Financial Performance - The company incurred net losses of 9,296,202and9,841,638 for the years ended December 31, 2024 and 2023, respectively[129]. - The company has not generated any revenue to date[170]. - Annual revenue for the most recently completed fiscal year was less than 100million,allowingthecompanytomaintainitssmallerreportingcompanystatus[183].RevenueGenerationandOfferings−Thecompanygeneratednorevenuesinceitsinceptionin2017untilthefourthquarterof2022,whenitbeganbuildinginventoryofsyringeproducts[129].−Thecompanyraisedapproximately20.0 million in gross proceeds from the 2025 Offering, with net proceeds of approximately 18.2millionafterexpenses[133].−The2025Offeringincluded14,285,714units,generatinggrossproceedsof12.6 million from Common Units and 7.4millionfromPre−FundedUnits[134].−ThecompanycompletedanInitialPublicOfferingonApril19,2022,raisingnetproceedsofapproximately14.2 million[132]. - The company entered into a securities purchase agreement on September 20, 2024, for an aggregate principal amount of 4,375,000,resultingingrossproceedsofapproximately3.5 million[138]. Expenses and Financial Position - The company has incurred significant research and development expenses, primarily related to its syringe products, and expects these expenses to increase in the foreseeable future[131]. - Research and Development (R&D) expenses increased to 2,471,762in2024from1,605,547 in 2023, representing a 54% increase[171]. - General and Administrative (G&A) expenses decreased to 7,154,948in2024from8,521,103 in 2023, a reduction of 16%[172]. - Net interest expense changed from income of 138,118in2023toanexpenseof1,664,712 in 2024, a change of 1,305%[173]. - Cash balance decreased to 864,041in2024from3,012,908 in 2023, indicating a significant reduction in liquidity[176]. - Working capital deficit increased to 2,011,678in2024fromaworkingcapitalof1,145,569 in 2023[176]. - Net cash used in operating activities was 6,929,545in2024,downfrom8,507,300 in 2023[178]. - Net cash used in investing activities increased to 1,163,137in2024from698,277 in 2023[179]. - Net cash provided by financing activities decreased to 5,907,407in2024from8,029,628 in 2023[180]. Compliance and Regulatory Status - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, and is awaiting a hearing date for its appeal[141]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of various reporting exemptions[181]. - The company will cease to be an emerging growth company if annual gross revenue exceeds 1.07billionorifthemarketvalueofcommonstockheldbynon−affiliatesexceeds700 million[182]. - The company is also a "smaller reporting company," with a market value of stock held by non-affiliates and gross proceeds from the IPO being less than 700million[183].−Asasmallerreportingcompany,thecompanymaypresentonlythetwomostrecentfiscalyearsofauditedfinancialstatementsinitsAnnualReportonForm10−K[183].−Thecompanyintendstoutilizeexemptionsfromcertaindisclosurerequirementsavailabletobothemerginggrowthandsmallerreportingcompanies[183].−Thecompanyhasnotissuedmorethan1.0 billion in non-convertible debt securities in the previous three-year period[182]. - The company may face a less active trading market for its common shares if investors find the reduced disclosures less attractive[182]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[184]. Distribution Agreement - The company has a distribution agreement that was mutually terminated on February 5, 2025, with no economic benefit obtained from it[140].