Company Focus and Clinical Programs - Traws Pharma, Inc. focuses on developing novel antiviral therapies targeting respiratory viral diseases, expanding its business after a merger with Trawsfynydd Therapeutics, Inc. on April 1, 2024[18]. - The company has four clinical programs: tivoxavir marboxil for influenza, ratutrelvir for COVID-19, narazaciclib for cancer, and rigosertib for various cancers[18]. - The merger with Trawsfynydd Therapeutics has shifted the company's focus from cancer therapies to include critical respiratory viral diseases[18]. Clinical Trial Results - Tivoxavir marboxil demonstrated a 100% protection rate in mice against H5N1 bird flu at a dose of 50 mg/kg, which is comparable to a human dose of 240 mg[26]. - In a Phase 1 clinical trial in Australia, tivoxavir marboxil maintained plasma drug levels above the EC90 for over 23 days after a single dose[22]. - Ratutrelvir showed non-inferiority to the combination of nirmatrelvir and ritonavir in an animal study, indicating its potential effectiveness against SARS-CoV-2[35]. - The Phase 1 trial for ratutrelvir included 40 participants, with a maximum dose of 600 mg showing no adverse events related to the study drug[36]. - Narazaciclib is a multi-targeted kinase inhibitor with a differentiated profile, potentially overcoming limitations of current CDK 4/6 inhibitors[38]. - Narazaciclib demonstrates a favorable kinase inhibitory profile compared to approved CDK4/6 inhibitors, potentially leading to both tumorigenic and safety benefits[45]. - In a Phase 1 study in China, 75% of enrolled patients had metastatic breast cancers, with 2 out of 3 patients at the 200 mg dose achieving stable disease[47]. - The Phase 1/2a trial of narazaciclib in combination with letrozole for recurrent metastatic endometrial cancer established a maximum tolerated dose of 160 mg[51]. - Narazaciclib inhibits CSF1R with IC50 values between 0.7 to 10 nM, indicating potential efficacy in cancers dependent on CSF1R signaling[40]. - The Phase 1 study in the US (Study 19-01) commenced in May 2021, assessing safety and pharmacokinetics of narazaciclib in patients with advanced cancer[48]. - In the Phase 1 study in China, dose-limiting toxicities were observed in 2 patients at the 200 mg dose, including Grade 4 ALT increase and Grade 3 platelet count decrease[47]. - Rigosertib has shown promising results in treating advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, with 2 complete responses observed[56]. Regulatory and Approval Processes - The company plans to meet with the FDA in the first half of 2025 to discuss accelerated approval for tivoxavir marboxil under the "Animal Rule" for H5N1 bird flu treatment[24]. - The process of obtaining regulatory marketing approvals is time-consuming and requires substantial financial resources[107]. - The FDA aims to complete its review of New Drug Applications (NDAs) for new molecular entities within 10 months of acceptance for filing[124]. - An approval letter from the FDA authorizes commercial marketing of the drug with specific prescribing information for designated indications[128]. - Post-approval requirements may include Phase 4 clinical trials and ongoing safety monitoring to assess the drug's effectiveness after commercialization[131]. - The FDA's approval process for new chemical entities (NCE) grants five years of marketing exclusivity, preventing ANDA or 505(b)(2) applications for the same active moiety during this period[143]. - The FDA allows for a patent term extension of up to five years for relevant drug patents, calculated based on the drug's testing and review phases, with a maximum total patent term of 14 years from the date of approval[145]. - The FDA's Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[159]. - The FDA's priority review designation sets a target action date of six months for drugs that provide significant improvements in treatment for serious conditions[165]. - The FDA's Fast Track designation allows for more frequent development meetings and a rolling review process for drugs addressing unmet medical needs[164]. - The Clinical Trials Regulation (EC) 536/2014 enables a single application for cross-border trials within the EU, streamlining the approval process[147]. - The FDA's regulations allow for expanded access to investigational drugs for patients with serious or life-threatening diseases under certain conditions[150]. - The FDA's Animal Rule permits approval of certain drugs based on animal studies when human efficacy studies are not ethical or feasible[154]. Financial Performance and Concerns - The company reported recurring operating losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern without obtaining adequate new financings[198]. - The independent registered accounting firm's report for the fiscal year ended December 31, 2024, contains an explanatory paragraph regarding the company's ability to continue as a going concern[200]. - The company has identified material weaknesses in its internal control over financial reporting, which could impair its ability to produce timely and accurate financial statements[200]. - The company needs to obtain additional funding to continue operations; failure to do so may require scaling back or ceasing operations[200]. - The company reported net losses of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for the year ended December 31, 2023, with an accumulated deficit of $649.2 million as of December 31, 2024[210]. - The company has incurred recurring losses from operations, leading to substantial doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[205]. - The company plans to explore various financing options, including equity financings and strategic alliances, to alleviate liquidity concerns and fund ongoing clinical trials and operations[204]. - The company has not generated any revenue from product sales to date and may never become profitable, depending on the successful commercialization of its product candidates[215]. - The company anticipates continuing to incur significant expenses and operating losses for the foreseeable future, which may increase as it seeks regulatory approvals for its product candidates[211]. - The company may need to delay or pause planned clinical trials until adequate additional funding is secured, impacting its development efforts[206]. Market and Competitive Landscape - The biotechnology and pharmaceutical industries are highly competitive, with many competitors having greater financial and technical resources[96]. - The company anticipates intense competition as new drugs enter the market and advanced technologies become available[97]. - Several companies have advanced drug candidates for COVID-19, including remdesivir and oral Paxlovid, both of which have received full FDA approval[99]. - The company faces substantial competition, which may result in others discovering, developing, or commercializing products before it does[201]. - The company expects to incur substantial expenses related to the integration of Trawsfynydd[201]. Regulatory Compliance and Risks - The company is subject to extensive regulation by the FDA and other agencies, impacting research, development, and marketing of product candidates[105]. - Manufacturers must comply with stringent regulations regarding advertising and promotion, ensuring claims are consistent with FDA-approved labeling[130]. - Changes to approved applications, such as modifications in indications or manufacturing processes, require submission of a new NDA or NDA supplement[129]. - The Hatch-Waxman Amendments require applicants to list all relevant patents with the FDA upon drug approval, which are published in the Orange Book[137]. - The FDA conducts periodic inspections to ensure compliance with current Good Manufacturing Practices (cGMP) after drug approval[132]. - Compliance with regulatory requirements is critical, as failure may result in sanctions including product recalls, fines, or withdrawal of approval[152]. Economic and Geopolitical Factors - The company is currently operating in a period of economic uncertainty and capital markets disruption, which could materially adversely affect its business and financial condition[219]. - The ongoing military conflicts and geopolitical tensions may impact the company's operations and access to funding, although it has not been materially affected to date[223]. - International trade disputes may lead to tariffs and protectionist measures, adversely affecting the company's business and financial condition[224]. - Changes in U.S.-China relations and regulations could impact the company's operating results and ability to raise capital[225]. - Potential new legislation or tariffs could have negative effects on the company's financial condition and market share[227]. - Inflation may increase the company's overall cost structure, affecting liquidity and financial results[228]. - Higher interest rates and capital costs due to inflation could lead to supply shortages and increased operational costs[228].

Financial Performance - For the full year 2024, total Gross Written Premium decreased by almost 50% to $72.1 million from $143.8 million in 2023, while Net Earned Premium fell by 27.5% to $60.9 million[2][4][8]. - The Company reported a net income allocable to common shareholders of $23.5 million for the full year 2024, translating to $1.93 per share, while the Q4 2024 net loss was $25.4 million, or $2.08 per share[4][17]. - Adjusted operating loss for Q4 2024 was $25,821 thousand, compared to a loss of $19,411 thousand in Q4 2023, indicating a decline in performance[25]. - Net income (loss) for the year ended December 31, 2024, was $24,347 thousand, compared to a loss of $25,904 thousand in 2023, showing an improvement in profitability[27]. - Total revenue and other income for the year ended December 31, 2024, was $67,271 thousand, a decrease from $90,522 thousand in 2023, representing a decline of about 25.5%[27]. Premiums and Business Segments - Personal Lines business saw a 10.6% increase in Gross Written Premium for Q4 2024, totaling $10.6 million, and a 23.4% increase for the full year 2024, reaching $45.4 million[3][11][12]. - The Commercial Lines business experienced a 79% decline in Gross Written Premium for Q4 2024, contributing only 23% to total gross written premium[10][12]. - The Company anticipates that future premiums will primarily come from Personal Lines, particularly homeowner's insurance in Texas and the Midwest[3][10]. Loss Ratios and Claims - The loss ratio for the combined business in Q4 2024 was 254.6%, significantly higher than 191.1% in Q4 2023, indicating increased claims relative to premiums[13]. - Adjusted operating loss for Q4 2024 was $25.8 million, or $2.11 per share, reflecting ongoing challenges in the commercial lines segment[18]. Investment Income and Assets - Net investment income increased by 5.8% to $5.8 million for the year ending December 31, 2024, compared to $5.4 million in the prior year[15]. - The company reported a net investment income of $5,763 thousand for the year ended December 31, 2024, compared to $5,447 thousand in 2023, reflecting a growth of approximately 5.8%[27]. - Total assets decreased to $281,656 thousand as of December 31, 2024, from $315,606 thousand in 2023, a reduction of approximately 10.7%[26]. Liabilities and Valuation - The company recorded total liabilities of $260,131 thousand as of December 31, 2024, down from $312,717 thousand in 2023, a decrease of about 16.8%[26]. - Unpaid losses and loss adjustment expenses increased to $189,285 thousand in 2024, up from $174,612 thousand in 2023, indicating a rise of about 8.4%[26]. - The company has recorded a full valuation allowance against its deferred tax assets as of December 31, 2024, resulting in no taxable impacts to adjusted operating income from the adjustments to net income[25]. Shareholder Metrics - Book value per share improved to $1.76 as of December 31, 2024, compared to $0.24 in the previous year[4][12]. - The diluted loss per common share for Q4 2024 was $(2.08), compared to $(1.59) in Q4 2023, indicating a worsening in earnings per share[27]. Other Financial Highlights - The Company recorded a $61 million gain from the sale of its insurance agency operations in August 2024, which contributed to the overall financial results[4][17]. - Net earned premiums for Q4 2024 were $12,708 thousand, down from $14,821 thousand in Q4 2023, reflecting a decrease of approximately 14.2%[27].

Revenue and Financial Performance - Total revenue for Q4 2024 was $1.79 million, flat compared to $1.64 million in Q4 2023[4] - Total revenue for Q4 2024 was $1,786,075, a 8.6% increase from $1,644,677 in Q4 2023[22] - The company reported a total comprehensive loss of $5,126,469 for Q4 2024, compared to a loss of $7,330,103 in Q4 2023, reflecting a 30.1% improvement[24] - Net loss decreased by $2.2 million to $5.1 million in Q4 2024, compared to a net loss of $7.3 million in Q4 2023[9] - Net loss for Q4 2024 was $5,098,817, compared to a net loss of $7,319,240 in Q4 2023, representing a 30.3% improvement[22] - The net loss for 2024 was $17,426,412, a significant improvement from the net loss of $31,296,787 in 2023, representing a reduction of approximately 44%[26] - Operating loss for the year 2024 was $20,460,431, down from $32,105,275 in 2023, indicating a 36.3% reduction[22] Expenses and Cost Management - Operating expenses, excluding cost of sales, decreased by $2.0 million to $5.9 million in Q4 2024, down from $7.9 million in Q4 2023[3] - Research and development expenses decreased by 61.3% to $0.8 million in Q4 2024, down from $2.0 million in Q4 2023[7] - Selling, general and administrative expenses decreased by 13.7% to $5.1 million in Q4 2024, compared to $5.9 million in Q4 2023[6] - Research and development expenses for Q4 2024 were $767,558, a decrease of 61.3% from $1,981,189 in Q4 2023[22] - The company reported a depreciation and amortization expense of $337,971 in 2024, down from $396,210 in 2023, a decrease of approximately 15%[26] Assets and Liabilities - Total assets decreased to $16,797,812 in 2024 from $20,950,506 in 2023, a decline of 19.7%[20] - Total liabilities increased to $18,087,459 in 2024 from $13,960,043 in 2023, an increase of 29.5%[20] - Cash and cash equivalents decreased significantly to $371,497 in 2024 from $1,534,660 in 2023, a drop of 75.8%[20] - Accounts receivable increased to $2,148,198 in 2024 from $1,724,899 in 2023, an increase of 24.6%[20] Cash Flow and Financing - Net cash used in operating activities decreased to $15,734,334 in 2024 from $21,254,328 in 2023, indicating a 26% improvement[26] - Cash and restricted cash at the end of 2024 was $691,497, down from $2,014,660 at the end of 2023, reflecting a decrease of 66%[26] - The company raised $8,502,086 from common stock offerings in 2024, compared to $884,586 in 2023, marking an increase of over 867%[26] - The net cash provided by financing activities in 2024 was $14,462,917, a substantial increase from $5,862,746 in 2023, reflecting enhanced financing efforts[26] Operational Metrics - Customer backlog exceeded $18 million at the start of 2025, supporting growth prospects[3] - Megawatts under management increased by 22.3% to 30.7 megawatts as of December 31, 2024[3] - Cost of product and service revenues increased by 28.8% to $1.5 million in Q4 2024, up from $1.2 million in Q4 2023[5] - Other income (expense) shifted from $0.13 million of income in Q4 2023 to $0.52 million of expense in Q4 2024[8] - Inventory increased by $1,297,551 in 2024, contrasting with a decrease of $5,445,390 in 2023, indicating a shift in inventory management strategy[26] - The change in fair value of warrants liability resulted in a gain of $3,263,697 in 2024, compared to a loss of $216,263 in 2023[26] - The effect of exchange rate on cash resulted in a loss of $6,351 in 2024, compared to a gain of $35,624 in 2023, indicating potential currency risk[26] Ownership and Acquisitions - Nuvve became the 100% owner of Levo after acquiring the remaining 49% membership interest in October 2024[12] Shareholder Information - The weighted-average shares used in computing net loss per share increased to 881,144 in Q4 2024 from 107,711 in Q4 2023[22]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________ FORM 10-K ____________________________________________________________ (Mark One) x 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 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________to ___ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 RAIL VISION LTD. (Exact name of registrant as specified in its charter) Translation of registrant's name into English: Not applicable OR ☒ 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 SECUR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ 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: 0-25023 FIRST CAPITAL, INC. (Exact name of registrant as specified in its charter) Indiana 35-2056949 (State or other jurisdic ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x 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 o 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 001-39532 Humacyte, Inc. (Exact name of registrant as specified in its charter) ___________________________________ (St ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ 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 Commission File Number 001-39852 Scilex Holding Company (Exact Name of Registrant as Specified in Its Charter) Delaware 92-1062542 (State or Other Jurisdiction of Incorporat ...

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 001-39114 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 Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ 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: 001-39727 REBORN COFFEE, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-4752305 | | --- | --- | | (State ...