HOUSTON, Nov. 13, 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,
today announced its financial results for the quarter ended
September 30, 2020 and provided a
business update.
Management Discussion
"We are extremely encouraged by the progress we made in the
third quarter. Despite the sustained headwinds from the COVID-19
pandemic, we were able to drive the development of Annamycin both
in our AML and lung indications, further progress our clinical
trials for WP1066, expand and accelerate our infectious disease
platform, and bolster our experienced leadership team," commented
Walter Klemp, Chairman and CEO of
Moleculin.
"We were particularly encouraged by the progress we made
advancing our lead candidate Annamycin, a 'next generation
anthracycline' demonstrating little to no cardiotoxicity. In June,
we conducted our End of Phase 1 meeting with the US Food and Drug
Administration ("FDA"). As a result of this meeting, we will expand
our protocol-mandated testing for cardiotoxicity throughout the
remainder of the Phase 1 trial. This will provide additional safety
data, including investigating the continued evidence of little to
no cardiotoxicity, and efficacy data which both US and European
regulators may consider as we prepare to transition to a Phase 2
clinical trial. We also received approval from Polish authorities
to increase the dose-escalation from 30 mg/m2 per cohort to 60
mg/m2 per cohort which will accelerate finding the maximum
tolerated dose."
"We were also excited by the promise Annamycin shows in
targeting lung localized tumors. Currently there is an extreme
unmet need for a more effective treatment of sarcomas that have
metastasized to the lungs, and limited treatment options available
for lung metastases resulting from a primary tumor, even though the
primary tumor may have been treatable. In September, we were
pleased to announce results from an independent laboratory
demonstrating in animal studies the ability of Annamycin to
generate a 30-fold greater concentration in lungs compared to the
current standard of care drug, enabling the targeting of this
cancer in its sanctuary site. These results further validate data
we presented at the American Association of Cancer Research, which
illustrated Annamycin's uniquely high uptake and retention in the
lungs, resulting in consistently high in vivo activity against a
wide range of lung-localized tumors in mice. Due to Annamycin's
strong pre-clinical data in this indication, we successfully
completed a pre-IND (Investigational New Drug) meeting with the FDA
and discussed our development plan for Annamycin, including the
clinical study design and dosing strategy for an initial Phase
1b/2 protocol for soft tissue
sarcomas with lung metastases. Based on our conversations, and the
compelling pre-clinical data, we are optimistic that we will be
able to file an IND with the FDA for this indication before the end
of the year."
"In addition to driving the development of Annamycin, we
continued to advance WP1066, the lead molecule in Moleculin's
portfolio of immune stimulators and modulators of transcription.
Importantly, we were able to report positive data from both our
adult and pediatric Phase 1 clinical trials. In our adult Phase 1
clinical trial being conducted at a major cancer center in
Houston, we reported positive
preliminary data in adult patients with glioblastoma ("GBM"), which
supports the progression of the trial to the fourth and final dose
escalation cohort. In our Phase 1 clinical trial of WP1066 for the
treatment of brain tumors in children being at conducted at the
Aflac Cancer & Blood Disorders Center at Children's Healthcare
of Atlanta, the first three
patients in the trial received treatment at a dose level of 4 mg/kg
with no adverse events related to WP1066 and the study is now
proceeding to the next higher dose of 6 mg/kg. Importantly, one
patient with diffuse intrinsic pontine glioma ("DIPG"), showed an
apparent response to the treatment with both clinical improvement
and radiologic reduction of tumor size. We believe this to be
particularly notable given the clinical trial history of DIPG, as
approximately 200 clinical trials have been conducted with no drug
showing significant activity in this disease."
"Although we remain laser focused on advancing our clinical
pipeline, we are very encouraged by the potential our infectious
disease pipeline continues to offer. Our initial preclinical focus
for the WP1122 program was to help provide a treatment for the
growing COVID-19 pandemic. Following strong preclinical data and
independent research demonstrating WP1122's unique mechanism of
action and in-vitro activity, we were pleased to further progress
our studies as we prepare for submission of an IND to test WP1122
in COVID-19 patients. During the quarter, we also discovered that
two other molecules within our portfolio of antimetabolites
displayed significant in vitro antiviral activity against
SARS-CoV-2 and other hard to treat viruses. Independent laboratory
testing of our new drug candidates, called WP1096 and WP1097, not
only showed significant antiviral activity against SARS-CoV-2, but
also showed greater potential against HIV, Zika, and Dengue Fever.
While we are encouraged by the strong preclinical data, we believe
our best course of action for advancing this portfolio given its
early stage will be through relying on collaborations and
externally funded pathways. Subsequently, we entered into an
agreement with the University of Campinas in São Paulo,
Brazil to further enable
collaboration into research on the anti-viral capabilities of
WP1122, specifically for the coronavirus. We continue to be
optimistic about the data demonstrated in the WP1122 portfolio and
are planning to file an IND application or its equivalent for
either cancer-related or virus-related clinical trials in the first
half of 2021."
Mr. Klemp concluded, "As we head into the final months of 2020,
we believe we remain well-positioned to progress our three core
technologies. To help drive this effort, we recently appointed
Liz Cermak to our Board of
Directors. Liz brings nearly four decades of healthcare experience,
has helped oversee drugs through commercialization, and has
licensed drugs to well respected big pharmaceutical companies. With
our experienced leadership team, and the progress we made
throughout the third quarter, we look forward to building on our
momentum, and executing on our strategic plan as we head into
2021."
Recent Milestones and Accomplishments:
Next Generation Anthracycline - Annamycin
- Announced results from an independent laboratory demonstrating
the ability of Annamycin to target lung localized tumors,
validating previous internal animal studies
- Successfully completed a pre-IND (Investigational New Drug)
meeting with the FDA regarding the development plan for Annamycin,
including the clinical study design and dosing strategy for the
initial phase 1b/2 protocol for soft
tissue sarcomas with lung metastases
- Announced positive preclinical data corroborating the efficacy
of Annamycin in lung metastases at AACR
- Received approval to accelerate European clinical trial in AML,
URPL doubled dose escalation. Currently in process with Polish
regulatory authorities to open two additional clinical sites for
the Phase 1/2 clinical study
- Announced positive independent report confirming absence of
cardiotoxicity in Annamycin (unlike currently approved
anthracyclines)
- Successfully completed Phase 1 portion of the AML Phase 1/2
trial in the US with positive results
Immune/Transcription Modulators - WP1066 Portfolio
- Announced preliminary data from the Phase 1 clinical trial of
WP1066, in patients with glioblastoma (GBM). Data supports the
progression of trial to the fourth and final dose escalation
cohort
- Reported positive interim results in Emory
University pediatric brain tumor Phase 1 clinical trial. One
patient with diffuse intrinsic pontine glioma (DIPG) showed an
apparent response to the treatment with both clinical improvement
and radiologic reduction of tumor size
- Reported preclinical data demonstrating 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
- Patent protection filed by our licensor covering combination of
immune stimulating/transcriptional modulator, including combination
with radiation therapy
- Received Orphan Drug Designation from FDA
Infectious Disease and Metabolism/Glycosylation Inhibitors-
WP1122, WP1096 and WP1097 Portfolio
- Entered into an agreement with the University of Campinas in
São Paulo, Brazil to further
research the anti-viral capabilities of WP1122, specifically for
the coronavirus
- Announced in vitro results demonstrating the significant
antiviral activity of WP1096 and WP1097, in a range of infectious
diseases including against: SARS-CoV-2, HIV, Zika and Dengue
Fever
- Independent research conducted 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 our licensor covering WP1122 as anti-viral drug
candidate
Corporate Strategy and Events
- Appointed Elizabeth (Liz)
Cermak, an accomplished life sciences board director with
deep pharmaceutical business development expertise, to Board of
Directors
- Participated in a panel at ROTH Capital's, "COVID-19
Therapeutics in Development," healthcare event
- Presented virtually at the H.C. Wainwright & Co. 22nd
Annual Global Investment Conference, the Oppenheimer Fall
Healthcare Life Sciences & MedTech Summit and the LD Micro 500
Virtual Investor Conference in September
- Presented at the Life Sciences Investor Forum in June
- In November replaced our prior purchase agreement with Lincoln
Park Capital with a new $22 million
purchase agreement, including an initial investment of $2 million, with enhanced capabilities to draw
upon
Anticipated 2020 Milestones
- IND submission for Annamycin for the treatment of tumor
metastases to the lung
- Expanding infectious disease portfolio via preclinical testing
of WP1122 in preparation for submitting an IND for a COVID-19
clinical trial in the first half of 2021
- Continued clinical testing in adult and pediatric brain tumors
with WP1066 via physician sponsored trials
Financial Results for the Quarter Ended September 30, 2020
Research and development (R&D) expense was $4.4 million and $2.8
million for the three months ended September 30, 2020 and 2019, respectively. The
increase of $1.6 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 for the three months ended
September 30, 2020 and 2019,
respectively.
Loss from operations for the third quarter was $6.2 million compared to a net loss of
$4.5 million for the third quarter of
2019. This increase was largely due to the above-mentioned increase
in R&D.
Net loss for the third quarter of 2020 was $3.4 million, compared to a net loss of
$4.1 million in the third 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 gain from the change in the fair value of
the warrant liability for the third quarter of 2020 was
$2.7 million compared to a gain of
$0.1 million in the same quarter in
2019. This is a non-cash item.
Liquidity and Capital Resources
As of September 30, 2020, we had
cash and cash equivalents of $12.8
million and prepaid expenses and other of $2.5 million. We also had $1.3 million of accounts payable and $2.1 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 nine
months ended September 30, 2020 and
2019, we used approximately $14.6
million and $12.5 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 nine months ended September 30, 2020 and 2019, net proceeds from
financing activities were $17.1
million and $20.9 million,
respectively, predominately from the sale of our common stock and
the exercise of warrants. Cash used in investing activities for the
nine months ended September 30, 2020
and 2019 was approximately $0.4
million and $0.04 million,
respectively.
We believe that our existing cash and cash equivalents as of
September 30, 2020 plus the
$2.6 million cash raised and
committed subsequent to the quarter will be sufficient to fund our
planned operations into the third quarter of 2021, without the
issuance of additional equity for cash. Any such issuances should
extend the funding of our planned operations beyond the third
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 the first half of 2021; establishing a recommended
Phase 2 Dose for Annamycin in 2021; the ability to make an IND
submission for Annamycin for the treatment of tumor metastases to
the lung in 2020; and the ability to file for W1122 an IND
application or its equivalent for either cancer-related or
virus-related clinical trials in the first half of 2021. 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--
Moleculin Biotech,
Inc.
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
(in
thousands)
|
|
September
30, 2020
|
|
|
December
31, 2019
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
12,795
|
|
|
$
|
10,735
|
|
Prepaid expenses and
other current assets
|
|
|
2,455
|
|
|
|
2,749
|
|
Total current
assets
|
|
|
15,250
|
|
|
|
13,484
|
|
Furniture and
equipment, net
|
|
|
522
|
|
|
|
316
|
|
Intangible
assets
|
|
|
11,148
|
|
|
|
11,148
|
|
Operating lease
right-of-use asset
|
|
|
224
|
|
|
|
287
|
|
Total
assets
|
|
$
|
27,144
|
|
|
$
|
25,235
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
$
|
3,438
|
|
|
$
|
3,570
|
|
Total current
liabilities
|
|
|
3,438
|
|
|
|
3,570
|
|
Operating lease
liability - long-term, net of current portion
|
|
|
190
|
|
|
|
276
|
|
Warrant liability -
long term
|
|
|
9,049
|
|
|
|
5,818
|
|
Total
liabilities
|
|
|
12,677
|
|
|
|
9,664
|
|
Total stockholders'
equity
|
|
|
14,467
|
|
|
|
15,571
|
|
Total liabilities and
stockholders' equity
|
|
$
|
27,144
|
|
|
$
|
25,235
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September, 30
|
|
(in thousands,
except share and per share amounts)
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
4,435
|
|
|
|
2,785
|
|
|
|
10,971
|
|
|
|
7,816
|
|
General and
administrative and depreciation
|
|
|
1,716
|
|
|
|
1,723
|
|
|
|
5,276
|
|
|
|
4,895
|
|
Total operating
expenses
|
|
|
6,151
|
|
|
|
4,508
|
|
|
|
16,247
|
|
|
|
12,711
|
|
Loss from
operations
|
|
|
(6,151)
|
|
|
|
(4,508)
|
|
|
|
(16,247)
|
|
|
|
(12,711)
|
|
Other
income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
|
2,743
|
|
|
|
124
|
|
|
|
1,489
|
|
|
|
3,059
|
|
Other income,
net
|
|
|
10
|
|
|
|
5
|
|
|
|
32
|
|
|
|
5
|
|
Interest income,
net
|
|
|
3
|
|
|
|
5
|
|
|
|
10
|
|
|
|
10
|
|
Net loss before
taxes
|
|
$
|
(3,395)
|
|
|
$
|
(4,374)
|
|
|
$
|
(14,716)
|
|
|
$
|
(9,637)
|
|
Income tax
benefit
|
|
|
—
|
|
|
|
229
|
|
|
|
—
|
|
|
|
229
|
|
Net loss
|
|
$
|
(3,395)
|
|
|
$
|
(4,145)
|
|
|
$
|
(14,716)
|
|
|
$
|
(9,408)
|
|
Net loss per common
share - basic and diluted
|
|
$
|
(0.06)
|
|
|
$
|
(0.09)
|
|
|
$
|
(0.26)
|
|
|
$
|
(0.24)
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
|
61,474,857
|
|
|
|
45,464,746
|
|
|
|
56,979,507
|
|
|
|
39,034,303
|
|
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SOURCE Moleculin Biotech, Inc.