— FDA Cleared IND Application for STAR-0215 for the Treatment of Hereditary Angioedema —
— Phase 1a Clinical Trial of STAR-0215 in Healthy Subjects Initiated, Preliminary Results Anticipated by Year-End 2022 —
— Company to Host a Virtual R&D Day on September 30 —
BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the second quarter ended June 30, 2022, and provided a corporate update.
“We are thrilled to announce that we have initiated dosing in our Phase 1a trial of STAR-0215 which will provide data that we believe will validate STAR-0215’s differentiated best-in-class profile, including prolonged half-life,” said Jill C. Milne, Ph.D., Chief Executive Officer of Astria. “This is an important milestone as we evaluate STAR-0215 in humans for the first time, and it advances us one step closer to achieving our goal of bringing patients with HAE a therapy that could reduce their disease and treatment burden. We expect preliminary results from the Phase 1a trial by the end of this year.”
Phase 1a Clinical Trial of STAR-0215
- The Food and Drug Administration cleared Astria’s Investigational New Drug application for STAR-0215 and the company initiated a Phase 1a clinical trial with preliminary results anticipated by year-end 2022.
- The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center. Approximately 24 healthy subjects are expected to receive a single dose of STAR-0215 or placebo in at least three cohorts of 100 mg, 300 mg, and 600 mg administered subcutaneously.
- The trial will assess safety and tolerability and aims to establish the prolonged half-life and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism for STAR-0215 as a potential best-in-class treatment for HAE.
- The company plans to initiate a multi-center, global Phase 1b/2 trial in participants with HAE in 2023.
STAR-0215 Highlights
- At the Fc Receptor and IgG Targeted Therapies Conference in April, Astria presented pharmacokinetic modeling data supporting the potential that STAR-0215 could effectively inhibit plasma kallikrein and prevent HAE attacks with subcutaneous dosing volumes appropriate for a self-injectable device dosed once every three months or longer.
- Astria presented new preclinical data at the European Academy of Allergy and Clinical Immunology 2022 Hybrid Congress that demonstrate STAR-0215’s rapid and durable inhibition of plasma kallikrein in cynomolgus monkeys, supporting the potential for once every three month or longer dosing in humans. The study demonstrated rapid inhibition of plasma kallikrein after subcutaneous administration. Inhibition of high molecular weight kininogen cleavage was rapid and sustained throughout the entire 84-day dose-free period in the extended portion of the study. These data confirm the long half-life of STAR-0215 and demonstrate prolonged pharmacological activity of STAR-0215 in circulation in cynomolgus monkeys.
Corporate Highlights
- Astria named Chris Morabito, M.D., as Chief Medical Officer. Dr. Morabito brings more than 20 years of clinical development experience in rare diseases and other indications to Astria. He has spent his career developing innovative medicines that improve the health outcomes of patients with complex and difficult to treat diseases.
- The company plans to host a virtual R&D Day: Update on STAR-0215 and its Clinical Development for the Prevention of HAE Attacks on September 30, 2022 from 10:30am to 12:00pm ET. Registration for the event can be accessed using the following link: https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MTk2MA==
First Quarter 2022 Financial Results
Cash Position: As of June 30, 2022, Astria had cash, cash equivalents and short-term investments of $102.5 million, compared to $112.8 million as of March 31, 2022. 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 June 30, 2022, was $10.1 million, compared to $7.4 million for the three months ended June 30, 2021.
R&D Expenses: Research and development expenses were $6.6 million for the three months ended June 30, 2022, compared to $3.5 million for the three months ended June 30, 2021.
G&A Expenses: General and administrative expenses were $4.8 million for the three months ended June 30, 2022, compared to $4.0 million for the three months ended June 30, 2021.
Operating Loss: Loss from operations was $11.4 million for the three months ended June 30, 2022, compared to $7.5 million for the three months ended June 30, 2021.
Net Loss: Net loss was $11.3 million for the three months ended June 30, 2022, compared to a net loss of $7.5 million for the three months ended June 30, 2021.
Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.86 for the three months ended June 30, 2022, compared to a net loss basic and diluted of $5.33 per share for the three months ended June 30, 2021.
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 clinical development for the treatment of hereditary angioedema. 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: the Company’s projected cash runway; the expected timing and nature of the preliminary results from the Phase 1a clinical trial for STAR-0215; the planned timing of initiation of a Phase 1b/2 clinical trial of STAR-0215; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE, including the anticipated half-life and dosing frequency, volumes and administration, suggested by preclinical and pharmacokinetic modeling data, 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 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 and modeling data 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 and supply 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 anticipated position and attributes of STAR-0215 in HAE based on its pre-clinical profile, pharmacokinetic modeling and other data; 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) (Unaudited) |
||||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
||
| Operating expenses: | ||||||||||||||||
| Research and development |
$ |
6,617 |
|
$ |
3,478 |
|
$ |
16,975 |
|
$ |
6,071 |
|
||||
| General and administrative |
|
4,832 |
|
|
4,008 |
|
|
9,852 |
|
|
6,881 |
|
||||
| Acquired in-process research and development |
|
– |
|
|
– |
|
|
– |
|
|
164,617 |
|
||||
| Total operating expenses |
|
11,449 |
|
|
7,486 |
|
|
26,827 |
|
|
177,569 |
|
||||
| Loss from operations |
|
(11,449 |
) |
|
(7,486 |
) |
|
(26,827 |
) |
|
(177,569 |
) |
||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income |
|
214 |
|
|
40 |
|
|
269 |
|
|
53 |
|
||||
| Other expense, net |
|
(15 |
) |
|
(20 |
) |
|
(16 |
) |
|
(34 |
) |
||||
| Total other income, net |
|
199 |
|
|
20 |
|
|
253 |
|
|
19 |
|
||||
| Net loss |
|
(11,250 |
) |
|
(7,466 |
) |
|
(26,574 |
) |
|
(177,550 |
) |
||||
| Dividend on convertible preferred stock related to beneficial conversion feature and issuance costs |
|
– |
|
|
(24,437 |
) |
|
– |
|
|
(24,437 |
) |
||||
| Net loss attributable to common shareholders |
$ |
(11,250 |
) |
$ |
(31,903 |
) |
$ |
(26,574 |
) |
$ |
(201,987 |
) |
||||
| Net loss per share – basic and diluted |
$ |
(0.86 |
) |
$ |
(5.33 |
) |
$ |
(2.04 |
) |
$ |
(41.55 |
) |
||||
| Weighted-average common shares outstanding used in net loss per share – basic and diluted |
|
13,016,955 |
|
|
5,980,097 |
|
|
13,016,955 |
|
|
4,861,279 |
|
||||
|
Astria Therapeutics, Inc. Selected Consolidated Balance Sheets Data (In thousands) (Unaudited) |
||||||||
|
June 30, |
|
December 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
||
| Assets | ||||||||
| Cash and cash equivalents |
$ |
29,826 |
|
$ |
86,508 |
|
||
| Short-term investments |
|
72,652 |
|
|
39,000 |
|
||
| Right-of-use asset |
|
1,282 |
|
|
394 |
|
||
| Other current and long-term assets |
|
1,533 |
|
1,612 |
||||
| Total assets |
|
105,293 |
|
|
127,514 |
|
||
| Liabilities and stockholders’ equity | ||||||||
| Current portion of operating lease liabilities |
|
573 |
|
|
365 |
|
||
| Long-term portion of operating lease liabilities |
|
649 |
|
|
– |
|
||
| Other current and long-term liabilities |
|
4,652 |
|
|
4,838 |
|
||
| Total liabilities |
|
5,874 |
|
|
5,203 |
|
||
| Total stockholders’ equity |
$ |
99,419 |
|
$ |
122,311 |
|
||
|
Astria Therapeutics, Inc. Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited) |
||||||||
|
Six Months Ended June 30, |
||||||||
|
|
2022 |
|
|
|
2021 |
|
||
| Net cash used in operating activities |
$ |
(22,620 |
) |
$ |
(16,116 |
) |
||
| Net cash (used in) provided by investing activities |
|
(33,899 |
) |
|
26,445 |
|
||
| Net cash provided by financing activities |
|
– |
|
|
104,261 |
|
||
| Net (decrease) increase in cash, cash equivalents and restricted cash |
$ |
(56,519 |
) |
$ |
114,590 |
|
||
Contacts
Investor relations:
Andrea Matthews
investors@astriatx.com
Media:
Elizabeth Higgins
media@astriatx.com