Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing novel, targeted
therapies for rare and difficult to treat cancers, today announced
financial results for the fourth quarter and full year ended
December 31, 2020, and provided an overview of recent business
highlights.
“In the second quarter of 2020, we in-licensed a
promising new radiotherapeutic platform and portfolio of
investigational drugs, then made substantial clinical progress for
the lead compound and also moved additional opportunities closer to
clinical phase,” said Marc Hedrick M.D., President and Chief
Executive Officer of Plus Therapeutics. “In 2021, we intend to make
even greater progress advancing our CNS oncology portfolio through
the development process and bringing it closer to a potential
registrational clinical trial read out.”
Rhenium NanoLiposome (RNL™) Program -
Background and 2020 Highlights
The Company’s lead investigational drug is RNL™,
a radiotherapy in development for several rare cancer targets,
including recurrent glioblastoma (GBM) in the U.S. multi-center
ReSPECT™ Phase 1 dose-finding trial. RNL™ is designed to safely,
effectively, and conveniently deliver a very high dose of radiation
directly into the brain tumor compared to traditional external beam
radiation therapy (EBRT). 2020 highlights for RNL™ include:
- ReSPECT™ trial
of RNL™ for recurrent glioblastoma supported by a multi-phase and
multi-year financial grant from the U.S. National Institutes of
Health/National Cancer Institute (NIH/NCI).
- RNL™ received
Orphan Drug and Fast Track designations from the U.S. Food and Drug
Administration (FDA) for the treatment of GBM.
- Presented
positive interim data from the first 15 patients, through Cohort 5,
in the ReSPECT™ trial at the 2020 Society for Neuro-Oncology Annual
Meeting (SNO 2020 E-poster).
- Completed the
6th dose escalation cohort, with 18 total patients treated in
ReSPECT™, with increases in both the RNL™ drug volume and radiation
dose.
- Thus far, RNL™
can be successfully delivered with up to 15 times the absorbed dose
of radiation administered by standard EBRT without significant
toxicity.
- ReSPECT™
clinical trial expanded to two additional locations.
- Established
Clinical Advisory and Scientific Advisory Boards with leading
experts in the fields of neurosurgery, neuro-oncology, preclinical
drug development, and nanotechnology.
Expected Upcoming Milestones and
Events
In upcoming quarters, the Company intends to
focus on a number of additional business objectives and potential
milestones:
- Complete
enrollment of the ReSPECT™ Phase 1 trial for RNL™ in recurrent
glioblastoma.
- Complete pivotal
trial planning with FDA for RNL™ in recurrent glioblastoma.
- Complete pre-IND
meeting with the FDA, execute IND-enabling studies, if needed, and
move into clinical trials for follow-on RNL™ indications,
leptomeningeal metastases and pediatric brain cancer.
- Continue
development and evaluation of additional external and internal drug
development candidates to expand the pipeline.
- Continue
partnership discussions for three clinical-stage injectable drugs:
RNL™, DocePLUS™, and generic DoxoPLUS™.
Fourth Quarter 2020 Financial
Results
- As of December
31, 2020, the Company’s cash balance was $8.3 million, compared to
$17.6 million as of December 31, 2019.
- Net cash used in
operating activities was $8.4 million for the year ended December
31, 2020, compared to net cash used in operating activities of $5.9
million during the same period in 2019.
- During the
second quarter of 2020, $5.0 million of the Oxford debt principal
was paid down to a current principal balance of $4.3 million at
December 31, 2020.
- Net loss for
full year 2020 was $8.2 million, or $(1.86) per share, compared to
a net loss of $11.4 million, or $(8.27) per share (on a fully
diluted basis including preferred stock), for full year 2019.
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.
Event: |
Plus Therapeutics Fourth Quarter and Full Year 2020 Financial
Results Conference Call and Webcast |
Date: |
Monday, February 22, 2021 |
Time: |
5:00 p.m. Eastern Time |
Live Call: |
877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID:
6206747 |
The webcast can be accessed live via the
investor section of the Plus Therapeutics website at
ir.plustherapeutics.com/events and will be available for replay
beginning two hours after the conclusion of the conference
call.
About Plus Therapeutics,
Inc.
Plus Therapeutics (Nasdaq: PSTV) is a
clinical-stage pharmaceutical company whose radiotherapeutic
portfolio is concentrated on nanoliposome-encapsulated
radionuclides for several cancer targets. Central to the Company’s
drug development is a unique nanotechnology platform designed to
reformulate, deliver and commercialize multiple drugs targeting
rare cancers and other diseases. The platform is designed to
facilitate new delivery approaches and/or formulations of safe and
effective, injectable drugs, potentially enhancing the safety,
efficacy and convenience for patients and healthcare providers.
More information may be found at www.PlusTherapeutics.com and
www.respect-trials.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 “will,” “believe,” “plan,” “can,” “enable,”
“design,” “intend,” “potential,” “expect,” “estimate,” “project,”
“prospect,” “target,” “focus,” “anticipate,” “could,” “should,” 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 design
and potential of the Plus Therapeutics portfolio to reformulate,
deliver and commercialize multiple novel, proprietary drugs
targeting rare cancers and other diseases and to facilitate new
delivery approaches and/or formulations of safe and effective,
injectable drugs; the potential of the Company’s new, in-licensed
portfolio of investigational drugs; the Company’s intent to advance
its CNS oncology portfolio through the clinical development
process; the ability of RNL to safely, effectively and conveniently
deliver a very high dose of radiation greater than traditional EBRT
directly into the brain tumor; and the Company’s anticipated
milestones and events, including with respect to enrollment,
pivotal trial planning, IND process, and clinical phase plans for
RNL, pipeline expansion through additional drug development
candidates, and partnership discussions for RNL, DocePLUS and
DoxoPLUS. 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 risk that the Company is not
able to successfully develop product candidates that can leverage
the U.S. FDA’s accelerated regulatory pathways; the early stage of
the Company’s product candidates and therapies, the results of its
research and development activities, including uncertainties
relating to the clinical trials of its product candidates and
therapies; the Company’s history of losses; the Company’s need for,
and ability to raise, additional cash or obtain other sources of
funding in the immediate future; the Company’s ability to: (a)
obtain and maintain regulatory approvals, (b) continue as a going
concern, (c) remain listed on the Nasdaq Capital Market, (d) to
obtain or maintain sufficient levels of reimbursement for its
tests, and (d) to repay or refinance some or all of its outstanding
indebtedness; the outcome of the Company’s partnering/licensing
efforts; market and economic conditions; the impact of the COVID-19
pandemic on the Company and the effectiveness of the efforts it has
taken or may take in the future in response thereto; 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.CONSOLIDATED BALANCE
SHEETS(in thousands, except share and par value
data)
|
|
As of December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,346 |
|
|
$ |
17,552 |
|
Accounts receivable |
|
|
— |
|
|
|
1,169 |
|
Restricted cash |
|
|
— |
|
|
|
40 |
|
Inventories, net |
|
|
— |
|
|
|
107 |
|
Other current assets |
|
|
829 |
|
|
|
957 |
|
Total current assets |
|
|
9,175 |
|
|
|
19,825 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
1,820 |
|
|
|
2,179 |
|
Operating lease right-use-of
assets |
|
|
636 |
|
|
|
781 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Intangible assets, net |
|
|
86 |
|
|
|
— |
|
Other assets |
|
|
16 |
|
|
|
72 |
|
Total assets |
|
$ |
12,105 |
|
|
$ |
23,229 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
2,081 |
|
|
$ |
3,279 |
|
Operating lease liability |
|
|
123 |
|
|
|
147 |
|
Term loan obligation, net of discount |
|
|
6,335 |
|
|
|
11,060 |
|
Total current liabilities |
|
|
8,539 |
|
|
|
14,486 |
|
|
|
|
|
|
|
|
|
|
Noncurrent operating lease
liability |
|
|
528 |
|
|
|
646 |
|
Warrant liability |
|
|
7 |
|
|
|
6,929 |
|
Other noncurrent liabilities |
|
|
— |
|
|
|
8 |
|
Total liabilities |
|
|
9,074 |
|
|
|
22,069 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,954 and 1,959 shares issued and outstanding in 2020 and 2019,
respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
6,749,028 and 3,880,588 shares issued and outstanding in 2020 and
2019, respectively |
|
|
7 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
436,535 |
|
|
|
426,426 |
|
Accumulated deficit |
|
|
(433,511 |
) |
|
|
(425,270 |
) |
Total stockholders’ equity |
|
|
3,031 |
|
|
|
1,160 |
|
Total liabilities and stockholders’ equity |
|
$ |
12,105 |
|
|
$ |
23,229 |
|
PLUS THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except share and
per share data)
|
|
For the Years Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
Development revenue: |
|
|
|
|
|
|
|
|
Government contracts and other |
|
$ |
303 |
|
|
$ |
6,998 |
|
|
|
|
303 |
|
|
|
6,998 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,700 |
|
|
|
5,365 |
|
In process research and development acquired from NanoTx |
|
|
781 |
|
|
|
— |
|
General and administrative |
|
|
6,406 |
|
|
|
5,290 |
|
Total operating expenses |
|
|
9,887 |
|
|
|
10,655 |
|
Operating loss |
|
|
(9,584 |
) |
|
|
(3,657 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
50 |
|
|
|
55 |
|
Interest expense |
|
|
(1,107 |
) |
|
|
(1,855 |
) |
Change in fair value of liability instruments |
|
|
2,400 |
|
|
|
3,407 |
|
Issuance cost of warrants |
|
|
— |
|
|
|
(1,233 |
) |
Total other expense |
|
|
1,343 |
|
|
|
374 |
|
Loss from continuing operations |
|
$ |
(8,241 |
) |
|
$ |
(3,283 |
) |
Loss from discontinued operations |
|
|
— |
|
|
|
(7,604 |
) |
Net loss |
|
$ |
(8,241 |
) |
|
$ |
(10,887 |
) |
|
|
|
|
|
|
|
|
|
Loss from continuing
operations |
|
$ |
(8,241 |
) |
|
$ |
(3,283 |
) |
Beneficial conversion feature for
convertible preferred stock |
|
|
— |
|
|
|
(554 |
) |
Net loss allocable to common
stockholders - continuing operations |
|
$ |
(8,241 |
) |
|
$ |
(3,837 |
) |
Net loss allocable to common
stockholders - discontinued operations |
|
|
- |
|
|
|
(7,604 |
) |
Net loss allocable to common
stockholders |
|
$ |
(8,241 |
) |
|
$ |
(11,441 |
) |
Basic and diluted net loss per
share attributable to common stockholders – continuing
operations |
|
$ |
(1.86 |
) |
|
$ |
(2.77 |
) |
Basic and diluted net loss per
share attributable to common stockholders - discontinued
operations |
|
|
- |
|
|
|
(5.49 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.86 |
) |
|
$ |
(8.27 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted weighted
average shares used in calculating net loss per share attributable
to common stockholders |
|
|
4,427,835 |
|
|
|
1,384,012 |
|
PLUS THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF CASH
FLOWS(in thousands)
|
|
For the Years Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
Cash flows used in
operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,241 |
) |
|
$ |
(10,887 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
366 |
|
|
|
896 |
|
Amortization of deferred financing costs and debt discount |
|
|
584 |
|
|
|
550 |
|
In process research and development acquired from NanoTx
Therapeutics |
|
|
781 |
|
|
|
— |
|
Change in fair value of liability instruments |
|
|
(2,400 |
) |
|
|
(3,407 |
) |
Share-based compensation expense |
|
|
247 |
|
|
|
127 |
|
Inventory write off |
|
|
107 |
|
|
|
— |
|
Noncash lease expense |
|
|
3 |
|
|
|
12 |
|
Loss on sale of business |
|
|
— |
|
|
|
6,508 |
|
Allocation of issuance cost associated with warrants |
|
|
— |
|
|
|
1,233 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,169 |
|
|
|
(1,203 |
) |
Inventories |
|
|
— |
|
|
|
259 |
|
Other current assets |
|
|
126 |
|
|
|
(211 |
) |
Other assets |
|
|
58 |
|
|
|
263 |
|
Accounts payable and accrued expenses |
|
|
(1,234 |
) |
|
|
(28 |
) |
Deferred revenue |
|
|
— |
|
|
|
29 |
|
Other long-term liabilities |
|
|
— |
|
|
|
(47 |
) |
Net cash used in operating activities |
|
|
(8,434 |
) |
|
|
(5,906 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from (used in)
investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and
equipment |
|
|
(93 |
) |
|
|
(67 |
) |
In process research and
development acquired from NanoTx Therapeutics |
|
|
(400 |
) |
|
|
— |
|
Proceeds from sale of
business |
|
|
— |
|
|
|
5,637 |
|
Net cash provided by (used in) investing activities |
|
|
(493 |
) |
|
|
5,570 |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
|
Principal payments of long-term
obligations |
|
|
(5,307 |
) |
|
|
(3,692 |
) |
Payment of financing lease
liability |
|
|
(117 |
) |
|
|
(131 |
) |
Proceeds from exercise of
warrants |
|
|
1,098 |
|
|
|
490 |
|
Proceeds from sale of common
stock |
|
|
4,007 |
|
|
|
15,964 |
|
Net cash (used in) provided by financing activities |
|
|
(319 |
) |
|
|
12,631 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
— |
|
|
|
(4 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
(9,246 |
) |
|
|
12,291 |
|
Cash, cash equivalents, and
restricted cash at beginning of period |
|
|
17,592 |
|
|
|
5,301 |
|
Cash, cash equivalents, and
restricted cash at end of period |
|
$ |
8,346 |
|
|
$ |
17,592 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure
of cash flows information: |
|
|
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
567 |
|
|
$ |
1,188 |
|
Supplemental schedule of
non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Issuance costs paid in common stock |
|
$ |
463 |
|
|
$ |
— |
|
Common stock issued in payment for in process research and
development |
|
$ |
381 |
|
|
$ |
— |
|
Unpaid offering cost |
|
$ |
125 |
|
|
$ |
— |
|
Proceeds from sales of business, net, paid directly to lender for
principal payment of long-term obligations |
|
$ |
— |
|
|
$ |
3,050 |
|
Offering cost paid in warrants |
|
$ |
— |
|
|
$ |
213 |
|
Reclassification of warrants upon exercise from liability to
equity |
|
$ |
4,504 |
|
|
$ |
794 |
|
Fair value of Convertible Preferred Stock beneficial conversion
feature |
|
$ |
— |
|
|
$ |
554 |
|
|
|
|
|
|
|
|
|
|
Investor ContactPeter VozzoWestwicke/ICR(443)
377-4767 Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerWestwicke/ICR(203)
856-4326Terri.Clevenger@westwicke.com
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