patient recruitment challenges, site deviations, or manufacturing issues, which could harm the company's business prospects and delay revenue generation[108][110] Operational and Strategic Risks - The company's subsidiary, Certainty, holds a 4.4% equity stake in Wistar as of October 31, 2024, due to dilution from company funding[16] - The company does not expect to generate revenue from its vaccine or therapeutics programs in the near term and aims to license technologies to large pharmaceutical companies[27] - The company leases 2,000 square feet of office space in San Jose, California, with a base rent of approximately $5,000 per month and an option to extend the lease until September 30, 2029[153] - The company has not experienced any cybersecurity threats that have materially affected its operations[148] - The company is a smaller reporting company (SRC) and may remain so until its market value exceeds $250 million or it achieves over $100 million in annual revenues with a market value exceeding $700 million[143] - The company's operating lease liability as of October 31, 2024, has a present value of $232,000, with future minimum lease payments totaling $312,000 over the next five years[299] - The company has committed approximately $150,000 under technology license agreements for therapeutic and vaccine development programs over the next twelve months[301] - Future payments under research and development agreements, including for a breast cancer vaccine Phase 2 trial and CAR-T technology development, may total approximately $4.2 million over up to five years[302] - The company has federal tax net operating loss carryforwards of approximately $99.87 million and tax credit carryforwards of $1.95 million as of October 31, 2024[303] - California tax net operating loss carryforwards amount to approximately $60.62 million, expiring between 2025 and 2044[304] - The company's ability to use net operating loss carryforwards may be limited due to potential ownership changes[71] - The company's CAR-T ovarian cancer therapeutic and cancer vaccines are in early development stages, requiring significant resources for FDA approvals[72] - The company faces risks related to reliance on a single or limited number of suppliers for raw materials, which could disrupt production if suppliers go out of business or are acquired by competitors[105] - The company may pursue strategic alliances, joint ventures, or licensing arrangements, but these could lead to increased costs, dilution of stock, or integration challenges, with no guarantee of successful outcomes[106] - The company's investment policy includes diversified financial instruments, such as U.S. government debt securities and Bitcoin Assets, with Bitcoin Assets measured at fair value based on active market prices[260][261] - As of October 31, 2024, the company's financial assets measured at fair value totaled $19.8 million, including $1.2 million in Level 1 cash equivalents and $18.7 million in Level 2 U.S. treasury bills[266] - Research and development expenses for 2024 and 2023 included $4.4 million in stock-based compensation for employees and directors, with $4.8 million in unrecognized compensation costs as of October 31, 2024[272] - The company recorded $125,000 in consulting expenses related to stock options granted to consultants in 2024, with $180,000 in unrecognized consulting expenses as of October 31, 2024[273] - The company uses the Black-Scholes pricing model to estimate the fair value of stock options, with grants during 2024 and 2023 having 5-year and 10-year terms vesting over 12 to 36 months[274] - The company's short-term investments as of October 31, 2024, included $18.7 million in U.S. treasury bills and certificates of deposit, compared to $22.9 million in 2023[268] - FASB issued Accounting Standards Update 2023-07, effective for fiscal years beginning after December 15, 2023, requiring more disaggregated expense information[281] - FASB issued Accounting Standards Update 2023-09, effective for fiscal years beginning after December 15, 2024, requiring disaggregated information about effective tax rate reconciliation[282] - FASB issued Accounting Standards Update 2024-03, effective for fiscal years beginning after December 15, 2026, improving disclosures about expense types[283]

Foreign Currency and Revenue - 61% of the company's revenue in fiscal year 2024 was derived from customers outside the Americas, with transactions conducted in various foreign currencies[233] - The company sources products from foreign suppliers and subsidiaries in Taiwan, the U.S., Italy, and China, with purchases predominantly in foreign currencies, primarily the New Taiwan Dollar and the Euro[234] - The company entered into foreign currency forward exchange contracts to hedge cash flow risks, with notable contracts including €7.5 million in Euro, £3.4 million in Sterling, and NT$490 million in New Taiwan Dollar[236] - A forward contract with a notional amount of €3.0 million was entered into in November 2023 to hedge net investment in Euro-denominated assets, maturing in November 2024 with a realized gain of $1.2 million[238] Product Line Enhancements - The TMX product line was enhanced with higher speed 20,000rpm motorized spindles and refreshed designs for the TM-Mi and TMXi product lines, including the introduction of TM8MY and TM10MY multi-axis live tooling lathes[40] - The Milltronics line introduced the INSPIRE+ control console in 2024, featuring enhanced hardware and graphics, and launched two new product lines: TRL toolroom flatbed lathes and X5 five-axis integrated machines[51] - The Takumi brand offers high-precision, high-speed milling machines, with the H Series featuring direct-drive spindles up to 20,000rpm and options for 24,000rpm and 36,000rpm, targeting die and mold and aerospace customers[56] - The U Series product line consists of six models, with four offering trunnion table sizes of 10, 16, 24, and 31.5 inches, and the UB version featuring a 12,000rpm built-in spindle and a spacious X-axis travel of 126 inches[58] - The G Series product line includes three models with X-axis travels of 22, 30, and 40 inches, designed for machining graphite or copper electrodes with up to 20,000rpm spindles[59] - The BC Series models are available in eight sizes, with X-axis travels ranging from 83 to 197 inches, designed for heavy cutting applications[60] - The HMX Series high-speed horizontal machining centers are available in 400-, 500-, and 630-millimeter pallet sizes, with expandable automatic tool changers holding up to 220 tools[61] - In fiscal year 2024, Takumi introduced the UVC600 five-axis machine with a 600-millimeter cantilever table and the UA400 five-axis model, both featuring 15,000rpm direct drive spindles[63] Research and Development - Research and development expenses totaled $3.9 million, $4.2 million, and $3.4 million in fiscal years 2024, 2023, and 2022, respectively[298] - Estimated amortization expense for software development costs is projected to be $1,065,000 in 2025, $931,000 in 2026, and $1,302,000 in 2027[301] - Intangible asset amortization expense was $237,000, $271,000, and $272,000 for fiscal years 2024, 2023, and 2022, respectively[303] Financial Performance - Net loss for fiscal year 2024 was $16.6 million, compared to net income of $4.4 million in 2023 and $8.2 million in 2022[306] - Inventories decreased to $153,037 thousand in 2024 from $157,952 thousand in 2023, with finished goods remaining stable at $104,224 thousand compared to $104,574 thousand in 2023[319] Credit Facilities and Borrowings - The company has a $40.0 million unsecured revolving credit facility under the 2018 Credit Agreement, with a scheduled maturity date of December 31, 2025[321] - Borrowings under the 2018 Credit Agreement bear interest at floating rates, with letters of credit carrying an annual rate of 1.00%[322] - The 2018 Credit Agreement requires the company to maintain a minimum working capital of $125.0 million and a minimum tangible net worth of $176.5 million[323] - The company has uncommitted revolving credit facilities in Taiwan (150 million New Taiwan Dollars) and China (32.5 million Chinese Yuan), renewed in 2023[324] - As of October 31, 2024, the company had no borrowings under its credit facilities and approximately $50.9 million of available borrowing capacity[326] International Operations and Assets - Long-lived tangible assets in foreign countries increased significantly to $13,025 thousand in 2024 from $4,034 thousand in 2023[384] - Net assets in Europe grew to $88,810 thousand in 2024 from $81,730 thousand in 2023, while Americas decreased to $45,798 thousand from $70,649 thousand[384] - The company operates through approximately 180 independent agents and distributors across the Americas, Europe, and Asia, with direct sales and service organizations in key regions[315] Competitive and Intellectual Property Risks - The company faces competition from larger companies with greater financial resources, which may impact its ability to remain competitive[116] - The company's success depends on its ability to protect intellectual property, which may be inadequately protected in some foreign countries[118]

Assets and Equipment - Property and equipment, net decreased to $12,404 as of June 30, 2024, from $18,239 as of December 31, 2023[2] - Long-lived assets decreased to $710,369 as of June 30, 2024, from $803,549 as of December 31, 2023, with $591,021 located in Mexico and $119,348 in the United States[24] - Capitalized software, net, as of June 30, 2024, was $684,195, compared to $771,133 as of December 31, 2023[113] Liabilities and Accrued Expenses - Total accrued expenses decreased to $1,525,355 as of June 30, 2024, from $2,239,171 as of December 31, 2023[3] - The borrowing balance under the revolving line of credit was $4,443,944 as of June 30, 2024[10] - The Company secured a term loan of $750,000 on March 11, 2024, and an additional term loan of $125,000 on June 4, 2024, both accruing interest at 8% per annum[12][13] - The fair value of the convertible note decreased to $219,840 as of June 30, 2024, from $242,442 as of December 31, 2023[20] - The company canceled a Convertible Promissory Note and two promissory notes totaling $1,095, including accrued interest, on September 4, 2024[36] - Total liabilities increased from $7.410 million as of December 31, 2023 to $9.065 million as of June 30, 2024[71] - The company reported negative working capital of $0.8 million and short-term debt of $5.6 million as of June 30, 2024[82] Revenue and Expenses - Total revenue for the six months ended June 30, 2024, was $8,125,602, with $5,043,432 coming from Mexico and $3,082,170 from the United States[24] - Revenue increased by $507 (6.7%) to $8,126 for the six months ended June 30, 2024, driven by a 135% increase in Fr8Fleet dedicated services, partially offset by a 24% decrease in spot services[39] - Cost of revenue rose by $233 (3.4%) to $7,170 for the six months ended June 30, 2024, with gross margin percentage improving from 9.0% to 11.8% due to a focus on higher-margin customers[40] - Compensation and employee benefits expenses decreased by $24 (0.8%) to $2,818 for the six months ended June 30, 2024, primarily due to lower commissions and employee mix changes[41] - General and administrative expenses increased by $588 (54.2%) to $1,672 for the six months ended June 30, 2024, driven by foreign exchange variances and higher professional fees[42] - Net revenue for the six months ended June 30, 2024, increased by 6.7% to $8,126,000 compared to $7,619,000 in the same period in 2023[50] - Operating loss for the six months ended June 30, 2024, increased by 9.0% to $3,788,000 compared to $3,475,000 in the same period in 2023[50] - Net loss for the six months ended June 30, 2024, decreased by 0.3% to $4,211,000 compared to $4,223,000 in the same period in 2023[57] - Sales and marketing expenses decreased by 12.8% to $34,000 for the six months ended June 30, 2024, compared to $39,000 in the same period in 2023[51] - Depreciation and amortization expenses increased by 14.6% to $220,000 for the six months ended June 30, 2024, compared to $192,000 in the same period in 2023[52] - Other financial expenses decreased by 52.2% to $405,000 for the six months ended June 30, 2024, compared to $847,000 in the same period in 2023[55] - Revenue for the six months ended June 30, 2024 was $8.126 million, compared to $7.619 million for the same period in 2023[73] - Net loss for the six months ended June 30, 2024 was $4.211 million, compared to $4.234 million for the same period in 2023[73] - Comprehensive loss for the six months ended June 30, 2024 was $4.626 million, compared to $4.032 million for the same period in 2023[73] - Net loss per share attributable to common stockholders for the six months ended June 30, 2024 was $15.94, compared to $158.98 for the same period in 2023[73] - Weighted average number of common shares basic and diluted for the six months ended June 30, 2024 was 264,225, compared to 26,568 for the same period in 2023[73] - Net loss for the six months ended June 30, 2024, was $4,211,006, compared to $4,223,808 in the same period in 2023[77] - Share-based compensation for the six months ended June 30, 2024, was $515,380, compared to $549,371 in the same period in 2023[77] - Depreciation and amortization for the six months ended June 30, 2024, was $220,246, compared to $192,484 in the same period in 2023[77] - Freight Transportation Brokerage revenue for the six months ended June 30, 2024, was $4,675,171, a decrease from $6,152,222 in the same period in 2023[107] - Dedicated Capacity revenue for the six months ended June 30, 2024, was $3,450,431, a significant increase from $1,467,100 in the same period in 2023[107] - Total revenue for the six months ended June 30, 2024, was $8,125,602, compared to $7,619,322 in the same period in 2023[107] - Amortization expense for the six months ended June 30, 2024, was $212,306, up from $183,307 in the same period in 2023[113] - Estimated amortization for capitalized software for the remainder of 2024 (July 1 – December 31) is $187,101[114] Cash Flow and Financing - The Company incurred $357,599 in interest expense related to the revolving line of credit for the six months ended June 30, 2024, compared to $133,038 for the same period in 2023[11] - The company raised $1,471,839 net of commissions and fees by selling 138,466 ordinary shares at an adjusted price of $11.01 per share as of June 30, 2024[33] - 318,820 Ordinary Share warrants were exercised for 270,995 Ordinary Shares during the six months ended June 30, 2024, based on a conversion ratio of 0.85[28] - The company entered into a Sales Agent Agreement to offer and sell ordinary shares with an aggregate offering price of up to $2,300,000, paying AGP a 3.0% commission on gross proceeds[30] - Freight Opportunities, LLC exercised 29,917,656 Ordinary Share warrants for 1,190,000 shares from July 1, 2024, through January 10, 2025[38] - The company effected a one-for-twenty-five reverse stock split on September 25, 2024, retroactively adjusting all ordinary shares and per-share information[35] - Net cash used in operating activities increased to $4,857,000 for the six months ended June 30, 2024, compared to $1,608,000 in the same period in 2023[62] - Net cash provided by financing activities was $3,924,000 for the six months ended June 30, 2024, driven by equity sales and borrowing[67] - Net cash provided by financing activities for the six months ended June 30, 2023 was $2.879 million, driven by proceeds from convertible notes of $4.8 million, partially offset by net repayment on borrowing facilities of $1.726 million, repayment of insurance premium funding of $153,000, and transaction costs of $42,000[68] - Cash and cash equivalents decreased from $1.560 million as of December 31, 2023 to $460,576 as of June 30, 2024[71] - Total current assets decreased from $9.153 million as of December 31, 2023 to $8.268 million as of June 30, 2024[71] - Cash used in operating activities for the six months ended June 30, 2024, was $4,857,126, compared to $1,608,102 in the same period in 2023[77] - Cash provided by financing activities for the six months ended June 30, 2024, was $3,923,593, compared to $2,878,519 in the same period in 2023[77] - Cash and cash equivalents at the end of the period were $460,576, compared to $1,837,713 in the same period in 2023[77] - Proceeds from short-term borrowings for the six months ended June 30, 2024, were $9,848,259, compared to $8,615,881 in the same period in 2023[77] - Repayment of short-term borrowings for the six months ended June 30, 2024, was $8,150,791, compared to $10,342,407 in the same period in 2023[77] - Capitalization of software development costs for the six months ended June 30, 2024, was $171,997, compared to $64,431 in the same period in 2023[77] - The company has an accumulated deficit of $43.5 million and negative working capital of $0.8 million as of June 30, 2024[58] - The company anticipates the need for additional capital to fund operations and capital investments until achieving cash self-sufficiency[59] - The company has an accumulated deficit of $43.5 million and a negative shareholders' equity of $0.03 million as of June 30, 2024[82] - The company projects it will need additional capital to fund operations until it achieves cash self-sufficiency[83] Stock and Equity - The Company recognized $511,619 of stock compensation expense for the six months ended June 30, 2024, compared to $537,670 for the same period in 2023[7] - Total stockholders' equity as of June 30, 2024, was $(32,356), compared to $3,035,270 as of June 30, 2023[75] - Anti-dilutive ordinary share equivalents as of June 30, 2024, totaled 6,571,894, a substantial increase from 65,022 in the same period in 2023[109] Accounts Receivable and Credit - One customer accounted for 79% of the company's accounts receivable as of June 30, 2024, up from 66% at December 31, 2023[92] - 83% of accounts receivable were held by the Mexican entity as of June 30, 2024, compared to 76% at December 31, 2023[93] - One customer accounted for 46% of the company's revenues for the six months ended June 30, 2024, up from 30% for the same period in 2023[93] - The company's allowance for credit losses was $281,937 as of June 30, 2024, slightly down from $282,058 at December 31, 2023[94] - Unbilled receivables decreased to $637,566 as of June 30, 2024 from $961,747 at December 31, 2023[95] - The company recognized $3,343,913 in unbilled receivables during the six months ended June 30, 2024[96] - The company's cash balances exceeded federally insured limits by $101,226 as of June 30, 2024, down from $1,188,813 at December 31, 2023[91] Accounting Standards and Disclosures - The Company is evaluating the potential impact of adopting ASU 2023-07 on its consolidated financial statements and related disclosures[111] - The Company is evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements and disclosures[112] - The Company does not expect the adoption of ASU 2020-04 to have a material impact on its consolidated financial statements[110]

Financial Results Announcement - NioCorp Developments Ltd. announced preliminary financial results for the three-month and six-month periods ended December 31, 2024 [5] - The financial results were disclosed in a press release dated January 10, 2025 [7] - The press release is attached as Exhibit 99.1 to the Form 8-K filing [7] Regulatory and Filing Information - The information in the press release is not deemed filed under Section 18 of the Securities Exchange Act of 1934 [5] - The press release is not incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act [5] Company Trading and Contact Information - The company's common shares and warrants are traded on The Nasdaq Stock Market LLC under the symbols NB and NIOBW, respectively [3] - The company's principal executive offices are located at 7000 South Yosemite Street, Suite 115, Centennial, Colorado 80112 [3] - The company's telephone number is (720) 334-7066 [3] Company Incorporation and Identification - The company is incorporated in British Columbia, Canada [2] - The company's IRS Employer Identification Number is 98-1262185 [2]

Financial Results Announcement - Boot Barn Holdings, Inc. announced preliminary financial results for Q3 ended December 28, 2024, to be discussed at the 2025 ICR Conference on January 13, 2025 [5] - The investor presentation and press release dated January 10, 2025, are attached as Exhibits 99.1 and 99.2 [10] ICR Conference Participation - The company will host a fireside chat at the 2025 ICR Conference on January 13, 2025, at 10:30 a.m. Eastern Time, which will be webcast live [7] Presentation and Information Disclaimer - The company disclaims any obligation to update or revise the information in the presentation [9] - The presentation is available on the company's investor relations website, but the company reserves the right to discontinue its availability [9]

Market Share and Revenue Growth - Tilray's market share in Canada decreased marginally from 9.8% to 9.4% in the quarter, reflecting efforts to preserve margins amid price compression[129] - Tilray acquired four craft brands and breweries on September 1, 2024, expected to enhance beverage segment revenues and market penetration[144] - Manitoba Harvest's US branded business grew 6.2% in multi-outlet consumption for the six months ended November 30, 2024, driven by value-added innovation[142] - Tilray's international cannabis business benefits from EU-GMP cultivation facilities in Portugal and Germany, along with a fully owned route-to-market infrastructure in key regions[131] Operational Efficiency and Product Innovation - Wellness gross margin increased to 31% for both the three and six months ended November 30, 2024, driven by operational efficiencies and higher-margin product sales[177] - Tilray's Breckenridge Distillery received Double Gold awards, including the World's best finished Bourbon at the 2024 World Whiskies Awards[126] - Tilray launched a lineup of Hemp Derived Delta-9 (HD-D9) products, Non-Alcoholic beverages, and Energy drinks as part of its innovation strategy[128] - In Germany, Tilray received the first license for domestic medical cannabis cultivation under the new MedCanG regulations, leading to increased prescription numbers and business growth[133] Financial Performance and Expenses - Operating expenses increased by $14.2 million (16%) to $103.4 million for the three months and by $32.0 million (19%) to $199.7 million for the six months ended November 30, 2024, primarily due to the inclusion of expenses from the Craft Acquisition II[179] - Selling costs increased by 113% to $16.2 million for the three months and by 93% to $27.9 million for the six months ended November 30, 2024, driven by higher freight costs and increased sales from the Craft Acquisition II[179][187] - Research and development costs increased by 7% to $60,000 for the three months and by 22% to $165,000 for the six months ended November 30, 2024, related to external costs for new product development[179][190] - Salaries and wages increased by 19% to $22.7 million for the three months and by 23% to $44.3 million for the six months ended November 30, 2024, due to the inclusion of employees from the Craft Acquisition II[181] - Office and general expenses increased by 17% to $9.5 million for the three months and by 15% to $18.7 million for the six months ended November 30, 2024, primarily due to the Craft Acquisition II[182] - Stock-based compensation decreased by 12% to $7.2 million for the three months and by 14% to $14.2 million for the six months ended November 30, 2024, due to fully vested stock options and RSUs[184] - Insurance expense increased by 26% to $3.2 million for the three months but decreased by 12% to $5.6 million for the six months ended November 30, 2024, driven by lower premiums and additional policies for the beverage business[185] - Rent expense decreased by 34% to $1.0 million for the three months and by 5% to $2.3 million for the six months ended November 30, 2024, due to the exit from the Truss Lease and reduced lease payments[186] - Marketing and promotion costs increased by 6% to $9.7 million for the three months and by 20% to $21.3 million for the six months ended November 30, 2024, due to the Craft Acquisition II and quarterly variability in discretionary expenses[189] - Change in fair value of contingent consideration was $nil for both the three and six months ended November 30, 2024, compared to a loss of $0.3 million and a gain of $10.8 million in the prior year period[191] - Net loss for the three months ended November 30, 2024, increased by 85% to $(85.275) million compared to $(46.183) million in the same period last year[206] - Adjusted EBITDA for the three months ended November 30, 2024, decreased by 11% to $9.017 million compared to $10.086 million in the same period last year[206] Cash Flow and Debt Management - Long-term investments decreased to $7.416 million as of November 30, 2024, from $7.859 million as of May 31, 2024[56] - The company has drawn down $10,000 from a $30,000 revolving credit facility as of November 30, 2024[59] - Net carrying amount of long-term debt decreased to $164.709 million as of November 30, 2024, from $173.858 million as of May 31, 2024[62] - The company issued 67,210,864 shares under the ATM program, generating gross proceeds of $114.3 million during the six months ended November 30, 2024[213] - Net cash used in operating activities increased to $(76.031) million for the six months ended November 30, 2024, compared to $(46.251) million in the same period last year[215] - Net cash used in investing activities increased to $(60.120) million for the six months ended November 30, 2024, compared to $55.207 million in the same period last year[215] - Cash and marketable securities totaled $252.249 million as of November 30, 2024, compared to $259.791 million as of November 30, 2023[215] - The company repaid the remaining principal of the APHA 24 Notes in cash upon maturity on June 1, 2024[68] - Cash flows from financing activities increased to $38.2 million for the three months ended November 30, 2024, compared to ($85.4) million in the prior year period[219] - Cash flows from financing activities increased to $98.8 million for the six months ended November 30, 2024, compared to ($71.3) million in the prior year period[219] - The company received $21.6 million from the overallotment issuance of TLRY 27 Notes in the prior period ended November 30, 2023[219] - The company repaid $107.3 million for the TLRY 23 and APHA 24 Notes in the prior period ended November 30, 2023[219] Legal and Accounting Matters - The company believes that the reasonably possible losses from litigation are not material and will not have a material adverse effect on its financial position[221] - Critical accounting estimates include revenue recognition, valuation of inventory, long-lived assets, goodwill, intangible assets, stock-based compensation, and deferred tax assets[222] - The company's financial statements are prepared in accordance with U.S. GAAP, requiring significant estimates and assumptions[222] - Recently issued accounting pronouncements may impact the company's financial position and results of operations[223] - There have been no material changes in market risk during the six months ended November 30, 2024[224] Business Expansion and Brand Promotion - The company operates 20 brew pubs across the U.S., including the Breckenridge Distillery restaurant, to promote craft beer brands and drive revenue growth[128] - The company incurred $2.0 million in transaction expenses for the six months ended November 30, 2024, related to acquisitions and strategic transactions[143]

KIMMTRAK Performance and Market Potential - KIMMTRAK Q1-Q3 2024 net sales reached $226M, with potential to help up to 6K patients per year in the US and Europe[11] - KIMMTRAK has been launched in 45 countries as of December 31, 2024, with Q1-Q3 2024 net revenue from these launches[13] - KIMMTRAK active in cutaneous melanoma (CM) with Phase 1/2 study showing durable disease control in patients who progressed on prior anti-PD1 therapy[15] - KIMMTRAK's dosing frequency in CM patients shows durable response regardless of time since last dose of anti-PD1 therapy[15] - KIMMTRAK (tebentafusp) is being evaluated in a Phase 3 trial for adjuvant uveal melanoma, targeting ~1,200 patients[47] - The company's preliminary, unaudited year-end cash position is $820M, with $226M in commercial revenues from KIMMTRAK[43] Clinical Trials and Pipeline Development - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma targets a market opportunity of up to 4,000 patients, with expected enrollment completion in 1H 2026[18][19] - ATOM Phase 3 trial for KIMMTRAK in adjuvant uveal melanoma shows 88% ctDNA reduction in 1st line treatment and 71% in 2nd+ line treatment[21] - HIV STRIVE Phase 1 trial for IMC-M113V has enrolled 15 people living with HIV (PLWH) as of June 2024, with biologically active dose reached and Phase 1 MAD data planned for 1Q 2025[30] - Immunocore's pipeline includes candidates across oncology, autoimmune diseases, and infectious diseases, with multiple Phase 1/2 and Phase 3 trials ongoing[6][7] - PRISM-MEL-301, a Phase 3 trial for first-line advanced cutaneous melanoma, is enrolling ~10,000 HLA-A02+ patients annually in the US and Europe[72] - The company is evaluating brenetafusp in combination with standard-of-care therapies for ovarian and NSCLC, with enrollment expected in 2025[54] - PRAME franchise expansion opportunities include HLE and A24 programs, with IND/Phase 1 trials planned[54] Therapeutic Potential and Innovation - Immunocore's TCR therapeutics can target >90% of the human proteome, offering a broad therapeutic potential[5] - Immunocore's vision for autoimmunity includes tissue-specific downmodulation of the immune system, aiming to suppress activation only in inflamed tissues[33] - IMC-S118AI for type 1 diabetes (T1D) is expected to submit CTN for Phase 1 trial by end of 2025, targeting 160,000 newly diagnosed T1D patients annually in the US and EU5[35] - IMC-U120AI is a non-HLA restricted bispecific candidate for dermatology, addressing a broader patient population beyond HLA-A02[43] - PRAME-A02-HLE targets 20,000 PIWIL+ CRC patients, expanding the addressable patient population[43] Brenetafusp Clinical Data - Brenetafusp monotherapy in cutaneous melanoma showed a median H-score of 215 for PRAME expression, with 89% of patients being PRAME positive[58] - Brenetafusp monotherapy demonstrated a durable disease control rate (DCR) of 58% in PRAME+ patients, with a median progression-free survival (mPFS) of 3.7 months[69] - Median age of patients in monotherapy group is 63 years (range 40-80) and in chemo combo group is 65 years (range 47-72)[75] - 51% of monotherapy patients had ECOG PS 0, compared to 25% in chemo combo group[75] - 94% of monotherapy patients were PRAME positive, while 81% in chemo combo group were PRAME positive[75][77] - Disease Control Rate (DCR) for monotherapy was 58% with a median Progression-Free Survival (mPFS) of 3.3 months[82] - 6-month Overall Survival (OS) rate for monotherapy was 73%[82] - Treatment-related adverse events (TRAE) occurred in 97% of monotherapy patients and 100% of chemo combo patients[78] - Grade 3/4 TRAE were reported in 19% of monotherapy patients and 50% of chemo combo patients[78] - Cytokine Release Syndrome (CRS) was observed in 57% of monotherapy patients and 75% of chemo combo patients[78] - ALT increased in 11% of monotherapy patients and 50% of chemo combo patients[78] - AST increased in 5% of monotherapy patients and 50% of chemo combo patients[78]

Preliminary Financial Results Announcement - Accelerate Diagnostics, Inc. announced preliminary results for the quarter and year ending December 31, 2024 on January 10, 2025 [3] - The press release detailing the preliminary results is attached as Exhibit 99.1 and incorporated by reference [3] Regulatory and Filing Information - The information in Item 2.02, including Exhibit 99.1, is not deemed "filed" for purposes of Section 18 of the Exchange Act [4] - The report includes an Interactive Data File (XBRL) as Exhibit 104 [5] Executive Signatory - The report was signed by David Patience, Chief Financial Officer of Accelerate Diagnostics, Inc., on January 10, 2025 [8]

Sales Performance - Consolidated net sales increased by $13.1 million or 9% to $153.5 million compared to the prior year, driven by higher sales volume and price increases[97] - Americas segment sales grew 8% to $69.4 million, led by 9% growth in WD-40 Multi-Use Product sales[98][99] - EIMEA segment sales surged 18% to $57.5 million, with WD-40 Multi-Use Product sales up 21%[98][105] - Asia-Pacific segment sales declined 4% to $26.6 million, with WD-40 Multi-Use Product sales down 6%[98][108] - Net sales increased to $153.5 million in Q3 2024, up 9.3% from $140.4 million in Q3 2023[16] - Total net sales for the three months ended November 30, 2024, were $153.495 million, up from $140.416 million in the same period in 2023[68] - WD-40 Multi-Use Product sales increased to $118.547 million in Q3 2024 from $107.677 million in Q3 2023[68] - WD-40 Specialist sales rose to $19.172 million in Q3 2024 from $16.842 million in Q3 2023[68] - Foreign currency exchange rates favorably impacted consolidated net sales by $1.5 million[97] - Asia-Pacific segment net sales decreased, with WD-40 Multi-Use Product sales down $1.3 million (6%), driven by a $2.6 million decline in Asia distributor markets, partially offset by a $1.0 million increase in China[109] - WD-40 Specialist sales in the Asia-Pacific segment increased $1.2 million (17%), driven by higher sales volume in Iberia, U.K., and Italy, each up $0.5 million, $0.3 million, and $0.3 million respectively[109] Profitability and Margins - Gross profit margin improved to 54.8% from 53.8% in the prior year period[97] - Net income rose 8% to $18.9 million, with diluted EPS increasing 9% to $1.39[97] - Gross profit increased to $84.1 million, up $8.5 million, with gross margin improving to 54.8% from 53.8% (100 basis points increase)[111] - Net income rose to $18.9 million in Q3 2024, an 8.3% increase from $17.5 million in Q3 2023[16] - Gross profit margin improved to 54.8% in Q3 2024, up from 53.8% in Q3 2023[16] - Net income for the three months ended November 30, 2024, was $18.925 million, compared to $17.482 million for the same period in 2023[19] - Net income for the three months ended November 30, 2024, was $18.925 million, compared to $17.482 million for the same period in 2023[67] Expenses and Costs - SG&A expenses increased to $50.5 million, up $6.4 million (14%), representing 32.9% of net sales compared to 31.4% in the prior year[113] - Advertising and sales promotion expenses increased to $8.4 million, up $1.4 million (20%), representing 5.5% of net sales compared to 5.0% in the prior year[116] - Operating expenses increased to $59.0 million in Q3 2024, up 14.8% from $51.4 million in Q3 2023[16] - Americas segment operating income decreased to $12.7 million, down $1.5 million (11%), with operating expenses increasing $4.1 million primarily due to higher employee-related costs[121] Shareholder Returns and Capital Allocation - The company repurchased 13,750 shares at an average price of $263.75 per share for a total cost of $3.6 million under its $50 million share repurchase plan[161][163] - Returned $15.6 million to stockholders through share repurchases and dividends in the quarter[97] - The company declared a 7% increase in the regular quarterly cash dividend, raising it from $0.88 per share to $0.94 per share, payable on January 31, 2025[88] - Treasury stock purchases totaled $3.6 million in Q3 2024, up 50.2% from $2.4 million in Q3 2023[22] - Dividends paid increased to $12.0 million in Q3 2024, up 5.9% from $11.3 million in Q3 2023[22] - Cash dividends paid in Q3 2024 were $0.88 per share, totaling $11.958 million, compared to $0.83 per share and $11.297 million in Q3 2023[19] - The company repurchased 13,750 shares at an average price of $263.75 per share, totaling $3.6 million, leaving $38.3 million authorized under the 2023 Repurchase Plan[66] Cash Flow and Liquidity - Cash and cash equivalents grew to $54.9 million as of November 30, 2024, up 17.6% from $46.7 million at August 31, 2024[14] - Total current assets increased to $262.8 million as of November 30, 2024, up 2.9% from $255.4 million at August 31, 2024[14] - Net cash provided by operating activities was $14.9 million in Q3 2024, down 44.5% from $26.9 million in Q3 2023[22] - The company extended its revolving credit facility maturity date to April 30, 2029, under the Second Amended and Restated Credit Agreement[58] - The company's revolving credit agreement includes a $125.0 million limit on other unsecured indebtedness[62] Tax and Financial Adjustments - The release of an unrecognized tax benefit is expected to generate a favorable income tax adjustment of $11.9 million in the fiscal second quarter ending February 28, 2025[89] - The effective tax rate decreased by 2.2% from 24.2% in 2023 to 22.0% in 2024, primarily due to increased excess tax benefits from stock-based equity awards[81] Inventory and Assets - Total inventories decreased from $79.088 million as of August 31, 2024, to $74.887 million as of November 30, 2024, with finished goods inventory increasing from $60.331 million to $63.874 million[45] - Total assets held for sale as of November 30, 2024, were $9.865 million, including intangibles, goodwill, and inventory[44] - Goodwill decreased by $1.069 million due to assets held for sale, with the balance as of November 30, 2024, at $96.584 million[47] - The carrying amount of definite-lived intangible assets decreased from $6.222 million as of August 31, 2024, to $2.287 million as of November 30, 2024, due to amortization and translation adjustments[52] - The gross carrying amount of definite-lived intangible assets increased slightly from $38.863 million as of August 31, 2024, to $39.091 million as of November 30, 2024[51] - The company's goodwill showed no indicators of impairment as of November 30, 2024, with no impairment losses recorded[48] Liabilities and Debt - Total liabilities decreased to $221.0 million as of November 30, 2024, down 1.1% from $218.5 million at August 31, 2024[14] - The fair value of the company's senior notes was estimated at $60.3 million as of November 30, 2024, compared to a carrying value of $66.4 million[39] Operational and Strategic Changes - The company changed the functional currency of its U.K. subsidiary from Pound Sterling to Euro effective September 1, 2024[36] - The company has no outstanding commitments for purchasing finished goods and components as of November 30, 2024[75] Homecare and Cleaning Products - Homecare and cleaning product sales decreased 3% to $7.99 million, with a 7% decline in the Americas segment[97][99] - Homecare and cleaning product sales in the Asia-Pacific segment decreased $0.4 million (19%) due to reduced demand in the U.K. from lower advertising and promotional activities[109]

Strategic Updates and Restructuring - The company announced a strategic update to halt further development of imvotamab and IGM-2644, resulting in an approximately 73% reduction in force to preserve cash[6] - The company is unable to estimate the costs and charges associated with the 2025 Restructuring at this time and will file an amendment once determined[7] Evaluation of Strategic Alternatives - The company is evaluating internal options and potential strategic alternatives to maximize shareholder value[8]