-- New Phase 1a Results Confirm Potential for
STAR-0215 to Prevent HAE Attacks with Dosing 2 or 4 Times Per Year
--
-- ALPHA-STAR Trial of STAR-0215 Initial
Proof-of-Concept Data in Patients Now Expected Q1 2024 --
-- STAR-0310, Potential Best-in-Class OX40
Program for the Treatment of Atopic Dermatitis, Expected IND
Submission by Year-End 2024 and Phase 1a Initiation in Q1 2025
--
-- Webcast Today at 8:30am ET --
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for rare and
niche allergic and immunological diseases, today reported financial
results for the third quarter ended September 30, 2023 and provided
a corporate update.
“We are realizing our vision of growing an allergy and
immunology company with a pipeline of potential best-in-class
therapies,” said Jill C. Milne, Ph.D., Chief Executive Officer at
Astria Therapeutics. “The STAR-0215 program is in a strong position
to achieve our goal of becoming a first-choice preventative therapy
for hereditary angioedema, and data from the Phase 1a healthy
subject trial recently shared at ACAAI support the potential to
provide patients with dosing options two or four times per year,
without compromising on safety or efficacy. We now expect to
deliver initial proof-of-concept results in Q1 2024 from the Phase
1b/2 ALPHA-STAR trial in HAE patients. With the addition of
STAR-0310, an OX40 inhibitor for atopic dermatitis which we believe
has the potential to be best-in-class, we are excited about the
future for Astria as we work towards important milestones for
STAR-0215 and STAR-0310 next year.”
STAR-0215
- Additional results from the Phase 1a trial were shared at the
ACAAI Annual Meeting in Anaheim, CA. STAR-0215 was well-tolerated
with no serious adverse events or discontinuations due to an
adverse event, and low risk of injection pain. STAR-0215 achieved
potentially therapeutic levels in less than one day and showed an
estimated half-life of up to 127 days. Pharmacokinetic (PK)
modeling of every 3 month and every 6 month clinical dose regimens
predict concentrations that will continuously maintain drug levels
believed to be sufficient for HAE attack prevention.
Pharmacodynamic (PD) data showed statistically significant
inhibition of plasma kallikrein for 140 to 224 days after single
doses greater than 100 mg. These results demonstrate early proof of
concept in healthy subjects for STAR-0215 as a potential
preventative HAE therapy with a favorable safety profile, long
half-life, and durable PD.
- The ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with
hereditary angioedema (HAE) is on track and enrolling the third and
final cohort. Initial proof-of-concept results are now expected in
the first quarter of 2024. ALPHA-STAR is a global, open-label,
proof-of-concept trial assessing single and multiple doses of
STAR-0215 in patients with HAE types I and II. The trial is
evaluating safety and tolerability, changes in HAE attack rate, PK,
PD, and quality-of-life assessments. For each dose cohort, efficacy
will be assessed at 3 months and 6 months after the last STAR-0215
dose administered.
- A Long-Term Open-Label Trial named ALPHA-SOLAR has been
initiated and is enrolling participants from ALPHA-STAR, with data
now accruing in participants who have received multiple doses of
STAR-0215. The trial is assessing the long-term safety,
tolerability, and efficacy of STAR-0215. Participants are receiving
STAR-0215 every three or six months.
- Pending proof-of-concept results from the ALPHA-STAR trial,
Astria expects to progress directly to a pivotal Phase 3 trial
which is anticipated to initiate in the first quarter of 2025.
- Additional preclinical results were shared in the Journal of
Pharmacology and Experimental Therapeutics that support STAR-0215’s
potential as a best-in-class plasma kallikrein inhibitor.
- Astria presented at the Hereditary Angioedema Association
(HAEA) National Summit in July, and the Hereditary Angioedema
International EMEA meeting in September, sharing results from a
research survey where patients prioritized attack-free status as
their most important target for therapeutic efficacy in HAE
clinical trials.
STAR-0310
- Astria entered into an exclusive worldwide license agreement
with Ichnos Sciences for an inhibitory OX40 portfolio. Astria is
developing STAR-0310, a monoclonal antibody OX40 antagonist that
incorporates YTE technology, for the treatment of atopic dermatitis
(AD).
- STAR-0310, a preclinical stage program, has the potential to
have the best-in-class profile in AD. Astria expects to submit an
Investigational New Drug (IND) application for STAR-0310 by
year-end 2024 and plans to initiate a Phase 1a clinical trial in
healthy subjects in the first quarter of 2025, with initial results
from the trial expected in the third quarter of 2025.
Webcast Information
- The Company will host a webcast today at 8:30am ET. Interested
parties may join via the Investors section of the Astria website,
www.astriatx.com, or with the following link:
https://lifescievents.com/event/astria-2/. The webcast will be
archived for 90 days.
Third Quarter 2023 Financial Results
Cash Position: As of September 30, 2023, Astria had cash,
cash equivalents and short-term investments of $188.8 million,
compared to $203.0 million as of June 30, 2023. The Company expects
that its cash, cash equivalents and short-term investments as of
September 30, 2023, together with proceeds from a $64.0 million
underwritten offering in October 2023, will be sufficient to fund
its current operating plan into 2026. The Company’s current
operating plan includes the development of STAR-0215 and STAR-0310,
including (i) for STAR-0215, support for all program activities up
to the initiation of the planned Phase 3 pivotal trial and (ii) for
STAR-0310, the anticipated submission of an IND and the initiation
and completion of the planned Phase 1a clinical trial of healthy
subjects (and any related anticipated milestone payments). Net cash
used in operating activities for the three months ended September
30, 2023 was $14.3 million, compared to $10.2 million for the three
months ended September 30, 2022.
R&D Expenses: Research and development expenses were
$13.3 million for the three months ended September 30, 2023,
compared to $7.7 million for the three months ended September 30,
2022. The increase in research and development expenses was
associated with advancement of STAR-0215 clinical development.
G&A Expenses: General and administrative expenses
were $6.9 million for the three months ended September 30, 2023,
compared to $4.7 million for the three months ended September 30,
2022.
Operating Loss: Loss from operations was $20.2 million
for the three months ended September 30, 2023, compared to $12.4
million for the three months ended September 30, 2022.
Net Loss: Net loss was $17.7 million for the three months
ended September 30, 2023, compared to a net loss of $12.0 million
for the three months ended September 30, 2022.
Net Loss Per Share Basic and Diluted: Net loss per share
basic and diluted was $0.63 for the three months ended September
30, 2023, compared to $0.87 per share for the three months ended
September 30, 2022.
About Astria Therapeutics: Astria Therapeutics is a
biopharmaceutical company, and our mission is to bring
life-changing therapies to patients and families affected by
allergic and immunological diseases. Our lead program, STAR-0215,
is a monoclonal antibody inhibitor of plasma kallikrein in clinical
development for the treatment of hereditary angioedema. Our second
program, STAR-0310, is a monoclonal antibody OX40 antagonist in
preclinical development for the treatment of atopic dermatitis.
Learn more about our company on our website, www.astriatx.com, or
follow us on Twitter and Instagram @AstriaTx and on Facebook and
LinkedIn.
Forward Looking Statements: This press release contains
forward-looking statements within the meaning of applicable
securities laws and regulations including, but not limited to,
statements regarding: our expectations regarding the potential
significance of the results from the Phase 1a clinical trial of
STAR-0215; our expectations regarding the timing, nature, goals and
results of our Phase 1b/2 ALPHA-STAR clinical trial of STAR-0215,
including the expected timing of release of initial
proof-of-concept data from such trial, and that favorable results
from such trial could allow us to move directly into a Phase 3
pivotal trial of STAR-0215 as a potential treatment for HAE; the
expected timing of the start of the Phase 3 pivotal trial of
STAR-0215; the potential for STAR-0215 to have the best-in-class
profile in HAE, the potential therapeutic benefits of STAR-0215 as
a treatment for HAE and our vision and goals for the program; the
potential for STAR-0310 to have the best-in-class profile in AD and
the potential therapeutic benefits and potential attributes of
STAR-0310 as a treatment for AD; expectations regarding the timing
of regulatory filings for STAR-0310; expectations regarding the
timing of initiation and planned design of clinical trials for
STAR-0310; the expectations regarding the timing and nature of
anticipated data for planned trials of STAR-0310; our goals and
vision for STAR-0310; ; anticipated cash runway; and the goal to
meet the unmet needs of patients with rare and niche allergic and
immunological diseases. The use of words such as, but not limited
to, “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would,” or
"vision," and similar words expressions are intended to identify
forward-looking statements. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based on Astria’s current beliefs, expectations and
assumptions regarding the future of its business, future plans and
strategies, future financial performance, results of pre-clinical
and clinical results of the Astria’s product candidates and other
future conditions. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including the following risks and uncertainties:
changes in applicable laws or regulations; the possibility that we
may be adversely affected by other economic, business, and/or
competitive factors; risks inherent in pharmaceutical research and
development, such as: adverse results in our drug discovery,
preclinical and clinical development activities, the risk that the
results of preclinical studies may not be replicated in clinical
trials, that the preliminary or interim results from clinical
trials may not be indicative of the final results, that the results
of early stage clinical trials, such as the results from the Phase
1a clinical trial, may not be replicated in later stage clinical
trials, including the ALPHA-STAR trial, the risk that we may not be
able to enroll sufficient patients in our clinical trials on a
timely basis, and the risk that any of our clinical trials may not
commence, continue or be completed on time, or at all; decisions
made by, and feedback received from, the U.S. Food and Drug
Administration and other regulatory authorities on our regulatory
and clinical trial submissions and other feedback from potential
clinical trial sites, including investigational review boards at
such sites, and other review bodies with respect to STAR-0215,
STAR-0310, and any other future development candidates; our ability
to manufacture sufficient quantities of drug substance and drug
product for STAR-0215, STAR-0310, and any other future product
candidates on a cost-effective and timely basis, and to develop
dosages and formulation for STAR-0215, STAR-0310, and any other
future product candidates that are patient-friendly and
competitive; our ability to develop biomarker and other assays,
along with the testing protocols therefore; our ability to obtain,
maintain and enforce intellectual property rights for STAR-0215,
STAR-0310, and any other future product candidates; our potential
dependence on collaboration partners; competition with respect to
STAR-0215, STAR-0310, or any of our other future product
candidates; the risk that survey results and market research may
not be accurate predictors of the commercial landscape for HAE, the
ability of STAR-0215 to compete in HAE and the anticipated position
and attributes of STAR-0215 in HAE based on clinical data to date,
its preclinical profile, pharmacokinetic modeling, market research
and other data; risks that any of our clinical trials of STAR-0310
may not commence, continue or be completed on time, or at all;
risks that results of preclinical studies of STAR-0310 will not be
replicated in clinical trials; risks with respect to the ability of
STAR-0310 to compete in AD and the anticipated position and
attributes of STAR-0310 in AD based on its preclinical profile; our
ability to manage our cash usage and the possibility of unexpected
cash expenditures; our ability to obtain necessary financing to
conduct our planned activities and to manage unplanned cash
requirements; the risks and uncertainties related to our ability to
recognize the benefits of any additional acquisitions, licenses or
similar transactions; and general economic and market conditions;
as well as the risks and uncertainties discussed in the “Risk
Factors” section of our Annual Report on Form 10-K for the period
ended December 31, 2022 and in other filings that we may make with
the Securities and Exchange Commission.
New risks and uncertainties may emerge from time to time, and it
is not possible to predict all risks and uncertainties. Astria may
not actually achieve the forecasts or expectations disclosed in our
forward-looking statements, and investors and potential investors
should not place undue reliance on Astria’s forward-looking
statements. Neither Astria, nor its affiliates, advisors or
representatives, undertake any obligation to publicly update or
revise any forward-looking statement, whether as result of new
information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as
representing Astria’s views as of any date subsequent to the date
hereof.
Astria Therapeutics,
Inc.
Consolidated Statements of
Operations
(In thousands, except share and
per share data)
(Unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Operating expenses: Research and development
$
13,338
$
7,698
$
30,460
$
24,673
General and administrative
6,898
4,688
18,371
14,540
Total operating expenses
20,236
12,386
48,831
39,213
Loss from operations
(20,236
)
(12,386
)
(48,831
)
(39,213
)
Other income (expense): Interest and investment income
2,527
437
7,404
706
Other expense, net
(18
)
(48
)
(54
)
(64
)
Total other income, net
2,509
389
7,350
642
Net loss
(17,727
)
(11,997
)
(41,481
)
(38,571
)
Net loss per share attributable to common shareholders - basic and
diluted
$
(0.63
)
$
(0.87
)
$
(1.48
)
$
(2.91
)
Weighted-average common shares outstanding used in net loss per
share - basic and diluted
28,040,173
13,742,385
28,002,663
13,261,422
Astria Therapeutics,
Inc.
Selected Consolidated Balance
Sheets Data
(In thousands)
(Unaudited)
September 30,
December 31,
2023
2022
Assets Cash and cash equivalents
$
119,806
$
20,525
Short-term investments
69,000
205,912
Right-of-use asset
514
948
Other current and long-term assets
4,541
3,248
Total assets
193,861
230,633
Liabilities and stockholders’ equity Current portion of
operating lease liabilities
488
582
Long term portion of operating lease liabilities
-
357
Other current and long-term liabilities
8,894
8,478
Total liabilities
9,382
9,417
Total stockholders’ equity
$
184,479
$
221,216
Astria Therapeutics,
Inc.
Selected Consolidated
Statements of Cash Flows Data
(In thousands)
(Unaudited)
Nine Months Ended September
30,
2023
2022
Net cash used in operating activities
$
(38,207
)
$
(32,869
)
Net cash provided by (used in) by investing activities
137,068
(31,949
)
Net cash provided by financing activities
420
24,324
Net increase (decrease) in cash, cash equivalents and restricted
cash
$
99,281
$
(40,494
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113805218/en/
Astria: Investor Relations and
Media: Elizabeth Higgins investors@astriatx.com
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