Alcohol Use Disorder

The newly released data highlights an increase in people seeking treatment – particularly among older adults – and reveals alcohol and opioid use disorders are the leading diagnoses at admission to Gaudenzia treatment centers. Regional data further emphasizes the need for culturally competent care and expanded access to evidence-based treatments for stimulant and opioid use disorders across PA, MD, DE, and D.C. PHILADELPHIA, Oct. 24, 2024 /PRNewswire/ -- Gaudenzia, Inc., one of the country's largest nonprofit treatment providers for people with substance use disorder (SUD) and co-occurring conditions, released its 2024 annual FrontLine Report today. The FrontLine Report is the only annual, comprehensive and data-driven look at SUD trends, county-by-county, in the Mid-Atlantic region where Gaudenzia operates over 50 facilities and provides over 120 licensed treatment programs to more than 15,800 admissions. Continue Reading Dr. Deja Gilbert, President and CEO of Gaudenzia, unveils the 2024 FrontLine report during a press conference in Philadelphia at Gaudenzia’s West Mill Place facility. First launched in 2021, the report highlights Gaudenzia's ongoing efforts to provide a full continuum of care for SUD and expand treatment accessibility while spotlighting emerging trends in SUD care across Pennsylvania, Maryland, Delaware, and Washington, D.C. The report was unveiled today by Gaudenzia leadership at a news conference in Philadelphia. Key findings from the 2024 FrontLine report include: Increased Treatment Admissions: Admissions to Gaudenzia's treatment programs increased by 5 percent to 15,855 from 15,045 in FY-23. Growth in Older Adult Admissions: The number of adults aged 55 and older seeking treatment increased by 3 percent in FY-24, for a total increase of 8 percent over FY-22. High Prevalence of Mental Health Diagnoses: 70.3 percent of individuals completing biopsychosocial assessments reported a past mental health diagnosis. Alcohol and Opioid Use Disorder Lead Diagnoses: Both alcohol use disorder and opioid use disorder remain the leading diagnoses at admission at 31 percent each. "Our 2024 FrontLine report offers valuable insight to what we are experiencing at a local level at our facilities and highlights the vital necessity to improve access to lifesaving and life-changing treatments for the millions of Americans struggling with addiction," said Dr. Deja Gilbert, President and CEO of Gaudenzia. "At Gaudenzia, we understand that access to evidence-based SUD treatment looks different depending on who you are, where you live, and who you are responsible for. By collaborating with the community, policymakers, advocates, families and other partners we will be able to create more avenues to treatment, eliminate barriers to care, and provide evidence-based care to make a difference in thousands of lives every day." While Gaudenzia saw increased admissions to its treatment programs, the Substance Abuse and Mental Health Services Administration (SAMHSA) notes that over 94 percent of individuals over the age of 18 with a SUD did not receive or seek treatment in 2023 – emphasizing more work needs to be done to ensure individuals receive available treatment. "We need to understand why so many people struggling with SUD are not getting the treatment they need," continued Dr. Gilbert. "By evaluating data, we can identify addressable barriers to care including lack of transportation, treatment options, and financial need." Increasing access to evidence-based care is a priority for Gaudenzia, whose mission is to promote long-term recovery regardless of individual circumstances. This includes: Meeting the Needs of Women and Families Since 1979, Gaudenzia has been a pioneer in offering SUD treatment specifically designed for women with children, such as family-centered treatment programs like the Claymont Center for Pregnant and Parenting Women, the only treatment program of its kind in Delaware. In 2023, the cohort of women served at Claymont was primarily between the ages of 25-44, with nearly 60 percent reporting an opioid use disorder – underscoring a significant need for medications for opioid use disorder access for pregnant and parenting women. Addressing Barriers to Access To increase access for more individuals, Gaudenzia has implemented several new programs, including the launch of Driving Recovery for PA, Pennsylvania's only mobile licensed narcotic treatment program and the introduction of open-access treatment models at key sites. The FrontLine report also affirms an industry-wide trend of significant racial disparities in access to medication-assisted treatment (MAT). Research shows that MAT is an effective approach in treating SUD that reduces relapse and overdose rates, but white clients were prescribed MAT at more than twice the rate of Black patients in both the six months before and after a SUD-related health emergency. Gaudenzia continues to address this disparity by advocating for equitable treatment options, working to repair relationships with the communities we serve, and providing culturally competent care and harm reduction services. Providing Complex Care Through Innovative Solutions Gaudenzia has seen an uptick in admissions of adults over the age of 55 for the second consecutive year – which reflects the national trend of overdose deaths among adults over the age of 65 quadrupling over the last two decades. Gaudenzia is urging for Medicare reforms to expand coverage of SUD treatment, improve access to MAT, and expand coverage to include community-based treatment settings. The 2024 report data also shows that polysubstance use remains common, with 45 percent of individuals with a secondary SUD reporting a stimulant use disorder. Gaudenzia is expanding its usage of the Matrix Model, a treatment approach designed to treat stimulant use disorder by integrating multiple evidence-based therapies to provide individualized care. Offering Housing as Healthcare Integration Access to stable housing remains a critical component of recovery. In FY-24, Gaudenzia served 2,813 individuals through its emergency, transitional, and permanent supportive housing programs. The report also highlights how Gaudenzia treatment centers serve a diverse client base across various demographics, including gender, age, and race/ethnicity in various counties and programs. Out of more than 15,800 admissions served across the organization, 44 percent of admissions served were white, 42 percent were Black/African American, 6 percent were Hispanic, and 6 percent were Multiracial. The county-by-county data in the FrontLine Report comes as the CDC reported 107,543 drug overdose deaths in the calendar year 2023. To access the complete FrontLine Report, visit . More information on Gaudenzia's evidence-based treatment programs for people with substance use and co-occurring disorders can be found at . Those who are in need of treatment can call Gaudenzia's 24/7 Treatment and Recovery Helpline at 833-976-HELP (4357). ABOUT GAUDENZIA, INC. Gaudenzia, Inc. is one of the largest nonprofit providers of treatment for people with substance use and co-occurring disorders in the United States, with 51 facilities operating in Pennsylvania, Maryland, Delaware, and Washington, D.C. The agency serves about 15,000 individuals annually and operates 120 programs providing a full continuum of care. Since 1968, Gaudenzia has provided specialized services and programs for all demographics, including pregnant and parenting women, adolescents, people with substance use and co-occurring disorders, and more. Those seeking help can call Gaudenzia's 24/7 Treatment and Referral HelpLine at 833-976-HELP (4357). For more information, visit . SOURCE Gaudenzia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHIELD I Study is One of the Largest Phase 3 Trials in the Prevention of SSIs in Colorectal Resection Conducted in Over a Decade Pre-Specified and Post-Hoc Analyses Suggested that D-PLEX100 May Benefit Patients with Increased SSI Risk, Including Those with Lengthy Incisions SHIELD II Study, the Ongoing Second Phase 3 with D-PLEX100, Focuses on Patients with Large Surgical Incisions; Top-line Results Expected in Q1 2025 PETACH TIKVA, Israel, Oct. 21, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a publication in the International Journal of Surgery (IJS) titled, "Effect of Local Prolonged-Release Incisional Doxycycline on Surgical Site Infection Prophylaxis in Abdominal Colorectal Surgery: The SHIELD I Randomized Clinical Trial.” The article highlights the full dataset from the first Phase 3 study (NCT04233424) of D-PLEX100, from which top-line results were announced in September 2022. “The overall infection rate in SHIELD I was significantly impacted by the COVID-19-related safety restrictions introduced in the surgical setting during the pandemic,” said Prof. Oded Zmora, Professor of Surgery at the Shamir Medical Center in Tel Aviv Israel, and President of the European Society of Coloproctology. “Given this unexpected change in baseline infection rate, the SHIELD I primary outcome became extraordinarily difficult to meet. For this reason, while the SHIELD I study did not achieve its primary endpoint, both pre-specified and post-hoc analyses suggested that D-PLEX100 may benefit patients at increased risk of surgical site infections (SSIs), including those with lengthy incisions. While SHIELD II is ongoing, the clinical data generated by D-PLEX100 to date suggest it may be a promising future adjunctive component of surgical care bundles.” A virtual KOL event hosted by the Company in June 2024, highlighted that procedural and patient-related risk factors, such as smoking, alcohol abuse, type 2 diabetes and a high BMI, are known to have a significant negative impact on the risk of developing an SSI, and this increase in risk is compounded when patients have multiple risk factors. During the presentation, Prof. Charles E. Edmiston, Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin, also confirmed that the long-term cost of SSIs to commercial payers is substantial and concluded there remains a significant unmet need for additional measures that prevent the development of SSIs. “We are thrilled to have the SHIELD I study results published in the highly regarded International Journal of Surgery, ranked second out of 212 titles in the Surgery category by impact factor1. Importantly, in the post-COVID-19 setting, we are seeing infection rates normalize to levels on par with those prior to the pandemic. We expect the SHIELD II infection rate to be more in line with the pre-pandemic rate and remain encouraged by the data generated in the SHIELD I pre-specified subgroup analysis that evaluated the primary endpoint in patients with incision lengths over 20 cm, which showed a 54% reduction in SSI rates between the D-PLEX100 treatment arm and the control arm,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Earlier this month, we enrolled the last patient required to conduct the planned SHIELD II unblinded interim analysis, which is anticipated to occur later this quarter and will be followed by the availability of top-line results, expected in the first quarter of 2025.” Phase 3 SHIELD I Trial Results The IJS article presents results of the Phase 3 SHIELD I trial (Surgical site Hospital acquired Infection prEvention with Local D-PLEX), a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which included prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial was the combination of incisional SSIs, incisional reinterventions due to suspected SSI or to poor wound healing including wound dehiscence, as determined by a blinded and independent adjudication committee, and mortality for any reason within 30 days post-surgery. The trial enrolled 977 patients, with 488 in the D-PLEX100 arm and 489 in the SoC arm, from more than 60 centers in the United States, Europe and Israel. A total of 104 patients experienced a primary outcome event: 45/485 (9.3%) in D-PLEX100 versus 59/489 (12.1%) in SoC. The clinically meaningful 23% event reduction in the D-PLEX100 treatment arm was not statistically significant (p=0.1520).In the greater than 20 cm incision length pre-specified subgroup, a statistically significant 54% reduction in primary outcome events was observed in D-PLEX100 (8%, 17/212) compared with SoC (17.5%, 37/211, p=0.0032).Analysis of the key secondary efficacy outcome, incisional SSI, also indicated a 54.6% reduction in the greater than 20 cm incision subgroup (4.4% in D-PLEX100 vs. 9.7% in SoC, p= 0.0410).Exploratory analysis of the additional secondary efficacy outcomes indicated marked differences in favor of D-PLEX100 vs. SoC in the greater than 20 cm incision length subgroup. Notably, the need for any surgical reintervention decreased by 54.6% in the D-PLEX100 treatment arm compared to the SOC arm (4.4% vs. 9.7%, p= 0.0333).There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD I. The overall incidence of treatment emergent adverse events (TEAEs) was similar between the study arms, with numerically lower incidences of severe and serious TEAEs, and any TEAEs requiring surgical reinterventions in the D-PLEX100 arm compared to the SoC arm. About SHIELD IISHIELD II is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with SoC, which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel. About D-PLEX100D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. About PolyPidPolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses potential benefits and advantages of D-PLEX100, that D-PLEX100 may be a promising future adjunctive component of surgical care bundles, the Company’s expectation that the SHIELD II infection rate will be more in line with the pre-pandemic rates, total recruitment time into the SHIELD II study and the timing of the top-line results and an unblinded interim analysis. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on March 6, 2024. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@Polypid.com Investors:Brian RitchieLifeSci Advisors212-915-2578BRitchie@lifesciadvisors.com 1 Based on OOIR.org https://ooir.org/journals.php?field=Clinical+Medicine&category=Surgery&metric=jif