Aptar Reports Third Quarter 2024 Results




Aptar Reports Third Quarter 2024 Results

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE:ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today reported strong third quarter results due to solid operational performance and margin improvement across the company. Results were driven by growth in proprietary drug delivery systems, as well as increased demand for closure technologies. Reported sales and core sales increased by 2%, as currency and acquisition effects did not impact the quarter. Aptar reported net income of $100 million for the quarter, a 19% increase from the prior year.

“Aptar delivered another strong quarter driven by our Pharma and Closures segments. We saw increased demand for our proprietary drug delivery systems, active material science solutions and closure technologies, especially for food applications. The Beauty segment saw growth in the personal care and home care markets, but it was not enough to offset tough comparisons from tooling and fragrance dispensing solutions from the prior year period. All three segments continued to demonstrate solid operational performance and margin improvement. We are proud of the strong results and progress we have made for the first nine months of the year and are positioned to achieve double-digit adjusted EPS growth for the full year,” said Stephan B. Tanda, Aptar President and CEO.

Third Quarter 2024 Highlights

• Reported and core sales increased 2%
• Reported earnings per share increased 17% to $1.48 and adjusted earnings per share increased 6% to $1.49
• Reported net income of $100 million increased 19% and adjusted EBITDA increased 8% from the prior year to $208 million, delivering an adjusted EBITDA margin of 23%, which is at the high end of the long-term target range
• Pharma segment delivered reported sales growth of 8% and core sales growth of 7% with continued demand for proprietary drug delivery systems, which grew double digits in the quarter
• Closures segment achieved a solid quarter, with sales and margins within its long-term target ranges
• Earlier this month, closed the previously announced joint venture transaction in China, following regulatory approvals, strengthening dispensing technology footprint

First Nine Months 2024 Highlights

• Double-digit earnings per share growth over the prior year period
• Net cash provided by operations increased to $465 million compared to $356 million in the prior year period
• Free cash flow increased to $255 million compared to $124 million in the prior year

Third Quarter Results

For the quarter ended September 30, 2024, reported sales increased 2% to $909 million compared to $893 million in the prior year. Core sales, which were not impacted by currency exchange rates and acquisitions, increased 2%.

Aptar Pharma’s reported sales increased 8% from the prior year quarter and core sales were up 7%. The segment’s strong performance was driven by continued demand for proprietary drug delivery systems, which grew double digits in the quarter after growing double digits in the prior year period. Growth in the third quarter was driven by allergy, emergency medicine and central nervous system therapeutics, as well as growing royalty revenues, boosting margins to 36%, which is at the top end of the long-term range. The Active Material Science division also grew double digits, with demand increasing across a number of end markets.

Aptar Beauty’s reported sales decreased 7%, and including currency effects core sales were down 6% compared to the prior year quarter. Approximately 4% of the decline in core sales can be attributed to lower tooling sales, with less favorable product mix contributing the remaining 2% of the decline. While revenue increased from the personal care and home care markets, this increase could not offset the challenging comparisons from prestige fragrance sales in the prior year period. Sales in North America improved progressively, while the Chinese beauty market remains soft. Margins were up year over year for Beauty, with improved operational performance and cost management remaining important points of focus for the segment.

Aptar Closures’ reported sales increased 3% from the prior year quarter and the segment’s core sales increased 4%. The increase in core sales was driven mainly by demand for closures in the food end market. Closures delivered a solid quarter and was within its long-term target ranges for both core sales and adjusted EBITDA margins. The segment’s margins increased by nearly 200 basis points over the prior year quarter, due to increased plant utilization and ongoing cost containment efforts.

Aptar reported third quarter earnings per share of $1.48, an increase of 17%, compared to $1.26 during the same period a year ago. Third quarter adjusted earnings per share, excluding restructuring charges and the unrealized gains or losses on an equity investment, were $1.49, an increase of 6%, compared to $1.40 in the prior year, including comparable exchange rates. The third quarter had an effective tax rate of 24% compared to the prior year period effective tax rate of 23%.

Year-To-Date Results

For the nine months ended September 30, 2024, reported sales increased 3% to $2.73 billion compared to $2.65 billion in the prior year. Core sales, which were not impacted by currency exchange rates and acquisitions, also increased 3%.

For the nine months ended September 30, 2024, Aptar’s reported earnings per share were $4.05, an increase of 22%, compared to $3.32 reported a year ago. Current year adjusted earnings per share, excluding restructuring charges, acquisition costs, and the unrealized gains or losses on an equity investment, were $4.12 and increased 15% from prior year adjusted earnings per share of $3.58, including comparable exchange rates. The current year had an effective tax rate of 23% comparable to the prior year period effective tax rate of 25%.

Outlook

Regarding Aptar’s outlook, Tanda stated, “Looking to the fourth quarter, we anticipate a solid finish to a strong year. The top line is expected to grow in the fourth quarter, even with some customers having indicated seasonal inventory right-sizing in the beauty and cough & cold end markets. Our pharma business should finish full year 2024 within its core sales long-term target range of 7-11%, driven by demand for allergy medication, emergency medicine and central nervous system therapies. The segment will deliver solid, double-digit adjusted EBITDA growth in 2024 due in part to sales of higher value products and royalties. Our Closures segment has returned to growth and we expect a strong finish to 2024, with healthy adjusted EBITDA margin improvements over the prior year. Beauty is battling a tough macro environment but continues to focus on the bottom line. Innovation, cost mitigation, improved operational leverage and accelerating efficiencies remain key priorities for our teams.”

Aptar currently expects earnings per share for the fourth quarter of 2024, excluding any restructuring expenses, changes in the fair value of equity investments and acquisition costs, to be in the range of $1.22 to $1.30. This guidance is based on an effective tax rate range of 20% to 22% with a comparable adjusted prior year effective tax rate of 24%. The earnings per share guidance range is based on spot rates at the end of September for all currencies. Based on the fourth quarter guidance, full year adjusted EPS would be in the range of $5.34 to $5.42, a double-digit increase over full year 2023.

Share Repurchase Authorization and Cash Dividend

As previously reported, Aptar’s Board of Directors authorized the repurchase of $500 million of the Company’s common stock. This new authorization replaces all previous authorizations. Aptar may repurchase shares through the open market, privately negotiated transactions or other programs, subject to market conditions. The Board also approved the quarterly cash dividend of $0.45 per share. The payment date is November 14, 2024, to stockholders of record as of October 24, 2024. During the third quarter, Aptar repurchased 95 thousand shares for approximately $14 million.

Open Conference Call

There will be a conference call held on Friday, October 25, 2024 at 8:00 a.m. Central Time to discuss the company’s third quarter results for 2024. The call will last approximately one hour. Interested parties are invited to listen to a live webcast by visiting the Investor Relations website at investors.aptar.com. Replay of the conference call can also be accessed for a limited time on the Investor Relations page of the website.

About Aptar

Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

Presentation of Non-GAAP Information

This press release refers to certain non-GAAP financial measures, including current year adjusted earnings per share and adjusted EBITDA, which exclude the impact of restructuring initiatives, acquisition-related costs, certain purchase accounting adjustments related to acquisitions and investments and net unrealized investment gains and losses related to observable market price changes on equity securities. Core sales and adjusted earnings per share also neutralize the impact of foreign currency translation effects when comparing current results to the prior year. Adjusted EBITDA is defined as earnings before net interest, taxes, depreciation, amortization, restructuring initiatives, acquisition-related costs, net unrealized investment gains and losses related to observable market price changes on equity securities and other special items. Adjusted EBITDA margin is adjusted EBITDA divided by reported net sales. Non-GAAP financial measures may not be comparable to similarly titled non-GAAP financial measures provided by other companies. Aptar’s management believes these non-GAAP financial measures provide useful information to our investors because they allow for a better period over period comparison of operating results by removing the impact of items that, in management’s view, do not reflect Aptar’s core operating performance. These non-GAAP financial measures also provide investors with certain information used by Aptar’s management when making financial and operational decisions. Free cash flow is calculated as cash provided by operating activities less capital expenditures plus proceeds from government grants related to capital expenditures. We use free cash flow to measure cash flow generated by operations that is available for dividends, share repurchases, acquisitions and debt repayment. We believe that it is meaningful to investors in evaluating our financial performance and measuring our ability to generate cash internally to fund our initiatives. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial results but should be read in conjunction with the unaudited condensed consolidated statements of income and other information presented herein. A reconciliation of non-GAAP financial measures to the most directly comparable GAAP measures is included in the accompanying tables. Our outlook is provided on a non-GAAP basis because certain reconciling items are dependent on future events that either cannot be controlled, such as exchange rates and changes in the fair value of equity investments, or reliably predicted because they are not part of the company’s routine activities, such as restructuring and acquisition costs.

This press release contains forward-looking statements, including certain statements set forth under the “Outlook” section of this press release. Words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: geopolitical conflicts worldwide including the invasion of Ukraine by the Russian military and the recent events in the Middle East and the resulting indirect impact on demand from our customers selling their products into these countries, as well as rising input costs and certain supply chain disruptions; the availability of raw materials and components (particularly from sole sourced suppliers for some of our Pharma solutions) as well as the financial viability of these suppliers; lower demand and asset utilization due to an economic recession either globally or in key markets we operate within; economic conditions worldwide, including inflationary conditions and potential deflationary conditions in other regions we rely on for growth; the execution of our fixed cost reduction initiatives, including our optimization initiative; fluctuations in the cost of materials, components, transportation cost as a result of supply chain disruptions and labor shortages, and other input costs (particularly resin, metal, anodization costs and energy costs); significant fluctuations in foreign currency exchange rates or our effective tax rate; the impact of tax reform legislation, changes in tax rates and other tax-related events or transactions that could impact our effective tax rate; financial conditions of customers and suppliers; consolidations within our customer or supplier bases; changes in customer and/or consumer spending levels; loss of one or more key accounts; our ability to successfully implement facility expansions and new facility projects; our ability to offset inflationary impacts with cost containment, productivity initiatives and price increases; changes in capital availability or cost, including rising interest rates; volatility of global credit markets; our ability to identify potential new acquisitions and to successfully acquire and integrate such operations, including the successful integration of the businesses we have acquired, including contingent consideration valuation; our ability to build out acquired businesses and integrate the product/service offerings of the acquired entities into our existing product/service portfolio; direct or indirect consequences of acts of war, terrorism or social unrest; cybersecurity threats against our systems and/or service providers that could impact our networks and reporting systems; the impact of natural disasters and other weather-related occurrences; fiscal and monetary policies and other regulations; changes, difficulties or failures in complying with government regulation, including FDA or similar foreign governmental authorities; changing regulations or market conditions regarding environmental sustainability; work stoppages due to labor disputes; competition, including technological advances; our ability to protect and defend our intellectual property rights, as well as litigation involving intellectual property rights; the outcome of any legal proceeding that has been or may be instituted against us and others; our ability to meet future cash flow estimates to support our goodwill impairment testing; the demand for existing and new products; the success of our customers’ products, particularly in the pharmaceutical industry; our ability to manage worldwide customer launches of complex technical products, particularly in developing markets; difficulties in product development and uncertainties related to the timing or outcome of product development; significant product liability claims; and other risks associated with our operations. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investor Relations Contact:
Mary Skafidas

mary.skafidas@aptar.com
815-479-5530

Media Contact:
Katie Reardon

katie.reardon@aptar.com
815-479-5671

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Axol Bioscience Acquires Phenocell to Advance Human Disease Models




Axol Bioscience Acquires Phenocell to Advance Human Disease Models

Acquisition expands Axol’s iPSC-derived cell models and service offering to include ophthalmology and dermatology

CAMBRIDGE, England & EDINBURGH, Scotland & GRASSE, France–(BUSINESS WIRE)–Axol Bioscience Ltd. (Axol), a leading induced pluripotent stem cell (iPSC) technology provider for drug discovery, today announced it has fully acquired Phenocell SAS, a pioneer in iPSC-based products and bioassays for skin and retinal disorders.

The acquisition extends Axol’s portfolio of iPSC-derived cell models, adding skin and human retinal iPSC-derived cell lines to its existing neuroscience, pain and touch, and cardiovascular products and services. Phenocell’s offering includes market-leading human iPSC-derived sebocytes and retinal pigment epithelium (RPE) and photoreceptor cells. Additionally, the company provides custom, skin and dry age-related macular degeneration (AMD) services to support drug discovery companies.

Liam Taylor, CEO, Axol Bioscience, said: “Axol has previously operated in three areas of drug research and discovery: neuroscience, pain and touch, and cardiovascular drug discovery. This acquisition enables us to extend our product portfolio into ophthalmology and dermatology and offer iPSC-based skin and vision loss models. We are delighted to welcome Phenocell to the Axol Bioscience family and look forward to building an even wider range of advanced in vitro models of human disease, combining our shared values and passion to accelerate drug discovery.”

“We have built a unique set of products and services over the last decade to meet the growing requirements from the drug discovery and cosmetic industries to move from primary models to more consistent, human iPSC-derived models,” said Brigitte Onteniente, CEO and founder of Phenocell. “As part of Axol Bioscience we look forward to working with Liam and the team to develop a larger range of models, to serve a wider market.”

Financial terms of the agreement are not disclosed.

For more information on Axol, please visit https://axolbio.com/

Contacts

Sarah Jeffery

Tel: +44 (0)7771 730 919

E-mail: sarah.jeffery@zymecommunications.com

CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara®




CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara®

• IMULDOSA obtained an approval recommendation from CHMP, who often sets the course of an EU marketing authorisation

SEOUL, South Korea–(BUSINESS WIRE)–#Approval—Dong-A ST (President/CEO Jae-Hun Jung, KRX:170900) announced on October 18^th that its biosimilar IMULDOSA^® (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara^®, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Accord Healthcare Limited (Accord), a subsidiary of Intas Pharmaceuticals and Dong-A ST’s partner, submitted the Marketing Authorisation Application (MAA) to the EMA in June 2023. On October 18^th (CET), the CHMP issued a recommendation for approval, further advancing DMB-3115’s journey toward the European Union.

The CHMP evaluates medicinal products based on scientific assessments of their quality, safety, and efficacy, providing guidance to the EMA. A positive CHMP recommendation is typically a key determinant in the European Commission’s (EC) marketing approval and after the CHMP Marketing Authorization Opinion, the EC decides whether to grant an official marketing authorization.

This achievement follows Dong-A ST’s success earlier this month, securing FDA approval for IMULDOSA^® on October 10, showcasing its R&D excellence to the world.

The biosimilar aims to treat-various immunology conditions, by offering an alternative to Stelara^®, originally developed by Janssen Biotech.

Stelara® is indicated for range of immunology indications and has recorded global sales of US$ 19 billion of which US$ 3.2 billion sales coming from Europe as per IQVIA MAT Jun’24 data.

IMULDOSA^® has been under joint development since 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, Dong-A ST took over the R&D and commercialisation responsibilities to streamline global project management. A year later, the company signed a global licensing agreement with Intas Pharmaceuticals, paving the way for the biosimilar’s commercialisation through Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada.

Dong-A ST stated that its R&D expertise has been reaffirmed by the positive CHMP opinion, following the FDA approval for IMULDOSA. The company also added that it is now focused on a successful launch of IMULDOSA in both the US and European markets, aiming to provide better treatment options for patients worldwide.

Contacts

Dong-A ST CO., Ltd

Shin-Hee Park

+82-32-610-2481

sh-park@donga.co.kr

Agilent Revolutionizes HPLC with the Launch of the Agilent Infinity III LC Series




Agilent Revolutionizes HPLC with the Launch of the Agilent Infinity III LC Series

Elevating lab efficiency with enhanced automation, connectivity, and sustainability capabilities

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced the release of its next generation Agilent InfinityLab LC Series portfolio, which includes the 1290 Infinity III LC, 1260 Infinity III Prime LC, and 1260 Infinity III LC systems, all including the biocompatible versions. These are the first HPLC systems on the market to feature the new Agilent InfinityLab Assist Technology, offering enhanced, built-in system assistance capabilities. This technology allows labs to focus more on achieving results rather than on daily operation and maintenance tasks.

With the introduction of these new LC systems, Agilent is revolutionizing the LC user experience. These systems significantly enhance task automation, connectivity, predictive feedback, and error reduction. The innovative built-in sample tracking, utilizing barcoding and camera technologies ensures the elimination of sample mix-ups, providing users with greater accuracy and peace of mind.

The incorporation of the new InfinityLab Assist is designed to enhance the on-board capabilities of the LC for all users. It supports analysts of all skill levels by automating instrument routines, simplifying sample preparation, assisting with maintenance and troubleshooting, and providing context-sensitive help content and solvent management guidance. These features will transform the user experience by eliminating repetitive and error-prone manual tasks, reducing the time required for training and onboarding, and delivering greater robustness and instrument insights that strengthen confidence in the results.

“Analytical lab managers face intense pressure to optimize operational efficiency without sacrificing result quality. With InfinityLab Assist, our customers can significantly reduce the time and effort spent on operator training, troubleshooting, and automating daily startup routines and system health notifications,” said Sudharshana Seshadri, vice president and general manager of Agilent’s Liquid Chromatography, Mass Spectrometry, and Automation divisions. “While the three new LC families fully incorporate the InfinityLab Assist Technology, we continue to offer modularity and upgradeability to support our installed base, both now and in the future, to safeguard existing investments as new InfinityLab Assist features are added over time.”

Additionally, the instruments in the new Infinity III LC Series feature method compatibility with earlier LC systems and seamless chromatography data systems (CDS) integration. The new systems feature third-party verification by My Green Lab’s revised ACT 2.0 Ecolabel, a global standard for assessing the environmental impact of laboratory equipment and supplies. They will also be the first LC systems to provide their CO₂ footprint to customers, demonstrating Agilent’s commitment to environmental sustainability. It is also noteworthy that all new features are available as upgrades to the existing Infinity II LC Series, representing an outstanding level of investment protection.

“Collectively, the instruments in the Infinity III LC Series establish a new benchmark in liquid chromatography,” said Philip Binns, president of Agilent’s Life Sciences and Applied Markets group. “Agilent is committed to exceeding user expectations by delivering intelligent instrumentation that simplify operations and enhance productivity. Our customers can look forward to a future with seamless system integration, minimal downtime, and consistently reliable results. Today’s release marks a significant milestone in our journey of continuous innovation, and we are excited to continue pushing the boundaries of LC technology.”

With the introduction of these next-generation LC systems, Agilent reinforces its market position as a leading provider of innovative and differentiated analytical solutions that elevate the laboratory experience and materially grow return-on-investment opportunities.

The launch of the new Agilent Infinity III LC Series will take place simultaneously across the globe in October including HPLC 2024, Dalian, China, AAPS 2024 PharmSci 360, US, and 23rd Human Proteome Organization World Congress (HUPO), Germany.

About Agilent Technologies

Agilent Technologies Inc., (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers’ most challenging questions. The company generated revenue of $6.83 billion in fiscal 2023 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

Contacts

Media Contact
Catherine Kaye

Agilent Technologies

+44 7775 410632

Catherine.kaye@agilent.com

PureTech Founded Entity Seaport Therapeutics Closes $225 Million Oversubscribed Series B Financing Round




PureTech Founded Entity Seaport Therapeutics Closes $225 Million Oversubscribed Series B Financing Round

Financing led by General Atlantic with participation from other top tier investors

Proceeds will support key clinical milestones in Seaport’s pipeline of first and best-in-class neuropsychiatric medicines

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, (“Seaport”) a biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the closing of an oversubscribed $225 million Series B financing round. The syndicate was led by General Atlantic, a leading global growth investor, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., Foresite Capital, Invus, Goldman Sachs Alternatives, CPP Investments, and other new investors. Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder PureTech also participated. Following the Series B financing, PureTech will hold equity ownership in Seaport of 36.7% on a diluted basis.

The financing brings the total capital raised by Seaport to $325 million since the Company’s launch in April 2024. Seaport will use the proceeds to advance its clinical-stage pipeline of first and best-in-class medicines through important clinical milestones as well as further advance the capabilities of the Glyph™ technology platform, which has demonstrated clinical proof-of-concept. The programs in Seaport’s pipeline use the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations.

Commenting on today’s announcement, Bharatt Chowrira, PhD, JD, Chief Executive Officer of PureTech and a member of the Seaport Board of Directors, said:

“We’re very pleased with Seaport’s $225 million Series B financing. Led by a syndicate of top-tier investors, this milestone highlights the significant progress we’re making across our portfolio. The strong support from this stellar investor group not only reinforces the value generated by our unique R&D engine but also underscores our commitment to advancing transformative therapies for patients. As we look ahead to the upcoming data readout for our internal LYT-100 (deupirfenidone) program, we’re excited to continue driving innovation across our portfolio with the goal of delivering impactful treatments that address significant medical needs.”

The full text of the announcement from Seaport is as follows:

Seaport Therapeutics Closes $225 Million Oversubscribed Series B Financing Round

Financing led by General Atlantic with participation from T. Rowe Price Associates, Foresite Capital, Invus, Goldman Sachs Alternatives, Canada Pension Plan Investment Board (CPP Investments) as well as other new investors

Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and PureTech Health also participated

Proceeds will support key clinical milestones in Seaport’s pipeline of first and best-in-class neuropsychiatric medicines

BOSTON, October 21, 2024 – Seaport Therapeutics (“Seaport”), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the closing of an oversubscribed $225 million Series B financing round. The syndicate was led by General Atlantic, a leading global growth investor, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., Foresite Capital, Invus, Goldman Sachs Alternatives, CPP Investments, and other new investors. Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder PureTech Health also participated.

The financing brings the total capital raised by Seaport to $325 million since the company’s launch in April 2024. Seaport will use the proceeds to advance its clinical-stage pipeline of first and best-in-class medicines through important clinical milestones as well as further advance the capabilities of the Glyph™ technology platform, which has demonstrated clinical proof-of-concept.

“We are grateful to have the partnership of this incredible group of new and existing investors who share our commitment of delivering better medicines for those suffering from depression, anxiety and other neuropsychiatric disorders,” said Daphne Zohar, Founder and CEO of Seaport Therapeutics. “Seaport is advancing novel therapeutics that have proven clinical efficacy but had previously been held back by an issue we can now address with our Glyph platform. This financing enables the important clinical work that brings us another step closer to delivering new medicines to make a difference in the lives of patients and their families.”

“We are excited to partner with Daphne Zohar, Steve Paul and the team at Seaport,” said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic. “We are impressed with the team’s outstanding CNS clinical track record, as well as Seaport’s Glyph platform and innovative pipeline. The approach to clinical development and trial design demonstrates the deep neuropsychiatric expertise around the table, which we believe offers unique advantages that will contribute to Seaport’s success. We look forward to supporting the company’s next phase of development.”

The programs in Seaport’s pipeline use the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations. The most advanced therapeutic candidate in the pipeline is SPT-300, an oral prodrug of allopregnanolone that is being advanced into a Phase 2b study for major depressive disorder with or without anxious distress that has the potential to be registration-enabling. Allopregnanolone is an endogenous neurosteroid with clinically validated rapid anti-depressant and anxiolytic activity, and SPT-300 retains this activity in an oral form.

“The development of important new neuropsychiatric medicines is often halted due to poor drug-like properties or unacceptable tolerability, challenges that our Glyph platform can now uniquely address,” said Steve Paul, M.D., Founder and Board Chair at Seaport Therapeutics. “For instance, xanomeline was an effective drug that faced tolerability challenges, but once resolved, led to the FDA approval of Cobenfy™ (formerly KarXT) for schizophrenia. With Glyph, we believe each of Seaport’s programs could create similar life-changing value for patients.”

SPT-320, a novel prodrug of agomelatine being advanced into Phase 1 studies for the treatment of generalized anxiety disorder (GAD), has the potential to be the first new mechanism for GAD in decades. SPT-320 uses Glyph to bypass liver first-pass metabolism and thus has the potential to lower the dose and reduce liver exposure while retaining efficacious systemic exposure of agomelatine that has been validated in multiple clinical studies in GAD. The reduction in dose has the potential to eliminate the need for liver function monitoring that has previously held back agomelatine’s development in GAD. SPT-348, a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, uses Glyph to create a potential first-in-class treatment. Beyond these programs, Seaport has multiple discovery and preclinical programs underway.

About the Glyph™ Platform

Glyph is Seaport’s proprietary technology platform which uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. The Glyph platform has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism leading to low bioavailability and/or side effects, including liver enzyme elevations or hepatotoxicity. Seaport exclusively licensed this technology from Monash University based on the pioneering research of the Porter Research Group. Advanced initially at PureTech Health and now at Seaport, Glyph has been applied to create therapeutic candidates for the company’s pipeline resulting in new intellectual property, including composition of matter. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology and the Journal of Controlled Release supporting the Glyph platform’s capabilities. See Glyph in action here.

About Seaport Therapeutics

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Ownership Information

PureTech contributed $14.4 million to the Series B financing and now holds equity ownership in Seaport of 36.7 percent on a diluted basis. Additionally, as the founder of Seaport, PureTech has a right to royalty payments on a percentage of net sales of any commercialized product as well as the right under the terms of the license agreement with Seaport to receive milestone payments upon the achievement of certain regulatory approvals and a percentage of sublicense income.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to additional milestones or royalties potentially due to PureTech, Seaport’s development plans for its pipeline of therapeutics for the treatment of depression, anxiety and other neuropsychiatric disorders, potential benefits to patients, the anticipated use of proceeds from the Series B financing and Seaport’s and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

UK/EU Media
Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com

US Media
Justin Chen

+1-609-578-7230

jchen@tenbridgecommunications.com

ASDS 2024: New Phase III READY-4 Data Demonstrate Long-Term Safety and Efficacy of Galderma’s RelabotulinumtoxinA (Relfydess™)




ASDS 2024: New Phase III READY-4 Data Demonstrate Long-Term Safety and Efficacy of Galderma’s RelabotulinumtoxinA (Relfydess™)

• First results from the phase III READY-4 trial demonstrate the long-term safety of repeated injections of RelabotulinumtoxinA for both frown lines and crow’s feet, with efficacy and patient satisfaction maintained across multiple treatments¹
• These results were presented alongside additional data from the phase III READY clinical trial program showing RelabotulinumtoxinA’s long duration of effect for six months for frown lines and crow’s feet^2,3
• Data presented add to the body of evidence demonstrating the safety and efficacy of RelabotulinumtoxinA, including its onset of action as early as day one^4,5
• Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator developed using PEARL^™ Technology that is optimized for simple volumetric dosing to increase ease-of-use^6-8
• Further update on neuromodulators: the International Chamber of Commerce (ICC) reaffirmed the scope of Galderma’s exclusive distribution rights with respect to Azzalure^® and Dysport^® and Galderma’s rights to commercialize these products in additional countries in Eastern Europe and Central Asia, following the completion of arbitration proceedings in October 2024

ZUG, Switzerland–(BUSINESS WIRE)–Galderma today announced new phase III data from the READY-4 clinical trial, demonstrating the long-term safety of RelabotulinumtoxinA (Relfydess^™) for frown lines and crow’s feet after repeated injections.¹ The READY-4 study met its primary and secondary endpoints, with less than one in five participants experiencing treatment-related treatment-emergent adverse events (TEAEs), and all events deemed mild or moderate.¹ Efficacy and patient satisfaction were also maintained across multiple treatments.¹ The data were presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, held in Florida from October 17-20.

Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL^™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule.^6-8 Previously announced data from the READY clinical trial program have demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with RelabotulinumtoxinA.^4,5,9

READY-4 is a phase III, multicenter, open-label study, designed to evaluate the safety of RelabotulinumtoxinA for the long-term treatment of moderate-to-severe frown lines and crow’s feet in more than 900 participants. Injections were administered at a minimum of 12 weeks apart, in up to four cycles over 12 months.^1,10

Results demonstrate the long-term safety of repeated RelabotulinumtoxinA injections, consistent with the safety profile observed in the phase III READY-1, -2 and -3 clinical trials.^1,4,9,11 TEAEs were all mild to moderate, reported by 18% of participants and with similar occurrence across cycles one to four (11%, 7%, 7%, and 10% in cycle one, two, three, and four, respectively).¹

Efficacy was also maintained, with most participants achieving none-or-mild wrinkle severity at one month, which was maintained across multiple treatments throughout 12 months. Participants also reported high treatment satisfaction at one month (≥84%).¹

Additional data on RelabotulinumtoxinA were presented at ASDS, including:

• Data from the phase III READY-3 study, previously presented at the TOXINS 2024 conference, demonstrated that RelabotulinumtoxinA significantly improves both frown lines and crow’s feet, when treated alone or simultaneously, with long duration of effect for six months, a favorable safety profile, and high patient satisfaction^2,11
• Pooled data from a post-hoc analysis of the READY-1, -2 and -3 studies showed that there were similarly high rates of improvement for both frown lines and crow’s feet following treatment with RelabotulinumtoxinA in people with different skin types, ethnicity, and race, affirming its efficacy and safety across diverse populations³

More details on Galderma’s scientific presentations at ASDS can be found here.

As previously communicated, Galderma completed its European decentralized procedure for RelabotulinumtoxinA in July 2024, resulting in a positive decision, and national approvals are now under finalization. RelabotulinumtoxinA also received a marketing authorization in Australia earlier this year. Regulatory applications for RelabotulinumtoxinA for the treatment of frown lines and crow’s feet will continue to be submitted and assessed by additional authorities globally. The development of RelabotulinumtoxinA is a key outcome of our exciting and compelling innovation pipeline and Galderma is working to launch it in the markets in which it is approved in the first half of 2025.

Update on International Chamber of Commerce (ICC) arbitration

The arbitration proceeding initiated by Galderma against Ipsen at the ICC related to the territorial scope of the Azzalure^® and Dysport^® (abobotulinumtoxinA) commercial partnership under the 2007 European development and distribution agreement has now been completed. The Tribunal of the ICC issued a final award in October 2024, reaffirming the scope of Galderma’s exclusive distribution rights with respect to Azzalure^® and Dysport^®. The award confirmed Galderma’s rights to commercialize Azzalure^® and Dysport^® in certain additional countries, including in Eastern Europe and Central Asia, that had been in dispute between the parties but dismissed Galderma’s claim for monetary compensation related to the timing of the transfer of such rights. Galderma and Ipsen continue to work in close partnership to grow Azzalure^® and Dysport^® sales in the territories of their commercial alliance.

About RelabotulinumtoxinA

Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL^™ Technology that is designed to preserve molecule integrity.^6,7 PEARL^™ Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.^4-7,9 RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^6,7 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About the READY-4 clinical trial (NCT04225260)^1,10

READY-4 is a phase III, multicenter, open-label study, designed to evaluate the safety of RelabotulinumtoxinA for the long-term treatment of moderate-to-severe frown lines and crow’s feet in more than 900 participants.^1,10

READY-4 is part of Galderma’s phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, composed of four phase III clinical trials which enrolled more than 1,900 participants, and investigated the safety, efficacy, rapidity of onset, and/or durability of RelabotulinumtoxinA for six months on:^1,4,5,10,12

• Frown lines (READY-1)⁴
• Crow’s feet (READY-2)⁵
• Frown lines and crow’s feet when treated alone or simultaneously (READY-3)¹²

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Beer K, et al. READY-4: Long-term safety with repeated injections using RelabotulinumtoxinA, a novel liquid formulation botulinum toxin, in the treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
2. Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
3. Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
4. Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. ASJ. 2024; sjae131
5. Galderma. Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021
6. Sundberg AL and Stahl U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting
7. Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) – relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA
8. Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
9. Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
10. Galderma. Data on file. Clinical Study Report for Protocol 43QM1903: READY-4. Galderma Laboratories; 2021
11. Bertucci V, et al. Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, when used for Combination Treatment of Glabellar and Lateral Canthal Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
12. Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Blue Lake Biotechnology and CyanVac Announce Presentation on Intranasal Vaccine Candidates at the International Society for Vaccines Annual Congress




Blue Lake Biotechnology and CyanVac Announce Presentation on Intranasal Vaccine Candidates at the International Society for Vaccines Annual Congress

ATHENS, Ga. & SAN JOSE, Calif.–(BUSINESS WIRE)–Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, and its affiliate CyanVac LLC, today announced the presentation of positive interim pediatric clinical data on BLB201, Blue Lake’s vaccine candidate against respiratory syncytial virus (RSV), at the 2024 ISV Annual Congress in Seoul, South Korea. The oral presentation also included discussion of Phase 1 clinical data on CVXGA, the companies’ clinical stage vaccine candidate against COVID-19.

Hong Jin, Ph.D., Chief Scientific Officer of Blue Lake and CyanVac, presented a talk entitled “PIV5-Vectored RSV and COVID-19 Intranasal Vaccines Show Great Promise in Clinical Studies” which included results from an interim analysis of RSV-seropositive children who are participating in the company’s ongoing Phase 1/2a pediatric study. The data demonstrated the safety and immunogenicity of BLB201 in this population, including RSV F-specific systemic and mucosal antibody responses and cell-mediated immune responses in CD4+ and CD8+ T cells. Similarly, COVID S-specific systemic and mucosal antibody responses and T cell-mediated responses were detected in the Phase 1 clinical trial of CVXGA.

“Our vaccine approach is designed to stimulate potent immune responses from the humoral, cellular, and mucosal pillars of the immune system,” said Biao He, Ph.D., CEO of Blue Lake and CyanVac. “Many currently available vaccine technologies such as mRNA vaccines and protein-based vaccines are not effective in inducing mucosal immunity because they are given intramuscularly. By robustly stimulating all three pillars of immunity, our intranasal vaccine may prevent disease transmission and generate longer lasting immunity than other types of vaccines.”

In addition to the clinical data presented by Dr. Jin at the Congress, Cristina Gingerich, PhD, a CyanVac scientist, will present preclinical data on a PIV5-based vaccine for Lyme disease in a poster entitled “An intranasal parainfluenza virus 5 (PIV5)-based vaccine for Lyme Disease induces protection against multi-strain Borrelia burgdorferi tick challenge in mice.”

The Lyme disease project was a collaboration between CyanVac and Immuno Technologies, Inc. and was supported by the National Institute of Allergy and Infectious Disease of the National Institutes of Health under award number R44AI167605.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects.

Learn more at Blue Lake Biotechnology and CyanVac.

Contacts

Media Contact

Carolyn Hawley

Inizio Evoke Comms

carolyn.hawley@inizioevoke.com 

619-849-5382

Company Contact

Samuel Wu, Chief Business Officer

Blue Lake Biotechnology, Inc. and CyanVac LLC

swu@cyanvacllc.com 

650-609-2231

Emily E. Volk, MD, MBA, FCAP, Named Pathologist of the Year




Emily E. Volk, MD, MBA, FCAP, Named Pathologist of the Year

College of American Pathologists Honors 31 Members/Residents at CAP24 Annual Meeting

LAS VEGAS–(BUSINESS WIRE)–#CAP–The College of American Pathologists (CAP), the world’s largest organization of board-certified pathologists, has honored Emily E. Volk, MD, MBA, FCAP, with the Pathologist of the Year award. This award, presented at CAP’s annual meeting held in Las Vegas, Nevada, from October 19-22, 2024, recognizes her outstanding contributions to the field of pathology.

Dr. Volk trained at the Cleveland Clinic in anatomic and clinical pathology and completed a fellowship in cytopathology at William Beaumont Hospital in Royal Oak, MI. She is a practicing pathologist at UofL Health in Louisville, Kentucky where she also serves as the Vice President of System Laboratories and Pathology as well as the Chief Medical Officer at UofL Health South Hospital. She served for 11 years on the CAP Board of Governors and has contributed to the organization for over two decades. She has chaired key committees and councils, including the Council on Government and Professional Affairs, the Economic Affairs Committee Performance Assessment Subcommittee, and the Ad Hoc Committee for the Pathologists Quality Registry. Dr. Volk’s dedication to political advocacy on behalf of pathology is reflected in her ongoing support for the Pathologists Leadership Summit and Hill Day.

As CAP president from 2021-2023, Dr. Volk spearheaded numerous initiatives that positioned the organization as a leader in healthcare. She advocated for health equity, addressing forums like the Congressional Black Caucus Health Braintrust, promoting non-race-based eGFR testing, and improving laboratory access in underserved communities. She also supported modernizing blood donation protocols, developing inclusive reference ranges, and establishing the Council on Informatics and Pathology Innovation and the Ethics and Professionalism Committee.

Dr. Volk’s efforts also laid the groundwork for CAP’s innovation acceleration pathway. She made hundreds of media appearances, earning the CAP national recognition through the Profiles of Excellence Award in Communications from the American Association of Medical Society Executives (AAMSE). Additionally, she championed the J1 Visa Waiver for international medical graduates, advanced member learning, and engaged record numbers of CAP Today readers through her President’s Desk column.

“It is an incredible honor to be recognized by my colleagues with this award,” says Dr. Volk. “The time I have invested in the organization has been central to my success overall in my career. Early in my career, I worked alongside accomplished pathologists and talented staff members on CAP committees. These leaders inspired me to work harder on behalf of our patients and our profession.”

The CAP also recognized several of its members for their outstanding contributions to pathology and laboratory medicine during its annual meeting.

This year’s honorees are:

CAP Advocate of the Year Award in Honor of George F. Kwass, MD, FCAP

• Jonathan L. Myles, MD, FCAP

CAP Distinguished Patient Care Award

• Aaron Auerbach, MD, MPH, FCAP
• Vinita Parkash, MBBS, MPH, FCAP

CAP Distinguished Service Award

• Thomas P. Baker, MD, FCAP
• Anil V. Parwani, MD, PhD, MBA, FCAP
• Deborah A. Perry, MD, FCAP

CAP Laboratory Accreditation Program Service Award Established in Honor of Major General Joseph M. Blumberg, MD, FCAP

• Leonas G. Bekeris, MD, FCAP

CAP Laboratory Improvement Programs Service Award

• Jonathan R. Genzen, MD, PhD, MBA, FCAP
• David B. Sacks MB, ChB, FRCPath, FCAP
• Amy B. Karger, MD, PhD, FCAP, DABCC

CAP Lifetime Achievement Award

• Phyu P. Aung, MD, PhD, FCAP
• Matthew D. Carr, MD, FCAP
• Ann Moyer, MD, PhD, FCAP
• Glenn E. Ramsey, MD, FCAP
• Amyn M. Rojiani, MD, PhD, CPE, FCAP
• Marisa C. Saint Martin, MD, ACC, FCAP

CAP Outstanding Communicator Award Established in Honor of William L. Kuehn, PhD

• Marianne Hamel, MD, PhD, FCAP

Outstanding Contribution to Pathology Informatics Standards Award

• Franklin R. Elevitch, MD, FCAP

CAP Outstanding Educator Award

• Robert Michael Najarian, MD, FCAP

CAP Outstanding Service Award Established in Honor of Frank W. Hartman, MD, FCAP

• James H. Harrison, Jr., MD, PhD, FCAP

CAP Pathology Advancement Award

• Romney M. Humphries, PhD, D(ABMM)
• Isabella Martin, MD, FCAP
• Kaede Ota Sullivan, MD, MBA, FRCPC, FAAP, D(ABMM)
• Carol A. Rauch, MD, PhD, FCAP
• Rosemary She, MD, FCAP
• Patricia J. Simner, PhD, D(ABMM)

CAP Public Service Award Established in Honor of Frank C. Coleman, MD, FCAP

• David S. Wilkinson, MD, PhD, FCAP

CAP Resident Advocate Award

• Stephen Simalchik, MBA

CAP Resident of the Year Award

• Amanda Herrmann, MD, PhD

CAP Staff Outstanding Achievement Award

• Helena L. Duncan, MJ

To see more of the CAP24 Meritorious Awards, visit CAP.org.

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.

Contacts

Abby Watson

Phone: 847-832-7513

Email: media@cap.org

Castle Biosciences Presents New Data at ASDS from Prospective, Multicenter CONNECTION Study Supporting Use of DecisionDx®-Melanoma to Guide SLNB Decisions in T1a Tumors with High-Risk Features and T1b Tumors




Castle Biosciences Presents New Data at ASDS from Prospective, Multicenter CONNECTION Study Supporting Use of DecisionDx®-Melanoma to Guide SLNB Decisions in T1a Tumors with High-Risk Features and T1b Tumors

Data from prospective, multicenter CONNECTION study indicate that using DecisionDx-Melanoma test results to guide sentinel lymph node biopsy (SLNB) decisions in patients with T1 melanoma tumors could have reduced the number of unnecessary biopsies by up to 64%, which, in turn, could have reduced procedure-related complications and health care costs

New findings support DecisionDx^®-SCC’s use in guiding radiologic surveillance imaging in patients with stage T2b squamous cell carcinoma (SCC) tumors based on Brigham and Women’s Hospital (BWH) staging, including deferring imaging for patients with low-risk test results and proceeding with imaging for patients with high-risk results

FRIENDSWOOD, Texas–(BUSINESS WIRE)–$CSTL #ASDS–Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data supporting the clinical utility of its DecisionDx-Melanoma and DecisionDx-SCC tests in guiding risk-aligned treatment decisions, including SLNB for patients with melanoma and surveillance imaging for those with SCC. The data were shared in two video abstracts at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting, held Oct. 17-20, 2024, in Orlando, Florida.

“While staging is an important part of skin cancer risk assessment, well-validated molecular tests like DecisionDx-Melanoma and DecisionDx-SCC are designed to look deeper into the biology of a patient’s tumor to provide additional insight into its likely behavior,” said Etan Marks, D.O., board-certified pathologist, laboratory director and primary investigator at Advanced Dermatology and Cosmetic Surgery in Delray Beach, Florida. “As demonstrated in the studies at ASDS, these insights can enhance clinical decision-making and arm clinicians with more precise risk information to help route patients to the most appropriate modality aligned to their risk of metastasis and survival.”

Details regarding Castle’s video abstracts presented at ASDS are included below:

DecisionDx-Melanoma

• Title: The i31-GEP identifies patients with T1 cutaneous melanoma who can safely avoid sentinel lymph node biopsy: Results from a prospective, multicenter study
• Lead Author: Etan Marks, D.O., Advanced Dermatology and Cosmetic Surgery, Delray Beach, Florida
• Key take-aways:
  
  National Comprehensive Cancer Network® (NCCN) guidelines regarding SLNB are most ambiguous for patients with T1a tumors with high-risk features and T1b tumors, for whom SLNB may be considered due to an increased risk of metastasis. Data from this ongoing prospective, multicenter study (CONNECTION) confirm that DecisionDx-Melanoma can identify patients with T1 tumors with a low risk of sentinel lymph node positivity who can safely forgo SLNB (negative predictive value of 98.4%), while maintaining very high survival rates in low-risk patients who did not have an SLNB (three-year recurrence free survival rate of 99.5%).¹ Additionally, the data indicate that using DecisionDx-Melanoma test results to guide SLNB decisions in patients with T1 tumors could have reduced the number of unnecessary biopsies by up to 64%, as well as procedure-related complications and health care costs.
• View video abstract here.

DecisionDx-SCC

• Title: The 40-gene expression profile (40-GEP) test enhances risk-aligned guidance for surveillance imaging in high-risk cutaneous squamous cell carcinoma (cSCC)
• Lead Author: Emily S. Ruiz, M.D., MPH, Brigham and Women’s Hospital and Harvard Medical School, Boston
• Key take-aways:
  
  Radiologic surveillance imaging in patients with high-risk SCC can identify disease recurrence earlier, which may improve patient outcomes. This study evaluated the utility of the DecisionDx-SCC test in guiding these decisions in patients with higher stage disease (i.e., patients with BWH T2b SCC tumors), whom studies have shown are at a higher likelihood of nodal or distant metastasis relative to lower-staged patients. In the study, approximately 42% of the patients with T2b tumors who received radiologic surveillance imaging received a Class 1 (low risk) test result and had a metastasis rate of 5.9%, indicating that clinicians could have safely deferred surveillance imaging for these Class 1 patients due to the low metastatic rate. For patients who were not imaged, almost 50% received a Class 2A or 2B (higher or highest risk) test result and had an 18.8% metastasis rate, suggesting that these patients may have benefitted from imaging to promote early detection of disease progression and improved outcomes. Overall, these data demonstrate the utility of DecisionDx-SCC to help improve selection of BWH T2b patients for radiologic surveillance imaging based on their biological risk of metastasis, as provided by the test.
• View video abstract here.

About DecisionDx^®-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2024, DecisionDx-Melanoma has been ordered more than 173,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of the DecisionDx-Melanoma test to (i) reduce the number of unnecessary biopsies in patients with T1 melanoma tumors and (ii) reduce procedure-related complications and health care costs; the ability of DecisionDx-SCC to guide radiologic surveillance imaging in patients with SCC tumors; the ability of DecisionDx-Melanoma and DecisionDx-SCC to (i) provide additional insight into the likely behavior of a patient’s tumor, (ii) enhance clinical decision-making and (iii) arm clinicians with more precise risk information to help route patients to the most appropriate modality aligned to their risk of metastasis and survival . The words “believe,” “can,” “could,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

1. Guenther JM, et al. Patients who forego sentinel lymph node biopsy after 31-GEP testing are not harmed: A prospective, multicenter analysis. Poster presented at: 20th European Association of Dermato-Oncology (EADO) Congress; April 4-6, 2024; Paris, France. https://eado2024.com/wp-content/uploads/2024/04/EADO2024Book_of_Abstracts.pdf

Contacts

Investor Contact:
Camilla Zuckero

czuckero@castlebiosciences.com

Media Contact:
Allison Marshall

amarshall@castlebiosciences.com

Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48




Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48

– Novel Investigational Combination Regimen is Advancing to Phase 3 and has the Potential to Become the First Weekly Oral HIV Treatment –

FOSTER CITY, Calif., & RAHWAY, N.J.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor. These late-breaking data were presented during an oral session at IDWeek 2024, taking place in Los Angeles, and virtually, from October 16-19.

At 48 weeks, the novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study. Zero participants had a viral load of ≥50 copies/mL at Week 48. Week 24 results, including the study’s primary endpoint, were previously presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).

“The future of HIV treatment is person-centered, with long-acting options tailored to help meet the needs and preferences of people affected by HIV,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “There is no ‘one size fits all’ approach. The complexities of HIV care require putting people first in the development of biomedical innovations as we keep striving to offer options for all those living with HIV. These data presented at IDWeek demonstrate our commitment to continuous scientific discovery aimed at further transforming the HIV treatment landscape.”

In this open-label, active-controlled study (NCT05052996), virologically suppressed adults (n=104) on Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) were randomly allocated in a 1:1 ratio to receive either oral islatravir 2 mg and lenacapavir 300 mg once a week (n=52) or to continue daily oral Biktarvy (n=52). The median age of participants was 40 years (20-76). Eighteen percent of participants were assigned female at birth, 50% were non-white, and 29% were Latine.

The proportion of individuals with HIV-1 RNA <50 c/mL at Week 48 by FDA snapshot algorithm (a secondary endpoint), showed that participants who switched to treatment with once-weekly islatravir and lenacapavir (ISL + LEN) or continued Biktarvy maintained comparable high rates of HIV suppression at Week 48 (94.2% v. 92.3%, respectively). No participants treated with either ISL + LEN or Biktarvy had a viral load of ≥ 50 copies/mL at Week 48 (another secondary endpoint).

Treatment-related-adverse events (TRAEs), as attributed by study investigator, were experienced by 19.2% of participants (n=10/52) in the ISL + LEN group and the most common were dry mouth (n=2/52; 3.8%) and nausea (n=2/52; 3.8%). TRAEs were reported by 5.8% of participants in the Biktarvy group (n=3/52). No grade 3 or 4 TRAEs related to the study drug were reported in either treatment group. Two participants (n=2/52; 3.8%) discontinued ISL + LEN due to adverse events unrelated to the drug. At Week 48 no significant differences were seen between treatment groups in mean change from baseline in CD4+ T-cell counts or absolute lymphocyte counts. No participants discontinued due to a decrease in CD4+ T-cell or lymphocyte counts.

“Daily single-tablet regimens have helped to transform HIV care but can be challenging for some people to maintain. Novel HIV treatment options that allow for less frequent oral dosing have the potential to help support adherence, and address stigma faced by some individuals taking daily oral therapy,” said Dr. Elizabeth Rhee, Vice President, Global Clinical Development, Merck Research Laboratories. “We are pleased to see these encouraging 48-week data for this once-weekly oral combination regimen and advance to phase 3 clinical trials in collaboration with Gilead.”

Along with these most recent study results, the potent antiviral activities, and pharmacokinetic profiles of islatravir and lenacapavir support their continued development as an investigational once-weekly oral combination regimen for use in people with HIV who are virologically suppressed. This investigational combination of weekly oral ISL 2 mg + LEN 300 mg is being further evaluated as a fixed-dose combination regimen in two Phase 3 studies (NCT06630286 and NCT06630299) in virologically suppressed people with HIV.

Islatravir in combination with lenacapavir is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established.

Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment that could uniquely fit into the lives of people with HIV. The use of lenacapavir for HIV treatment in virologically suppressed individuals is investigational and not approved anywhere globally.

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.

There is currently no cure for HIV or AIDS.

About Islatravir (MK-8591) and Merck’s HIV Research

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1. Studies with islatravir are designed to offer different dosing options as potential daily and once-weekly treatments. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here.

About Lenacapavir

The multi-stage mechanism of action of lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle.

Lenacapavir is being evaluated as a potential long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. The goal is to offer both long-acting oral and injectable options with various dosing frequencies in combination with other antiretroviral agents for treatment or as a single agent for prevention. This approach aims to help address the individual needs and preferences of people with HIV and people who could benefit from pre-exposure prophylaxis (PrEP). The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use has not been established.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Merck’s Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has been pioneering in the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We want to ensure people are not defined by HIV and our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at the goal of helping to end the HIV epidemic for everyone.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

About Gilead Sciences in HIV

For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations, and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE OF BIKTARVY

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.

• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

• New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.

• Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

• Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

• Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.

• Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.

• Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

• Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.

• Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.

• Hepatic impairment: Not recommended in patients with severe hepatic impairment.

• Prior to or when initiating: Test patients for HBV infection.

• Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

• Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population.

• Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

U.S. full Prescribing Information for Biktarvy, including BOXED WARNING, is available at www.gilead.com.

Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Meaghan Smith, Media

public_affairs@gilead.com

Jacquie Ross, Investors

investor_relations@gilead.com

Julie Cunningham, Media

julie.cunningham@merck.com

Peter Dannenbaum, Investors

peter.dannenbaum@merck.com