Plus Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights
23 October 2020 - 7:05AM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today
announced financial results for the third quarter ended September
30, 2020, and provided an overview of recent business highlights.
“Our lead investigational drug, RNL™ for
recurrent glioblastoma, continues to progress toward its first
major data readout,” said Dr. Marc Hedrick, President and Chief
Executive Officer of Plus Therapeutics. “In the third quarter, we
advanced RNL successfully to the sixth dosing cohort and we are now
administering over 1,000% more radiation to patients in a single
treatment than can be delivered with traditional external beam
radiation therapy.”
Third Quarter 2020 and
Recent Clinical
Highlights
Plus Therapeutics has three clinical stage,
nanoscale injectable oncology drugs, each designed to provide
enhanced benefits versus existing therapies. The Company’s lead
investigational drug is Rhenium NanoLiposome (RNL™), a radiotherapy
being developed for several cancer targets. RNL is being evaluated
in the U.S. NIH/NCI-supported, multi-center ReSPECT™ Phase 1
dose-finding trial and for the treatment of recurrent glioblastoma.
RNL is designed to safely, effectively, and conveniently deliver a
targeted and very high dose of radiation directly to brain tumors.
In addition:
- The U.S. Food and Drug Administration (FDA) granted the Company
Orphan Drug and Fast Track Designations for RNL for the treatment
of glioblastoma patients.
- The Company established a Clinical Advisory Board of five
leading experts in the fields of neurological surgery and
neuro-oncology that will advise the Company as it advances its
nanoscale therapeutics to treat rare brain and neurological
cancers.
- The independent Data and Safety Monitoring Board (DSMB) of the
ReSPECT Phase 1 trial in recurrent glioblastoma approved the
Company to commence enrollment in the sixth cohort of
patients.
Expected
Upcoming
Milestones and
Events
The first nine months of 2020 marked the
successful implementation of the Company’s expanded development
focus, pipeline expansion and optimized costs and operational
structure. In upcoming quarters, the Company intends to focus on a
number of additional business objectives and potential
milestones:
- Report preliminary RNL data from the ReSPECT Phase 1
dose-finding trial in recurrent glioblastoma at the Society of
Neuro-Oncology Annual Meeting being held virtually November 19-22,
2020.
- Finalize plans for the next stage of clinical development for
RNL in recurrent glioblastoma.
- Continue evaluations of additional external and internal drug
development candidates.
- Initiate IND-enabling RNL studies for additional
indications.
- Explore partnership opportunities for RNL, DocePLUS™ and
DoxoPLUS™ assets.
Third Quarter
2020
Financial
Results
- As of September 30, 2020, the Company had cash of approximately
$7.6 million, compared to cash of approximately $17.6 million as of
December 31, 2019. During the third quarter of 2020, 317,521 series
U warrants were exercised, raising $0.7 million. Net cash used in
operating activities was $5.2 million for the nine months ended
September 30, 2020, compared to net cash used of $6.9 million
during the same period in 2019. During the second quarter of 2020,
$5 million of the Oxford debt principal was paid down.
- On September 30, 2020, the Company entered into a purchase
agreement and registration rights agreement with Lincoln Park
Capital Fund, LLC (LPC) pursuant to which and following the filing
and effectiveness of a registration statement, the Company will
have the right at its sole discretion, but not the obligation, to
sell to LPC up to $25 million worth of shares over the 36-month
term of the agreement, subject to various terms and
conditions.
- On October 9, 2020 the Company filed a shelf registration on
Form S-3 allowing for the sale of securities “at the market” of up
to $10 million.
- Loss from continuing operations for the third quarter 2020 was
$1.7 million, or $(0.39) per share, compared to operating income of
$0.5 million, or $(0.03) per share (on a fully diluted basis
including preferred stock), for the same period in 2019.
- Net loss in the third quarter of 2020 was $1.7 million, or
$(0.39) per share, compared to net income of $0.5 million, or
$(0.03) per share (on a fully diluted basis including preferred
stock), for the third quarter of 2019.
- Clinical expenses relating to the ReSPECT Phase 1 dose-finding
trial in recurrent glioblastoma continue to be funded under a $3
million grant with the U.S. NIH/NCI.
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 Third Quarter 2020 Financial Results Conference
Call and Webcast |
Date: |
Thursday, October 22,
2020 |
Time: |
5:00 p.m. Eastern Time. |
Live Call: |
877-402-3914; 631-865-5294
(Intl.); Conference ID: 2108916 |
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 Company’s belief as to the platform’s
capacity to leverage new delivery approaches and/or formulations to
enable significant potential enhancements of safety, efficacy and
convenience for patients and healthcare providers; the potential of
the Company’s portfolio generally, and the potential of RNL™ to
safely and effectively deliver a dose of radiation directly to the
tumor up to 25 times greater than that currently being given to
patients using external beam radiation therapy; the Company’s
belief as to the potential of RNL™ to improve brain tumor therapy
and that of other difficult to treat radiosensitive tumors; the
timing, status, outcome, and anticipated expansion of clinical
trials for RNL™, including the planned initiation of an additional
Phase 1 study and enrollment at additional sites, and the
anticipated timing thereof; the Company’s business expansion
outlook for the second half of 2020, including its intended focus
on certain additional business expansion milestones; the Company’s
expectations regarding the progress and prospect of advancement for
the Company, RNL™, and the Company’s portfolio during the second
half of 2020; and the potential impact of the COVID-19 pandemic on
the Company and its clinical programs, operating results, and
financial condition. 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
CONDENSED BALANCE
SHEETS(UNAUDITED)(in thousands,
except share and par value data) |
|
|
|
|
|
As of September
30,2020 |
|
|
As of December 31,2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,626 |
|
|
$ |
17,552 |
|
Accounts receivable |
|
|
— |
|
|
|
1,169 |
|
Restricted cash |
|
|
— |
|
|
|
40 |
|
Inventories, net |
|
|
107 |
|
|
|
107 |
|
Other current assets |
|
|
916 |
|
|
|
957 |
|
Total current assets |
|
|
8,649 |
|
|
|
19,825 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
1,943 |
|
|
|
2,179 |
|
Operating lease right-of-use assets |
|
|
671 |
|
|
|
781 |
|
Other
assets |
|
|
18 |
|
|
|
72 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Total assets |
|
$ |
11,653 |
|
|
$ |
23,229 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
2,083 |
|
|
$ |
3,279 |
|
Operating lease liability |
|
|
140 |
|
|
|
147 |
|
Term loan obligations, net of discount |
|
|
6,181 |
|
|
|
11,060 |
|
Total current liabilities |
|
|
8,404 |
|
|
|
14,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent operating lease liability |
|
|
545 |
|
|
|
646 |
|
Warrant
liability |
|
|
83 |
|
|
|
6,929 |
|
Other
noncurrent liabilities |
|
|
— |
|
|
|
8 |
|
Total liabilities |
|
|
9,032 |
|
|
|
22,069 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,954 and 1,959 shares issued and outstanding at September 30, 2020
and December 31, 2019, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
4,591,415 and 3,880,588 shares issued and outstanding at September
30, 2020 and December 31, 2019, respectively |
|
|
5 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
432,540 |
|
|
|
426,426 |
|
Accumulated deficit |
|
|
(429,924 |
) |
|
|
(425,270 |
) |
Total stockholders’ equity |
|
|
2,621 |
|
|
|
1,160 |
|
Total liabilities and stockholders’ equity |
|
$ |
11,653 |
|
|
$ |
23,229 |
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC. CONSOLIDATED
CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(UNAUDITED)(in
thousands, except share and per share data) |
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Development revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government contracts and other |
|
$ |
— |
|
|
$ |
4,771 |
|
|
$ |
303 |
|
|
$ |
5,810 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
336 |
|
|
|
921 |
|
|
|
1,604 |
|
|
|
3,636 |
|
In process research and development acquired from NanoTx |
|
|
— |
|
|
|
— |
|
|
|
781 |
|
|
|
— |
|
Sales and marketing |
|
|
104 |
|
|
|
94 |
|
|
|
319 |
|
|
|
305 |
|
General and administrative |
|
|
956 |
|
|
|
1,076 |
|
|
|
3,788 |
|
|
|
3,313 |
|
Total operating expenses |
|
|
1,396 |
|
|
|
2,091 |
|
|
|
6,492 |
|
|
|
7,254 |
|
Operating income (loss) |
|
|
(1,396 |
) |
|
|
2,680 |
|
|
|
(6,189 |
) |
|
|
(1,444 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
6 |
|
|
|
47 |
|
|
|
20 |
|
Interest expense |
|
|
(253 |
) |
|
|
(366 |
) |
|
|
(854 |
) |
|
|
(1,477 |
) |
Change in fair value of warrants |
|
|
(81 |
) |
|
|
(561 |
) |
|
|
2,342 |
|
|
|
(69 |
) |
Warrant issuance cost |
|
|
— |
|
|
|
(1,233 |
) |
|
|
— |
|
|
|
(1,233 |
) |
Total other income (expense) |
|
|
(332 |
) |
|
|
(2,154 |
) |
|
|
1,535 |
|
|
|
(2,759 |
) |
Income (Loss) from continuing operations |
|
|
(1,728 |
) |
|
|
526 |
|
|
|
(4,654 |
) |
|
|
(4,203 |
) |
Loss from discontinued operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,568 |
) |
Net income (loss) |
|
$ |
(1,728 |
) |
|
$ |
526 |
|
|
$ |
(4,654 |
) |
|
$ |
(11,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(Loss) from continuing operations |
|
$ |
(1,728 |
) |
|
$ |
526 |
|
|
$ |
(4,654 |
) |
|
$ |
(4,203 |
) |
Beneficial conversion feature for convertible preferred stock |
|
|
— |
|
|
|
(554 |
) |
|
|
— |
|
|
$ |
(554 |
) |
Net loss
allocable to common stockholders - continuing operations |
|
$ |
(1,728 |
) |
|
$ |
(28 |
) |
|
$ |
(4,654 |
) |
|
$ |
(4,757 |
) |
Net loss
allocable to common stockholders - discontinued operations |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(7,568 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share attributable to common stockholders
- continuing operations |
|
$ |
(0.39 |
) |
|
$ |
(0.03 |
) |
|
$ |
(1.13 |
) |
|
$ |
(8.78 |
) |
Basic
and diluted net loss per share attributable to common stockholders
- discontinued operations |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(13.97 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.03 |
) |
|
$ |
(1.13 |
) |
|
$ |
(22.75 |
) |
Basic
and diluted weighted average shares used in calculating net loss
per share attributable to common stockholders |
|
|
4,402,221 |
|
|
|
826,548 |
|
|
|
4,113,928 |
|
|
|
541,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONSOLIDATED
CONDENSED STATEMENTS OF CASH
FLOWS(UNAUDITED)(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
|
2020 |
|
|
2019 |
|
Cash flows used in operating activities: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(4,654 |
) |
|
$ |
(11,771 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
273 |
|
|
|
778 |
|
Amortization of deferred financing costs and debt discount |
|
|
428 |
|
|
|
354 |
|
In process research and development acquired from NanoTx
Therapeutics |
|
|
781 |
|
|
|
— |
|
Noncash lease expenses |
|
|
2 |
|
|
|
22 |
|
Change in fair value of warrants |
|
|
(2,342 |
) |
|
|
69 |
|
Share-based compensation expense |
|
|
149 |
|
|
|
106 |
|
Loss on sale of business |
|
|
— |
|
|
|
6,508 |
|
Allocation of issuance costs associated with warrants |
|
|
— |
|
|
|
1,233 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,169 |
|
|
|
(4,851 |
) |
Inventories |
|
|
— |
|
|
|
274 |
|
Other current assets |
|
|
516 |
|
|
|
252 |
|
Other assets |
|
|
54 |
|
|
|
298 |
|
Accounts payable and accrued expenses |
|
|
(1,586 |
) |
|
|
(297 |
) |
Deferred revenues |
|
|
— |
|
|
|
29 |
|
Other long-term liabilities |
|
|
— |
|
|
|
54 |
|
Net cash used in operating activities |
|
|
(5,210 |
) |
|
|
(6,942 |
) |
Cash flows provided by (used in) investing
activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(37 |
) |
|
|
(8 |
) |
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 |
|
|
(437 |
) |
|
|
5,629 |
|
Cash flows used in financing activities: |
|
|
|
|
|
|
|
|
Principal payments of long-term obligations |
|
|
(5,307 |
) |
|
|
(3,490 |
) |
Payment
of financing lease liability |
|
|
(93 |
) |
|
|
(75 |
) |
Proceeds
from exercise of warrants |
|
|
1,081 |
|
|
|
491 |
|
Proceeds
from sale of common stock, net |
|
|
— |
|
|
|
15,964 |
|
Net cash provided by (used in) financing activities |
|
|
(4,319 |
) |
|
|
12,890 |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
|
— |
|
|
|
(4 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
(9,966 |
) |
|
|
11,573 |
|
Cash,
cash equivalents, and restricted cash at beginning of period |
|
|
17,592 |
|
|
|
5,301 |
|
Cash,
cash equivalents, and restricted cash at end of period |
|
|
7,626 |
|
|
|
16,874 |
|
Supplemental disclosure of cash flows
information: |
|
|
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
470 |
|
|
$ |
1,071 |
|
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 |
|
|
$ |
— |
|
Offering cost paid in warrants |
|
$ |
— |
|
|
$ |
213 |
|
Unpaid offering costs |
|
$ |
12 |
|
|
$ |
403 |
|
|
|
|
|
|
|
|
|
|
Contact: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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Plus Therapeutics (NASDAQ:PSTV)
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From May 2023 to May 2024