– Positive advancements, encouraging
preclinical and clinical data, and development activity in all
three core technologies –
– Multiple key clinical and regulatory
milestones expected throughout 2022 –
– Company has sufficient capital to fund
operations into 2024 –
HOUSTON, May 12, 2022
/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 reported its financial results
for the quarter ended March 31, 2022.
The Company also provided an update on its portfolio of oncology
drug candidates for the treatment of highly resistant tumors and
viruses.
"We have continued to make excellent progress across our entire
pipeline since the start of 2022, paving the way for important data
readouts throughout this year," commented Walter Klemp, Chairman and CEO of Moleculin.
"Importantly, our clinical and regulatory strategies have expanded
significantly outside of the U.S. and we recently bolstered the
expertise of our leadership team to drive our EU clinical trials
forward. Our development programs for Annamycin in STS lung mets
and AML, as well as WP1122 for COVID-19 and GBM continue to
advance. With the progress we've made and the milestones ahead,
2022 is poised to be an important year for not only providing more
clarity for each clinical program's path towards registration, but
also an opportunity to unlock value for all stakeholders, and
importantly, addressing unmet needs for people with highly
resistant tumors and viruses."
Recent Highlights
- Received required authorizations for an amendment to commence a
Phase 1a clinical trial of WP1122 in the United Kingdom (UK) for the treatment of
COVID-19.
- Received allowance from the Polish Department of Registration
of Medicinal Products (URPL), as well as the requisite Ethics
Committee approval, to proceed with its Phase 1/2 clinical
trial in Poland of Annamycin
(L-ANN) in combination with Cytarabine (Ara-C) in the treatment of
subjects with acute myeloid leukemia (AML) who are refractory to or
relapsed after induction therapy.
- Engaged Wolfram C. M. Dempke,
MD, PhD, MBA as its European Chief Medical Officer and part-time
contractor for its European clinical trials.
- Received IND clearance to conduct Phase 1 study of WP1066 for
the treatment of recurrent malignant glioma.
- Presented preclinical data at the AACR 2022 Annual Meeting
demonstrating Annamycin exhibited robust antitumor activity in
experimental colorectal cancer liver and lung metastasis
models.
- Launched new corporate branding and website.
Programs Update
Next Generation Anthracycline –
Annamycin
Annamycin is the Company's next-generation anthracycline that
has been shown in animal models to accumulate in the lungs at up to
30-fold the level of doxorubicin, as well as demonstrating the
ability to avoid the multidrug resistance mechanisms that typically
limit the efficacy of doxorubicin and other currently prescribed
anthracyclines. Importantly, Annamycin has also demonstrated a lack
of cardiotoxicity in multiple human clinical trials, including
ongoing trials for the treatment of relapsed or refractory acute
myeloid leukemia (AML) and soft tissue sarcoma (STS) lung
metastases, and the Company believes that the use of Annamycin may
not face the same usage limitations imposed on doxorubicin, one of
the most common currently prescribed anthracyclines. Annamycin is
currently in development for the treatment of AML and STS lung
metastases and the Company believes it may have the potential to
treat a number of additional indications.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of STS lung metastases, in addition to Orphan Drug
Designation for the treatment of relapsed or refractory acute
myeloid leukemia.
For more information about the Phase 1b/2 study evaluating Annamycin for the treatment
of STS lung metastases, please visit clinicaltrials.gov and
reference identifier NCT04887298.
Upcoming Milestones
Expectations
- Q2 2022: Commence Phase 1/2 study in Europe for the treatment of AML evaluating
combination therapy of Annamycin + Ara-C.
- Q2 2022: Commencement of an investigator-funded, second Phase
1b/2 clinical trial of Annamycin in
sarcoma lung metastases in Europe.
- Q2 2022: Report topline data from Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of
sarcoma lung metastases in the US.
Metabolism/Glycosylation
Inhibitor – WP1122
WP1122, the Company's lead metabolism/glycosylation inhibitor,
is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose
(2-DG), currently being developed by an unrelated third party in
India for inhibition of viral
replication and disease manifestations in humans infected with
SARS-CoV-2, the virus responsible for COVID-19. The Company is also
evaluating WP1122 for the treatment of Glioblastoma Multiforme
(GBM). The mechanism of action of 2-DG includes both the inhibition
of glycolysis and the disruption of glycosylation, two processes
that are important to both viral activity and tumor development.
WP1122 was developed as a 2-DG prodrug to provide a more favorable
pharmacological profile, and was found to have greater potency than
2-DG alone in preclinical models where tumor cells require higher
glycolytic activity than normal cells. WP1122 has also been shown
to have a more potent antiviral effect than 2-DG against SARS-CoV-2
in MRC-5 cells (one of the most common human-derived cell lines
used for antiviral research) in culture.
COVID-19
The Company has received authorization from the Medicines and
Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a
clinical trial of WP1122 in the United
Kingdom (UK). The Company also received a favorable opinion
from the London – Riverside
Research Ethics Committee in the UK to begin the study, which is
expected to be conducted at the Medicines Evaluation Unit in
Manchester, United Kingdom. In
May 2022, the Company received
approval from both the Riverside Ethics Committee and the MHRA for
its amended study protocol to update the dilution of the oral
solution to achieve full dissolution of WP1122. No risk/benefit to
the study was affected because of this change. The Phase 1a study
in healthy human volunteers will investigate the effects of a
single ascending dose (SAD) and multiple days of ascending dosing
(MAD) of WP1122 administered as an oral solution. Dose escalation
will take place in sequential SAD cohorts, and MAD will start as
soon as SAD has completed at least 3 dosing cohorts in which WP1122
is found to be safe and well-tolerated. This study in healthy
volunteers will explore safety and pharmacokinetics (PK), and
subsequent clinical development will be in patients infected with
SARS-CoV-2 to further evaluate safety and establish a favorable
risk/benefit profile. The Company expects to enroll approximately
80 healthy volunteers in the United
Kingdom.
Glioblastoma Multiforme
Additionally, Moleculin recently received IND clearance from the
U.S. Food and Drug Administration (FDA) to initiate a Phase 1 open
label, single arm, dose escalation study of the safety,
pharmacokinetics and efficacy of oral WP1122 in adult patients with
GBM, which the Company expects to commence in 2022.
Upcoming Milestones
Expectations
- Q2 2022: Commence recruitment in Phase 1a study of WP1122 for
the treatment of COVID-19 in the UK.
- H2 2022: Potential to launch Phase 2 study of WP1122 for the
treatment of COVID-19 outside of the US.
- 2022: Identify investigators interested in initiating a Phase 1
open label, single arm, dose escalation study of the safety,
pharmacokinetics and efficacy of oral WP1122 in adult patients with
GBM.
- Ongoing preclinical development work in additional anti-viral
indications such as HIV, Zika, and Dengue. Collaborations targeted
for 2022.
Summary of Financial Results for
the First Quarter 2022
Research and development (R&D) expense was $4.6 million and $4.1
million for the three months ended March 31, 2022 and 2021, respectively. The
increase of $0.5 million is mainly
related to increased clinical trial activity as described above, a
license termination fee, and costs related to manufacturing of
additional drug product.
General and administrative expense was $2.4 million and $1.9
million for the three months ended March 31, 2022 and 2021, respectively. The
increase of $0.5 million is mainly related to an
increase in regulatory legal services, consulting and advisory
fees.
For the three months ended March 31,
2022 and 2021, the Company reported a net loss of
$6.9 million and $4.4 million, respectively, and had net cash
flows used in operating activities of $4.8
million and $3.6 million,
respectively.
The Company ended the quarter with $66.1
million of cash. The Company believes that this cash is
sufficient to meet its projected operating requirements, which
include a forecasted increase over its current R&D rate of
expenditures, into 2024.
About Moleculin Biotech,
Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of drug
candidates for the treatment of highly resistant tumors and
viruses. The Company's lead program, Annamycin is a next-generation
anthracycline designed to avoid multidrug resistance mechanisms
with little to no cardiotoxicity. Annamycin is currently in
development for the treatment of relapsed or refractory acute
myeloid leukemia (AML) and soft tissue sarcoma (STS) lung
metastases.
Additionally, the Company is developing 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 and
other cancers, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in the development of a portfolio of antimetabolites, including
WP1122 for the potential treatment of COVID-19 and other viruses,
as well as cancer indications including brain tumors, pancreatic
and other cancers.
For more information about the Company, please visit
www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
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 Company's ability to meet
the milestones described in this release under the sections
"Upcoming Milestones Expectations", the Company's forecasted cash
burn rate, and due to the volatility and unpredictability of
COVID-19 incidence in various countries, the Company's ability to
recruit subjects to conduct such a study. 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
Moleculin Biotech,
Inc.
|
|
|
|
|
Unaudited Condensed
Consolidated Balance Sheets
|
|
|
(in
thousands)
|
|
March 31,
2022
|
|
December 31,
2021
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
66,104
|
|
$
70,903
|
Prepaid expenses and
other current assets
|
|
1,156
|
|
1,594
|
Total current
assets
|
|
67,260
|
|
72,497
|
Furniture and
equipment, net
|
|
312
|
|
338
|
Intangible
assets
|
|
11,148
|
|
11,148
|
Operating lease
right-of-use asset
|
|
81
|
|
107
|
Total assets
|
|
$
78,801
|
|
$
84,090
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
$
4,834
|
|
$
3,622
|
Total current
liabilities
|
|
4,834
|
|
3,622
|
Operating lease
liability - long-term, net of current portion
|
|
50
|
|
63
|
Warrant liability -
long term
|
|
1,252
|
|
1,412
|
Total liabilities
|
|
6,136
|
|
5,097
|
Total stockholders'
equity
|
|
72,665
|
|
78,993
|
Total liabilities and
stockholders' equity
|
|
$
78,801
|
|
$
84,090
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(in thousands,
except share and per share amounts)
|
|
2022
|
|
2021
|
Revenues
|
|
$
-
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
4,620
|
|
4,105
|
General and
administrative and depreciation
|
|
2,454
|
|
1,983
|
Total operating
expenses
|
|
7,074
|
|
6,088
|
Loss from
operations
|
|
(7,074)
|
|
(6,088)
|
Other
income:
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
160
|
|
1,577
|
Other income,
net
|
|
5
|
|
9
|
Interest income,
net
|
|
42
|
|
57
|
Net loss
|
|
(6,867)
|
|
(4,445)
|
|
|
|
|
|
Net loss per common
share - basic and diluted
|
|
$
(0.24)
|
|
$
(0.20)
|
Weighted average common
shares outstanding - basic and diluted
|
|
28,578,338
|
|
21,808,565
|
|
|
|
|
|
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SOURCE Moleculin Biotech, Inc.