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Press Release

GILEAD SCIENCES TO ACQUIRE MIROBIO

Acquisition Provides Gilead with MiroBio’s Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform

MiroBio’s Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead’s Inflammation Research and Development Strategy

Foster City, Calif. and Oxford, U.K., August 4, 2022 – Gilead Sciences, Inc. (Nasdaq: GILD) and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.

The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.

“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”

“We are excited to be joining Gilead,” said Eliot Charles, Chairman of MiroBio. “MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”

Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Cowen is acting as financial advisor to Gilead. Centerview Partners is acting as financial advisor to MiroBio. Davis Polk & Wardwell LLP, Mayer Brown LLP, and Mishcon de Reya LLP are serving as legal counsel to Gilead and Goodwin Procter LLP and Wilson Sonsini Goodrich & Rosati are serving as legal counsel to MiroBio.

About MiroBio

MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.

For more information on MiroBio, please visit the company website: https://www.mirobio.com/

About Gilead Sciences

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

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the transaction; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio’s product pipeline and successfully commercialize MiroBio’s products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead Contacts:

Jacquie Ross, Investors
investor_relations@gilead.com

Hayley Home, Media
Hayley.Home@gilead.com

MiroBio Contact:

Tom Donovan, Media
tom@tenbridgecommunications.com

Press Release

MiroBio Raises $97 Million Series B Financing to Develop Checkpoint Agonists for Treatment of Autoimmune Diseases

• Financing led by Medicxi with significant participation from new and existing shareholders
• Lead program MB272 targeting checkpoint receptor BTLA, entering Phase I clinical trials
• Funds will be used to advance pipeline of immune checkpoint agonists into clinical trials in autoimmune diseases

OXFORD, United Kingdom, June 29 2022 – MiroBio (the “Company”), a leader in the development of checkpoint agonists to treat autoimmune diseases, today announces the completion of a US$97million (£80 million) Series B financing led by Medicxi with participation from new investors, OrbiMed and Monograph Capital and existing Series A investors, Oxford Science Enterprises, Samsara BioCapital, SR One and Advent Life Sciences.

Funds will primarily be used to advance MiroBio’s two lead antibody candidates into clinical trials and obtain safety and efficacy data in patients with autoimmune diseases. MB272 and MB151 are differentiated, precision-engineered checkpoint receptor agonists for BTLA (B- and T-Lymphocyte Attenuator) & PD-1 (Programmed cell Death protein 1) respectively, offering transformative therapeutic potential for patients. Proceeds will also be used to advance MiroBio’s pre-clinical pipeline and further develop the Company’s proprietary I-ReSToRE discovery platform. Following the fundraising Nick Williams of Medicxi and Erez Chimovits of OrbiMed will join MiroBio’s Board of Directors.

Eliot Charles, Chairman of MiroBio, said: “We are pleased to have such strong support from our new and existing investors. The addition of Medicxi, Orbimed and Monograph to our syndicate further consolidates our transatlantic investor base and board.  As our lead asset, MB272 enters the clinic, this investor base provides us with the resources to demonstrate the unique potential of our checkpoint agonists as a new and exciting class of therapies for autoimmune patients. Beyond MB272, Miro is leveraging its I-ReSToRE platform to advance our pipeline programs towards the clinic and help realize our vision of restoring immune homeostasis in patients with autoimmune diseases”

MiroBio created the I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) to develop best- and first-in-class medicines to treat autoimmune diseases. This unique platform combines the proprietary Checkpoint Atlas™ of receptor expression and function, sophisticated antibody discovery processes and advanced bioinformatics enabling a precision medicine approach to autoimmune disease.  I-ReSToRE supports identification and therapeutic application of checkpoint receptor agonists to restore immune homeostasis for patients.

Nick Williams, Partner at Medicxi, commented: “We are excited to be working with MiroBio to bring a new class of agents to patients. Despite recent advances, significant clinical unmet need remains in autoimmune disease. By restoring immune homeostasis, checkpoint agonists have the potential to provide novel and differentiated treatments to these patients. We’ve been deeply impressed by Miro’s best-in-class discovery engine and look forward to supporting the company as it transitions into the clinic.”

-Ends-

About MiroBio

MiroBio is a private biotechnology company formed out of Oxford University and backed by a strong group of international investors: Medicxi, OrbiMed, Oxford Science Enterprises, Samsara BioCapital, SR One, Advent Life Sciences and Monograph.

The Company is entering clinical stage development with a new class of checkpoint agonist antibodies to restore immune balance. MiroBio has developed I-ReSToRE, a proprietary discovery platform including the Checkpoint Atlas™ to generate multiple checkpoint agonist candidates for the treatment of autoimmune diseases.

The platform combines cutting-edge receptor mapping with epitope and antibody engineering. It is the product of more than 15 years’ foundational research from Oxford University into identifying and triggering checkpoint receptors to deliver safe, efficacious medicines to restore immune homeostasis.

Visit our website for more information: https://www.mirobio.com/

For more information please contact:

Consilium Strategic Communications

Mary-Jane Elliott / Jessica Hodgson / Stella Lempidaki

Tel: +44 (0) 20 3709 5700

MiroBio@consilium-comms.com

Press Release

MiroBio Continues Expansion of Executive Leadership Team with Key Appointments to Advance Development of Checkpoint Agonist Antibodies for Autoimmune Disease

• Sanjay Keswani, MBBS, FRCP to join company as Chief Medical Officer bringing extensive experience in drug development and life sciences leadership
• Lynne Murray, Ph.D., MBA appointed as Chief Scientific Officer after leading MiroBio’s R&D efforts since October 2020
• Enhanced leadership team will support the clinical development of lead assets MB272 and MB151 and advance pipeline of checkpoint agonist antibodies designed to treat autoimmune disease 

OXFORD, United Kingdom, March 8, 2022 – MiroBio, a biotechnology company advancing checkpoint agonist therapies to restore immune balance, today announced two key additions to its leadership team. Sanjay Keswani, MBBS has joined the company as Chief Medical Officer to lead clinical development activities and strategy, and Lynne Murray, Ph.D., MBA will assume the role of Chief Scientific Officer directing the advancement of MiroBio’s discovery platform.

“We are thrilled to have Sanjay and Lynne join MiroBio’s executive leadership team as we advance a potentially transformative therapeutic approach for patients suffering from autoimmune diseases,” said Dr. Carolin Barth, M.D., CEO of MiroBio. “MiroBio’s inhibitory receptor agonist approach represents a promising new mode of action for treating these complex diseases. With our enhanced leadership team, we look forward to moving our therapies into the clinic and delivering our ultimate goal of providing durable remission to patients with autoimmune diseases.”

Dr. Sanjay Keswani is an accomplished physician-scientist with broad R&D expertise in multiple therapeutic areas and is a former neurology faculty member at the Johns Hopkins Hospital as well as an elected Fellow of the Royal College of Physicians, United Kingdom. Dr. Keswani has held senior executive positions in the pharmaceutical industry, including at Roche, where he was Senior Vice President and Global Head of Neuroscience, Ophthalmology and Rare Diseases Research and Early Development, and most recently Annexon Biosciences, where he served as Executive Vice President and Chief Medical Officer. He has been instrumental in the development of multiple approved medicines, including Cymbalta, Aimovig, Emgality, Risdiplam and Faricimab. Dr. Keswani graduated in medicine at St. Bartholomew’s Hospital and holds a First-class Honors degree from St. Mary’s Hospital, London in molecular immunology. He completed his residency in neurology at Johns Hopkins, where he also ran a R01-funded neuroimmunology research lab.

Dr. Murray has served as Senior Vice President of Research and Development for MiroBio since October 2020 and brings substantial experience in the discovery and development of pharmaceuticals from preclinical to Phase 2 in both large pharmaceutical and small biotech environments. Prior to joining MiroBio she served as Head of Regeneration at AstraZeneca’s early respiratory & immunology department. Over her tenure, she led multiple large and small molecule programs and gained significant business development experience in the partnering & strategy department at AZ. Before this, she was Director of Pharmacology at a U.S.-based biotech, Promedior and also held a research position at Janssen, Philadelphia after her postdoc at UCLA. Dr. Murray received her MBA from Judge Business School of the University of Cambridge and holds a Ph.D. in immunology and pathology from Imperial College London. She is an author of numerous publications and patents.

Miro Bio’s pipeline is built on 15 years of foundational research and focuses on targets with the greatest potential in autoimmunity. The company’s lead program, MB272, targets the immune receptor BTLA and will undergo clinical research in 2022. MiroBio’s PD-1 agonist program, MB151, is progressing in preclinical development with clinical plans being developed for 2023.

About Checkpoint Agonist Antibodies

MiroBio is creating a new class of therapies for autoimmune disease: Checkpoint agonist antibodies. These therapies are designed to precisely restore a balanced immune response and prevent the body from attacking its own cells. Checkpoint pathways are powerful regulators of immune cell function. Each has its own role in specific types of immune cells and differing activity in disease. By selectively activating, or agonizing, the appropriate checkpoint receptor, MiroBio’s therapies can deliver a highly potent inhibitory signal to overactive immune cells without being broadly immunosuppressive.

About MiroBio (www.mirobio.com)

MiroBio is a biotechnology company advancing a new class of precision therapies designed to address the immune imbalance that drives autoimmune disease. Its proprietary drug discovery platform, I-ReSToRE, comprehensively evaluates inhibitory receptors for therapeutic potential and designs checkpoint agonist antibody candidates that precisely modulate immune signalling to restore health. MiroBio’s pipeline includes several candidates against validated and novel targets with potential in a variety of autoimmune diseases. MiroBio is based in Oxford, U.K.

For more information about MiroBio contact:

Ten Bridge Communications

TBCMiroBio@tenbridgecommunications.com

Press Release

MiroBio launches with £27m ($34m) Series A from leading life sciences investors

Oxford start-up developing novel therapeutics based on deep expertise in immune cell regulation

Oxford, UK, October 7 2019 – MiroBio, a novel therapeutics company based on insights into the regulation of receptor signalling in immune cells, has raised £27m ($34m) from a syndicate of international specialist life sciences investors. Oxford Sciences Innovation and Samsara Biocapital co-led the round and have been joined by Advent Life Sciences and SR One. Proceeds from the Series A fundraising will allow the company to advance its lead programmes, strengthen its proprietary platform, expand its discovery efforts, and build out its management team for the next phase of growth. In conjunction with the financing, Srini Akkaraju MD/PhD, Managing General Partner of Samsara Biocapital, Deborah Harland PhD, Partner of SROne, Andrew Mclean MD, Principal of OSI and Shahzad Malik MD, General Partner of Advent Life Sciences, will join the Board of Directors.

MiroBio’s unique platform has its foundations in research and technology from the laboratories of Simon Davis, Professor of Molecular Immunology at the MRC Weatherall Institute of Molecular Medicine, and Richard Cornall, Nuffield Professor of Clinical Medicine at the University of Oxford. The company is developing proprietary antibodies and variants to stimulate specific immune cell signals, allowing MiroBio to harness the natural control mechanisms of the immune system for therapeutic benefit across a range of diseases. Initially, MiroBio will focus on applications in auto-immune disease, and is exploring other applications opportunistically.

Dr Srini Akkaraju, Samsara Biocapital, said, “MiroBio has an innovative approach to regulating immune cell activity. By combining this understanding of receptor signalling with detailed knowledge of disease biology and expertise in drug development, we are building a compelling company which has the potential to create meaningful new medicines in a variety of therapeutic indications.”

“MiroBio has a robust technology and the ambition to bring new medicines to patients in need of improved therapies,” said Dr Eliot Charles, Executive Chairman of MiroBio and Venture Partner at SROne. “To help realize this goal, we have assembled a strong syndicate of leading healthcare investors who have a solid track record of creating successful biotech companies and backing world leading teams like the one we have started to build.”

Professor Simon Davis, University of Oxford, said, “We have been studying key aspects of signalling through immune cell receptors for over 15 years. Working collaboratively with MiroBio and its investors, we now have the opportunity to translate our insights, ideas and technologies into important new medicines that could significantly improve patients’ lives.”

For further information please contact:

MiroBio
Dr Eliot Charles, Executive Chairman
comms@mirobio.com

About MiroBio
MiroBio was established as a spin-out from the University of Oxford in 2019. It is developing antibody modulators of immune cell receptors, an approach that has potential across a range of diseases, with an initial focus on auto-immune disease. Its platform is based on the work of its founding scientists, Simon Davis, Professor of Molecular Immunology, MRC Weatherall Institute of Molecular Medicine, and Richard Cornall, Nuffield Professor of Clinical Medicine at the University of Oxford. Their understanding of how immune receptor signalling takes place at the cell surface has generated a platform of IP and technologies which is being exploited by MiroBio. The company has assembled a team of drug discovery and development experts and is based at the BioEscalator on the University of Oxford’s Old Road clinical campus. It recently raised £27m from an international syndicate of life sciences investors including Advent Life Sciences, Oxford Sciences Innovation, Samsara Biocapital and SR One. For more information please go to www.mirobio.com.