
OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma
OST-HER2 has already received Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for osteosarcoma from the U.S. FDA. If OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the Company will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent publicly disclosed PRV sale, valued at $155 million, occurred in May 2025.
The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. Upon receipt of the Type D Meeting feedback, the Company intends to promptly request the End of Phase 2 meeting with FDA in which it will be seek agreement to allow it to begin a rolling BLA submission in the third quarter of 2025. The grant of the RMAT designation in the third quarter of 2025 complements the company's parallel efforts in other major markets, including Europe and the United Kingdom, where the company plans to seek EMA PRIME Designation and Conditional Market Access (CMA) applications.
In parallel to regulatory engagement and market access planning for OST-HER2, the Company is preparing for the late stage clinical development of other pipeline candidates. As such, the Company is well positioned for sustained growth across multiple therapeutic modalities.
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the U.S. FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.
In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Business Wire
an hour ago
- Business Wire
Llama Group SA Announces a Capital Increase via a Private Placement of € 1.000.000
BRUSSELS--(BUSINESS WIRE)--Regulatory News: Llama Group SA (Euronext Growth Paris and Brussels: ALLAM), ('Llama Group' or the 'Company'), a digital music company and owner of the Winamp platform, today announces a capital increase for a total gross amount of € 1.000.000, subscribed by a limited number of investors (the 'Private Placement'). 'I would like to thank investors for their trust. This fundraising represents a key milestone for Llama Group and highlights the importance of our project in the music industry,' said Alexandre Saboundjian, CEO of Llama Group. 'Investors have recognised the potential of Winamp and the ambition driving our platform, designed to meet the needs of artists in a rapidly evolving music landscape. We remain more committed than ever to building an independent and innovative solution serving creators.' Use of Proceeds This transaction is part of Llama Group's ongoing strategic development. The funds raised will be primarily used to support the commercial launch of its new platform Winamp for Creators, by financing the initial phases of its go-to-market strategy — a central pillar of Llama Group's growth strategy. In parallel, the Company will continue to invest in the development of its two flagship products, Winamp for Creators and the Winamp Player, with the goal of enhancing features, improving user experience, and strengthening its positioning in the digital music market. The proceeds will also enable the Company to cover current operating expenses and meet its short-term financial commitments, in a context where its existing cash position requires supplementary funding alongside existing financing arrangements. Given current market conditions and the Company's stage of development, the private placement route was deemed the most appropriate and efficient financing solution at this time. Terms of the Private Placement The capital increase is carried out under the authorised capital framework, via the issuance of 1.666.668 new ordinary shares (the 'New Shares') at a subscription price of 0,60 € per share, representing a discount of approximately 21% compared to the Company's closing share price on the day prior to the announcement. The Private Placement is exclusively reserved for qualified investors — as defined under Rule 144A of the U.S. Securities Act of 1933 for subscribers located in the United States, and Article 2(e) of Regulation (EU) 2017/1129 for those based in the European Economic Area — with the statutory preferential subscription rights of existing shareholders being waived in the corporate interest. The New Shares: will be ordinary shares carry the same rights as the existing shares; will be fully paid-up, without nominal value, and issued in dematerialised form; will be entitled to dividends for the financial year starting 1 January 2025 if any; An application has been be made for admission to trading of the New Shares on Euronext Growth Brussels and Euronext Growth Paris as from their settlement and delivery. The capital increase for an amount of € 1.000.000 will raise the Company's share capital from € 29.859.118,30 to € 30.859.119,10. As the issue price is below the accounting par value, the entire subscribed amount will be allocated to the 'capital' account, without any share premium, so that all shares – both existing and new – will have the same accounting par value after completion. Subject to the closing of the capital increase having occurred, the Board of Directors will convene an Extraordinary General Meeting within fifteen (15) days following such closing. This meeting will take place no later than forty (40) days following the closing. 1 During such meeting, the shareholders will be asked to approve the issuance of 1.666.668 subscription rights ('Warrants') in favour of the investors who subscribed to the capital increase, without preferential subscription rights for existing shareholders. Each Warrant will entitle its holder to subscribe to one new ordinary share at an exercise price of 0,80 €, in accordance with the terms agreed between the Company and the investors. If a holder wishes to exercise its Warrants, it may do so only once for all Warrants owned by such holder, within five (5) years following the date on which the Warrants will have been effectively issued. The Company has committed to a 45-day standstill on the issuance of New Shares and transfer of shares of the Company, and the reference shareholder Maxximum SA has committed to a 60-day standstill on the transfer of shares of the Company, subject to customary and market-based exceptions. This structure enables Llama Group to quickly secure the resources needed while relying on professional investors able to support its long-term value creation strategy. Legal Basis of the Transaction In accordance with Article 7 of the Company's Articles of Association, the Board of Directors is authorised to increase the Company's share capital, in one or more tranches, until 4 March 2026, up to a maximum amount of € 22.841.742,87 (excluding any share premium), through the issuance of new shares, subscription rights or convertible bonds, via contributions in cash and/or in kind, with the ability to waive existing shareholders' preferential subscription rights. Immediately prior to this transaction, € 14.665.699,80 (excluding share premium) remained available under the authorised capital. Impact on Share Capital and Voting Rights Subject to the successful settlement and delivery of the New Shares, the Company's share capital will increase from € 29.859.118,30 to € 30.859.119,10, represented by 15.183.434 shares. The breakdown of the share capital and voting rights before and after the Private Placement is as follows: Before Private Placement Shareholders Shares Capital % Voting Rights Voting Rights % Maxximum SA 4,629,917 34.25% 8,615,636 49.23% Public 8,886,849 65.75% 8,886,849 50.77% Total 13,516,766 100.00% 17,502,485 100.00% Expand After Private Placement Shareholders Shares Capital % Voting Rights Voting Rights % Maxximum SA 4,629,917 30.49% 8,615,636 44.95% Public 10,553,517 69.51% 10,553,517 55.05% Total 15,183,434 100.00% 19,169,153 100.00% Expand Impact on Shareholders The stake of a shareholder holding 1% of the Company's share capital prior to the capital increase, and not participating in the Private Placement, would be diluted to approximately 0,89% following the issuance of 1.666.668 New Shares. In the event of full exercise of the 1.666.668 Warrants attached to the New Shares, this stake would be further reduced to approximately 0,80%. Financial Advisors Maxim Group LLC acted as placement agent and Allegra Finance acted as listing sponsor in the context of the Private Placement. The Private Placement is governed by agreements entered into between the Company and the placement. Risk Factors The public's attention is drawn to the risk factors relating to the Company and its business, as presented in the 2024 annual financial report published by the Company on April 1, 2025, available free of charge on its website ( The occurrence of some or all of these risks could have an adverse effect on the Company's business, financial position, results, development, or outlook. Prospectus Exemption The Private Placement, which is exclusively reserved for qualified investors, is not subject to the obligation to publish a prospectus or information note approved by the FSMA, in accordance with Article 10, § 3, 1° of the Law of 11 July 2018 on public offers of investment instruments and admissions of investment instruments to trading on regulated markets. The admission of the New Shares to trading on Euronext Growth Brussels and Paris is governed by the Royal Decree of 23 September 2018 on the publication of an information note in the event of a public offer or admission to trading on an MTF. In this respect, a verification was carried out and confirmed that the number of New Shares to be issued represents 12,3% of the number of Llama Group shares already admitted to trading on Euronext Growth over the past twelve months — i.e. below the 20% regulatory threshold. As a result, the transaction satisfies the exemption conditions under Article 3 of the Royal Decree, and no information note will be published. Next Meeting July 07, 2025 – Settlement and delivery of the Private Placement About Llama Group Llama Group is a pioneer and leader in the digital music industry. With extensive expertise across various sectors, the group owns the iconic Winamp platform, the Bridger copyright management company, and the Jamendo music licensing company. Llama Group's ambition is to build the future of the music industry through sustained investment in a range of innovative solutions and in the talent and skills of people who love music. The group stands by its brand values: empowerment, access, simplicity, and fairness. Winamp's vision is a world where a cutting-edge music platform connects artists and their fans like never before. Bridger's mission is to support songwriters and composers by providing a simple and innovative solution for collecting royalties. Jamendo enables independent artists to generate additional income through commercial licenses. Finally, Hotmix offers a bouquet of more than sixty thematic and free digital radio stations. Disclaimer This press release is for information purposes only. This press release does not constitute, and shall not be deemed to constitute, an offer to the public, an offer to subscribe or a solicitation of interest to the public with a view to a public offering of financial securities. The information set out above does not constitute and should not be considered as constituting a public offer, a subscription or purchase offer, or a solicitation of public interest in connection with a public offering of financial securities requiring the publication of a prospectus approved by the Financial Markets Authority (Autorité des Services et Marchés Financiers). The publication of this information in certain countries may constitute a breach of applicable legal provisions. This information must not be published, transmitted, released, or distributed, directly or indirectly, in or into the United States of America (including its territories and possessions), Canada, Australia, South Africa or Japan, or any other jurisdiction in violation of the relevant laws of such jurisdiction. The information made available above does not constitute an offer to sell or a solicitation of an offer to buy securities of the Company in the United States, Canada, Australia, South Africa, Japan, or in any other jurisdiction where such an offer or solicitation would be unlawful. The offering of the securities of the Company described in this press release is exclusively reserved to qualified investors, as provided in section « Terms of the Private Placement » of this press release. With respect to the member states of the European Economic Area, no action has been or will be taken to permit a public offering of the securities of the Company described in this press release that would require the publication of a prospectus in any such member state. Consequently, the securities of the Company described in this press release may not and will not be offered in any member state, except in accordance with the exemptions provided for in Article 1(4) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the 'Prospectus Regulation') or in other cases not requiring the publication of a prospectus by the Company under Article 3 of the Prospectus Regulation and/or applicable regulations in such member state. Without prejudice to any prohibitions in other jurisdictions, securities may not be offered or sold in the United States absent registration under the U.S. Securities Act of 1933, as amended (the 'U.S. Securities Act'), or an exemption from such registration. The securities of the Company described in this press release have not been and will not be registered under the U.S. Securities Act, and the Company does not intend to make any public offering of securities described in this press release in the United States.
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1 Dividend Giant Paying Over 7%, With Big Things Coming
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The Motley Fool has a disclosure policy. 1 Dividend Giant Paying Over 7%, With Big Things Coming was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data