Financial Performance - Research and development revenue for the nine months ended September 30, 2024, was 21.977million,asignificantincreasefrom12.769 million in the same period in 2023[6] - Net loss for the nine months ended September 30, 2024, was 7.573million,comparedtoanetlossof17.308 million in the same period in 2023[6] - Gross profit for the nine months ended September 30, 2024, was 9.926million,upfrom5.444 million in the same period in 2023[6] - Operating loss for the nine months ended September 30, 2024, was 5.471million,animprovementfrom10.055 million in the same period in 2023[6] - Total other expense, net for the nine months ended September 30, 2024, was 1.974million,comparedto7.221 million in the same period in 2023[6] - Net loss for the nine months ended September 30, 2023, was 17.308million[11]−ResearchanddevelopmentrevenueforthethreemonthsendedSeptember30,2024,was8,173,000, compared to 3,440,000forthesameperiodin2023[6]−NetlossforthethreemonthsendedSeptember30,2024,was1,504,000, compared to 10,629,000forthesameperiodin2023[6]−NetlosspershareforthethreemonthsendedSeptember30,2024,was0.08, compared to 0.77forthesameperiodin2023[6]−TotalcomprehensivelossfortheninemonthsendedSeptember30,2024,was7,560,000, compared to 17,308,000forthesameperiodin2023[6]ResearchandDevelopment−Thecompanyrecognizedresearchanddevelopmentexpenseof5.2 million for the three months ended September 30, 2024, compared to 3.6millionforthesameperiodin2023[64]−FortheninemonthsendedSeptember30,2024,researchanddevelopmentexpensewas14.9 million, up from 11.3millioninthesameperiodin2023[64]−4.5 million of the R&D expenses for the three months ended September 30, 2024, were related to BARDA and MTEC contracts, compared to 2.0millioninthesameperiodin2023[64]−FortheninemonthsendedSeptember30,2024,12.0 million of R&D expenses were related to BARDA and MTEC contracts, up from 7.3millioninthesameperiodin2023[64]ContractsandGrants−Thecompanyexecutedamulti−yearProjectBioShieldcontractwithBARDAvaluedatupto150.0 million, with an initial award of 54.9million[20]−Thecompanyreceiveda4.0 million grant from MTEC in April 2023 for the development of a handheld version of the DeepView System, with the project expected to be completed by April 2025[21] - The MTEC award was increased to 4.9millioninAugust2024,withanadditional0.9 million received in September 2024 for further development of the handheld device[21] - The company received an additional 0.5millionawardfromtheDefenseHealthAgencyinMarch2024forfurtherdevelopmentofthehandhelddevice[21]−AsofSeptember30,2024,thecompanyhas2.5 million and 0.2millionremainingtobillundertheMTECandDHAawards,respectively[21]StockandEquity−WeightedaveragecommonsharesoutstandingfortheninemonthsendedSeptember30,2024,were17,342,203,upfrom13,410,287inthesameperiodin2023[6]−Stock−basedcompensationfortheninemonthsendedSeptember30,2024,totaled858,000[8] - Issuance of common stock under the SEPA for the nine months ended September 30, 2024, totaled 1.47million[8]−Thecompanyissued906,706sharesofcommonstockundertheSEPAduringthequarterendedSeptember30,2024[8]−Thecompanyhas8,433,333PublicWarrantsoutstandingasofSeptember30,2024,withanexercisepriceof11.50 per share[56] - There are 73,978 SP Angel Warrants outstanding as of September 30, 2024, which were converted from Legacy Spectral warrants with a strike price of 7.32[57]−ThecompanyaccountsforitsPublicWarrantsandSPAngelWarrantsasderivativeliabilities,adjustingthemtofairvalueateachreportingperiod[58]−ThecompanyenteredintoaCommonStockPurchaseAgreementwithB.RileyPrincipalCapitalII,LLCinDecember2023,allowingthecompanytosellupto10.0 million in newly issued shares of Common Stock[25] - The company entered into a Standby Equity Purchase Agreement with YA II PN, LTD in March 2024, allowing the company to sell up to 30.0millioninsharesofCommonStock,with12.5 million advanced in convertible promissory notes[27] - The company issued 1,187,398 shares to B. Riley under the ELOC for 2.7millioninaggregategrossproceedsduringtheninemonthsendedSeptember30,2024[113]−Thecompanyissued906,706sharesasrepaymentofprincipalundertheSEPAduringthethreeandninemonthsendedSeptember30,2024[114]−The2023LongTermIncentivePlanallowsfortheissuanceofupto8,000,000shares,withanannualadditionofupto52.16 per share[124] - Total unrecognized compensation expense related to RSUs was 0.8millionasofSeptember30,2024,expectedtoberecognizedover1.8years[124]−TheCompanygranted443,437stockoptionsintheninemonthsendedSeptember30,2024,withaweightedaverageexercisepriceof1.76 per share[128] - As of September 30, 2024, there was 0.8millionofunrecognizedstock−basedcompensationrelatedtostockoptiongrants,tobeamortizedover0.9years[129]−TheCompanyrecordedstock−basedcompensationexpenseof0.9 million for the nine months ended September 30, 2024[130] Cash and Liquidity - The company's cash balance at the end of September 30, 2023, was 7.348million[11]−Thecompany′snetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2023,was10.865 million[11] - The company's net cash provided by financing activities for the nine months ended September 30, 2023, was 4.039million[11]−AsofSeptember30,2024,thecompanyhadapproximately3.7 million in cash, an accumulated deficit of 40.4million,and5.0 million in short-term notes payable[24] - The company believes its cash and cash equivalents, along with various contracts and agreements, will be sufficient to fund operations for at least one year beyond the release date of the financial statements[29] - The company's cash and cash equivalents, along with the PBS BARDA Contract, MTEC Agreement, B. Riley ELOC, and Yorkville Transaction, are expected to fund operations for at least one year beyond the release date of the condensed consolidated financial statements[29] Business Combination and Subsidiaries - The company completed a Business Combination on September 11, 2023, resulting in the issuance of 14,094,450 shares of Company Common Stock at an exchange ratio of 10.31[16] - The Company recorded net liabilities of 2.4millionupontheBusinessCombination,withanoffsettingdecreasetoadditionalpaid−incapital[81]−TransactioncostsrelatedtotheBusinessCombinationtotaled7.6 million, including 1.9millionpaidincashand4.4 million in Company Common Stock issued[82] - Prior to the Business Combination, the Company incurred 0.7millionintransactioncostsforpotentialbusinesscombinationsthatdidnotoccur[83]−Thecompanyformedanewwholly−ownedsubsidiary,SpectralIP,Inc.,inMarch2024,whichreceiveda1.0 million investment for the development of its artificial intelligence intellectual property portfolio[22] - Spectral IP received a 1.0millioninvestmentfromanaffiliateofitslargestshareholder,structuredasanotepayablewithan835.0 million, with a 180-day period to regain compliance[28] DeepView System and Product Development - The company's DeepView System is focused on burn wounds and diabetic foot ulcer (DFU) indications, with no product revenue generated to date[19] - The Company's DeepView System uses proprietary AI algorithms to predict wound healing capacity, assisting physicians in treatment decisions[18] Leases and Operating Costs - The company amended its office lease in Dallas, Texas, extending the term to February 2028 and receiving a 0.3milliontenantimprovementallowance[105]−OperatingleasecostsfortheninemonthsendedSeptember30,2024,totaled857 thousand, with variable lease costs primarily attributable to utility charges, parking, and property taxes[109] - Future minimum payments under non-cancelable operating leases as of September 30, 2024, total 2.8million,withoperatingleaseliabilitiesof2.1 million after adjustments[110] Notes Payable and Financing - The company entered into Yorkville Convertible Notes with a total amount financed of 11.5million,ofwhich7.1 million is due by September 2024, and an outstanding balance of 4.4millionasofDecember31,2023[98]−Thecompanyreceived4.6 million in cash from the first Pre-Paid Advance under the Yorkville Convertible Notes, net of an 8% original issue discount, with a fixed conversion price of 3.16[99]−AsofSeptember30,2024,thecompanyhasmadeaggregateinstallmentpaymentsonthePre−PaidAdvancestotaling8.3 million, with 7.2millionsettledincashand1.1 million settled in shares[100] - The company recognized 0.2millionand0.8 million in issuance costs related to the SEPA for the three and nine months ended September 30, 2024, respectively[101] - The fair value of short-term notes payable to Yorkville as of September 30, 2024, was 4.377million,determinedusingLevel3inputs[91]−TheCompanyrecognizednochangeinderivativeliabilityfairvalueforthethreeandninemonthsendedSeptember30,2024,relatedtotheB.RileyELOCandYorkvilleSEPA[93]−ThepaymentperiodfortheremainingoutstandingbalanceofPre−PaidAdvanceswasextendedthroughFebruary2025[141]TaxandCompensation−Theeffectivetaxratewas2.5975[11] - The Company's issuance of common stock for transaction costs in 2023 is 1,800[11]OtherFinancialMetrics−Thecompany′stotalbalanceatSeptember30,2023,was15,688,268[10] - The company's cumulative translation adjustment at September 30, 2023, was (3)[10]−TheCompany′srevenuefortheninemonthsendedSeptember30,2024,was21.977 million, with 20.734millionfromBARDAand1.243 million from other U.S. governmental authorities[94] - Contract liabilities decreased from 2.311millionasofDecember31,2023,to731 thousand as of September 30, 2024, due to reductions of 5.818million[96]−AccruedexpensesasofSeptember30,2024,totaled3.253 million, including 1.957millioninsalaryandwagesand504 thousand in operating expenses[97] - The fair value of warrant liabilities as of September 30, 2024, was 1,101thousand,with1,096 thousand classified as Level 1 and 5thousandasLevel3[84]−TheCompany′spotentiallydilutivesecuritiestotaled12,762,902asofSeptember30,2024,including3,786,191commonstockoptionsand469,400unvestedRSUs[137]−TheannualinterestrateontheRelatedPartyNotewasreducedfrom850,000,000 of Common Stock, declared effective by the SEC on October 31, 2024[142] - As of November 5, 2024, there were 18,588,073 shares of Common Stock issued and outstanding[4]