Market Newsdesk

SAN DIEGO, March 30, 2023 (GLOBE NEWSWIRE) —  aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the publication of a review article, titled, “Efzofitimod: a novel anti-inflammatory agent for sarcoidosis,” in the peer-reviewed journal Sarcoidosis, Vasculitis and Diffuse Lung Diseases. The publication is available on the journal’s website and at:      https://doi.org/10.36141/svdld.v40i1.14396.

In the paper, the authors, led by Robert P. Baughman, M.D., Professor of Medicine at the University of Cincinnati Medical Center, describe the mechanism for efzofitimod as it relates to the granulomatous inflammation central to the pathophysiology of sarcoidosis, including the role of its binding partner neuropilin-2 (NRP2), a cell surface receptor that is highly expressed in sarcoid granulomas. The authors also review the preclinical and clinical data generated for efzofitimod that support its anti-inflammatory properties and the potential for it to be a novel therapeutic approach to immune-mediated fibrotic lung diseases such as pulmonary sarcoidosis.

“This publication highlights efzofitimod as a first-in-class biologic for the treatment of sarcoidosis based on a review of the evolving mechanistic understanding of this novel immunomodulator and the clinical data generated in pulmonary sarcoidosis patients,” said Dr. Baughman. “Oral corticosteroids remain the cornerstone of treatment for symptomatic sarcoidosis, but long-term treatment often comes with significant side effects and reduced quality of life. A treatment such as efzofitimod, which may reduce steroid burden while improving lung function and quality of life measures, is greatly needed—and long overdue— for patients with this disease.”

“This first-ever review recognizes the potential of efzofitimod to be a transformative therapy for patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “EFZO-FIT™ is the first Phase 3 interventional study to be conducted in pulmonary sarcoidosis and is currently enrolling patients at multiple centers in the U.S, Europe and Japan. We believe this study presents a landmark opportunity to generate the most comprehensive investigational dataset for a treatment for sarcoidosis and represents a historic step forward in the attempt to develop a new treatment for patients with this disease.”

Efzofitimod is a first-in-class immunomodulator that downregulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of NRP2. Efzofitimod is currently being investigated in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), in the global pivotal Phase 3 EFZO-FIT™ study and a Phase 2 study in patients with systemic sclerosis (SSc, or scleroderma)-associated ILD is planned to start this year.

About Pulmonary Sarcoidosis

Sarcoidosis is an immune-mediated disease characterized by the formation of granulomas, clumps of inflammatory cells, in one or more organs of the body, predominantly in the lungs. Approximately 200,000 Americans live with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, with 1 in 5 cases resulting in fibrosis, or scarring, of the lungs, which causes permanent loss of lung function and in many cases death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side effects that many patients cannot tolerate long-term.

Abo
ut Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate immunes response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr is currently conducting EFZO-FIT™, a Phase 3 study of efzofitimod in pulmonary sarcoidosis patients.

Abo
ut aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is efzofitimod, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to downregulate immune engagement in fibrotic lung disease. For more information, please visit www.atyrpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding potential therapeutic benefits of efzofitimod and plans with respect to certain clinical activities. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic conditions, risks associated with the discovery, development and regulation of our product candidates, the risk that we or our partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our Quarterly Report on Form 10-Q for the quarter ended December 31, 2022 filed with the SEC on March 14, 2023, and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Ashlee Dunston
Director, Investor Relations and Corporate Communications
[email protected]

SEATTLE, Wash. and VANCOUVER, British Columbia, March 30, 2023 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced changes to the Company’s Board of Directors to continue to support the future direction of the Company.

As provided in the previously reported Cooperation Agreement, as amended, between the Company and certain of its shareholders, Mr. Stuart Duty, Mr. Thomas King, and Mr. Tom Sellig have been appointed to the Board of Directors and will be nominated for election at the Company’s Annual Meeting of Stockholders to be held in June 2023. Additionally, each of Mr. Donald Joseph, Dr. Martin Mattingly, and Mr. Jay Moyes will not be nominated for re-election at the Annual Meeting.

“We thank Mr. Joseph, Dr. Mattingly, and Mr. Moyes for their years of service to the Company and for their invaluable strategic guidance to Achieve through the Company’s growth and success,” commented Rick Stewart, Achieve’s Co-Founder and Chairman of the Board of Directors. “As we look to the future, we welcome three industry veterans who bring a wealth of leadership and experience that will be imperative as we continue to work to advance cytisinicline towards FDA approval and commercialization.”

• Mr. Stuart Duty is an experienced financial executive with over 30 years in finance and investment banking. Mr. Duty has focused primarily on biotechnology and specialty pharmaceuticals clients for much of his career, advising senior executives and boards on a range of financing activities and strategic transactions. Mr. Duty is currently a Senior Advisor to Guggenheim Securities, LLC. Previously, he held senior roles at Piper Jaffray, Montgomery Securities, and held operating roles at Oracle Partners and Curative Technologies. Mr. Duty holds a B.A. in Biochemistry from Occidental College and an M.B.A. from Harvard Business School.
• Mr. Thomas King has over 40 years of leadership experience in both publicly traded and privately owned biopharmaceutical organizations, ranging from large to development-stage companies. He currently serves on the board of directors of Satsuma Pharmaceuticals, Concentric Analgesics, Inc. and Kinaset Therapeutics, Inc. Previously, Mr. King served as President, Chief Executive Officer, and a member of the board of directors of each of Vivus Inc., Alexza Pharmaceuticals, Cognetix Inc., and Anesta Corporation. Mr. King received a B.A. in chemistry from McPherson College and an M.B.A. from the University of Kansas Graduate School of Business.
• Mr. Tom Sellig brings more than 30 years of global experience in the life sciences and pharmaceutical services industries. He is currently Chief Executive Officer of Adare Pharma Solutions, a global technology-driven Contract Development and Manufacturing Organization. Mr. Sellig previously served as Chief Executive Officer of LabConnect, a clinical trial laboratory services organization. He received his B.A. in Economics from Vanderbilt University and an M.B.A. from New York University.

Investors are invited to read the Company’s Current Reports on Form 8-K filed with the Securities and Exchange Commission on March 6, 2023, for a further description of these events.

About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.²

In addition, there are over 9 million adults in the United States who use e-cigarettes, also known as vaping.³ While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.⁴ In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.⁵ Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.⁶ Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.

Investor Relations Contact 
Rich Cockrell  
[email protected] 
(404) 736-3838  

Media Contact 
Glenn Silver 
[email protected] 
(646) 871-8485 

References

¹World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
²U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
³Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep 2022;71:397–405.
⁴Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].
⁵Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.
⁶Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.

PLANO, Texas, March 30, 2023 (GLOBE NEWSWIRE) — Integer Holdings Corporation (NYSE:ITGR) announced today that it plans to release financial and operational results for first quarter 2023, at 7 a.m. Central Time (CT) / 8 a.m. Eastern Time (ET) on Thursday, April 27, 2023. Following the release, Integer management will host a webcast at 8 a.m. CT / 9 a.m. ET to discuss these results. Other forward-looking and material information may also be discussed during this call.

Conference call details:

• Date:  Thursday, April 27, 2023
• Time:  8 a.m. CT / 9 a.m. ET
• Domestic dial-in number: (888) 330-3567
• International dial-in number: (646) 960-0842
• Conference ID:  9252310
• Webcast Registration: ITGR Q1 2023 Earnings Call

An audio replay will be available for 7 days and can be accessed by dialing (800) 770-2030 or (647) 362-9199 and using Conference ID 9252310. The conference call will also be available live or via archived replay on the Investor Relations section of the Integer website at: investor.integer.net.

From time to time, the Company posts information that may be of interest to investors on its website at investor.integer.net. To automatically receive Integer financial news by email, please visit investor.integer.net and subscribe to email alerts.

About Integer


^®



Integer Holdings Corporation (NYSE:ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, vascular, portable medical and orthopedics markets. The Company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide. In addition, the Company develops batteries for high-end niche applications in energy, military, and environmental markets. The Company’s brands include Greatbatch Medical^®, Lake Region Medical^® and Electrochem^®. Additional information is available at www.integer.net.