Life Science News

Transaction is expected to bolster Ginkgo's growing biosecurity platform and provide expanded epidemic tracking, modeling, and forecasting offerings to public health leaders and communities

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the purchase of certain epidemiological data infrastructure assets from Baktus, Inc., a Delaware -based public benefit corporation. Under the terms of the deal, Ginkgo will assume ownership of proprietary datasets, modeling and analytic tools, and a software platform with the capabilities to track, model, and forecast epidemics and associated risks and impacts. Ginkgo also expects to integrate several ongoing epidemiological analysis projects and a team of epidemiological data experts into its biosecurity and public health initiative, Concentric by Ginkgo.

(PRNewsfoto/Ginkgo Bioworks)

Baktus, through its subsidiary, Metabiota, Inc., has built an extensive database of infectious disease outbreaks. In addition to epidemiological tracking and forecasting, the company created specialized data infrastructure to help governments and other partners understand and model the risks and disruptive impacts of pathogens in order to promote resilience to pandemics and epidemics. Baktus and Metabiota are expected to continue their independent operations after transferring the assets and epidemiological data personnel included in this transaction.

"We believe robust public health data is the bedrock of biosecurity—it's what enables public health leaders to direct resources where they're needed the most and researchers to develop targeted vaccines, diagnostics, and therapeutics," said Matt McKnight , General Manager for Biosecurity at Ginkgo. "Integrating state-of-the-art epidemiological modeling and predictive capabilities with our end-to-end biosecurity offerings will help us continue making the data we gather on pathogen spread and evolution that much more meaningful and actionable for public health leaders and communities."

"Our team has spent nearly a decade building epidemiological data and risk modeling tools for the public and private sector to more effectively quantify, mitigate and manage epidemic risk. This transaction demonstrates the importance of these efforts and capabilities," said Nita Madhav , outgoing CEO of Metabiota, who will be joining Ginkgo as part of the transaction. "Ginkgo's biosecurity initiative is an ideal home for our data, analytics, and expertise, and we are very excited to join the Ginkgo team."

Concentric has built a large-scale biosecurity platform, bolstered by a nationwide laboratory and operational network, to deliver comprehensive COVID-19 monitoring programs and services across thousands of sites in the U.S., including schools, airports , and other congregate settings. Concentric is building upon this foundation to create a sustainable global biosecurity infrastructure to help detect, mitigate and respond to a wide variety of biological threats, and we expect this transaction to be a key milestone towards developing that infrastructure.

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization, and therapeutics discovery. For more information, visit www.ginkgobioworks.com .

Forward-Looking Statements of Ginkgo Bioworks

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the transaction and Ginkgo's biosecurity platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com

GINKGO BIOWORKS MEDIA CONTACT:
press@ginkgobioworks.com

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SOURCE Ginkgo Bioworks

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DNA
BriaCell Partners with Caris Life Sciences® to Expand Patient Outreach and Molecular Profiling

BriaCell Partners with Caris Life Sciences® to Expand Patient Outreach and Molecular Profiling

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that it has signed an agreement with Caris Life Sciences ® (Caris), a leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare.

"Our goal is to develop immunotherapies that are personalized for each patient, and Caris' extensive library of clinical data, cutting-edge biomarker technology, and expertise will be invaluable in achieving our objectives," stated Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. "We expect Caris' unique platform to help us identify patients who do not respond to existing treatments and are more likely to benefit from our immunotherapy treatments."

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Renee Wegrzyn Slated to Lead New Advanced Research Projects Agency for Health

Renee Wegrzyn Slated to Lead New Advanced Research Projects Agency for Health

The White House today announced that President Biden intends to appoint Renee Wegrzyn PhD, as the first Director of the Advanced Research Projects Agency for Health ( ARPA-H ). Dr. Wegrzyn is currently the Vice President for Business Development at Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming. ARPA-H was established in March 2022 to drive transformative health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

(PRNewsfoto/Ginkgo Bioworks)

"I am deeply honored to have the opportunity to shape ARPA-H's ambitious mission and foster a vision and approach that will improve health outcomes for the American people, including President Biden's Cancer Moonshot," said Dr. Wegrzyn. "Some of the problems we face every day - especially in health and disease - are so large they can seem insurmountable. I have seen firsthand the tremendous expertise and energy the U.S. biomedical and biotechnological enterprise can bring to solve some of the toughest health challenges. ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health—not only for complex diseases like cancer, but also systemic barriers like supply chain gaps and equitable access to breakthrough technologies and cures for everyone."

Dr. Wegrzyn holds a PhD and BS in Applied Biology from the Georgia Institute of Technology , was a Fellow in the Center for Health Security Emerging Leaders in Biosecurity Initiative (ELBI), and completed her postdoctoral training as an Alexander von Humboldt Fellow in Heidelberg, Germany . Early in her career, she led research and development teams in private industry in the areas of biosecurity, gene therapies, emerging infectious disease, neuromodulation, synthetic biology, and diagnostics. She served as Program Manager in the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA), where she leveraged the tools of synthetic biology and gene editing to enhance biosecurity, support the domestic bioeconomy, and thwart biothreats. Since joining Ginkgo in August 2020 , she has built out its innovation pipeline for biosecurity, developing and scaling new tools to combat infectious disease and other biological threats through broad community access.

"This is a really great moment for health and biomedical innovation. Dr. Wegrzyn stands out as a thoughtful, innovative, and practical leader," said Matt McKnight , General Manager for Biosecurity at Ginkgo. "She understands the health innovation ecosystem from every angle—from early-stage research and development to commercialization and community impact, across the public, private, and academic sectors. In her time at Ginkgo, she has been an incredible leader, and her work has shaped the emerging biosecurity industry for years to come. Renee uniquely understands what is needed in the next era of invention, and ARPA-H will benefit tremendously from being shaped by her vision."

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

MEDIA CONTACT:

press@ginkgobioworks.com

INVESTOR CONTACT:

investors@ginkgobioworks.com

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SOURCE Ginkgo Bioworks

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Ginkgo Bioworks Appoints Dr. Behzad Mahdavi as Senior Vice President of Biopharma Manufacturing & Life Science Tools

Ginkgo Bioworks Appoints Dr. Behzad Mahdavi as Senior Vice President of Biopharma Manufacturing & Life Science Tools

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced that Behzad Mahdavi Ph.D., MBA, has joined as senior vice president of biopharma manufacturing and life sciences tools. In this new role, Dr. Mahdavi will lead Ginkgo's commercial efforts in the growing areas of bio-reagents, cell and gene therapies and new biopharmaceutical modalities. Dr. Mahdavi brings more than 20 years of experience in developing and leading innovative patient-centric growth strategies in challenging environments in the biopharmaceutical, cell and gene therapy, personalized medicine and life sciences sectors.

Dr. Behzad Mahdavi

Prior to joining Ginkgo, Dr. Mahdavi most recently served as vice president of global open innovation at Catalent Pharma Solutions, where he created a distinctive portfolio of innovative services and expanded its customer base in new market segments. Prior to his work at Catalent, he held numerous leadership positions during his 13 years at Lonza and served as CEO of SAM Electron Technologies. Throughout his career, Dr. Mahdavi has built expertise in defining and developing optimal growth strategies and actionable business plans across biologics, cell therapy, and viral pharmaceutical modalities. In addition to his company leadership roles, he has also served in multiple Board of Directors and Advisory Board roles. Dr. Mahdavi holds a Doctorate in Chemistry from the University of Sherbrooke , Canada , and also has a Master in Business Administration from the University of Quebec in Montreal .

Ginkgo has significant experience in the design of custom organisms and the discovery of novel enzymes that bring new biopharma products to life. Ginkgo's robust codebase and ability to search and screen candidates in high throughput allows it to support programs across all aspects of biopharma manufacturing and discovery. Ginkgo's projects in this space span its expertise with both microbial and mammalian cells, and include publicly announced collaborations with Antheia , Aldevron , Biogen , Microba , Moderna , Novo Nordisk , Optimvia , Persephone , SaponiQx , Selecta Biosciences , Synlogic , Tantu , Totient , and Roche , as well as additional programs at various stages in the pipeline. With its strong enzyme discovery, optimization and metabolic engineering capabilities, Ginkgo hopes to enable the creation of new products and to improve product development across all therapeutic modalities.

"Ginkgo is integrating capabilities at massive scale in genetic engineering, manufacturing process optimization and bioinformatics along with innovative technologies from third-party developers," said Dr. Mahdavi. "There are a tremendous number of opportunities in this space, and I joined Ginkgo because I believe this company is the partner of choice that the industry needs to realize those boundless opportunities. I am thrilled to work alongside Ginkgo's world-class team to help create a platform of choice for our partners, who strive to benefit patients around the world."

"Dr. Mahdavi brings outstanding experience in global business growth, expansion and commercial innovation, which will be instrumental as we aim to redefine the landscape of treating diseases," said Jennifer Wipf , senior vice president of commercial cell engineering at Ginkgo Bioworks. "We've proven how much our platform can help newcomers and incumbents in the growing biopharma space. As we continue to evolve our horizontal platform applications, having Dr. Mahdavi on our team will strengthen our ability to deliver innovative services to our customers and we can't wait to onboard more programs in the coming months and years."

To discuss how you can leverage Ginkgo's biopharma and life science capabilities, s ign up for Ginkgo Office Hours to speak with our team today!

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .

Forward-Looking Statements of Ginkgo Bioworks

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding Ginkgo's growth and potential innovations. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com

GINKGO BIOWORKS MEDIA CONTACT:
press@ginkgobioworks.com

(PRNewsfoto/Ginkgo Bioworks)

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SOURCE Ginkgo Bioworks

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Ayana Bio Announces Appointment of Frank Jaksch as Chief Executive Officer

Ayana Bio Announces Appointment of Frank Jaksch as Chief Executive Officer

Health and wellness industry veteran will lead the company to scale sustainable bioactives using plant cell technology instead of agriculture

Ayana Bio, the plant cell technology company making sustainable bioactives for consumer products, today announced the appointment of Frank Jaksch as the company's chief executive officer. Jaksch founded, was the longtime CEO and presently serves as Board Chair of health and wellness company ChromaDex, manufacturer of popular NAD product, Tru Niagen (Nasdaq: CDXC).

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Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

$145 million of Total revenue in Q2 2022, representing 231% growth over Q2 2021

13 new Cell Programs added in Q2 2022, representing 86% growth over Q2 2021

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Cybin Obtains Exclusive License to a Novel Catalog of Psychedelic-Based Compounds

Cybin Obtains Exclusive License to a Novel Catalog of Psychedelic-Based Compounds

Provides access to large catalog of compounds complementary to Company's preclinical assets –

Strengthens drug discovery and development platform to build future potential novel drug candidates

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Mindset Pharma Provides Strategic Intellectual Property License to Cybin

Mindset Pharma Provides Strategic Intellectual Property License to Cybin

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced an exclusive licensing agreement for Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) to acquire intellectual property rights for a subset of Mindset's preclinical compounds (the "Agreement"). Under the terms of the Agreement, Cybin will license intellectual property related to preclinical compounds within Mindset's "Family 1" portfolio, excluding MSP-1014, Mindset's lead psychedelic drug candidate.

"Over the last two years, Cybin has assembled a leading psychedelic drug development organization and we are pleased that our novel preclinical compounds have been recognized to potentially support their R&D pipeline. Both our companies share the same ultimate goal of discovering and developing superior new psychedelic treatments to better meet the needs of patients," said James Lanthier, CEO of Mindset Pharma. "This licensing agreement – Mindset's second such agreement to advance its innovations to clinical study – is another example of Mindset successfully executing on its scientific and business strategies. Coupled with our existing collaboration, Mindset now has multiple "shots on goal" for commercializing its innovations, with additional potential from its recently announced new families."

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Eupraxia Pharmaceuticals Announces Expansion of Intellectual Property For EP-104IAR

Eupraxia Pharmaceuticals Announces Expansion of Intellectual Property For EP-104IAR

Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced the grant of a patent and a notice of allowance for EP-104IAR.

EP-104IAR is the Company's lead product candidate designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee osteoarthritis.

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Vegan lentil burgers with kale

Plant-based Food Stocks: 10 Biggest Companies in 2022

The plant-based food industry has attracted a lot of interest in the past few years. Consumers are hungry for more plant-based diets, and their enthusiasm is creating a juicy growth market that investors can really sink their teeth into.

In 2021, several companies garnered more than US$100 million in 13 separate funding rounds. One of the biggest winners was privately held Impossible Foods, which completed a US$500 million raise for lifetime funding of over US$2 billion.

One of 2022's most notable financings was the US$400 million Series C round for cultured meat company Upside Foods. It included money from Tyson (NYSE:TSN), Cargill and Givaudan (SWX:GIVN) to help build a commercial-scale manufacturing facility and a solid supply chain for cell growth media. The funding will also provide for more research and development on cell-based meat.

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Cybin to Participate in Upcoming Scientific and Investor Conferences

Cybin to Participate in Upcoming Scientific and Investor Conferences

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics TM , is pleased to announce its participation in the following upcoming conferences:

Interdisciplinary Conference on Psychedelic Research, Psychedelic Science, Ethics & Business Event, September 21, 2022 in Haarlem, Amsterdam

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Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

  • Treatment with CNM-Au8 significantly improved long-term survival with approximately a 70% decreased risk of mortality vs. original placebo randomization
  • Comparable survival benefits were also shown compared to ENCALS predicted median survival
  • C NM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.

The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .

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