Full Press Release Details
Astria Therapeutics Reports Third Quarter 2021
Financial Results and Provides a Corporate Update
-- STAR-0215, in Development to Treat
HAE, on Track for Initial Phase 1 Clinical Results Expected by Year End 2022 --
-- New Preclinical Data on STAR-0215
Demonstrating High Potency and Extended Plasma Half-Life --
-- Findings on Burdens of Disease
and Treatment in HAE Support Substantial Need to Decrease Patient Burden --
BOSTON, Mass., November 10, 2021 - Astria
Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE),
today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
"Our new company name, Astria, embodies
our commitment to put patients first in all that we do. Astria originates from the Greek word for star, and patients are our guiding stars.
Our goal is to develop the most patient-friendly preventative treatment option for HAE with dosing once every three months or longer,"
said Jill C. Milne, Ph.D., Chief Executive Officer of Astria Therapeutics. "With STAR-0215, we believe we can reduce treatment burden,
and we are looking forward to advancing development of STAR-0215 through clinical proof of concept with initial results anticipated by
STAR-0215 (formerly QLS-215) for the Treatment
Corporate Highlights
Third Quarter 2021 Financial Results
Position: As of September 30, 2021, Astria had cash and cash equivalents of $131.8
million, compared to $139.5 million as of June 30,
2021. The Company expects that it has sufficient cash to fund its current operating plan through 2023. Net cash used in operating activities
for the three months ended September 30, 2021, was $7.7 million, compared to $9.9
million for the three months ended September 30, 2020.
Expenses: Research and development expenses were $3.8 million for the three months ended
September 30, 2021, compared to $7.8 million for the three months ended September 30, 2020.
Expenses: General and administrative expenses were $4.1 million for the three months ended September 30, 2021, compared to $3.1 million
for the three months ended September 30, 2020.
Loss: Loss from operations was $7.9 million for the three months ended September 30, 2021, compared to $10.9 million for the three
months ended September 30, 2020.
Net loss was $7.9 million for the three months ended September 30, 2021, compared to a net loss of $10.9 million for the three months
ended September 30, 2020.
Per Share Basic and Diluted: Net loss per share basic and diluted was $0.61 for the three months ended September 30, 2021, compared
to a net loss basic and diluted of $3.36 per share for the three months ended September 30, 2020.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company,
and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases.
Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of
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: the
Company's projected cash runway; expectations regarding the timing for the filing of an IND and commencement of a Phase 1
clinical trial for STAR-0215, the timing of the initial results from such trial and that the results from such trial could provide
clinical proof of concept for the activity and plasma half-life improvements for STAR-0215; the potential attributes and
differentiated profile of STAR-0215 as a treatment for HAE, and the potential commercial opportunity for STAR-0215 in HAE; the need
for effective treatments for HAE; and the Company's broader 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," or "would" 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 the Company'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 Company'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 risks and uncertainties:
related to the Company's ability to recognize the anticipated benefits of the Quellis acquisition; changes in applicable laws
or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors,
including the COVID-19 pandemic; 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 pre-clinical studies may not be replicated
in clinical studies, the Company's ability to enroll patients in our clinical trials, and the risk that any of the
Company's clinical trials may not commence, continue or be completed on time, or at all; decisions made by, or feedback
received from, the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and other review
bodies with respect to STAR-0215 and any future product candidates; the Company's ability to manufacture sufficient quantities
of drug substance and drug product on a cost-effective and timely basis; the Company's ability to obtain, maintain and enforce
intellectual property rights for STAR-0215 and any other future product candidates; competition with respect to STAR-0215 in HAE or
with respect to any other future product candidates; the risk that survey results and market research may not be accurate predictors
of the commercial landscape for HAE and the anticipated position of STAR-0215 in HAE based on its pre-clinical profile; the
Company's ability to manage its cash usage and the possibility of unexpected cash expenditures; the Company's ability to
obtain necessary financing to conduct its planned activities and to manage unplanned cash requirements; general economic and market
conditions; as well as the risks and uncertainties set forth under the caption "Risk Factors" in the Company's
most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other
important factors in the Company's subsequent filings with the SEC. New risks and uncertainties may emerge from time to time,
and it is not possible to predict all risks and uncertainties. The Company 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 the
Company's forward-looking statements. Neither the Company, 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 the Company'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)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,788 | $ | 7,806 | $ | 9,859 | $ | 19,845 | ||||||||
| General and administrative | 4,110 | 3,057 | 10,992 | 8,612 | ||||||||||||
| Acquired in-process research and development | - | - | 164,617 | - | ||||||||||||
| Total operating expenses | 7,898 | 10,863 | 185,468 | 28,457 | ||||||||||||
| Loss from operations | (7,898 | ) | (10,863 | ) | (185,468 | ) | (28,457 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 35 | 4 | 89 | 231 | ||||||||||||
| Other expense, net | (8 | ) | (3 | ) | (42 | ) | (96 | ) | ||||||||
| Total other income, net | 27 | 1 | 47 | 135 | ||||||||||||
| Net loss | (7,871 | ) | (10,862 | ) | (185,421 | ) | (28,322 | ) | ||||||||
| Dividend on convertible preferred stock related to beneficial conversion feature and issuance costs | - | - | (24,437 | ) | - | |||||||||||
| Net loss attributable to common shareholders | $ | (7,871 | ) | $ | (10,862 | ) | $ | (209,858 | ) | $ | (28,322 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.61 | ) | $ | (3.36 | ) | $ | (27.81 | ) | $ | (9.56 | ) | ||||
| Weighted-average common shares outstanding used in net loss per share - basic and diluted | 12,830,782 | 3,237,477 | 7,546,969 | 2,961,623 |
Astria Therapeutics, Inc.
Selected Consolidated Balance Sheets Data
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 131,777 | $ | 24,930 | ||||
| Short-term investments | - | 20,000 | ||||||
| Right-of-use asset | 557 | 966 | ||||||
| Other current and long-term assets | 2,795 | 1,560 | ||||||
| Total assets | 135,129 | 47,456 | ||||||
| Liabilities and stockholders' equity | ||||||||
| Current portion of operating lease liabilities | 541 | 649 | ||||||
| Long-term portion of operating lease liabilities | - | 397 | ||||||
| Other current and long-term liabilities | 4,159 | 5,741 | ||||||
| Total liabilities | 4,700 | 6,787 | ||||||
| Total stockholders' equity | $ | 130,429 | $ | 40,669 |
Astria Therapeutics, Inc.
Selected Consolidated Statements of Cash Flows
| Nine Months Ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| Net cash used in operating activities | $ | (23,865 | ) | $ | (24,424 | ) | ||
| Net cash provided by investing activities | 26,445 | 26,310 | ||||||
| Net cash provided by financing activities | 104,267 | 40,829 | ||||||
| Net increase in cash, cash equivalents and restricted cash | $ | 106,847 | $ | 42,715 |