– Recently announced
interim data from ongoing MB-106 study demonstrating Annamycin in
combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54%
CR) in 1st and 2nd line AML subjects
(N=13)
– Also announced
MB-106 reaches 20 subjects enrolled
– Company to host
conference call and webcast today, Monday,
May 13th at 8:30 AM
ET
HOUSTON, May 13, 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 quarter ended March 31,
2024. As previously announced, the Company will host a
conference call and live audio webcast to discuss the operational
and financial results at 8:30 AM ET on Monday, May 13, 2024. (details below).
"We recently hosted a virtual AML Clinical Day featuring
renowned KOLs, Dr. Martin Tallman
and Dr. Michael Andreeff. It was
great to hear their support of and thoughts on Annamycin's recent
developments in AML. You can hear that discussion here. Combined
with the encouraging Annamycin data demonstrated to date and the
positive feedback from the KOLs, we continue to believe that our
results in 2nd line subjects fill a significant unmet
need. We believe this is supported by the exceptional CRc
rate demonstrated by AnnAraC in 2nd line patients, which
substantially exceeds the performance reported by any drug
currently approved in the U.S. for use in 2nd line AML.
We believe we are well-positioned for a highly productive End of
Phase 2 meeting with FDA to discuss our planned pivotal study of
Annamycin for AML," commented Walter
Klemp, Chairman and Chief Executive Officer of
Moleculin.
Recent Highlights
- Bolstered the patent estate with issuance of U.S. patents. We
recently received an Issue Notification from the United States
Patent and Trademark Office (USPTO) for U.S. Patent number
11,980,634 titled, "Method of Reconstituting Liposomal
Annamycin." Earlier, we received an Issue Notification titled,
"Preparation of Preliposomal Annamycin Lyophilizate." Both
provide claims to compositions that contain Annamycin with a base
patent term extending until mid-2040.
- Hosted a virtual AML clinical day highlighting positive interim
data for Annamycin from its ongoing acute myeloid leukemia (AML)
clinical development program.
- Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st –
7th line, with median durability at 4.9 months and
climbing.
- 1st and 2nd line patients reached a CRc
rate of 62% and a CR rate of 54%.
- The 2nd line performance from the combination of
Annamycin with Ara-C (AnnAraC) exceeds the approval data for all
currently approved 2nd line drugs.
- Interim data supports advancement to development of Phase 2
registration-directed clinical trial (MB-108) to further provide
data for efficacy to support an eventual application for New Drug
Approval (NDA).
- Announced the formation of its Annamycin Scientific Advisory
Board and inaugural appointment of Dr. Martin Tallman.
- Granted Orphan Drug Designation of Annamycin for the treatment
of AML from the European Medicines Agency (EMA), adding to US
Orphan Drug and Fast Track designations.
- Presented positive data demonstrating high anti-cancer activity
of Annamycin and non-cardiotoxic properties at the American
Association for Cancer Research (AACR) Annual Meeting.
Ongoing AML Clinical Trial Summary
The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in
combination with Cytarabine (also known as "Ara-C" and for which
the combination of Annamycin and Ara-C is referred to as AnnAraC)
for the treatment of subjects with AML as both first line therapy
and for subjects who are refractory to or relapsed after induction
therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10
or clinicaltrials.gov: NCT05319587.
A summary table of the MB-106 preliminary results is shown
below. These subjects had 0-6 prior therapies. The preliminary data
for MB-106 demonstrate a CRc rate of 45% and an overall remission
rate (ORR) of 55% for all subjects, regardless of the number of
prior treatments (N=20). Segmenting the MB-106 subject population
for 1st line (N=3) and, most notably, 2nd
line (N=10) therapies in the trial, yields a CRc rate of 67% and
60% and an ORR of 67% and 70%, both respectively.
Table 1 - Summary of Annamycin Remissions
in MB-106 as of May 2, 2024
Study MB-106
Combination Therapy –
Phase 1B/2 with
Ara-C + Annamycin "5+3"
|
All Lines (Range
1-7)
|
1st
Line
|
2nd
Line
|
1st and
2nd Line
Combined
|
All
Subjects
|
|
|
|
|
Recruited and
Evaluable
|
20
|
3
|
10
|
13
|
Subjects Evaluable Not
Dosed Per Protocol
|
2
|
0
|
1
|
1
|
Median Age - Years
(Range)
|
69 (19-78)
|
49 (19-69)
|
71 (53 - 78)
|
67 (19-78)
|
Complete Remissions
(CR)
|
8
|
2
|
5
|
7
|
CR with incomplete
recovery (CRi)
|
1
|
0
|
1
|
1
|
Total Composite
Complete Remission (CRc)
|
9
|
2
|
6
|
8
|
Complete Remission (CR)
Rate
|
40 %
|
67 %
|
50 %
|
54 %
|
Complete Remission
Composite (CRc) Rate
|
45 %
|
67 %
|
60 %
|
62 %
|
Partial Remissions
(PRs)
|
2
|
0
|
1
|
1
|
Overall Response Rate
(CRc's + PRs) or ORR
|
55 %
|
67 %
|
70 %
|
69 %
|
CRc Relapsed or Death
to Date
|
2
|
0
|
2
|
2
|
BMT To Date (in
CR's)
|
2
|
0
|
1
|
1
|
See Note 1
below
|
|
|
|
|
Notes for Table 1: Data from MB-106 is for Intent To
Treat (ITT) subjects and is preliminary and subject to change.
Expected Milestones for Annamycin AML Development
Program
- H1 2024: Complete MB-106 Phase 1B/2 clinical trial.
- H1 2024: MB-106 End of Phase 2 Meeting with FDA.
- H1 2025: Initiate pivotal trial.
- H2 2026: Feedback from the FDA EOP2 Meeting
- H2 2026: Conclude pivotal trial.
- 2027: Potential NDA submission.
Summary of Financial Results for the First Quarter
2024
Research and development (R&D) expense was $4.3 million and $5.7
million for the three months ended March 31, 2024 and 2023, respectively. The
decrease of $1.4 million is
mainly related to the clinical trials activity levels.
General and administrative expense was $2.4 million and $2.6
million for the three months ended March 31, 2024 and 2023, respectively. The
decrease of $0.2 million is mainly
related to a decrease in regulatory and legal fees.
As of March 31, 2024, the Company
had cash and cash equivalents of $16.8
million and believes that this cash is sufficient to meet
its projected operating requirements, which includes the Company's
current Phase 1B/2 clinical programs
and preparations for future clinical trials, 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, May 13, 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 audio 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 and to eliminate the
cardiotoxicity common with currently prescribed anthracyclines.
Annamycin is currently in development for the treatment of relapsed
or refractory acute myeloid leukemia (AML) and soft tissue sarcoma
(STS) lung metastases. All interim and preliminary data discussed
above are subject to change.
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 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) and the achievement of the
expected milestones set forth above. 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)
|
|
March 31,
2024
|
|
December 31,
2023
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
16,824
|
|
$
23,550
|
Prepaid expenses and
other current assets
|
|
2,133
|
|
2,723
|
Total current
assets
|
|
18,957
|
|
26,273
|
Furniture and
equipment, net
|
|
240
|
|
272
|
Intangible
assets
|
|
11,148
|
|
11,148
|
Operating lease
right-of-use asset
|
|
500
|
|
524
|
Total assets
|
|
$
30,845
|
|
$
38,217
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued expenses and other current liabilities
|
|
$
5,408
|
|
$
6,815
|
Total current
liabilities
|
|
5,408
|
|
6,815
|
Operating lease
liability - long-term, net of current portion
|
|
450
|
|
474
|
Warrant liability -
long term
|
|
3,400
|
|
4,855
|
Total liabilities
|
|
9,258
|
|
12,144
|
Total stockholders'
equity
|
|
21,587
|
|
26,073
|
Total liabilities and
stockholders' equity
|
|
$
30,845
|
|
$
38,217
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(in thousands,
except share and per share amounts)
|
|
2024
|
|
2023
|
Revenues
|
|
$
-
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
4,252
|
|
5,687
|
General and
administrative and depreciation and amortization
|
|
2,425
|
|
2,667
|
Total operating
expenses
|
|
6,677
|
|
8,354
|
Loss from
operations
|
|
(6,677)
|
|
(8,354)
|
Other
income:
|
|
|
|
|
Gain from change in
fair value of warrant liability
|
|
1,455
|
|
39
|
Other income,
net
|
|
11
|
|
8
|
Interest income,
net
|
|
241
|
|
392
|
Net
loss
|
|
(4,970)
|
|
(7,915)
|
|
|
|
|
|
Net loss per common
share - basic and diluted
|
|
$
(2.02)
|
|
$
(4.13)
|
Weighted average common
shares outstanding - basic and diluted
|
|
2,466,174
|
|
1,916,665
|
|
|
|
|
|
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SOURCE Moleculin Biotech, Inc.