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TuHURA Biosciences, Inc.(HURA) - 2025 Q1 - Quarterly Results
HURATuHURA Biosciences, Inc.(HURA)2024-10-21 12:30

Merger and Acquisition - The merger between Kintara and TuHURA resulted in TuHURA stockholders owning approximately 96.0% of the combined company post-merger[4]. - The merger is accounted for as a reverse recapitalization, treating Kintara as the acquired company for financial reporting purposes[4]. - The pro forma financial statements reflect the merger as if it had occurred on January 1, 2023, with no historical operating relationship between the companies prior to the merger[5]. - The merger transaction was completed on April 2, 2024, with TuHURA continuing as a wholly owned subsidiary of Kintara[16]. - The pro forma adjustments for the merger and related transactions are based on preliminary information and may differ materially from actual results[25]. - The merger was accounted for as a reverse recapitalization, treating Kintara as the accounting acquiree and TuHURA as the accounting acquirer[24]. Financial Performance - Total assets held by TuHURA and Kintara as of June 30, 2024, were 14,093thousandand14,093 thousand and 6,202 thousand, respectively, with cash and cash equivalents of 12,311thousandand12,311 thousand and 4,909 thousand[4]. - As of June 30, 2024, total current assets amounted to 23,069,000,withcashandcashequivalentsat23,069,000, with cash and cash equivalents at 22,043,000[9]. - Total liabilities were reported at 5,124,000,withcurrentliabilitiesof5,124,000, with current liabilities of 4,813,000 and long-term liabilities of 311,000[10].−ForthesixmonthsendedJune30,2024,totaloperatingexpenseswere311,000[10]. - For the six months ended June 30, 2024, total operating expenses were 12,694,000, with research and development expenses at 7,105,000[12].−Thenetlossforthesameperiodwas7,105,000[12]. - The net loss for the same period was 12,494,000, with a net loss per share of 0.30[12].−ThecombinedbalancesheetasofJune30,2024,showedtotalassetsof0.30[12]. - The combined balance sheet as of June 30, 2024, showed total assets of 24,198,000[11]. - Total operating expenses for the pro forma combined entity amounted to 49,525,000,withresearchanddevelopmentexpensescontributing49,525,000, with research and development expenses contributing 20,753,000[14]. - The net loss for the pro forma combined entity was 49,011,000,resultinginanetlosspershareof49,011,000, resulting in a net loss per share of 1.17[14]. - Pro forma net loss for the six months ended June 30, 2024, is projected at 12,494,000,withanetlosspershareof12,494,000, with a net loss per share of (0.30)[37]. - Pro forma net loss for the year ended December 31, 2023, is projected at 49,011,000,withanetlosspershareof49,011,000, with a net loss per share of (1.17)[37]. Capital Structure and Financing - The convertible promissory notes issued by TuHURA were increased to an aggregate principal amount of 35million,witha2035 million, with a 20% annual interest rate[7]. - The exercise price for TuHURA Warrants issued in the Note Financing is set at 1.02 per share, with a three-year exercise period[7]. - TuHURA's board approved a private offering of Convertible Debt, increasing the aggregate principal amount to 35million,primarilyforclinicaldevelopmentandcorporateexpenses[19].−Theissuanceof4,009,623sharesinJuly2024PrivatePlacementgeneratedproceedsof35 million, primarily for clinical development and corporate expenses[19]. - The issuance of 4,009,623 shares in July 2024 Private Placement generated proceeds of 5,000,000, netting 4,695,990aftercosts[33].−Theconversionof4,695,990 after costs[33]. - The conversion of 22,242,770 of Convertible Debt will result in the issuance of 55,489,176 shares[35]. - The fair value of the derivative liability related to the Convertible Debt is recorded at 2,884,000[35].ResearchandDevelopment−TuHURAplanstolaunchtheREM−001Study,asecond−generationPDTphotosensitizeragent,totesta0.8mgdoseandoptimizestudydesignaheadofaPhase3trialinitiation[4].−TuHURAanticipatessuccessfulenrollmentoftenCMBCpatientsfortheREM−001Study,withnosignificantvalueexpectedfromKintara′sin−processresearchanddevelopmentassetsatthetimeofthemerger[4].−KintaraenteredintoaContingentValueRightsAgreement,allowingholderstoreceivesharesbasedonachievingamilestonerelatedtotheREM−001study[20].−AsofAugust19,2024,30outofaprojected39patientshavebeenenrolledintheongoingVISTA−101Phase1/2clinicaltrial,whichincludesbothmonotherapyandcombinationtherapyarms[31].−KVA12123hasclearedfiveofsixmonotherapydoselevelsandtwooffourcohortsincombinationwithMerck′sKEYTRUDA®,withinitialresultsshowingpartialresponseandstabledisease[31].AgreementsandTransactions−TuHURAhasenteredintoanExclusivityAgreementwithKinetaforthepotentialacquisitionoftheKVA12123anti−VISTAantibodyandrelatedassets[7].−TuHURApaidKinetaatotalfeeof2,884,000[35]. Research and Development - TuHURA plans to launch the REM-001 Study, a second-generation PDT photosensitizer agent, to test a 0.8 mg dose and optimize study design ahead of a Phase 3 trial initiation[4]. - TuHURA anticipates successful enrollment of ten CMBC patients for the REM-001 Study, with no significant value expected from Kintara's in-process research and development assets at the time of the merger[4]. - Kintara entered into a Contingent Value Rights Agreement, allowing holders to receive shares based on achieving a milestone related to the REM-001 study[20]. - As of August 19, 2024, 30 out of a projected 39 patients have been enrolled in the ongoing VISTA-101 Phase 1/2 clinical trial, which includes both monotherapy and combination therapy arms[31]. - KVA12123 has cleared five of six monotherapy dose levels and two of four cohorts in combination with Merck's KEYTRUDA®, with initial results showing partial response and stable disease[31]. Agreements and Transactions - TuHURA has entered into an Exclusivity Agreement with Kineta for the potential acquisition of the KVA12123 anti-VISTA antibody and related assets[7]. - TuHURA paid Kineta a total fee of 5,000,000 under the Exclusivity Agreement, with 2,500,000paidatsigningandanother2,500,000 paid at signing and another 2,500,000 due on July 15, 2024[8]. - The company has not allocated any of the 5,000,000purchasepriceconsiderationtotheroyaltyagreementduetouncertaintiessurroundingregulatoryapproval[8].−TheaccountingtreatmentfortheExclusivityAgreementandtheJulyPrivatePlacementispreliminaryandwillbefinalizedbasedonfurtheranalysis[8].−TuHURAmadenonrefundablepaymentsof5,000,000 purchase price consideration to the royalty agreement due to uncertainties surrounding regulatory approval[8]. - The accounting treatment for the Exclusivity Agreement and the July Private Placement is preliminary and will be finalized based on further analysis[8]. - TuHURA made nonrefundable payments of 5,000,000 for exclusive rights to acquire Kineta's patents and related assets, with additional payments of 150,000eachfortworenewalperiods[34].−Estimatedtransactioncostsrelatedtothemergeramountto150,000 each for two renewal periods[34]. - Estimated transaction costs related to the merger amount to 3,827,530, including a one-time special bonus of $327,030[35].