Samsung Biologics เลือกแพลตฟอร์ม Growth Direct® ของ Rapid Micro Biosystems เพื่อทำการทดสอบการควบคุมคุณภาพทางจุลชีววิทยาที่สำคัญโดยอัตโนมัติ

บริษัทต่าง ๆ มีความมุ่งมั่นร่วมกันในการสร้างสรรค์นวัตกรรมกระบวนการควบคุมคุณภาพ เพื่อตอบสนองความท้าทายด้านการผลิตทางชีวภาพ เช่น ขนาด ความสมบูรณ์ของข้อมูล และการเร่งเวลาออกสู่ตลาด

โลเวลล์ แมสซาชูเซตส์ , Jan. 04, 2024 (GLOBE NEWSWIRE) — Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (“บริษัท”) ซึ่งเป็นบริษัทเทคโนโลยีวิทยาศาสตร์เพื่อชีวิตเชิงนวัตกรรมที่นำเสนอโซลูชันระบบอัตโนมัติที่สำคัญต่อภารกิจเพื่ออำนวยความสะดวกในการผลิตที่มีประสิทธิภาพและการปล่อยผลิตภัณฑ์ด้านการดูแลสุขภาพที่รวดเร็วและปลอดภัย ได้ประกาศในวันนี้ว่า Samsung Biologics (KRX: 207940.KS) ได้เลือกใช้ Growth Direct® แพลตฟอร์มเพื่อทำให้กระบวนการควบคุมคุณภาพจุลินทรีย์เป็นไปโดยอัตโนมัติเพื่อมอบประสิทธิภาพที่เพิ่มขึ้น ความสมบูรณ์ของข้อมูลที่แข็งแกร่งยิ่งขึ้น และการดำเนินการควบคุมคุณภาพที่สามารถปรับขนาดได้

“Samsung Biologics เป็นองค์กรพัฒนาตามสัญญาและการผลิต (CDMO) ระดับโลก และได้แสดงให้เห็นถึงความมุ่งมั่นอย่างแน่วแน่ที่มีต่อระบบอัตโนมัติและการจัดการคุณภาพในการผลิตชีวเภสัชภัณฑ์” Robert Spignesi ประธานและเจ้าหน้าที่บริหารของ Rapid Micro Biosystems กล่าว “The Growth Direct® ปรับปรุงประสิทธิภาพการดำเนินงานและความสมบูรณ์ของข้อมูลในห้องปฏิบัติการจุลชีววิทยาควบคุมคุณภาพ และเราภูมิใจที่ได้เป็นพันธมิตรกับ Samsung Biologics”

ผู้ผลิตยารายต่าง ๆ ในระดับโลกพึ่งพาแพลตฟอร์ม Growth Direct เพื่อให้เป็นไปตามมาตรฐานการควบคุมคุณภาพทางจุลชีววิทยาในปัจจุบันและความท้าทายในอนาคต โดย Growth Direct เป็นแพลตฟอร์มแบบอัตโนมัติเต็มรูปแบบและเอื้อให้ทำการทดสอบได้โดยต้องไม่ทำลายเพียงแพลตฟอร์มเดียวสำหรับการทดสอบการควบคุมคุณภาพทางจุลชีววิทยาที่ให้เวลาผลลัพธ์เร็วขึ้น ความสมบูรณ์ของข้อมูลที่ดีขึ้น และความแม่นยำที่เพิ่มขึ้น พร้อมทั้งมีความจุตัวอย่างที่มากขึ้น

หากต้องการเรียนรู้เพิ่มเติมเกี่ยวกับบริษัทและแพลตฟอร์ม Growth Direct® กรุณาเยี่ยมชม: Rapid Micro Biosystems

เกี่ยวกับ Rapid Micro Biosystems

Rapid Micro Biosystems เป็นบริษัทเทคโนโลยีชีววิทยาศาสตร์เชิงนวัตกรรมที่นำเสนอโซลูชันระบบอัตโนมัติที่สำคัญต่อภารกิจ เพื่ออำนวยความสะดวกในการผลิตที่มีประสิทธิภาพและการปล่อยผลิตภัณฑ์ดูแลสุขภาพอย่างรวดเร็วและปลอดภัย เช่น ยาชีวภาพ วัคซีน การบำบัดด้วยเซลล์และยีน และยาฉีดฆ่าเชื้อ ระบบ Growth Direct ซึ่งเป็นระบบเรือธงของบริษัททำให้ขั้นตอนการทดสอบการควบคุมคุณภาพจุลินทรีย์แบบแมนนวล (“MQC”) ซึ่งเป็นรูปแบบเก่าที่ใช้ในการดำเนินงานการผลิตยาที่ใหญ่ที่สุดและซับซ้อนที่สุดทั่วโลกให้เป็นไปโดยอัตโนมัติและทำให้ทันสมัย ระบบ Growth Direct นำห้องปฏิบัติการควบคุมคุณภาพมาสู่พื้นที่การผลิต ปลดล็อกพลังของระบบอัตโนมัติของ MQC เพื่อมอบสิ่งที่ลูกค้าพึ่งพาและใช้ประโยชน์ ซึ่งได้แก่ ผลลัพธ์ที่รวดเร็วยิ่งขึ้น แม่นยำยิ่งขึ้น ประสิทธิภาพการดำเนินงานที่เพิ่มขึ้น ปฏิบัติตามกฎระเบียบด้านความสมบูรณ์ถูกต้องของข้อมูลได้ดีขึ้น และการตัดสินใจได้รวดเร็วยิ่งขึ้น เพื่อให้มั่นใจได้ว่าการจัดหาผลิตภัณฑ์ดูแลสุขภาพที่สำคัญที่ปลอดภัยและสม่ำเสมอ บริษัทมีสำนักงานใหญ่และมีการผลิตในสหรัฐอเมริกา ในเมืองโลเวลล์ รัฐแมสซาชูเซตส์ และมีสถานที่ตั้งทั่วโลกในเมืองเล็กซิงตัน แมสซาชูเซตส์ สวิตเซอร์แลนด์ เยอรมนี และเนเธอร์แลนด์ สำหรับข้อมูลเพิ่มเติม กรุณาเยี่ยมชม www.rapidmicrobio.com หรือติดตามบริษัททางทวิตเตอร์ได้ที่ @rapidmicrobio หรือบน LinkedIn

เกี่ยวกับ Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) คือผู้ให้บริการการผลิตตามสัญญา (CDMO) แบบครบวงจรตั้งแต่ต้นจนจบ โดยนำเสนอโซลูชันการพัฒนาและการผลิตที่ราบรื่น ตั้งแต่การพัฒนาเซลล์ไลน์ไปจนถึงการบรรจุ/การทำให้เสร็จสิ้นขั้นสุดท้ายแบบปลอดเชื้อ ตลอดจนการสนับสนุนการทดสอบในห้องปฏิบัติการสำหรับผลิตภัณฑ์ชีวเภสัชภัณฑ์ที่เราผลิต สิ่งอำนวยความสะดวกอันล้ำสมัยของเราเป็นไปตามหลักเกณฑ์การผลิตที่ดีและเป็นปัจจุบัน (cGMP) ด้วยเครื่องปฏิกรณ์ชีวภาพตั้งแต่ขนาดเล็กไปจนถึงขนาดใหญ่ เพื่อตอบสนองความต้องการที่แตกต่างกันของลูกค้า เพื่อเพิ่มประสิทธิภาพการดำเนินงานของเราให้สูงสุดและขยายขีดความสามารถของเราเพื่อตอบสนองความต้องการด้านการผลิตทางชีวภาพที่เพิ่มขึ้น เมื่อเร็ว ๆ นี้ Samsung Biologics ได้เสร็จสิ้นการสร้าง Bio Campus I โดยมีโรงงานที่ 4 ซึ่งมีกำลังการผลิตรวมรวม 604KL และเปิดตัว Bio Campus II พร้อมกับการก่อสร้างโรงงานที่ 5 ซึ่งจะเปิดดำเนินการในเดือนเมษายน 2568 ซึ่งจะเพิ่มกำลังการผลิตชีวภาพอีก 184KL นอกจากนี้ Samsung Biologics America ยังช่วยให้บริษัทสามารถทำงานใกล้ชิดกับลูกค้าที่อยู่ในสหรัฐอเมริกาและยุโรปได้มากขึ้น เรายังคงยกระดับขีดความสามารถของเราเพื่อรองรับลูกค้าของเราโดยการลงทุนในเทคโนโลยี เช่น โรงงานผลิตคอนจูเกตของแอนติบอดี-ยา (Antibody-Drug Conjugate หรือ ADC) โรงงานผลิต mRNA โดยเฉพาะ และกำลังการผลิตการบรรจุแบบปลอดเชื้อเพิ่มเติม ในฐานะพันธมิตรทางเลือกด้านการผลิตตามสัญญาที่ยั่งยืน เราจึงมุ่งมั่นที่จะส่งมอบผลิตภัณฑ์ที่เราผลิตอย่างตรงเวลาและครบถ้วนด้วยโซลูชันการผลิตที่ยืดหยุ่น ความเป็นเลิศในการปฏิบัติงาน และความเชี่ยวชาญที่ได้รับการพิสูจน์แล้ว

ข้อความเชิงคาดการณ์เหตุการณ์ในอนาคต

ข่าวประชาสัมพันธ์ฉบับนี้ประกอบด้วยข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตตามความหมายของมาตรา 27A ของกฎหมายหลักทรัพย์ปี 2476 ซึ่งแก้ไขเพิ่มเติม และมาตรา 21E แห่งพระราชบัญญัติหลักทรัพย์และตลาดหลักทรัพย์ของปี 2477 ซึ่งแก้ไขเพิ่มเติม ข้อความทั้งหมดที่มีอยู่ในข่าวประชาสัมพันธ์ฉบับนี้ซึ่งไม่เกี่ยวข้องกับข้อเท็จจริงในอดีตควรได้รับการพิจารณาว่าเป็นข้อความเชิงคาดการณ์เหตุการณ์ในอนาคต ซึ่งรวมถึงแต่ไม่จำกัดเพียงข้อความเกี่ยวกับผลกระทบที่คาดหวังของระบบ Growth Direct ที่มีต่อประสิทธิภาพการดำเนินงานและความสมบูรณ์ของข้อมูลของ Samsung Biologics

ข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตเกี่ยวข้องกับความเสี่ยง ความไม่แน่นอน และการสันนิษฐานที่ทราบและไม่ทราบ ซึ่งอาจทำให้ผลลัพธ์ที่แท้จริงแตกต่างอย่างมากจากผลลัพธ์ใด ๆ ที่แสดงหรือบอกเป็นนัยในข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตใด ๆ ซึ่งรวมถึงปัจจัยสำคัญที่ระบุไว้ภายใต้หัวข้อ “ปัจจัยความเสี่ยง” ในรายงานประจำปีของบริษัทในแบบฟอร์ม 10-K ที่ยื่นต่อสำนักงานคณะกรรมการกำกับหลักทรัพย์และตลาดหลักทรัพย์ (“SEC”) เมื่อวันที่ 10 มีนาคม 2566 เนื่องจากปัจจัยดังกล่าวอาจมีการปรับปรุงเป็นครั้งคราวในเอกสารอื่น ๆ ที่ยื่นต่อ SEC ซึ่งมีอยู่บนเว็บไซต์ของ SEC ที่ www.sec.gov และหน้านักลงทุนสัมพันธ์ของเว็บไซต์ที่ investor.rapidmicrobio.com แม้ว่าบริษัทจะเชื่อว่าความคาดหวังที่สะท้อนอยู่ในข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตนั้นสมเหตุสมผล แต่ก็ไม่สามารถรับประกันผลลัพธ์ในอนาคตได้ บริษัทไม่มีภาระผูกพัน และไม่มีการให้คำสัญญาว่าจะมีภาระผูกพันใด ๆ ในการปรับปรุงหรือแก้ไขข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตใด ๆ ที่ทำขึ้นในข่าวประชาสัมพันธ์ฉบับนี้เพื่อให้สะท้อนถึงการเปลี่ยนแปลงนับตั้งแต่วันที่เผยแพร่ข่าวประชาสัมพันธ์นี้ เว้นแต่จะเป็นไปตามที่กฎหมายกำหนด


ติดต่อด้านนักลงทุนของ Rapid Micro Biosystems:
Michael Beaulieu
นักวิเคราะห์การเงินชาร์เตอร์รองประธาน ฝ่ายนักลงทุนสัมพันธ์และการสื่อสารขององค์กร
investor@rapidmicrobio.com

ติดต่อด้านสื่อของ Rapid Micro Biosystems:
media@rapidmicrobio.com
ติดต่อด้านสื่อของ Samsung Biologics
Claire Kim หัวหน้าฝ่ายสื่อสารด้านการตลาด
cair.kim@samsung.com

GlobeNewswire Distribution ID 9012680

Recursion Adds New Chemical Entity Targeting Fibrotic Diseases to Late Discovery Pipeline

Potential First-in-Class Novel Molecule with Novel Target In-Licensed from Collaboration with Bayer

SALT LAKE CITY, Jan. 04, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed an agreement with Bayer AG to in-license a new chemical entity that emerged from the companies’ fibrosis research collaboration. The compound represents a novel approach to treating fibrotic diseases with compelling early data suggesting the potential to reverse disease-related fibrotic processes, including immuno-mesenchymal dysfunction.

“Since initiating our research collaboration with Bayer in 2020, we have worked diligently to apply the power of the Recursion OS to identify and advance potential candidates in challenging areas of disease biology,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “We are excited to bring this asset into our internal pipeline and accelerate the compelling science behind this program while our research collaboration with Bayer focuses on precision oncology.”

Recursion applied phenotypic screening of human cells to identify small molecules that reverse the phenotypic features of disease-state fibrocyte cells into those of healthy-state cells. Leveraging the power of Recursion’s Maps of Biology and Chemistry revealed a relationship between small molecule hits and a novel target that could impact fibrotic diseases. The most promising small molecule hits were confirmed as potent inhibitors of this novel target in validation experiments, and lead optimization studies are currently ongoing.

Fibrotic diseases are a significant cause of morbidity and mortality worldwide with high unmet need for patients. One of the biggest challenges in the treatment of fibrotic diseases is the underlying complex biology and the associated difficulty in discovering disease-modifying drug targets. Recursion’s technology is uniquely suited to accelerate discoveries in these and other complex areas of disease biology.

About Recursion
Recursion (NASDAQ: RXRX) 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 and chemical 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, and chemistry 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, Montréal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on 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 early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; 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,” “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. 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 9012419

nCino to Participate in Upcoming Investor Conference

WILMINGTON, N.C., Jan. 04, 2024 (GLOBE NEWSWIRE) — nCino, Inc. (NASDAQ: NCNO), a pioneer in cloud banking for the global financial services industry, today announced its participation in the following investor conference:

26th Annual Needham Growth Conference
Presentation: Wednesday, January 17, at 2:15 p.m. ET

A live webcast, as well as a replay, will be available on the Company’s Investor relations website at https://investor.ncino.com/news-events/events-and-presentations.

About nCino
nCino (NASDAQ: NCNO) is the worldwide leader in cloud banking. Through its single software-as-a-service (SaaS) platform, nCino helps financial institutions serving corporate and commercial, small business, consumer, and mortgage customers modernize and more effectively onboard clients, make loans, manage the loan lifecycle, and open accounts. Transforming how financial institutions operate through innovation, reputation and speed, nCino is partnered with more than 1,800 financial services providers globally. For more information, visit www.ncino.com.

INVESTOR CONTACT
Harrison Masters
nCino
+1 910.734.7743
Harrison.masters@ncino.com

MEDIA CONTACT
Natalia Moose
nCino
press@ncino.com

GlobeNewswire Distribution ID 9012156

Samsung Biologics selects Rapid Micro Biosystems’ Growth Direct® platform to automate critical microbiology quality control testing

Companies share commitment to innovating quality control processes to meet biomanufacturing challenges such as scale, data integrity and accelerating time to market

LOWELL, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) — Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today announced that Samsung Biologics (KRX: 207940.KS) has selected the Growth Direct® platform to automate its microbial quality control processes to deliver increased efficiency, more robust data integrity and scalable quality control operations.

“Samsung Biologics is a leading global contract development and manufacturing organization (CDMO) and has demonstrated an unwavering commitment to automation and quality management in biopharmaceutical manufacturing,” said Robert Spignesi, President and CEO of Rapid Micro Biosystems. “The Growth Direct® improves operational efficiency and data integrity in the quality control microbiology lab, and we are proud to partner with Samsung Biologics.”

Global pharmaceutical manufacturers rely on the Growth Direct platform to meet both today’s microbiological quality control standards and tomorrow’s challenges. It is the only fully automated, non-destructive growth-based platform for microbiology quality control testing that offers faster time to results, improved data integrity, and enhanced accuracy, with greater sample capacity.

To learn more about the Company and the Growth Direct® platform please visit: Rapid Micro Biosystems.

About Rapid Micro Biosystems

Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The Company’s flagship Growth Direct system automates and modernizes the antiquated, manual microbial quality control (“MQC”) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct system brings the quality control lab to the manufacturing floor, unlocking the power of MQC automation to deliver the faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The Company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, with global locations in Lexington, Massachusetts, Switzerland, Germany, and the Netherlands. For more information, please visit www.rapidmicrobio.com or follow the Company on Twitter at @rapidmicrobio or on LinkedIn.

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated, end-to-end CDMO service provider, offering seamless development and manufacturing solutions from cell line development to final aseptic fill/finish as well as laboratory testing support for the biopharmaceutical products we manufacture. Our state-of-the-art facilities are cGMP compliant with bioreactors ranging from small to large scales to serve varying client needs. To maximize our operational efficiency and expand our capabilities in response to growing biomanufacturing demand, Samsung Biologics recently completed Bio Campus I with Plant 4 offering a combined 604KL total capacity, and launched Bio Campus II with the construction of Plant 5, which will be operational in April 2025 adding 184KL biomanufacturing capacity. Additionally, Samsung Biologics America enables the company to work in closer proximity to clients based in the U.S. and Europe. We continue to upgrade our capabilities to accommodate our clients by investing in technologies such as an antibody-drug conjugate (ADC) facility, a dedicated mRNA manufacturing facility, and additional aseptic filling capacity. As a sustainable CDMO partner of choice, we are committed to on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the expected impact of the Growth Direct system on Samsung Biologics’ operational efficiency and data integrity.

Forward-looking statements involve known and unknown risks, uncertainties and assumptions which may cause actual results to differ materially from any results expressed or implied by any forward-looking statement, including the important factors outlined under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 10, 2023, as such factors may be updated from time to time in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov and the Investor Relations page of its website at investors.rapidmicrobio.com. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it cannot guarantee future results. The Company has no obligation, and does not undertake any obligation, to update or revise any forward-looking statement made in this press release to reflect changes since the date of this press release, except as may be required by law.

Rapid Micro Biosystems Investor Contact: 
Michael Beaulieu, CFA 
Vice President, Investor Relations and Corporate Communications 
investors@rapidmicrobio.com 
 
Rapid Micro Biosystems Media Contact: 
media@rapidmicrobio.com

Samsung Biologics Media Contact
Claire Kim, Head of Marketing Communications
cair.kim@samsung.com

GlobeNewswire Distribution ID 9011969

Zymeworks Outlines Strategic Priorities and Outlook for 2024 and 2025

  • Company well-positioned for further progress and broadening of R&D pipeline
  • Cash resources of approximately $455 million as of December 31, 2023 (unaudited)
  • Expected cash runway, including proceeds from recent private placement, into 2H 2027
  • Top-line data readout from the Phase 3 trial evaluating zanidatamab in HER2-positive gastroesophageal adenocarcinoma (GEA), HERIZON-GEA-01, expected in 2024
  • Expected regulatory reviews ongoing during 2024 for zanidatamab in second-line biliary tract cancers (BTC) in the United States and China with our partners Jazz Pharmaceuticals and BeiGene
  • Expected Investigational New Drug (IND) applications and first-in-human (FIH) studies for ZW171 and ZW191 candidates in 2024 and ZW220 and ZW251 in 2025
  • Progression on ‘5 by 5’ portfolio and ADVANCE with R&D Day scheduled for Q4-24
  • Additional leadership appointments announced separately today
  • Company presentation on Thursday, January 11, 2024 at 08:15 a.m. Pacific Time (PT) at the J.P. Morgan 42nd Annual Healthcare Conference

VANCOUVER, British Columbia, Jan. 04, 2024 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today provided an update on key strategic priorities for 2024 and 2025.

“We begin 2024 in an exciting position, having met key objectives set for our programs in 2022 and 2023, including generating data supporting the clinical development of zanidatamab, identifying strong new preclinical product candidates and ensuring that we continue to have the financial resources and leadership necessary to support the Company’s strategic objectives,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “We’re looking forward to 2024 as we approach a pivotal Phase 3 data readout this year with our partners Jazz Pharmaceuticals and BeiGene from the HERIZON-GEA-01 clinical trial for our lead candidate, zanidatamab, in first-line gastroesophageal andenocarcinoma. These data, coupled with the potential for initial regulatory approvals for zanidatamab in second-line biliary tract cancers in 2025 or earlier, are expected to be significant events in our progress to make a meaningful difference in the lives of cancer patients. Beyond zanidatamab, our growing global presence helps position us to achieve efficiency in clinical development, with a continued focus on advancing nominated product candidates from our ‘5 by 5’ portfolio and our ADVANCE R&D strategy. We will continue to evaluate opportunities to broaden or accelerate our development efforts through the formation of strategic partnerships and collaborations.”

“Our most important current R&D priority is to progress our differentiated portfolio of antibody-drug conjugates (ADCs) into clinical studies during 2024 and 2025, especially our potential best-in-class folate receptor-alpha-targeted ADC, ZW191, expected to enter FIH studies during 2024. Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025. All three ADCs were designed with our moderate-potency, proprietary topoisomerase 1 inhibitor, ZD06519. Beyond ADCs, we look to make progress in our differentiated approach to next-generation multi-specific antibodies, starting with our planned IND filing and FIH studies in 2024 for ZW171, our 2+1 mesothelin-directed T-cell engager.”

“We were also able to strengthen our board of directors with the additions of Carlos Campoy, Dr. Nancy Davidson and Derek Miller in 2023,” said Mr. Galbraith. “These appointments, together with the separate announcement today of the broadening of the Zymeworks leadership team, underscore our commitment to having the expertise and experience in place at all levels to achieve our business objectives in 2024 and 2025.”

Key 2023 Accomplishments:

  • Our partner, Jazz Pharmaceuticals, presented positive pivotal Phase 2b trial data (NCT04466891) evaluating zanidatamab in HER2-amplified BTC at the American Society of Clinical Oncology annual meeting and initiated rolling Biologics License Application (BLA) submission for accelerated approval in second-line BTC with completion expected in the first half of 2024;
  • Our partner, Jazz Pharmaceuticals, gained alignment with FDA on the confirmatory trial evaluating zanidatamab in first-line metastatic BTC patients;
  • Continued patient enrollment in the HERIZON-GEA-01 (NCT05152147) pivotal clinical study for zanidatamab in first-line HER2-positive GEA remains on track to announce top-line data during 2024;
  • Nominated two new preclinical product candidates (ZW220 and ZW251) that leverage Zymeworks’ novel ADC technology platforms, with planned IND applications for both candidates in 2025;
  • Through a series of publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of IND candidates in our ‘5 by 5’ program (ZW171, ZW191, ZW220, and ZW251);
  • Regained full development rights for zanidatamab zovodotin (ZW49) with plans to conduct a Phase 2 study in NSCLC in 2024;
  • Strengthened board of directors through the addition of three new members, Carlos Campoy, Dr. Nancy Davidson, and Derek Miller;
  • Expanded the global footprint of our Early-Stage Development team into Dublin, California, and Singapore while retaining key talent and establishing fit-for-purpose facilities;
  • Inclusion of common stock in Russell 3000 Index and Nasdaq Biotechnology Index (NBI) as a result of redomicile to Delaware and switch from NYSE to Nasdaq completed in 2022; and
  • Completed $50 million private placement to EcoR1 Capital, with proceeds expected to help extend cash runway into H2 2027.

“2023 was an important year for Zymeworks and for our shareholders,” said Mr. Galbraith. “With the significant accomplishments of last year, we believe we have the resources and expertise in place to continue to make substantial progress in 2024 and 2025, to advance our fully unencumbered development programs, and execute on our mission to improve the standard of care for difficult-to-treat diseases.”

Updated Financial Guidance

Zymeworks provided an update on its unaudited cash resources, which consist of cash, cash equivalents, and marketable securities. As of December 31, 2023, Zymeworks had cash resources on hand of approximately $455 million (unaudited).

“Based on current operating plans and including the recent private placement with EcoR1 Capital, we expect to have cash resources to fund our R&D programs and business operations into the second half of 2027,” said Chris Astle, Ph.D., Senior Vice President and Chief Financial Officer at Zymeworks. “Our strong financial position allows us to be opportunistic in evaluating additional R&D opportunities and pursuing potential strategic partnerships and collaborations. We are committed to ensuring that future spending remains prioritized and allocated to development programs that we believe are differentiated and most likely to drive future increases in enterprise value. We will continue to assess clinical data emerging from our development programs and the rapidly evolving competitive environment to ensure efficient allocation of our cash and human resources.”

Key 2024 and 2025 Priorities

Zanidatamab Development Collaborations

Our collaboration agreements with Jazz Pharmaceuticals (“Jazz”) and BeiGene, Ltd (“BeiGene”) represent important components of the commercialization strategy for zanidatamab and our strategy to continue to expand our future product pipeline.

Under our amended agreement with Jazz, we have received an aggregate of $375 million in proceeds to date, and remain eligible to receive up to $525 million upon the achievement of certain regulatory milestones and up to $862.5 million in potential commercial milestone payments, and tiered royalties between 10% and 20% on future zanidatamab sales, pending regulatory approval of zanidatamab. Our collaboration agreement with BeiGene in certain Asia Pacific (APAC) regions (excluding Japan but including the People’s Republic of China, South Korea and other countries, Australia, and New Zealand) remains important given the high prevalence of BTC and GEA in the APAC region. Through our collaboration with BeiGene on zanidatamab, we remain eligible to receive up to $195 million in additional development and commercial milestones together with tiered royalties ranging from the high single digit percentages up to 19.5% on net sales of zanidatamab, pending regulatory approval.

During 2024, we look forward to providing further updates on our collaboration agreements and our progress towards regulatory filings and potential approvals, new clinical studies, and future data releases, including the anticipated announcement of top-line clinical data from the ongoing pivotal study, HERIZON-GEA-01, in first-line HER2-positive GEA.

Research and Early-Stage Development Programs

Our scientific strategy supports our goal to build a broad and differentiated product pipeline of ADCs and multispecific antibody therapeutics (MSATs) to be developed from our technology platforms, targeting five new INDs by 2026 (‘5 by 5’ program). We expect to submit INDs for ZW171 and ZW191 in 2024, and INDs for ZW220 and ZW251 in 2025. During 2024, we expect to nominate the final ‘5 by 5’ product candidate for preclinical development with an expected IND filing in 2026.

Zanidatamab zovodotin represents a unique and differentiated product candidate among the HER2 ADCs currently under active development. Based on our development efforts to date, we believe that zanidatamab zovodotin has the potential to become a novel treatment option for advanced HER2+ cancers, supporting further but limited clinical development. It will be evaluated in a planned Phase 2 study in HER2 over-expressing NSCLC patients in combination with a checkpoint inhibitor. We anticipate the results of this clinical study may provide the rationale for one or more registrational studies, which we would expect to undertake with a future collaboration partner.

We plan to continue to be active in presenting and publishing data from our preclinical and clinical programs in 2024 as well as evaluate opportunities beyond our ‘5 by 5’ program by leveraging our proprietary technologies to target additional therapeutic applications such as autoimmune and inflammatory diseases, bispecific biparatopic ADCs, dual-payload ADCs, multi-specific immune cell engagers and immune-oncology pursuant to our ADVANCE R&D strategy. An R&D Day to highlight our progress and future R&D strategy will be held in the fourth quarter of 2024.

Legacy Partnerships and Future Collaborations

Zymeworks continues to have active licensing arrangements with seven key pharmaceutical and biotechnology partners, with two product candidates currently in clinical development. During 2024 and 2025, the Company remains eligible to earn additional milestone payments under our existing agreements as products continue to advance in development as well as potential payments for expansion or extension of existing agreements. The Company will also continue to evaluate the feasibility of monetization of all or a portion of our rights to receive future milestone payments and royalties under these legacy agreements.

We will also explore new opportunities for development collaborations in early-stage clinical programs, and plan to continue to evaluate the potential for additional multi-product collaborations and partnerships to broaden or accelerate our development plans.

J.P. Morgan Healthcare Conference Presentation and Webcast

Management will participate in the J.P. Morgan 42nd Annual Healthcare Conference taking place in San Francisco, California, from January 8-11, 2024, and present on January 11 at 8:15 am PT. The presentation and webcast will be available on Zymeworks’ website.

About Zanidatamab

Zanidatamab is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

About Zymeworks Inc.

Zymeworks is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities, including those with respect to its pipeline and R&D strategy; preliminary and unaudited estimates of its cash, cash equivalents, and marketable securities; Zymeworks’ anticipated financial runway and funding of its current operations; Zymeworks’ estimated reimbursements from collaboration partners; future financial position; timing of milestones with respect to zanidatamab, zanidatamab zovodotin and other potential product candidates; potential therapeutic effects and commercial potential of zanidatamab and Zymeworks’ other product candidates; the anticipated benefits of the collaboration agreement with Jazz; the anticipated benefits of Zymeworks’ agreements with BeiGene and its other collaborators; Zymeworks’ ability to receive additional payments pursuant to its collaboration agreements, including any future milestone payments and royalties; the commercial potential of zanidatamab and Zymeworks’ and its partners’ ability to obtain regulatory approval of and successfully commercialize zanidatamab; the timing of and results of the interactions with regulators, including anticipated regulatory filings and the timing thereof; current and future partnerships and strategic collaborations; Zymeworks’ development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future clinical trials and studies and presentation of related data; the ability to advance product candidates into later stages of development; the timing of anticipated IND filings; and other information that is not historical information. When used herein, words such as “believe”, “future”, “anticipate”, “approximately”, “will”, “plans”, “may”, “potential”, “expect”, “should”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: Zymeworks’ assumptions regarding its financial condition may be incorrect; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; Zymeworks may be unable to maintain or enter into new partnerships or strategic collaborations; and the other risks described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2023 (a copy of which may be obtained at www.sec.gov and www.sedar.com).

Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2023, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding year-end cash, cash equivalents, and marketable securities are the responsibility of management, are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2023, based on the foregoing estimates.

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:
Shrinal Inamdar
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com

GlobeNewswire Distribution ID 9012435

Zymeworks Outlines Strategic Priorities and Outlook for 2024 and 2025

  • Company well-positioned for further progress and broadening of R&D pipeline
  • Cash resources of approximately $455 million as of December 31, 2023 (unaudited)
  • Expected cash runway, including proceeds from recent private placement, into 2H 2027
  • Top-line data readout from the Phase 3 trial evaluating zanidatamab in HER2-positive gastroesophageal adenocarcinoma (GEA), HERIZON-GEA-01, expected in 2024
  • Expected regulatory reviews ongoing during 2024 for zanidatamab in second-line biliary tract cancers (BTC) in the United States and China with our partners Jazz Pharmaceuticals and BeiGene
  • Expected Investigational New Drug (IND) applications and first-in-human (FIH) studies for ZW171 and ZW191 candidates in 2024 and ZW220 and ZW251 in 2025
  • Progression on ‘5 by 5’ portfolio and ADVANCE with R&D Day scheduled for Q4-24
  • Additional leadership appointments announced separately today
  • Company presentation on Thursday, January 11, 2024 at 08:15 a.m. Pacific Time (PT) at the J.P. Morgan 42nd Annual Healthcare Conference

VANCOUVER, British Columbia, Jan. 04, 2024 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today provided an update on key strategic priorities for 2024 and 2025.

“We begin 2024 in an exciting position, having met key objectives set for our programs in 2022 and 2023, including generating data supporting the clinical development of zanidatamab, identifying strong new preclinical product candidates and ensuring that we continue to have the financial resources and leadership necessary to support the Company’s strategic objectives,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “We’re looking forward to 2024 as we approach a pivotal Phase 3 data readout this year with our partners Jazz Pharmaceuticals and BeiGene from the HERIZON-GEA-01 clinical trial for our lead candidate, zanidatamab, in first-line gastroesophageal andenocarcinoma. These data, coupled with the potential for initial regulatory approvals for zanidatamab in second-line biliary tract cancers in 2025 or earlier, are expected to be significant events in our progress to make a meaningful difference in the lives of cancer patients. Beyond zanidatamab, our growing global presence helps position us to achieve efficiency in clinical development, with a continued focus on advancing nominated product candidates from our ‘5 by 5’ portfolio and our ADVANCE R&D strategy. We will continue to evaluate opportunities to broaden or accelerate our development efforts through the formation of strategic partnerships and collaborations.”

“Our most important current R&D priority is to progress our differentiated portfolio of antibody-drug conjugates (ADCs) into clinical studies during 2024 and 2025, especially our potential best-in-class folate receptor-alpha-targeted ADC, ZW191, expected to enter FIH studies during 2024. Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025. All three ADCs were designed with our moderate-potency, proprietary topoisomerase 1 inhibitor, ZD06519. Beyond ADCs, we look to make progress in our differentiated approach to next-generation multi-specific antibodies, starting with our planned IND filing and FIH studies in 2024 for ZW171, our 2+1 mesothelin-directed T-cell engager.”

“We were also able to strengthen our board of directors with the additions of Carlos Campoy, Dr. Nancy Davidson and Derek Miller in 2023,” said Mr. Galbraith. “These appointments, together with the separate announcement today of the broadening of the Zymeworks leadership team, underscore our commitment to having the expertise and experience in place at all levels to achieve our business objectives in 2024 and 2025.”

Key 2023 Accomplishments:

  • Our partner, Jazz Pharmaceuticals, presented positive pivotal Phase 2b trial data (NCT04466891) evaluating zanidatamab in HER2-amplified BTC at the American Society of Clinical Oncology annual meeting and initiated rolling Biologics License Application (BLA) submission for accelerated approval in second-line BTC with completion expected in the first half of 2024;
  • Our partner, Jazz Pharmaceuticals, gained alignment with FDA on the confirmatory trial evaluating zanidatamab in first-line metastatic BTC patients;
  • Continued patient enrollment in the HERIZON-GEA-01 (NCT05152147) pivotal clinical study for zanidatamab in first-line HER2-positive GEA remains on track to announce top-line data during 2024;
  • Nominated two new preclinical product candidates (ZW220 and ZW251) that leverage Zymeworks’ novel ADC technology platforms, with planned IND applications for both candidates in 2025;
  • Through a series of publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of IND candidates in our ‘5 by 5’ program (ZW171, ZW191, ZW220, and ZW251);
  • Regained full development rights for zanidatamab zovodotin (ZW49) with plans to conduct a Phase 2 study in NSCLC in 2024;
  • Strengthened board of directors through the addition of three new members, Carlos Campoy, Dr. Nancy Davidson, and Derek Miller;
  • Expanded the global footprint of our Early-Stage Development team into Dublin, California, and Singapore while retaining key talent and establishing fit-for-purpose facilities;
  • Inclusion of common stock in Russell 3000 Index and Nasdaq Biotechnology Index (NBI) as a result of redomicile to Delaware and switch from NYSE to Nasdaq completed in 2022; and
  • Completed $50 million private placement to EcoR1 Capital, with proceeds expected to help extend cash runway into H2 2027.

“2023 was an important year for Zymeworks and for our shareholders,” said Mr. Galbraith. “With the significant accomplishments of last year, we believe we have the resources and expertise in place to continue to make substantial progress in 2024 and 2025, to advance our fully unencumbered development programs, and execute on our mission to improve the standard of care for difficult-to-treat diseases.”

Updated Financial Guidance

Zymeworks provided an update on its unaudited cash resources, which consist of cash, cash equivalents, and marketable securities. As of December 31, 2023, Zymeworks had cash resources on hand of approximately $455 million (unaudited).

“Based on current operating plans and including the recent private placement with EcoR1 Capital, we expect to have cash resources to fund our R&D programs and business operations into the second half of 2027,” said Chris Astle, Ph.D., Senior Vice President and Chief Financial Officer at Zymeworks. “Our strong financial position allows us to be opportunistic in evaluating additional R&D opportunities and pursuing potential strategic partnerships and collaborations. We are committed to ensuring that future spending remains prioritized and allocated to development programs that we believe are differentiated and most likely to drive future increases in enterprise value. We will continue to assess clinical data emerging from our development programs and the rapidly evolving competitive environment to ensure efficient allocation of our cash and human resources.”

Key 2024 and 2025 Priorities

Zanidatamab Development Collaborations

Our collaboration agreements with Jazz Pharmaceuticals (“Jazz”) and BeiGene, Ltd (“BeiGene”) represent important components of the commercialization strategy for zanidatamab and our strategy to continue to expand our future product pipeline.

Under our amended agreement with Jazz, we have received an aggregate of $375 million in proceeds to date, and remain eligible to receive up to $525 million upon the achievement of certain regulatory milestones and up to $862.5 million in potential commercial milestone payments, and tiered royalties between 10% and 20% on future zanidatamab sales, pending regulatory approval of zanidatamab. Our collaboration agreement with BeiGene in certain Asia Pacific (APAC) regions (excluding Japan but including the People’s Republic of China, South Korea and other countries, Australia, and New Zealand) remains important given the high prevalence of BTC and GEA in the APAC region. Through our collaboration with BeiGene on zanidatamab, we remain eligible to receive up to $195 million in additional development and commercial milestones together with tiered royalties ranging from the high single digit percentages up to 19.5% on net sales of zanidatamab, pending regulatory approval.

During 2024, we look forward to providing further updates on our collaboration agreements and our progress towards regulatory filings and potential approvals, new clinical studies, and future data releases, including the anticipated announcement of top-line clinical data from the ongoing pivotal study, HERIZON-GEA-01, in first-line HER2-positive GEA.

Research and Early-Stage Development Programs

Our scientific strategy supports our goal to build a broad and differentiated product pipeline of ADCs and multispecific antibody therapeutics (MSATs) to be developed from our technology platforms, targeting five new INDs by 2026 (‘5 by 5’ program). We expect to submit INDs for ZW171 and ZW191 in 2024, and INDs for ZW220 and ZW251 in 2025. During 2024, we expect to nominate the final ‘5 by 5’ product candidate for preclinical development with an expected IND filing in 2026.

Zanidatamab zovodotin represents a unique and differentiated product candidate among the HER2 ADCs currently under active development. Based on our development efforts to date, we believe that zanidatamab zovodotin has the potential to become a novel treatment option for advanced HER2+ cancers, supporting further but limited clinical development. It will be evaluated in a planned Phase 2 study in HER2 over-expressing NSCLC patients in combination with a checkpoint inhibitor. We anticipate the results of this clinical study may provide the rationale for one or more registrational studies, which we would expect to undertake with a future collaboration partner.

We plan to continue to be active in presenting and publishing data from our preclinical and clinical programs in 2024 as well as evaluate opportunities beyond our ‘5 by 5’ program by leveraging our proprietary technologies to target additional therapeutic applications such as autoimmune and inflammatory diseases, bispecific biparatopic ADCs, dual-payload ADCs, multi-specific immune cell engagers and immune-oncology pursuant to our ADVANCE R&D strategy. An R&D Day to highlight our progress and future R&D strategy will be held in the fourth quarter of 2024.

Legacy Partnerships and Future Collaborations

Zymeworks continues to have active licensing arrangements with seven key pharmaceutical and biotechnology partners, with two product candidates currently in clinical development. During 2024 and 2025, the Company remains eligible to earn additional milestone payments under our existing agreements as products continue to advance in development as well as potential payments for expansion or extension of existing agreements. The Company will also continue to evaluate the feasibility of monetization of all or a portion of our rights to receive future milestone payments and royalties under these legacy agreements.

We will also explore new opportunities for development collaborations in early-stage clinical programs, and plan to continue to evaluate the potential for additional multi-product collaborations and partnerships to broaden or accelerate our development plans.

J.P. Morgan Healthcare Conference Presentation and Webcast

Management will participate in the J.P. Morgan 42nd Annual Healthcare Conference taking place in San Francisco, California, from January 8-11, 2024, and present on January 11 at 8:15 am PT. The presentation and webcast will be available on Zymeworks’ website.

About Zanidatamab

Zanidatamab is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

About Zymeworks Inc.

Zymeworks is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities, including those with respect to its pipeline and R&D strategy; preliminary and unaudited estimates of its cash, cash equivalents, and marketable securities; Zymeworks’ anticipated financial runway and funding of its current operations; Zymeworks’ estimated reimbursements from collaboration partners; future financial position; timing of milestones with respect to zanidatamab, zanidatamab zovodotin and other potential product candidates; potential therapeutic effects and commercial potential of zanidatamab and Zymeworks’ other product candidates; the anticipated benefits of the collaboration agreement with Jazz; the anticipated benefits of Zymeworks’ agreements with BeiGene and its other collaborators; Zymeworks’ ability to receive additional payments pursuant to its collaboration agreements, including any future milestone payments and royalties; the commercial potential of zanidatamab and Zymeworks’ and its partners’ ability to obtain regulatory approval of and successfully commercialize zanidatamab; the timing of and results of the interactions with regulators, including anticipated regulatory filings and the timing thereof; current and future partnerships and strategic collaborations; Zymeworks’ development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future clinical trials and studies and presentation of related data; the ability to advance product candidates into later stages of development; the timing of anticipated IND filings; and other information that is not historical information. When used herein, words such as “believe”, “future”, “anticipate”, “approximately”, “will”, “plans”, “may”, “potential”, “expect”, “should”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: Zymeworks’ assumptions regarding its financial condition may be incorrect; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; Zymeworks may be unable to maintain or enter into new partnerships or strategic collaborations; and the other risks described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2023 (a copy of which may be obtained at www.sec.gov and www.sedar.com).

Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2023, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding year-end cash, cash equivalents, and marketable securities are the responsibility of management, are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2023, based on the foregoing estimates.

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:
Shrinal Inamdar
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com

GlobeNewswire Distribution ID 9012435

Zymeworks Announces Additional Leadership Appointments

  • Dr. Jeffrey Smith named Executive Vice President and Chief Medical Officer
  • Dr. John Fann promoted to Senior VP, Process Sciences
  • Seven new Vice Presidents appointed, underscoring commitment to leadership development

VANCOUVER, British Columbia, Jan. 04, 2024 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced significant additions to its leadership team. These additions to the leadership team highlight Zymeworks’ commitment to nurturing and advancing internal talent to key leadership roles while strengthening the capabilities and experience of the organization.

“At Zymeworks, we recognize that our greatest asset is our people. Elevating talented individuals is a reflection of their strong performance for the company, our confidence in their abilities and the emphasis we place on cultivating leaders from within. As we continue to grow, their expanded roles will play crucial parts in advancing our ‘5 by 5’ development programs into the clinic in 2024 and 2025, planning to develop our ADVANCE preclinical programs into clinical studies by 2027 and helping to form the necessary collaborations and partnerships for our emerging product portfolio,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks.

Leadership Team

Dr. Jeffrey Smith has been promoted to Executive Vice President and Chief Medical Officer, where he will play a key role in leading the clinical development of our early-stage programs and overseeing our integrated global early-stage development group.

Dr. John Fann has been promoted to Senior Vice President, Process Sciences, where he will continue to play a key role in supporting the advancement of our new product candidates from preclinical studies into clinical trials.

In addition, the following individuals have been appointed to the leadership team:

  • Raquera Brown, Vice President, Quality
  • Bijal Desai, Vice President, Finance & Strategy
  • Lucas Donigian, Vice President, Business & Commercial Development
  • Dr. Lindsey Foulkes, Vice President, Corporate Development
  • Cathie Graham, Vice President, Legal
  • Laura O’Connor, Vice President, Human Resources & DEI
  • Dr. Joe Woolery, Vice President, Early-Stage Development (Americas)

“These outstanding individuals have consistently demonstrated exceptional leadership abilities, commitment, and a deep understanding of our business objectives and our commitment to patients,” Mr. Galbraith added. “After reducing the management team to a small core group upon my appointment in early 2022, these new appointments reflect the additional management resources necessary to manage and advance our emerging product portfolio.”

Additional information on the background and experience of these individuals is available on the Company’s website at www.zymeworks.com.

About Zymeworks Inc.

Zymeworks is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements regarding Zymeworks’ expectations regarding implementation of its strategic priorities; the timing of and results of interactions with regulators; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; expectations regarding future regulatory filings and approvals and the timing thereof; potential therapeutic effects of zanidatamab and Zymeworks’ other product candidates; commercial potential of technology platforms and product candidates; Zymeworks’ preclinical pipeline; Zymeworks’ ability to maintain existing and execute new collaborations and partnerships and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; inability to maintain or enter into new partnerships or strategic collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; and the other risks described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2023 (a copy of which may be obtained at www.sec.gov and www.sedar.com).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:
Shrinal Inamdar
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com

GlobeNewswire Distribution ID 9012333