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Plus Therapeutics(PSTV) - 2024 Q3 - Quarterly Report
PSTVPlus Therapeutics(PSTV)2024-11-14 21:01
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Product Development and Clinical Trials - Plus Therapeutics is developing targeted radiotherapeutics for CNS cancers, utilizing innovative drug formulations to enhance radiation delivery and minimize exposure to healthy tissues[74]. - The lead candidate, rhenium (186Re) obisbemeda, aims to treat recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancers through localized delivery methods[77]. - Interim results from the Phase 1/2a ReSPECT-GBM trial indicate that rhenium (186Re) obisbemeda can deliver up to 740 Gy of absorbed radiation to tumor tissue without significant toxicities, compared to the typical maximum of ~30-35 Gray with external beam radiation therapy[91]. - The ReSPECT-GBM trial is set to proceed to Phase 2, with a focus on further dose exploration and collecting additional safety and efficacy data[95]. - The ReSPECT-GBM Phase 2 trial has enrolled 42 patients, with a median overall survival (mOS) of 13 months, which is 63% better than the standard of care of 8 months[98]. - The median progression-free survival (mPFS) in the same trial is reported at 11 months, compared to 4 months for the standard of care[98]. - Rhenium (186Re) obisbemeda has shown a favorable safety profile, with most adverse events being mild (73.5%) or moderate (18.8%) and only 2 out of 9 severe adverse events related to the study drug[99]. - The average absorbed radiation dose to the tumor in the Phase 2 trial was 300 Gy, with 88.9% of patients meeting key drug delivery parameters correlating with overall survival[99]. - The ReSPECT-LM Phase 1 trial has treated 26 patients with no dose-limiting toxicities observed at radiation doses up to 66.14 millicuries[107]. - The company plans to submit a pediatric brain tumor IND for the ReSPECT-PBC clinical trial in the fourth quarter of 2024[115]. Regulatory and Designation Achievements - The FDA granted Orphan Drug and Fast Track designations to rhenium (186Re) obisbemeda for GBM treatment, supporting its clinical development[92]. - The FDA granted Orphan Drug designation to rhenium (186Re) obisbemeda for the treatment of patients with breast cancer with leptomeningeal metastases in November 2023[108]. Financial Performance and Funding - Grant revenue recognized was 1.5millionforthethreemonthsendedSeptember30,2024,comparedto1.5 million for the three months ended September 30, 2024, compared to 1.3 million for the same period in 2023, reflecting an increase of approximately 15.4%[127]. - Research and development expenses for the three months ended September 30, 2024, totaled 2.858million,upfrom2.858 million, up from 2.493 million in the same period in 2023, an increase of approximately 14.6%[128]. - General and administrative expenses increased to 2.397millionforthethreemonthsendedSeptember30,2024,from2.397 million for the three months ended September 30, 2024, from 1.998 million in the same period in 2023, representing an increase of approximately 20.0%[131]. - The company incurred net losses of 9.1millionfortheninemonthsendedSeptember30,2024,withanaccumulateddeficitof9.1 million for the nine months ended September 30, 2024, with an accumulated deficit of 489.6 million[139]. - Cash and cash equivalents decreased to 1.223millionasofSeptember30,2024,downfrom1.223 million as of September 30, 2024, down from 8.554 million as of December 31, 2023[139]. - Current liabilities increased to 12.112millionasofSeptember30,2024,comparedto12.112 million as of September 30, 2024, compared to 10.727 million as of December 31, 2023[139]. - The company expects aggregate research and development expenses to increase for the remainder of 2024 compared to the same period in 2023[130]. - The company recognized a net fair value gain on warrant liability of 1.0millionforthethreemonthsendedSeptember30,2024,and1.0 million for the three months ended September 30, 2024, and 5.7 million for the nine months ended September 30, 2024[136]. - In May 2024, the company completed a private placement, issuing 3,591,532 shares and raising approximately 7.3millioningrossproceeds,withpotentialadditionalproceedsof7.3 million in gross proceeds, with potential additional proceeds of 12.0 million if all warrants are exercised[140]. - The company received a CPRIT Grant of 17.6milliontofundtwo−thirdsofthedevelopmentcostsforrhenium(186Re)obisbemeda,recognizing17.6 million to fund two-thirds of the development costs for rhenium (186Re) obisbemeda, recognizing 4.4 million in grant revenue for the nine months ended September 30, 2024[141]. - A DoD Award was secured for 3.0milliontosupporttheexpansionofclinicaltrialsforpediatricbraincancer,withthefirstpaymentof3.0 million to support the expansion of clinical trials for pediatric brain cancer, with the first payment of 0.9 million received on October 4, 2024[142]. - Under the 2022 Purchase Agreement with Lincoln Park, the company has the right to sell up to 50.0millioninshares,with527,166sharessoldfornetproceedsofapproximately50.0 million in shares, with 527,166 shares sold for net proceeds of approximately 3.2 million from August 2022 to December 2022[143][145]. - For the nine months ended September 30, 2024, net cash used in operating activities was 9.3million,adecreasefrom9.3 million, a decrease from 11.0 million in the same period of 2023, primarily due to increased reimbursement under the CPRIT grant[160]. - Net cash used in investing activities for the nine months ended September 30, 2024 included 0.5millionforBioceptassetsand0.5 million for Biocept assets and 7.1 million for short-term investments[161]. - Financing activities for the nine months ended September 30, 2024 provided net cash of 6.2million,primarilyfromtheMay2024PrivatePlacementanda6.2 million, primarily from the May 2024 Private Placement and a 3.3 million drawdown from the Pershing Credit Facility[162]. - As of September 30, 2024, the company had 0.8millionofdeferredrevenuerelatedtotheCPRITGrant[141].OperationalandStrategicDevelopments−PlusTherapeuticshasexpandeditsmanufacturingcapabilitiesthroughaservicesagreementinIndiana,ensuringarobustsupplychainforongoingclinicaltrials[81].−Thecompanyisfocusedonaddressingsignificantunmetmedicalneedsintreatingrareanddifficult−to−treatcancers,withapipelinethatincludespotentialapplicationsforheadandneck,ovarian,andbreastcancers[80].−TheCNSide®diagnosticportfolioisbeingdevelopedalongsiderhenium(186Re)obisbemeda,withplansforstrategicpartnershipstoenhanceitsmarketpresence[78].−ThecompanyisdevelopinganovelradioembolizationtechnologycombiningRheniumNanoLiposomewithBiodegradableAlginateMicrospheretechnologyfortargetedradiationdelivery[119].−ThecompanyenteredintoamanufacturingservicesagreementwithSpectronRxfordrugproductdevelopmentandmanufacturing,effectiveJanuary2025[123].−TheDepartmentofDefensehasawarded0.8 million of deferred revenue related to the CPRIT Grant[141]. Operational and Strategic Developments - Plus Therapeutics has expanded its manufacturing capabilities through a services agreement in Indiana, ensuring a robust supply chain for ongoing clinical trials[81]. - The company is focused on addressing significant unmet medical needs in treating rare and difficult-to-treat cancers, with a pipeline that includes potential applications for head and neck, ovarian, and breast cancers[80]. - The CNSide® diagnostic portfolio is being developed alongside rhenium (186Re) obisbemeda, with plans for strategic partnerships to enhance its market presence[78]. - The company is developing a novel radioembolization technology combining Rhenium NanoLiposome with Biodegradable Alginate Microsphere technology for targeted radiation delivery[119]. - The company entered into a manufacturing services agreement with SpectronRx for drug product development and manufacturing, effective January 2025[123]. - The Department of Defense has awarded 3.0 million for research and development to support the expansion of the pediatric brain cancer clinical trial[118]. - The company has ongoing cash requirements for clinical trials, regulatory approvals, and operational expansions, with no assurance of future capital raising success[152][153]. - The company reviews goodwill for impairment annually, with the test conducted in the fourth quarter[164]. - The company experienced significant volatility in its share price during the year[164]. - In May 2024, the company issued Series A and Series B Warrants, initially classified as liabilities due to their potential exercise into common stock or Pre-Funded Warrants[165]. - The balance of the warrant liability at the amendment date was $5.2 million, which was reclassified to equity following amendments made on August 9, 2024[165].