Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer

Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer




Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine

Company on track to conduct formal interim analysis in early 2026

VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.

Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy (Mono-Cap). This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa’s NGC platform.

The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.

“These emerging data continue to validate the central premise of our Next Generation Cancer strategy,” said Dr. David Young, President of Research and Development at Processa. “NGC-Cap (capecitabine combined with PCS6422) appears to meaningfully increase exposure to the capecitabine metabolites responsible for killing cancer cells, while reducing exposure to the catabolite metabolites associated with dose-limiting toxicity such as hand-foot-syndrome (HFS), a profile that is difficult to achieve with conventional Mono-Cap dosing.”

“As we approach our planned interim analysis, we believe NGC-Cap continues to demonstrate a differentiated pharmacologic profile that could meaningfully improve the therapeutic index of capecitabine-based therapy,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “We view this program as a key value driver for the Company and an important opportunity for patients with advanced or metastatic breast cancer.”

Preliminary Phase 2 study findings suggest that NGC-Cap may allow patients to receive greater exposure to the most effective cancer-killing components of therapy while avoiding increased severity of side effects commonly associated with standard treatment. The Company believes this balance between potential efficacy and tolerability is central to improving outcomes in patients with advanced breast cancer.

Key Safety and Pharmacokinetic Observations

19 patients have been randomized to receive either NGC-Cap (150 mg twice daily) or a standard-dose Mono-Cap (1,000 mg/m² twice daily). The evaluation of safety data from the first 16 patients provides preliminary findings consistent with higher exposure to active cancer-killing metabolites in the NGC-Cap arm. The data from all 19 patients were not available for this preliminary analysis.

As expected with increased exposure to active metabolites, a greater proportion of patients receiving NGC-Cap experienced side effects related to these capecitabine cancer-killing metabolites, and the total number of such side effects per patient was higher compared to patients receiving capecitabine alone. Importantly, the severity of these side effects was similar between treatment arms, indicating that the increased activity did not translate into more severe toxicity.

In addition to forming active metabolites, capecitabine is also broken down into catabolite metabolites, including FBAL, which are associated with certain side effects such as HFS. Patients receiving NGC-Cap demonstrated substantially lower exposure to FBAL — up to ten times less than with Mono-Cap.

Consistent with this reduced exposure, the number of patients reporting HFS was similar between treatment groups, but patients in the NGC-Cap arm experienced only mild (Grade 1) symptoms, while patients receiving capecitabine monotherapy experienced symptoms of greater severity (up to Grade 2).

“What we are seeing in patients aligns closely with our pharmacologic expectations,” added Dr. Young. “The distribution and severity of observed side effects are consistent with enhanced exposure to active cancer-killing metabolites and reduced formation of catabolites, including FBAL.”

Upcoming Clinical Milestone

Processa anticipates completing enrollment of the final patient in the formal 20-patient interim analysis of Phase 2 safety and efficacy study by the end of the first quarter of 2026, in accordance with the trial protocol.

About PCS6422+Cap (NGC-Cap)

NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy.

About Processa Pharmaceuticals, Inc.

Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value.

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com

Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com

Lifeward Expands International Distribution of its ReWalk® Personal Robotic Exoskeleton into Mexico, Thailand, and the United Arab Emirates

Lifeward Expands International Distribution of its ReWalk® Personal Robotic Exoskeleton into Mexico, Thailand, and the United Arab Emirates




Lifeward Expands International Distribution of its ReWalk® Personal Robotic Exoskeleton into Mexico, Thailand, and the United Arab Emirates

Distribution agreement with Singapore-based Verita Neuro will provide patients the ReWalk Personal Exoskeleton as part of its multi-layered treatment modalities

New delivery model for ReWalk will integrate in-patient training and rehabilitation to support clinical adoption in physical rehabilitation settings

Over 7 million survivors of spinal cord injury (SCI) globally could potentially benefit from ReWalk, an estimated $1.75 billion total addressable market for Lifeward

MARLBOROUGH, Mass., YOKNEAM ILLIT, Israel and BERLIN, Dec. 17, 2025 (GLOBE NEWSWIRE) — Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology designed to transform the lives of people with physical limitations or disabilities, announced today the expansion of patient access to the ReWalk Personal Exoskeleton through a new international distribution agreement with Verita Neuro, a Verita Healthcare Ltd. company. This collaboration supports Lifeward’s long-term growth strategy by extending its commercial footprint into new international markets through a partner-led, capital-efficient model. Verita Neuro has an established international footprint, with the partnership launching across multiple international geographies. Verita Neuro will be the exclusive distributor of ReWalk initially in Mexico, Thailand, and the United Arab Emirates, where it has advanced centers that offer innovative treatments for people living with neurological and spinal cord injuries.

Verita Neuro offers unparalleled reach through its international database of over 25,000 spinal cord injury patients plus a growing network of international rehabilitation centers able to deliver highly personalized care.

“This latest distribution agreement with Verita Neuro is consistent with Lifeward’s strategy to expand global access to the ReWalk Personal Exoskeleton for patients with spinal cord injury, building our established distribution and reimbursement presence in the United States and Germany,” said Mark Grant, CEO of Lifeward. “The Company’s hybrid commercial model, combining direct sales in the United States with third-party distribution and servicing in select international markets, is intended to support increased sales volumes while managing operating expenses and advancing long-term, sustainable growth.”

Lifeward selected Verita as its partner in these targeted regions to integrate ReWalk into their multi-modal treatment methodologies for people living with neurological and spinal cord injuries. Today, Verita Neuro modalities include surgical neural stimulation, stem cell therapy, and neurorehabilitation.

Verita’s CEO, Julian Andriesz, commented, “As the global pioneer in neurological restoration, Verita Neuro redefined epidural stimulation reconnecting brain-body pathways to regain voluntary movement and vital autonomic functions. We are excited to empower our patients with the most cutting-edge robotic physical rehabilitation systems. Through Lifeward’s ReWalk exoskeleton in our in-patient program, we’re achieving another world first, seamless multimodal enablement.”

Verita will be performing patient-specific setup and training in the ReWalk Personal Exoskeleton in an intensive, daily, in-patient neurorehabilitation program. This new delivery method is an alternative to the current protocol of outpatient training and rehabilitation. We expect this progressive intensive in-patient program will support clinical adoption in physical rehabilitation settings across a range of patient cases and global markets.

About Verita

Verita Healthcare is a next generation integrated healthcare group offering precision diagnostics, leading-edge treatments and advanced Med-Tech solutions. Its healthcare ecosystem has expanded from the Asia Pacific Region to Europe, USA, South America and the Middle East. Wholly owned subsidiary, Verita Neuro, launched in 2015 is a global pioneer in advanced treatments for spinal cord injuries, brain injuries, stroke and other neurological conditions. As the first provider worldwide to offer epidural stimulation outside clinical trials, Verita Neuro combines neuromodulation, regenerative therapies and intensive rehabilitation to deliver personalized, life-changing care to patients from over 50 countries.

About Lifeward

Lifeward designs, develops, and commercializes life-changing solutions spanning the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings, as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products, including the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany.

Lifeward®, ReWalk®, ReStore®, and Alter G® are registered trademarks of Lifeward Ltd. and/or its affiliates.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward looking statements may include projections regarding the Company’s future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward looking statements include, among others: the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; the impact of the distribution agreement on Lifeward’s revenue and cash flow; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company’s ability to have sufficient funds to meet certain future capital requirements, which could impair the Company’s efforts to develop and commercialize existing and new products; the Company’s ability to maintain and grow its reputation and the market acceptance of its products; the Company’s ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company’s limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company’s expectations as to its clinical research program and clinical results; the Company’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company’s ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company’s ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer and transitioning the manufacturing of its ReWalk products to its in-house manufacturer; the Company’s ability to improve its products and develop new products; the Company’s compliance with medical device reporting regulations to report adverse events involving the Company’s products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on the Company’s ability to market and sell its products; the Company’s ability to gain and maintain regulatory approvals; the Company’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company’s IT systems significantly disrupting its business operations; the Company’s ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading “Risk Factors” in the Company’s annual report on Form 10-K, as amended, for the year ended December 31, 2024 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Lifeward Media Relations:
Almog Adar
Chief Financial Officer
E: media@golifeward.com

Lifeward Investor Contact:
Almog Adar
Chief Financial Officer
Lifeward
E: ir@golifeward.com

Festive drinking and hormones: Clue shares science-backed guidance for Christmas

Festive drinking and hormones: Clue shares science-backed guidance for Christmas




Festive drinking and hormones: Clue shares science-backed guidance for Christmas

LONDON, Dec. 17, 2025 (GLOBE NEWSWIRE) — With office parties, cocktails with friends and end-of-year celebrations in full swing, many of us brace for hangovers without realising that festive drinking can have a real and often overlooked impact on menstrual and hormonal health.

According to experts at Clue, the #1 women-led period and cycle tracker, the holiday season can create a perfect storm of disrupted routines, heightened stress, altered sleep patterns and often, increased alcohol consumption – all factors that can amplify menstrual symptoms and make cycles feel significantly harder to manage.

Drawing on insight from its annual Our Year in Cycles data set, Clue said that across the full 2024-2025 cycle year, its users logged millions of days of alcohol consumption as part of the app’s partying tracking option, with 25-34-year-olds logging more alcohol than any other age group. Perhaps unsurprisingly, the most popular day for alcohol tracking was December 31, 2024.

“Alcohol doesn’t cancel your cycle but it does change the conditions in which your body operates,” said Clue Chief Medical Officer Dr Charis Chambers.

“If your cycle coincides with a busy social calendar, the combination of disrupted sleep, dehydration, inflammation and hormonal shifts can intensify cramps, worsen PMS and make period symptoms trickier than usual. This can be confusing as PMS symptoms can often present themselves as similar to what a hangover often feels like.

“Being mindful about how and what you drink can make all the difference. Research shows alcohol can influence hormone levels, disrupt ovulation patterns, increase inflammation and interfere with the body’s normal pain response. One result we see is that symptoms including cramps, mood swings, bloating, headaches and fatigue may feel sharper and harder to recover from, particularly for those who already experience PMS or heavy periods. While moderate drinking doesn’t break the menstrual cycle, it can push an already sensitive system over the edge.”

Dr Chambers advised women to be aware of what happens when festive habits collide with hormonal timing and think about how they plan out their social engagements at such a busy time of year.

“The second half of the menstrual cycle, known as the luteal phase, is particularly vulnerable to these stresses. That’s when many people already experience heightened sensitivity, mood changes and fatigue. Layer alcohol onto that and it may be hard to determine what is a hangover vs. hormones.

“There is nothing weak or dramatic about your body reacting to alcohol differently at certain points in your cycle. Your hormones affect everything from sleep, to mood, to digestion. If alcohol disrupts any of those processes, your period will notice. For example, during ovulation you may metabolise alcohol slightly differently due to hormone shifts, or the release of progesterone (post-ovulation) can slow digestion, meaning the effects of alcohol might feel stronger. Planning ahead, eating before drinking, staying hydrated and prioritising sleep can make celebrations enjoyable without leaving your body overwhelmed.”

“Behind all of this lies a deeper message,” said Dr Chambers. “Menstrual symptoms aren’t random and they’re not character flaws. They are in effect physiological feedback. Alcohol doesn’t create hormonal chaos out of nowhere but it can amplify what’s already happening. A little foresight not only supports hormonal balance but also transforms festive pressure into something kinder, calmer and more cycle-respectful.”

Dr Charis’ Top Tips for Navigating the Festive Party Season

1. Check your cycle before you RSVP: It’s useful to track where you’re likely to be in your menstrual timeline during big events. Only you know how and when you feel at your best and most sociable, but keeping a record of when symptoms spike can help you determine if a festive night out might heighten the impact and help you work around it accordingly.

2. Make hydration a priority: Alcohol, when combined with salty party food and hormonal shifts are a triple combination for possible dehydration. Try drinking a glass of water between festive beverages to help combat common dehydration symptoms such as cramps, headache and fatigue.

3. Eat intentionally, and not on a whim: While this can be hard to pull off when canapés and mince pies are being handed around, try to focus on balanced meals with protein and

complex carbs that help stabilise blood sugar, reducing the potential for mood swings, nausea and dizziness. Anti-inflammatory foods are a good option if you’re on or approaching your period as they can reduce inflammation and cramps. Salmon, nuts, leafy greens, berries, turmeric and ginger are all great options.

4. Prioritise sleep: During your luteal phase, sleep is already typically lighter or more disrupted. Alcohol can worsen such effects. Try not to overload your calendar, allowing for a night of restful sleep after each event where possible.

5. Prep for pain relief in case it’s needed: Whether you’re prone to headaches or cramps, pack what you may need before you leave the house, being mindful of course that some over-the-counter medicines such as ibuprofen are known to interact with alcohol. If you’re not sure, it’s generally safer not to drink.

About Clue
Clue is the #1 women-led period and cycle tracker, loved by over 100 million women and people with cycles around the world.

Beyond period tracking, Clue helps you turn your cycle into a powerful tool to help navigate your health journey by making sense of your hormones and discovering your unique patterns.

Whether you want to simply understand your cycle, try to conceive,
track your pregnancy, or navigate perimenopause, Clue is your intelligent, science-backed, data-driven health guide.

Join the movement that’s changing the future of female health, one data point at a time. Try Clue free, today.

CONTACT: Press
For more information about this particular press release, contact press@helloclue.com.

Rakovina Therapeutics Management to Attend Partnering Meetings During JPM Week, January in San Francisco, California

Rakovina Therapeutics Management to Attend Partnering Meetings During JPM Week, January in San Francisco, California




Rakovina Therapeutics Management to Attend Partnering Meetings During JPM Week, January in San Francisco, California

VANCOUVER, British Columbia, Dec. 17, 2025 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (“Rakovina” or the “Company”), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, today announced that senior members of the Company’s executive leadership will be in San Francisco, California during the week of the annual J.P. Morgan Healthcare Conference (January 12-16, 2026) for a series of meetings with potential partners and members of the investment community.

In addition, members of the Rakovina team will participate in Fierce JPM Week as part of the week’s broader industry programming.

“JPM week brings together a broad cross-section of global biotech and pharma leaders, and it remains one of the most efficient windows of the year for high-quality, in-person partnering discussions,” said Jeffrey Bacha, executive chairman of Rakovina. “Given the interest in AI drug development and the excitement stemming from the Company’s most recent data presented at Society for Neuro-Oncology meeting in November 2025, we are looking forward to meeting with various groups to explore strategic opportunities aligned with Rakovina’s technology and long-term objectives.”

In a press release dated November 24th, the Company released key preclinical data that show its AI-designed ATR/mTOR dual inhibitors not only effectively penetrate the central nervous system (addressing a key shortcoming of current ATR inhibitors) but also match or exceed the potency of leading clinical comparators while co-targeting two critical cancer pathways, suggesting potential for improved treatment of PTEN-deficient and brain-involved tumors.

Parties interested in scheduling a meeting with Rakovina Therapeutics during the week are encouraged to contact the Company’s Director of Corporate Development, Michelle Seltenrich at: michelle.seltenrich@rakovinatherapeutics.com

About Rakovina Therapeutics Inc.
Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.

The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners. Further information may be found at www.rakovinatherapeutics.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:
This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the biopharmaceutical industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:
Michelle Seltenrich, BSc MBA
Director, Corporate Development
michelle.seltenrich@rakovinatherapeutics.com
778-773-5432

Alvotech Successfully Places USD 108 Million Senior Unsecured Convertible Bonds in a Significantly Oversubscribed Offering

Alvotech Successfully Places USD 108 Million Senior Unsecured Convertible Bonds in a Significantly Oversubscribed Offering




Alvotech Successfully Places USD 108 Million Senior Unsecured Convertible Bonds in a Significantly Oversubscribed Offering

THIS PRESS RELEASE MAY NOT BE DISTRIBUTED, RELEASED, OR PUBLISHED, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, THE UNITED STATES OF AMERICA OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL OR DEMAND ADDITIONAL REGISTRATION OR OTHER MEASURES. PLEASE REFER TO “IMPORTANT INFORMATION” IN THE END OF THIS PRESS RELEASE.

REYKJAVIK, ICELAND (December 17, 2025) — Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announces the successful placing of USD 108 million senior unsecured convertible bonds due 2030 (the “Offering”). The Offering, which was significantly oversubscribed, is undertaken to continue Alvotech’s investment in R&D, expected to be around USD 250 million in 2026. Alvotech is focused on continuous execution and progression of its R&D pipeline, currently consisting of 30 products under development and one of the most valuable portfolios of biosimilar candidates in the industry. At the same time, Alvotech is scaling up its production capacity and the company’s supply chain to support 4 new global product launches through 2026.

The successful completion of the convertible bond placement will allow Alvotech to continue its journey and maintain its leading investment position in biosimilar development, while concurrently supporting manufacturing and global product launches.

“We appreciate the strong support and significant demand from international investors for this bond offering,” said Robert Wessman, Chairman and CEO of Alvotech. “Their confidence reflects the resilience of our business model, the value of our integrated manufacturing platform and the global opportunities ahead. This financing ensures we remain well positioned to advance our pipeline, support global launches and continue bringing important biologic treatments to patients worldwide.”

Details of the Convertible Bonds placement:

  • USD 108 million senior unsecured convertible bonds due December 22, 2030 (the “Convertible Bonds”), with net proceeds being to continue to invest in R&D pipeline, scale and product launches. Notwithstanding the significantly oversubscribed order book for the Convertible Bonds, the issue size was determined following an assessment based on the composition of demand, market capacity considerations and the Company’s objective of ensuring a stable and well-balanced investor base.
  • The Convertible Bonds carry a coupon of 6.875%, payable semi-annually in arrear, issued at par in denominations of USD 200,000.
  • The conversion premium is set to 25% over USD 4.7379 per share, and the initial conversion price is thus fixed at USD 5.9224 per share.
  • The Convertible Bonds are convertible from the 41st day of their issuance into Swedish Depositary Receipts (“Shares” or “SDRs”).
  • The Company may call the Convertible Bonds at any time on or after 3 years and 21 calendar day after the settlement date, if the volume weighted average trading price (VWAP) of the Share is at least 150% of the conversion price on at least 20 out of 30 consecutive trading days.
  • The Convertible Bonds include customary adjustments and anti-dilution provisions for convertible bonds. The Convertible Bonds also include a conversion price reset mechanism designed to maintain fair conversion conditions for Convertible Bond investors in the event of an equity or equity-linked capital raise during the first 24 months after settlement.
  • The board of directors of a wholly owned subsidiary of the Company, Alvotech Manco ehf (“Manco”), has resolved to provide a stock lending facility for the duration of the Convertible Bonds (unless bought back, redeemed or converted, in which case it will be reduced on a pro rata basis) for the purpose of facilitating Convertible Bond investors’ hedging activities. The full number of shares underlying the Convertible Bonds will be made available through a stock lending facility. The stock lending facility will remain in place for the duration of the Convertible Bonds.
  • Concurrently with the placement of the Convertible Bonds, the Sole Bookrunner in the Offering completed a placement of existing Shares (the “Concurrent Delta Placement”) on behalf of the Convertible Bonds investors hedging their market exposure. The number of Shares sold was determined by the allocation of the Convertible Bonds and amounted to approximately USD 56 million. The Share price in the Concurrent Delta Placement was set to USD 4.7379 using a Bloomberg BFIX exchange rate of USD/SEK of 9.2984, based on a SEK 48.95 closing price for the Shares trading on Nasdaq Stockholm 16 December 2025, with a discount of 10%. It is the board of directors’ assessment that the price in the Concurrent Delta Placement is on market terms, reflecting prevailing market conditions and investor demand.
  • The Offering and the Concurrent Delta Placement were conducted solely on a private placement basis to professional investors pursuant to Regulation S promulgated under the Securities Act of 1933, as amended or other applicable exemption from registration and to Swedish and international institutional, and other qualified investors within the meaning of the Prospectus Regulation (as defined below).
  • The Company has entered into lock-up undertakings, subject to certain conditions, customary, and exceptions from the Sole Bookrunner and exceptions relating to any issuance of shares to Manco for servicing existing obligations of the Company, including issuing additional shares in respect of the stock lending facility, and not to issue (a) new shares for a period of three months following the settlement of the Convertible Bonds; and (b) equity-linked securities (including any securities convertible, exchangeable for shares, or any bonds or warrant structures) for a period of twelve months from the settlement of the Convertible Bonds.

Indicative timeline of the transaction

16 December 2025: Launch of the Offering and Concurrent Delta Placement
  Pricing and Allocation of the Convertible Bonds and Concurrent Delta Placement
17 December 2025 Trade Date (T)
19 December 2025: (T+2) Settlement of the Concurrent Delta Placement
22 December 2025: (T+3) Settlement of the Convertible Bonds

Advisors

DNB Carnegie, a part of DNB Bank ASA (“DNB Carnegie”) acted as Sole Bookrunner in connection with the Offering. Roschier acted as legal advisors to the Company as to Swedish law, Arendt & Medernach SA acted as legal advisor to the Company as to Luxembourg law, BBA//Fjeldco acted as legal advisor to the Company as to Icelandic law and Cooley LLP acted as legal advisor to the Company as to U.S. law. Advokatfirmaet Thommessen AS acted as legal advisor to the Sole Bookrunner as to Norwegian law.

For further information, please contact:

ALVOTECH INVESTOR RELATIONS
Patrik Ling, VP Investor Relations Scandinavia (SE)
Benedikt Stefansson, VP Investor Relations and Global Communications (IS)
alvotech.ir@alvotech.com

ALVOTECH MEDIA RELATIONS
Sarah Macleod, Head Global Communications
Benedikt Stefansson, VP Investor Relations and Global Communications
alvotech.media@alvotech.com

This constitutes information that Alvotech is legally obliged to publish under the EU’s Market Abuse Regulation. The information was released for publication, through the agency of the contact person above, at the date and time indicated by the dateline of publication.

About Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars, to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab) are already approved. The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

Non-IFRS Financial Measures
Adjusted EBITDA is a non-IFRS measure which is defined in our latest Annual Report on Form 20-F filed with the SEC. Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Alvotech’s current performance, performance trends, and financial condition. Alvotech has presented its expectations regarding adjusted EBITDA without presenting the most directly comparable IFRS measure or a corresponding quantitative reconciliation, as such information is not available to Alvotech without unreasonable efforts at the time of the release of this preliminary financial information. Alvotech is not able to estimate net (loss) income on a forward-looking basis without unreasonable efforts due to the variability and complexity with respect to the charges excluded from adjusted EBITDA.

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions by law. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release is for information purposes only and does not constitute an offer to sell or an offer, or the solicitation of an offer, to acquire or subscribe for SDRs, shares or other securities issued by the Company, neither by the Company or anyone else, in any jurisdiction where such offer or invitation would be illegal prior to registration, exemption from registration or qualification under the securities laws of such jurisdiction.

This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorised any offer to the public of SDRs, shares or other securities in any member state of the EEA and no prospectus has been or will be prepared in connection with the Offering and placement. In any EEA Member State, this communication is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of the Prospectus Regulation.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The Convertible Bonds, the SDRs into which the Convertible Bonds could be exercised, the ordinary shares underlying the SDRs and other ordinary shares referred to herein may not be offered or sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), or under the securities laws of any state or other jurisdiction of the United States. There is no intention to register any securities referred to herein in the United States or to make an offering of the securities in the United States.

The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Belarus, Canada, Hong Kong, Japan, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea, the United States of America or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

In the United Kingdom, this press release and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of Article 86(7) of the British Financial Services and Market Act 2000) who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the SDRs, shares or other securities issued by the Company. Any investment decision to acquire or subscribe for securities in connection with the Offering and placement must be made on the basis of all publicly available information relating to the Company and the Company’s securities. Such information has not been independently verified by the Sole Bookrunner. The Sole Bookrunner is acting for the Company and no one else in connection with the Offering and the placement and is not responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the Offering and the placement or any other matter referred to herein.

This press release does not constitute a recommendation for any investors’ decisions regarding the Offering and the placement. Each investor or potential investor should conduct a self-examination, analysis and evaluation of the business and information described in this press release and any publicly available information. The price and value of the securities can decrease as well as increase. Achieved results do not provide guidance for future results. Neither the contents of the Company’s website nor any other website accessible through hyperlinks on the Company’s website are incorporated into or form part of this press release.

Failure to follow these instructions may result in a breach of the Securities Act or applicable laws in other jurisdictions.

Alvotech forward-looking statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s intentions, assessments, or expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the expectations with respect to resolving CRL issues, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches, financial projections and the markets in which Alvotech operates, including financial guidance and projections for 2025 and 2026, the ability to successfully execute and close the Offering and the expected use of proceeds from the Offering. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim”, or “might”, or, in each case, their negative, or similar expressions. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change. Neither Alvotech nor anyone else undertake any duty to review, update, confirm or to release publicly any revisions to these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication, unless this is required under law or Nasdaq Stockholm’s rulebook for issuers. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Company’s shares, SDRs and other securities have been subject to a product approval process, which has determined that such shares, SDRs and other securities are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II (the “Positive Target Market”); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II.

Distributors should note that: the price of the shares, SDRs and other securities in the Company may decline and investors could lose all or part of their investment; the shares, SDRs and other securities in the Company offer no guaranteed income and no capital protection; and an investment in the shares, SDRs and other securities in the Company is suitable only for investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. Conversely, an investment in the shares, SDRS or other securities of the Company is not suitable for investors who need full capital protection or full repayment of the amount invested, cannot bear any risk, or who require guaranteed or predictable return (the “Negative Target Market”, and together with the Positive Target Market, the “Target Market Assessment”).

The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering and the placement.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares, SDRs and other securities in the Company.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the shares, SDRs and other securities in the Company and determining appropriate distribution channels.

Heidi Hunter Appointed New Vice Chair of the Board of Directors of Bavarian Nordic

Heidi Hunter Appointed New Vice Chair of the Board of Directors of Bavarian Nordic




Heidi Hunter Appointed New Vice Chair of the Board of Directors of Bavarian Nordic

COPENHAGEN, Denmark, December 17, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that, following the recent appointment of Anne Louise Eberhard as new Chair of the Board of Directors, and in accordance with the Company’s Articles of Association, the Board has convened and has appointed Ms. Heidi Hunter as new Vice Chair.

Ms. Hunter has been a member of the board since 2023. She has over 25 years of industry experience, working across the pharmaceutical value chain, from clinical and commercial development through to launch execution. She is formerly President at Cardinal Health, where she led the Specialty Solutions Businesses. Prior to Cardinal Health, Ms. Hunter held senior leadership positions at UCB, Boehringer Ingelheim, IQVIA and Centocor, a J&J company. She also led women’s health and oncology business at Wyeth (today part of Pfizer) in the U.S. and women’s health at Novo Nordisk in Denmark.  Ms. Hunter holds a BA from the University of Michigan and an MBA from the University of Chicago.

In addition to the role as Vice Chair, Ms. Hunter’s duties on the Board include memberships of the Nomination and Compensation Committee and the Science and Technology Committee.

Her external duties include board memberships with Vicore Pharma Holding AB, IO Biotech, Inc. and Sutro BioPharma Inc.

The Board continues its search for a couple of candidates with relevant competencies to be nominated for election at the annual general meeting in April 2026, while at the same time securing continuity.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

Attachment

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system




CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

16 December 2025

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

  • Regulatory clearance of CMR’s most advanced system paves the way for upcoming US commercial launch
  • Strong clinical interest received from US surgeons nationwide for the system

CMR Surgical, a global medical technology company, today announces its second-generation surgical robotic platform, Versius Plus, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for cholecystectomy procedures.

With a flexible, modular design and data-driven digital ecosystem, Versius Plus represents a new market offering, providing more choice for surgeons and hospitals. The system brings next-generation innovation to the operating room, designed not only for the surgeon but for the entire OR team. Its open console facilitates communication between the surgeon and other medical professionals, which supports real-time decision making.

The FDA previously granted marketing authorization for CMR’s first-generation Versius Surgical System through the De Novo process in October 2024. With the 510(k) clearance of Versius Plus, CMR is on track to begin commercialization in 2026.

Outside of the United States, CMR’s robotic surgical platforms have already completed over 40,000 surgical procedures, establishing a strong foundation for their performance across multiple specialties and care settings, and making the soft tissue robotic platforms the second most utilized globally.

Massimiliano Colella, Chief Executive Officer at CMR Surgical, commented:
“This 510(k) clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market. Built on years of global clinical use data, Versius Plus delivers the flexibility and intelligence today’s healthcare institutions need to advance robotic-assisted surgery. It’s inspiring to see our new technology transforming the landscape of surgical care.”

Chris O’Hara, President & General Manager US at CMR Surgical, commented:
“Versius Plus is designed to meet the practical realities of today’s healthcare environment — adaptable to different settings, efficient to integrate, and scalable for long-term growth. FDA clearance represents an exciting opportunity to partner with healthcare systems across the U.S. Versius Plus is designed to support a broad range of soft-tissue procedures, and we are diligently advancing additional indications in the U.S. and aim to help make robotic-assisted surgery more accessible than ever before.”

Key Benefits of Versius Plus

Adaptable

Owing to its compact, modular design, Versius Plus moves easily between departments and operating rooms – with no dedicated OR required. Hospitals can seamlessly switch between robotic and non-robotic procedures in the same space. Surgeons benefit from flexible port placement, choosing the setup that best fits their patient and their technique.

Versatile

Through design and technology, Versius Plus delivers the precision and efficiency surgeons’ demand. Its integrated fluorescence visualisation system, vLimeLite, enables real-time ICG imaging, delivering multiple visualization modes with overlay and grayscale options. With a full surgical toolkit, Versius Plus is ready to transform surgical experiences in the OR.

Digitally-Driven

The Versius Plus ecosystem puts data at the user’s fingertips with Versius Connect: A dedicated surgeon app with a near-real-time logbook of procedures and Versius Team: A live dashboard for surgical teams and hospitals, tracking usage, case volume, and system efficiency to help optimize robotics programs.

To learn more about CMR Surgical and its Versius Plus system, please visit https://cmrsurgical.com/.

 

Enquiries

ICR Healthcare

Mary-Jane Elliott / Angela Gray / Jonathan Edwards

CMRSurgical@icrhealthcare.com

 


About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius Plus, a next-generation surgical robot.

Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius Plus, CMR Surgical is on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care. Founded in 2014, CMR Surgical is a private limited company backed by an international shareholder base.

The Versius Plus Surgical Robotic System

Versius Plus is a next-generation, portable surgical robot designed to help surgeons perform minimal access surgery (MAS). The Versius Plus Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Plus Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

In the U.S. the Versius Plus Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy. Clinical indications vary by geography.
https://us.cmrsurgical.com/safety-information

Versius Plus resets expectations of robotic surgery. Versius Plus fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic MAS. The compact, portable and modular design of Versius Plus allows the surgeon to only use the minimum number of arms needed for a given procedure.

Biomimicking the human arm, Versius Plus gives surgeons the choice of optimized port placement alongside the dexterity and accuracy of small fully wristed instruments. With 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue while allowing for clear communication with the surgical team. By thinking endoscopically and operating robotically with Versius Plus, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it’s more than just a robot. Versius Plus captures meaningful data with its wider digital ecosystem to support a surgeon’s continuous learning. Through the Versius Plus Connect app, Versius Plus Trainer and CMR clinical registry, Versius Plus unleashes a wealth of insights to ultimately improve surgical care. For more information on Versius Plus, please visit: https://us.cmrsurgical.com

Disclaimer:

Versius Plus is 510k cleared by FDA and is approved for sale in the United States.

Versius Plus is part of a Versius ecosystem comprised of the Versius Surgical System, the EIZO CuratOR product, the vLimeLite visualisation system, and a suite of electrosurgical and nonelectrosurgical instruments in the United States

CMR Surgical, the CMR Surgical logo, vLimeLite and Versius are trademarks or registered trademarks of CMR Surgical in the UK and other jurisdictions. EIZO, the EIZO logo, and CuratOR are trademarks or registered trademarks of EIZO Corporation in Japan and other countries Indocyanine green (ICG) is a drug and is not provided by CMR Surgical and must be independently sourced by the customer. The approval status of the drug may vary by country.

The Versius System vLimeLite Instructions for Use, including the approved indications, contraindications and warnings can be found in the product labelling supplied with each Versius Plus System. The Ultrasonic Dissector is not approved for sale in the United States. Versius and its associated products are commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. Please contact your local CMR Surgical representative for product availability in your region. Refer to the product-specific user manual for indications, contraindications, warnings, and other product information. The information is correct at the time of publication of this press release.

Safety Information

The Versius Plus Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Plus Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

The Versius Plus Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

Vireo Growth Inc. Enters into Definitive Agreement to Acquire Certain Assets of PharmaCann Inc.

Vireo Growth Inc. Enters into Definitive Agreement to Acquire Certain Assets of PharmaCann Inc.




Vireo Growth Inc. Enters into Definitive Agreement to Acquire Certain Assets of PharmaCann Inc.

Acquired assets further optimize Vireo’s operating footprint in Colorado with addition of 17 dispensaries

Transaction expands Vireo’s leadership position in the Colorado retail market with 41 total dispensaries

Parties also enter into Management Services Agreement through closing which is expected in 1H’26

MINNEAPOLIS, Dec. 16, 2025 (GLOBE NEWSWIRE) — Vireo Growth Inc. (“Vireo”) (CSE: VREO; OTCQX: VREOF) (“Vireo” or the “Company”) today announced that it and its subsidiary Vireo Health, Inc. have entered into an Asset Purchase Agreement (“APA”) to acquire certain retail assets and properties of PharmaCann Inc. in the State of Colorado. The transaction will expand Vireo’s position in Colorado’s adult-use retail market to 41 total active dispensaries, and is subject to satisfaction of closing conditions and state and local regulatory approvals.

Total consideration for the acquired assets and property will be approximately $49.0 million, payable in subordinate voting shares of the Company at closing, as well as the assumption of certain liabilities. The share consideration payable in the transaction will be subject to adjustment based on inventory levels and trade payables of the acquired dispensaries, as well as the occurrence of certain other events by the closing date. The share consideration will be subject to customary resale restrictions under Canadian securities law and hold period under the rules of the Canadian Securities Exchange. Vireo also announced one of Vireo’s subsidiaries has entered into a Management Services Agreement with the sellers pursuant to which one of Vireo’s subsidiaries will provide management services to operate the acquired dispensaries through closing, upon necessary regulatory approvals. The transaction is expected to close during the first half of calendar year 2026.

Chief Executive Officer John Mazarakis commented, “We are pleased to announce this transaction which reflects the continuation of our strategy to continue growing our business through accretive M&A. This transaction will complement our other recently acquired assets in Colorado.”

About Vireo Growth Inc.

Vireo was founded in 2014 as a pioneering medical cannabis company. Vireo is building a disciplined, strategically aligned, and execution-focused platform in the industry. This strategy drives our intense local market focus while leveraging the strength of a national portfolio. We are committed to hiring industry leaders and deploying capital and talent where we believe it will drive the most value. Vireo operates with a long-term mindset, a bias for action, and an unapologetic commitment to its customers, employees, shareholders, industry collaborators, and the communities it serves. For more information about Vireo, visit www.vireogrowth.com.

Contact Information

Joe Duxbury
Chief Accounting Officer
investor@vireogrowth.com
(612) 314-8995

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, this information is being provided as preliminary financial results; the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “should,” “believe,” “estimate,” “would,” “looking forward,” “may,” “continue,” “expect,” “expected,” “will,” “likely,” “subject to,” and variations of such words and phrases, or any statements or clauses containing verbs in any future tense and includes statements regarding the Company’s future M&A strategy and optimization of all areas of the Company’s business; expectations around the proposed transactions involving PharmaCann Inc. and its assets, including the anticipated timing of the closing thereof and the potential complementary nature of such transaction to Vireo’s other recently acquired assets in Colorado. These statements should not be read as guarantees of future performance or results. Forward-looking information includes both known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company or its subsidiaries to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements or information contained in this press release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein and in our Annual Report on Form 10 K and our Quarterly Reports on Form 10 Q filed with the Securities Exchange Commission. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue, EBITDA, Adjusted EBITDA, and cash on hand may differ materially from the values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions, and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, the reader should not place undue reliance on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to: risks involved with the adverse impact of the transactions contemplated by the APA on the Company’s business, financial condition, and results of operations; the Company’s ability to successful consummate the transactions contemplated by the APA; the Company’s ability to maintain relationships with suppliers, customers, employees and other third parties as a result of the transactions contemplated by the APA; the effects of the transactions contemplated by the APA on the Company and the interests of various constituents; risks and uncertainties associated with the transactions contemplated by the APA, some of which are beyond the Company’s control; risks related to the timing and content of adult-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to epidemics and pandemics; federal, state, local, and foreign government laws, rules, and regulations, including federal and state laws and regulations in the United States relating to cannabis operations in the United States and any changes to such laws or regulations; operational, regulatory and other risks; execution of business strategy; management of growth; difficulties inherent in forecasting future events; conflicts of interest; risks inherent in an agricultural business; risks inherent in a manufacturing business; liquidity and the ability of the Company to raise additional financing to continue as a going concern; the Company’s ability to meet the demand for flower in its various markets; our ability to dispose of our assets held for sale at an acceptable price or at all; and risk factors set out in the Company’s Annual Reports on Form 10 K and Quarterly Reports on Form 10 Q, which are available on EDGAR with the U.S. Securities and Exchange Commission and filed with the Canadian securities regulators and available under the Company’s profile on SEDAR+ at www.sedarplus.com.

The statements in this press release are made as of the date of this release. Except as required by law, we undertake no obligation to update any forward-looking statements or forward-looking information to reflect events or circumstances after the date of such statements.

Pathway Health’s Lisa Thomson Receives 2026 McKnight’s Pinnacle Award

Pathway Health’s Lisa Thomson Receives 2026 McKnight’s Pinnacle Award




Pathway Health’s Lisa Thomson Receives 2026 McKnight’s Pinnacle Award

LAKE ELMO, Minn., Dec. 16, 2025 (GLOBE NEWSWIRE) — Pathway Health, a leading provider of health care consulting services, interim and permanent talent, technology implementation, and training, is pleased to announce that Lisa A. Thomson, Chief Operating Officer, has been chosen as a 2026 Pinnacle Award honoree, elected from a remarkable pool of nominations in the competition’s fourth year of honoring distinguished industry leaders. This year’s honorees are listed here.

The McKnight’s Pinnacle Awards recognize sector veterans with 20 or more years of service who have set new standards, driven innovation and inspired colleagues across the senior care, skilled nursing and home care fields.

“Lisa’s recognition as a 2026 Pinnacle Award honoree is a testament to her unwavering dedication to developing leaders and strengthening organizations across the continuum of care,” said Peter B. Schuna, President & CEO of Pathway Health. “Her compassion, insight, and steadfast commitment have not only propelled Pathway Health’s success but have also shaped national conversations on regulatory readiness, workforce development, and organizational excellence. Lisa pours her heart into this work, and her influence is felt in every provider, team, and resident she touches. We are incredibly proud of her achievements and deeply grateful for the meaningful difference she continues to make each and every day.”

Lisa has devoted more than 25 years to advancing quality, regulatory readiness, and leadership development across the post-acute and long-term care continuum. Since joining Pathway Health in 2001, she has played a pivotal role in shaping the organization’s national footprint, guiding strategic initiatives, and supporting providers through complex operational and regulatory challenges. Known for her deep industry expertise and practical, solutions-driven approach, Lisa is a highly respected speaker, educator, and mentor whose work has strengthened care delivery and elevated leadership standards.

For more information, visit PathwayHealth.com.

About Pathway Health
Pathway Health is a professional management, consulting, interim management, executive search and education services organization serving clients across the post-acute care continuum. Since 1997, Pathway Health has been keeping a pulse on industry clinical, regulatory, quality and reimbursement trends to keep clients on the path to success. With over 150 experienced professionals, we engage and employ leading clinical and operational experts to assist our clients in achieving the next level of performance. For more information, call 877-777-5463 or visit pathwayhealth.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00739f64-b3d5-4116-9d2b-d7c240293ca2

Alvotech Launches $100 Million Senior Unsecured Convertible Bond Offering to Continue Strong Investment in R&D, Support Manufacturing, Global Product Launches and Enhance Liquidity Position, reaffirms 2025 outlook and provides 2026 guidance

Alvotech Launches $100 Million Senior Unsecured Convertible Bond Offering to Continue Strong Investment in R&D, Support Manufacturing, Global Product Launches and Enhance Liquidity Position, reaffirms 2025 outlook and provides 2026 guidance




Alvotech Launches $100 Million Senior Unsecured Convertible Bond Offering to Continue Strong Investment in R&D, Support Manufacturing, Global Product Launches and Enhance Liquidity Position, reaffirms 2025 outlook and provides 2026 guidance

THIS PRESS RELEASE MAY NOT BE DISTRIBUTED, RELEASED, OR PUBLISHED, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, THE UNITED STATES OF AMERICA OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL OR DEMAND ADDITIONAL REGISTRATION OR OTHER MEASURES. PLEASE REFER TO “IMPORTANT INFORMATION” IN THE END OF THIS PRESS RELEASE.

REYKJAVIK, ICELAND (December 16, 2025) — Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company dedicated exclusively to biosimilars, today announces the launch of an offering of USD 100 million senior unsecured convertible bonds due 2030 (the “Offering”). The Offering is being undertaken to continue significant investment in R&D of around USD 250 million in 2026. Alvotech is focused on continuous execution and progression of its R&D pipeline, currently consisting of 30 products under development and one of the most valuable portfolios of biosimilars in the industry.  At the same time, Alvotech is scaling up its production capacity and the company´s supply chain with the goal of launching 4 new products globally for the year 2026.  

The execution of the Offering will allow Alvotech to continue on its journey and keep its lead in investment into biosimilar development, while at the same time working on its launch readiness into global markets.  

The company is reconfirming its financial guidance for 2025 and providing financial guidance for 2026. The guidance for 2026 takes into account the impact of any further FDA approval delays as a result of the CRL received for AVT05 (PFS/AI and vial presentations), biosimilars to Simponi® and Simponi Aria® and AVT06, a biosimilar to Eylea®.  It also assumes a CRL may be received in Q4 2025 for AVT03, biosimilar to Prolia® and Xgeva®.  Alvotech continues to work on its response to the FDA and remains optimistic that it will resolve the outstanding issues. Financial guidance for 2026 has also taken into account global launches of 3 new biosimilars into global markets, that are taking place during December 2025.   Alvotech and its partners are in a lead position with AVT05 (bSimponi) and the company has a strong orderbook for AVT06 (bEylea).   

Outlook for 2025 and 2026

The Company continues to expect strong underlying operating performance in the fourth quarter of 2025 based on committed orders for new launches in markets outside the U.S. and continued momentum from currently marketed products. It is therefore well positioned to deliver top line and EBITDA growth in 2026.

Alvotech reaffirms the full year outlook for 2025, updated on November 2, 2025, with anticipated total revenues in 2025 to be in the range of $570 to $600 million and adjusted EBITDA in the range of $130 to $150 million.

Alvotech’s long-term growth opportunity remains unchanged, underpinned by a growing portfolio of biosimilar candidates addressing multi-billion-dollar markets, an integrated manufacturing platform with high barriers to entry, and a global network of commercial partners.

In 2026, Alvotech anticipates total revenues in the range of $650-$700 million, reflecting continued sales growth.  Adjusted EBITDA is expected to increase to $180-$220 million, supported by higher volumes of commercialized products and launches of newly approved products in Europe and Japan. Alvotech assumes to receive U.S. approval by late 2026 for the 3 products currently with applications pending with the FDA and remains optimistic to be the first or among the first with approved biosimilars to Simponi® and Simponi Aria® in the US. Alvotech and its U.S. commercial partner have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances. In its guidance the Company has made the conservative assumption that U.S. launches of new biosimilars will have minimum impact on topline revenues in 2026, and while it is intent on gaining FDA approvals, the lower end of the revenue range reflects the conservative view with revenues from new launches taken out. The Company remains focused on delivering solid sales growth and driving operational efficiencies to support margin expansion.

The Company notes that its outlook reflects a substantial ongoing investment programme, including significant commitments to R&D, manufacturing capacity, quality systems and global commercial readiness, which are integral to the execution of its strategy. The timing and sequencing of elements of this programme are subject to inherent uncertainties that may affect the phasing of revenues and cash flows. Based on current assumptions, the Company believes its plans are appropriately funded; however, in the ordinary course of executing a large-scale investment programme, the Company may from time to time consider additional sources of capital to support continued execution and maintain financial flexibility. Alvotech will continue to monitor its capital position and funding alternatives as appropriate.

The Offering

Alvotech is today launching an offering of USD 100 million senior unsecured convertible bonds with an option to increase the offering prior to the time of pricing and allocations. 

Details of the Offering:

  • Base Issue Size of USD 100 million with an increase option of USD 25 million of senior unsecured convertible bonds due December 2030 (the “Convertible Bond”), with net proceeds to continue to invest in R&D pipeline, scale and product launches.  
  • The Convertible Bonds are expected to carry a coupon of between 6.375% and 6.875%, payable semi-annually in arrear, issued at par in denominations of USD 200,000.
  • The Convertible Bond will be convertible from the 41st day of their issuance into new and/or existing Swedish Depositary Receipts (“Shares” or “SDRs”) with an expected conversion premium of between 25% and 30% over the reference Share price, being the placement price per Share in the Concurrent Delta Placement (as defined below).
  • The Company may call the Convertible Bonds at any time on or after 3 years and 21 calendar day after the settlement date, if the volume weighted average trading price (VWAP) of the Share is at least 150% of the conversion price on at least 20 out of 30 consecutive trading days.
  • The Convertible Bond will include customary adjustments and anti-dilution provisions for convertible bonds. The Convertible Bond will also include a conversion price reset mechanism designed to maintain fair conversion conditions for Convertible Bond investors in the event of an equity or equity-linked capital raise during the first 24 months after settlement.
  • The board of directors of a wholly owned subsidiary of the Company, Alvotech Manco ehf (“Manco”), has resolved to provide a stock lending facility for the duration of the Convertible Bonds (unless bought back, redeemed or converted, in which case it will be reduced on a pro rata basis) for the purpose of facilitating Convertible Bond investors’ hedging activities.  Up to 20 million existing Shares will initially be made available through a stock lending facility, and no later than end of February 2026 an amount representing the full number of shares underlying the Convertible Bonds. The stock lending facility will remain in place for the duration of the bonds.  
  • Concurrently with the placement of the Convertible Bonds, the Sole Bookrunner in the Offering will conduct a placement of existing Shares (the “Concurrent Delta Placement”) on behalf of the Convertible Bonds investors who wish to sell such Shares to hedge the market risk of an investment in the Convertible Bonds. The number of Shares to be sold will be determined by the allocation of the Convertible Bonds and is currently expected to be approximately SEK 500m, with the price per Share to be determined by way of an accelerated bookbuilding process. The amount to be sold in the Concurrent Delta Placement is fully underwritten by two of the Company’s larger shareholders, ATP Holdings ehf (controlled by Robert Wessman) and Alvogen Lux Holdings S.à. r.l., The price to be paid by the aforementioned shareholders shall be the same price as determined in the accelerated bookbuilding process, but not lower than 15% discount to the closing price for the Shares trading on Nasdaq Stockholm today, 16 December 2025. It is the board of directors’ assessment that the price in the Concurrent Delta Placement will be considered to be on market terms, reflecting prevailing market conditions and investor demand. The process will commence immediately after publication of this press release. The completion of the bookbuilding, pricing and allotment of Shares in the Concurrent Delta Placement is expected to take place before trading commences on Nasdaq Stockholm at 09:00 CET on 17 December 2025. The timing of the closing of the bookbuilding, pricing, and allotment will be determined by the Sole Bookrunner. The Company will announce the outcome of the Concurrent Delta Placement through a press release after closing of the bookbuilding. The aforementioned shareholders will not receive any fee in connection with their commitments. The Company is not the seller of the Shares and will not receive any proceeds from the Concurrent Delta Placement.
  • Both the Offering and the Concurrent Delta Placement are being conducted solely on a private placement basis to professional investors pursuant to Regulation S promulgated under the Securities Act of 1933, as amended or other applicable exemption from registration and to Swedish and international institutional, and other qualified investors within the meaning of the Prospectus Regulation (as defined below).
  • The Company has undertaken, subject to certain conditions, customary exceptions from the Sole Bookrunner and exceptions relating to any issuance of shares to Manco for servicing existing obligations of the Company, including issuing additional shares in respect of the stock lending facility, and provided that the Offering is completed, not to issue (a) new shares for a period of three months following the settlement of the Convertible Bonds; and (b) equity-linked securities (including any securities convertible, exchangeable for shares, or any bonds or warrant structures) for a period of twelve months from the settlement of the Convertible Bonds.


Indicative timeline of the transaction

16 December 2025: Launch of the Offering and Concurrent Delta Placement
  Pricing and Allocation of the Convertible Bonds and Concurrent Delta Placement
19 December 2025: (T+2) Settlement of the Concurrent Delta Placement
22 December 2025: (T+3) Settlement of the Convertible Bonds

Investor call

In connection with the convertible bond offering, Alvotech will host an investors call on 16 December 2025 at 18:00 CET / 17:00 UK / 12:00 PM ET to provide an update on the transaction and the company.

Attendee link

Advisors

DNB Carnegie, a part of DNB Bank ASA (“DNB Carnegie”) is acting as Sole Bookrunner in connection with the Offering. Roschier is acting as legal advisors to the Company as to Swedish law, Arendt & Medernach SA acting as legal advisor to the Company as to Luxembourg law, BBA//Fjeldco acting as legal advisor to the Company as to Icelandic law and Cooley LLP acting as legal advisor to the Company as to U.S. law. Advokatfirmaet Thommessen AS is acting as legal advisor to the Sole Bookrunner as to Norwegian law.

For further information, please contact:

ALVOTECH INVESTOR RELATIONS
Patrik Ling, VP Investor Relations Scandinavia (SE)
Benedikt Stefansson, VP Investor Relations and Global Communications (IS)
alvotech.ir@alvotech.com

ALVOTECH MEDIA RELATIONS
Sarah Macleod, Head Global Communications
Benedikt Stefansson, VP Investor Relations and Global Communications
alvotech.media@alvotech.com

This constitutes information that Alvotech is legally obliged to publish under the EU’s Market Abuse Regulation. The information was released for publication, through the agency of the contact person above, at the date and time indicated by the dateline of publication.

About Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

Non-IFRS Financial Measures
Adjusted EBITDA is a non-IFRS measure which is defined in our latest Annual Report on Form 20-F filed with the SEC. Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Alvotech’s current performance, performance trends, and financial condition.  Alvotech has presented its expectations regarding adjusted EBITDA without presenting the most directly comparable IFRS measure or a corresponding quantitative reconciliation, as such information is not available to Alvotech without unreasonable efforts at the time of the release of this preliminary financial information. Alvotech is not able to estimate net (loss) income on a forward-looking basis without unreasonable efforts due to the variability and complexity with respect to the charges excluded from adjusted EBITDA.

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions by law. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release is for information purposes only and does not constitute an offer to sell or an offer, or the solicitation of an offer, to acquire or subscribe for SDRs, shares or other securities issued by the Company, neither by the Company or anyone else, in any jurisdiction where such offer or invitation would be illegal prior to registration, exemption from registration or qualification under the securities laws of such jurisdiction.

This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorised any offer to the public of SDRs, shares or other securities in any member state of the EEA and no prospectus has been or will be prepared in connection with the Offering and placement. In any EEA Member State, this communication is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of the Prospectus Regulation.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The Convertible Bonds, the SDRs into which the Convertible Bonds could be exercised, the ordinary shares underlying the SDRs and other ordinary shares referred to herein may not be offered or sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), or under the securities laws of any state or other jurisdiction of the United States. There is no intention to register any securities referred to herein in the United States or to make an offering of the securities in the United States.

The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Belarus, Canada, Hong Kong, Japan, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea, the United States of America or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

In the United Kingdom, this press release and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of Article 86(7) of the British Financial Services and Market Act 2000) who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the SDRs, shares or other securities issued by the Company. Any investment decision to acquire or subscribe for securities in connection with the Offering and placement must be made on the basis of all publicly available information relating to the Company and the Company’s securities. Such information has not been independently verified by the Sole Bookrunner. The Sole Bookrunner is acting for the Company and no one else in connection with the Offering and the placement and is not responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the Offering and the placement or any other matter referred to herein.

This press release does not constitute a recommendation for any investors’ decisions regarding the Offering and the placement. Each investor or potential investor should conduct a self-examination, analysis and evaluation of the business and information described in this press release and any publicly available information. The price and value of the securities can decrease as well as increase. Achieved results do not provide guidance for future results. Neither the contents of the Company’s website nor any other website accessible through hyperlinks on the Company’s website are incorporated into or form part of this press release.

Failure to follow these instructions may result in a breach of the Securities Act or applicable laws in other jurisdictions.

Alvotech forward-looking statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s intentions, assessments, or expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the expectations with respect to resolving CRL issues, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches, financial projections and the markets in which Alvotech operates, including financial guidance and projections for 2025 and 2026, the ability to successfully execute and close the Offering and the expected use of proceeds from the Offering. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim”, or “might”, or, in each case, their negative, or similar expressions. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change. Neither Alvotech nor anyone else undertake any duty to review, update, confirm or to release publicly any revisions to these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication, unless this is required under law or Nasdaq Stockholm’s rulebook for issuers. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Company’s shares, SDRs and other securities have been subject to a product approval process, which has determined that such shares, SDRs and other securities are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II (the “Positive Target Market”); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II.

Distributors should note that: the price of the shares, SDRs and other securities in the Company may decline and investors could lose all or part of their investment; the shares, SDRs and other securities in the Company offer no guaranteed income and no capital protection; and an investment in the shares, SDRs and other securities in the Company is suitable only for investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. Conversely, an investment in the shares, SDRS or other securities of the Company is not suitable for investors who need full capital protection or full repayment of the amount invested, cannot bear any risk, or who require guaranteed or predictable return (the “Negative Target Market”, and together with the Positive Target Market, the “Target Market Assessment”).

The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering and the placement.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares, SDRs and other securities in the Company.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the shares, SDRs and other securities in the Company and determining appropriate distribution channels.