Clene Inc., a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel clean surfaced nanotechnology (CSN) therapeutics. The company has a nanotechnology drug suspension; and engages in the development and commercialization of dietary supplements. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2 study for the treatment of stable multiple sclerosis; a Phase 2 biomarker study in Parkinson's; and Phase 2 and Phase 3 trials to investigate the potential for disease modification for neurodegenerative diseases. The company's products also include CNM-AgZn17, a topical gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; CNM-ZnAg, a broad-spectrum antiviral and antibacterial agent to treat disease-causing infections, such as COVID-19 and to provide immune support for symptom resolution; and CNM-PtAu7, a gold-platinum CSN therapeutic for oncology applications. Clene Inc. is headquartered in Salt Lake City, Utah.
IPO Year:
Exchange: NASDAQ
Website: clene.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 10/4/2022 | Outperform → Perform | Oppenheimer | |
| 7/18/2022 | $16.00 | Buy | H.C. Wainwright |
| 5/2/2022 | $10.00 | Buy | Canaccord Genuity |
| 9/28/2021 | $20.00 | Outperform | Oppenheimer |
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Secures new $10.0 million debt facility to replace remaining $7.85 million of Avenue Capital debt Improves cash position enabling Clene to generate the additional data to support the new drug application of CNM-Au8® for ALS via an accelerated regulatory pathwayCarries a 12% interest rate per annum and is secured by all assets of CleneIncludes conversion feature on 65% of the new debt facility at a fixed conversion price of $5.67, a 130% premium to Clene's closing stock price on the day of signing SALT LAKE CITY, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage
FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier presented findingsFDA recommends a follow-up meeting to discuss in more detail the analyses needed to support the accelerated approval pathway Additional NfL biomarker collection and analyses are underway and planned to be completed during the second quarter of 2025Clene is proceeding with its New Drug Application (NDA) for ALS with a planned submission in mid-2025 following incorporation of the EAP NfL biomarker analysesClene plans to commence the confirmatory Phase 3 trial (RESTORE-ALS) evaluating the survival bene
Clene met with the U.S. Food and Drug Administration (FDA) on November 1, 2024, in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS and are awaiting meeting minutesCash, cash equivalents and marketable securities of $14.6 million as of September 30, 2024Amended debt agreement with Avenue Capital to defer principal payments and extend maturity of facility to second quarter of 2025Completed registered direct offering and concurrent private placements to raise $7.3 million in gross proceeds on October 1, 2024 SALT LAKE CITY, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Cl
SALT LAKE CITY, Oct. 09, 2024 (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 improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it will participate in the following investor conferences in October. 2024 Maxim Healthcare Virtual SummitDate: October 15-17, 2024Location: VirtualPresentation: October 15, 2024, at 2:30 p.m. E.T.Format: Fireside Presentation and 1x1 meetingsAttendance: Sign up to become an M-Ve
Investment led by healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene's Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other previously existing shareholders$7.3 million registered direct offering and concurrent private placements priced at market under Nasdaq rulesAmended debt facility with Avenue Venture Opportunities Fund, L.P. in conjunction with financingAggregate financing, including amendment to debt facility, expected to be sufficient to fund Company into the first quarter of 2025, including a face-to-face meeting with th
SALT LAKE CITY, Sept. 30, 2024 (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 improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that on September 30, 2024 it entered into a securities purchase agreement with a healthcare focused institutional investor ("Healthcare Investor") for the issuance and sale of 742,626 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering
SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), announced today that it will meet in-person with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss CNM-Au8 development for ALS. The meeting will include the FDA's Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Di
SALT LAKE CITY, Sept. 03, 2024 (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 improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the H.C. Wainwright 26th Annual Global Investment Conference and host 1x1 investor meetings. Date: September 9, 2024Time of Presentation: 7:00 am ESTFormat: Virtual Presentation 1x1 Meetings: Please contact your H.C. Wainwright representativ
LOS ANGELES, Aug. 08, 2024 (GLOBE NEWSWIRE) -- via IBN – IBN, a multifaceted communications organization engaged in connecting public companies to the investment community, is pleased to announce the release of the latest episode of The BioMedWire Podcast as part of its sustained effort to provide specialized content distribution via widespread syndication channels. The BioMedWire Podcast features fast-paced interviews with experts guiding the next wave of pharmaceutical and biotech innovation. The latest episode features Rob Etherington, President and CEO of Clene Inc. (NASDAQ:CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting
Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baselineCNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-respondersCNM-Au8 demonstrated neuroprotective effects in an in vitro model of Rett Syndrome, a rare pediatric neurodevelopmental diseaseEnrolled first ALS patient in NIH-funded Expanded Access Program (EAP) in JuneRegained compliance with Na
The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeksPrespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks Survival signal consistent with prior results from the Phase 2 RESCUE-ALS trialClene will continue the open-label extension of CNM-Au8 in the Healey ALS Platform Trial and is in discussions with the Healey & AMG ALS Center to design and offer an Expanded Access Protocol (EAP) of CNM-Au8 30mg for eligible participants of closed regimens and othersClene is pursuing multiple paths, including ongoi
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 disease, today announced that it will report topline results of the CNM-Au8® regimen of the HEALEY ALS Platform Trial on Monday, Oct. 3. Clene's management team will host a conference call and webcast to discuss the results. Conference Call and Webcast DetailsTime and Date: 8:30 a.m. EDT on Oct. 3, 2022Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll)Conference ID: 5318408Webcast Link A live audio
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 populationConsistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers, providing physiological evidence for its potential neuroprotective and remyelinating effectsCNM-Au8 treatment was well-tolerated, and there were no significant safety findings reportedResults provide support to advance CNM-Au8 into Phase 3 clinical developmentClene to host a call and webcast at 7:30 am EDT today SALT LAKE CITY, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiarie
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 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) 770-7152Conference ID: 5318408Webcast link A live audio webcast can also be accessed by visiting the Investors section of the Company's website presentations page. A replay o
RESCUE-ALS Phase 2 Trial did not meet primary MUNIX biomarker endpoint or secondary FVC endpoint at week 36; MUNIX efficacy signal was observed at week 12 (p=0.057)MUNIX trial results demonstrated protection of lower motor neurons in the pre-specified subset of limb onset ALS subjects (Wk12, p=0.0385; Wk36, p=0.0741), which represents approximately 70% of the ALS populationStatistically significant reductions in clinically relevant outcomes including ALS disease progression (p=0.0125), ALSFRS-R responder analysis (p=0.035), and improved ALS specific quality of life (p=0.018)Evidence for potential long-term survival benefit Results for Healey ALS Platform Trial Expected in the Second Half of
SALT LAKE CITY, March 16, 2023 (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 disease, today announced the appointment of Benjamin Greenberg, M.D., M.H.S. as Head of Medical. An internationally recognized expert in treating disorders of the central nervous system, Dr. Greenberg brings extensive clinical and research experience to Clene as the company continues its development of CNM-Au8® as a potential treatment for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). "Dr. Green
SALT LAKE CITY, Feb. 01, 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 disease, today announced the appointment of Morgan Brown as Chief Financial Officer effective Feb. 1, 2022. "Morgan joins the executive team at a pivotal time in Clene's growth," stated Clene's President and CEO, Rob Etherington. "He is a seasoned healthcare executive and public-company biopharma CFO, who has led the out-licensing of commercial stage assets and M&A transactions as well as numerous substantial equity and
SALT LAKE CITY, Aug. 05, 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 nanotechnology to treat energetic failure, today announced the appointment of Vallerie V. McLaughlin, MD, to its board as its seventh independent director. Dr. McLaughlin is the Kim A. Eagle MD Endowed Professor of Cardiovascular Medicine, Associate Chief Clinical Officer for Cardiovascular Services of the University of Michigan Medical Group, Associate Chief, Division of Cardiovascular Medicine, and Director of the Pulm
SALT LAKE CITY, May 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 dedicated to the treatment of neurodegenerative disease using bioenergetic nanocatalysis, today announced the appointment of David J. Matlin as Chairman of the Board. He has served as a Director of Clene since 2020. Mr. Matlin is the Chief Executive Officer of MatlinPatterson Global Advisers, a global private equity firm he co-founded in 2002. Previously, he was a Managing Director at Credit Suisse First Boston and a founding partner of Merrion Group. He currently serve
Oppenheimer downgraded Clene from Outperform to Perform
H.C. Wainwright initiated coverage of Clene with a rating of Buy and set a new price target of $16.00
Canaccord Genuity initiated coverage of Clene with a rating of Buy and set a new price target of $10.00
Oppenheimer initiated coverage of Clene with a rating of Outperform and set a new price target of $20.00
Maxim Group initiated coverage of Clene with a rating of Buy and set a new price target of $18.00
Cantor Fitzgerald initiated coverage of Clene with a rating of Overweight and set a new price target of $22.00
Benchmark initiated coverage of Clene with a rating of Buy and set a new price target of $25.00
Benchmark initiated coverage of Clene with a rating of Buy and set a new price target of $25.00
Benchmark initiated coverage of Clene with a rating of Buy
Roth Capital initiated coverage of Clene with a rating of Buy and set a new price target of $24.00
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4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)
4 - Clene Inc. (0001822791) (Issuer)