Press Releases

Novel Approach to Treat Late-Stage and Metastatic Cancers

SEATTLE, WA, – March 16, 2022, KayoThera, Inc. (“KayoThera”), an early-stage therapeutics company developing novel cancer immunotherapies, today announces the closing of an $8 million Series A round of financing. The financing was led by Accelerator Life Science Partners (“ALSP”) with participation from BioAdvance and 7G Bioventures. KayoThera will focus its therapeutic development efforts on its lead oncology program to further advance the technology towards a product that will benefit patients with late-stage and metastatic cancers.

“KayoThera is developing a paradigm-shifting cancer immunotherapy that has significant clinical and commercial potential,” said Ken Mohler, PhD, Chief Development Officer at ALSP. “We believe that this Series A investment will provide the financial resources to rapidly advance the company’s development program towards the clinic, which will open the door to an exciting new therapeutic approach.”

KayoThera’s science is based on research conducted by Mark Esposito, PhD and Yibin Kang, PhD at Princeton University. Dr. Kang, a Warner-Lambert/Parke-Davis Professor of Molecular Biology, and Dr. Esposito, a postdoctoral research associate in the Kang lab, co-founded KayoThera in 2019 to pursue the development of therapies based on their research.

“KayoThera is founded on a deep understanding of the underlying biology of metastatic cancers. We have identified and validated a family of key enzymes that can be targeted with novel small molecule inhibitors to treat advanced cancers,” described Dr. Kang.

Dr. Esposito will continue at KayoThera as Vice President of Research and Development and Dr. Kang will serve as the Chair of the Scientific Advisory Board. “We are extremely excited about the investment by ALSP, and the opportunity to work with a partner that provides exceptional drug development experience and resources which will be critical to the success of KayoThera,” stated Dr. Esposito, Co-Founder of KayoThera.

About KayoThera Inc
KayoThera, Inc. is an early-stage therapeutics company focused on the development of a new class of cancer immunotherapeutics. KayoThera is developing therapies to treat late-stage and metastatic cancers including breast, lung, pancreatic, colorectal, brain, and kidney cancers. Based on discoveries from Dr. Mark Esposito’s post-doctoral research in Princeton University and professor Yibin Kang, PhD. The company was initially funded by Foundation Venture Capital Group (FVCG). For more information, visit www.kayothera.com.

About Accelerator Life Science Partners
Accelerator Life Science Partners is an early-stage life science accelerator and investment firm that creates and builds next generation biotechnology companies centered on innovative science. ALSP catalyzes the development and commercialization of breakthrough biotechnology innovations by providing a holistic toolkit and leveraging its network and entrepreneurial expertise to accelerate the establishment and operation of early-stage biotechnology companies. ALSP’s portfolio companies are backed by some of the world’s leading life science investors and are comprised of industry-leading, transformative companies, including Petra Pharma (acquired by a global pharmaceutical company), Rodeo Therapeutics (acquired by Amgen Inc.) and Lodo Therapeutics (acquired by Zymergen). For more information, please visit www.acceleratorlsp.com.

About BioAdvance
BioAdvance is a $70 million early-stage life sciences fund with a focus in the mid-Atlantic region, investing up to $1.5 million initially and up to $5 million over the lifetime of companies that have the potential to improve human health. Since making its first investments in 2003, BioAdvance has committed more than $50 million in funding to approximately 100 organizations developing more than 160 products in the therapeutics, medtech, diagnostics, research tools and digital health sectors. BioAdvance portfolio companies have leveraged $3.7 billion in subsequent capital, including proceeds from acquisitions. Eleven products have received FDA approval. For more information, please visit www.bioadvance.com.

About 7G BioVentures
7G BioVentures is a venture fund focusing on first in class life science innovations in the U.S., Canada and Europe. Led by partners with decades of domain expertise and strong track records, we empower top scientists, clinicians, and entrepreneurs to translate breakthrough discoveries into lifesaving products. To our portfolio companies, our long-term commitment of capital and resources usually initiates at seed/startup stage.

Contact
Jessica Burback
Email: jburback@acceleratorlsp.com
Phone: 206-957-7302

SEATTLE, WA, January 6, 2022 — ALSP Orchid Acquisition Corporation I (Nasdaq: ALORU) (the “Company” or “ALSP Orchid”) announced today that, commencing January 10, 2022, holders of the units sold in the Company’s initial public offering of 172,500,000 units, completed on November 23, 2021, may elect to separately trade the Class A ordinary shares and warrants included in the units. Those units not separated will continue to trade on The Nasdaq Stock Market LLC (“Nasdaq”) under the symbol “ALORU,” and the Class A ordinary shares and warrants that are separated will trade on the Nasdaq under the symbols “ALOR” and “ALORW,” respectively. Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into Class A ordinary shares and warrants. No fractional warrants will be issued.

The units were initially offered by the Company in an underwritten offering. Stifel, Nicolaus & Company, Incorporated and Nomura Securities International, Inc. served as joint book-running managers of the offering. A registration statement relating to the units and the underlying securities was declared effective by the Securities and Exchange Commission (the “SEC”) on November 18, 2021.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com, or from Nomura Securities International, Inc., Attention: Equity Syndicate Department, Worldwide Plaza, 309 West 49th Street, New York, New York 10019-7316, or by telephone at 212-667-9000, or by email at equitysyndicateamericas@nomura.com.

About ALSP Orchid

ALSP Orchid is a blank check company formed by Accelerator Life Science Partners for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. While the Company may pursue an acquisition opportunity in any business, industry, sector or geographical location, it intends to pursue investments in North America and Singapore with an emphasis on life science companies developing assets and next-generation platform technologies with broad applicability. ALSP Orchid is led by CEO Thong Q. Le, CFO Ian A.W. Howes, COO Andras T. Forgacs, CBO Kevin T. Chow, Ph.D., and CDO Kendall M. Mohler, PhD. The Company’s independent board of directors is led by Board Chairman Bruce L.A. Carter, Ph.D. and includes Mark W. Hahn, Sundar R. Kodiyalam, Stephanie Read, and Eugene W. Yeo, Ph.D. The Company’s advisory board includes Philip Yeo Liat Kok, Ph.D. and Randall C. Schatzman, Ph.D.

Cautionary Note Concerning Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements,” including with respect to the anticipated use of the net proceeds. No assurance can be given that the net proceeds of the offering will be used as indicated. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus for the Company’s offering filed with the SEC. Copies are available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Company Contact:

Jessica Burback, Director of Investor Relations
IR@acceleratorlsp.com

SEATTLE, WA — November 23, 2021 — ALSP Orchid Acquisition Corporation I (NASDAQ: ALORU) (the “Company” or “ALSP Orchid”) today announced that it has closed its initial public offering of 17,250,000 units, including 2,250,000 units issued pursuant to the full exercise by the underwriters of their over-allotment option, at a price of $10.00 per unit. The units are listed on the Nasdaq Global Market (“Nasdaq”) and began trading under the ticker symbol “ALORU” on November 19, 2021. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant exercisable to purchase one Class A ordinary share at a price of $11.50 per share. After the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on Nasdaq under the symbols “ALOR” and “ALORW,” respectively.

ALSP Orchid is a newly organized blank check company formed by Accelerator Life Science Partners for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. While the Company may pursue an acquisition opportunity in any business, industry, sector or geographical location, it intends to pursue investments in North America and Singapore with an emphasis on life science companies developing assets and next-generation platform technologies with broad applicability.

ALSP Orchid is led by CEO Thong Q. Le, CFO Ian A.W. Howes, COO Andras T. Forgacs, CBO Kevin T. Chow, Ph.D., and CDO Kendall M. Mohler, PhD. The Company’s independent board of directors is led by Board Chairman Bruce L.A. Carter, Ph.D. and includes Mark W. Hahn, Sundar R. Kodiyalam, Stephanie Read, and Eugene W. Yeo, Ph.D. The Company’s advisory board includes Philip Yeo Liat Kok, Ph.D. and Randall C. Schatzman, Ph.D.

Stifel, Nicolaus & Company, Incorporated and Nomura Securities International, Inc. acted as joint book-running managers of the offering.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on November 18, 2021.  The offering is being made only by means of a prospectus. When available, copies of the prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com, or from Nomura Securities International, Inc., Attention: Equity Syndicate Department, Worldwide Plaza, 309 West 49th Street, New York, New York 10019-7316, or by telephone at 212-667-9000, or by email at equitysyndicateamericas@nomura.com.

This press release will not constitute an offer to sell or a solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Cautionary Note Concerning Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements,” including with respect to the initial public offering and the anticipated use of the net proceeds. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of ALSP Orchid, including those set forth in the Risk Factors section of the registration statement and prospectus for ALSP Orchid’s offering filed with the SEC. Copies are available on the SEC’s website, www.sec.gov. ALSP Orchid undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Company Contact:

Jessica Burback, Director of Investor Relations
IR@acceleratorlsp.com

SEATTLE, WA – August 5, 2021 – Accelerator Life Science Partners (“ALSP”), a leading early-stage life science accelerator and investment firm, today acknowledged the sudden passing of senior advisor and board member, Tadataka (Tachi) Yamada, M.D., who died unexpectedly at home on August 4, 2021.

“We are saddened to share the news of Tachi’s unexpected passing,” said Thong Q. Le, CEO and Senior Managing Director. “I have had the privilege and honor to have known and worked closely with Tachi for many years, and I was grateful to have the benefits of his knowledge, experience and leadership at ALSP. Tachi understood well the many challenges that early-stage biotechnology companies often face when developing disruptive technologies, and always reminded us to consider how the treatments we were developing would affect patients and (more broadly) global health. He is a “giant among giants” when it comes to our life sciences industry, and his impact on patients and global health will be felt for many years to come. The ALSP team and I will miss Tachi dearly, and we send our deepest, most heartfelt sympathies to the Yamada family during this difficult time.”

About Accelerator Life Science Partners
Accelerator Life Science Partners (ALSP) is an investment firm that catalyzes the development and commercialization of breakthrough biotechnology innovations by providing the complete business, scientific, and financial toolkit necessary for accelerating the establishment and operation of early-stage biotechnology companies. ALSP’s portfolio companies are backed by some of the world’s leading pharmaceutical companies and comprise of industry-leading, transformative companies, including Lodo Therapeutics (acquired by Zymergen), Lydian Neurosciences, Magnolia Neurosciences, Petra Pharma (acquired by a global pharmaceutical company), and Rodeo Therapeutics (acquired by Amgen Inc.). ALSP is a minority-owned firm that seeks to promote diversity and inclusion in the healthcare industry. For more information, please visit www.acceleratorlsp.com.

Pioneering Biotech Company Builder Adds Ronald Howell as Senior Advisor

SEATTLE, WA – June 24, 2021 – Accelerator Life Science Partners (“ALSP”), a leading early-stage life science accelerator and investment firm, today announced that it has strengthened its executive leadership team with the promotion of Alice Chen, Ph.D., to executive vice president and the addition of Ronald Howell as Senior Advisor. This expansion enables the firm to better serve a broader, more diverse range of scientific founders and entrepreneurs in the life science community.

Dr. Chen has more than 15 years of research, drug development, and executive management experience. She joined ALSP as a Principal in 2013 to support ALSP portfolio company operations and to provide executive oversight over a broad range of preclinical development activities across the ALSP portfolio.

Mr. Howell most recently served as President and CEO of Washington Research Foundation (WRF), where he led the expansion of WRF from primarily an intellectual property management organization into one of the largest private foundations in the State of Washington. Mr. Howell developed an impressive track record of success supporting and investing in early-stage university innovations.

“We are delighted to announce Alice’s well-deserved promotion and to add Ron, a dear friend with whom I’ve had the honor to work closely with for more than 14 years at WRF Capital as an ALSP senior advisor. The COVID-19 pandemic has made it clear that there is unequal access to therapeutic treatments across underserved communities and a lack of financial commitment to invest in life science technologies and companies developed and led by diverse teams,” says Thong Q. Le, Senior Managing Director, President, and Chief Executive Officer, Accelerator Life Science Partners. “While record amounts of capital have flowed into biotech-focused investment vehicles, I believe that as an industry we can do a better job of enhancing and incorporating diversity at all levels. ALSP and our portfolio companies will benefit from the professional experiences and diverse perspectives that both Alice and Ron will bring to our company-building activities as we work to develop the next generation of transformative biotechnology companies.”

About Alice Chen, Ph.D.
Dr. Chen is an experienced life sciences operating executive and investment professional. In her role at ALSP, Alice has been actively involved in sourcing and evaluating emerging biotechnology investment opportunities and has played an instrumental role in the formation and oversight of several ALSP’s portfolio companies, including Acylin Therapeutics (asset acquisition by a global pharmaceutical company), Petra Pharma (acquired by a global pharmaceutical company), Nemean Pharma, Rodeo Therapeutics (acquired by Amgen Inc.) and Magnolia Neurosciences. Prior to joining ALSP, Dr. Chen served as a scientific consultant and drug development project leader for several venture-backed biotechnology companies. She also served as Director of Technologies at Qwell Pharmaceuticals, a venture-backed biotechnology company developing novel, small-molecule drugs focused on cancer and inflammation. Dr. Chen received a Ph.D. in Chemical Engineering from Stanford University and a B.S. degree in Chemical Engineering from U.C. Berkeley. She served as an Engineering Fellow at Merck & Company and is a graduate of the Kauffman Fellows Program (Class 19). Dr. Chen currently serves on the board of Life Science Washington, the life science trade association for the State of Washington, and on the governing boards of several technology review committees in the U.S. and abroad.

About Ron Howell
Ron Howell recently retired from the Washington Research Foundation (WRF), a non-profit organization founded in 1981 to support research and scholarship in Washington state, with a focus on life sciences and enabling technologies. Mr. Howell was instrumental in developing a number of innovative grant-making programs to support breakthrough, early-stage research developed within Washington state’s institutions. In 1994, Mr. Howell established the WRF’s venture investment arm, WRF Capital, which has become a critical investment partner for numerous university spinouts in Washington State. Under Mr. Howell’s leadership, WRF earned more than $445 million in licensing revenue for the University of Washington (UW), provided more than $113 million in grants to nonprofit research institutions in Washington State, and invested more than $90 million in 112 technology focused startup companies. WRF Capital continues to be an active investor in supporting early-stage life science investment opportunities in the Pacific Northwest.

About Accelerator Life Science Partners
Accelerator Life Science Partners (ALSP) is an investment firm that catalyzes the development and commercialization of breakthrough biotechnology innovations by providing the complete business, scientific, and financial toolkit necessary for accelerating the establishment and operation of early-stage biotechnology companies. ALSP’s portfolio companies are backed by some of the world’s leading pharmaceutical companies and comprise of industry-leading, transformative companies, including Lodo Therapeutics (acquired by Zymergen), Lydian Neurosciences, Magnolia Neurosciences, Petra Pharma (acquired by a global pharmaceutical company), and Rodeo Therapeutics (acquired by Amgen Inc.). ALSP is a minority-owned firm that seeks to promote diversity and inclusion in the healthcare industry. For more information, please visit www.acceleratorlsp.com.

SEATTLE, WA – May 28, 2021 — Accelerator Life Science Partners (“ALSP”), a leading early-stage life science accelerator and investment firm, today announced that its portfolio company, Lodo Therapeutics Corporation (“Lodo” or the “Company”), has been acquired by Zymergen Inc. (NASDAQ: ZY) for an undisclosed amount. The transaction is the third exit from ALSP’s investment fund, Accelerator Life Science Partners I (ALSP I) in the last year.

Lodo Therapeutics discovered and developed novel therapeutics to address undruggable targets by applying its proprietary platform to tap the vast collections of undiscovered molecules encoded in environmental microbial DNA.

“The Lodo Therapeutics metagenomic platform compliments Zymergen’s discovery efforts by expanding their natural product discovery capabilities,” said Sean Brady, Ph.D., cofounder, Lodo Therapeutics and professor, Rockefeller University. “I am grateful for the support that the ALSP team provided during Lodo’s development and am eager to incorporate our technology into Zymergen’s platform.”

ALSP invested in Lodo as part of the Company’s $17 million Series A financing. ALSP managed the Company business, research, and development (R&D) operations for more than four years. In 2018 ALSP helped Lodo to establish a multi-target collaboration with Genentech worth up to $969 million. ALSP also recruited serial entrepreneur Dale Pfost, Ph.D., as the Company’s Chairman and CEO, and helped to fill key executive leadership positions as the Company graduated from ALSP’s operations.

“We are delighted to see Lodo’s technology, and their talented R&D team become a part of Zymergen’s innovative technology platform,” said Thong Q. Le, Senior Managing Director and CEO of Accelerator Life Science Partners. “Combining Lodo’s platform with Zymergen’s growing technology stack will create meaningful opportunities to access unique chemistry and to accelerate biological design and manufacturing. We look forward to the combined team’s continued successes as they work collaboratively to create and commercialize breakthrough products.”

About Accelerator Life Science Partners

Accelerator Life Science Partners (ALSP) is an investment firm that catalyzes the development and commercialization of breakthrough biotechnology innovations by providing the complete business, scientific and financial toolkit necessary for accelerating the establishment and operations of early-stage biotechnology companies. ALSP’s portfolio companies are backed by some of the world’s leading pharmaceutical companies and comprises industry-leading, transformative companies, including Lodo Therapeutics (acquired by Zymergen), Lydian Neurosciences, Magnolia Neurosciences, Petra Pharma (acquired by global pharmaceutical company), and Rodeo Therapeutics (acquired by Amgen Inc.). ALSP is minority-owned firm that seeks to promote diversity and inclusion in the healthcare industry.

THOUSAND OAKS, Calif. and SEATTLE, March 30, 2021 /PRNewswire/ — Amgen Inc. (NASDAQ:AMGN) and Rodeo Therapeutics Corporation (Rodeo) today announced an agreement under which Amgen will acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo’s 15-PGDH program is a strong strategic fit with Amgen’s inflammation portfolio and efforts to develop first-in-class therapeutics for patients.

Under terms of the agreement, Amgen will acquire all outstanding shares of Rodeo in exchange for a $55 million upfront payment as well as future contingent milestone payments potentially worth up to an additional $666 million in cash. The transaction has been approved by the shareholders and the Board of Directors of Rodeo.

Rodeo is focused on developing first-in-class, orally available modulators of prostaglandin biology that play an important role in tissue regeneration and repair. Rodeo’s lead 15-prostaglandin dehydrogenase (15-PGDH) modulators have generated compelling data in extensive preclinical studies and have clinical potential in multiple indications.

“The enzyme 15-PGDH plays a key role in many disease-relevant processes such as stem cell self-renewal and epithelial barrier repair. Given the encouraging preclinical data to date, we are excited about the opportunity to develop a novel therapy with potential in a range of important inflammatory disease indications,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen.

Thong Q. Le, president and chief executive officer of Rodeo commented, “We are thrilled that Amgen recognizes the potential value and differentiated profile of our 15-PGDH inhibitor program. With decades of experience in developing, manufacturing and commercializing innovative therapies for patients suffering from a broad range of immunologic diseases and conditions, Amgen is ideally positioned to rapidly advance our program into the clinic.”

Cooley LLP acted as legal advisor to Rodeo and Gunderson Dettmer LLP acted as legal advisor to Amgen on this transaction.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Rodeo Therapeutics
Rodeo Therapeutics (Rodeo) was founded in July 2017 by Accelerator Life Science Partners (ALSP), a venture capital firm that catalyzes the creation of high-quality, cutting edge life science companies.  Rodeo focuses on developing small-molecule therapies that increase tissue levels of prostaglandin PGE2.  Preclinical studies have shown that increasing PGE2 through modulation of a prostaglandin-degrading enzyme (15-PGDH) protects against colitis and idiopathic pulmonary fibrosis (IPF), accelerates hematopoietic stem cell reconstitution following bone marrow transplant, and promotes liver regeneration in a variety of animal models.  Since its founding, Rodeo has been exclusively managed by ALSP, validating the firm’s ability to identify, nurture, and efficiently manage ground-breaking start-up companies that address unmet medical needs and advance patient care and outcomes.  For more information, please visit: www.rodeotherapeutics.com and www.acceleratorlsp.com.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the integration of Otezla^® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Rodeo Therapeutics acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen’s business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgenmay fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen’s manufacturing activities, the distribution of Amgen’s products, the commercialization of Amgen’s product candidates, and Amgen’s clinical trial operations, and any such events may have a material adverse effect on Amgen’s product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect Amgen’s business. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for Amgen’s products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT:

Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

Rodeo Therapeutics Corporation, Seattle, Washington
Jessica Burback, 206-234-6481, jburback@acceleratorlsp.com  (media and investors)