Plus Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
14 Agosto 2024 - 3:16PM
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 second quarter ended June 30, 2024, and provided an
overview of recent and upcoming business highlights.
Q2 2024 RECENT HIGHLIGHTS AND
MILESTONES
- Presented positive ReSPECT-LM Phase
1 study data at the 2024 Society for NeuroOncology /American
Society for Clinical Oncology (SNO/ASCO) CNS Metastases Conference.
Rhenium (186Re) Obisbemeda was safe and well-tolerated in the first
4 dosing cohorts (n=16 patients). Current median overall survival
is 12 months with 8 of 16 patients treated remaining alive.
Additional detail can be found here
- Reported topline FORESEE clinical
trial 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 over
90% of provider decisions (n=50/55 clinical decisions) and helped
to inform therapy selection in 24% of provider decisions (n=13/55
clinical decisions). Furthermore, the CNSide test improved tumor
cell detection in LM patients compared to cytology (80% vs. 29%) in
matched 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-emitting
radionuclides at the 2024 Society of Nuclear Medicine and Molecular
Imaging (SNMMI) annual meeting
- Submitted a new clinical protocol
to the U.S. Food and Drug Administration (FDA), under its active
Investigational New Drug application (IND 153715) for a Phase 1
study to evaluate multiple administrations of Rhenium (186Re)
Obisbemeda for the treatment of patients with LM
- Received $3.3 million grant payment
from Cancer Prevention & Research Institute of Texas (CPRIT) in
June 2024 to support the clinical development of Rhenium (186Re)
Obisbemeda for LM
“Plus’ lead investigational drug Rhenium (186Re)
Obisbemeda continues to show safety and promising signs of efficacy
after a single administration in patients with LM,” said Marc H.
Hedrick, M.D., Plus Therapeutics President and Chief Executive
Officer. “We are on track to complete the single administration
ReSPECT-LM Phase 1 trial soon, expand to multiple doses, and move
to Phase 2 funded by our existing CPRIT award.”
UPCOMING EVENTS AND
MILESTONES
- Presentations planned for the
following upcoming medical conferences:
- Congress of Neurological
Surgeons (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 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 Oncogenetic 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
- Complete ReSPECT-LM Phase 1 single
administration trial and determine the recommended Phase 2
dose
- Initiate ReSPECT-LM Phase 1
multiple administration trial
- Obtain IND approval for a Phase 1/2
trial of Rhenium (186Re) Obisbemeda via convection enhanced
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 FINANCIAL
RESULTS
- The Company’s cash and investments
balance was $8.4 million at June 30, 2024 compared to $8.6 million
at December 31, 2023
- The Company recognized $3.0 million
in grant revenue in the first half of 2024 compared to $2.4 million
in the same period 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 loss for the first
half of 2024 was $7.0 million compared to $6.2 million in the same
period of 2023. The increase is primarily due to increased spend
related 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 the
prior year
SECOND 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.
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 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 “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 Expected Events and
Milestones and statements regarding the following: 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 candidate; 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; reporting
results of preclinical combination studies of rhenium (186Re)
obisbemeda with PD-1 and PD-L1 checkpoint inhibitors; development
and potential submission of ReSPECT-PBC investigational new drug
application (IND) for pediatric ependymoma and high grade glioma;
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, 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, 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) |
|
|
|
|
June 30,2024 |
|
|
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-use
assets |
|
139 |
|
|
|
202 |
|
Goodwill |
|
372 |
|
|
|
372 |
|
Intangible assets, net |
|
557 |
|
|
|
42 |
|
Other assets |
|
32 |
|
|
|
32 |
|
Total assets |
$ |
11,212 |
|
|
$ |
11,388 |
|
Liabilities and
Stockholders’ 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 lease
liability |
|
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 December
31, 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 OF
OPERATIONS(Unaudited)(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
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 common
stock - basic |
$ |
(0.45 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.15 |
) |
|
$ |
(2.60 |
) |
Weighted average number of shares
of common stock outstanding - basic |
|
6,500,831 |
|
|
|
2,509,378 |
|
|
|
5,411,382 |
|
|
|
2,415,221 |
|
Net loss per share of common
stock - diluted |
$ |
(0.71 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.45 |
) |
|
$ |
(2.60 |
) |
Weighted average number of shares
of common stock outstanding - diluted |
|
10,742,924 |
|
|
|
2,509,378 |
|
|
|
7,532,428 |
|
|
|
2,415,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF CASH
FLOWS(Unaudited)(In
thousands) |
|
|
|
|
For the Six Months Ended June 30, |
|
|
2024 |
|
|
2023 |
|
Cash flows used in operating activities: |
|
|
|
|
|
Net loss |
$ |
(6,201 |
) |
|
$ |
(6,287 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
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 assets
and 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 financing
activities: |
|
|
|
|
|
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-funded
warrants, 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 flows
information: |
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
Interest |
$ |
32 |
|
|
$ |
135 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
Unpaid offering cost |
$ |
375 |
|
|
$ |
35 |
|
Plus Therapeutics (NASDAQ:PSTV)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Plus Therapeutics (NASDAQ:PSTV)
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De Ago 2023 a Ago 2024