Financial Performance - Revenues for the year ended December 31, 2024, were $26,350,819, a decrease of $12,440,518 or 32% compared to $38,791,337 in 2023, primarily due to delayed contract signings [105]. - Gross profit for 2024 was $19,412,515, down $8,000,558 or 29% from $27,413,073 in 2023, with a gross profit margin of 74% in 2024 compared to 71% in 2023 [107]. - Net income for 2024 was $1,363,681, representing a decrease of $7,787,154 or 85% from $9,150,835 in 2023, largely driven by the revenue decline [111]. - Adjusted EBITDA for 2024 was $2,926,169, a decrease of $9,447,710 or 76% from $12,373,879 in 2023 [112]. - Cash and cash equivalents as of December 31, 2024, were $18,040,827, down from $18,849,842 in 2023 [112]. - Net cash provided by operating activities decreased to $1,257,266 in 2024 from $6,682,616 in 2023, primarily due to lower net income [113]. Operating Expenses - Operating expenses increased by $386,676 or 2% to $17,416,184 in 2024, with R&D expenses rising by $208,988 or 7% [108]. Market Strategy - The Company plans to broaden its product offerings and enter new market segments through innovative products and services [101]. - VirTra aims to expand its total addressable market by targeting new customer types and enhancing marketing efforts [101]. - The Company is open to partnerships and acquisitions to optimize long-term growth and shareholder value [102]. Bookings and Backlog - The Company received bookings totaling $12.2 million for Q4 2024, bringing total bookings for the year to $29.6 million [117]. - The Company has a backlog of $22 million as of December 31, 2024, which includes $10.6 million in Capital, $6.6 million in Service, and $4.8 million in STEP [118]. - Management estimates that the majority of new bookings from Q4 2024 will convert to revenue in 2025, although contract terms and install dates may change [119]. - There are $5.3 million in renewable STEP contract options outstanding, with an expected 95% exercise rate based on current renewal rates [117]. - The Company has strengthened booking qualifications by ensuring STEP contracts are recorded for their full three-year value, adding $1.9 million to bookings [117]. Funding and Financial Strategy - The Company is open to raising additional funds from capital markets to expand production capacity and enhance sales and marketing efforts, but there is no assurance that financing will be available [121]. Regulatory and Economic Environment - The impact of the new federal administration on bookings for 2025 is uncertain, with discussions of budget cuts and frozen federal funding observed [120]. Accounting and Warranty - Revenue recognition is based on ASC 606, with revenue recognized when performance obligations are satisfied [129]. - The Company provides a one-year warranty on products, estimating warranty liabilities based on historical claims data [138]. - The Company employs a conservative approach to bad debt reserves, calculating a percentage of all outstanding accounts receivable [125].

Drug Development - The company has four drug candidates in development targeting at least five different cancer indications, with the lead candidate BP1001 (prexigebersen) currently in a Phase 2 clinical trial for untreated AML patients[305]. - In the Phase 2 trial, 75% of newly diagnosed AML patients achieved complete remission or complete remission with incomplete blood count recovery (CR/CRi/CRh) after treatment with prexigebersen, decitabine, and venetoclax[309]. - The company plans to complete enrollment for the first two cohorts of the Phase 2 trial by 2026, with a total of approximately 98 evaluable patients in Cohort 1 and 54 in Cohort 2[309]. - The second drug candidate, BP1002, targeting the Bcl-2 protein, has discontinued enrollment in its Phase 1 trial due to challenges in recruiting patients in a competitive landscape[311]. - BP1003, targeting the STAT3 protein, is in IND enabling studies, with plans to file an IND application and initiate a Phase 1 study for pancreatic cancer and NSCLC[314]. - BP1001-A, a modified version of prexigebersen, is undergoing a Phase 1/1b trial, with the first dose cohort completed and no dose limiting toxicities reported[315]. - The company is exploring BP1001-A as a potential treatment for obesity and Type 2 diabetes, with preclinical studies showing it may enhance insulin sensitivity[316][317]. - The company is developing a molecular biomarker package to accompany prexigebersen treatment to identify patients more likely to respond to the investigational treatment[319]. - The company intends to apply its DNAbilize® technology to new disease-causing protein targets and develop new liposomal antisense drug candidates[318]. - The company holds intellectual property for its drug products in clinical development, including composition of matter and method of use patents for RNAi antisense nanoparticle drug products[320]. Financial Performance - As of December 31, 2024, the company had an accumulated deficit of $117.5 million and a net loss of $9.9 million, a decrease from $16.1 million in 2023[321]. - The company reported no revenue for the years ended December 31, 2024 and 2023, indicating a reliance on future drug candidate commercialization for revenue generation[322][329]. - Research and development expenses for 2024 were $7.3 million, down from $11.6 million in 2023, primarily due to decreased manufacturing expenses[330]. - General and administrative expenses increased to $4.7 million in 2024 from $4.2 million in 2023, attributed to higher salaries and expenses related to a special shareholder meeting[332]. - The net operating loss for 2024 was $12.0 million, a decrease of $3.8 million compared to 2023[332]. - The company had a cash balance of $1.2 million at December 31, 2024, which is insufficient to cover current liabilities and capital expenditures[336]. - Net cash used in operating activities for 2024 was $10.6 million, with the net loss contributing significantly to this figure[337]. - The net loss per share for 2024 was $4.12, a significant improvement from $33.63 per share in 2023[334]. - The company anticipates continued significant operating losses as it expands drug development and commercialization efforts[321]. Financing Activities - The company raised approximately $10.7 million through various financing activities in 2024, including registered direct offerings and private placements[339]. - The company entered into an At The Market Offering Agreement on April 4, 2024, allowing the sale of up to $2.0 million in common stock, resulting in the sale of 436,511 shares for gross proceeds of approximately $2.0 million and net proceeds of about $1.8 million after expenses[345]. - On April 19, 2024, the company increased the offering under the At The Market Offering Agreement by an additional $1.1 million, selling 334,929 shares for gross proceeds of approximately $1.1 million and net proceeds of about $1.0 million[346]. - The company completed a registered direct offering on April 19, 2024, selling 375,000 shares for gross proceeds of approximately $1.2 million, with net proceeds of around $0.9 million after fees[347]. - In June 2024, the company raised approximately $4.0 million through a private placement, selling 180,000 shares and various warrants, with net proceeds of about $3.3 million after expenses[350]. - The October 2024 private placement generated approximately $4.0 million in gross proceeds, with net proceeds of about $3.5 million after deducting fees, while canceling certain previously issued warrants[351]. - The company issued a promissory note for $161,000 on March 6, 2025, with a purchase price of $140,000 after a discount, requiring five payments totaling $161,000[352]. - The company expects to incur significant operating expenses for ongoing activities, including clinical trials and regulatory approvals, necessitating substantial additional capital[353]. - As of December 31, 2024, the company reported no material off-balance sheet arrangements[354].

Financial Performance - The net loss for Q4 2024 was $18.6 million, or $0.62 per share, compared to a net loss of $25.1 million, or $0.84 per share, in Q4 2023[7] - The net loss for the full year 2024 was $80 million, or $2.65 per share, compared to a net loss of $98.8 million, or $3.28 per share, in 2023[13] - Net loss for 2024 was $79,979,354, compared to a net loss of $98,791,746 in 2023, indicating an improvement of about 19%[33] Cash and Assets - The company reported a cash balance of $44.8 million as of December 31, 2024[1] - Cash and cash equivalents decreased to $3,857,026 as of December 31, 2024, down from $4,091,568 as of December 31, 2023[30] - Total current assets fell to $45,795,843 in 2024 from $97,508,917 in 2023, a decline of approximately 53%[30] Expenses - Research and development expenses for Q4 2024 totaled $11.0 million, a decrease of 25.2% from $14.7 million in Q4 2023[7] - General and administrative expenses for Q4 2024 were $8.1 million, down approximately 33.1% from $12.1 million in Q4 2023[7] - For the full year 2024, research and development expenses totaled $46.2 million, down from $54.8 million in 2023, a decrease of 15.7%[13] - Total operating expenses decreased to $83,891,036 in 2024 from $103,702,293 in 2023, representing a reduction of approximately 19%[33] - Research and development expenses decreased to $46,175,512 in 2024 from $54,807,348 in 2023, a reduction of approximately 16%[33] - General and administrative expenses decreased to $37,715,524 in 2024 from $48,894,945 in 2023, a decline of about 23%[33] Equity and Liabilities - Additional paid-in capital increased to $676,373,822 in 2024 from $646,229,824 in 2023, reflecting an increase of about 5%[30] - Total liabilities decreased to $10,295,857 in 2024 from $12,194,800 in 2023, a reduction of approximately 16%[30] - Stockholders' equity decreased to $35,521,961 in 2024 from $85,357,242 in 2023, a decline of about 58%[30] Development Programs - The company is advancing NDV-01, a Phase 2 program for high-grade non-muscle invasive bladder cancer, with topline data expected at AUA 2025[4] - Sepranolone, a Phase 2b-ready neurosteroid for Tourette syndrome, is also being developed with plans for evaluation in other compulsion-related disorders[4] - The company aims to initiate a registration-track study for NDV-01 in late Q4 2025 to early 2026[7] - The U.S. NMIBC market is estimated to be a multi-billion opportunity, driven by the increasing incidence of bladder cancer and demand for effective therapies[15] Share Information - The weighted average number of common shares outstanding increased to 30,163,751 in 2024 from 30,099,203 in 2023[33]

Financial Performance - Relmada reported a net loss of approximately $79,979,400 for the year ended December 31, 2024, compared to a net loss of $98,791,700 for 2023, with an accumulated deficit of approximately $640,882,000 as of December 31, 2024[46]. - The company expects to continue operating at a net loss for at least the next several years due to ongoing research and development efforts[139]. - The company has Federal net operating loss carryforwards of approximately $127.04 million, which begin expiring in 2027[143]. - The company has a history of losses and may never achieve or sustain profitability[141]. - There is substantial doubt about the company's ability to continue as a going concern for the next 12 months[152]. - The company had cash, cash equivalents, and short-term investments of approximately $44.9 million as of December 31, 2024[141]. Drug Development and Pipeline - The company has paused the development of esmethadone (REL-1017) after a Phase 3 study indicated it was unlikely to meet primary efficacy endpoints, leading to a strategic review of its development pipeline[21][22]. - The company has paused the REL-P11 program due to changing regulatory landscapes and the acquisition of more advanced product candidates[20][43]. - The company is now focusing on two new drug candidates, NDV-01 and Sepranolone, which are in early stages of development, with limited data on their safety and efficacy[126]. - The company aims to prioritize mid- to late-stage programs to concentrate resources on assets with a clear path to commercialization[23]. - Key upcoming milestones include the presentation of NDV-01 Phase 2a data at the 2025 American Urological Association Meeting and the initiation of clinical trials for Sepranolone in Prader-Willi syndrome by year-end 2025[33]. Acquisitions and Licensing - Relmada has successfully closed two significant transactions: the acquisition of Sepranolone for €3,000,000 (approximately $2,756,000) and the in-licensing of NDV-01, aimed at treating non muscle-invasive bladder cancer (NMIBC)[27][53]. - The Company entered into an Exclusive License Agreement with Trigone for NDV-01, making an upfront payment of $3,500,000 and issuing 3,017,420 shares, representing 10% of outstanding shares[55]. - The Company acquired rights to a psilocybin program from Arbormentis for an upfront fee of $12.7 million and potential milestone payments totaling up to approximately $160 million[59]. - Relmada paid an upfront, non-refundable license fee of $180,000 for the esmethadone license, with ongoing payments of $45,000 every three months until certain conditions are met[57]. - The License Agreement for esmethadone includes tiered royalties with a maximum rate of 2%, decreasing to 1.5% under certain circumstances[57]. Regulatory Environment - The FDA approval process for new drugs typically takes many years and involves multiple phases of clinical trials[66]. - FDA may require substantial post-approval testing and surveillance to monitor the drug's safety or efficacy[74]. - FDA's Fast Track Designation allows expedited review for drugs addressing serious conditions, with a decision made within 60 days of request[77]. - Orphan Drug Designation grants a seven-year exclusive marketing period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[79]. - The company faces risks related to compliance with federal and state pharmaceutical regulations, which could increase operational costs and expose it to potential fines[121]. - The company may need to shift its strategic focus to new therapeutic areas due to limited experience in areas outside of depression[176]. - Regulatory approvals may be subject to ongoing FDA obligations and additional post-marketing requirements, which could result in significant expenses[165]. - The overall regulatory environment remains uncertain, which could impact future business strategies[222]. Competition and Market Position - The pharmaceutical industry is characterized by intense competition, with many competitors having significantly more resources[62]. - The company competes with larger pharmaceutical firms and biotechnology companies, which may have greater financial resources and R&D capabilities, posing a risk to its market position[197]. - The company’s ability to generate revenue is contingent upon successfully developing and commercializing its drug candidates, which is subject to various risks[132]. Intellectual Property - Relmada's intellectual property portfolio includes over 40 patents related to Sepranolone, providing potential coverage beyond 2030, and over 10 patents related to NDV-01, with coverage extending beyond 2038[48][49]. - The company’s ability to secure and protect intellectual property is critical for its commercial success, with uncertainties surrounding patent validity and enforcement[201]. Human Capital and Operations - The company had a total of 17 employees as of December 31, 2024, emphasizing that human capital is its greatest asset[112]. - The company maintains a competitive compensation and benefits package, including performance-based incentives tied to both company and individual performance[113]. - The company employed a third-party consultant in 2023 to evaluate pay practices, finding no meaningful differences in compensation based on gender, race, or other characteristics[113]. Risks and Liabilities - The company currently carries clinical trial insurance but does not have product liability insurance, which may expose it to substantial liabilities if product liability claims arise[163]. - The company is exposed to liability claims associated with the use of hazardous materials, which could materially affect its financial condition[198]. - The company does not currently carry product liability insurance, which could expose it to significant liabilities from adverse reactions to its product candidates[200]. Strategic Focus and Future Outlook - The strategic review initiated in December 2024 has led to a refined approach focused on innovation, addressing unmet medical needs, and pipeline diversification[26][23]. - The company plans to expand its business through acquisitions, which may involve substantial cash expenditures and risks[149]. - The transition to new drug candidates may increase operational costs and extend development timelines, with no guarantee of success[126]. - The company is monitoring the situation closely to mitigate potential impacts on its operations[222].

Financial Performance - Sales for Q3 FY2025 were $678.2 million, a 20% increase from $567.3 million in Q3 FY2024[9] - Adjusted diluted EPS for Q3 FY2025 was $0.99, up 16% from $0.85 in the same quarter last year[10] - Adjusted EBITDA increased 39% to $81 million, with an adjusted EBITDA margin rising to 12.0% from 10.3% year-over-year[4] - Sales to commercial customers rose 22%, accounting for 72% of total consolidated sales, while sales to government customers increased by 15%[9] - The company reported a net loss of $8.9 million, or $0.25 per share, compared to a net income of $14.0 million, or $0.39 per diluted share, in the prior year[10] - Adjusted net income for the nine months ended February 28, 2025, was $98.1 million, compared to $87.1 million in 2024, reflecting a growth of 12.0%[33] - Adjusted diluted earnings per share for the three months ended February 28, 2025, was $0.99, compared to $0.85 in 2024, an increase of 16.5%[34] Cash Flow and Expenses - Cash flow used in operating activities was $18.7 million, impacted by a $56 million FCPA settlement during the quarter[14] - The company reported a net cash used in operating activities of $(18.7) million for the three months ended February 28, 2025, compared to $20.4 million provided in the same period of 2024[28] - Cash used in operating activities was $(18.7) million for the three months ended February 28, 2025, compared to cash provided of $20.4 million in the same period last year[35] - The adjusted cash provided by operating activities was $(15.0) million for the three months ended February 28, 2025, compared to $20.4 million in the same period last year[35] - Acquisition, integration, and amortization expenses totaled $7.5 million for the three months ended February 28, 2025, slightly up from $7.2 million in the previous quarter[35] - The company reported interest expense of $18.1 million for the three months ended February 28, 2025, compared to $11.3 million in the same period last year[35] Asset and Debt Management - Total assets increased to $2,859.1 million as of February 28, 2025, up from $2,770.0 million in May 2024, representing a growth of 3.2%[26] - Long-term debt increased to $1,022.3 million as of February 28, 2025, compared to $985.4 million in May 2024, indicating a rise of 3.8%[26] - Net debt rose significantly to $947.6 million as of February 28, 2025, compared to $207.8 million a year earlier, with a net debt to adjusted EBITDA ratio of 3.06[36] - The company aims for further margin expansion and deleveraging, reducing net leverage from 3.58x to 3.06x over the past year[15] Segment Performance - Parts Supply segment revenue for the three months ended February 28, 2025, was $270.7 million, a 11.7% increase from $242.3 million in the same period of 2024[30] - Operating income for the Repair & Engineering segment increased to $19.0 million for the three months ended February 28, 2025, up from $11.5 million in 2024, a rise of 65.2%[30] Strategic Initiatives - AAR announced a multi-year exclusive agreement with Chromalloy for the distribution of BELAC PW4000 PMA parts, enhancing its aftermarket service offerings[5] - The divestiture of the Landing Gear Overhaul business is expected to be completed for $51 million in Q4 FY2025, as part of the company's portfolio optimization strategy[7] - The company incurred $64.0 million in losses related to the sale and exit of business/joint ventures for the three months ended February 28, 2025[35]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-38546 NEURONETICS, INC. (Exact name of registrant as specified in its charter) incorporation or or ...

(Exact Name of Registrant as Specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________________________________________________________________________________ FORM 10-K _______________________________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year end ...

Alzheimer's Disease and Treatment - Alzheimer's disease currently affects approximately 7 million people in the U.S. and 55 million worldwide, with projections of 13 million in the U.S. by 2050 without effective treatments[24] - Sabirnetug's mechanism aims to slow disease progression and potentially improve memory function in early AD patients by neutralizing AßO toxicity[26] - The Phase 1 clinical trial demonstrated that sabirnetug met primary and secondary objectives in 62 participants with early Alzheimer's Disease (AD) [55] - The Phase 2 ALTITUDE-AD trial is designed to evaluate sabirnetug's efficacy with up to 540 participants, using doses of 35 mg/kg and 50 mg/kg administered IV Q4W[30][38] - The primary outcome measure for ALTITUDE-AD will be the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months[30] - The company expects to announce top-line results for the ALTITUDE-AD trial in late 2026[37] - The FDA granted Fast Track designation to ACU193 in October 2022, indicating potential for expedited development [67] - The FDA granted Fast Track designation for sabirnetug for the treatment of early Alzheimer's disease in October 2022, which may expedite the review process[214] - The company is focused on developing sabirnetug, a humanized monoclonal antibody targeting amyloid-beta oligomers for treating Alzheimer's disease (AD) [219] Clinical Trial Results - The Phase 1 clinical trial, INTERCEPT-AD, enrolled 65 participants, with 62 receiving at least one dose, and reported an overall ARIA-E rate of 10.4%[28][29] - In the INTERCEPT-AD trial, a dose-dependent ARIA-E incidence was observed: 7% for 10 mg/kg and 25 mg/kg, and 21% for 60 mg/kg[29] - Sabirnetug has shown improvements in biomarkers related to amyloid and tau pathology in cerebrospinal fluid (CSF) in the MAD cohorts of the INTERCEPT-AD trial[29] - A statistically significant reduction in amyloid plaque load was observed with sabirnetug (60 mg/kg Q4W and 25 mg/kg Q2W) after 6-12 weeks, with a p-value of 0.01 [55] - Statistically significant improvements in biomarkers p-tau181 and neurogranin were observed at the 60 mg/kg Q4W dose compared to placebo, with p-values of 0.049 and 0.037 respectively [66] - The exploratory evaluation indicated a dose-dependent trend toward sabirnetug effect on CSF biomarkers specific to amyloid and tau pathology [66] - The pharmacokinetic results showed dose proportionality in CSF, supporting monthly dosing of sabirnetug [59] - The pharmacokinetics study in rhesus monkeys indicated that sabirnetug concentrations in CSF were sufficient for target engagement at 28 days post-administration of 20 mg/kg doses[105] Regulatory and Development Challenges - The company plans to discuss the ALTITUDE-AD clinical trial design with the FDA to explore registration pathways for sabirnetug [67] - The FDA requires two adequate and well-controlled Phase 3 clinical trials for approval of a Biologics License Application (BLA)[146] - The FDA may impose a clinical hold at any time during the IND review period or ongoing clinical trials based on safety concerns[142] - The company is required to develop and submit a diversity action plan for each Phase 3 clinical trial as per the Food and Drug Omnibus Reform Act[144] - The FDA requires a substantial application user fee for the submission of a Biologics License Application (BLA) unless a waiver or exemption applies[150] - Approval of a BLA is contingent upon compliance with current Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCP)[152] - The FDA may issue a Complete Response Letter (CRL) detailing deficiencies in the BLA, which may delay or refuse approval if regulatory criteria are not met[153] - Regulatory authorities may require additional clinical trials or studies if initial results are negative or inconclusive [224] - The company has received feedback from the FDA regarding the design of clinical trials, which may impact the development timeline [229] Financial Overview - The company reported net losses of $102.3 million and $52.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $325.1 million as of December 31, 2024[201] - The company has no product candidates approved for commercial sale and has never generated revenue from product sales, indicating a high level of financial risk[201] - As of December 31, 2024, the company had $35.6 million in cash and cash equivalents and $195.9 million in marketable securities, which are expected to fund operations into the first half of 2027[206] - The company expects to incur significant commercialization expenses if sabirnetug receives marketing approval, impacting future financial performance[205] - The company is exposed to interest rate risk under its Loan Agreement, which bears a variable interest rate that could increase debt service obligations significantly[211] Manufacturing and Collaboration - A global collaboration with Halozyme was announced to develop a subcutaneous formulation of sabirnetug, with Phase 1 results showing mild injection site reactions in 62.5% of participants[31] - The collaboration with Merck resulted in the development of sabirnetug, with the company receiving a royalty-free license for its commercialization after Merck terminated the agreement[119] - The Company entered into a non-exclusive collaboration and license agreement with Halozyme, paying a seven-figure upfront payment for the ENHANZE drug delivery technology[123] - The Company will make milestone payments tied to development and commercialization milestones for the Halozyme Product, as well as single-digit royalty payments based on worldwide net sales[123] - The company relies on third-party manufacturers for sabirnetug production, ensuring compliance with extensive regulatory requirements[109] Market and Competitive Landscape - The market viability of sabirnetug will depend on the cost of production, which is currently uncertain [220] - The company faces challenges in obtaining adequate coverage and reimbursement from third-party payors, which can significantly impact market acceptance of its products[180] - Coverage and reimbursement policies can vary widely among third-party payors, affecting the pricing and profitability of the company's products[181] - Recent healthcare reforms, including the Inflation Reduction Act of 2022, are expected to significantly impact the pharmaceutical industry, particularly regarding drug pricing and reimbursement[189] - Legislative changes at federal or state levels could adversely affect the company's future business and financial results[193] Employee and Operational Considerations - The company had 61 full-time employees as of March 24, 2025, with 41 in research and development and 20 in general and administrative functions[195] - The company has good employee relations and aims to attract and retain talent through equity incentive plans[194] - The company is subject to various healthcare laws and regulations, which could lead to significant legal expenses and operational distractions if found non-compliant[177] - The company must navigate complex compliance requirements related to drug marketing and pricing, which may affect its operational strategies[178] Risks and Uncertainties - The company may need to raise additional funds sooner than anticipated if it chooses to expand operations more rapidly than currently planned[206] - The company is substantially dependent on the success of sabirnetug, its sole product candidate, which requires extensive clinical testing before seeking regulatory approval[212] - The company has limited experience in conducting clinical trials and has only recently completed its first clinical trial [226] - Clinical trials may face delays due to patient enrollment challenges and competition for eligible patients [233] - The company may incur additional costs or experience delays in the development and commercialization of sabirnetug [228] - Future enrollment delays could require abandonment of clinical trials, further harming business operations[236] - The company may face regulatory investigations and enforcement actions, which could affect reputation and sales[234] - Personal injury claims related to product candidates could arise, impacting financial stability[234]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to SK GROWTH OPPORTUNITIES CORPORATION (Exact name of registrant guarantor as specified in its charter) | Cayman Islands | 001-41432 | 98-1643582 | | --- | --- | --- | ...