Life Science News

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

H.C. Wainwright 24 th Annual Global Investment Conference
Dates: September 12-13, 2022
Location: Lotte New York Palace Hotel, New York, NY
Date, Time and Location of Presentation: September 13, 2022, at 12:00 ET (Kennedy I)
Format: Corporate Presentation and 1x1 meetings

About CNM-Au8 ®
CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was 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 .

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


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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 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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Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

  • 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.

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Clene to Host VISIONARY-MS Results Call and Webcast on August 15

Clene to Host VISIONARY-MS Results Call and Webcast on August 15

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 present results from its Phase 2 VISIONARY-MS trial at 7:30 a.m. EDT on Monday, August 15.

Conference Call and Webcast Details:
Presentation Time: 7:30 a.m. EDT on August 15, 2022
Investors (Toll free): 1 (888) 770-7152
Conference ID: 5318408
Webcast link

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Clene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8® for the Treatment of ALS

Clene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8® for the Treatment of ALS

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.

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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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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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Cybin Achieves Research and Development Milestones Ahead of Projected Timelines

Cybin Achieves Research and Development Milestones Ahead of Projected Timelines

-- Completion of Adelia milestones marks promising path toward clinical drug development --

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM ", announced that it has successfully achieved its research and development milestones that helped to build and progress its innovative pipeline of investigational psychedelic therapeutics ahead of projected timelines. These milestones were set forth in the acquisition agreement of Adelia Therapeutics Inc. in December 2020. The achievement of these milestones has supported Cybin's transition from a discovery- to clinical-stage development organization in less than two years.

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