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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 disease, today reported that it has received a positive opinion for its submission requesting Orphan Drug Designation for CNM-Au8® for the treatment of amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

Orphan Drug Designation in Europe is granted for a serious or life-threatening disease affecting not more than five in 10,000 people. Clene would benefit from this designation with protocol assistance, reduced regulatory fees and market exclusivity. The positive opinion for Orphan Drug Designation for CNM-Au8 in ALS was based on data submitted from the Phase 2 RESCUE-ALS trial and preclinical ALS models.

"It is extremely gratifying to receive Orphan Drug Designation in the European Union for the treatment of ALS with CNM-Au8," said Rob Etherington, President and CEO of Clene. "We are extremely encouraged by the recent statistically significant survival benefit demonstrated by CNM-Au8 in the long-term open-label extension of the RESCUE-ALS trial, and we await top-line data from the HEALEY ALS Platform Trial, which is expected this quarter. We plan to make CNM-Au8 broadly available to patients with this rapidly progressive neurodegenerative disease as soon as possible, and we look forward to working with the European Medicines Agency to advance toward this goal."

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook.

About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Media Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
858-717-2310
Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
617-283-2856

Source: Clene Inc.


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Clene Reports Significantly Decreased Mortality in RESCUE-ALS Long-Term Open Label Extension Trial

Clene Reports Significantly Decreased Mortality in RESCUE-ALS Long-Term Open Label Extension Trial

  • As of the July 5, 2022, data cutoff, early CNM-Au8 ® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)
  • CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during this open-label trial
  • Top-line results from HEALEY ALS Platform Trial are expected in current quarter

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 disease, today reported significantly improved survival in ALS patients initially treated with CNM-Au8 compared to initially randomized placebo treated participants during the long-term open-label extension of its RESCUE-ALS trial.

"We are very pleased to see these results and the apparent survival benefit that our investigational drug, CNM-Au8, appears to provide to people living with ALS," said Rob Etherington, President and CEO of Clene. "At this point, we are awaiting top-line data from the HEALEY ALS Platform Trial, which focuses on endpoints measuring patient function, survival and breathing over a six-month period in a much larger cohort. Clene expects to announce these results this quarter. Based on the larger number of patients treated in the HEALEY trial and the higher dose of CNM-Au8 being tested, we are optimistic that we will be able to adequately characterize the effects of our drug on this devastating disease."

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Ginkgo Bioworks Appoints Kathy Hopinkah Hannan to its Board of Directors

Ginkgo Bioworks Appoints Kathy Hopinkah Hannan to its Board of Directors

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced that Kathy Hopinkah Hannan PhD, CPA has joined its Board of Directors, effective August 2, 2022 . Dr. Hannan brings over thirty years of experience as a senior C-Suite executive, corporate advisor, independent board director and strategist leading significant operations and high priority initiatives.

(PRNewsfoto/Ginkgo Bioworks)

"As a pioneer in synthetic biology, Ginkgo Bioworks is undertaking critical work to make biology easier to engineer and to enable a more sustainable future," said Dr. Hannan. "I am honored to join Ginkgo's Board at such a significant time in the company's history, and look forward to working with Ginkgo's incredible team as they use synthetic biology to unlock innovations across industries."

Dr. Hannan is a retired senior partner from KPMG LLP, where she also served as Vice Chair. She brings extensive governance experience through her corporate board roles with Annaly Capital Management, Otis Worldwide Corporation, and Carpenter Technology Corporation, as well as her roles as Chair of the Board of Trustees for the Smithsonian National Museum of the American Indian and formerly as Chair of the Board of Directors of Girl Scouts of the USA . A member of the Ho-Chunk Nation, Dr. Hannan served as a commissioner for the Tribal Employment Rights Office and was a presidential appointee to the National Advisory Council on Indian Education. She also served as a member of the Committee to establish the Board of Directors for the Ho-Chunk Tribe's corporation under Section 17 of the Indian Reorganization Act.

"Dr. Hannan brings invaluable experience as a leader in enterprise sustainability and organizational effectiveness, with an impressive track record for leading key financial and advisory services for clients," said Marijn Dekkers, Chair of the Board of Directors for Ginkgo Bioworks. "Dr. Hannan's industry knowledge and financial acumen is a welcome addition to our Board as Ginkgo continues to grow as a public company. We are looking forward to working with her."

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, and (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations. 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 May 16, 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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GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

  • GreenLight's messenger RNA production process is transferable to large-scale equipment and CMO facilities​
  • Technology transfer and scale-up from lab bench to Samsung's commercial facility was completed in seven months
  • GreenLight's mRNA synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA
  • The mRNA synthesis reaction was achieved without the need for customization, using standard equipment for Contract Development and Manufacturing Companies (CDMO)
  • Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product

GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies' mRNA production partnership.

Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung's commercial facility was completed in seven months, demonstrating platform adaptability and scalability.

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NIH, GreenLight Biosciences to collaborate on COVID-19 vaccine development for new variants

NIH, GreenLight Biosciences to collaborate on COVID-19 vaccine development for new variants

GreenLight Biosciences has announced a collaboration with the National Institutes of Health (NIH) to develop COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects.

"This is a tremendous opportunity for us to partner with a premier vaccine discovery team and use our mRNA platform to accelerate the development of coronavirus vaccines which are more broadly protective and durable than those currently available," says Amin Khan, PhD, GreenLight's Chief Science Officer, Human Health.

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Cybin to Present at the Canaccord Genuity 42nd Annual Growth Conference

Cybin to Present at the Canaccord Genuity 42nd Annual Growth Conference

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 that Doug Drysdale, Cybin's Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 42 nd Annual Growth Conference being held at the InterContinental Boston Hotel on August 8-11, 2022.

Mr. Drysdale's fireside chat will be webcast live on Thursday, August 11, 2022 at 3:30 p.m. ET. To listen to the event, please click here to access the webcast. The archived webcast will also be available on the Company's investor relations website on the Events & Presentations page.

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BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Sharps Compliance Corp. , Infrastructure and Energy Alternatives, Inc. , AutoWeb, Inc. , Zymergen Inc.

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Sharps Compliance Corp. , Infrastructure and Energy Alternatives, Inc. , AutoWeb, Inc. , Zymergen Inc.

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

Infrastructure and Energy Alternatives, Inc. (Nasdaq - IEA)

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Cybin Announces Date of Annual Meeting of Shareholders

Cybin Announces Date of Annual Meeting of Shareholders

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM " announced today that its 2022 Annual Meeting of Shareholders will be held virtually on Monday, August 15, 2022 at 10:00 a.m. ET.

The notice of annual meeting and proxy statement containing meeting details are expected to be available on or about July 25, 2022 to shareholders of record as of the close of business on July 11, 2022. Meeting materials will be mailed and also made available under the Company's profile on SEDAR at www.sedar.com , and on the Company's website at www.cybin.com .

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