Plus Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
November 14 2024 - 3:15PM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing targeted
radiotherapeutics with advanced platform technologies for central
nervous system (CNS) cancers, today announced financial
results for the third quarter ended September 30, 2024, and
provided an overview of recent and upcoming business highlights.
Q3 2024 RECENT HIGHLIGHTS AND
MILESTONES
- Completed
enrollment in the Phase 1 ReSPECT-GBM trial
- Obtained agreement
from FDA to begin enrollment in the ReSPECT-LM multi-administration
trial for patients with LM (IND 153715). The trial is expected to
begin enrollment in early 2025 at seven U.S. trial sites
- Presented positive
ReSPECT-GBM Phase 1/2 Trial update data at the 2024 Congress of
Neurological Surgeons Annual Conference, showing Rhenium (186Re)
Obisbemeda continues to demonstrate promising feasibility, safety,
response, and efficacy signals across 42 treated patients.
Additional details can be found here
- Expanded the
ReSPECT-GBM Phase 1/2 Trial to new sites and referral regions:
North Shore University in New York and Ohio State University in the
Upper Midwest
- Entered into a
Research and Collaboration Agreement with Brainlab, a leading,
innovative software-driven med-tech company to implement optimized
case planning software for convection-enhanced delivery or CED of
Rhenium (186Re) Obisbemeda for brain cancers
- Received
a $0.9 million grant payment as part of the $3 million award
by the Department of Defense (DoD) Peer Reviewed Cancer Research
Program Advancing Cancer Care through Clinical Trials Award to
support the clinical development of Rhenium (186Re) Obisbemeda for
pediatric brain cancer
- Established a GMP
manufacturing partnership with SpectronRx to meet late-stage
clinical and commercial forecasts for Rhenium (186Re) Obisbemeda.
Additional details can be found here
- Obtained CLIA
registration for our Houston-based facility supporting the CNSide
Cerebrospinal Fluid Tumor Cell Enumeration Assay Platform, with
CLIA compliance certification anticipated in early 2025
“Securing agreement from the FDA to initiate a
Phase 1 multiple dose administration trial is a key next step in
our integrated development plan for Rhenium (186Re) Obisbemeda for
patients with LM,” said Marc H. Hedrick, M.D., Plus Therapeutics’
President and Chief Executive Officer. “We are on track to complete
both Phase 1 LM trials and move to later stage trials in 2025.”
UPCOMING EXPECTED EVENTS AND
MILESTONES
- Presentations
planned for the following upcoming medical conferences:
- Society for
Neuro-Oncology (SNO) Annual Conference (November 21-24,
2024)
- Rhenium (186Re) Obisbemeda (rhenium
nanoliposome,186RNL) for the treatment of leptomeningeal metastases
(LM): Summary of the Phase 1 dose escalation study and Phase 2
administered dose selection
- CSF Tumor Cell (CSF-TC) Detection,
Quantification and Biomarker assessment helps in clinical
management of breast cancer and Non-Small Cell Lung cancer patients
having Leptomeningeal Disease
- The Oncogenic Flip in Patients with
Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in
Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for
Differential Treatment of the LMD Tumor
- San Antonio Breast Cancer
Symposium (December 10-13, 2024)
- Rhenium (186Re) Obisbemeda (rhenium
nanoliposome,186RNL) for the treatment of leptomeningeal metastases
(LM): Update on Phase 1 dose escalation
- Complete ReSPECT-LM
Phase 1 single dose administration trial and determine the maximum
tolerated and recommended Phase 2 doses by year-end
- Initiate ReSPECT-LM
Phase 1 multiple dose administration trial in 2025
- Complete
ReSPECT-GBM Phase 2 enrollment by 2025
- Obtain IND approval
for a Phase 1/2 trial of Rhenium (186Re) Obisbemeda for pediatric
ependymoma and high-grade glioma
- Launch the CNSide
Cerebrospinal Fluid Tumor Cell Enumeration Assay Platform as a
laboratory-developed test (LDT) in 2025
THIRD QUARTER 2024 FINANCIAL
RESULTS
- The Company’s cash
and investments balance was $4.8 million at September 30, 2024
compared to $8.6 million at December 31, 2023. In addition, the
Company received a $0.9 million grant payment from the DoD in
October 2024, and is on track to receive the next CPRIT grant
advance of $3.9 million within 90 days following this release
- The Company
recognized $4.4 million in grant revenue year to date through
September 30, 2024, compared to $3.6 million for the same period in
2023, which in both periods represents the Cancer Prevention &
Research Institute of Texas’ (CPRIT) share of the costs incurred
for our Rhenium (186Re) Obisbemeda development for the treatment of
patients with LM
- Total operating
loss year to date through September 30, 2024, was $10.8 million
compared to $9.5 million for the same period in 2023. The increase
is primarily due to increased spend related to the ReSPECT-LM
trial
- Net loss year to
date through September 30, 2024, was $9.1 million, or $(1.46) per
basic share, compared to a net loss of $9.5 million, or $(3.54) per
basic share, for the same period the prior year
THIRD QUARTER 2024 RESULTS CONFERENCE
CALL
The Company will hold a conference call and live
audio webcast at 5:00 pm Eastern Time today to discuss its
financial results and provide a general business update.
The live audio 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 Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a supply chain through strategic partnerships
that enable the development, manufacturing and future potential
commercialization of its products. Plus Therapeutics is led by an
experienced and dedicated leadership team and has operations in key
cancer clinical development hubs, including Austin and San Antonio,
Texas. For more information, visit
https://plustherapeutics.com/.
Cautionary Statement Regarding
Forward-Looking StatementsThis press release contains
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws, including statements regarding
clinical trials, expected operations and upcoming developments. All
statements in this press release other than statements of
historical fact are forward-looking statements. These
forward-looking statements may be identified by future verbs, as
well as terms such as “expect” “potential,” “anticipating,”
“planning” and similar expressions or the negatives thereof. Such
statements are based upon certain assumptions and assessments made
by management in light of their experience and their perception of
historical trends, current conditions, expected future developments
and other factors they believe to be appropriate.
These statements include, without limitation,
statements under the heading Upcoming Events and Expected
Milestones, and statements regarding the following: CLIA compliance
certification of the Company’s Houston-based clinical laboratory;
the potential promise of rhenium (186Re) obisbemeda; expectations
as to the Company’s future performance, including the next steps in
developing the Company’s product candidates; the Company’s clinical
trials, including statements regarding the timing and
characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC
clinical trials; the continued evaluation of rhenium (186Re)
obisbemeda including through evaluations in additional patient
cohorts;; development and utility of CNSide leptomeningeal
metastases diagnostic test.
The forward-looking statements included in this
press release could differ materially from those expressed or
implied by these forward-looking statements because of risks,
uncertainties, and other factors that include, but are 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, including the ability of the Company to come into
compliance with The Nasdaq Capital Market listing requirements;
market conditions, product performance, litigation or potential
litigation, and competition within the cancer diagnostics and
therapeutics field; ability to develop and protect proprietary
intellectual property or obtain licenses to intellectual property
developed by others on commercially reasonable and competitive
terms; challenges associated with radiotherapeutic manufacturing,
production and distribution capabilities necessary to support the
Company’s clinical trials and any commercial level product demand;
and material security breach or cybersecurity attack affecting the
Company’s operations or property. This list of risks,
uncertainties, and other factors is not complete. Plus Therapeutics
discusses some of these matters more fully, as well as certain risk
factors that could affect Plus Therapeutics’ business, financial
condition, results of operations, and prospects, in its reports
filed with the SEC, including Plus Therapeutics’ annual report on
Form 10-K for the fiscal year ended December 31, 2023, quarterly
reports on Form 10-Q, and current reports on Form 8-K. These
filings are available for review through the SEC’s website at
www.sec.gov. Any or all forward-looking statements Plus
Therapeutics makes may turn out to be wrong and can be affected by
inaccurate assumptions Plus Therapeutics might make or by known or
unknown risks, uncertainties, and other factors, including those
identified in this press release. Accordingly, you should not place
undue reliance on the forward-looking statements made in this press
release, which speak only as of its date. The Company assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends or circumstances after the date they are
made unless the Company has an obligation under U.S. federal
securities laws to do so.
Investor ContactCharles Y. Huang, MBADirector
of Capital Markets and Investor RelationsOffice: (202)-209-5751 |
Direct (301)-728-7222chuang@plustherapeutics.com
PLUS THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(UNAUDITED) |
(in thousands, except share and par value
data) |
|
|
|
September 30,2024 |
|
|
December 31,2023 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,223 |
|
|
$ |
8,554 |
|
Investments |
|
|
3,565 |
|
|
|
— |
|
Other current assets |
|
|
— |
|
|
|
1,280 |
|
Total current assets |
|
|
4,788 |
|
|
|
9,834 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
591 |
|
|
|
906 |
|
Operating lease right-of-use assets |
|
|
106 |
|
|
|
202 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Intangible assets, net |
|
|
513 |
|
|
|
42 |
|
Other
assets |
|
|
32 |
|
|
|
32 |
|
Total assets |
|
$ |
6,978 |
|
|
$ |
11,388 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
7,912 |
|
|
$ |
6,631 |
|
Operating lease liability |
|
|
68 |
|
|
|
120 |
|
Deferred grant liability |
|
|
840 |
|
|
|
— |
|
Line of credit |
|
|
3,292 |
|
|
|
— |
|
Term loan obligation, current |
|
|
— |
|
|
|
3,976 |
|
Total current liabilities |
|
|
12,112 |
|
|
|
10,727 |
|
|
|
|
|
|
|
|
Noncurrent operating lease liability |
|
|
40 |
|
|
|
85 |
|
Deferred
grant liability |
|
|
— |
|
|
|
1,924 |
|
Total liabilities |
|
|
12,152 |
|
|
|
12,736 |
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,952 shares issued and outstanding at September 30, 2024 and
December 31, 2023, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
6,154,758 and 5,896,333 issued and outstanding at September 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 September
30, 2024 and December 31, 2023, respectively) |
|
|
(500 |
) |
|
|
(126 |
) |
Additional paid-in capital |
|
|
484,896 |
|
|
|
479,274 |
|
Accumulated deficit |
|
|
(489,576 |
) |
|
|
(480,501 |
) |
Total stockholders’ deficit |
|
|
(5,174 |
) |
|
|
(1,348 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
6,978 |
|
|
$ |
11,388 |
|
|
PLUS THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(UNAUDITED) |
(in thousands, except share and per share
data) |
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Grant revenue |
|
$ |
1,456 |
|
|
$ |
1,240 |
|
|
$ |
4,412 |
|
|
$ |
3,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,858 |
|
|
|
2,493 |
|
|
|
8,394 |
|
|
|
6,896 |
|
General and administrative |
|
|
2,397 |
|
|
|
1,998 |
|
|
|
6,813 |
|
|
|
6,167 |
|
Total operating expenses |
|
|
5,255 |
|
|
|
4,491 |
|
|
|
15,207 |
|
|
|
13,063 |
|
Loss from operations |
|
|
(3,799 |
) |
|
|
(3,251 |
) |
|
|
(10,795 |
) |
|
|
(9,463 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Financing expense |
|
|
— |
|
|
|
— |
|
|
|
(3,545 |
) |
|
|
— |
|
Change in fair value of warrants |
|
|
960 |
|
|
|
— |
|
|
|
5,654 |
|
|
|
— |
|
Warrant issuance costs |
|
|
(54 |
) |
|
|
— |
|
|
|
(486 |
) |
|
|
— |
|
Interest income |
|
|
80 |
|
|
|
119 |
|
|
|
219 |
|
|
|
290 |
|
Interest expense |
|
|
(61 |
) |
|
|
(87 |
) |
|
|
(122 |
) |
|
|
(333 |
) |
Total other income (expense) |
|
|
925 |
|
|
|
32 |
|
|
|
1,720 |
|
|
|
(43 |
) |
Net loss |
|
$ |
(2,874 |
) |
|
$ |
(3,219 |
) |
|
$ |
(9,075 |
) |
|
$ |
(9,506 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per
share information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock - basic |
|
$ |
(0.37 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.46 |
) |
|
$ |
(3.54 |
) |
Weighted
average number of shares of common stock outstanding - basic |
|
|
7,855,763 |
|
|
|
3,225,351 |
|
|
|
6,232,123 |
|
|
|
2,688,232 |
|
Net loss
per share of common stock - diluted |
|
$ |
(0.37 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.67 |
) |
|
$ |
(3.54 |
) |
Weighted
average number of shares of common stock outstanding - diluted |
|
|
7,855,763 |
|
|
|
3,225,351 |
|
|
|
8,452,338 |
|
|
|
2,688,232 |
|
|
PLUS THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
(UNAUDITED) |
(In thousands) |
|
|
|
For the Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
Cash flows used in operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(9,075 |
) |
|
$ |
(9,506 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
524 |
|
|
|
477 |
|
Amortization of deferred financing costs and debt discount |
|
|
20 |
|
|
|
160 |
|
Share-based compensation expense |
|
|
422 |
|
|
|
428 |
|
Accretion of discount on short-term investments |
|
|
(70 |
) |
|
|
— |
|
Non-cash financing expense |
|
|
3,545 |
|
|
|
— |
|
Change in fair value of warrants |
|
|
(5,654 |
) |
|
|
— |
|
Loss on disposal of property and equipment |
|
|
— |
|
|
|
2 |
|
Amortization of operating lease right-of-use assets |
|
|
96 |
|
|
|
86 |
|
Stock issued for research and development |
|
|
— |
|
|
|
75 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
Grant receivable |
|
|
— |
|
|
|
(91 |
) |
Other current assets |
|
|
704 |
|
|
|
3,190 |
|
Accounts payable and accrued expenses |
|
|
1,326 |
|
|
|
(4,061 |
) |
Change in operating lease liabilities |
|
|
(97 |
) |
|
|
(87 |
) |
Deferred grant liability |
|
|
(1,084 |
) |
|
|
(1,643 |
) |
Net cash used in operating activities |
|
|
(9,343 |
) |
|
|
(10,970 |
) |
|
|
|
|
|
|
|
Cash flows used in investing activities: |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(135 |
) |
|
|
(118 |
) |
Redemption of short-term investments |
|
|
3,650 |
|
|
|
— |
|
Purchase
of short-term investments |
|
|
(7,145 |
) |
|
|
— |
|
Purchase
of intangible assets |
|
|
(545 |
) |
|
|
— |
|
Net cash used in investing activities |
|
|
(4,175 |
) |
|
|
(118 |
) |
|
|
|
|
|
|
|
Cash flows provided by financing activities: |
|
|
|
|
|
|
Principal payments of term loan obligation |
|
|
(3,996 |
) |
|
|
(1,206 |
) |
Proceeds
from credit facility |
|
|
3,292 |
|
|
|
— |
|
Purchase
of treasury stock |
|
|
(374 |
) |
|
|
— |
|
Proceeds
from sale of common stock, net of offering costs of $0.2
million |
|
|
— |
|
|
|
5,180 |
|
Proceeds
from sale of common stock, warrants and pre-funded warrants,
net |
|
|
7,265 |
|
|
|
— |
|
Net cash provided by financing activities |
|
|
6,187 |
|
|
|
3,974 |
|
Net decrease in cash and cash equivalents |
|
|
(7,331 |
) |
|
|
(7,114 |
) |
Cash and
cash equivalents at beginning of period |
|
|
8,554 |
|
|
|
18,120 |
|
Cash and
cash equivalents at end of period |
|
$ |
1,223 |
|
|
$ |
11,006 |
|
|
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