Market Newsdesk

SEATTLE and VANCOUVER, British Columbia, May 06, 2025 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV) a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that it will report its first quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Tuesday May 13, 2025, at 8:30 AM EDT.

To access the webcast, please use the following link: 1Q25 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13752599. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.

About Achieve Life Sciences, Inc.

Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

About Cytisinicline

There are approximately 29 million adults in the United States who smoke combustible cigarettes.¹ 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.^2,3 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.³

In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.⁴ In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.⁵ There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need.

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 nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.

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 and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. 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 and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes 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 macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict 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.

Achieve Contact

Nicole Jones
[email protected]
425-686-1510

References

¹VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
³U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
⁴Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
⁵Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

Two posters presented at Digestive Disease Week (DDW) 2025

Preclinical results indicate that PALI-2108 effectively modulates inflammatory pathways in the colon, promoting a favorable immune response

Company advancing Phase 1a/b study of PALI-2108 and has demonstrated a favorable safety profile in single-ascending-dose cohorts

Carlsbad, CA, May 06, 2025 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the presentation of positive preclinical data from PALI-2108, an orally administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients with ulcerative colitis (UC). The presented data highlighted the efficacy and safety profile of PALI-2108 in a mouse model of colitis, with a particular focus on its impact on PDE4B expression, cAMP levels, and TNF-α suppression as well as predicting efficacious PALI-0008 levels in patients.

The first poster titled, “PALI-2108, A Colon-Specific PDE4 Inhibitor Prodrug, as Bioactivated in the Colon and Reduces Colon Tissue PDE4B in a Dose-Dependent Manner, Increasing c-AMP and Suppressing TNF-α in A Mouse Model of Colitis” was presented as a Poster of Distinction as part of the “In Vivo Models of Gastrointestinal Disorders” session at Digestive Disease Week^® (DDW) 2025 being held May 3–6, in San Diego, California.

“We continue to build a growing body of preclinical and clinical results for PALI-2108 that underscores its potential to be an important option for patients with inflammatory bowel diseases, like ulcerative colitis,” said Mitch Jones, MD, Ph.D., Chief Medical Officer of Palisade Bio. “We continue to make encouraging progress in our ongoing Phase 1a/b study of PALI-2108 in UC and expect to report topline data from the completed Phase 1a portion of the study by the end of May 2025.”

For the preclinical study, colitis was induced in mice using 4% dextran sulfate sodium (DSS) in drinking water. Mice were treated with PALI-2108 at 20, 40, or 80 mg/kg BID, cyclosporine A (40 mg/kg), or apremilast (12.5 mg/kg). Clinical disease progression was monitored through changes in body weight, stool consistency, and fecal blood scores, with the Disease Activity Index (DAI) calculated to quantify disease severity. Colon biopsies were collected for analysis of PDE4B expression, expression of inflammation related genes, cAMP levels, and TNF-α expression.

Pharmacokinetic (PK) modeling using data from healthy volunteers suggested that PALI-2108 has favorable absorption and bioavailability, supporting its potential for clinical use

Key Highlights

• PALI-2108 treatment significantly improved clinical parameters of colitis, including the DAI, body weight, and colon length in a dose-dependent manner.
• PALI-2108 administration resulted in a marked dose-dependent reduction of PDE4B expression in colon tissues, with higher cAMP levels and a notable suppression of TNF-α compared to standard treatments like cyclosporine A and apremilast.
• By increasing cAMP levels and modulating key inflammatory mediators such as TNF-α, PALI-2108 shows significant potential for reducing symptoms associated with UC.
• The preclinical data underscore PALI-2108’s efficacy and safety profile, with minimal CNS toxicity and favorable dose-dependent effects.

In addition to the selected Poster of Distinction, Palisade Bio presented a second poster titled, “A Bioinformatic Approach to PALI-2108 Treatment in Ulcerative Colitis Reveals the Potential for Anti-Fibrotic Efficacy with Local PDE4 Inhibition in Intestinal Fibrosis.” The presented posters are now available on the Publications page of the Company’s website.

The Company is currently conducting a Phase 1a/b single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

About Palisade Bio

Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the safety and tolerability, PK and drug release characteristics of PALI-2108 based on the Company’s preclinical studies and preliminary data from the Company’s Phase 1b/2a clinical study, indications and anticipated benefits of PALI-2108 and the expected timing of the release of topline data from the Phase 1b/2a clinical study. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company is heavily dependent on the success of PALI-2108, which is in the early stages of clinical development and may not successfully progress through clinical development or receive regulatory approval; preliminary clinical study results or the results from earlier preclinical studies may not be predictive of final or future results and unexpected adverse side effects or inadequate efficacy of PALI-2108 may limit its development, regulatory approval and/or commercialization; the Company needs to raise significant additional funds to support its operations and the continued development of PALI-2108; the timing and outcome of the Company’s current and anticipated clinical studies related to its product candidates; indications of use and estimates about the size and growth potential of the markets for the Company’s product candidates, and its ability to serve those markets, including any potential revenue generated; the Company’s ability to maintain the Nasdaq listing of its securities; the Company’s ability to compete effectively in a competitive industry; the Company’s ability to identify and qualify manufacturers to provide API and manufacture drug product; the Company’s ability to enter into commercial supply agreements; the Company’s ability to attract and retain key scientific or management personnel; the accuracy of the Company’s estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and the impact of any global event on the Company’s business, and operations, and supply. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company 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 the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
[email protected]

TYSONS CORNER, Va. and PETAH TIKVA, Israel, May 06, 2025 (GLOBE NEWSWIRE) —  Cellebrite (NASDAQ: CLBT), a global leader in premier Digital Investigative solutions for the public and private sectors, today announced its Spring 2025 Release, featuring a new cloud foundation and AI-powered innovations across its portfolio. These enhancements are already playing an important role in helping customers modernize their digital workflows, speed up their investigations and elevate operational productivity and efficiency.

The Spring 2025 Release introduces the Cellebrite Cloud, which delivers a purpose-built user experience that scales investigative capabilities and accelerates decision-making across public safety, intelligence and enterprise sectors. As digital evidence continues to grow in volume and complexity, investigators now spend an average of 69 hours per case reviewing data. Cellebrite’s technology reduces that burden by delivering AI-powered productivity and efficiency across a secure, unified cloud infrastructure powered by Amazon Web Services (AWS) (NASDAQ: AMZN)—while always keeping human expertise and engagement at the center. With more customers adopting a broader range of the Company’s integrated portfolio, Cellebrite is evolving its Case-to-Closure (C2C) Platform into the next-generation Digital Investigation Platform.

“Helping our customers navigate the growing complexity of digital evidence is at the core of what we do,” said Ronnen Armon, Cellebrite’s chief product and technologies officer. “More teams are rethinking how they approach digital evidence, and we’re introducing innovations to support that shift. Cellebrite Cloud enables a more efficient and secure approach to digital investigations, meeting teams where they are today and partnering for the future – whether it’s on premises, the cloud or a hybrid workflow.”

The Spring 2025 Release includes the following innovations, all of which are supported by expert consultative services to enable faster time to value:

• Cellebrite Cloud, a new foundational layer across Cellebrite’s SaaS portfolio, brings consistent and purpose-built experiences, AI-powered productivity, advanced security and compliance and a framework for integrations.
• Inseyets, Cellebrite’s flagship digital forensics software, introduces advanced media analysis capabilities—leveraging AI-powered forensic insights and pattern recognition to accelerate evidence review and understanding.
• Guardian, Cellebrite’s evidence management solution, now includes timeline review and AI-powered search built on Cellebrite Cloud to surface hidden connections, streamline case organization and accelerate investigative workflows. Guardian continues to gain strong traction across agencies.
• Smart Search, the Company’s single-click, SaaS-based intelligence offering for investigators, built on the Cellebrite Cloud, adds a new dashboard that highlights data connections and notable insights from publicly available sources, helping investigators gather online intelligence on people and organizations of interest more efficiently at the early stages of a case.
• Pathfinder, the AI-driven investigative analytics solution trusted by leading law enforcement agencies, introduces automated transcription and translation workflows, simplifying the review of audio and video artifacts.
• Endpoint Inspector, Cellebrite’s remote collection solution for enterprises, now offers Cellebrite Cloud-based mobile decoding that transforms mobile data into a review-ready format—eliminating the need for additional processing and integrating seamlessly with review platforms.

Cellebrite’s technology is used in more than 1.5M investigations globally each year, equipping more than 7,000 customers worldwide to resolve legally sanctioned investigations of child exploitation, homicide, anti-terror, border control, sex crimes, drugs and other organized crime, human trafficking, fraud, intellectual property theft, financial crimes, internal investigations, eDiscovery cases and more, while ensuring compliance with agency protocols and various regulatory requirements.

References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.

About Cellebrite

Cellebrite’s (Nasdaq: CLBT) mission is to enable its global customers to protect and save lives by enhancing digital investigations and intelligence gathering to accelerate justice in communities around the world. Cellebrite’s AI-powered Digital Investigation Platform enables customers to lawfully access, collect, analyze and share digital evidence in legally sanctioned investigations while preserving data privacy. Thousands of public safety organizations, intelligence agencies, and businesses rely on Cellebrite’s digital forensic and investigative solutions—available via cloud, on-premises, and hybrid deployments—to close cases faster and safeguard communities.  To learn more, visit us at www.cellebrite.com,https://investors.cellebrite.com and find us on social media @Cellebrite.

Caution Regarding Forward Looking Statements

This document includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “will,” “appear,” “approximate,” “foresee,” “might,” “possible,” “potential,” “believe,” “could,” “predict,” “should,” “could,” “continue,” “expect,” “estimate,” “may,” “plan,” “outlook,” “future” and “project” and other similar expressions that predict, project or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include, but are not limited to, the following: Such forward-looking statements including the potential impact of the Spring release on the Company’s 2025 revenue, annual recurring revenue (ARR), adjusted EBITDA, operating profitability and earnings are based on current expectations that are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to: Cellebrite’s ability to keep pace with technological advances and evolving industry standards; Cellebrite’s material dependence on the purchase, acceptance and use of its solutions by law enforcement and government agencies; real or perceived errors, failures, defects or bugs in Cellebrite’s DI solutions; Cellebrite’s failure to maintain the productivity of sales and marketing personnel, including relating to hiring, integrating and retaining personnel; intense competition in all of Cellebrite’s markets; the inadvertent or deliberate misuse of Cellebrite’s solutions; failure to manage its growth effectively; Cellebrite’s ability to introduce new solutions and add-ons; its dependency on its customers renewing their subscriptions; the low volume of business Cellebrite conducts via e-commerce; risks associated with the use of artificial intelligence; the risk of requiring additional capital to support the growth of its business; risks associated with higher costs or unavailability of materials used to create its hardware product components; fluctuations in foreign currency exchange rates; lengthy sales cycle for some of Cellebrite’s solutions; near term declines in new or renewed agreements; risks associated with inability to retain qualified personnel and senior management; the security of Cellebrite’s operations and the integrity of its software solutions; risks associated with the negative publicity related to Cellebrite’s business and use of its products; risks related to Cellebrite’s intellectual property; the regulatory constraints to which Cellebrite is subject; risks associated with Cellebrite’s operations in Israel, including the ongoing Israel-Hamas war and the risk of a greater regional conflict; risks associated with different corporate governance requirements applicable to Israeli companies and risks associated with being a foreign private issuer and an emerging growth company; market volatility in the price of Cellebrite’s shares; changing tax laws and regulations; risks associated with joint, ventures, partnerships and strategic initiatives; risks associated with Cellebrite’s significant international operations; risks associated with Cellebrite’s failure to comply with anti-corruption, trade compliance, anti-money-laundering and economic sanctions laws and regulations; risks relating to the adequacy of Cellebrite’s existing systems, processes, policies, procedures, internal controls and personnel for Cellebrite’s current and future operations and reporting needs; and other factors, risks and uncertainties set forth in the section titled “Risk Factors” in Cellebrite’s annual report on Form 20-F filed with the SEC on April 27, 2023 and in other documents filed by Cellebrite with the U.S. Securities and Exchange Commission (“SEC”), which are available free of charge at www.sec.gov. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, in this communication or elsewhere. Cellebrite undertakes no obligation to update its forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws.

Media 
Jackie Labrecque
Sr. Manager of Content Strategy and Operations
[email protected]
+1 771.241.7010

Investor Relations 
Andrew Kramer 
Vice President, Investor Relations 
[email protected] 
+1 973.206.7760