San Diego, Calif., July 13, 2021 – Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and Macrophage cellular immunotherapies, today announced the appointments of Boyan Litchev, M.D. as Senior Vice President and Head of Global Clinical Development, Steven Neben, Ph.D. as Vice President, Alliance and Project Management, and Bjorn Dahle as Vice President, Smart Manufacturing.

“We are thrilled to welcome such quality individuals to the growing team of senior leaders at this pivotal time in Shoreline’s development,” said Kleanthis G. Xanthopoulos, Ph.D., Chairman and CEO.  “Boyan, Steve and Bjorn bring a wealth of diverse expertise to Shoreline that will benefit us greatly as we advance our cell therapy candidates toward the clinic.” 

New Management Team Bios

Boyan Litchev, MD brings to the company more than two decades of global experience in the pharmaceutical and biotechnology industry, with significant experience in the development of CAR-T, nucleotides (RNA), peptides, small molecules and gene therapies for various diseases.

Dr. Litchev joins Shoreline from Poseida Therapeutics, where he was Head of Clinical Development Oncology and was responsible for leading the company’s CAR-T programs in solid tumors.  Before that, he was Executive Medical Director, Head of Clinical Development Oncology for Halozyme Therapeutics, and Executive Medical Director, RNA-targeted therapies Clinical Development for Akcea Therapeutics, a wholly owned subsidiary of Ionis.  Prior to Akcea, Dr. Litchev worked at Takeda (formerly Shire) where he led clinical development programs in gene therapy and hematology. Dr. Litchev previously held roles of increasing responsibility at Ferring Pharmaceuticals, Syneos Health (INC research), IQVIA (Quintiles) and University of California San Diego. Dr. Litchev is a board-certified physician in Obstetrics and Gynecology. Dr. Litchev received his MD degree from Medical University Plovdiv. Prior to joining the pharmaceutical industry, he has treated patients and conducted clinical research.

Steven Neben, PhD has more than two decades of experience in project and alliance management in the biopharmaceutical industry at both small and large companies.  Prior to joining Shoreline, Dr. Neben served as Executive Director, Project and Alliance Management for Regulus Therapeutics where he was responsible for the management of drug discovery and development partnerships with pharmaceutical partners and management of the research stage project portfolio of RNA therapeutic programs.  Prior to Regulus, Dr. Neben was Senior Director, Project and Alliance Management at AnaptysBio, Director, Project and Alliance Management at Xoma and principal scientist at Bayer Pharmaceuticals.  Dr. Neben holds a BA and PhD from the University of California, Berkeley.

Bjorn Dahle, MBA has extensive experience in various industries in advancing products through manufacturing to sales and marketing.  Prior to joining Shoreline, Mr. Dahle was Co-founder and CEO of Inspire Solutions LLC, CEO of VersaCall Technologies and President of KIC, a technology company.  Prior to that, he held key executive, global roles at St. Bernardo Software and MPM.  Mr. Dahle holds an MBA in marketing from San Diego State University and a bachelor’s degree in mechanical engineering from Norwegian University of Science and Technology.

About Shoreline’s iPSC NK cell and Macrophage Technology Platform

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shoreline’s approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner.

About Shoreline Biosciences

 Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer, inflammatory and genetic diseases that overcome the current limitations of first-generation cell therapy products.  We are building a pipeline of natural killer (NK) cell and macrophage-cell therapy candidates derived from our deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways.  Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, and is supported by high-quality institutional investors.  Shoreline Biosciences is headquartered in San Diego, CA.

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

Shoreline Biosciences Investor and Media Contact:

Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

San Diego, Calif., June 28, 2021 – Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and Macrophage cellular immunotherapies, today announced the appointment of Mohammad El-Kalay, Ph.D., as Senior VP and Head of CMC (Chemistry, Manufacturing, and Control).  

Dr. El-Kalay brings over three decades of experience in global biopharmaceutical operations to Shoreline, including key leadership roles in cell therapy companies where he led the successful translation of several cell therapy candidates into late-stage clinical development, as well as developing a T-cell purging device that was later marketed.  Dr. El-Kalay will be responsible for overseeing Shoreline’s manufacturing, technical, and supply chain operations. 

“We are thrilled to welcome Mohammad as SVP and Head of CMC at such a pivotal time in the growth of Shoreline,” said William Sandborn MD, Shoreline Chief Medical Officer. “Mohammad’s extensive technical expertise in process development and manufacturing of cell therapies, combined with his executive management experience, will benefit us greatly as we advance our emerging pipeline of cell therapy candidates toward the clinic.” 

Dr. El-Kalay joins Shoreline from Poseida Therapeutics, where he was VP, Technical Operations and was responsible for developing processes to manufacture their autologous and allogeneic CAR-T cell products. Prior to Poseida, he was SVP, Technical Operations for San Bio, Inc., directing development of manufacturing processes of their gene modified allogeneic mesenchymal stem cells to treat CNS diseases.  Before that, he held senior technical and leadership roles at Sangamo Therapeutics, Stem Cells, Inc., and was Founder, President, and CEO of EyeCyte, an autologous cell therapy company.  He also held senior leadership R&D and Technical Operation roles at MicroIslet, Telos Pharmaceuticals, MorphoGen Pharmaceuticals, Osiris Therapeutics, SyStemix, and Applied ImmuneSciences.  Dr. El-Kalay holds a B.Sc., M.Sc. and Ph.D. from Strathclyde University in Glasgow, UK.

“This is an exciting time to join the Shoreline team as it advances its core iPSC cell therapy technologies with the support of well-known biotech investors and two major partnerships with industry leaders Kite and BeiGene,” commented Dr. El-Kalay.  “I look forward to leveraging my thirty years of experience to develop and commercialize next-generation iPSC-derived allogeneic cell immunotherapies for cancer.”

About Shoreline’s iPSC NK cell and Macrophage Technology Platform

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shoreline’s approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner.

Shoreline Biosciences Investor and Media Contact:

Amy Conrad

Juniper Point

amy@juniper-point.com

858-366-3243

— Partnership Follows Kite’s Investment in Shoreline’s Recent Series A Financing —

 Santa Monica, Calif., and San Diego, June 17, 2021 – Kite, a Gilead Company (Nasdaq: GILD), and Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced a strategic partnership to develop novel cell therapies across a variety of cancer targets.

The collaboration will leverage Shoreline’s deep expertise in iPSC differentiation and genetic reprogramming in combination with Kite’s extensive cell therapy development, commercialization and manufacturing expertise to develop novel allogeneic candidates for a range of hematologic malignancies. The collaboration will focus initially on chimeric antigen receptor (CAR) NK targets, with Kite having an option to expand the collaboration to include an iPSC CAR Macrophage program for an undisclosed target to be selected post deal execution. This agreement follows Kite’s investment in Shoreline’s recent Series A financing. 

“As the leader in cell therapy, we are focused on investing in and delivering on the most promising opportunities to further optimize the therapeutic potential of cell therapy,” said Mert Aktar, Vice President of Corporate Development and Strategy at Kite. “We are excited about the potential of Shoreline’s next-generation approach to allogeneic development, and how our collaboration can accelerate this research across different leukemias and lymphomas.”

“We’re thrilled to strengthen our relationship with Kite, which has been at the forefront of cancer immunotherapy for over a decade, through this strategic partnership,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder, Chairman and CEO. “The combined strength of Kite’s leadership in CAR T-cell therapies and our cutting-edge iPSC platform will potentially accelerate Shoreline’s timeline to the clinic, expand our pipeline opportunities and deliver transformational treatment options for cancer.”

Under the terms of the agreement, Shoreline will receive an upfront payment and will be eligible to receive additional payments totaling over $2.3 billion as well as royalties based on achievement of certain development and commercial milestones.

About Shoreline Biosciences

Shoreline is a biotechnology company dedicated to advancing the development of intelligently designed allogeneic off-the-shelf, targeted and standardized cellular immunotherapies for cancer and other serious diseases.  Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways. Shoreline has a strategic manufacturing relationship with the Advanced Cell Therapy Laboratory and is supported by high-quality institutional investors including Boxer Capital, BVF Partners L.P., Commodore Capital, Cormorant Capital, Janus Henderson Investors, Logos Capital, Kite, a Gilead Company, Wedbush Healthcare Partners, Stork Capital and others. Shoreline Biosciences is headquartered in San Diego, CA.

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead and Kite Forward-Looking Statement

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 risk that Kite may not realize the anticipated benefits of this collaboration with Shoreline; difficulties or unanticipated expenses in connection with the collaboration and the potential effect on Kite’s earnings; and the possibility that the parties may make a strategic decision to terminate this collaboration at any time. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. 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 Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

Kite, the Kite logo and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Gilead and Kite Contacts:

Jacquie Ross, Investors 

(650) 358-1054

Nathan Kaiser, Media

(650) 522-1853

Shoreline Contact:

Amy Conrad

amy@juniper-point.com

858-366-3243

SAN DIEGO, CA, CAMBRIDGE, MA & BEIJING, China – June 9, 2021 — Shoreline Biosciences, Inc., a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a global biotechnology company, today announced an exclusive worldwide strategic collaboration to develop and commercialize a portfolio of NK-based cell therapeutics with Shoreline’s iPSC NK cell technology and BeiGene’s research and clinical development capabilities for different malignancies.

“BeiGene is a globally recognized biotechnology leader, and we are thrilled to announce our collaboration today,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Chairman & CEO. “We look forward to combining our iPSC NK cells with BeiGene’s discovery and clinical development expertise as the parties work to accelerate the development of the next generation of cell therapies for patients around the world.”

Under the terms of the agreement, Shoreline will receive an upfront cash payment of $45 million from BeiGene and will be eligible to receive additional R&D funding, milestone payments and royalties based upon the achievement of certain development, regulatory, and commercial milestones. In the multi-target collaboration, the companies have agreed to work jointly to develop cell therapies for four designated therapeutic targets, with an option to expand the collaboration at a future date. Clinical development will be led by BeiGene globally, with Shoreline responsible for clinical manufacturing. BeiGene will have commercial rights globally, with Shoreline having an option to retain U.S. and Canadian commercialization rights for two targets. In connection with the agreement, BeiGene has an option to acquire an equity stake in Shoreline in its next round of equity financing, subject to specified conditions.

“We are excited to collaborate with Shoreline as BeiGene looks to expand our pipeline of  transformative medicines from small molecule and antibody therapeutics to off-the-shelf cell therapies, a compelling area of research that has been primarily out of reach for many of the world’s patients,” said John V. Oyler, Co-Founder, Chairman, and Chief Executive Officer of BeiGene. “We look forward to collaborating with Shoreline, a leading company in developing iPSC-derived allogeneic cell therapies, as we combine our protein engineering technologies with Shoreline’s standardized NK cell therapy technology. We are hopeful that this combination, along with our clinical development expertise for solid tumor and hematologic malignancies, will bring cell therapies to more patients who need them.”

About Shoreline’s iPSC NK cell technology

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shoreline’s approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner. Shoreline’s technology is at the forefront of regenerative medicine and is being used to develop potential therapies to treat a wide range of diseases including cancer, inflammatory and genetic diseases.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

BeiGene’s Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future development and potential commercialization of therapeutic candidates using the licensed technology; potential payments to Shoreline Biosciences; the potential of the licensed technology; and the parties’ commitments and the potential benefits of the collaboration. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Shoreline Biosciences Investor and Media Contact:
Amy Conrad
Juniper Point
(858) 366-3243
amy@juniper-point.com

BeiGene Investor Contact:
Craig West
(857) 302-5189
ir@beigene.com

BeiGene Media Contact:
Liza Heapes or Vivian Ni
(857) 302-5663 or (857) 302-7596
media@beigene.com

San Diego, Calif., May 19, 2021 – Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced the appointment of  Kimberly Manhard as a member of the Board of Directors. Ms. Manhard has more than 25 years of experience in drug development, regulatory affairs and pharmaceutical operations, and has been instrumental in the development and approval of eight drugs across multiple therapeutic categories. 

“We are very pleased to have such an accomplished drug developer and regulatory expert like Kimberly join our board as we continue to grow Shoreline,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Chairman and CEO.  “Kimberly has a diversified background both as an industry executive, and board member who is responsible for delivering eight important commercial drugs to patients.  We are thrilled to welcome Kimberly to our board and look forward to gaining valuable insights as we advance our cell therapy programs toward the clinic and beyond.”

“Shoreline has great potential to improve the development of safe, effective and affordable allogeneic cell therapies and carve out a leading position in the dynamic field of immunotherapy,” commented Ms. Manhard. “I am pleased to join such an experienced board and look forward to leveraging my experience to guide Shoreline in the successful development of iPSC-derived allogeneic cell immunotherapies.”

Ms. Manhard currently serves as Executive Vice President, Drug Development and director of Heron Therapeutics, where she has played a key role in the development and regulatory approvals of oncology care products Sustol® and Cinvanti® and Zynrelef™ for postoperative pain.  Prior to joining Heron, Ms. Manhard served as the Senior Vice President of Regulatory Affairs and Development Operations at Ardea Biosciences, Inc. (acquired by AstraZeneca), where she was was key to the development and regulatory approval of Zurampic® (lesinurad). Prior to joining Ardea, she was President of her own consultancy firm, Vice President of Regulatory Affairs for Exelixis, Inc. and held multiple regulatory positions at Agouron Pharmaceuticals, Inc., a division of the Warner-Lambert Company, supporting development and commercialization of anticancer and antiviral products, including Viracept® (nelfinavir).  Ms. Manhard was also previously with Bristol-Myers Squibb Company in regulatory affairs, responsible for oncology compounds, including Taxol® (paclitaxel) and infectious disease compounds, including Videx® (didanosine) and Zerit® (stavudine). She began her career in clinical research with Eli Lilly and Company and G.H. Besselaar Associates (Covance Inc.).  Ms. Manhard also currently serves as a member of the board of directors of InhibRx, Inc. and Shoreline Biosciences and is a member of the board of trustees for the Fleet Science Center.  She received a B.S. degree in zoology and a B.A. degree in French from the University of Florida.

For more information, please engage with us on LinkedIn.

Shoreline Biosciences Investor and Media
Contact: Amy Conrad Juniper
Pointamy@juniper-point.com
858-366-3243