Plus Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights
14 Agosto 2023 - 10:05PM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing targeted
radiotherapeutics with advanced platform technologies for central
nervous system cancers, today announced financial results for the
second quarter ended June 30, 2023, and provided an overview of
recent business highlights.
“The past 12 months have been transformative for
the company,” said Marc H. Hedrick M.D., President and Chief
Executive Officer of Plus Therapeutics. “We now have two lead
indications, recurrent glioblastoma and leptomeningeal metastases,
for our rhenium (186Re) obisbemeda investigational drug and we plan
to fully leverage available external third-party funding to move
both clinical development programs through Phase 2 and evaluate
accelerated approval opportunities.”
Q2 HIGHLIGHTS AND MILESTONE
ACHIEVEMENTS
Leptomeningeal Metastases
- Completed Phase
1/Part A of the ReSPECT-LM clinical trial.
- Presented
preliminary safety and efficacy results from Phase 1/Part A of the
ReSPECT-LM clinical trial at the Society for Neuro Oncology
(SNO)/American Society of Clinical Oncology (ASCO) Central Nervous
System (CNS) Cancer Conference.
- Received U.S.
Food and Drug Administration (FDA) approval to move to Phase 1/Part
B of the ReSPECT-LM clinical trial.
- In the second
quarter of 2023, achieved all Year 1 goals and objectives set forth
in the Company’s 3-Year, $17.6M Cancer Prevention & Research
Institute of Texas (CPRIT) grant.
Recurrent Glioblastoma
- Presented
clinical updates on the ReSPECT-GBM Phase 1 dose escalation and
Phase 2b trials for recurrent glioblastoma (GBM) at the SNO/ ASCO
CNS Cancer Conference.
- Announced
topline results from our propensity matched, recurrent GBM external
control analysis for comparative evaluation of outcomes in our
prospective recurrent glioblastoma trials at American Society of
Clinical Oncology (ASCO) 2023.
Supply Chain
- Expanded
collaboration with Piramal Pharma Solutions to produce additional
cGMP liposome intermediate drug product to meet the increase in
demand for rhenium (186Re) obisbemeda in ongoing and planned
clinical trials.
Organization
- Strengthened
clinical development leadership with the appointment of Pius
Maliakal, M. Pharm., Ph.D., as Vice President of Clinical
Operations.
SECOND QUARTER
2023 FINANCIAL RESULTS
- The
Company’s cash balance was $10.9 million at June 30, 2023, compared
to $18.1 million at December 31, 2022. A second grant payment from
CPRIT, in the amount of $1.9 million, has been approved and is
expected to be received prior to the end of August 2023.
- The Company
recognized $1.9 million of grant revenue in the second quarter of
2023, which represents the CPRIT’s share of costs incurred in the
development of rhenium (186Re) obisbemeda for the treatment of
patients with LM.
- Total operating
expenses for the second quarter of 2023 were $3.3 million, compared
to total operating expenses of $5.1 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 the National Institutes of Health and $17.6 million
from CPRIT. The Company also has discretionary, or stockholder
approved access to capital, subject to market conditions and
securities laws compliance from its ATM and equity line of credit
of at least $49 million. In aggregate, these capital sources could
provide sufficient capital to fund currently planned and
anticipated activities through 2025, if fully utilized.
- Net loss for the
second quarter of 2023 was $(1.5) million, or $(0.59) per share,
compared to a net loss of $(5.3) million, or $(3.56) per share, for
the same period the prior year.
UPCOMING 2023 EVENTS AND
MILESTONES
During the remainder of 2023, the Company plans
to accomplish the following key business objectives:
- Initiate Phase
1/Part B of the ReSPECT-LM trial.
- Obtain FDA
approval and initiate the Phase 1 ReSPECT-PBC trial for pediatric
patients with ependymoma and high-grade glioma at Lurie Children’s
Hospital in Chicago.
- Determine FDA
regulatory designation for the 188RNL-BAM development.
- Add key second
source supply chain vendors to support late-stage clinical
trials.
- Publish
ReSPECT-GBM Phase 1 data in peer-reviewed publication.
- Present safety
and efficacy data from ReSPECT-GBM trials at the annual SNO
conference in Vancouver on November 16-19, 2023.
- Various data
presentations planned for the following 2023 medical meetings: EANM
on September 9-13 and CPRIT’s Innovations in Cancer Prevention and
Research Conference VI on October 2-3.
SECOND QUARTER 2023 RESULTS
CONFERENCE CALL
The Company will hold a conference call and live
audio webcast at 5:00 p.m. 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 Investor'
section. The webcast will be available on the Company’s website for
90 days following the live call
About Plus Therapeutics
Plus 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 robust
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 Statements
This press release contains statements that may
be deemed “forward-looking statements” within the meaning of U.S.
securities laws. 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 “designed to,” “will,” “can,” “potential,”
“focus,” “preparing,” “next steps,” “possibly,” 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 regarding the following: the
potential promise of 186Re including the ability of 186Re
to safely and effectively deliver radiation directly to the tumor
at high doses; expectations as to the Company’s future performance
including the next steps in developing the Company’s current
assets; the Company’s clinical trials including statements
regarding the timing and characteristics of the ReSPECT-GBM and
ReSPECT-LM clinical trials; possible negative effects
of 186Re; the continued evaluation of 186Re including
through evaluations in additional patient cohorts; the intended
functions of the Company’s platform and expected benefits from such
functions; and matters regarding the Company’s liquidity and access
to capital.
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. 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, and 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, including
because of market conditions and limitations under the securities
laws given the Company’s current market capitalization: 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 Securities and
Exchange Commission filings, including in the Company’s annual and
quarterly reports. There may be events in the future that the
Company is unable to predict, or over which it has no control, and
its business, financial condition, results of operations and
prospects may change in the future. 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.
PLUS THERAPEUTICS, INC. CONDENSED BALANCE
SHEETS(UNAUDITED)(in thousands,
except share and par value data) |
|
|
|
|
|
June 30, 2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,895 |
|
|
$ |
18,120 |
|
Grant receivable |
|
|
718 |
|
|
|
— |
|
Other current assets |
|
|
751 |
|
|
|
3,697 |
|
Total current assets |
|
|
12,364 |
|
|
|
21,817 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
1,143 |
|
|
|
1,324 |
|
Operating lease right-of-use
assets |
|
|
242 |
|
|
|
248 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Intangible assets, net |
|
|
64 |
|
|
|
94 |
|
Other assets |
|
|
12 |
|
|
|
12 |
|
Total assets |
|
$ |
14,197 |
|
|
$ |
23,867 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
6,580 |
|
|
$ |
10,134 |
|
Operating lease liability |
|
|
110 |
|
|
|
110 |
|
Term loan obligation |
|
|
4,709 |
|
|
|
1,608 |
|
Total current liabilities |
|
|
11,399 |
|
|
|
11,852 |
|
|
|
|
|
|
|
|
Term loan obligation |
|
|
— |
|
|
|
3,786 |
|
Noncurrent operating lease
liability |
|
|
136 |
|
|
|
141 |
|
Deferred grant liability |
|
|
— |
|
|
|
1,643 |
|
Total liabilities |
|
|
11,535 |
|
|
|
17,422 |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,952 shares issued and outstanding at June 30, 2023 and December
31, 2022, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
2,879,620 and 2,240,092 shares issued and outstanding at June 30,
2023 and December 31, 2022, respectively |
|
|
3 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
476,131 |
|
|
|
473,628 |
|
Accumulated deficit |
|
|
(473,472 |
) |
|
|
(467,185 |
) |
Total stockholders’ equity |
|
|
2,662 |
|
|
|
6,445 |
|
Total liabilities and stockholders’ equity |
|
$ |
14,197 |
|
|
$ |
23,867 |
|
PLUS THERAPEUTICS, INC. CONDENSED 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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Development revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Government contracts and other |
|
$ |
1,854 |
|
|
$ |
— |
|
|
$ |
2,360 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,420 |
|
|
|
2,831 |
|
|
|
4,403 |
|
|
|
4,615 |
|
General and administrative |
|
|
1,924 |
|
|
|
2,289 |
|
|
|
4,167 |
|
|
|
4,431 |
|
Total operating expenses |
|
|
3,344 |
|
|
|
5,120 |
|
|
|
8,570 |
|
|
|
9,046 |
|
Loss from operations |
|
|
(1,490 |
) |
|
|
(5,120 |
) |
|
|
(6,210 |
) |
|
|
(9,046 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
120 |
|
|
|
19 |
|
|
|
171 |
|
|
|
26 |
|
Interest expense |
|
|
(112 |
) |
|
|
(181 |
) |
|
|
(246 |
) |
|
|
(379 |
) |
Loss on disposal of property and equipment |
|
|
— |
|
|
|
— |
|
|
|
(2 |
) |
|
|
— |
|
Change in fair value of liability instruments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
Total other income (expense) |
|
|
8 |
|
|
|
(162 |
) |
|
|
(77 |
) |
|
|
(352 |
) |
Net loss |
|
$ |
(1,482 |
) |
|
$ |
(5,282 |
) |
|
$ |
(6,287 |
) |
|
$ |
(9,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.59 |
) |
|
$ |
(3.56 |
) |
|
$ |
(2.60 |
) |
|
$ |
(6.43 |
) |
Basic and diluted weighted
average shares used in calculating net loss per share attributable
to common stockholders |
|
|
2,509,378 |
|
|
|
1,483,655 |
|
|
|
2,415,221 |
|
|
|
1,461,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONDENSED STATEMENTS OF
CASH FLOWS(UNAUDITED)(In
thousands) |
|
|
|
|
|
For the Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows used in
operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(6,287 |
) |
|
$ |
(9,398 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
318 |
|
|
|
302 |
|
Amortization of deferred financing costs and debt discount |
|
|
119 |
|
|
|
218 |
|
Change in fair value of liability instruments |
|
|
— |
|
|
|
(1 |
) |
Loss on disposal of property and equipment |
|
|
2 |
|
|
|
— |
|
Stock-based compensation expense |
|
|
280 |
|
|
|
347 |
|
Amortization of operating lease right-of-use assets |
|
|
57 |
|
|
|
38 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
Grant receivable |
|
|
718 |
|
|
|
— |
|
Other current assets |
|
|
1,510 |
|
|
|
525 |
|
Accounts payable and accrued expenses |
|
|
(3,589 |
) |
|
|
1,527 |
|
Change in operating lease liabilities |
|
|
(56 |
) |
|
|
(74 |
) |
Deferred revenue |
|
|
(1,643 |
) |
|
|
— |
|
Net cash used in operating activities |
|
|
(8,571 |
) |
|
|
(6,516 |
) |
|
|
|
|
|
|
|
Cash flows used in
investing activities: |
|
|
|
|
|
|
Purchases of property and
equipment |
|
|
(108 |
) |
|
|
(348 |
) |
Purchase of intangible
assets |
|
|
— |
|
|
|
(117 |
) |
In process research and
development acquired |
|
|
— |
|
|
|
(250 |
) |
Net cash used in investing activities |
|
|
(108 |
) |
|
|
(715 |
) |
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
Principal payments of term loan
obligation |
|
|
(804 |
) |
|
|
(804 |
) |
Proceeds from sale of common
stock, net |
|
|
2,258 |
|
|
|
7,725 |
|
Net cash provided by financing activities |
|
|
1,454 |
|
|
|
6,921 |
|
Net decrease in cash and cash equivalents |
|
|
(7,225 |
) |
|
|
(310 |
) |
Cash and cash equivalents at
beginning of period |
|
|
18,120 |
|
|
|
18,400 |
|
Cash and cash equivalents at end
of period |
|
$ |
10,895 |
|
|
$ |
18,090 |
|
|
|
|
|
|
|
|
Supplemental disclosure
of cash flows information: |
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
Interest |
|
$ |
135 |
|
|
$ |
168 |
|
Supplemental schedule of
non-cash investing and financing activities: |
|
|
|
|
|
|
Unpaid offering cost |
|
$ |
35 |
|
|
$ |
50 |
|
Investor Contact Peter VozzoICR Westwicke (443)
377-4767 Peter.Vozzo@westwicke.com
Media Contact Terri Clevenger ICR
Westwicke (203) 856-4326
Terri.Clevenger@westwicke.com
Grafico Azioni Plus Therapeutics (NASDAQ:PSTV)
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