Financial Performance - As of September 30, 2024, the company had an accumulated deficit of 29,918,777andanetlossof4,769,774 for the nine months ended September 30, 2024[109]. - As of September 30, 2024, the Company reported a net loss of 1,685,060,adecreaseof162,022,344 in the same period of 2023[135]. - For the nine months ended September 30, 2024, the net loss was 4,769,774,a296,739,999 in 2023[143]. - The Company has not generated significant revenue from syringe product sales since its inception in 2017[109]. - The Company has not generated any significant syringe revenue to date[136]. Operational Challenges - The company has faced delays in the commercialization of the Sharps Provensa product line, with no current timeline for final commercialization[116]. - The company had working capital of 67,820, which is insufficient to fund planned operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[110]. Research and Development - The company has incurred substantial research and development expenses primarily related to its syringe products and plans to continue these efforts[117]. - Research and Development (R&D) expenses for the three months ended September 30, 2024, decreased to 145,611, down 35% from 225,191in2023[137].RevenueGenerationandSalesAgreements−Thecompanyhasproducedcommercialquantitiesofitsproductsandbuiltinventorytosupportordersinlate2024andin2025[113].−APurchaseOrderforthefirstSecuregardsalestoaSouthAmericadistributorwasshippedinJune2024,markingthecompany′sentryintointernationalmarkets[114].−ThecompanyenteredintoaSupplyAgreementwithStericareSolutionsforthepurchaseof520millionunitsof10mlpolypropyleneSologardsyringes,withexpectedrevenuesinexcessof50 million[124]. - The company entered into a cooperative sales and distribution agreement with Roncadelle, appointing each other as exclusive distributors in their respective regions[123]. Stock and Financing Activities - The Company approved a reverse stock split at a ratio of 1-for-22, effective October 16, 2024[128]. - The company’s common stock was at risk of delisting from Nasdaq due to non-compliance with listing rules, but a hearing request was filed to appeal the determination[126]. - The Company plans to seek funding through equity offerings and/or debt financing opportunities[150]. - On September 20, 2024, the Company entered into a securities purchase agreement for an aggregate principal amount of 4,375,000[151].−TheCompanyofferedwarrantinducementstocertainwarrantholders,reducingtheexercisepricefrom14.08 to 7.26pershare,resultingingrossproceedsof1.9 million[154]. - The Company completed two simultaneous offerings on September 29, 2023, receiving aggregate gross proceeds of approximately 5.6million,netof716,000 in expenses[155]. - The Shelf Offering generated net proceeds of approximately 2.5million,with164,478sharesissuedatanadjustedpriceof7.26 per share[156]. - The Private Placement yielded net proceeds of approximately 2.4million,withPIPEWarrantsissuedtopurchase397,727sharesatanadjustedexercisepriceof7.26[157]. - The Offering completed on February 3, 2023, resulted in net proceeds of approximately 3.2million,withunitspricedat37.18, adjusted to 7.26byMay30,2024[158].−TheCompany′sIPOgeneratednetproceedsofapproximately14.2 million, with 9.0millionrecordedinAdditionalPaidinCapitaland5.2 million as a liability under ASC 815[159]. Cash Flow Analysis - Cash balance as of September 30, 2024, was 2,473,197,downfrom3,012,908 as of December 31, 2023[149]. - Cash used in operating activities decreased to 5,172,135fortheninemonthsendedSeptember30,2024,from6,144,937 in the same period of 2023, due to lower operating expenses[159]. - Cash used in investing activities increased to 1,069,659in2024,primarilyforfixedassets,comparedto431,379 in 2023[160]. - Cash provided by financing activities was 5,707,946in2024,downfrom8,029,628 in 2023, reflecting various offerings and warrant exercises[161]. - The Company does not have any off-balance sheet arrangements as defined in Regulation S-K Item 303(a)(4)[162].
