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Fortrea Assina Contrato Definitivo de Transferência das Unidades Endpoint Clinical e Patient Access para a Arsenal Capital Partners

A proposta da transferência das unidades Endpoint Clinical e Fortrea Patient Access agiliza ainda mais o foco estratégico da Fortrea como uma organização de pesquisa sob contrato

Ela cria as melhores soluções independentes de Randomização e Gestão de Fornecimento de Ensaios e Acesso do Paciente posicionadas para diferenciação e crescimento

DURHAM, N.C., March 12, 2024 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE) (a “Empresa”), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje que assinou um contrato definitivo de transferência dos ativos relacionados ao seu segmento Enabling Services, ou seja, suas unidades Endpoint Clinical (“Endpoint”) e Fortrea Patient Access, para a Arsenal Capital Partners (“Arsenal”), uma empresa líder de private equity especializada na criação de empresas de saúde líderes de mercado e ricas em tecnologia.

Com a transferência dessas unidades, a Fortrea visa promover a estratégia de crescimento e soluções da Endpoint e da Fortrea Patient Access, posicionando–as para aumentar o investimento para acelerar o roteiro de tecnologia e aprimorar ainda mais as operações para apoiar as melhores soluções e entregas aos clientes. As outras unidades da Fortrea irão fortalecer seu foco nas fases de desenvolvimento clínico 1 a 4. A conclusão da transação está prevista para o segundo trimestre de 2024, estando sujeita às condições habituais de fechamento e aprovações regulatórias, bem como às partes que celebram certos serviços e contratos operacionais.

“Hoje é um marco significativo na jornada contínua da Fortrea, à medida que aprimoramos nosso foco em crescer organicamente como uma CRO pura, com flexibilidade financeira adicional”, disse o presidente e CEO da Fortrea, Tom Pike. “Depois de uma revisão estratégica de nossos negócios, concluímos que a transferência das unidades Endpoint e Fortrea Patient Access se alinha aos interesses dos nossos clientes. A Arsenal tem uma vasta experiência na criação de empresas que criam melhorias sistemáticas nos resultados de saúde, e estou confiante de que a Endpoint e a Fortrea Patient Access poderão fortalecer suas posições no mercado, cultivar talentos de primeira linha e investir em novas capacidades e recursos, ao mesmo tempo, oferecer soluções que melhoram a vida dos pacientes.”

“Estou muito entusiasmado com este próximo capítulo da Endpoint e a Fortrea Patient Access”, disse Sam Osman, presidente da Enabling Services da Fortrea, que atuará como CEO dessas empresas com a Arsenal. “Essas empresas estarão distintamente posicionadas para gerenciar efetivamente a jornada do paciente nos ensaios clínicos e na comercialização, impulsionando o acesso e a adesão do paciente às terapias aprovadas. Com a união da profunda perspicácia de investimento da Arsenal com a experiência operacional líder do setor, estou confiante de que as empresas Endpoint e Fortrea Patient Access estão bem posicionadas para o crescimento e a entrega de recursos aprimorados para pacientes e patrocinadores farmacêuticos. Quero dar continuidade ao impacto positivo no cuidado da saúde.”

“A Endpoint e a Fortrea Patient Access têm um histórico orgulhoso de décadas de liderança no mercado no apoio à pesquisa clínica e comercialização de terapias inovadoras. A Arsenal tem orgulho em criar organizações que melhoram significativamente os cuidados da saúde. Estamos entusiasmados com a parceria com a administração e os funcionários para acelerar o crescimento desses dois negócios”, disse Gene Gorbach, um Parceiro de Investimento da Arsenal.

Dimitris Agrafiotis, Ph.D., Diretor de Digital, Análise e IA da Arsenal, disse: “A Endpoint e a Fortrea Patient Access fornecem soluções essenciais que permitem a participação dos pacientes em ensaios clínicos e acesso a terapias. Tenho o prazer de apoiar a equipe talentosa da Endpoint e da Fortrea Patient Access. Juntos, aumentaremos ainda mais a sofisticação das capacidades tecnológicas que sustentam o compromisso dessas empresas em fornecer serviços da mais alta qualidade para a indústria farmacêutica.”

Endpoint Clinical
A Endpoint opera no mercado eClinical de alto crescimento como provedora líder de soluções de Randomização e Gerenciamento de Fornecimento de Ensaios (RTSM) para clientes biofarmacêuticos e CRO, com experiência no atendimento de ensaios clínicos complexos e em estágio avançado. Com mais de 15 anos, a Endpoint já apoiou com sucesso mais de 1.750 ensaios clínicos envolvendo 875.000 pacientes em 90 países e cultivou uma base de clientes de primeira linha e relacionamentos estratégicos de longa data.

Fortrea Patient Access
A Fortrea Patient Access é uma líder em escala no mercado de serviços de HUB e acesso do paciente, atendendo à indústria biofarmacêutica com suporte abrangente ao paciente, acesso ao produto, acessibilidade e soluções de adesão há mais de 30 anos. Avançando ainda mais com sua especializada farmácia não comercial recentemente expandida, a FortreaRx™, para apoiar a distribuição aprimorada de produtos de cadeia fria e sem ambiente, a Fortrea Patient Access está comprometida em impulsionar os resultados dos pacientes e aprimorar a acessibilidade aos cuidados da saúde por meio da sua ampla experiência, oferecendo suporte a mais de 2,5 milhões de pacientes e mais de 100 marcas exclusivas para mais de 25 indicações de doenças.

Arsenal Capital Partners
A Arsenal Capital Partners é uma empresa líder em investimentos em patrimônio privado especializada na criação de empresas líderes de mercado em crescimento industrial e saúde. Desde a sua criação em 2000, o Arsenal levantou fundos de investimento de capital institucional com um total de mais de US$ 10 bilhões, concluiu mais de 290 aquisições de plataformas e complementos, e alcançou mais de 35 realizações. A empresa trabalha com equipes de gestão para criar empresas estrategicamente importantes com posições de liderança no mercado, alto crescimento e alto valor agregado. Para mais informação, visite www.arsenalcapital.com.

Consultores
Barclays está atuando como consultor financeiro exclusivo da Fortrea, e Smith Anderson como consultor jurídico. A Sidley Austin LLP atuou como consultora jurídica da Arsenal.

Chamada e Replay de Ganhos
A Fortrea discutirá o anúncio da transferência na sua teleconferência de resultados do quarto trimestre de 2023, que será realizada hoje às 9h ET. A conferência pode ser acessada no site Investor Relations da Fortrea (Relacionamento com o Investidor) ou no seguinte link earnings webcast (Webcast de ganhos). Para evitar possíveis atrasos, acesse pelo menos 10 minutos antes do início da chamada. Um replay da teleconferência ao vivo estará disponível logo após a conclusão do evento e acessível na seção events and presentationts (eventos e apresentações) do site da Fortrea. Uma apresentação de slides suplementar também estará disponível no site Investor Relations da Fortrea antes do início da chamada.

Sobre a Fortrea
A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico e acesso ao paciente para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I–IV, farmacologia clínica, serviços de consultoria, soluções de testes com tecnologia diferenciada e serviços pós–aprovação. As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada de aproximadamente 18.000 pessoas que trabalham em mais de 90 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo. Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para paciente na Fortrea.com e siga–nos no LinkedIn e X (antigo Twitter) @Fortrea.

Advertência a Respeito de Declarações de Previsão

Este comunicado contém “declarações de previsão” de acordo com a definição do termo estabelecido na Seção 27A da Lei de Valores Mobiliários (Securities Act) e na Seção 21E da Lei de Mercados Mobiliários (Securities Exchange Act). As declarações de previsão, por sua natureza, abordam questões que são, em diferentes graus, incertas, como as declarações sobre os benefícios previstos da transação, incluindo o desempenho financeiro e operacional futuro, e o prazo previsto para a conclusão da transação. Neste contexto, as declarações de previsão geralmente abordam o desempenho futuro esperado e o desempenho financeiro e a condição financeira, e muitas vezes contêm palavras como “orientação”, “esperar”, “supor”, “antecipar”, “pretender”, “planejar”, “prever”, “acreditar”, “buscar”, “ver”, “irá”, “faria”, “alvo”, expressões semelhantes e variações ou negativos dessas palavras que se destinam a identificar declarações de previsão, embora nem todas as declarações de previsão contenham essas palavras de identificação. Os resultados reais podem diferir materialmente dessas declarações de previsão devido a uma série de fatores, incluindo, mas não se limitando a: satisfação das condições precedentes à consumação da transferência proposta da transação das unidades Endpoint Clinical e Fortrea Patient Access, incluindo a capacidade de garantir aprovações regulatórias e a capacidade da Empresa de concluir a transação em tempo hábil ou de alguma forma; a possibilidade de que a transação possa ser mais cara do que o previsto, inclusive como resultado de fatores ou eventos inesperados; a capacidade das partes de atender às expectativas em relação aos tratamentos contábeis e fiscais da transação proposta; e outros fatores descritos ocasionalmente nos documentos que a Empresa arquiva junto à SEC. Para uma discussão mais aprofundada dos riscos relacionados aos negócios da Empresa, consulte a Seção “Fatores de Risco” da Declaração de Registro da Empresa no Formulário 10, conforme arquivado na Comissão de Valores Mobiliários (a “SEC”), pois tais fatores podem ser alterados ou atualizados ocasionalmente nos registros periódicos e outros registros subsequentes da Empresa na SEC, acessíveis no site da SEC em www.sec.gov. Esses fatores não devem ser interpretados como exaustivos e devem ser lidos em conjunto com as outras declarações de advertência incluídas ou incorporadas por referência neste relatório e nos registros da Empresa na SEC. As declarações de previsão incluídas neste comunicado são válidas apenas a partir da presente data e não assumimos nenhuma obrigação de atualizar essas declarações de previsão para indicar eventos ou acontecimentos subsequentes.

Contatos da Fortrea:
Hima Inguva (Investidores) – 877–495–0816, hima.inguva@fortrea.com
Sue Zaranek (Mídia) – 919–943–5422, media@fortrea.com
Kate Dillon (Mídia) – 646–818–9115, kdillon@prosek.com

Contato da Arsenal:
Jackie Schofield, pro–Arsenal@prosek.com


GLOBENEWSWIRE (Distribution ID 9062251)

Fortrea Signs Definitive Agreement to Divest Endpoint Clinical and Patient Access Businesses to Arsenal Capital Partners

Proposed divestiture of Endpoint Clinical and Fortrea Patient Access businesses further streamlines Fortrea’s strategic focus as a pure–play contract research organization

Creates standalone best–in–class Randomization and Trial Supply Management and Patient Access solutions positioned for differentiation and growth

DURHAM, N.C., March 11, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced it has signed a definitive agreement to divest assets relating to its Enabling Services segment, namely its Endpoint Clinical (“Endpoint”) and Fortrea Patient Access businesses, to Arsenal Capital Partners (“Arsenal”), a leading private equity firm specializing in building market–leading, technology–rich healthcare companies.

By divesting these businesses, Fortrea aims to advance the growth strategy and solutions of Endpoint and Fortrea Patient Access, positioning them for increased investment to accelerate the technology roadmap and further enhance operations to support best–in–class customer solutions and delivery. The remaining business of Fortrea will strengthen its focus on clinical development phases 1 through 4. Closing is targeted for the second quarter of 2024, subject to customary closing conditions and regulatory approvals, as well as the parties entering into certain services and operating agreements.   

“Today marks a significant milestone in Fortrea’s ongoing journey, as we sharpen our focus on organically growing as a pure–play CRO, with added financial flexibility,” said Fortrea Chairman and CEO Tom Pike. “After undertaking a strategic review of our business, divesting Endpoint and Fortrea Patient Access aligns with the interests of our customers. Arsenal has extensive experience in building businesses that create systematic improvement in health outcomes, and I am confident that Endpoint and Fortrea Patient Access will be able to strengthen their market positions, nurture top–tier talent and invest in new capabilities and resources while delivering solutions that improve patients’ lives.”

“I am excited for this next chapter for Endpoint and Fortrea Patient Access,” said Sam Osman, president of Enabling Services at Fortrea, who will serve as the CEO of these businesses with Arsenal. “These businesses will be distinctively positioned to effectively manage the patient journey across clinical trials and into commercialization by driving patient access and adherence for approved therapies. Combining Arsenal’s deep investment acumen and leading industry operational expertise, I am confident the Endpoint and Fortrea Patient Access businesses are well positioned for growth and delivery of enhanced capabilities for patients and pharma sponsors. I look forward to our continued positive impact on healthcare.”

“Endpoint and Fortrea Patient Access have a proud, decades–long track record of market leadership in supporting clinical research and commercialization of innovative therapies. Arsenal takes pride in building organizations that meaningfully improve healthcare. We are excited to partner with management and employees to accelerate the growth of these two businesses,” said Gene Gorbach, an Investment Partner of Arsenal.

Dimitris Agrafiotis, Ph.D., Director of Digital, Analytics & AI at Arsenal said, “Endpoint and Fortrea Patient Access provide essential solutions that enable patients’ participation in clinical trials and access to therapies. I am delighted to support the talented team at Endpoint and Fortrea Patient Access. Together, we will further enhance the sophistication of technology capabilities that underpin these companies’ commitment to delivering the highest quality services to the pharmaceutical industry.”

Endpoint Clinical
Endpoint operates in the high growth eClinical market as a leading provider of Randomization and Trial Supply Management (RTSM) solutions to biopharmaceutical and CRO customers with expertise in serving complex and late–stage clinical trials. For more than 15 years, Endpoint has had a successful track record of effectively supporting more than 1,750 clinical trials involving 875,000 patients across 90 countries and has cultivated a blue–chip customer base and nurtured long–standing strategic relationships.

Fortrea Patient Access
Fortrea Patient Access is a scaled leader in the HUB services and patient access market, serving the biopharmaceutical industry with comprehensive patient support, product access, affordability and adherence solutions for more than 30 years. Further advanced by its recently expanded non–commercial specialty pharmacy, FortreaRx™, to support enhanced distribution of cold–chain and ambient free goods products, Fortrea Patient Access is committed to driving patient outcomes and improving healthcare accessibility through its extensive experience while currently supporting more than 2.5 million patients and over 100 unique brands across more than 25 disease indications.

Arsenal Capital Partners
Arsenal Capital Partners is a leading private equity investment firm that specializes in building market–leading industrial growth and healthcare companies. Since its inception in 2000, Arsenal has raised institutional equity investment funds totaling over $10 billion, completed more than 290 platform and add–on acquisitions, and achieved more than 35 realizations. The firm works with management teams to build strategically important companies with leading market positions, high growth, and high value–add.  For more information, visit www.arsenalcapital.com.

Advisors
Barclays is serving as exclusive financial advisor to Fortrea, and Smith Anderson is serving as its legal counsel. Sidley Austin LLP served as Arsenal’s legal counsel.

Earnings Call and Replay
Fortrea will discuss the divestiture announcement on its fourth quarter 2023 earnings conference call, which will be held today at 9:00 am ET. The conference can be accessed through the Fortrea Investor Relations website or the following earnings webcast link. To avoid potential delays, please join at least 10 minutes prior to the start of the call. A replay of the live conference call will be available shortly after the conclusion of the event and accessible on the events and presentations section of the Fortrea website. A supplemental slide presentation will also be available on the Fortrea Investor Relations website prior to the start of the call.

About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology, consulting services, differentiated technology–enabled trial solutions and post–approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 18,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Cautionary Statement Regarding Forward–Looking Statements

This press release contains “forward–looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward–looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the anticipated benefits of the transaction, including future financial and operating performance, and the anticipated timing for completing the transaction. In this context, forward–looking statements often address expected future business and financial performance and financial condition, and often contain words such as “guidance,” “expect,” “assume,” “anticipate,” “intend,” “plan,” “forecast,” “believe,” “seek,” “see,” “will,” “would,” “target,” similar expressions, and variations or negatives of these words that are intended to identify forward–looking statements, although not all forward–looking statements contain these identifying words. Actual results could differ materially from these forward looking statements due to a number of factors, including, but not limited to: satisfaction of the conditions precedent to consummation of the proposed divestiture of Endpoint Clinical and Fortrea Patient Access businesses transaction, including the ability to secure regulatory approvals, and the Company’s ability to complete the transaction in a timely manner or at all; the possibility that the transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; the parties’ ability to meet expectations regarding the accounting and tax treatments of the proposed transaction; and other factors described from time to time in documents that the Company files with the SEC. For a further discussion of the risks relating to the Company’s business, see the “Risk Factors” Section of the Company’s Registration Statement on Form 10, as filed with the Securities and Exchange Commission (the “SEC”), as such factors may be amended or updated from time to time in the Company’s subsequent periodic and other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included or incorporated by reference in this report and in the Company’s filings with the SEC. All forward–looking statements are made only as of the date of this report and the Company does not undertake any obligation, other than as may be required by law, to update or revise any forward–looking statements to reflect future events or developments.

Fortrea Contacts:
Hima Inguva (Investors) – 877–495–0816, hima.inguva@fortrea.com
Sue Zaranek (Media) – 919–943–5422, media@fortrea.com
Kate Dillon (Media) – 646–818–9115, kdillon@prosek.com

Arsenal Contact:
Jackie Schofield at  pro–Arsenal@prosek.com


GLOBENEWSWIRE (Distribution ID 9061141)

Recursion Announces Plans to Open New Office in London

LONDON, March 11, 2024 (GLOBE NEWSWIRE) — Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced plans to open a new office in London’s vibrant King’s Cross neighborhood. Set to formally open in June 2024, the site will provide Recursion and Valence Labs, the company’s artificial intelligence research engine, access to world–class talent across Europe’s rapidly growing TechBio sector and embed Recursion in a thriving innovation ecosystem of leading technology and life science companies.

“As Recursion continues to lead and define the TechBio industry, it's critical we hire the best possible talent, much of which is located in Europe,” said Chris Gibson, Ph.D., Co–founder and CEO at Recursion. “London stood out as an ideal location given its brilliant and interdisciplinary talent across the fields of technology, biology and chemistry. It’s also the epicenter for the rapidly growing TechBio sector in Europe, where leading technology and life science companies like Google and Merck both sit within walking distance of our new Recursion site. I look forward to expanding our operations in Europe and hiring many new Recursionauts who will help us advance our mission of decoding biology to radically improve lives.”

To support Recursion’s leadership in TechBio and entry into London, the company is excited to announce the addition of Michael Bronstein, DeepMind Professor of Artificial Intelligence at Oxford University, as a Scientific Advisor. Professor Bronstein is a world leader in geometric deep learning, graph neural networks, and protein design. Professor Bronstein joins AI luminary Professor Yoshua Bengio in supporting Recursion and Valence Labs in the development of state–of–the–art AI models to support the industrialization of drug discovery.

“Recursion is leading the field in advancing cutting–edge AI research for real–world applications with the potential to radically improve lives, and I’m honoured to join them in their mission,” said Prof Michael Bronstein. “I have collaborated with Valence prior to their acquisition by Recursion, and I look forward to continuing to work with the team to advance this important work, especially as Recursion continues to grow in London.”

Recursion’s 6,700 square foot London office will be located at 3 Pancras Square, King’s Cross London. The building is part of a 67–acre redevelopment project in the heart of King’s Cross, with over 4.5 million square feet of office space. Located within a 3–minute walk from King’s Cross Station and St. Pancras International, the site offers excellent transit access. The building includes an onsite cafe, bicycle storage, showers, prayer room and mothers room. In line with Recursion’s commitment to sustainability, the building meets the requirements for an “Excellent” rating by BREEAM building standards and is linked to a site–wide district heating and cooling network that results in net–zero carbon emissions.

“The UK Government’s plan for attracting more inward investment into the UK is working. Recursion’s investment is yet another vote of confidence in the UK, our top talent and our amazing tech and life sciences industries,” said Investment Minister Lord Johnson. “I’m delighted Recursion has chosen London, and we’ll continue to do everything we can to ensure the UK remains the top choice for investments like this.”

Today, Recursion has over 500 employees with a near–equal mix of life scientists and technologists across sites in Salt Lake City, Toronto, Montréal, and the San Francisco Bay Area. Recursion’s new London office will serve as an extension of both Recursion and Valence Labs’ teams. To launch recruiting efforts for the new site, Recursion has opened multiple new roles across technology and biology functions with immediate plans to hire the first 20 people to be based out of the new London office. Recursion and Valence Labs will also host a TechBio Mixer tomorrow, March 12, at the location of its new site to celebrate the office and network with the TechBio community.

For more information on open positions and to apply, visit recursion.com/careers and valencelabs.com/careers.

About Recursion
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological, chemical and patient–centric datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology, chemistry and patient–centric data to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montreal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements
This document contains information that includes or is based upon “forward–looking statements'' within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the opening of the London office and timing of such opening; the recruitment efforts and number of roles at the London office; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “could,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K for the Fiscal Year Ended December 31, 2023. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

 


GLOBENEWSWIRE (Distribution ID 9060948)

Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.

“2023 was an inflection point for Entera, with consistent validation of our disruptive N–Tab™ oral peptide technology platform and the unveiling of our goal to advance five potential first–in–class oral peptide programs, Phase 1 through Phase 3, into the clinic by the end of 2025. Each of these programs has been carefully selected to align with our platform and our mission to develop treatments that stand to become the number one choice for patients requiring peptide therapies, in a simple and convenient tablet format. Each of these programs is expected to have important catalysts during 2024. Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In March 2023, a Type D meeting between Entera and the U.S. Food and Drug Administration (FDA) re–affirmed that a placebo–controlled phase 3 study design with Bone Mineral Density (BMD) and not fracture as primary endpoint could support a New Drug Application for EB613
  • In November 2023, Entera echoed the American Society for Bone and Mineral Research (ASBMR) announcement that the Strategy to Advance BMD as a Regulatory Endpoint (SABRE) team had submitted its final qualification plan to the FDA
  • At the Annual ASBMR Meeting in October 2023, Entera presented the differentiated pharmacokinetic profile of EB613, versus Forteo® PTH(1–34) 20 µg which requires a daily subcutaneous injection. EB613 consistently shows an increased Cmax and shorter duration of systemic exposure versus Forteo®. Furthermore, EB613’s brief “pulsatile” action appears to simultaneously stimulate both a dual bone formation and a mild anti–resorptive effect, as compared to Forteo®
  • During the fourth quarter of 2023, Entera submitted its Phase 2 manuscript for potential publication in a major medical journal related to its phase 2, 6–month, 161–patient, placebo–controlled study in post–menopausal women with low bone mass and osteoporosis which met primary and secondary endpoints

“We expect an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture in 2024. We view this as the final de–risking event from a regulatory standpoint to move EB613 to Phase 3. We believe EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative which is also the first biomarker to potentially be approved as part of the 2016 21st Century Cures Act. As the first potential oral tablet osteoanabolic treatment, EB613 holds the potential to address the treatment chasm in this severe, potentially lethal disease which remains significantly undertreated despite efficacious injectable treatments. Fracture rates continue to rise globally, and we have not seen any new drugs approved for osteoporosis since 2019 due to the ethical concerns and the costs of fracture endpoint studies. Our discussions with key clinicians and patient advocacy groups and other key stakeholders in this ecosystem indicate that an oral anabolic treatment is absolutely warranted and a potential ‘game changer’ for the estimated 200 million women with osteoporosis globally. We continue to hold strategic discussions related to EB613 and look forward to initiating our pivotal phase 3 study once the final qualification of the SABRE endpoint is announced by FDA,” said Miranda Toledano, CEO of Entera.

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is being developed as the first oral PTH(1–34) peptide replacement treatment for hypoparathyroidism. Entera is currently evaluating its hypoparathyroidism program with an improved formulation of EB612 using the naked PTH(1–34) peptide and new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing. Entera is also combining its N–Tab™ platform with an alternative PTH receptor agonist in a third party collaboration. Entera expects to submit data from the Phase 1 of its next generation EB612 program using the naked PTH(1–34) peptide in the first half of 2024.

First GLP–2 Peptide Tablets for Short Bowel Syndrome
Under a collaboration agreement with OPKO Health (“OPKO”), Entera is combining its N–Tab™ technology with a proprietary long–acting GLP–2 peptide for the development of the first potential daily oral GLP–2 for the treatment of short bowel syndrome and other GI disorders such as Crohn’s and Celiac disease for which GLP–2 has relevance. Entera published pre–clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide (Gattex®), the only approved GLP–2 treatment, as a convenient potential tablet alternative to daily injections. Pre–IND in vivo PK data for oral GLP–2 using OPKO’s long–acting analogue is expected in the first half of 2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Under a collaboration agreement with OPKO, Entera is combining its N–Tab™ technology with a proprietary long–acting Oxyntomodulin (OXM) peptide for the development of the first potential daily OXM treatment for obesity and other metabolic diseases. Previously, an injectable pegylated version of this OXM peptide demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in over 420 patients in phase 2/2B studies. Pre–IND in vivo PK data for oral OXM using OPKO’s long acting, modified analogue is expected in mid–2024.

EB613: First Oral PTH(1–34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera is collaborating with leading researchers in orthopedics and sports medicine to contribute its proprietary oral PTH(1–34) tablets for an investigator sponsored Phase 2 Study seeking to treat young women and men athletes that experience stress fractures as a result of intense sports training. More details on this study are expected in the second half of 2024.

Financial Results for the year Ended December 31, 2023

As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million. The Company believes that its existing cash resources will be sufficient to meet its projected operating requirements through the second quarter of 2025, which includes the capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 PK study related to our new generation platform and the GLP–2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the year ended December 31, 2023 were $4.5 million, as compared to $5.8 million for the year ended December 31, 2022. The decrease of $1.3 million was primarily due to a decrease of $1.5 million in pre–clinical activity and materials costs and a decrease of $0.6 million in employee compensation, including a one–time payment made to a former employee pursuant to the terms of his separation agreement. The decrease was partially offset by an increase of $0.8 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612.

General and administrative expenses for the year ended December 31, 2023 were $4.4 million, compared to $7.3 million for the year ended December 31, 2022. The decrease of $2.8 million was mainly attributable to a decrease of $1.1 million in employee compensation, including a one–time payment to our former employee pursuant to the terms of his separation agreement, a decrease of $0.8 million as part of a restructuring of professional fees and other advisor expenses, a decrease in Board fees of $0.2 million due to the Board’s forfeiture of their fees for the third and fourth quarters of 2023 and a decrease of $0.7 million in D&O insurance costs.

Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

Net loss was $8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023, as compared to $13.1 million, or $0.45 per ordinary share (basic and diluted), for the year ended December 31, 2022.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur in 2024. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward–Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  December 31   December 31
  2023   2022
  (Unaudited)   (Audited)
   
Cash and cash equivalents 11,019   12,309
Accounts receivable and other current assets 238   540
Property and equipment, net 100   139
Other assets, net 408   139
Total assets 11,765   13,127
     
     
Accounts payable and other current liabilities 1,091   1,341
Total non–current liabilities 288   32
Total liabilities 1,379   1,373
Total shareholders' equity 10,386   11,754
Total liabilities and shareholders' equity 11,765   13,127

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
  Year Ended
December 31,
  2023   2022
       
REVENUES –   134
COST OF REVENUES –   101
GROSS PROFIT –   33
OPERATING EXPENSES:      
Research and development 4,510   5,848
General and administrative 4,430   7,253
Other income (49)   (51)
TOTAL OPERATING EXPENSES 8,891   13,050
OPERATING LOSS 8,891   13,017
FINANCIAL INCOME, NET (31)   (83)
LOSS BEFORE INCOME TAX 8,860   12,934
INCOME TAX EXPENSES 29   137
NET LOSS 8,889   13,071
       
BASIC AND DILUTED LOSS PER SHARE 0.31   0.45
WEIGHTED AVERAGE NUMBER OF SHARES      
OUTSTANDING USED IN COMPUTATION OF 29,007,794   28,808,090
BASIC AND DILUTED LOSS PER SHARE      


GLOBENEWSWIRE (Distribution ID 9060543)

Zenas BioPharma beruft Patricia Allen in den Verwaltungsrat

WALTHAM, Massachusetts, March 07, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, ein weltweit tätiges Biopharmazieunternehmen, dessen Ziel eine führende Rolle in der Entwicklung und Kommerzialisierung von Entzündungs– und Immunologietherapien ist, gab heute die Ernennung von Patricia Allen in den Verwaltungsrat des Unternehmens bekannt, in dem sie auch als Vorsitzende des Prüfungsausschusses fungieren wird. Frau Allen wird sich mit mehr als 20 Jahren Erfahrung in den Bereichen Finanzen, Anlegerbeziehungen, Geschäftsentwicklung, Personalwesen, Betrieb und IT in globalen börsennotierten und privaten Biotechnologieunternehmen in den Verwaltungsrat von Zenas einbringen.

„Wir freuen uns, Frau Allen in unserem Verwaltungsrat begrüßen zu dürfen“, so Lonnie Moulder, Gründer und Verwaltungsratsvorsitzender von Zenas BioPharma. „Sie hat erfolgreich organisationsübergreifende Funktionen geleitet und war im Verwaltungsrat von privaten und börsennotierten globalen Biotechnologieunternehmen tätig. Wir freuen uns auf Frau Allens Beitrag zur nächsten Wachstumsphase von Zenas, während wir unsere Mission vorantreiben, transformative immunologische Therapien für Patienten zu entwickeln und zu vermarkten, die diese dringend benötigen.“

„Ich freue mich auf die Zusammenarbeit mit dem erfahrenen Team von Zenas und dem Verwaltungsrat, die durch disziplinierte Umsetzung der Pipeline und Geschäftsentwicklung ein führendes, auf Entzündungen und Immunologie fokussiertes globales Biopharmazieunternehmen aufbauen“, so Frau Allen. „Dies ist eine aufregende Zeit für Zenas, da das Unternehmen aktuell versucht, mehrere Programme in der Klinik voranzutreiben, um letztendlich das Leben von Menschen mit Autoimmunkrankheiten zu verbessern.“

Frau Allen war zuletzt als Chief Financial Officer bei Vividion Therapeutics tätig, wo sie kürzlich ausschied. Während ihrer Zeit bei Vividion leitete sie das Fundraising und die Übernahme des Unternehmens durch die Bayer AG mit, während das Unternehmen wuchs und mehrere Programme in Richtung Klinik vorantrieb. Derzeit ist sie Mitglied des Verwaltungsrats und Vorsitzende des Prüfungsausschusses von Deciphera Pharmaceuticals, SwanBio Therapeutics und Anokion. Darüber hinaus war sie in der Vergangenheit Mitglied des Verwaltungsrats und Vorsitzende des Prüfungsausschusses von Inversago Pharma und Yumanity Therapeutics.

Vor ihrer Tätigkeit bei Vividion hielt Frau Allen die Position des Chief Financial Officer bei Zafgen, Inc. (jetzt Larimer Therapeutics) inne. Zuvor war sie Vice President of Finance and Treasurer, Principal Financial Officer bei Alnylam Pharmaceuticals, Inc. sowie Director of Finance bei Alkermes, Inc. und Wirtschaftsprüferin bei Deloitte & Touche, LLP. Sie besitzt einen B.S.–Abschluss in Betriebswirtschaft vom Bryant College.

Über Zenas BioPharma

Zenas BioPharma ist ein weltweit tätiges Biopharmazieunternehmen, das sich zum Ziel gesetzt hat, ein führendes Unternehmen in der Entwicklung und Vermarktung von entzündungs– und immunologieorientierten Therapien für dringend darauf angewiesene Patienten in aller Welt zu werden. Zenas verfügt über klinische Entwicklungskapazitäten und ist weltweit tätig, um ein Portfolio potenziell differenzierter Autoimmuntherapeutika in Bereichen mit hohem medizinischen Bedarf zu entwickeln. Wir nutzen die Erfahrung und die Fähigkeiten unseres Führungsteams und unsere etablierten Netzwerke in der Biopharmaziebranche, um Therapien zu entwickeln, die das Leben von Menschen mit Autoimmunerkrankungen und seltenen Krankheiten verbessern können. Für weitere Informationen über Zenas BioPharma besuchen Sie bitte www.zenasbio.com und folgen Sie uns auf X (früher Twitter) unter @ZenasBioPharma sowie LinkedIn.

Anleger– und Medienkontakt:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9059519)

Zenas BioPharma Nomeia Patricia Allen para o Conselho Diretor

WALTHAM, Mass., March 06, 2024 (GLOBE NEWSWIRE) — A Zenas BioPharma, uma empresa biofarmacêutica global comprometida em se tornar líder no desenvolvimento e comercialização de terapias voltadas para inflamações e imunologia, divulgou hoje a nomeação de Patricia Allen para o Conselho Diretor, onde atuará também como Presidente do Comitê de Auditoria. A Sra. Allen ingressa no Conselho Diretor da Zenas com mais de 20 anos de experiência liderando finanças, relações com investidores, desenvolvimento de negócios, recursos humanos, operações e TI em empresas globais públicas e privadas de biotecnologia.

“Estamos muito contentes com a vinda de Patty para o nosso Conselho Diretor”, disse Lonnie Moulder, Fundador e Diretor Executivo da Zenas BioPharma. “Ela liderou com sucesso funções interorganizacionais e atuou no conselho diretor de empresas privadas e públicas de biotecnologia global. Estamos prontos para as contribuições de Patty para a próxima fase do crescimento da Zenas, à medida que avançamos na nossa missão de desenvolver e comercializar terapias transformadoras baseadas em imunologia para pacientes necessitados.”

“Estou pronta para colaborar com a experiente equipe da Zenas e o Conselho Diretor, que estão ampliando uma empresa biofarmacêutica global líder em inflamação e imunologia por meio da execução disciplinada de pipeline e desenvolvimento de negócios”, disse a Sra. Allen. “A Zenas está muito empolgada com o progresso dos seus múltiplos programas clínicos que irão aprimorar as vidas das pessoas que sofrem de doenças autoimunes.”

Recentemente, a Sra. Allen atuou como Diretora Financeira da Vividion Therapeutics, de onde se aposentou recentemente. Na Vividion, ela co liderou a captação de recursos e a aquisição da empresa pela Bayer AG, durante o crescimento e avanço da empresa com vários programas em direção à clínica. Ela atua no conselho diretor e como presidente do comitê de auditoria da Deciphera Pharmaceuticals, SwanBio Therapeutics e Anokion, além de ser ex–membro do conselho e presidente do comitê de auditoria da Inversago Pharma e Yumanity Therapeutics.

Antes de ingressar na Zenas, a Sra. Allen atuou como Diretora Financeira da Zafgen, Inc. (atual Larimer Therapeutics). Anteriormente, ela foi Vice–Presidente de Finanças e Tesoureira, Diretora Financeira Principal da Alnylam Pharmaceuticals, Inc.; Diretora de Finanças da Alkermes, Inc.; e Auditora da Deloitte & Touche, LLP. Ela é formada em Administração de Empresas pelo Bryant College.

Sobre a Zenas BioPharma

A Zenas BioPharma é uma empresa biofarmacêutica mundial comprometida em se tornar líder global no desenvolvimento e comercialização de terapias voltadas para inflamações e imunologia para pacientes necessitados em todo o mundo. Com desenvolvimento clínico e operações globais, a Zenas está avançando um portfólio de terapêuticas autoimunes potencialmente diferenciadas em áreas de alta necessidade médica. Aproveitamos a experiência e a capacidade da nossa equipe de gestão executiva a das nossas existentes na indústria biofarmacêutica em busca do desenvolvimento de terapias que possam melhorar as vidas das pessoas com doenças autoimunes e raras. Para mais informação sobre a Zenas BioPharma, visite www.zenasbio.com e siga–nos no (ex Twitter ) em @ZenasBioPharma e LinkedIn.

Contato com Investidores e com a Mídia:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9059519)

Patricia Allen rejoint le Conseil d’administration de Zenas BioPharma

WALTHAM, Massachusetts, 07 mars 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, un laboratoire biopharmaceutique d’envergure mondiale déterminé à rejoindre les leaders du développement et de la commercialisation de thérapies orientées sur l’inflammation et l’immunologie, annonce la nomination de Patricia Allen à son Conseil d’administration et à la Présidence de son comité d’audit. Mme Allen rejoint le Conseil d’administration de Zenas après avoir dirigé pendant plus de 20 ans différentes divisions pour le compte de sociétés biotechnologiques internationales publiques et privées, notamment les départements des finances, relations avec les investisseurs, développement commercial, ressources humaines, opérations et informatique.

À propos de cette nomination, Lonnie Moulder, fondateur et PDG de Zenas BioPharma a déclaré : « Nous sommes ravis d’accueillir Patty au sein de notre Conseil d’administration. Elle a piloté avec succès des divisions transverses pour différentes entreprises, et a siégé au Conseil d’administration de sociétés biotechnologiques d’envergure mondiale des secteurs public et privé. Nous attendons avec impatience sa participation à la prochaine phase de croissance de Zenas, à l’heure où notre mission visant à développer et distribuer des immunothérapies modératrices du changement pour les patients qui en ont besoin prend de l’ampleur. ».

« J’ai hâte de travailler avec le concours des équipes expérimentées de Zenas et son Conseil d’administration, qui bâtissent ensemble une société biopharmaceutique internationale de premier plan axée sur des stratégies thérapeutiques orientées sur l’inflammation et l’immunologie au prix d’une exécution rigoureuse de leur pipeline et du développement commercial » observe Mme Allen, avant de poursuivre : « Le laboratoire Zenas traverse une période exaltante à l’heure où il s’efforce d’atteindre la phase clinique pour plusieurs de ses programmes dans l’objectif d’améliorer la vie des patients atteints de maladies auto–immunes ».

Actuellement retraitée, Mme Allen occupait encore très récemment la Direction des affaires financières de Vividion Therapeutics, dont elle a codirigé la levée de fonds et l’acquisition de Bayer AG, au moment où la société était en pleine croissance et faisait progresser plusieurs de ses programmes vers la phase clinique. Elle figure actuellement parmi les membres du Conseil d’administration de Deciphera Pharmaceuticals, SwanBio Therapeutics et Anokion, dont elle préside les comités d’audit, après avoir siégé aux Conseils d’administration des sociétés Inversago Pharma et Yumanity Therapeutics et en avoir également présidé les comités d’audit.

Avant son passage chez Vividion, Mme Allen pilotait la Direction financière de Zafgen, Inc., aujourd’hui Larimer Therapeutics. Avant cela, elle était vice–présidente des affaires financières, ainsi que trésorière et responsable financière principale chez Alnylam Pharmaceuticals, Inc., directrice des finances chez Alkermes, Inc., et auditrice chez Deloitte & Touche, LLP. Elle est titulaire d’une licence en gestion d’entreprises sanctionné par l’université privée américaine Bryant.

À propos de Zenas BioPharma

Zenas BioPharma est un laboratoire biopharmaceutique d’envergure mondiale déterminé à rejoindre les leaders du développement et de la commercialisation de thérapies orientées sur l’inflammation et l’immunologie pour répondre aux besoins des patients concernés partout dans le monde. À l’appui de ses capacités de développement et de ses installations de recherche clinique implantées aux quatre coins de la planète, Zenas fait progresser un ensemble de thérapies potentiellement différenciatrices ciblées sur les maladies auto–immunes dans des domaines thérapeutiques où les besoins médicaux restent insatisfaits. Son équipe de direction chevronnée et son réseau de partenaires commerciaux stimulent l’excellence opérationnelle visant à concevoir des traitements potentiellement révolutionnaires aux fins d’améliorer la qualité de vie des patients atteints de maladies auto–immunes rares. Pour en savoir plus sur Zenas BioPharma, rendez–vous sur www.zenasbio.com et suivez–nous sur X (anciennement Twitter) @ZenasBioPharma et LinkedIn.

Relations auprès des investisseurs et des médias :
Agence Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9059519)

Zenas BioPharma Appoints Patricia Allen to its Board of Directors

WALTHAM, Mass., March 06, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of inflammation and immunology–directed therapies, today announced the appointment of Patricia Allen to its Board of Directors, on which she also will serve as Chairperson of the Audit Committee. Ms. Allen joins the Zenas Board of Directors with over 20 years of experience leading finance, investor relations, business development, human resources, operations and IT at global public and private biotechnology companies.

“We are pleased to welcome Patty to our Board of Directors,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas BioPharma. “She has successfully led cross–organizational functions and served on the board of directors of both private and public global biotechnology companies. We look forward to Patty’s contributions to the next phase of Zenas’ growth as we advance our mission to develop and commercialize transformative immunology–based therapies for patients in need.”

“I look forward to collaborating with the experienced Zenas team and Board of Directors, who are building a leading of inflammation and immunology–focused global biopharmaceutical company through disciplined pipeline execution and business development,” said Ms. Allen. “This is an exciting time for Zenas as they seek to progress multiple programs through the clinic to ultimately improve the lives of those living with autoimmune diseases.”

Ms. Allen most recently served as the Chief Financial Officer at Vividion Therapeutics, from where she recently retired. While at Vividion, she co–led led fundraising and the company’s acquisition by Bayer AG, as the company grew and advanced multiple programs towards the clinic. She currently serves on the board of directors and as chair of the audit committee of Deciphera Pharmaceuticals, SwanBio Therapeutics and Anokion, in addition to holding past board member and audit committee chair roles at Inversago Pharma and Yumanity Therapeutics.

Prior to Vividion, Ms. Allen was the Chief Financial Officer at Zafgen, Inc. (now Larimer Therapeutics). Earlier, she was Vice President of Finance and Treasurer, Principal Financial Officer of Alnylam Pharmaceuticals, Inc.; Director of Finance at Alkermes, Inc.; and Auditor at Deloitte & Touche, LLP. She received a B.S. in Business Administration from Bryant College.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of inflammation and immunology–directed therapies for patients in need around the world. With clinical development capabilities and operations globally, Zenas is advancing a portfolio of potentially differentiated autoimmune therapeutics in areas of high unmet medical need. We leverage the experience and capabilities of our executive management team and our established networks throughout the biopharmaceutical industry as we seek to develop therapies that can improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on X (formerly Twitter) at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9058707)

Curia nomme Steve Lavezoli vice-président de sa division Produits biologiques

ALBANY, New York, 23 févr. 2024 (GLOBE NEWSWIRE) — Curia, l’un des principaux organismes de recherche, de développement et de fabrication sous contrat, a annoncé aujourd’hui la nomination de Steve Lavezoli au poste de vice–président des produits biologiques à compter du 26 février. M. Lavezoli dirigera la division des produits biologiques de Curia, dont il supervisera les services de découverte, de développement et de fabrication.

« C’est une période passionnante pour notre équipe en charge des produits biologiques, et nous sommes ravis que Steve rejoigne nos rangs », a déclaré Philip Macnabb, PDG de Curia. « L’expérience remarquable de Steve à la direction des opérations commerciales pour le développement et la fabrication de produits biologiques fait de lui un candidat naturel pour piloter nos initiatives dans le domaine des produits biologiques. Sous sa direction, je suis persuadé que nous poursuivrons notre mission dévolue aux sciences de la vie qui changent la vie. »

M. Lavezoli a récemment travaillé pour Scorpius Biologics, une start–up CDMO (organisation de développement et de fabrication sous contrat de médicaments) spécialisée dans le développement et la fabrication de produits biologiques microbiens et mammifères, en tant que vice–président des opérations commerciales. Avant de rejoindre Scorpius, il a passé quatre années chez Catalent Biologics, où il a concentré ses efforts sur le développement commercial des substances médicamenteuses aux États–Unis pour les programmes cliniques en phase initiale, puis sur l’intégration des programmes commerciaux en phase finale. Il a également passé 12 ans dans l’industrie des gaz industriels au sein de Linde Gas avant de rejoindre W.L. Goren, au sein de sa division biopharmaceutique en démarrage à un poste de développement des affaires commerciales et du marché des substances médicamenteuses en vrac à usage unique. Il est titulaire d’une licence en génie chimique de l’université d’État de Pennsylvanie.

« Curia occupe une position unique dans le secteur des CDMO, avec une offre de bout en bout impressionnante », a déclaré M. Lavezoli. « C’est un honneur de rejoindre une équipe dotée d’une expertise scientifique aussi approfondie et d’une volonté aussi forte d’avoir un impact positif sur la vie des patients. »

Pour en savoir plus sur les offres de produits biologiques de Curia, cliquez ici : https://curiaglobal.com/biologics/

À propos de Curia
Curia est une organisation de développement et de fabrication sous contrat (« CDMO ») avec plus de 30 ans d’expérience, un réseau intégré de 27 sites dans le monde et plus de 3 500 collaborateurs travaillant en partenariat avec les clients biopharmaceutiques pour mettre sur le marché des thérapies qui changent la vie. Notre offre de produits biologiques et de petites molécules couvre le cycle complet de la découverte jusqu’à la commercialisation, avec des capacités réglementaires et analytiques intégrées. Nos scientifiques, nos experts en processus et nos installations de pointe apportent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous exécutons toutes les étapes pour améliorer la vie des patients. Consultez notre site à l’adresse www.curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
corporatecommunications@CuriaGlobal.com

Une photo accompagnant ce communiqué de presse est disponible à l’adresse suivante : https://www.globenewswire.com/NewsRoom/AttachmentNg/f9784607–495c–40d3–9e39–b65c8147d1c5


GLOBENEWSWIRE (Distribution ID 9042529)

Curia Nomeia Steve como Vice-Presidente, Divisão Biológica

ALBANY, N.Y., Feb. 23, 2024 (GLOBE NEWSWIRE) — A Curia, uma organização líder em pesquisa, desenvolvimento e fabricação por contrato, anunciou hoje a nomeação de Steve Lavezoli como vice–presidente da divisão biológica a vigorar a partir de 26 de fevereiro. Lavezoli liderará a divisão de produtos biológicos da Curia, supervisionando seus serviços de descoberta, desenvolvimento e fabricação.

“Este é um momento emocionante para a nossa equipe de produtos biológicos, e temos muito prazer em ter Steve a bordo”, disse o CEO da Curia, Philip Macnabb. “A vasta experiência de Steve com liderança de operações comerciais para desenvolvimento e fabricação de produtos biológicos o torna perfeito para liderar nossos esforços de produtos biológicos. Sob sua orientação, estou certo de que promoveremos nossa missão de mudar a vida das ciências da vida.”

Lavezoli trabalhou recentemente na Scorpius Biologics, uma startup de CDMO focada no desenvolvimento e fabricação de produtos biológicos microbianos e de mamíferos como vice–presidente de operações comerciais. Antes de ingressar na Scorpius, ele passou quatro anos na Catalent Biologics, focado no desenvolvimento de negócios de medicamentos nos EUA para programas clínicos em estágio inicial e, posteriormente, focado na integração de programas comerciais em estágio avançado. Ele também passou 12 anos na indústria de gases industriais na Linde Gas antes de ingressar na W.L. Gore na nova divisão biofarmacêutica para ocupar a função de desenvolvimento comercial/de mercado em itens de uso único de medicamentos a granel. Ele fez bacharelado em engenharia química na Pennsylvania State University.

“A Curia ocupa uma posição única na indústria de CDMO com uma impressionante oferta integral”, disse Lavezoli. “É uma honra fazer parte de uma equipe com um conhecimento científico tão profundo e um propósito orientado por valores para gerar um impacto positivo na vida dos pacientes.”

Saiba mais sobre as ofertas de produtos biológicos da Curia aqui: https://curiaglobal.com/biologics/

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de 27 locais em todo o mundo e mais de 3.500 funcionários em parcerias com clientes biofarmacêuticos para lançar no mercado terapias que mudam a vida. Nossas ofertas de produtos biológicos e moléculas pequenas abrangem a descoberta através da comercialização, com capacidades regulatórias e analíticas integradas. Nossos especialistas científicos e de processos, e instalações de última geração oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas para a melhoria da vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 518 512 2111
corporatecommunications@CuriaGlobal.com

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GLOBENEWSWIRE (Distribution ID 9042529)