HOUSTON, Aug. 12, 2020 /PRNewswire/ -- Moleculin Biotech,
Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage
pharmaceutical company with a broad portfolio of drug candidates
targeting highly resistant tumors and viruses, announced its
financial results for the quarter ended June
30, 2020 and provided a business update.
Management Discussion
Walter Klemp, Chairman and CEO of
Moleculin, stated, "Despite the difficult backdrop resulting from
the global pandemic, we made tremendous progress across all three
of our core technologies, particularly in our infectious disease
platform of antimetabolites, bolstered our financial position, and
added to our experienced leadership team. Importantly, we were
pleased to progress our efforts to combat COVID-19, as WP1122,
which is often referred to as a "prodrug" of 2-DG and one of our
antimetabolites, demonstrated its potential in a number of
pre-clinical studies and independent research publications.
Independent research found 2-deoxy-D-glucose ("2-DG") reduced
replication of SARS-CoV-2, the virus that causes COVID-19, by 100%
in in vitro testing. A second independent publication at the
University of Campinas in São Paulo further demonstrated the
potential of WP1122's mechanism of action as it showed SARS-CoV-2
infection is supported by elevated glucose levels and that
inhibition of glycolysis with 2-DG effectively eliminated viral
load in vitro. Additionally, two rounds of preclinical testing at
one independent lab confirmed by a round of in-vitro testing at a
second independent lab in a separate virus host cell line continued
to demonstrate WP1122's antiviral activity in SARS-CoV-2. We are
very encouraged by this early demonstration of efficacy and are now
even more motivated to continue to drive its development. Based on
guidance from the FDA, we are pursuing additional studies in animal
models, which we believe is the critical path to our expected
timing, to further assess WP1122's antiviral capability, with the
goal of a possible IND filing in 2020, in preparation for beginning
a human clinical trial thereafter."
Mr. Klemp continued, "Although we have expanded the scope and
focus of our WP1122 program, our lead candidate, Annamycin, a 'next
generation anthracycline' demonstrating little to no
cardiotoxicity, still remains one of our key priories. The results
from the Phase 1 portion of our US Phase 1/2 clinical trial in
acute myeloid leukemia (AML) have been highly encouraging, as
Annamycin met its primary endpoint and demonstrated a clean safety
profile with no evidence of cardio-toxicity when delivered to
patients at or below the lifetime maximum anthracycline dose
established by the FDA. Following these strong results and an
independent review of Annamycin, in which the independent expert
concluded that he 'does not see evidence of cardio-toxicity', we
received authorization from the Polish Department of Registration
of Medicinal Products to increase the Phase 1 dose escalation
portion of our clinical trial for the treatment of AML. We believe
this to be a substantial development in the acceleration of our
trial as it allows for the increase in dose escalation increments
between cohorts from 30 mg/m2 to 60 mg/m2.
This will enable our next cohort to increase to 300
mg/m2, assuming all requirements for safety are met with
the 240 mg/m2 cohort, for which we are currently
recruiting. With these dosing expectations, the Company believes
that European dosing will increase in 2020, providing for a
recommended Phase 2 Dose to be established in 2021. In
addition to driving the development of Annamycin, during the second
quarter we saw the advancement of WP1066, the lead molecule in
Moleculin's portfolio of immune stimulators and modulators of
transcription. Importantly, Emory
University began recruiting and treating patients in its
Phase 1 clinical trial of WP1066 for the treatment of brain tumors
in children. We are pleased by the progress of the trial, which has
now enrolled and treated three patients. The Emory study, which is being at conducted at
the Aflac Cancer & Blood Disorders Center at Children's
Healthcare of Atlanta, represents
a new approach for treating pediatric brain cancer and benefits
from safety data generated in the ongoing clinical trial of WP1066
in adult brain tumors being conducted by MD Anderson Cancer
Center."
Mr. Klemp concluded, "With our focus on the continued
progression of our candidates and our expansion into infectious
disease, we found it prudent to bolster our expertise. As a result,
we made several strategic additions to our team at Moleculin. In
March, we added Dr. Hongbo Zhai, who
has two decades of research and development experience in
pharmaceuticals and biotechnology, to our Science Advisory Board.
To complement our expanded focus on COVID-19, we then added to our
Science Advisory Board Dr. Dominique
Schols, a leading virologist at the Rega Institute in
Leuven, Belgium, and Dr.
Richard Whitley, head of the NIAID
Antiviral Drug Discovery and Development Center. With the
additions to our team and the progress we made in all three of our
programs, we believe we are well positioned to continue to build on
the momentum we have achieved thus far in 2020."
Recent Milestones and Accomplishments:
Next Generation Anthracycline - Annamycin
- Announced preclinical data corroborating the efficacy of
Annamycin in lung metastases at AACR
- In process with the Polish regulatory authorities' approval to
open two additional clinical sites for the Phase 1/2 clinical
study
- Approved to accelerate European clinical trial in AML, URPL
doubled dose escalation
- Received additional positive safety data in EU AML trial, none
of the 19 patients evaluated thus far have shown signs of
cardiotoxicity
- Received positive independent report confirming absence of
cardiotoxicity (unlike currently approved anthracyclines)
- Announced positive results and successful completion of the
Phase 1 portion of the AML Phase 1/2 trial in the US
- Found to be active against tumor metastases to the lung in
pre-clinical testing
- Confirmed anti-tumor efficacy of Annamycin in AML through new
animal data
- Expanded drug production to support positive clinical
activity
- Received FDA Fast Track designation
Immune/Transcription Modulators - WP1066 Portfolio
- Reported findings that WP1066 used in combination with
traditional whole brain radiation therapy (WBRT) resulted in
long-term survivors and enhanced median survival time relative to
monotherapy in mice with implanted human brain tumors
- Emory University has treated three
patients in a Phase 1 clinical trial of WP1066 for the treatment of
brain tumors in children after receiving FDA Approval of IND and
Emory University Clinical Trial Review
Committee approval for STAT3 inhibitor in Investigator Initiated
Clinical Trial
- Patent protection filed by MD Anderson covering combination of
immune stimulating/transcriptional modulator, including combination
with radiation therapy
- Presented preclinical pancreatic cancer data at American
Association for Cancer Research Annual Meeting
- Received Orphan Drug Designation from FDA
Infectious Disease and Metabolism/Glycosylation Inhibitors -
WP1122 Portfolio
- Independent research team at the University of Campinas in São
Paulo, Brazil demonstrated that
SARS-CoV-2 infection is supported by elevated glucose levels and
that inhibition of glycolysis with 2-DG effectively eliminated
viral load in vitro
- Corroborated antiviral activity of WP1122 against coronavirus
in pre-clinical testing at IIT Research Institute in another virus
host cell line
- Agreement with Sterling Pharma USA LLC for U.S. production of WP1122 to
support expanded development efforts
- Two rounds of preclinical assessment of the potential for
WP1122 to address COVID-19 at ImQuest BioSciences demonstrated that
WP1122 has an antiviral effect on HCoV-229E. The virus yield
reduction assay demonstrated a 5 to 10-fold inhibition of
coronavirus production by WP1122 when compared to untreated virus
control.
- University of Frankfurt found
2-DG to reduce replication of SARS-CoV-2, the virus that causes
COVID-19, by 100% in in vitro testing
- Patent filed by MD Anderson covering WP1122 as anti-viral drug
candidate
- Final data from Phase 1 proof-of-concept clinical trial for the
treatment of cutaneous T-cell lymphoma
- Began preclinical testing of new approach to Pancreatic cancer,
opportunity to attack cancer by inhibiting tumor metabolism
Corporate Strategy
- Appointed Dr. Whitley, who leads the Drug Discovery and
Development Center for the National Institute of Allergy and
Infectious Diseases, to Science Advisory Board
- Added Dr. Dominique Schols, a
leading virologist from the Rega Institute to the Moleculin
development team as a consultant and a member of our Science
Advisory Board
- Appointed Dr. Hongbo Zhai,
former Senior Faculty and Supervisor of Postdoctoral Fellow at
University of California San Francisco,
to Science Advisory Board
Anticipated 2020 Milestones
- Achieving an MTD or a dose level at or above 300
mg/m2 in EU AML Phase 1/2 trial for Annamycin
- Expanding our infectious disease portfolio via testing of
WP1122 against CoV-2 in animal models and in vitro testing on CoV-2
and other hard to treat viruses with other antimetabolites -
resulting in a cancer or virus related IND or its equivalent
possibly being filed in 2020
- IND submission for Annamycin for the treatment of tumor
metastases to the lung
- Moving WP1220 for the treatment of CTCL forward via a new Phase
2 clinical trial by filing an IND or its equivalent or attempt to
join efforts with a strategic partner
- Continued clinical testing in adult and pediatric brain tumors
with WP1066 via physician sponsored trials
Financial Results for the Quarter Ended June 30, 2020
Research and development (R&D) expense was $3.3 million and $2.1
million for the three months ended June 30, 2020 and 2019, respectively. The
increase of $1.2 million is mainly
related to increased clinical trial activity, increased license
fees and costs related to sponsored research agreements, costs
related to manufacturing of additional drug product and two
additional employees in R&D headcount.
General and administrative expense was $1.7 million and $1.5
million for the three months ended June 30, 2020 and 2019, respectively. The
increase of $0.2 million was mainly
attributable to increased stock-based compensation expense for
annual employee stock options and increased costs for directors and
officer's liability insurance.
Loss from operations for the second quarter was $5.0 million compared to a net loss of
$3.6 million for the second quarter
of 2019. This increase was largely due to the above-mentioned
increase in R&D.
Net loss for the second quarter of 2020 was $10.1 million, compared to a net loss of
$1.2 million in the second quarter of
2019, and was attributed to the above-mentioned increase in R&D
and the change in fair value on revaluation of warrant liability
associated with warrants issued in conjunction with stock
offerings. Changes in our stock price can result in a material gain
or loss during the quarter related to the revaluation of our
warrant liability. The loss from the change in the fair value of
the warrant liability for the second quarter of 2020 was
$5.1 million compared to a gain of
$2.4 million in the same quarter in
2019. This is a non-cash item.
Liquidity and Capital Resources
As of June 30, 2020, we had cash
and cash equivalents of $16.7 million
and prepaid expenses and other of $3.0
million. We also had $1.9
million of accounts payable and $1.8
million of accrued expenses. A significant portion of the
accounts payable and accrued expenses are due to work performed in
relation to our clinical trials. For the six months ended
June 30, 2020 and 2019, we used
approximately $9.3 million and
$9.2 million of cash in operating
activities, respectively, which represents cash outlays for
research and development and general and administrative expenses in
such periods. For the six months ended June
30, 2020 and 2019, net proceeds from financing activities
were $15.3 million and $20.8 million, respectively, predominately from
the sale of our common stock and the exercise of warrants. Cash
used in investing activities for the six months ended June 30, 2020 and 2019 was approximately
$0.02 million and $0.03 million, respectively.
We believe that our existing cash and cash equivalents as of
June 30, 2020 plus the $1.9 million cash raised subsequent to the
quarter will be sufficient to fund our planned operations into the
first quarter of 2021, without the issuance of additional equity
for cash. Any such issuances should extend the funding of our
planned operations beyond the first quarter of 2021. Such plans are
subject to our stock price, market conditions, changes in planned
expenses depending on clinical enrollment progress, the use of drug
product or a combination thereof.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of oncology
drug candidates for the treatment of highly resistant tumors and
viruses. The Company's clinical stage drugs are: Annamycin, a Next
Generation Anthracycline, designed to avoid multidrug resistance
mechanisms with little to no cardiotoxicity being studied for the
treatment of relapsed or refractory acute myeloid leukemia, more
commonly referred to as AML, WP1066, an Immune/Transcription
Modulator capable of inhibiting p-STAT3 and other oncogenic
transcription factors while also stimulating a natural immune
response, targeting brain tumors, pancreatic cancer and hematologic
malignancies, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in preclinical development of additional drug candidates, including
other Immune/Transcription Modulators, as well as WP1122 and
related compounds capable of Metabolism/Glycosylation
Inhibition.
For more information about the Company, please visit
http://www.moleculin.com.
Forward-Looking Statements
Some of the statements in
this release are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995, which involve risks and
uncertainties. Forward-looking statements in this press release
include, without limitation, the ability to make an IND submission
for WP1122 in 2020; achieving an MTD in the EU AML Phase 1/2 trial
for Annamycin in 2021; the ability to make an IND submission for
Annamycin for the treatment of tumor metastases to the lung in
2020; moving WP1220 for the treatment of CTCL forward via a new
Phase 2 clinical trial by filing an IND or its equivalent or
attempt to join efforts with a strategic partner during 2020; and
the ability of WP1066 to be shown safe and effective for pediatric
brain tumor patients. Although Moleculin believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. Moleculin Biotech has attempted to
identify forward-looking statements by terminology including
''believes,'' ''estimates,'' ''anticipates,'' ''expects,''
''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,''
''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. These statements are
only predictions and involve known and unknown risks,
uncertainties, and other factors, including those discussed under
Item 1A. "Risk Factors" in our most recently filed Form 10-K filed
with the Securities and Exchange Commission ("SEC") and updated
from time to time in our Form 10-Q filings and in our other public
filings with the SEC. Any forward-looking statements
contained in this release speak only as of its date. We undertake
no obligation to update any forward-looking statements contained in
this release to reflect events or circumstances occurring after its
date or to reflect the occurrence of unanticipated events.
Contacts
James Salierno
/ Carol Ruth
The Ruth Group
973-255-8361 / 917-859-0214
jsalierno@theruthgroup.com
cruth@theruthgroup.com
-- Financial Tables Follow--
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|
|
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Moleculin Biotech,
Inc.
|
Unaudited
Condensed Consolidated Balance Sheets
|
(in
thousands)
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
|
16,734
|
|
|
$
|
10,735
|
|
Prepaid expenses and
other current assets
|
|
|
|
|
|
3,015
|
|
|
2,749
|
|
Total current
assets
|
|
|
|
|
|
19,749
|
|
|
13,484
|
|
Furniture and
equipment, net
|
|
|
|
|
|
238
|
|
|
316
|
|
Intangible
assets
|
|
|
|
|
|
11,148
|
|
|
11,148
|
|
Operating lease
right-of-use asset
|
|
|
|
|
|
245
|
|
|
287
|
|
Total assets
|
|
|
|
|
|
$
|
31,380
|
|
|
$
|
25,235
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
|
|
|
|
$
|
3,739
|
|
|
$
|
3,570
|
|
Total current
liabilities
|
|
|
|
|
|
3,739
|
|
|
3,570
|
|
Operating lease
liability - long-term, net of current portion
|
|
|
|
|
|
220
|
|
|
276
|
|
Warrant liability -
long term
|
|
|
|
|
|
11,792
|
|
|
5,818
|
|
Total liabilities
|
|
|
|
|
|
15,751
|
|
|
9,664
|
|
Total stockholders'
equity
|
|
|
|
|
|
15,629
|
|
|
15,571
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
$
|
31,380
|
|
|
$
|
25,235
|
|
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June, 30
|
(in thousands,
except share and per share amounts)
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,329
|
|
|
2,099
|
|
|
6,535
|
|
|
5,031
|
|
General and
administrative and depreciation
|
|
1,705
|
|
|
1,533
|
|
|
3,561
|
|
|
3,172
|
|
Total operating
expenses
|
|
5,034
|
|
|
3,632
|
|
|
10,096
|
|
|
8,203
|
|
Loss from
operations
|
|
(5,034)
|
|
|
(3,632)
|
|
|
(10,096)
|
|
|
(8,203)
|
|
Other income
(loss):
|
|
|
|
|
|
|
|
|
Gain (loss) from
change in fair value of warrant liability
|
|
(5,099)
|
|
|
2,407
|
|
|
(1,254)
|
|
|
2,936
|
|
Other income,
net
|
|
17
|
|
|
—
|
|
|
22
|
|
|
—
|
|
Interest income,
net
|
|
4
|
|
|
4
|
|
|
7
|
|
|
5
|
|
Net Loss
|
|
$
|
(10,112)
|
|
|
$
|
(1,221)
|
|
|
$
|
(11,321)
|
|
|
$
|
(5,262)
|
|
Net loss per common
share - basic and diluted
|
|
$
|
(0.17)
|
|
|
$
|
(0.03)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.15)
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
59,483,267
|
|
|
42,393,031
|
|
|
54,707,132
|
|
|
35,765,790
|
|
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SOURCE Moleculin Biotech, Inc.