MBX Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update
2024年11月7日 - 10:00PM
MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel precision peptide therapies for the treatment of endocrine
and metabolic disorders, today reported financial results for the
third quarter ended September 30, 2024, and highlighted recent
progress.
“The third quarter of 2024 has been transformational for MBX, as
we transitioned to a publicly traded company and advanced our
clinical-stage precision peptide programs,” said Kent Hawryluk,
President and Chief Executive Officer of MBX Biosciences. “Our team
is committed to delivering on our upcoming clinical milestones,
including completion of the last subject visit in the Phase 1 trial
of MBX 1416 anticipated by late November, and we expect to report
top line results for this trial in early January 2025. In addition,
enrollment in the Phase 2 trial of MBX 2109 in patients with
hypoparathyroidism is on track to be complete in the first quarter
of 2025, and we continue to expect topline results in the third
quarter of 2025. The capital raised in our initial public offering
in September and our Series C financing in August enables us to
execute on these clinical milestones and advance the development of
our early-stage pipeline programs, including our obesity portfolio,
as we aim to overcome limitations of current therapies and improve
the standard of care.”
Third Quarter 2024 and Recent Business
Highlights
MBX 2109
- Presented the rationale and design of the Phase 2
Avail™ trial of MBX 2109: In September
2024, the Phase 2 Avail trial of MBX 2109, the Company’s potential
long-acting parathyroid hormone (PTH) peptide prodrug, in adults
with hypoparathyroidism (HP) was featured in a poster presentation
at the American Society for Bone and Mineral Research 2024 Annual
Meeting held in Toronto, ON, Canada.
- Initiated Phase 2 Avail trial of MBX 2109: In
August 2024, the Company announced that the first patient was dosed
in the Phase 2 Avail trial of MBX 2109. Enrollment is expected to
complete in the first quarter of 2025 with topline results expected
in the third quarter of 2025.
MBX 1416
- Last Subject Last Visit in MBX 1416 Phase 1 trial
anticipated by late November 2024: MBX expects the last
subject visit to be completed by the end of November in the Phase 1
single and multiple ascending dose trial of MBX 1416, the Company’s
long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in
development for the treatment of post-bariatric hypoglycemia. The
Company plans to announce topline results in early January
2025.
MBX 4291
- Progressing MBX 4291 IND-enabling studies: MBX
is in the process of completing investigational new drug (IND)
enabling studies for its GLP-1/GIP co-agonist prodrug MBX 4291 for
the potential treatment of obesity and expects to submit an IND
application to the U.S. Food and Drug Administration in the second
quarter of 2025. The Company also has additional programs in the
lead optimization stage of development for the treatment of obesity
and associated comorbidities.
Corporate
- Completed upsized initial public offering (IPO) and
Series C financing: In September 2024, MBX completed its
IPO following its Series C financing in August. Total gross
proceeds from the Initial Public Offering and Series C financing
were approximately $251.2 million.
Third Quarter 2024 Financial Results
- Cash and Cash Equivalents and Marketable Securities: As of
September 30, 2024, MBX had cash, cash equivalents and marketable
securities of $277.1 million compared to $80.7 million as of
December 31, 2023. Based on its current operating plan, management
expects the combined cash, cash equivalents and marketable
securities balance to fund operations into mid-2027.
- R&D Expenses: Research and development expenses for the
three months ended September 30, 2024, were $16.7 million compared
to $9.1 million for the same period in 2023. The increase of $7.7
million was driven by costs associated with ongoing IND-enabling
studies for MBX 4291 and the ongoing MBX 2109 Phase 2 clinical
trial.
- G&A Expenses: General and administrative expenses for
the three months ended September 30, 2024, were $2.9 million
compared to $1.9 million for the same period in 2023. The increase
of $1.0 million was driven by increased personnel-related costs as
the Company expanded its infrastructure to support its growth in
operations.
- Net Loss: Net loss for the three months ended September
30, 2024, was $18.1 million compared to a net loss of $10.2 million
for the same period in 2023.
About MBX BiosciencesMBX
Biosciences is a biopharmaceutical company focused on the discovery
and development of novel precision peptide therapies based on its
proprietary PEP™ platform, for the treatment of endocrine and
metabolic disorders. The Company is advancing a pipeline of novel
candidates for endocrine and metabolic disorders with clinically
validated targets, established endpoints for regulatory approval,
significant unmet medical needs and large potential market
opportunities. The Company’s pipeline includes its lead product
candidate MBX 2109, in Phase 2 development for the treatment of
chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development
for the treatment of post-bariatric hypoglycemia (PBH); and an
obesity portfolio that includes MBX 4291, as well as multiple
discovery and pre-clinical candidates in development for the
treatment of obesity. The Company is based in Carmel, Indiana. To
learn more, please visit the Company website at www.mbxbio.com and
follow it on LinkedIn.
About MBX’s Proprietary Precision
Endocrine Peptide (PEP™) Platform MBX was founded by
global leaders with a transformative approach to peptide drug
design and development. Leveraging this expertise, the Company
designed its proprietary Precision Endocrine Peptide™ (PEP™)
platform to overcome the key limitations of unmodified and modified
peptide therapies and to improve clinical outcomes and simplify
disease management for patients. PEPs are selectively engineered to
have optimized pharmaceutical properties, including extended
time-action profiles and consistent drug concentrations with low
peak-to-trough concentration ratios, consistent exposure to target
tissues, and less frequent dosing.
Forward-Looking StatementsThis
press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, each as amended. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements include, but are not limited to, express
or implied statements regarding: MBX Biosciences’ expectations
regarding the Phase 2 Avail™ trial of MBX 2109, including the
timing of patient enrollment and topline results, the Phase 1 trial
of MBX 1416, including the timing of the last subject visit and
topline results, IND-enabling studies in MBX 4291, including MBX
Biosciences’ intention to submit an IND and the timing related
thereto, and other product candidates in the lead optimization
stage; and expectations regarding MBX Biosciences’ uses of capital,
expenses and financial results, including the expected cash
runway.
Forward-looking statements are based on management’s current
expectations and are subject to risks and uncertainties that could
negatively affect MBX Biosciences’ business, operating results,
financial condition and stock value. Factors that could cause
actual results to differ materially from those currently
anticipated include: risks relating to the Company’s research and
development activities; MBX Biosciences’ ability to execute on its
strategy including obtaining the requisite regulatory approvals on
the expected timeline, if at all; uncertainties relating to
preclinical and clinical development activities; the Company’s
dependence on third parties to conduct clinical trials, manufacture
its product candidates and develop and commercialize its product
candidates, if approved; MBX Biosciences’ ability to attract,
integrate and retain key personnel; risks related to the Company’s
financial condition and need for substantial additional funds in
order to complete development activities and commercialize a
product candidate, if approved; risks related to regulatory
developments and approval processes of the U.S. Food and Drug
Administration and comparable foreign regulatory authorities; risks
related to establishing and maintaining MBX Biosciences’
intellectual property protections; and risks related to the
competitive landscape for MBX Biosciences’ product candidates; as
well as other risks described in “Risk Factors,” in MBX
Biosciences’ Registration Statement on Form S-1 filed with the
Securities and Exchange Commission (SEC), as well as subsequent
filings with the SEC. MBX Biosciences expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in its expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law, and claims the protection of the safe
harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
MBX uses and intends to continue to use its Investor Relations
website as a means of disclosing material nonpublic information and
for complying with its disclosure obligations under Regulation FD.
Accordingly, investors should monitor the Company’s Investor
Relations website, in addition to following the Company’s press
releases, SEC filings, public conference calls, presentations, and
webcasts.
Media Contact:Kate BurdickInizio Evoke
Commskate.burdick@inizioevoke.com 860-462-1569
Investor Contact:Jim DeNikeMBX
Biosciencesjdenike@mbxbio.com
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MBX
BIOSCIENCES, INC. |
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CONDENSED
FINANCIAL INFORMATION |
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(Unaudited) |
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Condensed Statements of Operations Data: |
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
(in thousands, except per share and per share data) |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
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|
|
2023 |
|
|
Operating
expenses: |
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|
|
|
|
|
|
|
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Research and development |
|
$ |
16,747 |
|
|
$ |
9,073 |
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$ |
42,192 |
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$ |
20,807 |
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General and administrative |
|
|
2,865 |
|
|
|
1,872 |
|
|
|
7,392 |
|
|
|
4,513 |
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Total
operating expenses |
|
|
19,612 |
|
|
|
10,945 |
|
|
|
49,584 |
|
|
|
25,320 |
|
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Loss from
operations |
|
|
(19,612 |
) |
|
|
(10,945 |
) |
|
|
(49,584 |
) |
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|
(25,320 |
) |
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Interest and other income, net |
|
|
1,470 |
|
|
|
783 |
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|
|
3,248 |
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|
|
1,600 |
|
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Net
loss |
|
$ |
(18,142 |
) |
|
$ |
(10,162 |
) |
|
$ |
(46,336 |
) |
|
$ |
(23,720 |
) |
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Net loss per
common share, basic and diluted |
|
$ |
(2.78 |
) |
|
$ |
(9.40 |
) |
|
$ |
(15.42 |
) |
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$ |
(24.28 |
) |
|
Weighted
average number of common shares outstanding used in computation of
net loss per common share, basic and diluted |
|
|
6,515,616 |
|
|
|
1,081,349 |
|
|
|
3,004,382 |
|
|
|
976,824 |
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Condensed Balance Sheet Data: |
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September 30, |
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December 31, |
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(in
thousands) |
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2024 |
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2023 |
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Cash, cash
equivalents and marketable securities |
|
|
|
|
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$ |
277,063 |
|
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$ |
80,676 |
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Working
capital(1) |
|
|
|
|
|
|
270,250 |
|
|
|
79,539 |
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Total
assets |
|
|
|
|
|
|
282,400 |
|
|
|
84,180 |
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Total
liabilities |
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|
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11,032 |
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|
4,291 |
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Convertible
preferred stock |
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|
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- |
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|
|
152,357 |
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Accumulated
deficit |
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|
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(121,919 |
) |
|
|
(75,583 |
) |
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Total
stockholders equity (deficit) |
|
|
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271,368 |
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(72,468 |
) |
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(1) Working capital is
defined as total current assets less total current liabilities. See
our financial statements and the related notes thereto included in
our Quarterly Report on Form 10-Q for the Quarter Ending September
30, 2024 for further details regarding our current assets and
current liabilities. |
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MBX Biosciences (NASDAQ:MBX)
過去 株価チャート
から 11 2024 まで 12 2024
MBX Biosciences (NASDAQ:MBX)
過去 株価チャート
から 12 2023 まで 12 2024