– Ends Quarter with $24.6 million in Cash with Runway Estimated into
Third Quarter of 2024
– Third quarter marked by additional positive
clinical data from Annamycin lead development programs
– Growing body of Annamycin efficacy and
safety clinical data expected to support advancement into pivotal
studies for both AML and STS in 2024
– Company to host conference call and webcast
today at 8:30 AM ET
HOUSTON, Nov. 13,
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 September 30, 2023. As previously announced, the
Company will host a conference call and live audio webcast, today,
November 13, 2023, at 8:30 AM ET (details below).
"There remains a dire unmet need in AML and STS for a safer,
non-cardiotoxic chemotherapy for elderly and frail patients,"
commented Walter Klemp, Chairman and
Chief Executive Officer of Moleculin. "Our growing body of positive
clinical and encouraging safety data for Annamycin continues to
bolster our confidence that our next generation chemotherapy can
make a significant impact in the treatment landscape for these high
value indications. We remain focused on advancing our priority
pipeline programs to key data milestones in the near term, which we
be believe will support advancement into pivotal, registration
studies in both AML and STS. We believe our year of continued
data and the achievement of clinical and regulatory milestones will
translate into significant value creation for all of our
stakeholders."
Recent Highlights
- Dosed first subjects in Phase 2 portion of the clinical trial
evaluating Annamycin in combination with Cytarabine (Ara-C) for the
treatment of Acute Myeloid Leukemia (AML) (MB106);
- Completed enrollment in U.S. Phase 1B/2 clinical trial evaluating Annamycin for the
treatment of Soft Tissue Sarcoma (STS) Lung Metastases
(MB107);
- Announced a new positive independent assessment report was
published confirming the absence of cardiotoxicity in subjects
treated with Annamycin;
- Presented poster titled, "A Phase 1b/2 Study of Liposomal Annamycin (ANN) in
Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with
Pulmonary Metastases" at the 2023 Connective Tissue Oncology
Society Annual Meeting in Dublin,
Ireland;
- Participated in the Virtual Investor Ask the CEO Conference,
the webcast replay can be found here; and
- The Company will release a more detailed Clinical Trial Update
press release later this morning.
Summary of Financial Results for the Third Quarter
2023
Research and development (R&D) expense was $3.3 million and $6.0
million for the three months ended September 30, 2023 and 2022, respectively. The
decrease of $2.7 million is mainly
related to the timing of costs incurred for clinical trials and
timing of sponsored research payments.
General and administrative expense was $2.6 million and $3.1
million for the three months ended September 30, 2023 and 2022, respectively. The
decrease of $0.5 million is mainly
related to a decrease in regulatory and legal services, and
consulting & advisory fees.
As of September 30, 2023, the
Company had cash and cash equivalents of $24.6 million and believes that this cash is
sufficient to meet its planned operations, which include the
current Phase 2 clinical programs and preparations for future
clinical trials, 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, November 13, 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
Moleculin Biotech,
Inc.
|
|
|
|
|
|
|
|
|
Unaudited Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
September 30,
2023
|
|
December 31,
2022
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
24,579
|
|
$
43,145
|
Prepaid expenses and
other current assets
|
|
|
|
|
|
3,024
|
|
2,451
|
Total current
assets
|
|
|
|
|
|
27,603
|
|
45,596
|
Furniture and
equipment, net
|
|
|
|
|
|
225
|
|
275
|
Intangible
assets
|
|
|
|
|
|
11,148
|
|
11,148
|
Operating lease
right-of-use asset
|
|
|
|
|
|
547
|
|
403
|
Total assets
|
|
|
|
|
|
$
39,523
|
|
$
57,422
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
|
|
|
|
$
3,888
|
|
$
4,819
|
Total current
liabilities
|
|
|
|
|
|
3,888
|
|
4,819
|
Operating lease
liability - long-term, net of current portion
|
|
|
|
|
|
496
|
|
335
|
Warrant liability -
long term
|
|
|
|
|
|
1
|
|
77
|
Total liabilities
|
|
|
|
|
|
4,385
|
|
5,231
|
Total stockholders'
equity
|
|
|
|
|
|
35,138
|
|
52,191
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
$
39,523
|
|
$
57,422
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(in thousands,
except share and per share amounts)
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues
|
|
$
-
|
|
$
-
|
|
$
-
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,280
|
|
5,965
|
|
12,855
|
|
14,790
|
General and
administrative and depreciation and amortization
|
|
2,667
|
|
3,119
|
|
7,857
|
|
8,802
|
Total operating
expenses
|
|
5,947
|
|
9,084
|
|
20,712
|
|
23,592
|
Loss from
operations
|
|
(5,947)
|
|
(9,084)
|
|
(20,712)
|
|
(23,592)
|
Other
income:
|
|
|
|
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
1
|
|
421
|
|
76
|
|
1,184
|
Other income,
net
|
|
13
|
|
19
|
|
30
|
|
39
|
Interest income,
net
|
|
324
|
|
33
|
|
1,106
|
|
114
|
Net
loss
|
|
$ (5,609)
|
|
$ (8,611)
|
|
$
(19,500)
|
|
$
(22,255)
|
|
|
|
|
|
|
|
|
|
Net loss per common
share - basic and diluted
|
|
$
(0.19)
|
|
$
(0.30)
|
|
$
(0.66)
|
|
$
(0.78)
|
Weighted average common
shares outstanding - basic and diluted
|
|
29,809,236
|
|
28,627,610
|
|
29,419,904
|
|
28,596,501
|
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SOURCE Moleculin Biotech, Inc.