Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today
announced financial and business results for its Second Quarter
Fiscal Year 2020 ended June 30, 2020.
Q2 2020 net loss was $1.8 million, or $0.45 per share, including
payments to NanoTx LLC of $0.78 million. Net cash used in operating
activities for the six months ended June 30, 2020 was approximately
$2.9 million. Plus Therapeutics ended Q2 2020 with approximately
$9.3 million of cash and cash equivalents.
The Plus Therapeutics portfolio has three clinical-stage
injectable drugs being developed on a unique nanotechnology
platform designed to provide patient benefits through improved
formulation and delivery innovation. The Company believes the
platform can enable significant potential enhancements of safety,
efficacy and convenience for oncology patients and their health
providers compared to current standards of care.
The lead investigational drug in the Company’s licensed
radiotherapeutic portfolio is Rhenium NanoLiposomes (RNL™), a
nanoliposome-encapsulated radionuclide for several cancer targets.
Initially being developed for the treatment of recurrent
glioblastoma, RNL is being evaluated in the U.S. NIH/NCI-supported,
multi-center ReSPECT™ Phase 1 dose-finding clinical trial
(NCT01906385). RNL is designed to safely, effectively, and
conveniently deliver a very high dose of radiation directly into
the brain tumor that is up to 25 times greater than that currently
being given to recurrent glioblastoma patients using external beam
radiation therapy.
H2 2020 Business Expansion
Outlook
The first half of Fiscal Year 2020 marked the successful
implementation of the Company’s refined development focus, initial
pipeline expansion and optimized cost structure. In the second half
of Fiscal Year 2020, the Company intends to focus on a number of
additional business objectives and potential milestones:
- Report preliminary RNL™ data from the ReSPECT Phase I dose
finding trial in recurrent glioblastoma
- Finalize RNL Phase 2/pivotal trial plan in recurrent
glioblastoma
- Seek RNL Orphan Drug Designation decisions from regulatory
agencies
- Complete 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
“Following the close of our most recent in-licensing
transaction, we have made steady progress in expediting the ReSPECT
trial,” said Dr. Marc Hedrick, President and Chief Executive
Officer of Plus Therapeutics. “The second half of 2020
includes the prospect of further significant advancement for our
RNL program-- and for the Company. We believe RNL has the potential
of improving brain tumor therapy and that of other difficult to
treat radiosensitive tumors.”
Q2 2020 Financial
Highlights
- Net cash used in operating activities was $2.9 million for the
six months ended June 30, 2020, compared to $4.4 million during the
same period in 2019.
- In Q2 2020, 162,500 series U warrants were exercised, raising
$0.36M.
- Q2 2020 loss from continuing operations was $1.8 million, or $
0.45 per share, compared to $2.3 million, or $5.12 per share for Q2
2019.
- Q2 2020 net loss was $1.8 million, or $0.45 per share, compared
to $9.1 million, or $20.67 per share, for Q2 2019, reflecting a
loss from discontinued operations of $0 for Q2 2020 and $6.9
million in Q2 2019.
Investor Call Today at 5 p.m.
EDT
The Company plans to hold a conference call and live audio
webcast today at 5:00 PM Eastern Time to discuss its financial
results and provide a general business update.
Event: |
Plus Therapeutics Second Quarter Fiscal Year 2020 Financial Results
Conference Call and Webcast |
Date: |
Monday, August 10, 2020 |
Time: |
5:00 PM Eastern Time. |
Live Call: |
Phone Number: (877) 402-3914;
Conference ID: 5925129 |
Live Webcast: |
https://event.on24.com/wcc/r/2402905/A6C80D40192BA72B1FDF935FEAFD7277 |
|
Beginning two hours after the
conclusion of the conference call, a replay will be
available. |
Replay: |
http://ir.plustherapeutics.com/events/default.aspx |
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; 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 June 30,2020 |
|
|
As of December 31,2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,266 |
|
|
$ |
17,552 |
|
Accounts receivable |
|
|
951 |
|
|
|
1,169 |
|
Restricted cash |
|
|
— |
|
|
|
40 |
|
Inventories, net |
|
|
107 |
|
|
|
107 |
|
Other current assets |
|
|
469 |
|
|
|
957 |
|
Total current assets |
|
|
10,793 |
|
|
|
19,825 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
2,014 |
|
|
|
2,179 |
|
Operating lease right-of-use assets |
|
|
707 |
|
|
|
781 |
|
Other
assets |
|
|
18 |
|
|
|
72 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Total assets |
|
$ |
13,904 |
|
|
$ |
23,229 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
3,608 |
|
|
$ |
3,279 |
|
Operating lease liability |
|
|
139 |
|
|
|
147 |
|
Term loan obligations, net of discount |
|
|
6,026 |
|
|
|
11,060 |
|
Total current liabilities |
|
|
9,773 |
|
|
|
14,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent operating lease liability |
|
|
589 |
|
|
|
646 |
|
Warrant
liability |
|
|
242 |
|
|
|
6,929 |
|
Other
noncurrent liabilities |
|
|
— |
|
|
|
8 |
|
Total liabilities |
|
|
10,604 |
|
|
|
22,069 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,959 shares issued and outstanding at June 30, 2020 and December
31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
4,273,857 and 3,880,588 shares issued and outstanding at June 30,
2020 and December 31, 2019, respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
431,492 |
|
|
|
426,426 |
|
Accumulated deficit |
|
|
(428,196 |
) |
|
|
(425,270 |
) |
Total stockholders’ equity |
|
|
3,300 |
|
|
|
1,160 |
|
Total liabilities and stockholders’ equity |
|
$ |
13,904 |
|
|
$ |
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 June 30, |
|
|
For the Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Development revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government contracts and other |
|
$ |
185 |
|
|
$ |
302 |
|
|
$ |
303 |
|
|
$ |
1,039 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
327 |
|
|
|
1,289 |
|
|
|
1,268 |
|
|
|
2,715 |
|
In process research and development acquired from NanoTx |
|
|
781 |
|
|
|
— |
|
|
|
781 |
|
|
|
— |
|
Sales and marketing |
|
|
105 |
|
|
|
97 |
|
|
|
215 |
|
|
|
211 |
|
General and administrative |
|
|
1,324 |
|
|
|
875 |
|
|
|
2,832 |
|
|
|
2,237 |
|
Total operating expenses |
|
|
2,537 |
|
|
|
2,261 |
|
|
|
5,096 |
|
|
|
5,163 |
|
Operating loss |
|
|
(2,352 |
) |
|
|
(1,959 |
) |
|
|
(4,793 |
) |
|
|
(4,124 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
9 |
|
|
|
7 |
|
|
|
45 |
|
|
|
14 |
|
Interest expense |
|
|
(252 |
) |
|
|
(597 |
) |
|
|
(601 |
) |
|
|
(1,111 |
) |
Change in fair value of warrants |
|
|
756 |
|
|
|
282 |
|
|
|
2,423 |
|
|
|
492 |
|
Total other income (expense) |
|
|
513 |
|
|
|
(308 |
) |
|
|
1,867 |
|
|
|
(605 |
) |
Loss from continuing operations |
|
|
(1,839 |
) |
|
|
(2,267 |
) |
|
|
(2,926 |
) |
|
|
(4,729 |
) |
Loss from discontinued operations |
|
|
— |
|
|
|
(6,880 |
) |
|
|
— |
|
|
|
(7,568 |
) |
Net loss |
|
$ |
(1,839 |
) |
|
$ |
(9,147 |
) |
|
$ |
(2,926 |
) |
|
$ |
(12,297 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share attributable to common stockholders
- continuing operations |
|
$ |
(0.45 |
) |
|
$ |
(5.12 |
) |
|
$ |
(0.74 |
) |
|
$ |
(11.89 |
) |
Basic
and diluted net loss per share attributable to common stockholders
- discontinued operations |
|
$ |
— |
|
|
$ |
(15.55 |
) |
|
$ |
— |
|
|
$ |
(19.02 |
) |
Net loss
per share, basis and diluted |
|
$ |
(0.45 |
) |
|
$ |
(20.67 |
) |
|
$ |
(0.74 |
) |
|
$ |
(30.91 |
) |
Basic
and diluted weighted average shares used in calculating net loss
per share attributable to common stockholders |
|
|
4,053,242 |
|
|
|
442,512 |
|
|
|
3,967,392 |
|
|
|
397,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONSOLIDATED
CONDENSED STATEMENTS OF CASH
FLOWS(UNAUDITED)(in
thousands) |
|
|
|
For the Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
Cash flows used in operating activities: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(2,926 |
) |
|
$ |
(12,297 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
188 |
|
|
|
617 |
|
Amortization of deferred financing costs and debt discount |
|
|
275 |
|
|
|
257 |
|
In process research and development acquired from NanoTx
Therapeutics |
|
|
781 |
|
|
|
— |
|
Noncash lease expenses |
|
|
9 |
|
|
|
39 |
|
Change in fair value of warrants |
|
|
(2,423 |
) |
|
|
(492 |
) |
Share-based compensation expense |
|
|
55 |
|
|
|
77 |
|
Loss on sale of business |
|
|
— |
|
|
|
6,508 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
218 |
|
|
|
(28 |
) |
Inventories |
|
|
— |
|
|
|
235 |
|
Other current assets |
|
|
487 |
|
|
|
216 |
|
Other assets |
|
|
54 |
|
|
|
257 |
|
Accounts payable and accrued expenses |
|
|
371 |
|
|
|
108 |
|
Deferred revenues |
|
|
— |
|
|
|
29 |
|
Other long-term liabilities |
|
|
— |
|
|
|
54 |
|
Net cash used in operating activities |
|
|
(2,911 |
) |
|
|
(4,420 |
) |
Cash flows provided by (used in) investing
activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(23 |
) |
|
|
(6 |
) |
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 |
|
|
(423 |
) |
|
|
5,631 |
|
Cash flows used in financing activities: |
|
|
|
|
|
|
|
|
Principal payments of long-term obligations |
|
|
(5,307 |
) |
|
|
(3,490 |
) |
Payment
of financing lease liability |
|
|
(51 |
) |
|
|
(28 |
) |
Proceeds
from exercise of warrants |
|
|
366 |
|
|
|
— |
|
Proceeds
from sale of common stock, net |
|
|
— |
|
|
|
1,984 |
|
Net cash used in financing activities |
|
|
(4,992 |
) |
|
|
(1,534 |
) |
Effect of exchange rate changes on cash and cash
equivalents |
|
|
— |
|
|
|
(4 |
) |
Net decrease in cash and cash equivalents |
|
|
(8,326 |
) |
|
|
(327 |
) |
Cash,
cash equivalents, and restricted cash at beginning of period |
|
|
17,592 |
|
|
|
5,301 |
|
Cash,
cash equivalents, and restricted cash at end of period |
|
$ |
9,266 |
|
|
$ |
4,974 |
|
Supplemental disclosure of cash flows
information: |
|
|
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
372 |
|
|
$ |
826 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
Common stock issued in payment for in process research and
development |
|
$ |
381 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Contact:Plus
Therapeutics, Inc. Andrew Sims VP – Chief Financial
Officer, Investor Relations Phone: +1.619.333.4150
Email: ir@plustherapeutics.com Corporate
Website: plustherapeutics.comClinical Website:
respect-trials.com
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