HOUSTON, May 12, 2021 /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
March 31, 2021. The Company also
provided an update on its portfolio of oncology drug candidates for
the treatment of highly resistant tumors and viruses.
"Over the course of the first quarter, we continued to make
significant progress on multiple fronts. Importantly, we have
equipped the Company with the resources to advance our portfolio of
drug candidates across a number of oncology indications and
viruses. On the clinical front, we have the potential to see up to
seven clinical trials this year, including investigator sponsored
trials. We believe we are well-positioned to execute our strategy
and expect to continue to build momentum and drive shareholder
value in the near- and long-term," commented Walter Klemp, Chairman and CEO of Moleculin.
Recent Highlights
- Granted Rare Pediatric Disease Designation (RPD) from the U.S.
Food and Drug Administration (FDA) to its p-STAT3 inhibitor,
WP1066, for the treatment of ependymoma, increasing to a total of
four different indications for which a Priority Review Voucher may
be granted;
- Engaged IQVIA Biotech to manage Moleculin's effort to begin
potential clinical trials of WP1122 for the treatment of
COVID-19;
- Received Fast Track Designation from the FDA for its drug,
Annamycin, for the treatment of soft tissue sarcoma (STS) lung
metastases;
- Announced a $1.5 million grant
was awarded to the Maria Sklodowska-Curie National Research
Institute to fund an investigator-initiated Phase 1B/2 clinical trial of Annamycin for the
treatment of STS lung metastases;
- Successfully closed a public offering, including full exercise
of over-allotment option, for gross proceeds of approximately
$78.0 million, before deducting
underwriting discount and offering expenses;
- Announced 100% survival achieved in preclinical study in
animals which demonstrated a potentially significant therapeutic
benefit of Annamycin against metastatic osteosarcoma; and
- Signed an agreement with Catalyst Clinical Research to manage
its U.S. clinical trial to study the ability of Annamycin to treat
STS that has metastasized to the lungs.
Programs Update
Next Generation Anthracycline - Annamycin
Annamycin is the Company's "next generation" anthracycline that
has recently been shown in animal models to accumulate in the lungs
at up to 30-fold the level of doxorubicin (the standard of care
chemotherapy for STS lung metastases). Importantly, Annamycin has
also demonstrated a lack of cardiotoxicity in recently conducted
human clinical trials for the treatment of acute myeloid leukemia
(AML), so we believe that the use of Annamycin may not face the
same usage limitations imposed on doxorubicin. Annamycin is
currently in development for the treatment of AML and STS
lung metastases.
Upcoming Milestones
- 2H 2021: Report topline results from ongoing Phase 1/2 study
for treatment of AML.
- 2H 2021: Commence Phase 1/2 study in Europe for the treatment of AML evaluating
combination therapy of Annamycin + Ara-C.
- 2H 2021: Commence Phase 1b/2
clinical trial of Annamycin for the treatment of STS lung
metastases in the U.S.
- 2021: Based on recently announced reimbursement grant awarded
in Poland, the Company expects a
second Phase 1b/2 clinical trial of
Annamycin in sarcoma lung metastases to be primarily
investigator-funded in Europe.
First-in-class p-STAT3 inhibitors - WP1066 and WP1220
WP1066 is one of several Immune/Transcription Modulators,
designed to stimulate the immune response to tumors by inhibiting
the errant activity of Regulatory T-Cells (TRegs) while also
inhibiting key oncogenic transcription factors, including p-STAT3
(phosphorylated signal transducer and activator of transcription
3), c-Myc (a cellular signal transducer named after a homologous
avian virus called Myelocytomatosis) and HIF-1α (hypoxia inducible
factor 1α). These transcription factors are widely sought targets
that are believed to contribute to an increase in cell survival and
proliferation, and the angiogenesis (coopting vasculature for blood
supply), invasion, metastasis and inflammation associated with
tumors. They may also play a role in the inability of immune
checkpoint inhibitors to affect more resistant tumors. WP1220 is a
close analog to WP1066 that the Company has developed as a
potential topical therapy for skin-related diseases.
WP1220 is currently being evaluated for the treatment of
Cutaneous T-Cell Lymphoma (CTCL) and WP1066 is currently being
evaluated for the treatment of pediatric brain tumors, including
Diffuse Interstitial Pontine Glioma (DIPG). Additionally, WP1066 +
radiation is being evaluated in the treatment of treatment of
Glioblastoma Multiforme (GBM).
Upcoming Milestones
- 2H 2021: Facilitate Phase 1/2 study of WP1066 + radiation for
the treatment of GBM.
- 1H 2022: Facilitate launch of Phase 2 study of WP1066 for the
treatment of pediatric brain tumors, including DIPG.
- Actively seeking collaboration with a strategic partner in the
near term for external funding for the continued development of
WP1220 in a Phase 2 clinical trial as a topical therapy for
CTCL.
Infectious Disease and Metabolism/Glycosylation Inhibitors-
WP1122, WP1096 and WP1097 Portfolio
Moleculin has new compounds designed to target the roles of
glycolysis and glycosylation in both cancer and viral diseases. The
Company's lead Metabolism/Glycosylation Inhibitor, WP1122, is a
prodrug of 2-DG that appears to improve the drug-like properties of
2-DG by increasing its circulation time and improving tissue/organ
distribution. Recent published research has identified that
2-DG has antiviral potential against SARS-CoV-2 in vitro
and, based on publicly available information, a recently completed
Phase 2 clinical trial by an unrelated company in India has reported efficacy in COVID-19
patients, resulting in the Emergency Use Authorization of 2-DG by
the Drugs Controller General of India. Moleculin believes that the improved
drug-like properties of WP1122 may allow it to outperform 2-DG in
COVID-19 patients and may provide the opportunity for it to
become an important drug to potentiate existing therapies,
including checkpoint inhibitors. Although the Company has seen
superior efficacy for WP1122 over 2-DG against SARS-CoV-2 in vitro,
as well as in multiple animal tumor models, WP1122 has yet to be
tested in humans so there can be no assurance that this improved
preclinical performance will translate into improved clinical
outcomes. The Company is also engaged in preclinical development of
additional antimetabolites (WP1096 and WP1097) targeting glycolysis
and glycosylation.
Upcoming Milestones
- 2H 2021: Seek to initiate Phase 1a/1b study of WP1122 for the treatment of
COVID-19.
- 2H 2021: Potential to launch Phase 2 pivotal study of WP1122
for the treatment of COVID-19.
- 2H 2021: File an IND in the U.S. for the treatment of certain
cancers such as GBM and pancreatic cancer, with WP1122.
- Ongoing preclinical development work in anti-viral indications
such as HIV, Zika, and Dengue. IND targeted for 2022.
Summary of Financial Results for First Quarter 2021
Research and development expense was $4.1
million and $3.2 million for
the three months ended March 31, 2021
and 2020, respectively. The increase of $0.9
million is mainly related to increased clinical trial
activity as described above, increased costs related to sponsored
research agreements, and costs related to manufacturing of
additional drug product.
General and administrative expense was $1.9 million and $1.8
million for the three months ended March 31, 2021 and 2020, respectively. The
increase of $0.1 million is mainly
related to an increase in the Company's insurance, which was offset
by a similar decrease in travel expenses.
For the three months ended March 31,
2021 and 2020, the Company reported a net loss of
$4.4 million and $1.2 million, respectively, and had net cash
flows used in operating activities of $ 3.6
million and $4.3 million,
respectively.
The Company ended the quarter with approximately $86.3 million of cash.
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 timing of the announcement
of the results of our clinical trials; our ability to commence new
clinical trials for Annamycin for the treatment of AML and STS lung
metastases; our ability to commence new clinical trials for WP1066
for the treatment of GBM and DIPG; our ability to commence new
clinical trials for WP1122 for the treatment of COVID-19; whether
investigator-funded trials will proceed as expected; our ability to
find collaboration partners for the continued development of WP1220
for CTCL; our ability to file an IND in the U.S. for the treatment
of certain cancers with WP1122; and our ability to file an IND in
anti-viral indications such as HIV, Zika, and Dengue. 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 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
-- Financial Tables Follow--
Moleculin Biotech,
Inc.
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
(in
thousands)
|
|
March 31,
2021
|
|
|
December
31, 2020
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
86,293
|
|
|
$
|
15,173
|
|
Prepaid expenses and
other current assets
|
|
|
1,726
|
|
|
|
2,025
|
|
Total current
assets
|
|
|
88,019
|
|
|
|
17,198
|
|
Furniture and
equipment, net
|
|
|
438
|
|
|
|
483
|
|
Intangible
assets
|
|
|
11,148
|
|
|
|
11,148
|
|
Operating lease
right-of-use asset
|
|
|
179
|
|
|
|
202
|
|
Total
assets
|
|
$
|
99,784
|
|
|
$
|
29,031
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
$
|
4,578
|
|
|
$
|
2,920
|
|
Total current
liabilities
|
|
|
4,578
|
|
|
|
2,920
|
|
Operating lease
liability - long-term, net of current portion
|
|
|
127
|
|
|
|
159
|
|
Warrant liability -
long term
|
|
|
6,563
|
|
|
|
8,192
|
|
Total
liabilities
|
|
|
11,268
|
|
|
|
11,271
|
|
Total stockholders'
equity
|
|
|
88,516
|
|
|
|
17,760
|
|
Total liabilities and
stockholders' equity
|
|
$
|
99,784
|
|
|
$
|
29,031
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
(in thousands,
except share and per share amounts)
|
|
2021
|
|
|
2020
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
4,105
|
|
|
|
3,206
|
|
General and
administrative and depreciation
|
|
|
1,983
|
|
|
|
1,856
|
|
Total operating
expenses
|
|
|
6,088
|
|
|
|
5,062
|
|
Loss from
operations
|
|
|
(6,088)
|
|
|
|
(5,062)
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
|
1,577
|
|
|
|
3,845
|
|
Other income,
net
|
|
|
9
|
|
|
|
5
|
|
Interest income,
net
|
|
|
57
|
|
|
|
3
|
|
Net loss
|
|
$
|
(4,445)
|
|
|
$
|
(1,209)
|
|
Net loss per common
share - basic and diluted
|
|
$
|
(0.20)
|
|
|
$
|
(0.15)
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
|
21,808,565
|
|
|
|
8,321,833
|
|
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SOURCE Moleculin Biotech, Inc.