Life Science News

  • CNM-Au8 met primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population

  • Consistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers, providing physiological evidence for its potential neuroprotective and remyelinating effects

  • CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

  • Results provide support to advance CNM-Au8 into Phase 3 clinical development

  • Clene to host a call and webcast at 7:30 am EDT today

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 positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8 ® an investigational gold nanocrystal suspension, in participants with stable relapsing remitting multiple sclerosis (RRMS).

VISIONARY-MS was a Phase 2 proof-of-concept, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) as adjunctive therapy to currently available disease-modifying therapies (DMTs) versus placebo over 48 weeks in stable RRMS participants with chronic optic neuropathy.

As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, limiting enrollment to 73 out of the 150 planned participants. Due to the limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary analysis was conducted in a modified intent to treat (mITT) population, which censored invalid data. The mITT population excluded data from a single site (n=9) with LCLA testing execution errors and the timed 25-foot walk data from one subject with a change in mobility assist device. The ITT results were directionally consistent with the mITT results, although the ITT results were not significant.

"These data are very encouraging to us in the MS research and treatment community as we work to address functional improvement in patients," said Benjamin Greenberg, MD, MHS, FANA, FAAN, CRND Professor of Neurology and one of the trial's clinical advisors. "The MS community has been successful at limiting relapses, but we need therapies to address progression independent of relapse activity (PIRA). This study was designed as a proof-of-concept evaluation to establish that treatment of neuronal and glial energetic failure can support remyelination and neuroprotection in people living with MS. I am pleased to see the potential effectiveness of CNM-Au8 demonstrated in this trial."

Primary and secondary results from Baseline to Week 48 were:

  • Primary outcome: LCLA letter change in the clinically affected eye (least squares [LS] mean difference, 3.13; 95% CI: -0.08 to 6.33, p = 0.056)
  • Secondary outcomes:
    • mMSFC mean standardized change (LS mean difference, 0.28; 95% CI: 0.04 to 0.52, p = 0.0207)
    • mMSFC average rank score (LS mean difference, 13.38; 95% CI: 2.83 to 23.94, p = 0.0138)
    • Time to first repeated clinical improvement to Week 48 (45% vs. 29%, log-rank p=0.3991)

Consistent improvements favoring CNM-Au8 were observed across multiple paraclinical biomarkers, including multifocal visual evoked potentials (mfVEP) amplitude and latency, optical coherence tomography (OCT), and MRI endpoints, including magnetization transfer ratio and diffusion tensor imaging metrics. Placebo treated patients, in contrast, generally worsened as expected across these measures during the 48-week period. These data provide independently assessed quantitative physiological evidence that supports the potential neuroprotective and remyelinating effects of CNM-Au8. The full dataset will be reported at an upcoming scientific congress.

CNM-Au8 was well-tolerated, and there were no significant safety findings reported.

Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer, said, "In this study, CNM-Au8 demonstrated neurological improvements in people with stable relapsing MS as adjunctive therapy to immunomodulatory DMTs. I am very impressed by the consistency of structural and functional improvements demonstrated by CNM-Au8 throughout the neuraxis. With these data, Clene looks forward to initiating a Phase 3 clinical program in people with MS who are experiencing progression independent of relapse activity, the most urgent unmet medical need in MS today. We look forward to the next phase of clinical development."

Rob Etherington, Clene's Chief Executive Officer and President, added, "These results further demonstrate the potential of CNM-Au8 to drive neuronal cellular energy production in patients struggling with MS and other neurodegenerative diseases. We also await additional evidence of clinical efficacy from the HEALEY ALS Platform Trial, which is expected to report topline data later in this quarter. Clene will continue to work tirelessly to further CNM-Au8's development to treat neurodegenerative diseases."

Conference Call and Webcast Information
Clene will host a conference call and webcast at 7:30 am EDT to discuss the VISIONARY-MS topline results.

Toll free: 1 (888) 770-7152
Conference ID: 5318408
Press *1 to ask or withdraw a question, or *0 for operator assistance .

To access the live webcast, please register online at this link . Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months. A live audio webcast of the call will be available on the Investors section of the Company's website Presentation page . An archived webcast will be available on the Company's website approximately two hours after the event.

About VISIONARY-MS
VISIONARY-MS was a Phase 2 multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of CNM-Au8 in participants with stable relapsing remitting multiple sclerosis (RRMS) with a history of chronic visual impairment who are allowed disease-modifying therapy (DMT). Enrolled subjects were randomized 1:1:1 to CNM-Au8 15 mg/day, 30 mg/day, or placebo. As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, enrolling 73 out of the 150 planned participants. Due to limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary endpoint was the change in best corrected-low contrast letter acuity (BC-LCLA) from baseline to week 48 in the clinically affected eye. Key secondary efficacy outcomes assessed neurological function by the modified MS Functional Composite (mMSFC) including 25-Foot Timed Walk, Symbol Digit Modalities Test, 9-Hole Peg Test (dominant and non-dominant hands), and LCLA (affected and fellow eye) from baseline through Week 48. For more information, see ClinicalTrials.gov . Identifier: NCT03536559 . The open label extension of VISIONARY-MS is ongoing.

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.

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 .

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 Topline Results Demonstrating Survival Signal for CNM-Au8® in Healey ALS Platform Trial

Clene Reports Topline Results Demonstrating Survival Signal for CNM-Au8® in Healey ALS Platform Trial

  • The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeks
  • Prespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks
  • Survival signal consistent with prior results from the Phase 2 RESCUE-ALS trial
  • Clene will continue the open-label extension of CNM-Au8 in the Healey ALS Platform Trial and is in discussions with the Healey & AMG ALS Center to design and offer an Expanded Access Protocol (EAP) of CNM-Au8 30mg for eligible participants of closed regimens and others
  • Clene is pursuing multiple paths, including ongoing discussions with potential strategic partners, in its goal of marketing authorization
  • Clene to host investor call and webcast at 8:30 am EDT today

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 announced topline study results showing a survival benefit in the Healey ALS Platform trial of CNM-Au8®, an investigational gold nanocrystal suspension, in participants with amyotrophic lateral sclerosis (ALS).

The primary endpoint of slope of change in ALS Functional Rating Scale Revised (ALSFRS-R) scores adjusted for mortality was not significant (2% slowing, 95% CI: -20% to +19%) at 24 weeks. Secondary endpoints of Combined Assessment of Function and Survival (CAFS) and slow vital capacity (SVC) were also not met at 24 weeks across the combined 30 mg and 60 mg CNM-Au8 doses.

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Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3

Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3

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 announced that it will report topline results of the CNM-Au8® regimen of the HEALEY ALS Platform Trial on Monday, Oct. 3. Clene's management team will host a conference call and webcast to discuss the results.

Conference Call and Webcast Details
Time and Date: 8:30 a.m. EDT on Oct. 3, 2022
Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll)
Conference ID: 5318408
Webcast Link

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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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Clene to Present at Upcoming September Investor Conferences

Clene to Present at Upcoming September Investor Conferences

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 announced that it will participate in the following investor conferences in September:

Citi's 17 th Annual BioPharma Conference
Date: September 8, 2022
Location: Four Seasons Hotel, Boston, MA
Format: 1x1 meetings

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Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

  • Topline results from the Phase 2 VISIONARY-MS clinical trial with CNM- Au8 ® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population
  • Updated data from RESCUE-ALS demonstrate a statistically significant decrease in mortality in participants who entered open-label extension study ( 5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)
  • Topline results from HEALEY ALS Platform Trial expected this quarter
  • Cash, cash equivalents and marketable securities of $26.3 million as of June 30, 2022
  • Entered into a $3.0 million loan facility from State of Maryland to support development of commercial manufacturing facility

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 its second quarter 2022 and recent operating highlights.

"We are on the cusp of a transformative period for the Company as we await a key data readout in ALS for our lead asset, CNM-Au8 ® ," said Rob Etherington, President and CEO of Clene. "The ALS patient population is desperate for new treatments to help mitigate the disease course and following the statistically significant survival benefits demonstrated in our open label trial, we are hopeful that we can deliver an effective therapy for people living with ALS."

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Cybin Provides Update on its Intellectual Property Portfolio

Cybin Provides Update on its Intellectual Property Portfolio

-- Cybin strengthens its intellectual property library with more than 20 active patent filings across six patent families, and multiple license agreements that provide access to over 35 patents and applications --

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics ® , is pleased to provide an update on its intellectual property ("IP") progress in support of its research and development strategy. The Company continues to prioritize the development of in-house IP and licensing opportunities that support its active development programs and future novel drug candidates.

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GreenLight Biosciences and Queensland University of Technology partner to tackle destructive fall armyworm using RNA

GreenLight Biosciences and Queensland University of Technology partner to tackle destructive fall armyworm using RNA

  • GreenLight Biosciences and Queensland University of Technology (QUT) partner to create a solution for fall armyworm

  • Fall armyworm is one of the most destructive insect pests on the planet, causing more than US$2 billion in annual crop loss worldwide

  • The Australian government has been searching for a more environmentally-friendly solution to fall armyworm and is supporting the partnership with a AUD$400,000 grant

Researchers from Boston's GreenLight Biosciences and the Queensland University of Technology (QUT) in Brisbane, Australia, have announced an agreement to develop a solution to fall armyworm, which causes more than US$2 billion in annual global crop loss.

The partnership includes an Australian government grant to QUT of more than AUD$400,000 from the Australian Research Council. It brings together the teams of two preeminent researchers, Dr. Julia Bally and Professor Peter Waterhouse from the QUT Centre for Agriculture and the Bioeconomy , and GreenLight's Plant Health research and development team.

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Mindset Pharma Selects Lead Clinical Candidates From "Family 2" of its Next Generation Psychedelic Drug Portfolio

Mindset Pharma Selects Lead Clinical Candidates From "Family 2" of its Next Generation Psychedelic Drug Portfolio

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") 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 that after extensive preclinical screening studies, a lead psychedelic drug clinical candidate, MSP-2020, and a second back-up drug candidate, MSP-2003, have been selected from its Family 2 program in collaboration with The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, to advance to IND enabling studies.

MSP-2020 and MSP-2003 are both novel and patentable compounds. They are covered under Mindset's United States Patent and Trademark Office (USPTO) patent number 17/387,864, titled "3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders." Mindset has received a notice of allowance from the USPTO for this application.

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Ginkgo Bioworks Acquires Circularis to Strengthen Capabilities in Cell and Gene Therapy

Ginkgo Bioworks Acquires Circularis to Strengthen Capabilities in Cell and Gene Therapy

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform. When circularized, RNA is much longer-lived in cells, improving its robustness as a potential therapeutic modality. The Circularis platform also allows ultra-high-throughput screening of promoters and other enhancers. Ginkgo is excited to welcome the Circularis team and platform to enable new solutions across bioproduction, RNA therapeutics, cell therapy, and gene therapy partnerships.

(PRNewsfoto/Ginkgo Bioworks)

In recent years, Ginkgo has significantly expanded its work in cell and gene therapy, including a program to improve adeno-associated virus (AAV) manufacturing in partnership with Biogen , and a program to develop AAV capsids with altered tropism and immunogenicity in partnership with Selecta Biosciences . The field of nucleic acid therapeutics is a promising novel therapeutic modality, and Ginkgo has worked on programs across the space, including with Moderna and Aldevron , and is actively engaged in improving circular RNA efficacy and manufacturing yields.

The Circularis platform strengthens Ginkgo's platform for development of cell and gene therapies, providing the capability to rapidly identify novel promoters with appropriate strength and tissue-specificity designed into customer specific delivery modalities. Leveraging Ginkgo's ability to explore large numbers of genetic designs, these promoter libraries can be explored in combination with modified therapeutic payloads and capsids to provide gene therapy developers a solution that works across any range of cell or organism models. Similarly, the Circularis platform will give Ginkgo the ability to rapidly identify context-specific promoters for cell therapy applications, such as those that modulate gene expression in the tumor microenvironment.

"Circularis has built an exceptional platform to screen gene expression regulatory elements, a need across the cell and gene therapy space," said Narendra Maheshri, Head of Mammalian Foundry at Ginkgo Bioworks. "We are excited to leverage the strong expertise of the Circularis team to further develop circular RNA methods for therapeutic use, and can't wait to incorporate this technology into existing and upcoming cell programs across therapeutic applications as well as more broadly."

"Circularis was founded because we saw a need for better tools to control gene regulation in a range of species. Our team is incredibly proud of what we've built, and the opportunity to scale it on the Ginkgo platform means we're a major step closer to realizing this technology's potential," said Mat Falkowski, Chief Executive Officer at Circularis. "We are excited to bring the power of the Ginkgo platform to both Circularis' already existing customer base and future partners."

About Circularis

Circularis has been using the power of circRNA to control cells for the past eight years. Our novel biology has enabled new scales of experimental methods to help customers make advancements in gene therapy and treatment of rare diseases. Our advanced understanding of circular RNA across multiple cell types and organisms has guided our design towards a range of novel circular RNA materials for use in the growing field of RNA therapeutics.

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 acquisition and Ginkgo's cell programming 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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Ginkgo Bioworks Acquires Adaptive Laboratory Evolution Company Altar

Ginkgo Bioworks Acquires Adaptive Laboratory Evolution Company Altar

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Altar, a French biotechnology company that has developed a proprietary adaptive evolution platform. A fleet of Altar's automated adaptive laboratory evolution (ALE) instruments will be integrated into Ginkgo's Foundry to serve customers across food and beverage, biofuels, biomaterials, cosmetics, animal health and human health applications, among others. Ginkgo has successfully collaborated with Altar on customer programs historically and is excited to welcome them to the team.

(PRNewsfoto/Ginkgo Bioworks)

Despite the immense progress in rational genome editing and high-throughput testing of engineered strains over the last decade, it often remains challenging to engineer microorganisms that meet target specifications under industrially relevant conditions due to the complexity and unknowns of the underlying genetics. For the development of certain phenotypes, such as those based on improved growth under normally unfavorable conditions, ALE can be a powerful approach to address this challenge. By incorporating Altar's ALE platform to Ginkgo's existing strain engineering capabilities, Ginkgo expects to be able to routinely engineer those target phenotypes that can be selected for based on their improved growth properties under defined process conditions, such as in the presence of otherwise inhibitory concentrations of a target end product or prohibitively high temperatures. Selected strains coming out of these ALE-based selections will then be characterized and further validated by Ginkgo's existing suite of test workflows.

"As the range of programs we work on continues to expand, it is imperative that we have the best tools in rational design as well as the ability to leverage the inherent diversity and creativity that emerges from evolutionary processes," said Nikos Reppas , Senior Director, Foundry Technology at Ginkgo Bioworks. "We're excited to welcome the Altar team to Ginkgo and look forward to integrating the Altar technology into Ginkgo's suite of offerings so we can better serve existing and future customers."

"We founded Altar to increase the feasibility and reduce time-to-market for bio-manufactured products," said Simon Trancart, CEO of Altar. "We've been working with Ginkgo for a few years now, and are thrilled to join the Ginkgo platform as we work to accomplish our mission at an even greater scale by collectively using biology to drive innovation across industries."

About Altar

Altar is specialized in the development of microorganisms for industrial applications. Altar's technology, which was developed in collaboration with the French Alternative Energies and Atomic Energy Commission (CEA), automates Adaptive Laboratory Evolution and offers a unique capability to adapt microorganisms to the conditions required by industrial companies for their competitive utilization at commercial scale. Altar benefited from the support of the European Commission through the EIC Accelerator Pilot financing program. For more information, visit https://www.altar.bio/ .

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 acquisition and Ginkgo's cell programming 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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