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

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

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 41^st 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

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.

Market update




Market update

Paris – December 16, 2025 – EUROAPI announced today that its main shareholders, Sanofi and EPIC Bpifrance, have agreed to extend further the duration of their lock-up until December 18, 2026, subject to customary exceptions. This extension strengthens the stability of EUROAPI’s shareholding structure throughout the execution of its FOCUS-27 plan.

Based on its latest forecast, EUROAPI also provided the following business update:

• In a deteriorated overall business environment, Full Year 2025 Net Sales are expected to decrease mid-single digit on a comparable basis, compared to a low-single digit decline previously communicated.
• Full Year 2025 Core EBITDA margin objective remains within the 7% to 9% range thanks to effective cost reduction measures.

While the execution of the FOCUS-27 plan is progressing well, with continued improvements in cost efficiency across the organization, EUROAPI is assessing the implications of the evolving business environment. The company will provide further update on March 3, 2026, together with Full Year 2025 Results.

Financial agenda (all dates to be confirmed)

• 3 March 2026: FY 2025 results
• 27 May 2026: 2026 AGM
• 28 July 2026: H1 2026 results

About EUROAPI
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,270 people every day. With strong research and development capabilities and five manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on Linkedin.

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 1, 2025. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.

Attachment

• EUROAPI – Press release – December 16, 2025

Trethera Receives $2.7 Million NIH Grant, Validating the Potential of First-in-Class TRE-515 to Overcome KRAS Inhibitor Resistance in Lung Cancer




Trethera Receives $2.7 Million NIH Grant, Validating the Potential of First-in-Class TRE-515 to Overcome KRAS Inhibitor Resistance in Lung Cancer

LOS ANGELES, Dec. 16, 2025 (GLOBE NEWSWIRE) — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today the award of a new $2.7 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH).   The award evaluates the combination of Trethera’s lead drug candidate, TRE-515, with KRAS inhibitor therapies to treat non-small cell lung cancer (NSCLC). Lung cancer is responsible for more deaths annually than breast, prostate, and colorectal cancer combined— with NSCLC causing 80% of lung cancer deaths. The grant will fund testing TRE-515 with standard of care KRAS inhibitors (KRASi) in NSCLC mouse models to inform future clinical trials.

“Securing this NIH lung cancer grant continues our multiple indication momentum, coming less than six months after receiving FDA Fast Track designation for prostate cancer. Such dual external validations are rare and substantiate the strength of our scientific rationale and clinical observations,” said Dr. Ken Schultz, Chairman and CEO of Trethera. “Combining TRE-515 with targeted KRAS therapies, is intended to exploit a metabolic vulnerability in NSCLC and address the significant unmet need for the 60% of patients who do not respond to KRASi monotherapy and those who experience relapse.”

TRE-515 inhibits deoxycytidine kinase (dCK), the key enzyme for the nucleoside salvage pathway that becomes activated and essential for abnormal cell growth in autoimmune diseases and cancer. Consistent with observations that dCK activity is relatively minimal in the regulated cell division of healthy cells, inhibiting dCK with TRE-515 has demonstrated favorable safety in addition to clinical benefit in ongoing first-in-human trials.

Estimates by the World Health Organization indicate that more than 2.5 million new cases and 1.8 million deaths from lung cancer occurred globally in 2024. While FDA approved KRAS inhibitors have transformed the NSCLC market, KRASi have a 40% response rate. Thus, 6 of 10 patients experience no clinical benefit from the treatment. Furthermore, those patients who do benefit from KRASi therapy find their results transient, with an average duration of 8-10 months before tumor growth resumes.  

When treated with KRAS inhibitors alone, cancer cells can escape destruction by using the salvage pathway to gather additional nucleosides to repair the DNA damage. Combining TRE-515 with KRAS targeting drugs synergistically cripples the ability of cancer cells to grow or recover from DNA damage and enhances the therapeutic response.

“We are excited to receive this grant award, which underscores the strong mechanistic rationale for pairing a first-in-class dCK inhibitor with KRAS-targeted therapies,” said UCLA Assistant Professor Evan Abt and grant co-investigator. “KRAS inhibitor resistance remains a major challenge, and our data suggest that blocking the nucleoside salvage pathway directly disrupts a key metabolic escape route used by lung cancer cells.”

Dr. Steve Dubinett, Distinguished Professor at the UCLA School of Medicine and pulmonologist, added, “Lung cancer is the leading cause of cancer-related mortality worldwide, with limited effective therapies once the disease becomes resistant and metastatic. A novel, first-in-class drug such as TRE-515, paired with the KRAS inhibitor class, could redefine treatment for this devastating disease.”

In its written summary, the NIH peer review panel commented, “significance and market potential are high given the need for novel drug combinations for a deadly disease with limited treatment options… potential for commercialization in a short time if the research is successful… preclinical and early phase clinical data provide additional reassurance of safety… evaluation of biomarkers for the combinatorial approach so early in the drug development is a major strength… already shown clinical activity and demonstrates potential as a novel therapeutic agent… … a truly outstanding and accomplished group of investigators.”

Figure 1: Specialized [¹⁸F]CFA PET radiotracer showing persistent dCK activity following KRASi treatment in a mouse implanted with a tumor (left) then treated with TRE-515 to completely block dCK tumor activity (right).

Sources: Siegel, Cancer J Clin. 2024; 74(1); Bunimovich, PLoS One. 2014; 9(8); Hong, NEngl JMed. 2020; 383(13); Thandra, Cont Oncol 2021; 25(1); Lumakras^TM and Krazati^TM FDA labels

Note: Statements taken from the official NIH peer review written summary reflect their personal scientific assessment and are not official NIH endorsements.

About Trethera
Trethera is a clinical stage, privately held, biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases might also respond to TRE-515 treatment. The FDA has designated TRE-515 a Fast Track drug for prostate cancer and an Orphan Drug for two autoimmune neurologic diseases. Trethera is developing TRE-515 for use as a monotherapy or in combination to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.
For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com. You can also follow Trethera on Facebook and LinkedIn.

About KRAS Inhibitors
KRAS inhibitors represent a transformative advance in precision oncology, offering the first targeted therapies for patients whose tumors harbor the historically intractable KRAS G12C mutation. The two FDA approved agents, Lumakras^TM and Krazati^TM, are orally administered small molecule inhibitors that directly target mutant KRAS signaling, a central driver of cancer cell proliferation and survival. Their continued development underscores the high potential of KRAS inhibitors to reshape treatment paradigms across multiple cancer types, both as monotherapies and as foundational components of rational drug combinations designed to overcome resistance and improve patient outcomes.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3ccc8144-fe5f-44c9-b54d-a95e6add5a5f

Simple Consult Expands Access to $29 Online Healthcare Across 19 States




Simple Consult Expands Access to $29 Online Healthcare Across 19 States

The independently owned telehealth platform offers same-day visits, prescription refills, and everyday care with transparent pricing and no insurance required

Dover, Delaware, Dec. 16, 2025 (GLOBE NEWSWIRE) — Simple Consult, a fast-growing virtual care platform built by experienced nurse practitioners, announced the expansion of its affordable, no-insurance telehealth services to 19 U.S. states. Designed for patients seeking fast, transparent, and guideline-driven online care, the platform offers virtual urgent care, prescription renewals, and chronic condition management — all for just $29 per visit.

A telehealth platform providing fast, affordable, and insurance-free virtual care to patients across the U.S.

Focused on everyday healthcare needs, Simple Consult enables patients to book asynchronous or same-day video visits with U.S.-licensed clinicians who average over 20 years of experience. The service is particularly suited for the uninsured, underinsured, and high-deductible health plan holders who often struggle with access to affordable care.

“Simple Consult was built to remove the cost and complexity barriers that prevent people from getting the care they need,” said a representative from the company. “By eliminating hidden fees, subscriptions, or insurance requirements, we’ve made it possible for patients to access real, credentialed clinicians when they need them — not weeks later.”

The platform provides fast and secure access to medical care, supporting a wide range of non-emergency needs including medication refills, common illnesses, lab diagnostics, and chronic care consultations. The service does not treat emergencies or prescribe controlled substances, instead focusing on safe, HIPAA-compliant telemedicine for everyday health concerns.

Key features of the platform include:

• Flat $29 pricing per visit, no insurance or membership required
• Coverage in 19 U.S. states, with multi-state licensed clinicians
• Same-day video and asynchronous visit options
• Prescription refills sent directly to local pharmacies, if appropriate
• Transparent care tailored for patients who need quick, private solutions

Simple Consult is currently undergoing the LegitScript certification process and adheres to HIPAA compliance standards, ensuring data privacy and operational credibility as it scales. As part of its long-term commitment to patient-first care, the company remains independently owned and free from venture capital influence — an increasingly rare stance in the competitive telehealth space.

In addition to individual visits, the company has introduced its CarePass program: a pre-paid option offering 8 visits for $180. This package averages $15 per visit and includes appropriate prescriptions, blood work, diagnostic orders, and treatment for a range of everyday conditions.

Patients in Florida can now access fast Florida Online Prescription services without the need for insurance or long wait times. Similarly, residents in New York can benefit from New York Virtual Urgent Care, further expanding access in major urban markets.

To learn more about how Simple Consult is making healthcare affordable and accessible, visit their website or explore their Telehealth for $29 program.

With the rising demand for cost-effective online care options, Simple Consult continues to fill a growing need — providing affordable, private, and licensed Online Urgent Care to those who would otherwise go untreated or delay care due to cost.

A video accompanying this announcement is available here: https://www.youtube.com/watch?v=SakumF24upw

Digital healthcare service offering licensed clinician visits, online urgent care, and prescription refills at a fixed low cost.

About Simple Consult, LLC

Simple Consult, LLC is a Delaware-based digital healthcare provider committed to transforming how patients access routine medical services. Specializing in online consultations for adults aged 18 and older, the company focuses on non-emergency conditions and prescription refills. Its mission is to simplify healthcare by making it fast, affordable, and accessible. 

Press inquiries

Simple Consult, LLC
https://simple-consult.com/
Benjamin Domingo
contact@simple-consult.com
(407)536-9751
8 The Green Suite B
Dover, Delaware, 19901

A video accompanying this announcement is available here: https://youtube.com/watch?v=SakumF24upw

Starton Therapeutics to Present at Biotech Showcase 2026




Starton Therapeutics to Present at Biotech Showcase 2026

Company Will Also Host 1×1 Investor Meetings at the 15th Annual LifeSci Partners Corporate Access Event from January 13-14th in San Francisco

PARAMUS, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today that Chairman and Chief Executive Officer, Pedro Lichtinger, will present a company overview and provide an update on its lead program, STAR-LLD, at Biotech Showcase 2026, which is taking place in San Francisco, CA January 12-14, 2026. Starton senior management will also host one-on-one meetings during the conference.

Presentation and Meeting Details:

Event: Biotech Showcase 2026
Date: Monday, January 12, 2026
Time: 2:45 PM PT
Track: Franciscan D (Ballroom Level)

Event: 15^th Annual LifeSci Partners Corporate Access Event
Date: Tuesday-Wednesday, January 13-14, 2026
Location: Beacon Grand Hotel (450 Powell Street), San Francisco, CA

To schedule a one-on-one meeting, please email astarr@lifesciadvisors.com

About Biotech Showcase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather at Biotech Showcase during this bellwether week which sets the tone for the coming year. Now in its 18th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

About Starton Therapeutics

Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer live better, for longer. Starton’s proprietary technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.

Investor Relations Contact

Alex Starr
Managing Director
LifeSci Advisors
astarr@lifesciadvisors.com

Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic




Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic

• REX-8756 is a potent and selective oral STAT6 inhibitor that has shown complete 100% pathway inhibition and potent efficacy in preclinical models of asthma, acute lung inflammation and dermatitis
• Efficacy comparable to anti-IL-4/IL-13 antibody combination control with a favorable tolerability profile in preclinical models
• Being advanced under a strategic partnership with Sanofi, where Recludix has the option to participate in a 50:50 U.S. profit/loss share

SAN DIEGO, Dec. 16, 2025 (GLOBE NEWSWIRE) — Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to advance REX-8756, an oral STAT6 inhibitor, into Phase 1 clinical testing.

“With REX-8756, we are excited by the opportunity to pioneer a new therapeutic class for patients with inflammatory diseases,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “We have demonstrated preclinically that our reversible, orally available STAT6 inhibitor can achieve efficacy comparable to that of clinically validated biologics. By targeting the pathological overactivation of STAT6 observed in many diseases — without necessitating protein degradation and with an anticipated improved hematologic safety profile relative to JAK inhibitors — we believe this approach could be an important therapeutic option for patients. We look forward to initiating a Phase 1 clinical study of REX-8756 in healthy volunteers very shortly.”

REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain — a key mediator of protein-protein interactions that was long considered undruggable. In preclinical studies, REX-8756 demonstrated complete and sustained inhibition of STAT6 activity, thereby suppressing IL-4 and IL-13-induced inflammatory biomarkers. STAT6 is required for IL-4 and IL-13 signaling but is downstream in the disease pathway from other drug targets, and therefore, its inhibition has been shown in preclinical studies to be a more selective approach than Janus Kinase (JAK) family inhibitors, with the potential for fewer side effects. REX-8756 has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis, comparable to that of an anti-IL-4/IL-13 antibody combination control.

About STAT6
Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases.

About Recludix
Recludix is a company with leading, innovative platform approaches to discover and develop potent and selective inhibitors of challenging protein targets. The company’s management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors.

Recludix is initiating a Phase 1 study of REX-8756 (also known as SAR448755), an oral inhibitor of STAT6, in a strategic development and commercialization partnership with Sanofi where Recludix has the option to participate in an equal U.S. profit/loss share. Abnormal activation of STAT6 is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria.

Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional discovery programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company’s website at https://recludixpharma.com.

Recludix Contacts
Matt Caldemeyer
Chief Business Officer
mcaldemeyer@recludix.com

Alexandra Santos 
asantos@wheelhouselsa.com

Aljanae Reynolds
areynolds@wheelhouselsa.com

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA




BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) — BioCardia^®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.  

“Our autologous minimally invasive cell therapy presents a new mechanism of action of microvascular repair for ischemic heart failure patients evidencing active heart failure while on guideline directed medical therapy who have few additional therapeutic options.” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “The data from the three completed Phase I, II and III trials support positive outcomes in significant clinical efficacy endpoints, including improved survival and reduced major adverse cardiovascular events, along with improved heart function and quality of life measures relative to control patients.”

The existing clinical data supporting safety and efficacy of CardiAMP Cell Therapy for HFrEF is subject to ongoing regulatory discussions in Japan and the United States. The compilation includes data from the three clinical studies that BioCardia believes demonstrate a favorable benefit to risk profile.  

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells as treatment delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. 

CardiAMP Cell Therapy Clinical Development Highlights

Phase 1: TABMMI Heart Failure Trial; open label, n=20 (NCT00507468) ¹

• 90% of treated patients alive and well at three years
• Left ventricular ejection fraction (LVEF) improved by 7% at 24 months (p=0.001)
• Exercise tolerance improved 125 seconds at 24 months (p=0.006)

Phase 2: TACHFT Trial; double-blind placebo-controlled, n=33 with 29 randomized (NCT00768066) ^2,3

• All (100%) treated patients alive at one year (end of study); major adverse cardiac events (MACE) reduced 20% relative to controls
• Six-minute walk distance improved 56.3 meters at 12 months for treated patients compared to controls (p = 0.049)
• Quality of life measured using Minnesota Living with Heart Failure Quality of Life Questionnaire improved by 17.4 points (p=0.039) for treated patients compared to controls

Phase 3: CardiAMP HF Trial; multi-center, double-blind placebo-procedure controlled with 24-month follow-up, N=125, with 115 randomized (NCT02438306) ^{4, 5}

• Roll-in cohort patients demonstrated improved heart function measures, and the study procedure was feasible with an excellent safety profile
• Treated patients in the full study cohort had reduced fatal and nonfatal MACE, along with improved quality of life and echocardiography heart function measures on top of guideline-directed medical therapy compared to controls
• The primary Finkelstein Schoenfeld composite outcome endpoint including 6-minute walk test distance (6MWT) was not met due to potential confounding of this effort-based measure.

The subgroup of randomized patients with elevated NTproBNP before study enrollment (n=57) demonstrated strong efficacy signals, including:

• Met Finkelstein Schoenfeld composite endpoint consisting of fatal cardiac death, non-fatal MACE, and quality of life (p = 0.04)
• Demonstrated improved left ventricular systolic and diastolic volume measures at 24 months (LVESVi, p=0.01; LVEDVi, p=0.01) as assessed by the blinded echocardiography core lab, suggesting significantly improved heart function compared to controls through the end of the study

About BioCardia^®
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph^® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com.

References

¹ De la Fuente LM, Stertzer SH, Argentieri J. et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011; 7(7):805-812.

² Wong Po Foo C, Rouy D, Hare JM, et al. The transendocardial autologous bone marrow mononuclear cells in ischemic heart failure trial (TAC-HFT-BMC). Regenerative Medicine. 2015; 10(7S): S169.

³ Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014; 311(1):62-73.

⁴ Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20. PMID: 33091520.

⁵ Raval AN on behalf of the CardiAMP HF Investigators: A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Late Breaking Clinical Trials 2025.

Forward Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

Starton Therapeutics to Present at Biotech Showcase 2026




Starton Therapeutics to Present at Biotech Showcase 2026

Company Will Also Host 1×1 Investor Meetings at the 15th Annual LifeSci Partners Corporate Access Event from January 13-14th in San Francisco

PARAMUS, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today that Chairman and Chief Executive Officer, Pedro Lichtinger, will present a company overview and provide an update on its lead program, STAR-LLD, at Biotech Showcase 2026, which is taking place in San Francisco, CA January 12-14, 2026. Starton senior management will also host one-on-one meetings during the conference.

Presentation and Meeting Details:

Event: Biotech Showcase 2026
Date: Monday, January 12, 2026
Time: 2:45 PM PT
Track: Franciscan D (Ballroom Level)

Event: 15^th Annual LifeSci Partners Corporate Access Event
Date: Tuesday-Wednesday, January 13-14, 2026
Location: Beacon Grand Hotel (450 Powell Street), San Francisco, CA

To schedule a one-on-one meeting, please email astarr@lifesciadvisors.com

About Biotech Showcase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather at Biotech Showcase during this bellwether week which sets the tone for the coming year. Now in its 18th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

About Starton Therapeutics

Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer live better, for longer. Starton’s proprietary technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.

Investor Relations Contact

Alex Starr
Managing Director
LifeSci Advisors
astarr@lifesciadvisors.com