Moleculin Biotech, Inc., (NASDAQ: MBRX)
("Moleculin" or the "Company"), a clinical-stage pharmaceutical
company focused on the development of oncology drug candidates, all
of which are based on license agreements with The University of
Texas System on behalf of the MD Anderson Cancer Center, today
announced its financial results for the year ended December 31,
2018. Additionally, the Company announced potential upcoming
milestones and recent corporate developments.
Management Discussion
Walter Klemp, Chairman and CEO of Moleculin,
said, “On the strength of a successful 2018, we enter 2019 with a
great deal of momentum. The recent initiation of our WP1220 skin
cancer clinical trial in Poland achieves an important milestone -
Moleculin now has three unique drug candidates in four ongoing
clinical trials. We focus on being capital efficient and believe,
that for a company the size of Moleculin, this is a significant
achievement. All the years of painstaking research and visionary
drive are producing tangible results. This is a testament to the
dedication and focus of the entire Moleculin team to boldly advance
our vision for ‘multiple shots on goal’ in the treatment of certain
rare and highly resistant cancers.
"With our three core technologies and six
oncology drug candidates, we are increasingly better positioned to
develop treatments for highly resistant cancers in the coming
years. We are pleased that the FDA recently granted Orphan Drug
Designation for our drug candidate WP1066 for the treatment of
glioblastoma, one of the most aggressive forms of brain tumors. The
FDA grants Orphan Drug Designation to drugs and biologics that are
intended for the treatment of rare disease. In addition to
glioblastoma, WP1066 could be effective in the treatment of a range
of highly resistant tumors including acute myeloid leukemia (“AML”)
and pancreatic cancer. We have seen strong anti-tumor
activity with WP1066, our flagship Immune/Transduction Modulator
(an inhibitor of the activated form of STAT3, among other important
properties) in a wide range of animal models. We are extremely
excited with the results of our preclinical research, as the data
is showing positive results of combining our drug candidate WP1066
with checkpoint inhibitors, suggesting that WP1066 may have the
ability to improve the outcome of immune checkpoint therapy in
tumors that have been resistant to these therapies. We believe this
represents an important new approach to treating many types of
cancer. These important research developments along with the
regulatory approvals are a complement to our vision of developing
numerous drugs that support our ‘multiple shots on goal’
strategy.”
Recent milestones and accomplishments
include:
Next Generation Anthracycline –
Annamycin
- Received necessary approvals to ship Annamycin into Poland to
start treatment of adults with relapsed and refractory AML.
- Patient recruitment commencing for Annamycin clinical trial in
Poland for treatment of adults with relapsed and refractory
AML.
Immune/Transcription Modulators – WP1066
Portfolio
- FDA granted Orphan Drug Designation for our drug candidate
WP1066 for the treatment of glioblastoma, the most aggressive form
of brain tumor.
- Announcement that WP1066, an Immune/Transduction Modulator, has
shown to counteract resistance to checkpoint blockades;
specifically, inhibit immune checkpoint target PD-L1 in our own
sponsored research.
- Enrollment commencing for a physician-sponsored clinical trial
of WP1066 for the treatment of glioblastoma and brain metastases in
adults, and the first glioblastoma patients have received the
initial doses of WP1066 in the physician-sponsored IND
(investigational new drug) study at MD Anderson Cancer Center.
Positive progress in the Phase 1 clinical trial of WP1066 was
announced with initial results showing bioavailability of the drug
in patients treated. Investigators at MD Anderson have now dosed
the third cohort in a dose-escalation Phase 1 clinical trial for
the treatment of brain tumors.
- Investigators at Emory University presented animal model data
supporting the potential of WP1066 to treat pediatric brain tumors.
The drug exhibits activity in those models against the most common
form of childhood brain tumor, medulloblastoma, for which there is
a desperate need for more effective treatments.
- Received approval from the Polish authorities to commence
clinical trials for WP1220 for the topical treatment of Cutaneous
T-Cell Lymphoma (“CTCL”).
- Announcement that WP1732, a fully water-soluble drug candidate,
has demonstrated enhanced activity in combination with checkpoint
blockade antibodies in pancreatic cancer animal model.
Metabolism/Glycosylation Inhibitors – WP1122
Portfolio
- Announcement of new data relating to WP1122 during IND-enabling
research with animals that confirms a beneficial metabolism of
WP1122 and significant organ accumulation of the inhibitor of
glycolysis in the brain and the pancreas. We believe this is
especially significant because both brain and pancreatic tumors are
highly dependent upon glucose for survival and WP1122 appears to
have the ability to inhibit glycolysis, the primary process by
which these tumors convert glucose into energy.
General
- Announcement of Dr. James Abbruzzese, Chief of Medical Oncology
Division at Duke University, joining Moleculin’s Science Advisory
Board.
“Our two Annamycin clinical trials continue to
gain traction – particularly in Poland. The start of the clinical
trial in Poland was delayed in 2018 due to the uniquely European
approval process to ship the drug into Poland. Clinical supplies
are now in Poland and ready to treat patients. The sites there have
commenced the patient screening and recruitment process, and we
expect to have preliminary results later in 2019. On a macro level,
we are encouraged by animal models showing the significant
accumulation of WP1122 in the brain and the pancreas to potentially
starve brain and pancreatic tumors; and the water solubility of our
Immune/Transduction Modulator, WP1732, greatly enhancing the
potential for IV delivery of this unique class of compounds. We
believe there is a significant opportunity for the synergistic
combination of our drug candidates to develop additional treatments
for the oncologic conditions we are targeting. We are excited with
the opportunities ahead.”
Jonathan Foster, executive vice president and
chief financial officer of Moleculin, stated, “We finished the year
with cash of approximately $7.1 million and access to capital in an
equity line of up to $20 million. The equity line provides us with
the flexibility of accessing additional working capital to help
fund our ongoing research programs. With four drug candidates in
clinical trials, we will continue to carefully focus on being
capital efficient through this important developmental
process.”
Anticipated Milestones
Anticipated Milestones |
Potential Timeframe |
Next Generation Anthracycline – Annamycin |
|
Initial IRB (Institutional Review Board) approvals and site
initiations of various clinical sites participating in our Phase
I/II clinical trial of Annamycin |
Accomplished and ongoing 2019 |
Complete cohort of 150 mg/m2 - prior trial recommended Phase II
dose (RP2D) |
2019 |
Start treating patients in Annamycin Phase I/II clinical trial in
Poland |
Q1-2019 (Screening has begun with drug in country) |
Announcement of initial clinical data for Annamycin trial |
2019 |
Poland clinical trial (MB-105) begins Phase II |
2020 |
Approach FDA on U.S. trial (MB-104) regarding dose expansion using
Poland trial data |
2020 |
Immune/Transcription Modulators – WP1066
Portfolio |
|
Announced FDA grants Orphan Drug Designation to WP1066 for
treatment of glioblastoma |
Accomplished |
Announcement of preliminary clinical data from WP1066 clinician
sponsored trial |
2019 |
Phase I surgical cohort begins in MD Anderson clinical trial of
WP1066 for brain tumors |
Second Half of 2019 |
Transfer MD Anderson-sponsored WP1066 IND to Moleculin |
Second Half of 2019 |
Emory Physician Led Pediatric Medulloblastoma Trial begins |
Second Half of 2019 |
Announcement of further benefits of our sponsored research
agreement with MD Anderson |
Accomplished and Ongoing into 2019 |
Announced approval of Clinical Trial Authorization for WP1220 for
the treatment of cutaneous T-cell lymphoma (CTCL) in Poland |
Accomplished |
Assess preliminary patient data in WP1220 clinical trial |
Q4-2019 |
IND for WP1732 submitted |
2019 |
Dose first patient in Phase I trial for WP1732 |
2020 |
Announce further preclinical research results on WP1066
portfolio |
2019 |
Metabolism/Glycosylation Inhibitors – WP1122
Portfolio |
|
Begin preclinical work on WP1122 |
Accomplished |
File IND for WP1122 |
2020 |
General Clinical |
|
Announce a fourth approved clinical trial |
Accomplished |
Announce a fifth approved clinical trial |
2019 |
Fourth Quarter Highlights and Recent
Corporate Developments
Moleculin Announces Approval for Third
Drug to Commence Clinical Trials - MBRX will now have three
distinctive oncology drugs in clinic in four ongoing clinical
trials - WP1220, a STAT3 inhibitor, to begin clinical trials in
Poland for the treatment of CTCL, a rare and deadly skin
cancer - February 07, 2019, the Company announced it has
received approval to begin clinical trials in Poland for its
Immune/Transduction Modulator, WP1220, for the topical treatment of
CTCL. CTCL is a potentially deadly form of skin cancer involving
skin lesions that often have high levels of activated STAT3
(p-STAT3). As a potent inhibitor of p-STAT3, the Company believes
WP1220 may be ideally suited to treat these lesions through topical
application, which is what this clinical trial is designed to
evaluate. The Company has three unique drug candidates in four
ongoing clinical trials for the potential treatment of rare and
difficult cancers.
Moleculin Announces the FDA has Granted
Orphan Drug Designation for its Brain Tumor Drug -
February 05, 2019, the Company announced that the FDA has granted
Orphan Drug Status for its drug candidate WP1066 for the treatment
of glioblastoma, the most aggressive form of brain tumor. The
Company believes that WP1066 represents a new class of drugs which
it calls ‘Immune/Transduction Modulators’ because it has
demonstrated the ability in preclinical testing in animals to both
stimulate a natural immune response to tumors and directly attack
tumor cells by inhibiting multiple key oncogenic transcription
factors, including STAT3, HIF1-α and c-Myc.
In addition to the glioblastoma trial at MD
Anderson, the Company has received interest from additional
investigators, including Emory University and Mayo Clinic for
conducting clinical trials for the treatment of pediatric brain
tumors, as well as others interested in treating a range of highly
resistant tumors including AML and pancreatic cancer.
Moleculin Announces Dr. James L.
Abbruzzese, Chief of Medical Oncology Division at Duke University,
Joins Science Advisory Board - Dr. Abbruzzese to add significant
pancreatic cancer expertise to advance drug development -
January 17, 2019, the Company announced that Dr. James L.
Abbruzzese, Chief of Oncology at Duke University has joined
Moleculin’s Science Advisory Board. Dr. Abbruzzese is recognized as
one of the world’s leading experts in the clinical study and
treatment of pancreatic cancer and the addition of his expertise
will be invaluable to the Company’s efforts in developing a
potential treatment for pancreatic cancer.
Dr. James L. Abbruzzese is the Chief of the
Division of Medical Oncology at Duke University, and Member of the
Duke Cancer Institute at Durham, North Carolina. Dr. Abbruzzese
earned his medical degree with honors from the University of
Chicago Pritzker School of Medicine and completed his residency in
Internal Medicine at Johns Hopkins Hospital. He also completed
clinical fellowships in Infectious Diseases at the Johns Hopkins
and in Medical Oncology and Medical Oncology Research Laboratory of
Neoplastic Disease Mechanisms at the Dana-Farber Cancer Institute
of Harvard Medical School. Dr. Abbruzzese has spent most of his
professional career at M.D. Anderson, where he rose through the
ranks to his current leadership positions as Chairman of the
Department of Gastrointestinal Medical Oncology and Associate
Vice-Provost for Clinical Research.
Moleculin Announces Patient Recruitment
Begins in Annamycin Clinical Trial In Poland - Received European
approval to ship Annamycin into Poland to start treating
patients - January 09, 2019, the Company announced it has
begun recruiting patients in Poland for the Company’s second
clinical trial to study Annamycin for the treatment of relapsed and
refractory adults with AML. Clinical supplies of Annamycin are now
in Poland and ready to treat patients after clearing the unique
European approval process. The clinical sites in Poland have begun
the patient screening and recruitment process. The Company expects
that the fewer number of AML clinical trials in Poland as compared
with the U.S. will give it an opportunity to complete the Phase 1
arm more quickly.
Moleculin Announces Positive Data for
its Pancreatic Cancer Drug Candidate - WP1732 now second lead drug
demonstrating enhanced activity in combination with immune
checkpoint blockade antibodies - January 03, 2019, the
Company announced that in preliminary animal studies, a second of
its lead drugs, water-soluble, WP1732, has demonstrated enhanced
activity in combination with checkpoint blockade antibodies in
pancreatic cancer. This is significant for several reasons. It
shows that this is a consistent capability across the Company’s
platform of Immune/Transduction Modulators and it further supports
independent research suggesting that STAT3 may be a key to enabling
checkpoint blockade activity in otherwise resistant tumors.
Importantly, though, when coupled with its recent findings that
WP1732 accumulates disproportionately in the pancreas, the Company
believes it points to WP1732 as a potentially pivotal new approach
to treating pancreatic cancer. Expansion of the WP1732 and
WP1066 in vivo studies are in progress.
Moleculin Announces FDA Filing for
Orphan Drug Designation for Glioblastoma Drug - December
06, 2018, the Company announced it has filed a request with the FDA
for Orphan Drug Status for its drug candidate WP1066.
Moleculin Announces Breakthrough
Discovery for its WP1066 - WP1066 shown to counteract resistance to
checkpoint blockades - December 04, 2018, the Company
announced that its own sponsored research has now confirmed a
recently published study demonstrating the ability of its
clinical-stage Immune/Transduction Modulator, WP1066, to inhibit a
key immune checkpoint target known as PD-L1. This data suggests
that our drug WP1066 may be capable of having a major impact on the
field of checkpoint blockades. Recent independent research (Front
Pharmacol. 2018 May 22;9:536. doi: 10.3389/fphar.2018.00536.
eCollection 2018.) has linked STAT3, HIF1-a and c-Myc (all targets
of WP1066) to the mechanism (a ligand known as PD-L1) believed to
be largely responsible for resistance to current checkpoint
blockade therapies. The Company plans to run additional in vitro
and in vivo studies, some of which are already underway, with
WP1066 in combination with well-known checkpoint inhibitors to
gather more data on this response. The Company believes this could
put WP1066 center-stage in the field of immunotherapy.
Moleculin Announces New Data Further
Supporting Its Lead Drug for Treating Pancreatic Cancer - WP1732
shown to accumulate beneficially in pancreas - November
28, 2018, the Company announced that data from an independent test
in animal models confirmed, as previously believed, that its
Immune/Transduction Modulator achieves a disproportionately high
accumulation in the pancreas. The Company’s sponsored research
suggested that WP1732 might be an ideal candidate for treating
pancreatic cancer. Independent testing with radiolabeled drug
confirmed this in animal models. The propensity for such
enhanced pancreatic distribution could be highly beneficial for a
new pancreatic cancer drug. Published research shows that the
growth and survival of pancreatic cancer requires activated STAT3
(p-STAT3) and the Company’s research suggests that WP1732 may be an
effective inhibitor of p-STAT3 that has demonstrated activity in
vivo models. Confirming the disproportionately high
accumulation of WP1732 in the pancreas would put the Company one
step closer to introducing an entirely new approach to treating
pancreatic cancer. The Company is preparing to file an IND
application with the FDA in 2019.
Moleculin Requests FDA Meeting Regarding
IND for New Cancer Drug - Testing confirms ability of WP1732 to
target pancreatic cancer - November 15, 2018, the Company
announced it has filed a request with the FDA for a Pre- IND
Meeting to seek FDA’s guidance and concurrence that the WP1732
development plan will meet requirements for an Initial IND filing
and initiation of a proposed Phase 1 clinical trial. Independent
animal model testing has confirmed high uptake and retention of
WP1732 in the pancreas. Taken together with the previous
observations of consistent activity against pancreatic cancer in
vitro and in vivo tumor models, this could make WP1732 ideally
suited as a new therapy for treating pancreatic cancer.
Moleculin Announces New Independent
Study Expands Potential Use of Its Pancreatic Drug Candidate WP1122
- Documented potential for drug candidate with characteristics like
WP1122 to reverse immune suppression - November 08, 2018,
the Company announced that a new mechanism of action may have been
uncovered expanding the potential use of its inhibitor of
glycolysis, WP1122. A study recently published in the American
Cancer Journal of Cancer Research (Am J Cancer Res
2018;8(9):1837-1846) involving researchers at MD Anderson and the
Peking University Cancer Hospital & Institute has found that
2-deoxy-D-glucose (2-DG) has the potential to decrease resistance
to immune checkpoint blockade therapy in triple-negative breast
cancer (TNBC) in a process known as “glycosylation.” Based on
preclinical data, WP1122, a proprietary prodrug of 2-DG, appears to
address that problem and significantly increases the circulation
time of 2-DG and its ability to reach specific organs harboring
tumors, including the pancreas.
Moleculin Announces Significant
Milestone Achieved in Glioblastoma Trial - WP1066
demonstrating drug bioavailability in on-going Phase 1 clinical
trial - November 01, 2018, the Company announced positive
progress in Phase 1 clinical trial of its Immune/Transduction
Modulator, WP1066, with initial results showing bioavailability of
the drug in patients. Although this data is preliminary, it
represents a significant milestone for the development of WP1066.
In the first two cohorts of the Phase 1 study, the Company saw
measurable levels of the drug in the patient’s plasma resulting
from oral administration. The Company believes WP1066 is a
first-in-class compound capable of stimulating a natural immune
response in animal models while directly attacking tumors by
modulating transcriptional activity and repressing what is called
‘oncogenic transcription factors.’ Chief among these is STAT3,
considered a master regulator of tumor progression.
Moleculin Announces Positive Data on
WP1066 in Pre-Clinical Trials – October 25, 2018, the
Company announced that investigators at Emory University will
present animal model data supporting the potential of WP1066 to
treat pediatric brain tumors at the upcoming Society for
Neuro-Oncology Annual Scientific Meeting held November 15-18, 2018
in New Orleans. The Company believes the data to be presented from
Emory University will add to the enthusiasm for testing WP1066 in
humans. What makes this particularly important is that the drug,
WP1066, showed activity against the most common form of childhood
brain tumor, medulloblastoma, for which there is a desperate need
for more effective treatments. The Company is proud to have two
different Moleculin technologies, WP1066 and WP1122, presented at
this prestigious conference on brain tumors.
Moleculin Announces New Data Discovery Confirming
Significant Increase in Potential to Starve Cancerous
Tumors - Data to be Presented at
Neuro-Oncology Annual Scientific Meeting - October 10,
2018, the Company announced that new data relating to its molecule
WP1122 was presented at the Society for Neuro-Oncology Annual
Scientific Meeting held November 15-18, 2018 in New Orleans. The
discovery of new data of the inhibitor of glycolysis, WP1122,
during IND-enabling research with animals confirms a highly
beneficial metabolism of WP1122 and significant organ accumulation
of the inhibitor of glycolysis in the brain and also in the
pancreas. The Company believes this is especially significant
because both brain and pancreatic tumors are highly dependent upon
glucose for survival and WP1122 appears to have the ability to
inhibit glycolysis, the process by which these tumors convert
glucose into energy.
Financial Results for the Year Ended
December 31, 2018
Research and Development
Expense. Research and development (“R&D”) expense was
$9.7 million and $4.5 million for the years ended December 31, 2018
and 2017, respectively. The increase in R&D of approximately
$5.2 million mainly represents an increase of approximately: $2.9
million related to manufacturing and toxicology; $1.3 million
related to sponsored research and license agreements which includes
the HPI Out-Licensing Agreement; $0.3 million associated with
clinical trials and $0.7 million related to an increase in R&D
headcount and associated payroll costs. The increase in R&D
headcount mainly represents two positions added at the beginning of
2018, a VP/Executive director of Drug Development and a VP/Director
of Clinical Operations. These reflect increased clinical and
pre-clinical activity for our three core technologies - with
emphasis on Annamycin and the WP1066 Portfolio - as compared to
2017.
General and Administrative
Expense. General and administrative (“G&A”) expense
was $5.2 million and $4.1 million for the years ended December 31,
2018 and 2017, respectively. The increase in G&A of
approximately $1.1 million was mainly attributable to $1.0 million
increase in headcount and associated payroll costs including
stock-based compensation expense of $0.3 million; and approximately
$0.1 million in legal, accounting, consulting, and other
professional expenses. This increase in headcount was mainly in
accounting and finance with the addition of a controller during the
third quarter of 2017, a senior accountant in the first quarter of
2018, and a staff accountant and an office manager during the
fourth quarter of 2018. These increases reflect the support
required by our increase in clinical and pre-clinical activity
described above as compared to 2017.
Net Loss. The net loss for the
twelve months ended December 31, 2018 was $11.9 million which
included non-cash expenses of approximately $1.1 million of
stock-based compensation.
Liquidity and Capital
Resources
As of December 31, 2018, we had cash and cash
equivalents of $7.1 million and prepaid expenses and other of $0.9
million. We also had $1.2 million of accounts payable and $2.3
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 years ended December 31, 2018 and
2017, we used approximately $12.2 million and $7.3 million of cash
in operating activities, respectively, which represents cash
outlays for research and development and general and administrative
expenses in such periods. The increase in 2018 reflects the
increase in clinical and preclinical activity over 2017. For the
year ended December 31, 2018, net proceeds from financing
activities were $12.0 million, predominately from the sale of our
common stock and warrants. In 2017, approximately $6.0 million was
raised through the sale of shares of common stock and approximately
$4.0 million from the exercise of warrants. Cash used in
investing activities for the year ended December 31, 2018 was
approximately $0.4 million for the purchase of fixed assets related
to the new corporate office space and the implementation of a new
financial accounting system.
We believe that our cash resources as of
December 31, 2018, along with the additional funding received
subsequent to year-end, will be sufficient to meet our projected
operating requirements into the third quarter of 2019. This
expectation does not consider additional preclinical or clinical
activity or additional funding, including but not limited to,
equity issuances including the use of the Lincoln Park Purchase
Agreement which could shorten and/or extend the funding of our
planned operations. Such plans are subject to our stock price
and other limitations in the LP Purchase Agreement, change in
planned expenses depending on clinical enrollment progress and use
of drug product.
On October 4, 2018, we entered into a purchase
agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund,
LLC pursuant to which Lincoln Park agreed to purchase up to an
aggregate of $20.0 million worth of common stock. Under the terms
and subject to the conditions of the LP Purchase Agreement, we have
the right, but not the obligation, to sell to Lincoln Park, and
Lincoln Park is obligated to purchase up to $20.0 million worth of
shares of common stock. Such sales will be subject to certain
limitations, and may occur from time to time, at our sole
discretion, over the 36 months commencing on October 30, 2018. We
issued to Lincoln Park 243,013 shares of common stock as commitment
shares in consideration for entering into the LP Purchase Agreement
and may issue an additional 121,507 shares pro-rata when and if
Lincoln Park purchases (at our discretion) the $20,000,000
aggregate commitment. During the fourth quarter, we issued
1,399,153 shares to Lincoln Park which included 10,918 commitment
shares for $1.8 million. Subsequent to December 31, 2018, we sold
500,000 shares to Lincoln Park for an aggregate purchase price of
$0.7 million, and 4,510 commitment shares.
About Moleculin Biotech,
Inc.
Moleculin Biotech, Inc. is a clinical-stage
pharmaceutical company focused on the treatment of highly resistant
cancers. Moleculin has three core technologies, all of which are
based on discoveries made at M.D. Anderson Cancer Center by Dr.
Waldemar Priebe and his team. The Company’s clinical-stage drugs
are Annamycin, a Next Generation Anthracycline being studied for
the treatment of relapsed or refractory acute myeloid leukemia, or
AML, and WP1066, an Immune/Transcription Modulator targeting brain
tumors, pancreatic cancer and AML. The Company is also engaged in
preclinical development of additional drug candidates, including
additional Immune/Transcription Modulators, as well as
Metabolism/Glycosylation Inhibitors. Moleculin’s Next Generation
Anthracycline, Annamycin, we believe, is unlike any currently
approved anthracyclines, as it is designed to avoid multidrug
resistance mechanisms with little to no cardiotoxicity. Annamycin
has preliminary clinical data suggesting its potential to become
the first successful therapy suitable for the majority of relapsed
or refractory AML patients and is currently in two Phase I/II
clinical trials. WP1066 is one of several Immune/Transcription
Modulators capable of stimulating immune response to tumors by
inhibiting the errant activity of Regulatory T-Cells (TRegs) while
also inhibiting key oncogenic transcription factors, including
p-STAT3, c-Myc and HIF-1α. These transcription factors are widely
sought targets that may also play a role in the inability of immune
checkpoint inhibitors to affect more resistant tumors. Moleculin is
also developing new prodrugs to exploit the potential uses of
inhibitors of glycolysis. The Company’s lead
Metabolism/Glycosylation Inhibitor compound, WP1122, provides an
opportunity to cut off the fuel supply of tumors by taking
advantage of their overdependence on glucose as compared with
healthy cells. New research also points to the potential for the
glucose decoy (2-DG) within WP1122 to be capable of enhancing the
usefulness of checkpoint inhibitors.
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 of
Moleculin to successfully recruit sufficient patients to complete
its current clinical trials; the ability of Moleculin to obtain
clinical trial authorization for WP1220 for the treatment of CTCL
in Poland; the ability of Moleculin to file an IND for WP1732; and
the ability of Moleculin’s drug candidates to show safety and
efficacy in patients. Although Moleculin Biotech 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.
ContactsJoe Dorame, Robert Blum or Joe
DiazLytham Partners, LLC602-889-9700mbrx@lythampartners.com
---Financial tables on the following
page---
Moleculin Biotech, Inc. |
|
|
|
|
Unaudited Condensed Consolidated Balance
Sheets |
|
December 31 |
|
|
(in thousands) |
|
2018 |
|
2017 |
Current Assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
7,134 |
|
$ |
7,714 |
Prepaid expenses and
other |
|
840 |
|
588 |
Total current assets |
|
7,974 |
|
8,302 |
Furniture and equipment,
net |
|
463 |
|
33 |
Intangible assets |
|
11,148 |
|
11,148 |
Total Assets |
|
$ |
19,585 |
|
$ |
19,483 |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
3,548 |
|
$ |
1,712 |
Deferred compensation –
related party |
|
150 |
|
- |
Warrant
liability-current |
|
180 |
|
503 |
Total current liabilities |
|
3,878 |
|
2,215 |
Deferred compensation -
related party - long term |
|
- |
|
150 |
Deferred rent - long
term |
|
107 |
|
- |
Warrant liability - long
term |
|
1,328 |
|
- |
Total Liabilities |
|
5,313 |
|
2,365 |
Total Stockholders'
Equity |
|
14,272 |
|
17,118 |
Total Liabilities and Stockholders'
Equity |
|
$ |
19,585 |
|
$ |
19,483 |
|
|
|
|
|
Unaudited Condensed Consolidated Statements of
Operations |
|
|
|
|
|
|
Year Ended December 31, |
(in thousands,
except share and per share amounts) |
|
2018 |
|
2017 |
Revenues |
|
$ |
- |
|
$ |
- |
Operating Expenses: |
|
|
|
|
Research and
development |
|
9,728 |
|
4,545 |
General and Administrative
and depreciation |
|
5,297 |
|
4,108 |
Total operating expenses |
|
15,025 |
|
8,653 |
Operating loss |
|
(15,025) |
|
(8,653) |
Other income
(expense) |
|
|
|
|
Gain (loss) from change in
fair value of warrant liability |
|
3,185 |
|
(2,548) |
Gain from settlement of
liability |
|
— |
|
149 |
Gain from expiration of
warrants |
|
— |
|
1,238 |
Other (expense)
income |
|
(40) |
|
9 |
Interest income (expense),
net |
|
4 |
|
- |
Net Loss |
|
$ |
(11,876) |
|
$ |
(9,805) |
Net loss per common share
- basic and diluted |
|
$ |
(0.46) |
|
$ |
(0.53) |
Weighted average common
shares outstanding - basic and diluted |
|
25,904,170 |
|
18,569,193 |
|
|
|
|
|
Moleculin Biotech (NASDAQ:MBRX)
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