– Year marked by growing body of
positive Annamycin efficacy and safety clinical data expected to
support advancement into a pivotal study for AML
– Company to host conference call and
webcast Monday, March 25th
at 8:30 AM ET
– Company to issue separate clinical
trial update press release Monday prior to the conference
call
HOUSTON, March 22,
2024 /PRNewswire/ -- Moleculin Biotech,
Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical
stage pharmaceutical company with a broad portfolio of drug
candidates targeting hard-to-treat tumors and viruses, today
reported its financial results for the fiscal year ended
December 31, 2023. As previously
announced, the Company will host a conference call and live audio
webcast, Monday, March 25, 2024, at
8:30 AM ET (details below), issuing a
separate clinical trial update press release just prior.
"Over the course of 2023 we established a significant growing
body of positive clinical and encouraging safety data for Annamycin
that continues to strengthen our confidence in the potential of our
next generation, non-cardiotoxic chemotherapy in the treatment
landscape for hard-to-treat cancers and viruses," commented
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin. "Building off of our momentum, we
are laser focused on driving our priority pipeline programs toward
key data milestones in the near term and believe we are
well-positioned to achieve clinical and regulatory milestones that
will translate into significant value creation for all of our
stakeholders."
Recent Highlights
- Announced 2023 year-end Annamycin clinical trials preliminary
data and 2024 expectations for multiple data readouts and
transition to pivotal Phase 2B/3;
- Closed a registered direct offering priced at-the-market under
Nasdaq rules with a single healthcare-focused institutional
investor and certain of the Company's executive officers, a board
member and concurrent private placement for gross proceeds of
$4.5 million before deducting the
placement agent's fees and other estimated offering expenses
payable by the Company pushing the Company's cash runway into the
fourth quarter of 2024; and
- Presented positive interim data from the Company's ongoing
European Phase 1B/2 clinical trial
evaluating Annamycin for the treatment of AML (MB-106) to key
opinion leaders and current investigators at a meeting held in
conjunction with the 65th American Society of Hematology Meeting
and Exposition (ASH) in San Diego,
CA.
Summary of Financial Results for the Full Year 2023
Research and development (R&D) expenses were $19.5 million and $19.0
million for the years ended December
31, 2023 and 2022, respectively. The increase in R&D of
$0.5 million is mainly related to the
$1.5 million WPD sublicense
termination, which enabled the reacquisition of the Company's
intellectual property rights in certain territories, including
parts of the European Union. This was offset by $1.0 million in costs related to the timing of
costs incurred for clinical trials and sponsored research.
General and administrative (G&A) expenses were $10.0 million and $11.5
million for the years ended December
31, 2023 and 2022, respectively. The decrease in G&A of
$1.5 million was mainly attributable
to a decrease in regulatory and legal services, and consulting
& advisory fees.
The net loss for the year ended December
31, 2023 was $29.8 million,
which included a non-cash loss of $1.0
million on warrants in 2023 as compared to a gain of
$1.3 million in the prior year and
approximately $2.0 million of
stock-based compensation expense in 2023 as compared to
$2.3 million in 2022.
As of December 31, 2023, the
Company had cash and cash equivalents of $23.6 million. The Company believes that this
cash is sufficient to meet its projected operating requirements
into the fourth quarter of 2024.
Conference Call and Webcast
Moleculin management will host its quarterly conference call and
webcast for investors, analysts, and other interested parties
Monday, March 25, 2024, 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. Annamycin is currently in
development for the treatment of 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
Moleculin Biotech,
Inc.
|
|
|
|
|
Unaudited Condensed
Consolidated Balance Sheets
|
|
|
(in
thousands)
|
|
December 31,
2023
|
|
December 31,
2022
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
23,550
|
|
$
43,145
|
Prepaid expenses and
other current assets
|
|
2,723
|
|
2,451
|
Total current
assets
|
|
26,273
|
|
45,596
|
Furniture and
equipment, net
|
|
272
|
|
275
|
Intangible
assets
|
|
11,148
|
|
11,148
|
Operating lease
right-of-use asset
|
|
524
|
|
403
|
Total assets
|
|
$
38,217
|
|
$
57,422
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
$
6,815
|
|
$
4,819
|
Total current
liabilities
|
|
6,815
|
|
4,819
|
Operating lease
liability - long-term, net of current portion
|
|
474
|
|
335
|
Warrant liability -
long term
|
|
4,855
|
|
77
|
Total liabilities
|
|
12,144
|
|
5,231
|
Total stockholders'
equity
|
|
26,073
|
|
52,191
|
Total liabilities and
stockholders' equity
|
|
$
38,217
|
|
$
57,422
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
Year Ended December
31,
|
(in thousands,
except share and per share amounts)
|
|
2023
|
|
2022
|
Revenues
|
|
$
-
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
19,487
|
|
18,968
|
General and
administrative and depreciation and amortization
|
|
10,144
|
|
11,672
|
Total operating
expenses
|
|
29,631
|
|
30,640
|
Loss from
operations
|
|
(29,631)
|
|
(30,640)
|
Other
income:
|
|
|
|
|
(Loss) gain from change
in fair value of warrant liability
|
|
(1,044)
|
|
1,335
|
Transaction costs
allocated to warrant liabilities
|
|
(510)
|
|
-
|
Other income,
net
|
|
48
|
|
40
|
Interest income,
net
|
|
1,368
|
|
240
|
Net
loss
|
|
$
(29,769)
|
|
$
(29,025)
|
|
|
|
|
|
Net loss per common
share - basic and diluted
|
|
$
(15.07)
|
|
$
(15.22)
|
Weighted average common
shares outstanding - basic and diluted
|
|
1,975,610
|
|
1,906,960
|
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SOURCE Moleculin Biotech, Inc.