INDUSTRIAL IMPACT

Bicycle Therapeutics Announces Expansion of Genentech Immuno-Oncology Collaboration

Bicycle Therapeutics | October 26, 2021

Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that Genentech, a member of the Roche Group, has exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle®-based immuno-oncology therapies.

Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech has exercised an option to include a new program under the agreement, triggering a $10 million payment to Bicycle. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration.

We are pleased both with the progress achieved so far in our ongoing work with Genentech and that Genentech has elected to exercise an option to add a new program under the collaboration. We believe the expansion of our collaboration underscores the potential utility of Bicycles compared to other modalities, as well as the potential broad applicability of Bicycles in a wide-range of targets “We look forward to continuing to work closely with the preeminent immuno-oncology team at Genentech to develop potential new cancer treatments based on Bicycles.”

Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics

About Bicycle Therapeutics
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC™) targeting EphA2, and BT8009, a second-generation BTC™ targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC™ that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Centre for Drug Development of Cancer Research UK. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s collaboration with Genentech; the discovery, development and potential commercialization of potential product candidates using Bicycle’s technology and under the collaboration agreement; the therapeutic potential for Bicycles in immuno-oncology and other applications; and the potential to receive milestone payments and royalties under the strategic collaboration agreement. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration agreement with Genentech, including that Bicycle and Genentech may not successfully identify, develop and commercialize additional product candidates; the risk that Bicycle may not be able to maintain its collaboration with Genentech and realize the benefits thereof; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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CELL AND GENE THERAPY

BioMarin and Skyline Therapeutics Announce Strategic Collaboration to Develop Novel Gene Therapies for Cardiovascular Diseases

BioMarin Pharmaceutical Inc. | December 17, 2021

BioMarin Pharmaceutical Inc. and Skyline Therapeutics a gene and cell therapy company focused on developing novel treatments for unmet medical needs, announced a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated Virus gene therapies to treat genetic cardiovascular diseases. The partnership will leverage Skyline Therapeutics' integrated AAV gene therapy platform based on its proprietary vector engineering and design technology and manufacturing capability to develop innovative gene therapies with a focus on genetic dilated cardiomyopathies, a group of progressively advancing, devastating diseases with no targeted treatment options. Under the agreement, BioMarin and Skyline Therapeutics will collaborate on discovery and research through to an Investigational New Drug Application . BioMarin brings experience in gene therapy development, cardiovascular biology and insights into genetic basis of diseases, and Skyline contributes its expertise in developing gene therapy products including vector engineering and design technology and manufacturing capabilities to this collaboration. Each company will advance the programs through clinical development in their pre-defined territories. In support of its R&D efforts for the collaborative projects, Skyline Therapeutics will receive an undisclosed payment associated with signing, comprising an upfront payment and an equity investment from BioMarin, and is eligible to receive pre-specified payments for R&D, regulatory and commercial milestones. BioMarin will have the rights to commercialize therapeutic products resulting from the collaboration in its territories, including the United States, Europe, and Latin America, and Skyline Therapeutics will be responsible for commercialization in the Asia-Pacific region. In addition, Skyline Therapeutics will be eligible to receive royalty payments on future sales from BioMarin in its territories. "We are thrilled to announce what we anticipate will be a fruitful collaboration at the interface between Skyline's innovative approach to AAV vector engineering and design and our team's proven expertise in creating and developing gene therapies," Kevin Eggan, Group Vice President, Head of Research and Early Development, from BioMarin "We are excited to partner with Skyline Therapeutics to tackle these genetic forms of dilated cardiomyopathy. This collaboration strengthens our leadership in cardiac gene therapy and extends our R&D collaboration to Asia, where a large number of patients suffer from these devastating diseases," said Brinda Balakrishnan, Group Vice President, Corporate and Business Development at BioMarin. "We look forward to fostering this collaboration and bringing transformative medicines to patients worldwide." "Dilated cardiomyopathy is a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to complications such as arrhythmia and heart failure, resulting in substantial morbidity and mortality. Mutations in many genes are associated with the development of DCM, among other etiologies for the disease," said Jay Hou, Chief Scientific Officer at Skyline Therapeutics. "Together with BioMarin's team we have identified a number of critical genes associated with DCM. We are delighted to work closely with BioMarin and apply our AAV vector technology to interrogate these new targets and develop novel treatments for DCM patients." "The collaboration with BioMarin leverages both companies' capabilities in the development of gene therapies. With the BioMarin team, we share the goal of working in concert to develop therapies for genetic cardiovascular disease that address high unmet medical needs," said Amber Cai, CEO of Skyline Therapeutics. "Together, we will utilize gene therapy to tackle cardiovascular diseases with a disease modifying trailblazing approach that could change the treatment paradigm in these conditions." About Dilated Cardiomyopathy (DCM) DCM is a common cause of heart failure and end-stage DCM, which often leads to heart transplantation. Despite improvements in pharmacotherapy and care, the five-year survival rate of DCM is only about 50%. Hundreds of thousands of patients suffer from the genetic forms of DCM in U.S., EU, China, and Japan. More than 50 genes associated with DCM have been identified, accounting for 40-50% of familial DCM cases. Many of these genes encode proteins with important known functions in cardiomyocytes related to cytoskeletal, sarcomere and nuclear envelope biology. Our aim is to correct the pathways altered by these genetic contributors to DCM through AAV based gene therapy, in each case addressing the root cause of the disease. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates. About Skyline Therapeutics Skyline Therapeutics is a fully integrated gene and cell therapy company dedicated to the discovery, development and delivery of innovative therapies. Established in 2019, Skyline Therapeutics has built a proprietary AAV-based gene therapy platform that integrates novel capsid engineering and vector design, analytical and process development, and state-of-the-art GMP manufacturing capabilities that support large scale clinical-grade vector production. The Skyline team of world-class experts and leaders in science, technology and business brings industry-leading know-how and is advancing a pipeline of diversified programs that address multiple diseases including ocular, neurological, metabolic and blood disorders. Skyline Therapeutics is also broadening its therapeutic expertise to cover more disease areas with high unmet need such as cardiovascular disorders through strategic partnerships. Headquartered in China, Skyline Therapeutics currently has research, development and manufacturing capabilities in Shanghai and Hangzhou.

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MEDICAL

Ochre Bio Launches ‘Liver ICU’ in the United States to Evaluate Effects of RNA Therapies on Human Liver Performance

Ochre Bio | May 12, 2022

Ochre Bio, a biotech company developing RNA medicines for chronic liver diseases, announced today the launch of their ‘Liver ICU’. Housed in BioLabs@NYULangone, a biopharma incubator in New York City, this research site will evaluate the efficacy of new RNA therapeutics on whole human livers maintained on machines. The use of discarded donor livers for research is expected to enhance timelines and accuracy of liver medicine research by testing interventions directly in human livers maintained under conditions mimicking human physiology. This site is a part of a network of three leading liver perfusion research sites across the US. The other two US research sites are the laboratory of Greg Tietjen, Ph.D at Yale University, a pioneer in the field of ex vivo organ research, and LifeShare of Oklahoma, a leading US organ procurement organization. In addition, Ochre Bio is also announcing a partnership with OrganOx, a company at the forefront of changing the way donor livers are preserved in the critical time between donation and transplantation, and one of the first companies to have a liver perfusion device approved by the FDA. This research will involve hundreds of donor livers being kept alive outside the body for multiple days each. These are donor livers that cannot be used for transplant patients for various reasons, and so would be otherwise discarded. The livers will be maintained in human physiological conditions and used to test therapeutic interventions, with the goal of finding new therapies to improve liver transplant outcomes, in the hopes of thereby increasing the supply of transplantable livers, as well as uncovering insights relevant to a wider set of liver diseases. Greg Tietjen’s research group at Yale and LifeShare of Oklahoma will work with the Ochre research team towards being able to consistently perfuse organs for several days to study the effects of RNA therapy on liver performance. We’re excited to announce this new research site in the US, as well as these partnerships with world leaders in liver perfusion research and transplant medicine, This collaboration to evaluate the effects of RNA therapy directly in human livers preclinically is a step change for liver research, that we hope will lead to treatments for a number of liver diseases, and one day reduce the burden of liver transplantation for patients.” Jack O’Meara, CEO & Co-Founder at Ochre Bio. Thanks to the collaborative efforts of Ochre Bio, OrganOx, Yale University and, LifeShare of Oklahoma, the unique capabilities of the OrganOx metra are enabling multi-day isolated organ perfusion research and facilitating a new and exciting approach to developing novel therapeutics for liver diseases. We look forward to seeing the results of this approach leave research and enter the clinic in the future.” Craig Marshall, CEO, OrganOx. We view this work as an opportunity to honor the profound gift that every donor organ represents. While the organs enrolled in this study may not save the life of one transplant recipient, they have the potential to save hundreds of thousands of lives in the future by enabling breakthrough new therapies from Ochre Bio to treat end stage liver disease.” Gregory Tietjen, Ph.D., Assistant Professor of Transplant Surgery, Yale School of Medicine About Ochre Bio Ochre Bio is a biotechnology company developing RNA therapies for chronic liver diseases. Using a combination of genomic deep phenotyping, precision RNA medicine, and testing in live human donor livers, Ochre is developing therapies for important liver health challenges, from increasing donor liver supply to reducing cirrhosis complications. With laboratories across the UK, Asia and North America, the team has decades of experience leading liver genomics research and bringing advanced therapies to market.

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Cortexyme Successfully Completes Acquisition of Novosteo

Cortexyme | May 21, 2022

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company developing therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, today announced the completion of its acquisition of Novosteo, a privately-held biotech company focused on targeted therapeutics to treat rare skeletal diseases, bone cancer and injury. Novosteo stockholders now own approximately 15.5% of the combined company. With the completion of the acquisition, Cortexyme appointed former Novosteo executives Dr. Dirk Thye as Chief Executive Officer, and Dr. Karen Smith as Chief Medical Officer of Cortexyme. Dr. Thye and Dr. Philip Low have been appointed to the Cortexyme’s Board of Directors. Cortexyme plans to change its name to Quince Therapeutics, Inc. in the coming months to reflect the broadening pipeline of the company. Inducement Grant Under Nasdaq Listing Rule 5635(C)(4) In conjunction with the close of the Novosteo acquisition, Cortexyme reported that the Compensation Committee of the company’s Board of Directors approved grants of stock options to purchase an aggregate of 3,744,255 shares of Cortexyme’s common stock, which includes options to purchase (i) 1,979,650 shares to Dr. Dirk Thye, (ii) 1,365,449 shares to Dr. Karen Smith, (iii) 353,656 shares to Brendan Hannah, and (iv) an aggregate of 45,500 shares to six additional newly hired employees. The stock options will be issued under the Cortexyme, Inc. 2022 Inducement Plan with a grant date of May 23, 2022 and an exercise price equal to the closing price of a share of Cortexyme common stock on the grant date. The stock options are being issued as an inducement material to each new employee entering into employment with Cortexyme, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options vest over four years, with 25% vesting on the first anniversary of the vesting commencement date for each employee and the remainder vesting in 36 installments over the following three years, subject to each employee being continuously employed by Cortexyme as of such vesting dates. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company dedicated to improving the lives of patients diagnosed with degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others.

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INDUSTRIAL IMPACT

Moderna and Thermo Fisher Scientific Announce Long-Term Strategic Collaboration

Moderna, Inc. | February 24, 2022

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