Plus Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights
April 22 2021 - 4:05PM
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 first quarter ended March 31, 2021, and
provided an overview of recent business highlights.
The Company’s lead investigational drug is
Rhenium NanoLiposome (RNL™), a radiotherapy in development for
several rare cancer targets, including recurrent glioblastoma
(GBM). RNL™, currently being evaluated in the U.S. multi-center
ReSPECT™ Phase 1 dose-finding clinical trial, is designed to
safely, effectively, and conveniently deliver a very high dose of
radiation directly to brain tumors.
“In the first quarter of 2021, we made
meaningful progress in critical areas including advancing our drug
development and manufacturing activities, refining our clinical
understanding of RNL™ behavior in the glioblastoma patients and in
seeking FDA feedback on potential new clinical indications for
RNL™,” said Marc H. Hedrick M.D., President and Chief Executive
Officer of Plus Therapeutics.
First Quarter 2021 Clinical
Highlights
Company highlights during the first quarter of
2021 included:
- Entering into a master services agreement (MSA) with Piramal
Pharma Solutions for the development, manufacture, and supply of
RNL™ intermediate drug product.
- Completing the 6th dose escalation cohort, with 18 patients
treated in ReSPECT™, with concomitant increases in both RNL™ drug
volume and radiation dose.
- Beginning treatment in an expansion cohort at the 6th dose with
higher drug flow rates and faster drug infusion times.
- Submitting 2 RNL™ pre-IND meeting briefing packages to the U.S.
Food and Drug Administration (FDA) for treatment of leptomeningeal
metastases and pediatric brain cancers, specifically ependymoma,
high-grade glioma, and diffuse intrinsic pontine glioma.
Expected Upcoming Clinical
Milestones and Events for 2021
In upcoming quarters in 2021, 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 in conjunction with FDA
feedback for RNL™ in recurrent glioblastoma.
- Complete a pre-IND meeting with the FDA, execute IND-enabling
studies, if needed, and move into clinical trials for new RNL™
indications.
- Continue development and evaluation of additional external and
internal drug development candidates to expand the drug development
pipeline.
- Continue to explore partnership opportunities for three
clinical-stage investigational drugs: RNL™, DocePLUS™ and generic
DoxoPLUS™.
First Quarter 2021 Financial
Results
- As of March 31, 2021, the Company’s cash balance was $14.4
million, compared to $8.3 million as of December 31, 2020.
- Total operating expenses for the first quarter of 2021 was $2.5
million, compared to total operating expenses of $2.56 million for
the same quarter in 2020.
- Net loss for the first quarter of 2021 was $2.7 million, or
$(0.33) per share, compared to a net loss of $1.1 million, or
$(0.28) per share, for the same quarter in 2020. The net loss was
consistent year on year when excluding the book gains on the
warrants reported in Q1 2020. Remeasurement of warrant liabilities
was no longer required for Series U warrants that were amended in
Q2 and Q3 2020 and reclassified to equity.
First Quarter 2021 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.
Event: |
Plus Therapeutics First Quarter 2021 Results Conference Call |
Date: |
Thursday, April 22, 2021 |
Time: |
5:00 p.m. Eastern Time |
Live Call: |
877-402-3914 (toll free);
631-865-5294 (Intl.); Conference ID: 3084418 |
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 PlusTherapeutics.com and
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 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 directly into the brain
tumor; anticipated benefits of strategic collaborations and license
agreements, intellectual property, FDA approval process and
government regulation; and the Company’s anticipated milestones and
events, including with respect to additional sites, 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; and future development and/or expansion of its
product candidates and therapies in its markets. 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 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) |
|
|
|
|
|
March 31, 2021 |
|
|
December 31,2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,447 |
|
|
$ |
8,346 |
|
Other current assets |
|
|
999 |
|
|
|
829 |
|
Total current assets |
|
|
15,446 |
|
|
|
9,175 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
1,825 |
|
|
|
1,820 |
|
Operating lease right-of-use assets |
|
|
600 |
|
|
|
636 |
|
Goodwill |
|
|
372 |
|
|
|
372 |
|
Intangible assets, net |
|
|
77 |
|
|
|
86 |
|
Other
assets |
|
|
16 |
|
|
|
16 |
|
Total assets |
|
$ |
18,336 |
|
|
$ |
12,105 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,716 |
|
|
$ |
2,081 |
|
Operating lease liability |
|
|
113 |
|
|
|
123 |
|
Term loan obligations, net of discount |
|
|
6,486 |
|
|
|
6,335 |
|
Total current liabilities |
|
|
8,315 |
|
|
|
8,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent operating lease liability |
|
|
503 |
|
|
|
528 |
|
Warrant
liability |
|
|
5 |
|
|
|
7 |
|
Total liabilities |
|
|
8,823 |
|
|
|
9,074 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized;
1,952 and 1,954 shares issued and outstanding at March 31, 2021 and
December 31, 2020, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized;
10,180,525 and 6,749,028 shares issued and outstanding at March 31,
2021 and December 31, 2020, respectively |
|
|
10 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
445,734 |
|
|
|
436,535 |
|
Accumulated deficit |
|
|
(436,231 |
) |
|
|
(433,511 |
) |
Total stockholders’ equity |
|
|
9,513 |
|
|
|
3,031 |
|
Total liabilities and stockholders’ equity |
|
$ |
18,336 |
|
|
$ |
12,105 |
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONSOLIDATED
CONDENSED STATEMENTS OF
OPERATIONS(Unaudited)(in
thousands, except share and per share data) |
|
|
|
For the Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
Development revenues: |
|
|
|
|
|
|
|
|
Government contracts and other |
|
$ |
— |
|
|
$ |
118 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,127 |
|
|
|
941 |
|
General and administrative |
|
|
1,352 |
|
|
|
1,618 |
|
Total operating expenses |
|
|
2,479 |
|
|
|
2,559 |
|
Loss from operations |
|
|
(2,479 |
) |
|
|
(2,441 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
4 |
|
|
|
36 |
|
Interest expense |
|
|
(247 |
) |
|
|
(349 |
) |
Change in fair value of warrants |
|
|
2 |
|
|
|
1,667 |
|
Total other income (expense) |
|
|
(241 |
) |
|
|
1,354 |
|
Net loss |
|
$ |
(2,720 |
) |
|
$ |
(1,087 |
) |
|
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.28 |
) |
Basic
and diluted weighted average shares used in calculating net loss
per share attributable to common stockholders |
|
|
8,267,901 |
|
|
|
3,880,588 |
|
|
|
|
|
|
|
|
|
|
PLUS THERAPEUTICS, INC.CONSOLIDATED
CONDENSED STATEMENTS OF CASH
FLOWS(Unaudited)(in
thousands) |
|
|
|
For the Three Months Ended March 31, |
|
|
2021 |
|
2020 |
Cash flows used in operating activities: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(2,720 |
) |
|
$ |
(1,087 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
88 |
|
|
|
94 |
|
Amortization of deferred financing costs and debt discount |
|
|
151 |
|
|
|
122 |
|
Noncash lease expenses |
|
|
1 |
|
|
|
4 |
|
Change in fair value of warrants |
|
|
(2 |
) |
|
|
(1,667 |
) |
Share-based compensation expense |
|
|
107 |
|
|
|
12 |
|
Increases (decreases) in cash caused by changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
— |
|
|
|
191 |
|
Other current assets |
|
|
(170 |
) |
|
|
405 |
|
Other assets |
|
|
— |
|
|
|
14 |
|
Accounts payable and accrued expenses |
|
|
(461 |
) |
|
|
410 |
|
Net cash used in operating activities |
|
|
(3,006 |
) |
|
|
(1,502 |
) |
Cash flows provided by (used in) investing
activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(84 |
) |
|
|
(11 |
) |
Net cash used in investing activities |
|
|
(84 |
) |
|
|
(11 |
) |
Cash flows used in financing activities: |
|
|
|
|
|
|
|
|
Payment
of financing lease liability |
|
|
(6 |
) |
|
|
(18 |
) |
Proceeds
from exercise of warrants |
|
|
2,017 |
|
|
|
— |
|
Proceeds
from sale of common stock, net |
|
|
7,180 |
|
|
|
— |
|
Net cash provided by (used in) financing activities |
|
|
9,191 |
|
|
|
(18 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
6,101 |
|
|
|
(1,531 |
) |
Cash and
cash equivalents at beginning of period |
|
|
8,346 |
|
|
|
17,592 |
|
Cash and
cash equivalents at end of period |
|
|
14,447 |
|
|
|
16,061 |
|
Supplemental disclosure of cash flows
information: |
|
|
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
96 |
|
|
$ |
227 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
Unpaid offering costs |
|
$ |
102 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
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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