– Ongoing progress across ongoing clinical
development programs with growing body of positive preclinical and
clinical data
– Released Clinical Trial Update press release
yesterday providing the quarter's update on its clinical
activities
– Company to host conference call and webcast
today at 8:30 AM ET
HOUSTON, Aug. 11,
2023 /PRNewswire/ -- Moleculin Biotech, Inc.,
(Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage
pharmaceutical company with a growing pipeline, including Phase 2
clinical programs, for hard-to-treat tumors and viruses, today
reported its financial results for the quarter ended June 30, 2023. As previously announced, the
Company will host a conference call and live audio webcast, today,
August 11, 2023, at 8:30 AM ET (details below).
"We have continued our operational execution and clinical
progress over the past quarter," commented Walter Klemp, Chairman and Chief Executive
Officer of Moleculin. "We remain focused advancing our priority
pipeline programs to key data milestones in the near term. We
firmly believe we are well positioned not only to unlock
significant potential for all stakeholders but, importantly,
address the medical unmet needs of people with highly resistant
cancers and viruses."
Recent Highlights
- Released yesterday a press release Moleculin Provides
Update on Ongoing Clinical Trials and Outlines Expected Upcoming
Milestones providing an update on its clinical update for the
quarter:
-
- Reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy
treatment of soft tissue sarcoma metastasized to the lungs with 73%
(n=26) of the subjects exhibiting stable disease after two cycles
of treatment
- Announced successful completion of the Phase 1B portion of its Phase 1B/2 clinical trial Annamycin in combination with
Cytarabine for the treatment of AML (MB-106) and opens the Phase 2
portion for recruitment
- Announced a preliminary CR/CRi rate of 33% (n=6) in the Phase
1B portion of its MB-106 clinical
trial
- Announced that the Company is investigating potential naked
short selling of its stock and has retained well-known analytics
firm, Shareholder Intelligence Services, LLC; and
- Announced the publication of data from successful European
Phase 1 clinical trial evaluating Annamycin as single agent
treatment of relapsed or refractory acute myeloid leukemia titled,
"Results of a Phase 1 Study of Liposomal Annamycin for the
Treatment of Relapsed or Refractory AML Patients After Induction
Therapy," in the peer-reviewed British Journal of
Cancer Research.
Summary of Financial Results for the Second Quarter
2023
Research and development (R&D) expense was $3.9 million and $4.2
million for the three months ended June 30, 2023 and 2022, respectively. The
decrease of $0.3 million is mainly
related to the timing of costs incurred for clinical trials and
timing of sponsored research payments.
General and administrative expense was $2.5 million and $3.2
million for the three months ended June 30, 2023 and 2022, respectively. The
decrease of $0.7 million is mainly
related to a decrease in regulatory and legal services, and
consulting & advisory fees.
As of June 30, 2023, the Company
had cash and cash equivalents of $32.2
million and believes that this cash is sufficient to meet
its projected operating requirements into the third quarter of
2024.
Conference Call and Webcast
Moleculin management will host its quarterly conference call and
webcast for investors, analysts, and other interested parties
today, August 11, 2023, at
8:30 AM ET.
Interested participants and investors may access the conference
call by dialing (877) 407-0832 (domestic) or (201) 689-8433
(international) and referencing the Moleculin Biotech Conference
Call. The live webcast will be accessible on the Events page of the
Investors section of the Moleculin website, moleculin.com, and will
be archived for 90 days.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company with a growing pipeline, including Phase 2 clinical
programs, for hard-to-treat 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 forecasted cash
burn rate (including its estimate of cash sufficient to meet its
projected operating requirements). 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
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Moleculin Biotech, Inc
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance
Sheets
|
|
|
|
|
|
|
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(in thousands)
|
|
|
|
|
|
June 30, 2023
|
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December 31, 2022
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Current
assets:
|
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|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
32,172
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|
$
43,145
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|
Prepaid expenses and
other current assets
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|
|
|
|
|
3,208
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|
2,451
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|
Total current
assets
|
|
|
|
|
|
35,380
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|
45,596
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|
Furniture and
equipment, net
|
|
|
|
|
|
229
|
|
275
|
|
Intangible
assets
|
|
|
|
|
|
11,148
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|
11,148
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Operating lease
right-of-use asset
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|
|
|
|
|
358
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|
403
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|
Total assets
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|
|
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|
$
47,115
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|
$
57,422
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|
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|
|
|
|
|
Current
liabilities:
|
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|
|
|
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Accounts payable and
accrued expenses and other current liabilities
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$
6,554
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$
4,819
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Total current
liabilities
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|
|
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|
6,554
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|
4,819
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Operating lease
liability - long-term, net of current portion
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|
|
|
|
|
291
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|
335
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Warrant liability -
long term
|
|
|
|
|
|
2
|
|
77
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Total liabilities
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|
|
|
|
|
6,847
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|
5,231
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Total stockholders'
equity
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|
40,268
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|
52,191
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Total liabilities and
stockholders' equity
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|
|
|
|
|
$
47,115
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|
$
57,422
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|
|
|
|
|
|
|
|
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Unaudited Condensed Consolidated Statements of
Operations
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Three Months Ended June 30,
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Six Months Ended June 30,
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(in thousands, except share and per share
amounts)
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2023
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2022
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2023
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|
2022
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Revenues
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$
-
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$
-
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|
$
-
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|
$
-
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Operating
expenses:
|
|
|
|
|
|
|
|
|
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Research and
development
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|
3,888
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|
4,204
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|
9,576
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|
8,824
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General and
administrative and depreciation and amortization
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2,523
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|
3,230
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|
5,190
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|
5,683
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|
Total operating
expenses
|
|
6,411
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|
7,434
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|
14,766
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|
14,507
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Loss from
operations
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|
(6,411)
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|
(7,434)
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|
(14,766)
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|
(14,507)
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Other
income:
|
|
|
|
|
|
|
|
|
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Gain from change in
fair value of warrant liability
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|
36
|
|
603
|
|
75
|
|
763
|
|
Other income,
net
|
|
9
|
|
15
|
|
17
|
|
20
|
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Interest income,
net
|
|
390
|
|
39
|
|
783
|
|
80
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|
Net loss
|
|
$
(5,976)
|
|
$
(6,777)
|
|
$
(13,891)
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|
$
(13,644)
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|
|
|
|
|
|
|
|
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|
Net loss per common
share - basic and diluted
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|
$
(0.20)
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$
(0.24)
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|
$
(0.48)
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|
$
(0.48)
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Weighted average common
shares outstanding - basic and diluted
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|
29,688,862
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28,583,014
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29,222,012
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28,580,689
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SOURCE Moleculin Biotech, Inc.