Plus Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
Plus Therapeutics, Inc.(Nasdaq:PSTV) (the “Company”), aclinical-stage pharmaceutical company developing targetedradiotherapeutics with advanced platform technologies for centralnervous system (CNS) cancers, today announcedfinancialresults for the second quarter ended June 30, 2024, and provided anoverview of recent and upcoming business highlights.
Q2 2024 RECENT HIGHLIGHTS ANDMILESTONES
- Presented positive ReSPECT-LM Phase1 study data at the 2024 Society for NeuroOncology /AmericanSociety for Clinical Oncology (SNO/ASCO) CNS Metastases Conference.Rhenium (186Re) Obisbemeda was safe and well-toleratedin the first 4 dosing cohorts (n=16 patients). Current medianoverall survival is 12 months with 8 of 16 patients treatedremaining alive. Additional detail can be found here
- Reported topline FORESEE clinicaltrial results at SNO/ASCO. The trial demonstrated that CNSide,PLUS’ novel diagnostic platform met its primary clinical endpoint.The CNSide test was found to help clinical decision making in over90% of provider decisions (n=50/55 clinical decisions) and helpedto inform therapy selection in 24% of provider decisions (n=13/55clinical decisions). Furthermore, the CNSide test improved tumorcell detection in LM patients compared to cytology (80% vs. 29%) inmatched samples. Additional details can be found here
- Reported that isotopic rhenium-186,the active radioisotope in Rhenium (186Re) Obisbemeda,substantially spared the spinal cord vs. other beta-emittingradionuclides at the 2024 Society of Nuclear Medicine and MolecularImaging (SNMMI) annual meeting
- Submitted a new clinical protocolto the U.S. Food and Drug Administration (FDA), under its activeInvestigational New Drug application (IND 153715) for a Phase 1study to evaluate multiple administrations of Rhenium(186Re) Obisbemeda for the treatment of patients withLM
- Received $3.3 million grant paymentfrom Cancer Prevention & Research Institute of Texas (CPRIT) inJune 2024 to support the clinical development of Rhenium(186Re) Obisbemeda for LM
“Plus’ lead investigational drug Rhenium(186Re) Obisbemeda continues to show safety andpromising signs of efficacy after a single administration inpatients with LM,” said Marc H. Hedrick, M.D., Plus TherapeuticsPresident and Chief Executive Officer. “We are on track to completethe single administration ReSPECT-LM Phase 1 trial soon, expand tomultiple doses, and move to Phase 2 funded by our existing CPRITaward.”
UPCOMING EVENTS ANDMILESTONES
- Presentations planned for thefollowing upcoming medical conferences:
- Congress of NeurologicalSurgeons (CNS) Annual Conference (September 28-October 2,2024)
- Treatment Of Recurrent Glioblastoma(rGBM) Via Convection Enhanced Delivery (CED) With Rhenium(186Re) Obisbemeda (Rhenium-186 Nanoliposome,186RNL): ReSPECT-GBM Phase 2 Trial Update
- Society for Neuro-Oncology(SNO) Annual Conference (November 22-26, 2024)
- Rhenium (186Re)obisbemeda (rhenium nanoliposome,186RNL) for thetreatment of leptomeningeal metastases (LM): Summary of the phase 1dose escalation study and phase 2 administered dose selection
- CSF Tumor Cell (CSF-TC) Detection,Quantification and Biomarker assessment helps in clinicalmanagement of breast cancer and Non-Small Cell Lung cancer patientshaving Leptomeningeal Disease
- The Oncogenetic Flip in Patientswith Leptomeningeal Metastatic Disease (LMD): LongitudinalDetection in Cerebrospinal Fluid Tumor Cells (CSF-TCs)Reveals Implications for Differential Treatment of the LMDTumor
- Congress of NeurologicalSurgeons (CNS) Annual Conference (September 28-October 2,2024)
- Complete ReSPECT-LM Phase 1 singleadministration trial and determine the recommended Phase 2dose
- Initiate ReSPECT-LM Phase 1multiple administration trial
- Obtain IND approval for a Phase 1/2trial of Rhenium (186Re) Obisbemeda via convectionenhanced delivery (CED) funded by the Department of Defense (DoD)office of the Congressionally Directed Medical Research Programs(CDMRP) for pediatric ependymoma and high-grade glioma
FIRST HALF 2024 FINANCIALRESULTS
- The Company’s cash and investmentsbalance was $8.4 million at June 30, 2024 compared to $8.6 millionat December 31, 2023
- The Company recognized $3.0 millionin grant revenue in the first half of 2024 compared to $2.4 millionin the same period of 2023, which represents CPRIT’s share of thecosts incurred for our Rhenium (186Re) Obisbemedadevelopment for the treatment of patients with LM
- Total operating loss for the firsthalf of 2024 was $7.0 million compared to $6.2 million in the sameperiod of 2023. The increase is primarily due to increased spendrelated to the ReSPECT-LM trial
- Net loss for first half of 2024 was$6.2 million, or $(1.15) per basic share, compared to a net loss of$6.3 million, or $(2.60) per basic share, for the same period theprior year
SECOND QUARTER 2024 RESULTS CONFERENCECALL
The Company will hold a conference call and liveaudio webcast at 5:00 pm Eastern Time today to discuss itsfinancial results and provide a general business update.
A live webcast will be available atir.plustherapeutics.com/events.
Participants may also pre-register any timebefore the call here. Once registration is completed, participantswill be provided a dial-in number with a personalized conferencecode to access the call. Please dial in 15 minutes prior to thestart time.
Following the live call, a replay will beavailable on the Company’s website under the ‘For Investors’section. The webcast will be available on the Company’s website for90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical companydeveloping targeted radiotherapeutics for difficult-to-treatcancers of the central nervous system with the potential to enhanceclinical outcomes for patients. Combining image-guided local betaradiation and targeted drug delivery approaches, the Company isadvancing a pipeline of product candidates with lead programs inrecurrent glioblastoma (GBM) and leptomeningeal metastases (LM).The Company has built a supply chain through strategic partnershipsthat enable the development, manufacturing and future potentialcommercialization of its products. Plus Therapeutics is led by anexperienced and dedicated leadership team and has operations in keycancer clinical development hubs including Austin and San Antonio,Texas. For more information, visithttps://plustherapeutics.com/.
Cautionary Statement RegardingForward-Looking Statements
This press release contains statements that may be deemed“forward-looking statements” within the meaning of U.S. securitieslaws, including statements regarding clinical trials, expectedoperations and upcoming developments. All statements in this pressrelease other than statements of historical fact areforward-looking statements. These forward-looking statements may beidentified by future verbs, as well as terms such as “potential,”“anticipating,” “planning” and similar expressions or the negativesthereof. Such statements are based upon certain assumptions andassessments made by management in light of their experience andtheir perception of historical trends, current conditions, expectedfuture developments and other factors they believe to beappropriate.
These statements include, without limitation,statements under the heading Upcoming Expected Events andMilestones and statements regarding the following: the potentialpromise of rhenium (186Re) obisbemeda; expectations asto the Company’s future performance including the next steps indeveloping the Company’s product candidate; the Company’s clinicaltrials including statements regarding the timing andcharacteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBCclinical trials; the continued evaluation of rhenium(186Re) obisbemeda including through evaluations inadditional patient cohorts; reporting results of preclinicalcombination studies of rhenium (186Re) obisbemeda withPD-1 and PD-L1 checkpoint inhibitors; development and potentialsubmission of ReSPECT-PBC investigational new drug application(IND) for pediatric ependymoma and high grade glioma; developmentand utility of CNSide leptomeningeal metastases diagnostictest.
The forward-looking statements included in thispress release could differ materially from those expressed orimplied by these forward-looking statements because of risks,uncertainties, and other factors that include, but are not limitedto, the following: the early stage of the Company’s productcandidates and therapies, the results of the Company’s research anddevelopment activities, including uncertainties relating to theclinical trials of its product candidates and therapies; theCompany’s liquidity and capital resources and its ability to raiseadditional cash, the outcome of the Company’s partnering/licensingefforts, risks associated with laws or regulatory requirementsapplicable to it, market conditions, product performance,litigation or potential litigation, and competition within thecancer diagnostics and therapeutics field, ability to develop andprotect proprietary intellectual property or obtain licenses tointellectual property developed by others on commerciallyreasonable and competitive terms, and materialsecuritybreachor cybersecurity attackaffecting the Company’s operations or property. This list of risks,uncertainties, and other factors is not complete. Plus Therapeuticsdiscusses some of these matters more fully, as well as certain riskfactors that could affect Plus Therapeutics’ business, financialcondition, results of operations, and prospects, in its reportsfiled with the SEC, including Plus Therapeutics’ annual report onForm 10-K for the fiscal year ended December 31, 2023, quarterlyreports on Form 10-Q, and current reports on Form 8-K. Thesefilings are available for review through the SEC’s website atwww.sec.gov. Any or all forward-looking statements PlusTherapeutics makes may turn out to be wrong and can be affected byinaccurate assumptions Plus Therapeutics might make or by known orunknown risks, uncertainties, and other factors, including thoseidentified in this press release. Accordingly, you should not placeundue reliance on the forward-looking statements made in this pressrelease, which speak only as of its date. The Company assumes noresponsibility to update or revise any forward-looking statementsto reflect events, trends or circ*mstances after the date they aremade unless the Company has an obligation under U.S. federalsecurities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
chuang@plustherapeutics.com
| PLUS THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share and par valuedata) | |||||||
| June30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 4,912 | $ | 8,554 | |||
| Investments | 3,523 | — | |||||
| Other current assets | 945 | 1,280 | |||||
| Total current assets | 9,380 | 9,834 | |||||
| Property and equipment, net | 732 | 906 | |||||
| Operating lease right-of-useassets | 139 | 202 | |||||
| Goodwill | 372 | 372 | |||||
| Intangible assets, net | 557 | 42 | |||||
| Other assets | 32 | 32 | |||||
| Total assets | $ | 11,212 | $ | 11,388 | |||
| Liabilities andStockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 6,946 | $ | 6,631 | |||
| Operating lease liability | 92 | 120 | |||||
| Warrant liability | 6,160 | — | |||||
| Deferred grant liability | 2,297 | — | |||||
| Line of credit | 3,292 | — | |||||
| Term loan obligation, current | — | 3,976 | |||||
| Total current liabilities | 18,787 | 10,727 | |||||
| Noncurrent operating leaseliability | 50 | 85 | |||||
| Deferred grant liability | — | 1,924 | |||||
| Total liabilities | 18,837 | 12,736 | |||||
| Stockholders’ deficit: | |||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized;1,952 shares issued and outstanding at June 30, 2024 and December31, 2023, respectively | — | — | |||||
| Common stock, $0.001 par value; 100,000,000 shares authorized;5,962,644 and 5,704,219 issued and outstanding at June 30, 2024,and 4,522,656 issued and 4,444,097 outstanding as of December 31,2023, respectively | 6 | 5 | |||||
| Treasury stock (at cost, 258,425 and 78,559 shares as of June 30,2024 and December 31, 2023, respectively) | (500 | ) | (126 | ) | |||
| Additional paid-in capital | 479,571 | 479,274 | |||||
| Accumulated deficit | (486,702 | ) | (480,501 | ) | |||
| Total stockholders’ deficit | (7,625 | ) | (1,348 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 11,212 | $ | 11,388 | |||
| PLUS THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OFOPERATIONS (Unaudited) (in thousands, except share and per sharedata) | |||||||||||||||
| For the Three Months Ended June30, | For the Six Months Ended June30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Grant revenue | $ | 1,279 | $ | 1,854 | $ | 2,956 | $ | 2,360 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 2,773 | 1,420 | 5,536 | 4,403 | |||||||||||
| General and administrative | 2,203 | 1,924 | 4,416 | 4,169 | |||||||||||
| Total operating expenses | 4,976 | 3,344 | 9,952 | 8,572 | |||||||||||
| Loss from operations | (3,697 | ) | (1,490 | ) | (6,996 | ) | (6,212 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Financing expense | (3,545 | ) | — | (3,545 | ) | — | |||||||||
| Change in fair value of warrants | 4,694 | — | 4,694 | — | |||||||||||
| Warrant issuance costs | (432 | ) | — | (432 | ) | — | |||||||||
| Interest income | 67 | 120 | 139 | 171 | |||||||||||
| Interest expense | (27 | ) | (112 | ) | (61 | ) | (246 | ) | |||||||
| Total other income (expense) | 757 | 8 | 795 | (75 | ) | ||||||||||
| Net loss | $ | (2,940 | ) | $ | (1,482 | ) | $ | (6,201 | ) | $ | (6,287 | ) | |||
| Per share information: | |||||||||||||||
| Net loss per share of commonstock - basic | $ | (0.45 | ) | $ | (0.59 | ) | $ | (1.15 | ) | $ | (2.60 | ) | |||
| Weighted average number of sharesof common stock outstanding - basic | 6,500,831 | 2,509,378 | 5,411,382 | 2,415,221 | |||||||||||
| Net loss per share of commonstock - diluted | $ | (0.71 | ) | $ | (0.59 | ) | $ | (1.45 | ) | $ | (2.60 | ) | |||
| Weighted average number of sharesof common stock outstanding - diluted | 10,742,924 | 2,509,378 | 7,532,428 | 2,415,221 | |||||||||||
| PLUS THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASHFLOWS (Unaudited) (In thousands) | |||||||
| For the Six Months Ended June30, | |||||||
| 2024 | 2023 | ||||||
| Cash flows used in operating activities: | |||||||
| Net loss | $ | (6,201 | ) | $ | (6,287 | ) | |
| Adjustments to reconcile net loss to net cash used in operatingactivities: | |||||||
| Depreciation and amortization | 325 | 318 | |||||
| Amortization of deferred financing costs and debt discount | 20 | 119 | |||||
| Share-based compensation expense | 297 | 280 | |||||
| Accretion of discount on short-term investments | (23 | ) | — | ||||
| Non-cash financing expense | 3,545 | — | |||||
| Change in fair value of warrants | (4,694 | ) | — | ||||
| Loss on disposal of property and equipment | — | 2 | |||||
| Amortization of operating lease right-of-use assets | 63 | 57 | |||||
| Increases (decreases) in cash caused by changes in operating assetsand liabilities: | |||||||
| Grant receivable | — | 718 | |||||
| Other current assets | 335 | 1,510 | |||||
| Accounts payable and accrued expenses | 360 | (3,589 | ) | ||||
| Change in operating lease liabilities | (63 | ) | (56 | ) | |||
| Deferred grant liability | 373 | (1,643 | ) | ||||
| Net cash used in operating activities | (5,663 | ) | (8,571 | ) | |||
| Cash flows used in investing activities: | |||||||
| Purchases of property and equipment | (121 | ) | (108 | ) | |||
| Purchase of short-term investments | (3,500 | ) | — | ||||
| Purchase of intangible assets | (545 | ) | — | ||||
| Net cash used in investing activities | (4,166 | ) | (108 | ) | |||
| Cash flows used in/provided by financingactivities: | |||||||
| Principal payments of term loan obligation | (3,996 | ) | (804 | ) | |||
| Proceeds from credit facility | 3,292 | — | |||||
| Purchase of treasury stock | (374 | ) | — | ||||
| Proceeds from sale of common stock, warrants and pre-fundedwarrants, net | 7,265 | 2,258 | |||||
| Net cash provided by financing activities | 6,187 | 1,454 | |||||
| Net decrease in cash and cash equivalents | (3,642 | ) | (7,225 | ) | |||
| Cash and cash equivalents at beginning of period | 8,554 | 18,120 | |||||
| Cash and cash equivalents at end of period | $ | 4,912 | $ | 10,895 | |||
| Supplemental disclosure of cash flowsinformation: | |||||||
| Cash paid during period for: | |||||||
| Interest | $ | 32 | $ | 135 | |||
| Supplemental schedule of non-cash investing and financingactivities: | |||||||
| Unpaid offering cost | $ | 375 | $ | 35 | |||
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(Nasdaq:\u00a0PSTV) (\u201cPlus\u201d or the \u201cCompany\u201d), a clinical-stage pharmaceutical company developing targeted radiotherapeutics...","one_line_short_text":"AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. 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