Plus Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
Completed enrollment of Cohort 1 in ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL for Leptomeningeal Metastases
On track to complete key manufacturing objectives for cGMP 186RNL to support ongoing and planned clinical trials in 2022 and beyond
Multiple planned data presentations for glioblastoma and leptomeningeal metastasis indications planned for the second half of 2022
Management to host conference call today at
“During the second quarter, we maintained the momentum to successfully complete our key corporate goals for 2022,” said
Rhenium-186 NanoLiposome (186RNL), a novel radiotherapy in development for several rare cancer targets
July 2022, the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions. Additionally, the intermediate drug product is in stability testing and compliant with the U.S. Food and Drug Administration(FDA) guidance for manufacture of nanoliposomal drug products for use in late-stage clinical trials and commercialization. The Company expects to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastasis and future disease targets.
July 2022, at the Society of Nuclear Medicine and Molecular Imaging(SNMMI) 2022 Annual Meeting, the Company presented positive interim data on the lead investigational drug, 186RNL, from the Phase 1/2a ReSPECT-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM). During the presentation, the Company noted that the trial has evaluated 23 adult patients with recurrent GBM across 7 cohorts of increasing dose. To date, there have been no dose limiting toxicities and promising efficacy signals have been observed in patients receiving average absorbed doses of radiation > 100 Gy.
- The Company’s principal investigator will provide a full data update on the Phase 1/2a ReSPECT-GBM dose escalation clinical trial at the
European Society of Medical Oncology Meetingin Paris France, September 9-13, 2022.
- In the second quarter of 2022, the Company completed enrollment of Cohort 1 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM). 186RNL was successfully delivered without dose limiting toxicities in this initial cohort and the independent ReSPECT-LM trial Data Safety & Monitoring board has approved the plan to move ahead with the Cohort 2.
- The Company submitted two briefing packages to the FDA to seek their opinion on the recurrent GBM clinical program and CMC development plans.
- The Company entered into a multi-year agreement with Biocept, Inc. to employ its cerebrospinal fluid assay in the ReSPECT-LM Phase 1/2a dose-escalation clinical trial. Biocept’s assay provides a highly sensitive method to assess and quantify tumor cell burden in LM of the central nervous system. Assay results will be used to evaluate biologic response to treatment and treatment efficacy for patients enrolling in the ReSPECT-LM trial.
- The Company obtained FDA approval for the ReSPECT-GBM multiple dose extension trial.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), a novel radiotherapy in development for solid organ cancers
- The Company has completed key technology transfer activities from
UT Health Science Centerat San Antonioand is on track to complete key CMC feasibility and IND enabling preclinical studies in the fourth quarter of 2022.
SECOND QUARTER 2022 FINANCIAL RESULTS
- The Company’s cash balance was
$18.1 millionat June 30, 2022, compared to $18.4 millionat December 31, 2021.
- Total operating expenses for the second quarter of 2022 were
$5.1 million, compared to total operating expenses of $2.6 millionfor second quarter of 2021. The increase is due primarily to incremental CMC spend relating to the development of GMP 186RNL drug and key regulatory consulting activities, both of which are on track to be completed in the third quarter of 2022. In addition, to a lesser extent, the Company had a forecasted increase in legal, professional fees and other general corporate expenses.
- Net loss for the second quarter of 2022 was
$5.3 million, or $(0.24)per share, compared to a net loss of $2.8 million, or $(0.25)per share, for the second quarter of 2021.
UPCOMING EVENTS AND MILESTONES
During the remainder of 2022, the Company expects to accomplish the following key business objectives:
- Present updated data from the ReSPECT-GBM and ReSPECT-LM at
European Society of Medical Oncologyand Society of Neuro-Oncologyscientific conferences.
- Receive FDA feedback from CMC and clinical Type C meetings for the recurrent GBM program.
- Complete GMP manufacturing milestones for 186RNL.
- Submit a protocol for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
- Complete key CMC & IND-enabling studies for 188RNL-BAM.
Second Quarter 2022 Results Conference Call
The Company will hold a conference call and live audio webcast at
A live webcast will be available at ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the 'For Investor' section. The webcast will be available on the Company’s website for 90 days following the live call.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s
CONSOLIDATED CONDENSED BALANCE SHEETS
(in thousands, except share and par value data)
|Cash and cash equivalents||$||18,090||$||18,400|
|Other current assets||799||1,324|
|Total current assets||18,889||19,724|
|Property and equipment, net||1,560||1,477|
|Operating lease right-use-of assets||303||341|
|Intangible assets, net||131||51|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||5,259||$||4,151|
|Operating lease liability||104||111|
|Term loan obligation, current||1,608||1,608|
|Total current liabilities||6,971||5,870|
|Noncurrent operating lease liability||202||269|
|Term loan obligation||4,419||5,005|
|Additional paid-in capital||465,965||457,730|
|Total stockholders’ equity||9,679||10,836|
|Total liabilities and stockholders’ equity||$||21,271||$||21,981|
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|For the Three Months Ended
||For the Six Months Ended
|Research and development||2,831||1,106||4,615||2,233|
|General and administrative||2,289||1,469||4,431||2,821|
|Total operating expenses||5,120||2,575||9,046||5,054|
|Other income (expense):|
|Change in fair value of liability instruments||—||—||1||2|
|Total other expense||(162||)||(225||)||(352||)||(466||)|
|Net loss per share, basic and diluted||$||(0.24||)||$||(0.25||)||$||(0.43||)||$||(0.56||)|
|Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders||22,254,823||11,296,816||21,919,956||9,790,726|
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
|For the Six Months Ended
|Cash flows used in operating activities:|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Depreciation and amortization||302||179|
|Amortization of deferred financing costs and debt discount||218||283|
|Change in fair value of liability instruments||(1||)||(2||)|
|Stock-based compensation expense||347||245|
|Change of operating lease assets and liabilities||(36||)||—|
|Non-cash lease expense||—||4|
|Increases (decreases) in cash caused by changes in operating assets and liabilities:|
|Other current assets||525||(11||)|
|Accounts payable and accrued expenses||1,527||(583||)|
|Net cash used in operating activities||(6,516||)||(5,405||)|
|Cash flows (used in) investing activities:|
|Purchases of property and equipment||(348||)||(80||)|
|Purchases of intangible assets||(117||)||—|
|In process research and development acquired||(250||)||—|
|Net cash used in investing activities||(715||)||(80||)|
|Cash flows from financing activities:|
|Principal payments of long-term obligations||(804||)||—|
|Payment of financing lease liability||—||(8||)|
|Proceeds from exercise of warrants||—||2,017|
|Proceeds from sale of common stock, net||7,725||12,291|
|Net cash provided by financing activities||6,921||14,300|
|Net increase (decrease) in cash and cash equivalents||(310||)||8,815|
|Cash and cash equivalents at beginning of period||18,400||8,346|
|Cash and cash equivalents at end of period||$||18,090||$||17,161|
Source: Plus Therapeutics Inc.