New survival data from 15 patients in the Phase 2 ReSPECT-GBM trial of rhenium (186Re) obisbemeda in recurrent glioblastoma (rGBM) will be presented at SNO Annual Meeting on
Completed dosing in Cohort 4 of the Phase 1 ReSPECT-LM dose escalation trial with rhenium (186Re) obisbemeda for leptomeningeal metastases, the first of four additional planned cohorts in Part B (Cohorts 4-7); an update will also be provided at the SNO meeting in November
Current cash of
Management to Host Conference Call Today at
“Our active trials of Rhenium-186 Obisbemeda continue to show encouraging results in treating both recurrent glioblastoma and leptomeningeal metastases and we will provide significant updates on both trials at the
UPCOMING EVENTS AND MILESTONES
Through the remainder of 2023 and 2024, the Company plans to accomplish the following key business objectives:
- Present the latest safety and efficacy data from the Phase 2 ReSPECT-GBM trial at the annual SNO meeting in
Vancouver onNovember 15-19, 2023 . - Present the latest safety and efficacy data from the Phase 1 ReSPECT-LM trial at the annual SNO meeting in
Vancouver onNovember 15-19, 2023 . - Participate in virtual KOL webinar following SNO meeting to discuss GBM data presented at the SNO meeting.
- Complete enrollment in the Phase 2 ReSPECT-GBM trial and finalize pivotal design with FDA.
- Complete enrollment in the Phase 1 ReSPECT-LM trial and begin phase 2 trial.
- Complete internal implementation of the CNSide™ cerebrospinal fluid (CSF)-based biomarker and tumor cell capture and enumeration assay being utilized in the ReSPECT-LM clinical trial.
- Obtain FDA IND approval and initiate the Phase 1 ReSPECT-PBC trial for pediatric patients with ependymoma and high-grade glioma at the Lurie Children’s Hospital in
Chicago . - Complete key development milestones for the company’s next generation radioembolic device 188RNL-BAM.
- Add key second source GMP supply chain partners to support late-stage clinical trials and commercial supply.
- Publish ReSPECT-GBM Phase 1 data in a peer-reviewed publication.
Q3 HIGHLIGHTS AND MILESTONE ACHIEVEMENTS
- Completed dosing in Cohort 4 of the ReSPECT-LM Phase 1/2a dose escalation trial of rhenium (186Re) obisbemeda for the treatment of LM. Cohort 4 is the first of 4 planned cohorts in Part B.
- Presented preliminary safety and efficacy results from Phase 1/Part A of the ReSPECT-LM clinical trial at the
SNO/ASCO CNS Cancer Conference . Following the presentation, the Company hosted a key opinion leader roundtable on data presented at the conference. - Received advance payment of grant funds of approximately
$1.9 million from CPRIT, as planned, as part of its overall$17.6 million award contract. - Completed transfer of proprietary materials, protocols, and equipment from Biocept for CNSide, a cerebrospinal fluid (CSF)-based biomarker and tumor cell capture and enumeration assay being utilized in the ReSPECT-LM clinical trial.
- Strengthened clinical development leadership with the appointment of
Pius Maliakal ,M. Pharm ., Ph.D., as Vice President of Clinical Operations.
THIRD QUARTER 2023 FINANCIAL RESULTS
- The Company’s cash balance was
$11.0 million atSeptember 30, 2023 , compared to$18.1 million atDecember 31, 2022 . - The Company recognized
$1.2 million in grant revenue in the third quarter of 2023, which represents CPRIT’s share of the costs incurred for our rhenium (186Re) obisbemeda development for the treatment of patients with LM. - Total operating expenses for the third quarter of 2023 were
$4.5 million , compared to total operating expenses of$5.2 million for the same period the prior year. The decrease is due primarily to a decrease in research and development expenses from completion of the initial cGMP development work on rhenium (186Re) obisbemeda. - In addition to current cash on hand, the Company benefits from grant awards of
$3 million from theNational Institutes of Health and$17.6 million from CPRIT. - Net loss for the third quarter of 2023 was
$(3.2) million , or$(1.00) per share, compared to a net loss of$(5.2) million , or$(2.85) per share, for the same period the prior year.
THIRD QUARTER 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 Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About
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 cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s
Investor Contact
(212) 215-2577
cdavis@lifesciadvisors.com
CONDENSED BALANCE SHEETS (UNAUDITED) (in thousands, except share and par value data) | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,006 | $ | 18,120 | ||||
Grant receivable | 91 | — | ||||||
Other current assets | 487 | 3,697 | ||||||
Total current assets | 11,584 | 21,817 | ||||||
Property and equipment, net | 1,009 | 1,324 | ||||||
Operating lease right-of-use assets | 232 | 248 | ||||||
372 | 372 | |||||||
Intangible assets, net | 49 | 94 | ||||||
Other assets | 32 | 12 | ||||||
Total assets | $ | 13,278 | $ | 23,867 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 6,073 | $ | 10,134 | ||||
Operating lease liability | 117 | 110 | ||||||
Term loan obligation | 4,348 | 1,608 | ||||||
Total current liabilities | 10,538 | 11,852 | ||||||
Term loan obligation | — | 3,786 | ||||||
Noncurrent operating lease liability | 118 | 141 | ||||||
Deferred grant liability | — | 1,643 | ||||||
Total liabilities | 10,656 | 17,422 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 5 | 2 | ||||||
Additional paid-in capital | 479,308 | 473,628 | ||||||
Accumulated deficit | (476,691 | ) | (467,185 | ) | ||||
Total stockholders’ equity | 2,622 | 6,445 | ||||||
Total liabilities and stockholders’ equity | $ | 13,278 | $ | 23,867 |
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except share and per share data) | ||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Grant Revenue | $ | 1,240 | $ | 73 | $ | 3,600 | $ | 73 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 2,493 | 2,945 | 6,896 | 7,560 | ||||||||||||
General and administrative | 1,998 | 2,222 | 6,165 | 6,653 | ||||||||||||
Total operating expenses | 4,491 | 5,167 | 13,061 | 14,213 | ||||||||||||
Loss from operations | (3,251 | ) | (5,094 | ) | (9,461 | ) | (14,140 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 119 | 48 | 290 | 74 | ||||||||||||
Interest expense | (87 | ) | (173 | ) | (333 | ) | (552 | ) | ||||||||
Loss on disposal of property and equipment | — | — | (2 | ) | — | |||||||||||
Change in fair value of liability instruments | — | — | — | 1 | ||||||||||||
Total other income (expense) | 32 | (125 | ) | (45 | ) | (477 | ) | |||||||||
Net loss | $ | (3,219 | ) | $ | (5,219 | ) | $ | (9,506 | ) | $ | (14,617 | ) | ||||
Net loss per share, basic and diluted | $ | (1.00 | ) | $ | (2.85 | ) | $ | (3.54 | ) | $ | (9.22 | ) | ||||
Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders | 3,225,351 | 1,829,444 | 2,688,232 | 1,585,946 |
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) | ||||||||
For the Nine Months Ended | ||||||||
2023 | 2022 | |||||||
Cash flows used in operating activities: | ||||||||
Net loss | $ | (9,506 | ) | $ | (14,617 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 477 | 460 | ||||||
Amortization of deferred financing costs and debt discount | 160 | 309 | ||||||
Stock issued for research and development | 75 | — | ||||||
Loss on disposal of property and equipment | 2 | — | ||||||
Stock-based compensation expense | 428 | 476 | ||||||
Change in fair value of derivative instruments | — | (1 | ) | |||||
Amortization of operating lease right-of-use assets | 86 | 66 | ||||||
Increases (decreases) in cash caused by changes in operating assets and liabilities: | ||||||||
Grant receivable | (91 | ) | 73 | |||||
Other assets | 3,190 | 642 | ||||||
Accounts payable and accrued expenses | (4,061 | ) | 1,955 | |||||
Change in operating lease liabilities | (87 | ) | (101 | ) | ||||
Deferred grant liability | (1,643 | ) | — | |||||
Net cash used in operating activities | (10,970 | ) | (10,738 | ) | ||||
Cash flows used in investing activities: | ||||||||
Purchases of property and equipment | (118 | ) | (381 | ) | ||||
Purchase of intangible assets | — | (117 | ) | |||||
In process research and development acquired | — | (250 | ) | |||||
Net cash used in investing activities | (118 | ) | (748 | ) | ||||
Cash flows from financing activities: | ||||||||
Principal payments of term loan obligation | (1,206 | ) | (1,206 | ) | ||||
Proceeds from sale of common stock, net of offering cost of | 5,180 | 14,558 | ||||||
Net cash provided by financing activities | 3,974 | 13,352 | ||||||
Net increase (decrease) in cash and cash equivalents | (7,114 | ) | 1,866 | |||||
Cash and cash equivalents at beginning of period | 18,120 | 18,400 | ||||||
Cash and cash equivalents at end of period | $ | 11,006 | $ | 20,266 | ||||
Supplemental disclosure of cash flows information: | ||||||||
Cash paid during period for: | ||||||||
Interest | $ | 186 | $ | 248 | ||||
Supplemental schedule of non-cash investing and financing activities: | ||||||||
Unpaid offering cost | $ | 1 | $ | 68 | ||||
Right-of-use assets acquired by assuming operating lease liabilities | $ | 71 | $ | — | ||||
Common stock issued in payment for in process research and development | $ | 75 | $ | — |
Source:
2023 GlobeNewswire, Inc., source