Market Newsdesk

WALTHAM, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced it plans to report new clinical data from the Phase 1/2 ACHIEVE clinical trial on January 10, 2025, and to host a webcast at 8:00 a.m. ET. The company intends to issue a press release prior to the start of the event.

Investor Conference Call and Webcast

The live webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne’s website, and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To view the live webcast and replay, please visit https://investors.dyne-tx.com/news-and-events/events-and-presentations.

About Dyne Therapeutics

Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Contacts:

Investors

Mike Hencke
Kendall Investor Relations
[email protected]

Media

Stacy Nartker
Dyne Therapeutics
[email protected]
781-317-1938

Châtillon, France, January 8^th, 2025

DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study

• EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months
• 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12
• No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE
    
• DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company’s proposed labeling approach shared with FDA
• DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy & Comorbidity Conference, January 9-12, in Palm Beach, Florida
• Company to host investor webcast today at 5:00pm ET

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN® peanut 250 µg [VP250] in toddlers ages 1 to 3 years). The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.

DBV also announced today new Viaskin Peanut Patch efficacy and safety data based on average daily wear time from the EPITOPE study that is supportive of the Company’s VIASKIN peanut labeling strategy, proposed to FDA in June 2024. This post-hoc analysis identified subjects on Viaskin Peanut with low or high day-to-day variability in daily wear time during the first 90 days on treatment – a highly predictive marker of the average daily wear time (ADWT) during the course of the 12-month study. Subjects with low day-to-day variability in daily wear time had higher ADWT which correlated with a more robust efficacy response at 12 months.

These data are being presented in multiple poster presentations at the Eastern Food Allergy & Comorbidity Conference, which is being held January 9^th through 12^th, 2025, in Palm Beach, Florida.      

Twenty-Four Month EPITOPE OLE Results

After completing participation (12 months) in the EPITOPE study, eligible subjects could enroll in the OLE to receive a total of 36 months of VIASKIN peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment.

In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36 months of treatment across all efficacy parameters. Key data highlights include:

• 266 EPITOPE participants enrolled in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo).
  • After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study).
  • A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12;).
  • Those completing the DBPCFC without meeting stopping criteria increased to 68.2% at month 36 from 30.7% at month 12.
• Continued reductions in DBPCFC reaction severity occurred, with 66.5% having no/mild symptoms at month 36 vs 40.2% at month 12.
• No treatment-related anaphylaxis or serious treatment-related TEAEs occurred in Year 3.
  • Local application-site reactions occurred less frequently in Year 3 vs Years 1 and 2.
• In placebo-treated EPITOPE participants, outcomes after 24 months of VP250 in the OLE were consistent with 24-month results in EPITOPE VP250 participants.

“The compelling results from 36 months of Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study,”
said Pharis Mohideen, Chief Medical Officer, DBV Technologies.
“Notably, the data indicates that continued treatment with VIASKIN Peanut resulted in further improvement across all efficacy parameters in the second year of the OLE with no new safety signals. The data show that more than two-thirds of subjects completed the food challenge without meeting pre-defined stopping criteria, consuming the equivalent of 12-14 peanut kernels, and more than 83% reached an ED of ≥1,000mg, or the equivalent of 3-4 peanut kernels. Recall that this is a patient population that can experience devastating consequences from accidental exposure to just fractions of a peanut kernel. As we prepare to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a BLA submission, these results remind us of the tremendous potential of VIASKIN Peanut as a game changer for the peanut allergy community.”

Shared decision making for best response based on patch wear experience.

DBV also announced today new data from the Phase 3 EPITOPE study that supports the labeling approach that was proposed to FDA in June 2024. Patch wear time assessed daily by caregivers was averaged (i.e., average daily wear time or ADWT) for each subject for the first 90 days of treatment (excluding treatment initiation Days 1-28) and over the 12-month EPITOPE study.

Baseline markers of atopic disease severity such as peanut-specific IgE, skin prick test wheal size, SCORAD scores (measure of atopic dermatitis) and eliciting dose were similar between subjects with ADWT ≥ 20 hours/day and < 20 hours/day. The incidence rates and severity of local application site reactions and use of corticosteroids were also similar between groups, but the participants with ADWT < 20 hours reported markedly more scratching as a reason for patch detachments. This strongly suggests that these participants experienced lower tolerability (i.e., higher degree of “itchiness”) to peanut-induced local skin immune responses.

Data suggests that subjects with low day-to-day wear time variability (≥ 20 hours/day ADWT) had a more robust efficacy response relative to the high day-to-day variability (<20 hour/day ADWT) subjects.

Efficacy and safety data were compared for VP250 participants according to ADWT.

Key data highlights include:

• 167/244 (68.4%) VP250 participants had an ADWT ≥20 hours, with median ADWT (22.9 hours) similar to placebo (23.7 hours).
• 77/244 (31.6%) participants had an ADWT <20 hours (median: 16.7 hours).
• ADWT during the first 90 days on treatment was highly predictive of ADWT over the 12-month treatment period (r=0.81).
• Participants with ADWT ≥20 vs <20 hours during the first 90 days showed greater month 12 efficacy, according to EPITOPE responder criteria (75.7% vs 47.3%).
• Rates of key safety outcomes of interest were numerically lower in participants with ADWT ≥20 vs <20 hours, based on treatment-related: epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%), and permanent discontinuations (9.6% vs 19.5%).
• As a point of reference, overall clinical response in EPITOPE was 67.0% for patients on active, and 33.5% for patients on placebo.

“Average daily wear time is something that can easily be reported by my caregivers and patients and can be a very useful tool for me to guide shared decision making. Knowing that the ADWT during the first 90 days on treatment is highly predictive of ADWT over a full year and that these data further suggest that ADWT greater than 20 hours show a strong correlation with clinical efficacy response at 12 months will help to guide optimal use of VIASKIN peanut, if approved.”, stated
Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, University of North Carolina School of Medicine, and presenting author.

Eastern Food Allergy and Comorbidity Conference – Poster Presentations

January 9-12, 2025, Palm Beach, FL

All posters will be displayed from 3:00pm ET on Thursday, January 9^th through 11:45am ET on Saturday, January 11^th.

“EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: Results After 3 Years of Treatment”

• Presenter: Matthew Greenhawt, MD

“VP250 Average Daily Wear Time: Impact on Efficacy and Safety in the Phase 3 EPITOPE Study”

• Presenter: Edwin H. Kim, MD

“Changes in Biomarkers During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers”

• Presenter: Edwin H. Kim, MD

“We are very pleased with the progress that DBV continues to make advancing this novel therapy through its remaining regulatory steps, and believe that, if approved, it has the potential to revolutionize the treatment of peanut allergy,”
stated Eleanor Garrow-Holding, CEO, Food Allergy and Anaphylaxis Connection Team.
“It is encouraging to see new data that further inform the real-world use of VIASKIN Peanut, and we are hopeful that it will soon be an available treatment option for peanut allergic patients and their caregivers.”  

Investor Conference Call and Webcast

DBV management will host an investor conference call and webcast today, January 8^th, at 5:00pm EST, to discuss these clinical updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.

• United States: +1-877-346-6112
• International: +1-848-280-6350

A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.

About DBV Technologies

DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).

DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).

For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

VIASKIN is a registered trademark and EPIT is a trademark of DBV Technologies.

Investor Contact

Katie Matthews
DBV Technologies
[email protected]

Media Contact

Angela Marcucci
DBV Technologies
[email protected]

Attachment

• PDF Version

CHICAGO, Jan. 08, 2025 (GLOBE NEWSWIRE) — Sprout Social, Inc. (“Sprout Social”, the “Company”) (Nasdaq: SPT), an industry-leading provider of cloud-based social media management software, today announced that it will report its financial results for the fourth quarter ending December 31, 2024 after market close on Tuesday, February 25, 2025.

The financial results and business highlights will be discussed on a conference call and webcast scheduled at 4:00 p.m. Central Time (5:00 p.m. Eastern Time) on Tuesday, February 25, 2025. Online registration for this event conference call can be found at https://registrations.events/direct/Q4I1913111787. The live webcast of the conference call can be accessed from Sprout Social’s investor relations website at http://investors.sproutsocial.com.

Following completion of the events, a webcast replay will also be available at http://investors.sproutsocial.com for 12 months.

About Sprout Social

Sprout Social
is a global leader in social media management and analytics software. Sprout’s intuitive platform puts powerful social data into the hands of approximately 30,000 brands so they can deliver smarter, faster business impact. Named the #1 Best Software Product by G2’s 2024 Best Software Award, Sprout offers comprehensive publishing and engagement functionality, customer care, influencer marketing, advocacy, and AI-powered business intelligence. Sprout’s software operates across all major social media networks and digital platforms. For more information about Sprout Social (NASDAQ: SPT), visit sproutsocial.com.

Availability of Information on Sprout Social’s Website and Social Media Profiles

Investors and others should note that Sprout Social routinely announces material information to investors and the marketplace using SEC filings, press releases, public conference calls, webcasts and the Sprout Social Investors website. We also intend to use the social media profiles listed below as a means of disclosing information about us to our customers, investors and the public. While not all of the information that the Company posts to the Sprout Social Investors website or to social media profiles is of a material nature, some information could be deemed to be material. Accordingly, the Company encourages investors, the media, and others interested in Sprout Social to review the information that it shares at the Investors link located at the bottom of the page on www.sproutsocial.com and to regularly follow our social media profiles. Users may automatically receive email alerts and other information about Sprout Social when enrolling an email address by visiting “Email Alerts” in the “Shareholder Services” section of Sprout Social’s Investor website at https://investors.sproutsocial.com/.

Social Media Profiles:


www.twitter.com/SproutSocial



www.twitter.com/SproutSocialIR



www.facebook.com/SproutSocialInc



www.linkedin.com/company/sprout-social-inc-/



www.instagram.com/sproutsocial

Contact

Media:

Kaitlyn Gronek
Email: [email protected]
Phone: (866) 878-3231

Investors:

Alex Kurtz
Twitter: @SproutSocialIR
Email: [email protected]
Phone: (312) 528-9166

NEW YORK, Jan. 08, 2025 (GLOBE NEWSWIRE) — Nasdaq (Nasdaq: NDAQ) today reported monthly volumes for December 2024, as well as quarterly volumes, estimated revenue capture, number of listings, and index statistics for the quarter ended December 31, 2024 on its Investor Relations website.

A data sheet showing this information can be found at: http://ir.nasdaq.com/financials/volume-statistics.

About Nasdaq

Nasdaq (Nasdaq: NDAQ) is a leading global technology company serving corporate clients, investment managers, banks, brokers, and exchange operators as they navigate and interact with the global capital markets and the broader financial system. We aspire to deliver world-leading platforms that improve the liquidity, transparency, and integrity of the global economy. Our diverse offering of data, analytics, software, exchange capabilities, and client-centric services enables clients to optimize and execute their business vision with confidence. To learn more about the company, technology solutions, and career opportunities, visit us on LinkedIn, on X @Nasdaq, or at www.nasdaq.com.

Cautionary Note Regarding Forward-Looking Statements

Information set forth in this communication contains forward-looking statements that involve a number of risks and uncertainties. Nasdaq cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. Such forward-looking statements include, but are not limited to (i) projections relating to our future financial results, total shareholder returns, growth, trading volumes, products and services, ability to transition to new business models, taxes and achievement of synergy targets, (ii) statements about the closing or implementation dates and benefits of certain acquisitions, divestitures and other strategic, restructuring, technology, de-leveraging and capital allocation initiatives, (iii) statements about our integrations of our recent acquisitions, (iv) statements relating to any litigation or regulatory or government investigation or action to which we are or could become a party, and (v) other statements that are not historical facts. Forward-looking statements involve a number of risks, uncertainties or other factors beyond Nasdaq’s control. These factors include, but are not limited to, Nasdaq’s ability to implement its strategic initiatives, economic, political and market conditions and fluctuations, government and industry regulation, interest rate risk, U.S. and global competition, and other factors detailed in Nasdaq’s filings with the U.S. Securities and Exchange Commission, including its annual reports on Form 10-K and quarterly reports on Form 10-Q which are available on Nasdaq’s investor relations website at 

http://ir.nasdaq.com

 and the SEC’s website at 

www.sec.gov

. Nasdaq undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Relations Contacts:

Nick Jannuzzi
+1.973.760.1741
[email protected]

Nick Eghtessad
+1.929.996.8894
[email protected]

Investor Relations Contact:

Ato Garrett
+1.212.401.8737
[email protected]

-NDAQF-

• Investigational new drug (IND) applications for initiating first-in-human studies for ZW220 and ZW251 in solid tumors anticipated in 2025
• IND applications for initiating first-in-human studies for ZW209 and ZW1528 anticipated in 2026
• Phase 3 HERIZON-GEA-01 top-line results for Ziihera® (zanidatamab-hrii) in first-line HER2-positive
  gastroesophageal adenocarcinoma (
  GEA) are expected 2Q-2025, with potential supplemental biologics license application (sBLA) by Jazz Pharmaceuticals later in 2025
• Potential regulatory decisions in EU and China for approval of zanidatamab in second-line biliary tract cancer (BTC) as early as 2Q-2025
• Cash, cash equivalents, and marketable securities of approximately $324 million (unaudited) as of December 31, 2024, which when combined with certain anticipated regulatory milestone payments, provide projected cash runway into 2H-2027
• Company well-positioned for further progress and expansion of R&D pipeline into autoimmune and inflammatory diseases (AIID) and hematological cancers
• Company to present on Thursday, January 16, 2024 at 08:15 a.m. PT at the J.P. Morgan Annual Healthcare Conference

VANCOUVER, British Columbia, Jan. 08, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today provided an update on key strategic priorities for 2025 and 2026.

“2024 was a pivotal year for Zymeworks, marked by the first FDA approval of our internally developed product, zanidatamab, significant clinical progress with our novel, antibody-based therapeutic candidates in solid tumors and advancements in our emerging preclinical pipeline,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “With critical R&D milestones achieved approximately eighteen months ahead of our initial timelines, a strong financial position and the operational capabilities to advance multiple programs in solid tumors, hematological oncology, and autoimmune and inflammatory diseases, we are well-positioned to execute against our strategic priorities over the next two years, and continue addressing potential treatment options for some of the most challenging and complex diseases.”

Key 2024 Accomplishments:

• First-in-human global studies initiated for ZW171, a 2+1 trivalent T cell engager targeting mesothelin-expressing solid tumors (NCT06523803);
• First-in-human global studies initiated for ZW191, an antibody-drug conjugate (ADC) engineered to target folate receptor-⍺ utilizing our novel proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD-06519 (NCT06555744);
• U.S. Food and Drug Administration (FDA) granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line BTC;
• Nominated the fifth product in the Company’s ‘5 by 5’ R&D program, ZW209, a novel DLL3-targeting trispecific T cell engager incorporating co-stimulation that leverages Zymeworks’ clinically validated technology platform, AzymetricÔ, with a planned IND application in 1H-2026;
• Nominated the first product from our ADVANCE research strategy, ZW1528, the Company’s first development candidate in AIID, which demonstrates dual blockade of two complementary pathways of respiratory inflammation and offers potential benefit in mixed-type chronic obstructive pulmonary disease (COPD) with a planned IND application in 2H-2026;
• Through a series of publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of clinical programs and IND candidates in our solid tumor R&D portfolio (ZW171, ZW191, ZW220, ZW251 and ZW209) and our proprietary TOPO1i payload, ZD-06519;
• Strengthened our board of directors through the addition of three new members, Dr. Alessandra Cesano, Dr. Neil Gallagher, and Mr. Scott Platshon;
• Strengthened our leadership team through the addition of Ms. Leone Patterson as Chief Business and Financial Officer; and
• Successfully completed $30 million of share repurchases under the Company’s Share Repurchase Program announced in August 2024.

2025 and 2026 Priorities and Anticipated Milestones

Clinical Development of Wholly-Owned Solid Tumor Pipeline (‘5 by 5’)

• Advance ZW171 and ZW191 in solid tumors in ongoing Phase 1 trials; and
• Continue to drive the progression of the broad and differentiated product pipeline of ADCs and multispecific antibody therapeutics (MSATs) developed pursuant to the ‘5 by 5’ R&D program, targeting completion of all five IND applications by the end of 1H-2026.

ADVANCE R&D Program

• Leverage Zymeworks’ proprietary platforms to expand our ADVANCE R&D strategy and diversify our pipeline within and beyond solid tumor indications with additional therapeutic indications such as AIID and hematological cancers;
• Submission of first IND application in AIID expected in 2H-2026 for ZW1528, focused in COPD patients;
• Continue to drive product innovation with increased novelty in targets, and unique mechanisms of action through bispecific or biparatopic ADCs, dual-payload ADCs, multi-specific immune cell engagers and immune-oncology; and
• Continue to actively share peer-reviewed publications and data across preclinical and clinical programs.

Ziihera®
 (zanidatamab-hrii)

• Our partner Jazz Pharmaceuticals is expected to report top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating zanidatamab in HER2-positive GEA in 2Q-2025 with potential for submission for a sBLA in first-line GEA later in 2025;
• A BLA for zanidatamab in second-line BTC was accepted for review by the Center for Drug Evaluation of the National Medical Products Administration in China in 2024 and potential approval is anticipated as early as 2H-2025; and
• The European Medicines Agency validated the marketing authorization application for zanidatamab in second-line BTC in 2024 and potential approval is anticipated as early as 2Q-2025.

Updated Cash Runway Guidance

As of December 31, 2024, the Company had cash resources of approximately $324 million (unaudited), consisting of cash, cash equivalents, and marketable securities, not including a $25 million milestone payment earned in 4Q-2024 from Jazz Pharmaceuticals which is expected to be received in 1Q-2025. Based on current operating plans and assuming receipt of certain anticipated regulatory milestones, we continue to expect our existing cash resources, when combined with such anticipated milestone payments, will enable us to fund planned operations into 2H-2027.

J.P. Morgan Healthcare Conference Presentation and Webcast

Management will participate in the J.P. Morgan Annual Healthcare Conference taking place in San Francisco, California, from January 13-16, 2025, and present on January 16 at 8:15 am PT. The presentation and webcast will be available on Zymeworks’ website.

About Zymeworks Inc.

Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals), granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval of Ziihera^® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line biliary tract cancer (BTC). Ziihera^® is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. Zanidatamab is currently under regulatory review in the EU and China for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with investigational new drug applications for ZW220 and ZW251 planned for 2025. In addition to Zymeworks’ pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities, including those with respect to its pipeline and R&D strategy; preliminary and unaudited estimates of its cash, cash equivalents, and marketable securities; anticipated sufficiency of existing cash resources and certain anticipated regulatory milestone payments to fund Zymeworks’ planned operations into 2H-2027; future financial position; timing of milestones with respect to zanidatamab and other product candidates; potential therapeutic effects and commercial potential of zanidatamab and Zymeworks’ other product candidates; the anticipated benefits of the collaboration agreement with Jazz Pharmaceuticals; the anticipated benefits of Zymeworks’ agreements with BeiGene and its other collaborators; Zymeworks’ ability to receive additional payments pursuant to its collaboration agreements, including any future milestone payments and royalties; the commercial potential of zanidatamab and Zymeworks’ and its partners’ ability to obtain further regulatory approval of and successfully commercialize zanidatamab; the timing of and results of the interactions with regulators, including anticipated regulatory filings and the timing thereof; current and future partnerships and strategic collaborations; Zymeworks’ development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future clinical trials and studies and presentation of related data; the ability to advance product candidates into later stages of development; the timing of anticipated IND submissions; and other information that is not historical information. When used herein, words such as “believe”, “future”, “anticipate”, “approximately”, “will”, “plans”, “may”, “potential”, “expect”, “should”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: Zymeworks’ assumptions and estimates regarding its financial condition may be incorrect; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; Zymeworks may be unable to maintain or enter into new partnerships or strategic collaborations; and the other risks described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2024 (a copy of which may be obtained at www.sec.gov and www.sedar.com).

Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2024, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding year-end cash, cash equivalents, and marketable securities are the responsibility of management, are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2024, based on the foregoing estimates.

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:

Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
[email protected]

Media inquiries:

Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
[email protected]

EMERYVILLE, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) — Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today announced that Brian C. Thomas, PhD, CEO and founder of Metagenomi, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 4:30 p.m. PT in San Francisco.

A live webcast will be available in the investor section of the company’s website at https://ir.metagenomi.co/ and a replay will be available for a limited time at the same address.

About Metagenomi

Metagenomi is a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary, comprehensive metagenomics-derived toolbox. Metagenomi is harnessing the power of metagenomics, the study of genetic material recovered from the natural environment, to unlock four billion years of microbial evolution to discover and develop a suite of novel editing tools capable of correcting any type of genetic mutation found anywhere in the genome. Its comprehensive genome editing toolbox includes programmable nucleases, base editors, and RNA and DNA-mediated integration systems (including prime editing systems and clustered regularly interspaced short palindromic repeat associated transposases (CAST)). Metagenomi believes its diverse and modular toolbox positions the company to access the entire genome and select the optimal tool to unlock the full potential of genome editing for patients. For more information, please visit https://​metageno​mi​.co.

Cautionary Note Regarding Forward‐​Looking Statements

This press release contains ​“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as ​“anticipate,” ​“believe,” ​“could,” ​“estimate,” ​“expect,” ​“goal,” ​“intend,” ​“look forward to,” ​“may,” ​“plan,” ​“potential,” ​“predict,” ​“project,” ​“should,” ​“will,” ​“would” and similar expressions, include, but are not limited to, any statements relating to our growth strategy and product development programs, including the timing of and our ability to conduct IND-enabling studies, make regulatory filings such as INDs, statements concerning the potential of therapies and product candidates, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in ​“Risk Factors,” in our most recent Form 10-K and our most recent 10-Qs on file with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contact:

Simon Harnest – CIO, SVP Investor Relations

IR@​metagenomi.​co

CHARLESTOWN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that Bo Cumbo, President and CEO, will present at the 43^rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 3:45 p.m. PT (6:45 p.m. ET).

A live webcast of the presentation will be available on the Events page of the Investors section of the Company website or by clicking here. A webcast replay will be archived for 30 days on the Events page.

Institutional investors interested in meeting with management during the conference may reach out to their J.P. Morgan representatives.

About Solid Biosciences

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates including SGT-003 for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-212 for the treatment of Friedreich’s ataxia, SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for the treatment of TNNT2-mediated dilated cardiomyopathy, SGT-401 for the treatment of BAG3-mediated dilated cardiomyopathy, and additional assets for the treatment of fatal cardiac diseases. Solid is advancing its diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases. For more information, please visit www.solidbio.com.

Solid Biosciences Investor Contact:

Nicole Anderson
Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
[email protected]

Media Contact:

Glenn Silver
FINN Partners
[email protected]

LOS ANGELES, Jan. 08, 2025 (GLOBE NEWSWIRE) — The Honest Company (NASDAQ: HNST), a personal care company dedicated to creating cleanly-formulated and sustainably-designed products, today announced that Chief Financial Officer Dave Loretta will retire from the Company this year. The Company has begun a search for Loretta’s replacement, which is being supported by a leading executive search firm. Loretta will stay with the Company through the transition of the new CFO.

“Dave joined us at a pivotal time in our Transformation Initiative with the goal of restructuring our financial model and establishing a framework for long-term financial stability. We are deeply grateful for the mark he’s left on both our financial strategy and our organization as a whole,” said Carla Vernón, CEO of The Honest Company. “Thanks to Dave’s leadership, we have an exceptional finance team in place, the business is stronger than ever, and we are well-positioned for the future, all of which gives us great confidence as we move forward with the search for our next CFO. On behalf of everyone at The Honest Company, we thank Dave for his dedication, leadership and partnership, and we wish him the very best in this next chapter.”

Loretta joined The Honest Company in 2023, helping the Company deliver increased revenue, significant expansion in gross margin, and positive operating profitability in Q4 2023, which continued quarterly through our most recently reported Q3 2024 results versus the comparable periods in the prior year.

“It has been an honor to serve as The Honest Company’s CFO and to be part of this remarkable brand, working alongside such a talented group of people,” said Dave Loretta, CFO of The Honest Company. “I am proud that in my time at Honest, I was able to advance the strength of the business model as well as the finance organization. I leave knowing that The Honest Company is well positioned for continued success, and I am committed to ensuring a smooth transition.”

Loretta will continue in his role until his retirement and will work closely with the leadership team and the Board of Directors to facilitate a seamless transition to a new CFO.

In connection with this announcement, The Honest Company is reaffirming the following full year 2024 outlook previously provided on November 12, 2024, in conjunction with its third quarter 2024 results:

• Revenue growth of a high single digit percentage year-over-year
• Adjusted EBITDA in the range of $20 million to $22 million

The Honest Company’s consolidated financial statements for the year ended December 31, 2024 are not yet available. The Company’s financial closing procedures are not yet complete and, as a result, final results may vary from this outlook due to the completion of the Company’s financial closing procedures, final adjustments and other developments that may arise between now and the time the Company issues its consolidated financial statements for the year ended December 31, 2024.

Forward-Looking Statements

This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning our expectations regarding future results of operations and financial condition, including our revenue and adjusted EBITDA outlook for 2024; the timing and terms of Mr. Loretta’s retirement and our ability to find a suitable successor to Mr. Loretta and conduct a smooth transition; and that we are well-positioned for the future and our great confidence as we move forward with the search for our next CFO.

You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this press release and the earnings call referencing this press release primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results.

The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 8, 2024, as updated by Part II, Item 1A, “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.

About The Honest Company

The Honest Company (NASDAQ: HNST) is a personal care company dedicated to creating cleanly-formulated and sustainably-designed products spanning categories across diapers, wipes, baby personal care, beauty, apparel, household care and wellness. Launched in 2012, the Company is on a mission to challenge ingredients, ideals, and industries through the power of the Honest brand, the Honest team, and the Honest Standard. For more information about the Honest Standard and the Company, please visit www.honest.com.

Investor Inquiries:

Elizabeth Bouquard
[email protected]

Media Contact:

Brenna Israel Mast
[email protected]

FOSTER CITY, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that management will present at the 43^rd Annual J.P. Morgan Healthcare Conference on January 15^th, 2025 at 4:30 p.m. PT.

A live webcast of the presentation will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcasts will be archived on Terns’ website for at least 30 days following the presentations.

About Terns Pharmaceuticals

Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.

Contacts for Terns

Investors

Justin Ng
[email protected]

Media

Jenna Urban
Berry & Company Public Relations
[email protected]

– On track to report data from Phase 1 clinical trial evaluating VG-3927 for the treatment of Alzheimer’s disease in 1Q 2025 –

– Final analysis from IGNITE Phase 2 clinical trial evaluating iluzanebart in ALSP planned for 2Q 2025 –

– Company well-positioned for continued operational progress in 2025 –

WATERTOWN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) — Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today highlighted 2024 corporate achievements and upcoming 2025 milestones.

“2024 was a year of strong operational execution, driven by the progress of our two TREM2 agonist programs, VG-3927 and iluzanebart, and a $40 million strategic investment from Sanofi,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “Advancing these clinical programs requires both strong science and commitment, and we remain focused on delivering Phase 1 data on VG-3927 in the first quarter of 2025, and Phase 2 data on iluzanebart in the second quarter of 2025, both of which represent meaningful milestones for expanding our scientific insights and developing these programs into potential therapeutics.”

2024 Key Achievements

Iluzanebart, Monoclonal Antibody TREM2 Agonist:

• Announced clinical development strategy update following Type C Meeting with U.S. Food and Drug Administration (FDA) where the Agency stated it was open to considering the accelerated approval pathway for iluzanebart in ALSP.
• Completed enrollment of 20 patients for IGNITE Phase 2 clinical trial, exceeding the initially planned 15 patients.
• Surpassed enrollment of 50 participants in ILLUMINATE natural history study of ALSP. Findings from ILLUMINATE have provided critical insights on MRI and NfL biomarkers and continue to improve the overall understanding of ALSP disease pathophysiology and progression.

VG-3927, Small Molecule TREM2 Agonist:

• Reported interim data from the ongoing Phase 1 clinical trial evaluating VG-3927 in healthy volunteers. These data demonstrated the safety, tolerability, pharmacokinetic, and pharmacodynamic profile supported continued clinical development. Initiated dosing of an Alzheimer’s disease (AD) cohort in the ongoing Phase 1 clinical trial, including some participants who carry TREM2 or other disease-related variants, to explore the biomarker response of VG-3927 after a single dose.
• FDA removed the partial clinical hold on the Phase 1 clinical trial of VG-3927 based on a complete response submitted by the Company.
• Presented new preclinical data on the small molecule TREM2 agonist program at the Alzheimer’s Association International Conference (AAIC) that highlighted its differentiated mechanism of action compared with antibody TREM2 agonists. These data demonstrated that Vigil’s small molecules, including VG-3927, are fully brain penetrant, do not bind to sTREM2 resulting in more drug reaching the target, and also act as a positive allosteric modulator (PAM) which amplifies the functional response within sites of pathology leading to greater horsepower for superior neuroprotection.

Corporate:

• Secured a $40 million strategic investment from Sanofi to fund research and development activities. In connection with the equity investment, Vigil granted Sanofi the right of first negotiation (ROFN) for an exclusive license, grant or transfer of rights to research, develop, manufacture and commercialize the Company’s small molecule TREM2 agonist program, including its clinical candidate, VG-3927.
• Appointed Petra Kaufmann, M.D., M.S., F.A.A.N, as Chief Medical Officer to lead the Company’s clinical, regulatory, and patient advocacy efforts.

2025 Milestones

• On track to report data in the first quarter of 2025 from the Phase 1 clinical trial of VG-3927, including single-ascending and multiple-ascending dose data from healthy volunteers, data from a single cohort of AD patients and data from an elderly patient cohort. Vigil expects to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD.
• Final analysis from the IGNITE Phase 2 clinical trial, including all patients at 12 months dosed with either 20 mg/kg or 40 mg/kg of iluzanebart, is planned for the second quarter of 2025. The Company will pursue an accelerated approval pathway for iluzanebart in ALSP and expects to share an update on its progress when the final analysis is reported.

“Building on the momentum from 2024, we plan to report key data for both VG-3927 and iluzanebart in the first half of 2025. We expect these development milestones will further support our efforts to bring potentially transformative therapies to patients with ALSP and AD,” concluded Dr. Magovčević-Liebisch. “Looking ahead, we aim to leverage our deep expertise in microglial biology to explore additional targets to treat other rare and common neurodegenerative diseases.”

About Vigil Neuroscience

Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel immune cells of the brain. Vigil is utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in its efforts to develop precision-based therapies to improve the lives of patients and their families. Iluzanebart, Vigil’s lead clinical candidate, is a fully human monoclonal antibody agonist targeting human triggering receptor expressed on myeloid cells 2 (TREM2) in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. Vigil is also developing VG-3927, a novel small molecule TREM2 agonist, to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer’s disease (AD) patients, including some who carry TREM2 and other disease-associated variants.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience (“Vigil” or the “Company”) that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding: the Company’s strategy, business plans and focus; the potential therapeutic benefit of the Company’s product candidates, including iluzanebart and VG-3927, and the expected therapeutic benefits of such programs as well as the ability to improve the lives of patients and their families; the progress and timing of the clinical development of Vigil’s programs, including the availability of, and expected timing for reporting, data from both the IGNITE Phase 2 clinical trial and the VG-3927 Phase 1 clinical trial; beliefs about observations made analyzing preclinical study and clinical trial data to date; and the timing and outcomes of the Company’s interactions with regulatory authorities, including with the FDA regarding the accelerated approval pathway. Forward-looking statements are based on Vigil’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; and the timing and content of additional regulatory information from the FDA; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and any subsequent filings Vigil makes with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information on this page as current or accurate after its publication date.
                                                                                
Internet Posting of Information

Vigil Neuroscience routinely posts information that may be important to investors in the ‘Investors’ section of its website at https://www.vigilneuro.com. The company encourages investors and potential investors to consult our website regularly for important information about Vigil Neuroscience.

Investor Contact:

Leah Gibson
Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.
[email protected]

Media Contact:

Megan McGrath
CTD Comms, LLC
[email protected]