HOUSTON, May 14, 2019 /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,
today announced its financial results for the first quarter ended
March 31, 2019. Additionally, the
Company announced potential upcoming milestones and recent
corporate developments.
Management Discussion
Walter
Klemp, Chairman and CEO of Moleculin, said, "We are off to a
very good start in 2019, as we have achieved significant milestones
with the development of our oncology portfolio. This time last year
we had just commenced our first clinical trial for one drug.
Today, we have three drugs in four clinical trials under way with a
fifth clinical trial that may start before year end. We are excited
with the progress that has been achieved and we expect that 2019
will be the 'year of data' where we provide progress reports as our
various drug candidates proceed through their respective clinical
trials."
"One of the highlights of the just completed quarter was
FDA 'Fast Track' designation for Annamycin, our drug candidate for
the treatment of adults with relapsed or refractory acute myeloid
leukemia. Fast Track represents an important first step
toward accelerated approval. We presented the FDA a proposal
for the designation, and they determined that Annamycin should be
eligible for accelerated approval. This potentially cuts
years off our development timeline and should make Annamycin
attractive to development partners much sooner. We also announced
preclinical data supporting the expansion of Annamycin indications
to include lung cancer."
"It bears noting we announced last week that our Annamycin
clinical trial in Poland is
generating very encouraging results," continued Mr. Klemp. "We have
completed the first cohort of the trial and 2 out of 3 patients
treated responded sufficiently to qualify for a potentially
curative bone marrow transplant. Although we are still early in the
trial, we believe this small sample size is indicative of what
Annamycin is designed to produce. The standard of care failed these
relapsed or refractory patients, and we believe Annamycin has
provided new hope for an improved quality of life, and, or
possibly, an extension of life.
"We continue to see strong anti-tumor activity with WP1066, our
flagship Immune/Transduction Modulator in a wide range of animal
models. 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. We are extremely excited with the ongoing results
of this preclinical research. These important
developments, along with regulatory approvals, complement our
vision of developing numerous drugs that support our 'multiple
shots on goal' strategy.
"Also, during the quarter, the FDA granted Orphan Drug
Designation for 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 diseases. 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."
Mr. Klemp concluded, "This just completed first quarter yielded
a number of important developments that set the stage for a
successful 2019 and the years ahead. As we continue through our
various clinical trials and preclinical research, we are heartened
with the tangible progress being made and that we are advancing
toward our goal of developing effective treatments for rare and
difficult cancers that eclipse the outcomes of the standard of
care. Providing hope to patients, where it might have been lost, is
a driving force for the entire Moleculin team."
Recent milestones and accomplishments include:
Next Generation Anthracycline - Annamycin
- Announcement of additional positive interim safety and efficacy
data from our ongoing study of Annamycin in Poland. After receiving a single starting dose
of 120 mg/m2 in the first cohort of the dose escalation
phase of the trial, 2 of 3 patients treated responded sufficiently
to qualify for a potentially curative bone marrow transplant.
Additionally, no patients in the U.S. or in the European trials, to
date, have shown any signs of cardiotoxicity. The results for all 3
patients were reviewed by the Safety Review Committee, which
determined that no drug-related adverse events were observed that
would prevent advancing the trial to the next higher dose level of
150 mg/m2.
- FDA grants Fast Track Designation of our drug Annamycin for the
treatment of relapsed or refractory acute myeloid.
- Announcement that we have found Annamycin to be active against
metastases to the lungs in preclinical testing. Annamycin
significantly improved survival in an aggressive form for triple
negative breast cancer metastasized to the lungs in animal
models.
- U.S. clinical trial completed the first cohort and is currently
recruiting patients for the second cohort to be given a dose level
of 120 mg/m2.
Immune/Transcription Modulators - WP1066 Portfolio
- Agreement with Emory University to
conduct pediatric brain tumor trial. This will be a Phase 1
clinical trial of WP1066 in children with recurrent or refractory
malignant brain tumors. The study will be conducted at the Aflac
Cancer & Blood Disorders Center at Children's Healthcare of
Atlanta.
- Announcement that preclinical data supporting activity of our
STAT3-inhibiting Immune/Transcription Modulators was presented by
Dr. Waldemar Priebe, Founder and
Chair of the Scientific Advisory Board of Moleculin, Inc. at the
2019 Annual Meeting of the American Association for Cancer Research
("AACR") in Atlanta, GA. The
presentation included data resulting from preclinical evaluation in
pancreatic cancer models of STAT3 inhibitors WP1066 and
WP1732. WP1066 is an orally bioavailable drug with significant
brain uptake that is currently in Phase I clinical studies in
patients with brain tumors. Complementary to WP1066, we believe
STAT3 inhibitor WP1732 may be suitable for IV administration and
demonstrates high uptake by the pancreas without uptake to the
brain.
- Announcement of the first two patients enrolled in our European
clinical trial of WP1220 for the topical treatment of cutaneous
T-Cell Lymphoma (CTCL).
- FDA granted Orphan Drug Designation for our drug candidate
WP1066 for the treatment of glioblastoma, the most aggressive form
of brain tumor.
- Announcement that we have shown that WP1066, an
Immune/Transduction Modulator, appears to counteract resistance to
checkpoint blockade therapy (specifically, immune checkpoint target
PD-L1) in our own sponsored research.
General
- Announcement of Dr. Martin
Tallman, Chief of Leukemia for Memorial Sloan Kettering
Cancer Center has joined the Company's Science Advisory Board
(SAB).
Jonathan Foster, Executive Vice
president and Chief Financial Officer of Moleculin, stated, "We
finished the first quarter with cash of approximately $8.8 million and we received additional gross
proceeds of $16.6 million subsequent
to the quarter end from a public offering and the exercise of
various warrants. The strengthening of our balance sheet provides
us the ability to fund our ongoing research programs and clinical
trials. We believe our existing cash and cash equivalents will be
sufficient to fund our planned operations well into 2020.
Currently, we have four clinical trials ongoing, and 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 1/2 clinical
trial of Annamycin
|
Accomplished and ongoing 2019
|
Complete cohort of
150 mg/m2 - prior trial recommended Phase II dose
(RP2D)
|
2019 (Starting in
Europe)
|
Start treating
patients in Annamycin Phase 1/2 clinical trial in Poland
|
Accomplished
and ongoing 2019
|
Announcement of
initial clinical data for Annamycin trial
|
Accomplished
and ongoing 2019
|
Announced completed
first cohort of 120 mg/m2 in Poland and 100
mg/m2 in the U.S.
|
Accomplished
|
Poland clinical trial
(MB-105) begins Phase 2
|
2020
|
Approach FDA on
U.S. trial (MB-104) regarding dose expansion using Poland
trial data
|
2020
|
Announced FDA grants
Fast Track Designation to Annamycin for treatment of relapsed or
refractory acute myeloid leukemia (AML)
|
Accomplished
|
Immune/Transcription Modulators - WP1066
Portfolio
|
|
Announced FDA grants
Orphan Drug Designation to WP1066 for treatment of
glioblastoma
|
Accomplished
|
Announcement of
initial clinical data from WP1066 clinician sponsored
trial
|
2019
|
Phase 1 surgical
cohort begins in MD Anderson clinical trial of WP1066 for brain
tumors
|
Second Half of
2019
|
Transfer clinician 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 filing and
approval of Clinical Trial Authorization for WP1220 for the
treatment of cutaneous T-cell lymphoma (CTCL) in Poland
|
Accomplished
|
Assess WP1220 initial
patient data
|
Q4-2019
|
IND for WP1732
submitted
|
2020
|
Dose first patient in
Phase I trial for WP1732
|
2020
|
Announce further
preclinical research results on WP1066 portfolio
|
Accomplished and ongoing 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
|
First Quarter Highlights and Recent Corporate
Developments
Moleculin Announces Additional Positive Interim Results in
First Cohort of Phase 1/2 Clinical Studies of Annamycin in Acute
Myeloid Leukemia in Europe - 2
of 3 patients qualify to proceed to a potentially curative bone
marrow transplant; trial advances to next higher dose
level - May 7, 2019, the
Company announced additional positive interim safety and efficacy
data from its ongoing open label, single arm Phase 1/2 study of
Annamycin in Poland. After
receiving a single starting dose of 120 mg/m2 in the
first cohort of the dose escalation phase of the trial, 2 of 3
patients treated responded sufficiently to qualify for a
potentially curative bone marrow transplant. The results for all 3
patients were reviewed by the Safety Review Committee, which
determined that no drug-related adverse events were observed that
would prevent advancing the trial to the next higher dose level of
150 mg/m2. To date in the European trial, one patient
experienced grade 2 mucositis (which resolved to grade 1 within 2
days) and no other adverse events related to Annamycin have been
reported. No additional patient data have been developed in the
Company's parallel US clinical trial, which is currently recruiting
its second cohort to be given a dose level of 120 mg/m2
(the U.S. trial started at a lower initial dose of 100
mg/m2).
Moleculin Announces $15.0
Million Registered Direct Offering - April 23,2019, the Company announced that it has
entered into definitive agreements with institutional investors to
purchase an aggregate of 9,375,000 units at a public offering price
of $1.60 per unit in a registered
direct offering, which offering was closed on April 25, 2019. Each unit is comprised of one
share of common stock and 0.5 of a warrant to purchase one share of
common stock. Each warrant has an exercise price of $1.75 per share and is exercisable immediately.
The warrants will expire five years from the date of issuance. The
gross proceeds of the offering were approximately $15.0 million, prior to deducting the placement
agent fees and other estimated offering expenses.
Moleculin Receives FDA Approval of Fast Track Designation for
Annamycin - April 18, 2019,
the Company announced that the FDA has approved its request for
Fast Track Designation for its drug, Annamycin, for the treatment
of relapsed or refractory AML.
A drug that receives Fast Track designation is eligible for some
or all of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval;
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers;
- Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met;
- Rolling Review, which means that a drug company can submit
completed sections of its Biologic License Application (BLA) or New
Drug Application (NDA) for review by FDA, rather than waiting until
every section of the NDA is completed before the entire application
can be reviewed. BLA or NDA review usually does not begin until the
drug company has submitted the entire application to the FDA.
Moleculin Announces Significant Discovery in Lung Cancer
Models - Annamycin Found to be Active Against Metastases
to the Lungs in Preclinical Testing - April 17, 2019, the Company announced that its
ongoing sponsored research at The University
of Texas MD Anderson Cancer Center has now demonstrated that
Annamycin is able to significantly improve survival in an
aggressive form of triple negative breast cancer metastasized to
the lungs in animal models. The Company believes its success in
increasing the survival rate in mice with this tumor model in
combination with the previously observed high uptake of Annamycin
by the lungs is a promising indication that supports additional
clinical research in lung and metastatic lung cancers.
Moleculin Announces Agreement with Emory
University to Conduct Pediatric Brain Tumor Trial -
April 11, 2019, the Company announced
it has entered into an agreement with Emory
University to conduct a Phase 1 clinical trial of WP1066 in
children with recurrent or refractory malignant brain tumors. The
study will be conducted at the Aflac Cancer & Blood Disorders
Center at Children's Healthcare of Atlanta.
Moleculin Announces Preclinical Pancreatic Cancer Data
Presented at American Association for Cancer Research Annual
Meeting - April 3, 2019, the
Company announced that preclinical data supporting activity of its
STAT3-inhibiting Immune/Transcription Modulators was presented by
Dr. Waldemar Priebe, Founder and
Chair of the Scientific Advisory Board of Moleculin, Inc. at the
2019 Annual Meeting of the American Association for Cancer Research
in Atlanta, GA.
AACR Abstract:
https://www.moleculin.com/inhibition-of-stat3-in-pancreatic-ductal-adenocarcinoma-and-immunotherapeutic-implications/
The presentation included data resulting from preclinical
evaluation in pancreatic cancer models of STAT3 inhibitors WP1066
and WP1732, both discovered at The University
of Texas MD Anderson Cancer Center and licensed by
Moleculin. WP1066 is an orally bioavailable drug with significant
brain uptake that is currently in Phase 1 clinical studies in
patients with brain tumors. Complementary to WP1066, we believe
STAT3 inhibitor WP1732 may be suitable for IV administration and
demonstrates high uptake by the pancreas without uptake to the
brain.
Moleculin Announces Pricing of Underwritten Public
Offering - March 27, 2019,
the Company announced the pricing of an underwritten public
offering of an aggregate of 5,250,000 units at a public offering
price of $1.00 per unit, which
offering was closed on March 29,
2019. Each unit is comprised of one share of common stock
and 0.5 of a warrant to purchase one share of common stock for a
total of 5,250,000 shares of common stock and warrants to purchase
2,625,000 shares of common stock. Each warrant has an exercise
price of $1.10 per share and is
exercisable immediately. The warrants will expire five years from
the date of issuance. The gross proceeds of the offering were
$5.25 million, prior to deducting the
underwriting discount and other estimated offering expenses.
Moleculin Announces First Patients Enrolled in Lymphoma
Clinical Trial - March 19, 2019,
the Company announced that the first two patients have been
enrolled in its European clinical trial of WP1220 for the topical
treatment of cutaneous T-cell lymphoma (CTCL). The Company is
targeting CTCL with a topical p-STAT3 inhibitor in light of the
significant role that STAT3 appears to play in CTCL skin lesions.
The intent is to take an early read on the first five patients in
this trial to assess whether the activity supports an expansion of
clinical testing of this topical drug. The Company expects
preliminary data to be available during 2019.
Moleculin Announces Memorial Sloan Kettering Chief of
Leukemia Joins Science Advisory Board - March 18, 2019, the Company announced that Dr.
Martin Tallman, Chief of Leukemia
for Memorial Sloan Kettering Cancer Center has joined the Company's
Science Advisory Board (SAB).
Moleculin Announces Outlicensing Deal to Accelerate
Preclinical and Clinical Development - February 20, 2019, the Company announced that it
has entered into a sublicense agreement with WPD Pharmaceuticals
(WPD), located in Poland. The
agreement provides WPD with exclusive rights, subject to current
license agreements, to develop and market a range of Moleculin's
technologies in certain European countries (which does not include
the UK, France, Italy and Spain) in exchange for contributing a minimum
of $4 million in development
expenditures agreed upon by Moleculin during the term of the
agreement plus an ongoing royalty on future revenues. The agreement
is specifically geared to provide Moleculin with the benefit of
European Union (EU) grant funding, which may be available to
companies like WPD that are formed and present in EU countries.
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.
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.
Financial Results for the First Quarter ended March 31, 2019
Research and Development Expense. Research and
development ("R&D") expense was $2.9
million and $1.2 million for
the three months ended March 31, 2019
and 2018, respectively. The increase of approximately $1.7 million is mainly related to the increase in
clinical activity and slight increase in R&D headcount over the
prior period.
General and Administrative Expense. General and
administrative expense was $1.6
million and $1.4 million for
the three months ended March 31, 2019
and 2018, respectively. The increase of approximately $0.2 million was mainly attributable to an
increase in G&A related payroll costs, as well as increases in
stock-based compensation costs attributable to new employees and
new employee stock options.
Net Loss. The net loss for the three months ended
March 31, 2019 was $4.0 million, which included non-cash income of
$0.5 million on the gain in fair
value of our warrant liability, which was offset by non-cash
charges of $0.3 million related to
stock-based compensation and other stock-based expenses.
Liquidity and Capital Resources
As of March 31, 2019, the Company
had cash and cash equivalents of $8.8
million. Subsequent to the three months ended March 31, 2019, the Company received gross
proceeds of approximately $16.6
million, as a result of a completed public offering and the
exercise of various warrants from past public offerings.
Cash used in operations was $3.8
million for the three months ended March 31, 2019. This $1.0
million increase over the prior year of $2.8 million was mainly due to: 1) developing,
manufacturing and testing drug product as we prepared for clinical
trials; 2) an increase in R&D headcount and associated payroll
costs; 3) an increase in sponsored research and related expenses;
and 4) an increase in license fees. These are all a reflection of
the increased clinical and preclinical activity and the associated
increase in G&A support for our three core drug technologies as
compared to the prior year.
In March 2019, the Company
completed an underwritten offering of 5,250,000 units, each unit
consisting of one share of common stock, and 0.5 of a warrant to
purchase one share of common stock. The public offering price of
the units was $1.00 per unit, and the
underwriter agreed to purchase the units from the Company at a
price of $0.93 per Unit. The warrants
included in the units are immediately exercisable at a price of
$1.10 per share, subject to
adjustments in certain circumstances, and will expire five years
from the date of issuance. The net proceeds from the transaction
was approximately $4.65 million after
deducting the underwriting discount and estimated offering
expenses.
Subsequent to the three months ended March 31, 2019, on April
23, 2019, the Company entered into definitive agreements
with institutional investors to purchase an aggregate of 9,375,000
units at a public offering price of $1.60 per unit in a registered direct offering.
Each unit is comprised of one share of common stock and 0.5 of a
warrant to purchase one share of common stock resulting in gross
proceeds of $15.0 million. Each
warrant has an exercise price of $1.75 per share and is exercisable immediately.
The warrants will expire five years from the date of issuance. The
offering closed on April 25,
2019.
Also, 1,408,018 shares were issued due to the exercise of
various warrants related to past public offerings, subsequent to
March 31, 2019 and through the date
of filing of these financial statements. Gross proceeds received
due to these exercises approximated $1.6
million.
The Company believes that its existing cash and cash equivalents
as of March 31, 2019, combined with
the additional funds raised via the issuance of equity described
above, will be sufficient to fund planned operations into the
second quarter of 2020. Any additional issuances should extend the
funding of our planned operations significantly beyond the second
quarter of 2020. 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 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 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.
Contacts
Joe Dorame,
Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com
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|
|
Moleculin Biotech,
Inc.
|
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets
(in
thousands)
|
|
March 31,
2019
|
|
December 31,
2018
|
Current
Assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
|
8,782
|
|
|
$
|
7,134
|
|
Prepaid expenses and
other
|
|
|
|
|
|
831
|
|
|
840
|
|
Total current
assets
|
|
|
|
|
|
9,613
|
|
|
7,974
|
|
Furniture and
equipment, net
|
|
|
|
|
|
431
|
|
|
463
|
|
Intangible
assets
|
|
|
|
|
|
11,148
|
|
|
11,148
|
|
Operating lease
right-of-use asset
|
|
|
|
|
|
106
|
|
|
—
|
|
Total Assets
|
|
|
|
|
|
$
|
21,298
|
|
|
$
|
19,585
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and current liabilities
|
|
|
|
|
|
$
|
4,050
|
|
|
$
|
3,698
|
|
Warrant liability -
current
|
|
|
|
|
|
2,386
|
|
|
180
|
|
Total current liabilities
|
|
|
|
|
|
6,436
|
|
|
3,878
|
|
Operating lease
liability - long-term, net of current portion
|
|
|
|
|
|
180
|
|
|
—
|
|
Deferred rent - long
term
|
|
|
|
|
|
—
|
|
|
107
|
|
Warrant liability -
long term
|
|
|
|
|
|
—
|
|
|
1,328
|
|
Total Liabilities
|
|
|
|
|
|
6,616
|
|
|
5,313
|
|
Total Stockholders'
Equity
|
|
|
|
|
|
14,682
|
|
|
14,272
|
|
Total Liabilities and
Stockholders' Equity
|
|
|
|
|
|
$
|
21,298
|
|
|
$
|
19,585
|
|
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations
(in thousands, expect shares and per share amounts)
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
2019
|
|
2018
|
Revenues
|
|
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
|
|
2,932
|
|
|
1,237
|
|
General and
Administrative and depreciation and amortization
|
|
|
|
|
|
1,639
|
|
|
1,400
|
|
Total operating
expenses
|
|
|
|
|
|
4,571
|
|
|
2,637
|
|
Loss from
operations
|
|
|
|
|
|
(4,571)
|
|
|
(2,637)
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
|
|
|
|
529
|
|
|
709
|
|
Interest income
(expense), net
|
|
|
|
|
|
1
|
|
|
1
|
|
Net Loss
|
|
|
|
|
|
$
|
(4,041)
|
|
|
$
|
(1,927)
|
|
Net loss per common
share - basic and diluted
|
|
|
|
|
|
$
|
(0.14)
|
|
|
$
|
(0.08)
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
|
|
|
|
29,064,913
|
|
|
23,331,685
|
|
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SOURCE Moleculin Biotech, Inc.