| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
NDA Submission example | NDA | — | Subscribe to access the data. | Nanomedicine | Nervous System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Nanomedicine | Nervous System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Nanomedicine | Nervous System |
Recent Updates
Recently added Catalysts
Clene Inc.$6.27
+0.02 (+0.32%)
D 36Pipeline Score Overvalued Pharma · Clinical
Market Cap
85.61 M
EPS
-3.21
P/E Ratio
-
Value Trade
650.27 K
SEC Financials
Q1 2026Dilution Risk
Revenue
15.00 K
R&D Expenses
329.00 K
Operating CF
-4.53 M
Total Assets
21.66 M
Total Liabilities
40.47 M
Equity
-18.81 M
D/E Ratio
12,345
-1.33 %
Week
3.24 %
1 Month
37.3 %
3 Month
-23.69 %
6 Month
-96.64 %
5 Year
-96.54 %
All Time
Cash Data
Cash Position
5.94 M
Monthly Burn
1.51 M
Runway
2.2 mo
Burn Trend
StableSEC Filing
May 14, 2026
Overview
Volume
33.70 K
52 Week Range
2.36 - 13.50
% held by Insiders
20.4 %
% held by Institutions
13.79 %
Enterprise Value
101.72 M
Total Shares
11.78 M
Short %
11.94 %
Float Shares
8.28 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Clene Inc.
389Total events
5Upcoming
93Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 5
Event history 384
Q3 2026
●NDA SubmissionCNMAu8ApprovedRegulatory Filing
NDA submission for CNM-Au8 under accelerated approval pathway
ALSsource ↗
Jun 2026
◆NDA SubmissionCNMAu8ApprovedRegulatory Filing
Plan to file NDA for CNM-Au8 in ALS under accelerated approval pathway
ALSsource ↗
May 5, 2026
May 4, 2026
▲FDA Feedback ReceivedCNMAu8ApprovedFDA Meeting
FDA Type C meeting minutes confirm NfL data may support accelerated approval NDA
ALSsource ↗
May 2026
▲Debt Royalty FinancingCorporate
Amendment of $10 million convertible debt facility extending maturity to August 2027
Q2 2026
◆FDA Feedback ReceivedCNMAu8ApprovedFDA Meeting
Formal written meeting minutes from Type C FDA meeting expected
ALSsource ↗
Q2 2026
●NDA SubmissionCNMAu8ApprovedRegulatory Filing
NDA submission to FDA for CNM-Au8 via accelerated approval pathway
ALSsource ↗
Drug Pipeline Intelligence
D36
Pipeline Score $38M
Pipeline ValueOvervalued
Valuation Signal3
Drugs Scored0.4x
rNPV / MCap Top 50%
Micro Cap (rank 456 of 911)
Percentile RankClene Inc. faces pipeline headwinds (36/100), with $2.7B risk-adjusted pipeline value, led by CNM-Au8 in Relapsing Multiple Sclerosis (Phase 2), across $69B in total addressable markets, but cash runway is a concern.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CNM-Au8 Small molecule | Relapsing Multiple Sclerosis | Phase 2 | NCT04626921 | 24% | $1.5B | COMPLETED | 55 | - | - | Sep 6, 2023 | - | Dec 8, 2023 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
CNM-Au8 | Multiple Sclerosis | Phase 2 | 2025-09-25 | n: 39; cohort 1 n: 11; cohort 2 n: 15; cohort pd n: 13 | Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients Read More | |
CNM-Au8 | Multiple Sclerosis | Phase 2 | 2025-09-25 | n: 39; cohort 1 n: 11; cohort 2 n: 15; cohort pd n: 13 | Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients Read More | |
CNM-Au8 | Multiple Sclerosis | Phase 2 | 2025-09-25 | n: 39; cohort 1 n: 11; cohort 2 n: 15; cohort pd n: 13 | Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in CLNN
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
CLNN Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
CLNN▲ +8.5%on this news
Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights
Clene Inc. reported its first quarter financial results for 2026, highlighting a successful FDA Type C meeting that indicated the potential for accelerated approval of CNM-Au8 for ALS. The company plans to submit a New Drug Application in Q3 of 2026 and initiate a Phase 3 trial in early 2027. Financially, Clene has raised over $28 million through a registered direct offering and amended its debt facility to enhance liquidity. Despite a reported net loss of $8.1 million, the company remains optimistic about its progress in developing treatments for neurodegenerative diseases.
Read more →CLNN▼ -18.7%on this news
Clene to Present at Upcoming May Conferences
Clene Inc. will participate in two investor conferences in May 2026, focusing on its innovative therapies for neurodegenerative diseases. The Emerging Growth Conference will feature a virtual presentation on May 6, while the D. Boral Capital Global Conference will include one-on-one meetings on May 7. Clene aims to highlight its late-stage clinical developments and commitment to improving mitochondrial health.
Read more →CLNN▼ -18.7%on this news
Clene Announces $7 Million Underwritten Offering of Common Stock
Clene Inc. has announced a $7 million underwritten offering of common stock at $7.00 per share. The funds will primarily be used for general corporate purposes, including the preparation of a New Drug Application for its lead drug candidate, CNM-Au8. The offering is set to close on or about May 6, 2026, pending customary conditions.
Read more →CLNN▲ +31.8%on this newsshared move
After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS
Clene Inc. has received encouraging feedback from the FDA regarding its investigational drug CNM-Au8 for ALS. The FDA indicated that the data provided may support an NDA submission under the accelerated approval pathway, with NfL biomarker data potentially serving as a surrogate endpoint. Clene plans to submit the NDA in Q3 2026, marking a significant milestone for the company and the ALS community.
Read more →CLNN▲ +6.1%on this news
Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights
Clene Inc. reported its full year 2025 financial results, highlighting an upcoming Type C meeting with the FDA regarding its CNM-Au8 program for ALS. The company anticipates filing a new drug application (NDA) under an accelerated approval pathway by mid-2026, supported by positive biomarker data. Clene's recent financing efforts aim to extend its operational runway into 2027, despite reporting a significant net loss for the year.
Read more →CLNN▲ +9.8%on this news
Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts
Clene Inc. has issued a letter to stockholders detailing key regulatory and clinical milestones for its drug CNM-Au8 in 2026. The company plans to submit a New Drug Application (NDA) to the FDA, aiming for accelerated approval based on promising clinical data. Clene has also secured funding to support its operations and plans to initiate a Phase 3 trial later this year.
Read more →CLNNClene to Present at the Emerging Growth Conference
Clene Inc. (Nasdaq: CLNN) will present at the Emerging Growth Conference on February 25, 2026, at 1:45 p.m. ET. The presentation will serve as a corporate update regarding Clene's efforts in treating neurodegenerative diseases through their focus on mitochondrial health and neuronal function. Attendees can access the presentation via Clene's website and find additional content on related platforms afterward. The Emerging Growth Conference offers an opportunity for public companies to showcase their innovations to a wide audience of investors and analysts.
Read more →CLNN▼ -6.3%on this news
Clene to Present at the Emerging Growth Conference - January 16, 2026
Clene Inc. will present at the Emerging Growth Conference on January 21, 2026, focusing on their advancements in treating neurodegenerative diseases. The presentation will be available via webcast, allowing broad access for investors. Clene's innovative approach targets mitochondrial health to improve neuronal function.
Read more →CLNNClene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting
Clene Inc. announced that the FDA has scheduled an in-person Type C Meeting to discuss its biomarker data supporting the potential NDA filing for CNM-Au8. The company presented significant reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) linked to survival outcomes in ALS patients. New analyses also identified IGFBP7 as a promising biomarker associated with improved survival, although these findings are exploratory and need further validation.
Read more →CLNN▲ +7.1%on this newsshared move
Clene Announces Registered Direct Offering of Over $28 Million
Clene Inc. announced a registered direct offering of over $28 million, aimed at supporting its ongoing efforts in treating neurodegenerative diseases, particularly ALS. The offering attracted notable investors, including Boxer Capital and Vivo Capital. The proceeds will help fund Clene's planned New Drug Application for its investigational therapy, CNM-Au8, expected in 2026.
Read more →CLNN▼ -22%on this news· ran to -37% by day 3
Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8
Clene Inc. announced statistically significant biomarker improvements for its drug CNM-Au8 in ALS patients, as confirmed by FDA-recommended analyses. These reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) are strongly associated with improved survival outcomes. The company is preparing to present these findings at a Type C meeting with the FDA in early 2026 with the intent of filing for an accelerated approval submission. This data comes from a late-stage trial and supports the potential disease-modifying activity of CNM-Au8.
Read more →CLNNClene to Provide CNM-Au8 ALS Program Update
Clene Inc. announced it will update investors on its CNM-Au8 program for amyotrophic lateral sclerosis (ALS) on December 3, 2025. The update will be presented during a live investor call and webcast at 8:30 am ET. CNM-Au8 is designed to restore neuronal health through oral suspension of gold nanocrystals, potentially enhancing neuroprotection and resilience against stressors related to neurodegenerative diseases. The company promotes transparency by providing archived webcasts for future access.
Read more →CLNNClene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference
Clene Inc. will participate in the Benchmark 14th Annual Discovery One-on-One Investor Conference on December 4, 2025, in New York. The company, focused on therapies for neurodegenerative diseases, will host 1x1 investor meetings to discuss its clinical-stage developments. Clene's investigational therapy, CNM-Au8®, aims to improve mitochondrial health and neuronal function.
Read more →CLNN▼ -22.4%on this news
Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights
Clene Inc. reported its third quarter 2025 financial results, highlighting progress in its CNM-Au8 programs for neurodegenerative diseases. The company is preparing to submit a New Drug Application (NDA) for ALS treatment under the FDA's accelerated approval pathway. Clene also plans to initiate a Phase 3 trial for ALS and has received positive feedback from the FDA regarding endpoints for MS trials. However, the company faces financial challenges with a reported net loss and decreased cash reserves.
Read more →CLNNClene to Participate in a Panel Discussion at the Maxim Growth Summit
Clene Inc. will participate in a panel discussion at the Maxim Growth Summit on October 22, 2025, in New York City. The discussion will focus on under-the-radar innovations in treating neurodegenerative diseases. Clene aims to highlight its investigational therapy, CNM-Au8, which targets mitochondrial health to improve neuronal function.
Read more →CLNNClene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients
Clene Inc. presented new clinical data at the ECTRIMS 2025 meeting, showcasing the positive effects of CNM-Au8 on brain energy metabolism in multiple sclerosis patients. The Phase 2 REPAIR-MS studies indicated that CNM-Au8 could improve the brain NAD+/NADH ratio, potentially slowing disability progression. The treatment was found to be safe and well tolerated.
Read more →CLNN▲ +6.4%on this news· ran to +18% by day 3
Clene Presents Preclinical Data Supporting CNM-Au8® for the Treatment of Parkinson’s Disease
Clene Inc. has announced promising preclinical data for CNM-Au8, demonstrating its potential to improve cellular health in a novel model of Parkinson's disease. The findings, presented at the Michael J. Fox Foundation meeting, highlight the treatment's effects on mitochondrial health and neuroinflammation. Clene plans to advance CNM-Au8 into Phase 2 clinical studies for Parkinson's disease.
Read more →CLNN▲ +20.1%on this newsshared move
Clene to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Clene Inc. will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. The presentation will be available virtually on September 5, 2025. Clene focuses on developing therapies for neurodegenerative diseases, including ALS and MS, and will also host one-on-one investor meetings.
Read more →CLNNClene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights
Clene Inc. reported its financial results for the second quarter of 2025, highlighting encouraging regulatory interactions with the FDA regarding its lead product, CNM-Au8, for ALS and MS. The company plans to submit a New Drug Application for accelerated approval by the end of 2025, following positive feedback from the FDA on its biomarker analysis plans. However, Clene faces challenges, including a reported net loss and decreased cash reserves, raising questions about its financial sustainability moving forward. The company expressed its commitment to advancing therapies aimed at neurodegenerative diseases.
Read more →CLNNClene to Present at the Canaccord 45th Annual Growth Conference
Clene Inc. will present at the Canaccord 45th Annual Growth Conference on August 12, 2025, at 3:30 PM ET in Boston, MA. The company focuses on treating neurodegenerative diseases such as ALS and MS. A webcast of the presentation will be available on Clene's website, and one-on-one investor meetings will also be hosted.
Read more →CLNNClene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings
Clene, Inc. has provided a regulatory update following a constructive Type C meeting with the FDA regarding its neurofilament biomarker analysis plan. The FDA's feedback supports Clene's ongoing Expanded Access Protocol for ALS treatment. Clene has two additional FDA meetings scheduled for Q3 2025, which may further advance its ALS and MS programs.
Read more →CLNN▼ -10.5%on this news
Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights
Clene Inc. reported its first quarter 2025 financial results along with updates on its CNM-Au8 programs focused on neurodegenerative diseases. The company is preparing for an upcoming FDA meeting to discuss its statistical analysis plan regarding neurofilament light chain biomarker data. Clene presented new data suggesting that CNM-Au8 treatment may significantly improve survival in ALS patients and plans to submit a New Drug Application for potential Accelerated Approval later in the year. Despite a decrease in cash reserves and a net loss, the company has positioned its resources to support operations into the third quarter of 2025.
Read more →CLNN▲ +7.5%on this news
Clene Presents Evidence of Remyelination and Neuronal Repair With CNM-Au8 Treatment At the American Academy of Neurology Late-Breaking Science Session
Clene, Inc. has presented new findings from the VISIONARY-MS trial at the American Academy of Neurology that indicate significant improvements in remyelination and neuronal repair for MS patients treated with CNM-Au8. Analysis of MRI and visual electrophysiology data showed over 90% of participants experienced cognitive and visual enhancements. These improvements are supported by corresponding biomarker measurements, suggesting a robust link between the treatment and patient outcomes. The results from this trial could reinforce the therapeutic potential of CNM-Au8 as a remyelination therapy for MS.
Read more →CLNN▼ -16.2%on this news
Clene to Present at the Jones Healthcare and Technology Innovation Conference
Clene Inc. (Nasdaq: CLNN) has announced its participation in the upcoming Jones Healthcare and Technology Innovation Conference, where the management will give a presentation and host one-on-one investor meetings. The event aims to promote Clene's innovative approach to treating neurodegenerative diseases, such as ALS and MS. The presentation will take place in Las Vegas, NV, and a webcast will be available on Clene's website for interested parties.
Read more →CLNN▼ -5.3%on this news· ran to -23% by day 3
Clene Reports Full Year 2024 Financial Results and Recent Operating Highlights
Clene Inc. reported its full-year financial results for 2024, highlighting plans to submit a New Drug Application for CNM-Au8 in ALS by mid-2025. The company is set to begin a confirmatory Phase 3 trial, RESTORE-ALS, aimed at evaluating further efficacy of CNM-Au8. Despite financial challenges evidenced by a net loss, Clene's research shows promising survival benefits in ALS patients treated with CNM-Au8. Additionally, the FDA has provided guidance on the regulatory path, reinforcing Clene's commitment to advancing treatments for neurodegenerative diseases.
Read more →CLNNClene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8 Treatment
Clene, Inc. announced findings from the HEALEY ALS Platform Trial, demonstrating that treatment with CNM-Au8® 30 mg significantly improves survival in ALS patients. The CNM-Au8 group achieved a median survival of 951 days, representing a 198-day advantage over the control group. Notably, enhanced survival was noted in participants meeting specific criteria, suggesting the drug's efficacy may be more pronounced in certain subpopulations. Clene aims to launch a confirmatory Phase 3 RESTORE-ALS trial in mid-2025, reinforcing their commitment to advancing ALS treatments.
Read more →CLNNClene to Present at the 37TH Annual Roth Conference
Clene Inc. announced its participation at the 37th Annual Roth Conference, set for March 18, 2025. Management will engage in a virtual fireside chat and also offer one-on-one investor meetings. This event underscores Clene's focus on developing treatments for neurodegenerative diseases like ALS and MS. Information regarding the webcast can be found on the Clene website's events section.
Read more →CLNNClene and APST Enter Into an Agreement to Support FDA’s Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8 ’s Impact on NfL Reduction
Clene Inc. has entered an agreement with APST Research to utilize their extensive NfL database to support FDA analyses concerning the effect of CNM-Au8 on NfL reduction in ALS patients. By analyzing longitudinal data from APST, Clene aims to bolster its evidence for a New Drug Application (NDA) planned for submission in late 2025. This collaboration is expected to provide critical insights and may help secure accelerated approval for CNM-Au8 in ALS treatment.
Read more →CLNNClene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior Loan
Clene Inc. has successfully secured a $10 million debt facility to replace a remaining balance of $7.85 million owed to Avenue Capital. This new financing will enhance Clene's cash position and provide the necessary runway to generate additional data required for the new drug application of CNM-Au8 for ALS. The facility comes with a 12% interest rate and includes a conversion feature at a premium price, which could influence the stock's performance in the future. This move is aimed at facilitating the accelerated regulatory pathway for CNM-Au8, critical for patients with neurodegenerative diseases.
Read more →CLNN▼ -9.1%on this news
Clene Reports Third Quarter 2024 Financial Results and Recent Operating Highlights
Clene Inc. reported its third quarter 2024 financial results, highlighting a meeting with the FDA about accelerated approval for its ALS treatment, CNM-Au8. The company raised $7.3 million through a direct offering and amended a debt facility to extend repayment terms. However, it faced increased net losses and a significant drop in cash reserves compared to the previous year. The financial performance and upcoming funding are critical for maintaining operations into early 2025 as they pursue regulatory approval and clinical trials.
Read more →CLNNclnn:CommonStock00001ParValueCustomMember
Clene Inc. presented the preliminary design for its RESTORE-ALS Phase 3 clinical trial of CNM-Au8 at the 2024 Annual NEALS Meeting. The trial aims to explore potential treatment avenues for Amyotrophic Lateral Sclerosis. This presentation signifies an important step in the company's clinical development strategy and impacts its standing as an emerging growth company.
Read more →CLNN▲ +14%on this news
Clene to Present at Upcoming October Conferences
Clene Inc. has announced its participation in two upcoming investor conferences in October 2024. The company will present at the Maxim Healthcare Virtual Summit from October 15-17 and at the ThinkEquity Conference on October 30, both aimed at promoting its advancements in treating neurological diseases. These presentations will include both fireside chats and one-on-one meetings, allowing for direct engagement with potential investors. Clene's focus on mitochondrial health and neuronal function underlines its commitment to innovative biopharmaceutical solutions.
Read more →CLNNClene Announces Closing of $7.3 Million Registered Direct Offering and Concurrent Private Placements and Amendment of Debt Facility
Clene Inc. has successfully closed a $7.3 million registered direct offering and concurrent private placements to support its clinical programs. This funding will sustain operations through the first quarter of 2025, enabling discussions with the FDA about a potential new drug application for its drug candidate CNM-Au8. The company also amended its debt facility to ease future financial obligations, reflecting a strategic move to enhance its operational capacity. Key stakeholders participated in the offering, which indicates strong backing for Clene's developmental efforts in treating neurological diseases.
Read more →CLNNClene Announces $7.3 Million Registered Direct Offering and Concurrent Private Placements Priced at Market Under Nasdaq Rules
Clene Inc. has announced a $7.3 million registered direct offering and concurrent private placements involving shares and warrants. The funding will enhance the clinical development of its lead drug candidate, CNM-Au8, which targets neurological diseases. The offerings include participation from institutional investors and existing stockholders, with the expectation of closing by October 1, 2024, pending customary conditions. Clene plans to utilize the proceeds for corporate purposes and future research activities.
Read more →CLNN▼ -17.1%on this news
Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data
Clene Inc. has been granted an in-person meeting with senior FDA leadership to discuss the development of CNM-Au8 for amyotrophic lateral sclerosis (ALS). The meeting aims to reevaluate Clene's regulatory submission under the accelerated approval pathway, following previous indications that Clene's briefing package was not supportive of such a submission. Clene has compiled extensive safety data for CNM-Au8, showing no significant safety concerns to date. This meeting reflects the FDA's willingness to engage in dialogue about critical aspects of the drug's efficacy and safety.
Read more →CLNN▲ +12.3%on this news· ran to +26% by day 1
Clene to Present at the H.C. Wainwright 26th Annual Global Investment Conference
Clene Inc. has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, set to take place on September 9, 2024. The company, which specializes in treatments for neurodegenerative diseases, will present virtually at 7:00 am EST. Investors can also schedule one-on-one meetings with company management. A webcast of the presentation will be available on Clene's website.
Read more →CLNN▼ -23.5%on this news
Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights
Clene Inc. reported its second quarter 2024 financial results, highlighting promising data from its CNM-Au8 treatment for ALS. Participants showed improved survival rates and declines in neurofilament light levels after treatment. Additionally, preliminary findings indicated potential effectiveness for treating Rett Syndrome. Despite successful compliance with Nasdaq requirements, Clene's cash decreased significantly, raising potential concerns for funding future operations.
Read more →CLNN▲ +47%on this newsshared move
Clene Announces New CNM-Au8 Biomarker and Clinical Efficacy Data Submitted to FDA In Support of Treatment For ALS
Clene Inc. has submitted new biomarker and clinical efficacy data for its CNM-Au8 treatment for ALS to the FDA, building on previous discussions in late 2023. The data demonstrates significant clinical improvements in survival and functional status among participants who showed neurofilament light (NfL) declines. The results suggest that CNM-Au8 not only improves patient outcomes but also has a favorable safety profile, supporting the need for further regulatory discussions and potential Phase 3 trials. Independent analyses reveal marked decreases in all-cause mortality associated with the treatment, further solidifying its efficacy.
Read more →CLNN▼ -7.6%on this news· ran to +36% by day 1shared move
Clene to Present at the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase
Clene Inc. will present at the Canaccord Genuity 44th Annual Growth Conference on August 13, 2024. The presentation will focus on their efforts in treating neurodegenerative diseases through improving mitochondrial health. Clene's management will also host one-on-one investor meetings to further discuss their clinical initiatives. A webcast of the presentation will be available for online viewing.
Read more →CLNN▼ -9.6%on this newsshared move
Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8 in ALS
Clene Inc. plans to submit a briefing book to the U.S. FDA by July 13, 2024, following a Type C interaction regarding the potential accelerated approval of its drug CNM-Au8 for ALS. This book will include new analyses from prior clinical studies and address comments from the FDA made during a prior meeting in December 2023. Clene hopes to demonstrate CNM-Au8's efficacy through evidence of neurofilament light biomarker reduction and its association with improved patient outcomes. The topline FDA feedback will be announced publicly after the Type C interaction takes place in the third quarter of 2024.
Read more →CLNN▼ -21.5%on this newsshared move
Clene Announces 1-for-20 Reverse Stock Split
Clene Inc. announced a 1-for-20 reverse stock split effective July 11, 2024, following stockholder approval to maintain compliance with Nasdaq's minimum bid price requirement. The action will decrease the total number of shares from approximately 128.7 million to around 6.4 million, impacting all issued shares uniformly. Stockholders will not see changes in their ownership percentages, though they may receive cash for fractional shares. The company is currently focused on treating neurodegenerative diseases, including ALS and MS.
Read more →CLNNClene to Present at H.C. Wainwright’s 5th Annual Neuro Perspectives Virtual Conference
Clene Inc. will present at H.C. Wainwright’s 5th Annual Neuro Perspectives Virtual Conference, highlighting its initiatives in improving mitochondrial health for neurodegenerative diseases. The presentation will feature a fireside chat format and will be accessible online after the event. Additionally, Clene management is hosting one-on-one investor meetings to foster further engagement and investor interest.
Read more →CLNNClene Presents Preliminary Data for CNM-Au8 as a Potential Treatment for Rett Syndrome
Clene Inc. presented preliminary data for its nanotherapeutic CNM-Au8 at the International Rett Syndrome Foundation 2024 Annual Meeting. The findings demonstrate significant neuroprotective effects in an in vitro model of Rett Syndrome, showcasing improvements in neuronal health and mitochondrial respiration. These results suggest that CNM-Au8 may be a viable treatment option for Rett Syndrome, potentially expanding its application beyond ALS and MS. The study underscores Clene's commitment to addressing challenging neurological disorders.
Read more →CLNNClene Presents Extended Survival Data Through 3.5 Years and New NfL Responder Results with CNM-Au8 30 mg Treatment from the HEALEY ALS Platform Trial Open Label Extension at the 2024 ENCALS Meeting
Clene Inc. presented new survival and neurofilament light biomarker results from its CNM-Au8 treatment at the ENCALS meeting. The data indicate that patients treated with CNM-Au8 30 mg showed a significant improvement in survival compared to matched PRO-ACT controls, with a hazard ratio of 0.431 over 3.5 years. Additionally, a responder subset demonstrated an average reduction of 28% in neurofilament light levels, suggesting decreased axonal loss. The treatment was found to be safe and well-tolerated during the study.
Read more →CLNNClene Provides Update on Its NIH-Funded Expanded Access Program for CNM-Au8 in ALS (ACT-EAP)
Clene Inc. has announced significant updates regarding its NIH-funded Expanded Access Program for CNM-Au8 in ALS. The program has increased its participant enrollment capacity by 80%, now accommodating up to 180 individuals. The initiative aims to gather real-world data on the drug's efficacy and safety by monitoring its effects on survival and disease progression in ALS patients. The first patient visit is scheduled for early June 2024, highlighting the urgency and need for accessible treatments in the ALS community.
Read more →CLNNClene Reports First Quarter 2024 Financial Results and Recent Operating Highlights
Clene Inc. reported its first quarter 2024 financial results, highlighting progress in the clinical evaluation of CNM-Au8 for multiple sclerosis. The company noted significant improvements in repair and remyelination in participants from the long-term extension of the VISIONARY-MS clinical trial. Clene also announced a $7.3 million sub-award from the NIH for an expanded access program in ALS. However, despite these advancements, the company experienced a net loss of $11.1 million in this quarter compared to $11.8 million in the same quarter of 2023.
Read more →CLNNClene Announces Peer-Reviewed Publication Characterizing the Protein Corona of the Investigational Neurodegenerative Disease Drug, CNM-Au8
Clene Inc. announced the publication of a study characterizing the protein corona of its investigational neurodegenerative drug CNM-Au8. This research reveals how the drug's gold nanocrystals interact with human blood plasma proteins to enhance their penetration of the blood-brain barrier and prolong circulation time. The findings support previous clinical results that CNM-Au8 is safe and well-tolerated, demonstrating potential benefits in treating conditions like multiple sclerosis and Parkinson's disease. A Phase 3 clinical trial for amyotrophic lateral sclerosis is planned for 2024.
Read more →CLNNClene Reports Full Year 2023 Financial Results and Recent Operating Highlights
Clene Inc. reported its full-year 2023 financial results, emphasizing significant strides in the development of CNM-Au8 for the treatment of ALS and MS. Discussions with the FDA regarding an accelerated approval pathway are underway, with key data supporting its efficacy in reducing mortality risks and improving quality of life for patients. Financially, Clene is in a strong position, with $35 million in cash, ensuring operational support into late 2024. Ongoing clinical trials have shown promising long-term results, reinforcing the company's optimistic outlook for its therapeutic programs.
Read more →CLNNClene to Present at the 36th Annual ROTH Conference
Clene Inc. will present at the upcoming 36th Annual ROTH Conference scheduled for March 18-19, 2024, in Dana Point, California. Clene, a clinical-stage biopharmaceutical company focused on treatments for neurodegenerative diseases, will participate in a fireside chat format at 8:00 a.m. PST. Webcast access will be available for those interested in viewing the presentation through Clene's website.
Read more →CLNN▼ -7.3%on this news
Clene Presents Clinical Results of CNM-Au8 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024
Clene Inc. presented promising results for its CNM-Au8 treatment in participants with relapsing multiple sclerosis at the ACTRIMS Forum 2024. The treatment showed significant improvements in vision and cognition over 35 months, with no serious adverse events reported. The study, part of the VISIONARY-MS Trial, included data from a long-term open-label extension, confirming the efficacy and safety of CNM-Au8. A total of 80% of eligible participants continued the treatment, highlighting its well-tolerated profile and potential for enhancing quality of life in patients.
Read more →CLNNClene Reports Significant Survival Benefit With CNM-Au8 Treatment in ALS EAP Compassionate Use Programs
Clene Inc. announced significant survival benefits for its CNM-Au8 treatment in amyotrophic lateral sclerosis (ALS) patients, based on data from two Compassionate Use Expanded Access Programs. The study indicated a 68% and 57% reduced risk of all-cause mortality compared to respective control groups. Additionally, CNM-Au8 treatment was well-tolerated, with no serious adverse events reported. The findings support the drug's progression to Phase 3 clinical trials.
Read more →CLNN▲ +22.1%on this news· ran to +49% by day 3
Clene Reports Significant Improvement in Vision and Cognition With CNM-Au8 Treatment in VISIONARY-MS Trial Long-Term Open Label Extension
Clene Inc. has reported positive results from the long-term open label extension of its VISIONARY-MS trial, showing significant improvements in vision and cognitive function for participants treated with CNM-Au8 over nearly three years. The treatment demonstrated substantial gains in low contrast visual acuity and cognitive testing without serious adverse events. These results suggest that CNM-Au8 could play a major role in managing symptoms of multiple sclerosis, warranting further investigation in upcoming Phase 3 studies.
Read more →CLNN▼ -38.8%on this news· ran to -50% by day 3
Clene Reports Reduction in Biomarker Plasma Neurofilament Light (NfL) Levels and Improved Survival With CNM-Au8 Treatment From HEALEY ALS Platform Trial Long-Term Open Label Extension
Clene Inc. reported promising results from the long-term open label extension of its CNM-Au8 treatment within the HEALEY ALS Platform Trial. The data indicated a 16% reduction in plasma neurofilament light chain levels and a 60% decreased risk of long-term all-cause mortality for patients treated with CNM-Au8 compared to placebo. Additionally, the treatment showed a significant effect in delaying morbidity events among high-risk participants. Further analyses and reporting of additional biomarker and clinical data are expected in early 2024.
Read more →CLNN▼ -38.8%on this news· ran to -50% by day 3
Clene Provides Update on ALS Clinical Development Meeting With FDA
Clene Inc. recently held a meeting with the FDA to discuss CNM-Au8 for ALS treatment, highlighting initial Phase 2 results and positive long-term survival data. The FDA, however, deemed the current findings on Neurofilament Light Chain biomarker reduction insufficient for accelerated approval. Clene plans to provide additional data in 2024 and is encouraged by the recent biomarker trends associated with improved patient outcomes. The company remains committed to supporting ALS patients through ongoing programs and anticipates launching a Phase 3 confirmatory study next year.
Read more →CLNNClene Announces Peer-Reviewed Publication Describing CNM-Au8 Brain Target Engagement In Neurodegenerative Diseases
Clene Inc. has published a peer-reviewed article detailing positive results from its Phase 2 REPAIR clinical studies involving its drug candidate CNM-Au8. The studies showed a significant increase in brain NAD+/NADH ratios in patients with multiple sclerosis and Parkinson's disease after 12 weeks of treatment. Additionally, favorable effects on other brain energy metabolites were observed, suggesting potential benefits for neurodegenerative conditions. The study's findings may have significant implications for the treatment of these diseases.
Read more →CLNN▲ +8%on this news
Clene Reports Third Quarter 2023 Financial Results and Operating Highlights
Clene Inc. reported its third quarter 2023 financial results, highlighting clinically significant progress with its investigational drug CNM-Au8 for ALS. The company noted a median survival benefit of 19.3 months and a 70% reduced risk of death in patients treated with CNM-Au8. Clene also received a $45.1 million grant from the NINDS to support expanded access research. The company anticipates discussions with the FDA regarding the regulatory path for CNM-Au8.
Read more →CLNN▼ -5.3%on this news· ran to -15% by day 3
Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Catalytic Neuroprotective Mechanism of Action
Clene Inc. has announced the publication of research detailing the unique catalytic mechanism of its investigational drug, CNM-Au8, in the journal Small. The study, co-authored by researchers at the University of South Carolina, demonstrates CNM-Au8's ability to protect neurons from death induced by toxins. This discovery positions CNM-Au8 as a promising candidate for treating multiple neurodegenerative diseases, including ALS, MS, and PD. Insights from the research emphasize the importance of catalytic activity in enhancing cellular health and metabolism.
Read more →CLNNClene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls
Clene Inc. reported significant long-term survival improvement for patients treated with CNM-Au8 30mg in the HEALEY ALS Platform Trial. Results indicated a 49% decreased risk of death compared to PRO-ACT historical controls, with further analysis showing a 59% decreased risk when compared with pooled data from related trials. Moreover, over 500 patient years of exposure to CNM-Au8 showcased a clean safety profile with no severe adverse effects identified. This continued evidence of survival benefits emphasizes the potential of CNM-Au8 in treating ALS.
Read more →CLNNClene to Present at Cantor Fitzgerald Annual Global Healthcare Conference
Clene Inc. has announced its participation in the Cantor Fitzgerald Annual Global Healthcare Conference scheduled for September 26-28, 2023, in New York City. CEO Rob Etherington and CFO Morgan Brown will present and hold one-on-one investor meetings. This event marks an opportunity for the company to showcase its focus on mitochondrial health and treatment for neurodegenerative diseases.
Read more →CLNN▲ +7.9%on this news
Clene to Present at Upcoming September Conferences
Clene Inc. has announced its participation in two upcoming investor conferences in September 2023. The first event is the H.C. Wainwright 25th Annual Global Investment Conference, where Clene will provide a corporate presentation and conduct 1x1 meetings on September 11. The second event is the Cantor Fitzgerald Annual Global Healthcare Conference, with a panel presentation scheduled for September 26. These appearances aim to enhance engagement with investors and showcase Clene's commitment to developing treatments for neurodegenerative diseases.
Read more →CLNNClene Reports Significantly Improved Survival Benefit of 19.3 Months and Significantly Delayed Clinical Worsening in Rescue-Als Open-Label Extension Two Year Follow-Up
Clene Inc. reported promising results from the Phase 2 RESCUE-ALS trial, showing a median survival improvement of 19.3 months for participants treated with CNM-Au8 compared to placebo. Additionally, there was a 52% reduced risk of clinical worsening events associated with this treatment. The study included a long-term follow-up of 36 patients, demonstrating strong efficacy and a good safety profile, with no serious adverse events linked to CNM-Au8. This data is anticipated to enhance the understanding of treatment options for ALS patients.
Read more →CLNNClene Reports Second Quarter 2023 Financial Results and Operating Highlights
Clene Inc. has reported its second quarter 2023 financial results, highlighting significant advancements in its ALS and MS clinical programs. The company announced favorable outcomes from the HEALEY ALS trial, indicating CNM-Au8 showed effectiveness in lowering plasma neurofilament light chain levels. Additionally, Clene secured a grant from the National Multiple Sclerosis Society to continue its research on the drug's effects on MS. Despite financial losses this quarter, the company maintains a strong cash position to support ongoing trials and upcoming regulatory discussions.
Read more →CLNNClene to Present at the Canaccord Genuity 43rd Annual Growth Conference
Clene Inc. will present at the Canaccord Genuity 43rd Annual Growth Conference in Boston on August 10, 2023. The presentation will be led by CEO Rob Etherington and CFO Morgan Brown, who will also conduct 1x1 investor meetings. A webcast of the presentation will be available for those interested in following the event online.
Read more →CLNNClene Announces Publication of Phase 2 CNM-Au8 Clinical Data for the Treatment of ALS in LANCET’s eClinicalMedicine
Clene Inc. has announced a significant milestone with the publication of Phase 2 clinical data for its ALS treatment, CNM-Au8, in The Lancet's eClinicalMedicine. The publication includes findings from the RESCUE-ALS trial, highlighting a survival advantage for patients treated with CNM-Au8 and supporting its potential to slow disease progression. Additionally, the study demonstrated positive outcomes related to functional improvements and introduced a novel primary endpoint for ALS studies. Clene plans to provide further long-term data and engage with the FDA regarding future steps in their ALS program.
Read more →CLNN▼ -8%on this news· ran to -20% by day 3shared move
Clene Welcomes New Shareholder Base and Announces Closing of Underwritten Public Offering of $40 Million
Clene Inc. (NASDAQ: CLNN) has successfully closed an underwritten public offering that generated gross proceeds of $40 million, with further potential of $130.8 million through warrant exercises. The financing, led by Vivo Capital and other biotech investors, is aimed at supporting the regulatory approval and commercialization of Clene's lead drug candidate, CNM-Au8. The company is positioned to use the funds to advance clinical trials and regulatory submissions while preparing for a potential global Phase 3 ALS clinical trial. Clene's optimistic outlook reflects confidence in the path to approval for CNM-Au8.
Read more →CLNN▼ -18.8%on this newsshared move
Clene Announces Pricing of $40 Million Public Offering
Clene Inc. has announced the pricing of a public offering that includes 50 million shares of common stock and accompanying warrants, which are priced at $0.80 each. The anticipated gross proceeds from this offering are around $40 million and will support Clene's ongoing clinical development of its lead drug candidate, CNM-Au8®, among other corporate purposes. The closing of the offering is expected on or about June 21, 2023, pending customary conditions.
Read more →CLNNClene’s CNM-Au8 Shows Statistically Significant Difference in Plasma Neurofilament Light (NfL) levels in the HEALEY ALS Platform Trial
Clene Inc. has reported promising results from the HEALEY ALS Platform Trial, where its treatment CNM-Au8 showed a statistically significant reduction in plasma neurofilament light chain (NfL) levels compared to placebo after 24 weeks. NfL, a key biomarker for neurodegeneration, reflects the efficacy of the treatment and could support accelerated FDA approval. Notably, the benefits were particularly pronounced in faster progressing ALS patients. Clene plans to present the trial findings at an upcoming FDA meeting to facilitate the next stages of clinical development.
Read more →CLNNClene to Participate in the Maxim Group Virtual Healthcare Conference
Clene Inc. will partake in the Maxim Group Virtual Healthcare Conference on June 22, 2023. Rob Etherington, the CEO, will engage in a fireside chat with a senior biotech analyst. This event highlights Clene's focus on neurodegenerative diseases and its commitment to innovation in the biopharmaceutical sector.
Read more →CLNNClene Announces Launch of Proposed Public Offering
Clene Inc. has announced a proposed underwritten public offering of its common stock and accompanying warrants to fund its operations. The offering will involve a combination of shares and warrants that are sold together and will be managed by Canaccord Genuity as the bookrunner. Clene intends to use the funds for general corporate purposes, including the development of its lead drug candidate, CNM-Au8, and other research activities. However, the company indicated that the offering is subject to market conditions and there are inherent uncertainties regarding its completion.
Read more →CLNNClene Awarded Grant From National Multiple Sclerosis Society to Advance Development of CNM-Au8 in Non-Active Progressive Multiple Sclerosis
Clene, Inc. has received a grant from the National Multiple Sclerosis Society to advance the development of its drug candidate, CNM-Au8, for non-active progressive multiple sclerosis. The funding will support a clinical study which aims to assess the effects of CNM-Au8 on brain energy metabolism in MS patients. Clene intends to build on previous studies that demonstrated the drug's efficacy for other forms of MS. The one-year study will be conducted at the University of Texas Southwestern Medical School.
Read more →CLNNClene Reports First Quarter 2023 Financial Results and Recent Operating Highlights
Clene Inc. reported its first quarter 2023 financial results, highlighting significant progress in its clinical programs for ALS and MS. Notably, CNM-Au8 treatment showed promising survival benefits in ALS studies, with the company preparing for key regulatory discussions with the FDA later this year. Despite reporting a net loss of $11.8 million, Clene retains sufficient funds to continue operations through Q3 2023. Additionally, the appointment of neurology expert Dr. Ben Greenberg as Head of Medical indicates a strong focus on enhancing the clinical development team.
Read more →CLNNClene Announces the Plenary Presentations of MS and ALS Data Supporting the Efficacy and Safety of CNM-Au8 at the 2023 American Academy of Neurology Annual Meeting
Clene Inc. announced three significant presentations at the 2023 American Academy of Neurology Annual Meeting focusing on its treatment CNM-Au8 for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The presentations intend to showcase safety and efficacy results from clinical trials, including top-line results from the VISIONARY-MS Phase 2 study. These findings are expected to contribute valuable insights into the potential benefits of CNM-Au8, a gold nanocrystal formulation designed to enhance neuronal health and resilience against neurodegenerative diseases.
Read more →CLNNClene Appoints Neurology Expert to Executive Team
Clene, Inc. has appointed Dr. Benjamin Greenberg as the Head of Medical, enhancing its executive team. Dr. Greenberg, an expert in neurology, has been advising Clene for years and will focus on advancing the Phase 3 clinical trials of CNM-Au8, a potential treatment for ALS and MS. The leadership change is expected to bolster Clene's commitment to revolutionizing therapies for neurodegenerative diseases. The company aims to continue its collaborations with pharma partners and regulatory agencies.
Read more →CLNN▲ +7.9%on this newsshared move
Clene Reports Full Year 2022 Financial Results and Recent Operating Highlights
Clene Inc. reported its full year 2022 financial results and highlighted recent progress in clinical programs targeting ALS and MS. Positive data from trials for CNM-Au8 showed significant survival benefits in ALS patients and improvements in multiple sclerosis clinical outcomes. The company plans to engage with the FDA regarding the regulatory pathways for both indications. Despite a reported net loss of $29.9 million, Clene continues to advance its neurodegenerative disease treatments.
Read more →CLNNClene to Announce New CNM-Au8 Data From the Healey ALS Platform Trial
Clene Inc. is announcing a live audio webcast to present new data from the CNM-Au8 arm of the Healey ALS Platform Trial, focusing on clinical results related to ALS treatment. The trial is a comprehensive, multi-center study assessing the safety and efficacy of CNM-Au8 in conjunction with standard care. The results are anticipated to shed light on the efficacy of the investigational product, which aims to enhance neuronal health through unique mechanisms. This webcast will take place on March 9, allowing investors and stakeholders to gain insights into the findings.
Read more →CLNNClene Nanomedicine to Participate in Roth’s 35th Annual Healthcare Conference and Renmark Virtual Non-Deal Roadshow Series
Clene Inc. (Nasdaq: CLNN) and its subsidiary Clene Nanomedicine will participate in Roth's 35th Annual Healthcare Conference from March 12-14 and in the Renmark Virtual Non-Deal Roadshow Series on March 7 and 22. The company aims to share insights into its innovative approach to treating neurodegenerative diseases during these events. A live webcast of their presentations will be accessible through their website links. These engagements underscore Clene's efforts to connect with investors and stakeholders in the biopharmaceutical space.
Read more →CLNNClene Announces Updated VISIONARY-MS Phase 2 Trial Data Presented at 2023 ACTRIMS Forum Show CNM-Au8 Demonstrated Significant Improvements in Clinical Outcomes, Brain Structure, and Visual System
Clene Inc. announced positive updated results from the VISIONARY-MS Phase 2 trial for CNM-Au8 presented at the ACTRIMS Forum 2023. The trial showed significant improvements in clinical outcomes, brain structure, and visual system for stable relapsing multiple sclerosis patients. Key findings included improved visual evoked potential (VEP) and MRI results, indicating enhanced information transmission and neuronal preservation. CNM-Au8 was well-tolerated during the study with no major safety concerns reported.
Read more →CLNN▲ +7.4%on this news
Clene Reports New Data from the VISIONARY-MS Phase 2 Study in Multiple Sclerosis Demonstrating CNM-Au8 Treatment Improved Brain Neuronal Structural Integrity
Clene Inc. reported promising MRI results from its VISIONARY-MS Phase 2 study, showing that its treatment, CNM-Au8, significantly improved brain neuronal structural integrity in multiple sclerosis patients. The trial indicated enhanced axonal integrity and myelin improvement, reinforcing previous clinical findings of neurological enhancements. These results, achieved independently of immunomodulatory effects, signal the potential of CNM-Au8 as a neuroprotective therapy. Clene plans to initiate a Phase 3 study to further explore these promising outcomes.
Read more →CLNNClene Nanomedicine Announces Participation in Renmark Virtual Non-Deal Roadshow Series on January 18 and January 23
Clene Inc. (CLNN) has announced its participation in the Renmark Virtual Non-Deal Roadshow Series taking place on January 18 and January 23. The company encourages stakeholders and investors to register for the free live events, during which the CEO and CFO will provide updates on company developments followed by a Q&A session. Registration is limited, but replays will be available on Clene's Investor website shortly after the events. This engagement aims to strengthen investor relations and provide important insights into the company's future operations.
Read more →CLNNClene Nanomedicine Reports Topline Results of Phase 2 COVID-19 Study of CNM-ZnAg
Primary endpoint of time to substantial symptom resolution was not met in acutely symptomatic, non-hospitalized COVID-19 patients CNM-ZnAg treatment was safe and well-tolerated SALT LAKE CITY, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiar
Read more →CLNNClene Announces Closing of $5 Million Debt Facility from the State of Maryland Funding Demonstrates Importance of Working with Private Sector to Improve Lives of Marylanders, says Governor Hogan
Clene Announces Closing of $5 Million Debt Facility from the State of Maryland Funding Demonstrates Importance of Working with Private Sector to Improve Lives of Marylanders, says Governor Hogan SALT LAKE CITY, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along
Read more →CLNN▼ -12.7%on this news
Clene Reports Third Quarter 2022 Financial Results and Recent Operating Highlights • Secondary survival endpoint for the CNM-Au8 30 mg dose investigated in the Healey ALS Platform Trial demonstrated a 90% reductio
Clene Reports Third Quarter 2022 Financial Results and Recent Operating Highlights -Secondary survival endpoint for the CNM-Au8 30 mg dose investigated in the Healey ALS Platform Trial demonstrated a >90% reduction in the risk of death or death equivalent (permanently assisted
Read more →CLNNClene Announces $10.8 Million Registered Direct Offering and $5 Million Debt Facility from the State of Maryland
$10.8 Million Registered Direct Offering $5 Million Debt Facility from the State of Maryland SALT LAKE CITY, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries Clene ) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stag
Read more →CLNN▼ -28.2%on this news
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 &#x
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 endpoin
Read more →CLNNClene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3
SALT LAKE CITY, Sept. 30, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNNClene 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 CNM-Au8 treatment was well-tolerate
Read more →CLNNClene to Present at Upcoming September Investor Conferences
SALT LAKE CITY, Aug. 30, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNN▲ +5.8%on this news
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 biomarker
Read more →CLNN▲ +5.8%on this news
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 Contra
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
Read more →CLNNClene to Host VISIONARY-MS Results Call and Webcast on August 15
SALT LAKE CITY, Aug. 12, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNN▲ +5.8%on this news· ran to -19% by day 3
Forward Looking Statements This presentation 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
Corporate Presentation July 2022 Exhibit 99.1 Forward Looking Statements This presentation 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 a
Read more →CLNNClene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8 for the Treatment of ALS
SALT LAKE CITY, July 19, 2022 (GLOBE NEWSWIRE) -- 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 dis
Read more →CLNN▲ +43.4%on this news· ran to +62% by day 3shared move
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-lab
Read more →CLNN▲ +6.9%on this news
Clene to Participate in Panel Discussion About Innovations in ALS Presented by Maxim Group and Hosted by M-Vest on June 28
SALT LAKE CITY, June 27, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNN▲ +8.3%on this news· ran to +43% by day 3
Clene Salutes Collaboration of ALS Community and Major League Baseball on Lou Gehrig Day
SALT LAKE CITY, June 02, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNN▲ +8.6%on this news
Clene Receives $3 Million Loan from State of Maryland to Support Development of Commercial Manufacturing Facility $3 million 60-month loan to support capital equipment purchases in new 75,000-square-foot facility in Elkt
Clene Receives $3 Million Loan from State of Maryland to Support Development of Commercial Manufacturing Facility $3 million 60-month loan to support capital equipment purchases in new 75,000-square-foot facility in Elkton, Maryland, for manufacture of Clene's lead drug candida
Read more →CLNNClene to Present at Upcoming Investor Conferences
SALT LAKE CITY, May 16, 2022 (GLOBE NEWSWIRE) -- 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 dise
Read more →CLNN▼ -13.5%on this news· ran to -25% by day 3
Clene Reports First Quarter 2022 Financial Results and Recent Operating Highlights • Cash, cash equivalents, restricted cash and marketable securities of $36.6 million as of
Clene Reports First Quarter 2022 Financial Results and Recent Operating Highlights -Cash, cash equivalents, restricted cash and marketable securities of $36.6 million as of March 31, 2022 -Additional data from RESCUE-ALS presented at 2022 AAN Annual Meeting and MDA Clinical & S
Read more →CLNN▼ -7.6%on this news· ran to -19% by day 3
Disclosures & Acknowledgements MCK and the University of Sydney have received research funding from Clene to undertake Rescue-ALS RE PWe thank FightMND for its philanthropic support of the TRESCUE-ALS study We thank the
Matthew Kiernan matthew.kiernan@sydney.edu.au matthew.kiernan@sydney.edu.au Exhibit 99.1 Disclosures & Acknowledgements MCK and the University of Sydney have received research funding from Clene to undertake Rescue-ALS RE PWe thank FightMND for its philanthropic support of the T
Read more →CLNNClene Nanomedicine Presents Updated Clinical Data from Phase 2 RESCUE-ALS and REPAIR trials and Preclinical ALS data at 2022 MDA Clinical & Scientific Conference • Analyses of long-term open-label extension of RES
Clene Nanomedicine Presents Updated Clinical Data from Phase 2 RESCUE-ALS and REPAIR trials and Preclinical ALS data at 2022 MDA Clinical & Scientific Conference -Analyses of long-term open-label extension of RESCUE-ALS trial indicate improved survival compared to predictions de
Read more →CLNNClene Reports Full Year 2021 Financial Results and Recent Operating Highlights • Cash and restricted cash of $50.3 million as of
Clene Reports Full Year 2021 Financial Results and Recent Operating Highlights -Cash and restricted cash of $50.3 million as of December 31, 2021 -Visionary-MS Phase 2 Trial unblinded results expected 2H 2022 -Healey ALS Platform Trial top-line data expected 2H 2022 -COVID-19
Read more →CLNNClene Nanomedicine to Present at Upcoming Investor Conferences
SALT LAKE CITY, March 03, 2022 (GLOBE NEWSWIRE) -- 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 dise
Read more →CLNN▲ +7.2%on this news
Clene Nanomedicine Presents Data from Two Phase 2 Multiple Sclerosis Trials at ACTRIMS Forum 2022 • VISIONARY-MS Phase 2 blinded interim data suggest clinically relevant improvements in the modified MS Functional
Clene Nanomedicine Presents Data from Two Phase 2 Multiple Sclerosis Trials at ACTRIMS Forum 2022 -VISIONARY-MS Phase 2 blinded interim data suggest clinically relevant improvements in the modified MS Functional Composite for the study population through 48 weeks of treatment -
Read more →CLNNClene Nanomedicine to Present Data from Phase 2 Multiple Sclerosis Programs at ACTRIMS Forum 2022
SALT LAKE CITY, Feb. 18, 2022 (GLOBE NEWSWIRE) -- 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 disea
Read more →CLNNClene Nanomedicine Provides Clinical Program Update • Healey ALS Platform Trial fully enrolled; top-line data expected 2H 2022 • Significant survival benefit from RESCUE-ALS open label extension (OLE) Phase
Clene Nanomedicine Provides Clinical Program Update -Healey ALS Platform Trial fully enrolled; top-line data expected 2H 2022 -Significant survival benefit from RESCUE-ALS open label extension (OLE) Phase 2 trial to be presented at upcoming Muscular Dystrophy Association (MDA)
Read more →CLNN▲ +5.3%on this news
Clene Announces New Chief Financial Officer Morgan Brown
Clene Announces New Chief Financial Officer Morgan Brown SALT LAKE CITY, Feb. 1, 2022 -- -- 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
Read more →CLNN▼ -8.3%on this news
Clene Nanomedicine's Second Asset, CNM-ZnAg, Completes 50% Patient Enrollment in COVID-19 Trial Topline data is expected in 1H 2022 Trial is evaluating acutely symptomatic, non-hospitalized COVID-19 patients in Brazil CN
Clene Nanomedicine's Second Asset, CNM-ZnAg, Completes 50% Patient Enrollment in COVID-19 Trial SALT LAKE CITY, January 18, 2022 -- -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage bioph
Read more →CLNN▲ +8.1%on this news
Clene Nanomedicine’s Patent Portfolio Grows to More Than 150 Issued Worldwide, including Two Key Patents Now Validated Across Europe
Powerful combination of key patents comes as the Company looks ahead to topline results from a Phase 3 registration study in ALS in second half of 2022 SALT LAKE CITY, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries “Clene” and its wholly
Read more →CLNN▼ -9.4%on this newsshared move
CLNN (NASDAQ)
CLNN (NASDAQ) December 14, 2021 2 Forward Looking Statements This presentation contains "forward - looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 . Clene's actual results may differ from its expectat
Read more →CLNN▲ +13.1%on this newsshared move
Clene Nanomedicine's Facility Improvement Project Receives $1 Million Grant Award from the Maryland Department of Housing and Community Development (DHCD) Clene Nanomedicine's Maryland facility is among the projects and
Clene Nanomedicine's Facility Improvement $1 Million Grant Award from the Maryland Department of Housing and Community Development (DHCD) SALT LAKE CITY, Dec. 13, 2021 -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanome
Read more →CLNNClene Nanomedicine to Present RESCUE-ALS Phase 2 Data in Late-Breaking Session at 32nd International Symposium on ALS/MND
Late-breaker oral presentation by Professor Steve Vucic, University of Sydney Medical School and Northcott Chair of Neurology CNM-Au8®demonstrated significantly slowed disease progression, decreased risk of 6-point ALSFRS-R decline, and improved quality of life in early ALS pati
Read more →CLNNClene Nanomedicine’s RESCUE-ALS Phase 2 Results Selected for Late-Breaking Presentation at 32nd International Symposium on ALS/MND
Late-breaker oral presentation by Professor Steve Vucic, University of Sydney Medical School and Northcott Chair of Neurology CNM-Au8® demonstrated significantly slowed disease progression: decreased risk of 6-point ALSFRS-R decline, and improved quality of life in early ALS pat
Read more →CLNN▼ -7.6%on this news
Clene Nanomedicine Presents Updated Data from RESCUE-ALS Phase 2 Study at 4 th Annual ALS ONE Research Symposium CNM-Au8 has favorable impact on progression of ALS as measured by joint rank comparison of combined surviva
Clene Nanomedicine Presents Updated Data from RESCUE-ALS Phase 2 Study at 4th Annual ALS ONE Research Symposium SALT LAKE CITY, December 1, 2021 -- -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clin
Read more →CLNN▲ +10.6%on this news
Clene Announces Completion of Patient Enrollment in the HEALEY ALS Platform Trial Registration trial for CNM-Au8 , a gold nanocrystal suspension Topline data anticipated 2H 2022 World's first ALS platform trial accelerat
Announces Completion of Patient Enrollment in the HEALEY ALS Platform Trial SALT LAKE CITY, November 15, 2021 -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company f
Read more →CLNN▲ +9.5%on this news· ran to +20% by day 1
Clene Reports Third Quarter 2021 Operating and Financial Highlights Recently announced top-line results from RESCUE-ALS Phase 2 trial with CNM-Au8 , a gold nanocrystal suspension VISIONARY-MS blinded interim data show cl
Clene Reports Third Quarter 2021 Operating and Financial Highlights SALT LAKE CITY, Nov. 9, 2021 -- Clene Inc. (Nasdaq: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on rev
Read more →CLNN▼ -12.7%on this news
Clene Nanomedicine Announces Top-Line Results from Phase 2 RESCUE-ALS Clinical Trial RESCUE-ALS Phase 2 Trial did not meet primary MUNIX biomarker endpoint or secondary FVC endpoint at week 36; MUNIX efficacy signal was
Clene Nanomedicine Announces Top-Line Results Phase 2 RESCUE-ALS Clinical Trial SALT LAKE CITY, Nov. 2, 2021 -- Clene Inc. (Nasdaq: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company fo
Read more →CLNNClene Nanomedicine Presents Blinded Interim Update from VISIONARY-MS and Positive Results from REPAIR-MS Phase 2 Clinical Trials VISIONARY-MS blinded interim data show clinically relevant improvements in the modified MS
Nanomedicine Presents Blinded Interim Update from VISIONARY-MS and Results from REPAIR-MS Phase 2 Clinical Trials blinded interim data show clinically relevant improvements in the modified MS Functional Composite for the study population through 48 clinical trial demonstrated
Read more →CLNNClene Announces Initiation of a Second FDA Expanded Access Program with CNM-Au8 for People Living with Amyotrophic Lateral Sclerosis
Clene Announces Initiation of a Second FDA Expanded CNM-Au8 for People Living with Amyotrophic Lateral Sclerosis SALT LAKE CITY, September 23, 2021 -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clin
Read more →CLNNClene Presents Phase 2 CNM-Au8 CNS Target Engagement Data at the International Parkinson and Movement Disorder Society Virtual Congress 2021 CNM-Au8 , a catalytically active gold nanocrystal suspension, significantly imp
Clene Presents Phase 2 CNM-Au8 CNS Target Engagement International Parkinson and Movement Disorder Society Virtual Congress 2021 CNM-Au8 , a catalytically active gold nanocrystal suspension, significantly improved brain energetic metabolism in Parkinson's patients SALT LAKE
Read more →CLNNClene Completes Final Patient Visit in Phase 2 RESCUE-ALS Study: Topline Data Readout Expected Q4 2021 Final patient visit has been completed in its Phase 2 RESCUE-ALS study; study close-out activities have commenced 90%
Completes Final Patient Visit in Phase 2 RESCUE-ALS Study: Topline Data Readout Expected Q4 2021 LAKE CITY, September 9, 2021 -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmace
Read more →CLNNClene Nanomedicine to Present at Upcoming Virtual Investor Conferences
SALT LAKE CITY, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanot
Read more →CLNNClene Enters into Two Leases to Materially Expand Manufacturing Capacity of its Lead Asset CNM-Au8 Newly completed lease agreements to more than quadruple Clene's manufacturing capacity to support ongoing clinical trials
Clene Enters into Two Leases to Materially Expand Manufacturing Capacity of its Lead Asset CNM-Au8 Newly completed lease agreements to more than quadruple Clene's manufacturing capacity to support ongoing clinical trials, future clinical trials and the potential commercial p
Read more →CLNN▼ -7.1%on this newsshared move
Clene Reports Second Quarter 2021 Operating and Financial Highlights Phase 2 REPAIR program demonstrated statistically significant improvements in brain energetic metabolism with CNM-Au8 , a gold nanocrystal suspension P
Clene Reports Second Quarter 2021 Operating and Financial Highlights Phase 2 REPAIR program demonstrated statistically significant improvements in brain energetic metabolism with CNM-Au8 , a gold nanocrystal suspension Phase 2, placebo-controlled RESCUE-ALS trial remains on
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Clene Reports Positive Top-line Results from its Phase 2 REPAIR Clinical Trials in Parkinson's Disease and Multiple Sclerosis Achieved a statistically significant increase in the Phase 2 program's primary endpoint (mean
Positive Top-line Results from its Phase 2 REPAIR Clinical Trials in Parkinson's Disease and Multiple Sclerosis Achieved a statistically significant increase in the Phase 2 program's primary endpoint (mean change in brain NAD+/NADH ratio) a gold nanocrystal suspension, signi
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Clene Nanomedicine Appoints Dr. Vallerie McLaughlin to its Board of Directors
Clene Nanomedicine Appoints Dr. Vallerie McLaughlin to its Board of Directors SALT LAKE CITY, August 5, 2021 -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company d
Read more →CLNNClene to Present at Canaccord Genuity's Annual Growth Conference
SALT LAKE CITY, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanot
Read more →CLNNClene to Host Expert Perspectives Webinar on Cellular Energetic Failure and the Unmet Medical Needs in ALS and MS
SALT LAKE CITY, June 30, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of cellular energetic failure in neur
Read more →CLNNClene Added to Membership of Russell 2000 Index
SALT LAKE CITY, June 28, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using bi
Read more →CLNNClene to Present at the Raymond James Human Health Innovation Conference
SALT LAKE CITY, June 15, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using bi
Read more →CLNNClene Announces Plan to Expand its Manufacturing Capacity of CNM-Au8, Closing of Up to $30 Million Debt Facility, and Financing Agreements for $9.25 Million At-the-Market Private Placement
Clene Announces Plan to Expand its Manufacturing Capacity of CNM-Au8, Closing of Up to $30 Million Debt Facility, and Financing Agreements for $9.25 Million At-the-Market Private Placement SALT LAKE CITY, UT, May 24, 2021 -- Clene Inc. (NASDAQ: CLNN) (along with its subsidia
Read more →CLNNClene Appoints David J. Matlin as Chairman of the Board
Clene Appoints David J. Matlin as Chairman of SALT LAKE CITY, May 19, 2021 -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neu
Read more →CLNNClene Nanomedicine Receives Catalyst Award for Healthy Longevity from U.S. National Academy of Medicine to Accelerate the Development of CNM-Au8 for Neurodegenerative Diseases Associated with Aging
International award will fund preclinical study of CNM-Au8 nanocatalysis for the improvement of human health and lifespan in the contexts of aging and Alzheimer’s disease Clene anticipates the expansion of disease indications for CNM-Au8 beyond amyotrophic lateral sclerosis, Par
Read more →CLNNClene Nanomedicine Presents Updated Blinded Efficacy Data from Ongoing Phase 2 RESCUE-ALS Study at the ENCALS 2021 Annual Meeting
Preliminary blinded efficacy data suggest CNM-Au8 may have the potential for neuro-repair in amyotrophic lateral sclerosis (ALS) patients Patients demonstrated improvement from baseline, as compared to the expected continuous decline seen in published data from prior observation
Read more →CLNNClene Reports First Quarter 2021 Operating and Financial Highlights Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics and support its potential to drive meaningful neurological fu
First Quarter 2021 Operating and Financial Highlights Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics and support its potential to drive meaningful neurological functional improvements in MS patients Awarded Michael J. Fox Foundation
Read more →CLNNClene Nanomedicine Receives Two Patent Notice of Allowances in the U.S. for Its Platform Nanocrystal Therapeutic Technology
SALT LAKE CITY, April 30, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative
Read more →CLNNClene Reports Full Year 2020 Operating and Financial Highlights Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics Topline data from a Phase 2 ALS trial and two Phase 2 target enga
Clene Reports Full Year 2020 Operating and Financial Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics Topline data from a Phase 2 ALS trial and two Phase 2 target engagement studies in MS and Parkinson's disease expected in 2H 2021 F
Read more →CLNNClene Nanomedicine Announces Upcoming Presentations at the Maxim Group LLC Inaugural 2021 Emerging Growth Virtual Conference and Launch of Clene Spotlight Webpage on M Vest LLC
SALT LAKE CITY, March 10, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on the treatment of neurodegenerative disease using nan
Read more →CLNNClene Nanomedicine Announces Achievement of 50% Enrollment in the Phase 3 HEALEY ALS Platform Trial
SALT LAKE CITY, March 09, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative
Read more →CLNNClene Nanomedicine Awarded Michael J. Fox Foundation Grant to Accelerate the Development of CNM-Au8 as a Treatment for Parkinson’s Disease
Interim data from a Phase 2 target engagement study show that CNM-Au8 treatment was associated with improvements across key CNS bioenergetic metabolites in Parkinson’s disease patients Initiation of a Phase 2 proof-of-concept trial in Parkinson’s disease patients expected in 202
Read more →CLNNRobert Glanzman, MD FAAN For the VISIONARY - MS Investigators R . G l a n z m a n , M D F AA N 1 , H . Bea d n a l l MBBS F R A C P 2 , A . Klistorner , M. Barnett, MBBS FRACP 2 , R. Sergott MD 3 , A. Rynders 1 , K. Ho,
Robert Glanzman, MD FAAN For the VISIONARY - MS Investigators R . G l a n z m a n , M D F AA N 1 , H . Bea d n a l l MBBS F R A C P 2 , A . Klistorner , M. Barnett, MBBS FRACP 2 , R. Sergott MD 3 , A. Rynders 1 , K. Ho, PhD 1 , M. Mortenson MS 1, M. Hotchkin 1 1 Holladay, UT/Unit
Read more →CLNNClene Nanomedicine Presents Updated Interim Data from Phase 2 Multiple Sclerosis Programs at ACTRIMS Forum 2021
Blinded interim data from VISIONARY-MS continue to support the potential of CNM-Au8 to drive meaningful neurological functional improvements in MS patients Interim REPAIR-MS results provide further evidence of CNM-Au8’s homeostatic effect on brain bioenergetics in MS patients S
Read more →CLNNClene Nanomedicine to Present Updated Interim Data from Phase 2 Multiple Sclerosis Programs at ACTRIMS Forum 2021
SALT LAKE CITY, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced that it will present updated interim data from
Read more →CLNNClene Nanomedicine Initiates Phase 2 Study of CNM-ZnAg for Patients with COVID-19
Study to evaluate CNM-ZnAg in acutely symptomatic, non-hospitalized COVID-19 patients SALT LAKE CITY, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) today announced that its wholly owned subsidiary Clene Nanomedicine, Inc., a c
Read more →CLNNClene Nanomedicine Receives Patent Notice of Allowance in the United States for using Gold Nanocrystals for the Treatment of Multiple Sclerosis
Resulting patent to cover methods of using Clene’s lead candidate CNM-Au8, now in Phase 2 and 3 trials for Multiple Sclerosis (MS) and Amyotrophic lateral sclerosis (ALS) Latest patent allowance adds to Clene’s robust IP estate including over 130 patents issued and pending appli
Read more →CLNNClene Nanomedicine Closes Merger with Tottenham Acquisition I Limited and Provides Corporate Update Common stock of the merged company, Clene Inc., to commence trading on the NASDAQ Capital Market under the ticker symbol
Clene Nanomedicine Closes Merger with Tottenham Acquisition I Limited and Provides Corporate Update Common stock of the merged company, Clene Inc., to commence trading on the NASDAQ Capital Market under the ticker symbol "CLNN" on December 31, 2020 Clinical pipeline includes
Read more →CLNNClene Nanomedicine Presents Blinded Interim Results from RESCUE-ALS Phase 2 Study at the 31st International Symposium on ALS/MND
SALT LAKE CITY, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the presentation of blinded interim results from the Phase 2 RESCUE-ALS clinical trial investigating the effects of its lead clinical candidate,
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