Frequent inventory of the merged firm, Clene Inc., to begin buying and selling on the NASDAQ Capital Market beneath the ticker image “CLNN” on December 31, 2020
Medical pipeline contains an ongoing Part 3 examine in amyotrophic lateral sclerosis (ALS) and 4 concurrent Part 2 research in ALS, a number of sclerosis and Parkinson’s illness
Proceeds from the transaction totaled roughly $31.9 million, combining funds held in Tottenham’s belief account and a concurrent $22.4 million PIPE financing
SALT LAKE CITY, Dec. 30, 2020 (GLOBE NEWSWIRE) — Clene Nanomedicine, Inc. (“Clene”) (NASDAQ: CLNN), a clinical-stage biopharmaceutical firm, at present introduced the closing of a merger with Tottenham Acquisition I Restricted (“Tottenham”) and supplied a company replace. Proceeds from this transaction totaled roughly $31.9 million, which included funds held in Tottenham’s belief account and a concurrent personal placement funding in public fairness (PIPE) financing led by current Clene shareholders. Tottenham shareholders authorized the transaction on December 30, 2020. The mixed, publicly traded firm will function beneath the title Clene Inc., and its widespread inventory will begin buying and selling on the NASDAQ Capital Market on December 31, 2020, beneath the ticker image “CLNN.” Clene’s administration group will proceed main the merged firm following this transaction.
“Since its inception, Clene has sought to revolutionize the therapy of neurodegenerative illness by leveraging the facility of neuro-reparative nanocatalysis to reinforce mobile bioenergetic mechanisms,” mentioned Rob Etherington, president and chief govt officer of Clene. “Via the profitable execution of this technique, we have now superior our lead asset, CNM-Au8, into Part 2 and three scientific research that purpose to handle neurodegenerative illnesses of excessive unmet medical want, similar to a number of sclerosis, Parkinson’s illness, and amyotrophic lateral sclerosis. We’re thrilled to have the added monetary flexibility supplied by Tottenham, our PIPE buyers and current shareholders as we advance these trials and the remainder of our nanotherapeutic pipeline as a public firm. This, mixed with our interim scientific knowledge set, leaves us well-positioned to ship a number of value-creating milestones as we search to shift the paradigm of neurodegenerative illness therapy and enhance the lives of sufferers.”
Latest Achievements and Outlook
CNM-Au8 for the therapy of amyotrophic lateral sclerosis (ALS):
Blinded interim knowledge from the Part 2 RESCUE-ALS trial, as offered on the 31st Worldwide Symposium on ALS/MND:
Rescue-ALS is a Part 2, multi-center, randomized, double-blind, placebo-controlled examine designed to judge the efficacy, security, pharmacokinetics and pharmacodynamics of CNM-Au8, a neuro-reparative nanocatalyst, in early symptomatic ALS sufferers. Enrollment within the trial was accomplished forward of schedule in September 2020. Preliminary blinded knowledge offered on the 31st Worldwide Symposium on ALS/MND present that greater than 40% of enrolled sufferers with accomplished 12-week knowledge skilled enhancements in motor neuron operate as assessed by the imply motor unit quantity index-4 [MUNIX(4)] rating, the examine’s major endpoint. In comparison with baseline values, the common MUNIX(4) rating of the general trial inhabitants (together with each lively CNM-Au8 and placebo) confirmed an absolute enhance. This enhance exceeded the expectations of the statistical fashions on which the examine was primarily based, which predicted a seamless linear lower in common MUNIX(4) rating from examine onset (Neuwirth et al. JNNP 2015). These knowledge, although blinded, counsel that CNM-Au8 might have neuro-reparative potential in ALS sufferers. Clene expects to report the whole, unblinded outcomes from the RESCUE-ALS examine within the second half of 2021.
Launched affected person enrollment within the HEALEY ALS Platform Trial:
CNM-Au8 was chosen as one of many first drug regimens to be evaluated within the HEALEY ALS Platform Trial, a multi-center, multi-regimen, placebo-controlled, Part 3 registration trial evaluating the security and efficacy of investigational merchandise for the therapy of ALS. This primary-ever ALS platform trial is designed to cut back trial time, cut back prices and enhance affected person participation in creating novel therapies for ALS. It contains substantial monetary help from philanthropic donors and foundations and supplies entry to 54 professional ALS scientific trial websites throughout the U.S. Dosing was initiated within the Clene-specific portion of the platform trial in July 2020 and full enrollment is predicted by the tip of Q2 2021, with top-line knowledge accessible within the first half of 2022.
CNM-Au8 for the therapy of a number of sclerosis (MS):
Blinded interim knowledge from the Part 2 VISIONARY-MS trial, as offered on the MSVirtual2020 Assembly:
VISIONARY-MS is a Part 2, multi-center, double-blind, randomized, placebo-controlled trial evaluating the efficacy and security of CNM-Au8 as a remyelinating and neuro-reparative therapy in steady relapsing MS sufferers with persistent visible impairment. Preliminary blinded knowledge offered on the MSVirtual2020 Assembly demonstrated notable, exposure-related median enhancements in low distinction letter acuity (the examine’s major endpoint), in addition to the three remaining sub-scales of the modified MS Practical Composite: Image Digit Modalities Check (cognition), 9-Gap Peg Check (higher extremity operate) and Timed 25-foot Stroll (gait). The accessible security knowledge point out that CNM-Au8 is well-tolerated with no drug-related critical adversarial occasions reported thus far. These knowledge, although blinded, collectively present help for the potential of CNM-Au8 to drive clinically significant enhancements in MS visible and useful endpoints. Full enrollment in VISIONARY-MS is predicted by the tip of 2021, topic to ongoing COVID-19 associated web site analysis restrictions usually applied to guard MS sufferers taking standard-of-care immunosuppressive therapies.
Interim knowledge from the Part 2 REPAIR-MS trial, as offered on the MSVirtual2020 Assembly:
REPAIR-MS is a single-center, active-only, sequential group, investigator-blinded examine to evaluate the central nervous system (CNS) metabolic results, security, pharmacokinetics, and pharmacodynamics of CNM-Au8 in MS sufferers. An evaluation of mixed, interim outcomes from REPAIR-MS and the concurrent REPAIR-PD trial reveal vital CNS goal engagement of orally dosed CNM-Au8. The info additionally present enhancements throughout vital CNS bioenergetic metabolites, together with complete nicotinamide adenine dinucleotide (NAD+) ranges, NAD+/NADH ratio, and adenosine triphosphate (ATP) ranges, indicating a homeostatic impact of CNM-Au8 on mind bioenergetics. Such knowledge present proof for the flexibility of CNM-Au8 to positively have an effect on key metabolic markers within the human mind and spotlight its potential to reinforce elementary cell processes by way of broadly relevant bioenergetic mechanisms. Clene expects to report extra knowledge from REPAIR-MS within the second half of 2021.
CNM-Au8 for the therapy of Parkinson’s illness (PD):
Interim knowledge from the Part 2 REPAIR-PD trial, as offered on the MSVirtual2020 Assembly:
REPAIR-PD is a single-center, active-only, sequential group, investigator-blinded examine to evaluate the CNS metabolic results, security, pharmacokinetics and pharmacodynamics of CNM-Au8 in PD sufferers. As mentioned above, an evaluation of mixed, interim outcomes from REPAIR-PD and REPAIR-MS research have been offered throughout the joint MSVirtual2020 Assembly. Clene expects to report extra knowledge from REPAIR-PD within the first half of 2021 and to launch an extra Part 2 PD efficacy trial by the tip of 2021.
CNM-AgZn17 for the therapy of infectious illnesses, together with COVID-19:
Launching a Part 2 trial in COVID-19 sufferers in Brazil:
CNM-AgZn17 is Clene’s second key asset meant for broad anti-viral and anti-microbial use. A Part 2 examine is deliberate for conduct in Brazil to deal with acutely symptomatic non-hospitalized sufferers with COVID-19. This examine will consider time to symptomatic enchancment (as much as 28 days) and prevention of hospitalization. This examine is anticipated to launch within the first half of 2021.
Appointed Ted Jeong as Chief Monetary Officer:
Earlier this month, Clene appointed Dr. Ted (Tae Heum) Jeong as the corporate’s chief monetary officer (CFO). Dr. Jeong has greater than 20 years of expertise as a monetary govt and enterprise capitalist. He’s a Managing Accomplice at Kensington-SV International Improvements LP, a growth-stage funding agency which he co-founded in 2018. Dr. Jeong additionally serves on the Board of Administrators of Neurobo Prescription drugs, Inc. as chair of the audit committee. From 2002 to 2018, he was the CFO of Rexahn Prescription drugs, Inc., an oncology and CNS-focused biopharmaceutical firm. At Rexahn, Dr. Jeong accomplished fairness financings totaling greater than $170 million and was additionally answerable for forming strategic alliances and executing license offers within the U.S., Europe, and Asia. From 1997 to 2002, he served because the Senior Funding Supervisor at Hyundai Enterprise Funding Company, a subsidiary of the Hyundai Motors conglomerate and one of many largest enterprise capital companies in South Korea, the place he operated two of the nation’s first healthcare enterprise capital funds. Dr. Jeong acquired his B.S. and M.S. in Chemistry from Pohang College of Science & Expertise. He additionally holds an M.S. in Finance from Johns Hopkins College, and a Physician of Administration from the College of Maryland.
Matt Gardner, who has led the Clene finance group for the previous 5 years, is Vice President of Finance.
About this Transaction
On September 1, 2020, Clene, a privately held biopharmaceutical firm, entered right into a definitive enterprise mixture settlement with Tottenham, a particular goal acquisition firm (SPAC).
Because of this enterprise mixture, Clene acquired proceeds of roughly $31.9 million previous to transaction bills, which incorporates roughly $9.5 million from Tottenham’s belief account and roughly $22.4 million from PIPE buyers led by current Clene shareholders.
The outline of the enterprise mixture contained herein is simply a high-level abstract and is certified in its entirety by the extra detailed description of the phrases of the transaction supplied within the definitive proxy assertion/prospectus filed with the U.S. Securities and Alternate Fee on December 18, 2020.
Advisors: LifeSci Capital LLC and Chardan Capital Markets, LLC are performing as M&A and monetary advisors to the events on this transaction. Loeb & Loeb LLP is performing as authorized advisor to Tottenham. Kirkland & Ellis LLP and Stoel Rives LLP, Clene’s native counsel, are performing because the authorized advisors to Clene.
RESCUE-ALS is a Part 2 multi-center, randomized, double-blind, parallel-group, placebo-controlled examine analyzing the efficacy, security, pharmacokinetics and pharmacodynamics of CNM-Au8 in members who’re newly symptomatic with ALS (inside 24-months of screening or 12-months from analysis). Enrolled topics shall be randomized 1:1 to obtain both lively therapy with CNM-Au8 (30 mg) or placebo along with their present customary of care. Members will obtain their randomized therapy over 36 consecutive weeks throughout the Remedy Interval. The target of this examine is to evaluate the influence of bettering neuronal bioenergetics, decreasing reactive oxygen species and selling protein homeostasis with CNM-Au8 to sluggish illness development in sufferers with ALS.
Concerning the HEALEY ALS Platform Trial
The HEALEY ALS Platform trial is a multi-center, randomized, double-blind, placebo-controlled Part 2 examine designed to judge the efficacy, security, pharmacokinetics and pharmacodynamics of investigational merchandise, together with CNM-Au8, in early symptomatic ALS sufferers. It’s the first ALS platform trial and is designed to speed up the trail to new ALS therapies by testing a number of therapies towards a single placebo group. Enrolled topics shall be randomized 3:1 to obtain both lively therapy or placebo every day for a 24-week therapy interval. The first endpoint is change in illness severity over time as measured by the ALS Practical Ranking Scale-Revised (ALSFRS-R). Secondary endpoints embrace change in respiratory operate over time as measured by sluggish important capability and alter in muscle energy over time as measured isometrically utilizing hand-held dynamometry.
The target of the VISIONARY-MS (Remedy of Visible Pathway Deficits In Continual Optic Neuropathy for Evaluation of Remyelination in Steady RMS) trial is to evaluate the efficacy and security of CNM-Au8 as a neuroprotective and remyelinating therapy for individuals with steady relapsing MS who’ve persistent imaginative and prescient impairment. The first endpoint is enchancment in low distinction letter acuity from baseline to Week-24. Key secondary endpoints embrace enhancements from baseline to Week-24 within the remaining modified-A number of Sclerosis Practical Composite subscales (Image Digit Modalities Check, 9-Gap Peg Check, and Timed 25-Foot Stroll). Members drink a 2 oz. (60 ml) dose of the nanocrystal suspension (or placebo) every day every morning.
About REPAIR-MS and REPAIR-PD
REPAIR-MS and REPAIR-PD are Part 2, single-center, open-label, sequential group research analyzing the mind metabolic results, security, pharmacokinetics and pharmacodynamics of CNM-Au8 in sufferers who’ve been recognized with MS inside 15 years of screening or in sufferers with PD who’ve been recognized inside three years of screening. Investigators and members are blinded to dose, which may include a 15 or 30 mg orally delivered dose of the nanocrystal suspension every day every morning for 12 weeks. Members endure 31P-MRS mind imaging scans to semi-quantitatively measure bioenergetic mind metabolites at baseline, previous to administration of drug, and on the end-of-study. The target of this examine is to reveal goal engagement for CNM-Au8 on CNS biomarkers associated to bioenergetics and neuronal metabolism in sufferers with MS and PD. The examine is happening on the College of Texas Southwestern Medical Middle with a group of internationally acknowledged consultants in mind imaging and therapy of issues of the CNS.
CNM-Au8 is a concentrated, aqueous suspension of clean-surfaced faceted gold nanocrystals that act catalytically to help vital intracellular organic reactions. CNM-Au8 consists solely of gold nanoparticles, composed of clean-surfaced, faceted, geometrical crystals held in suspension in sodium bicarbonate buffered, pharmaceutical grade water. CNM-Au8 has demonstrated security in Part 1 research in wholesome volunteers and has proven each remyelination and neuroprotective results in a number of preclinical (animal) fashions. Preclinical knowledge, each revealed in peer-reviewed journals and offered at scientific congresses, reveal that therapy of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular ranges of reactive oxygen species and improves mitochondrial capability in response to mobile stresses induced by a number of disease-relevant neurotoxins. Oral therapy with CNM-Au8 improved useful behaviors in rodent fashions of ALS, MS and Parkinson’s illness versus car (placebo). CNM-Au8 is at present being examined in a Part 2 scientific examine for the therapy of persistent optic neuropathy in sufferers with MS, along with Part 2 and Part 3 scientific research for illness development in sufferers with ALS.
Clene is a clinical-stage biopharmaceutical firm targeted on the event of distinctive therapeutics for neurodegenerative illnesses. Clene has innovated a novel nanotechnology drug platform for the event of a brand new class of orally administered neurotherapeutic medication. Clene has additionally superior into the clinic an aqueous answer of ionic zinc and silver for anti-viral and anti-microbial makes use of. Based in 2013, the corporate is predicated in Salt Lake Metropolis, Utah with R&D and manufacturing operations positioned in North East, Maryland. For extra info, please go to www.clene.com.
This press launch comprises, and sure oral statements made by representatives of Tottenham, Clene, and their respective associates, on occasion might comprise, “forward-looking statements” inside the which means of the “secure harbor” provisions of the Non-public Securities Litigation Reform Act of 1995. Tottenham’s and Clene’s precise outcomes might differ from their expectations, estimates and projections and consequently, you shouldn’t depend on these forward-looking statements as predictions of future occasions. Phrases similar to “count on,” “estimate,” “mission,” “funds,” “forecast,” “anticipate,” “intend,” “plan,” “might,” “will,” “may,” “ought to,” “believes,” “predicts,” “potential,” “would possibly” and “continues,” and comparable expressions are meant to establish such forward-looking statements. These forward-looking statements embrace, with out limitation, Tottenham’s and Clene’s expectations with respect to future efficiency and anticipated monetary impacts of the enterprise mixture and the timing of the completion of the enterprise mixture. These forward-looking statements contain vital recognized and unknown dangers and uncertainties, lots of that are past Clene’s management and will trigger precise outcomes to vary materially from anticipated outcomes. Elements which will trigger such variations embrace, however should not restricted to: (1) the end result of any authorized proceedings that could be instituted towards Tottenham or Clene following the announcement of the Merger Settlement and the transactions contemplated therein; (2) the lack to acquire or keep the itemizing of the post-acquisition firm’s widespread inventory on NASDAQ following the enterprise mixture; (3) the chance that the enterprise mixture disrupts present plans and operations on account of the announcement and consummation of the enterprise mixture; (4) the flexibility to acknowledge the anticipated advantages of the enterprise mixture, which can be affected by, amongst different issues, competitors, the flexibility of the mixed firm to develop and handle progress profitably and retain its key staff; (5) modifications in relevant legal guidelines or laws; (6) the chance that the mixed firm could also be adversely affected by different financial, enterprise, and/or aggressive elements; and (9) different dangers and uncertainties to be recognized within the definitive proxy assertion/prospectus/info assertion filed on December 18, 2020, together with these beneath “Threat Elements” therein, and in different filings with the Securities and Alternate Fee (“SEC”) made by the mixed firm sooner or later. Tottenham and Clene warning that the foregoing listing of things is neither unique nor exhaustive. Tottenham and Clene warning readers to not place undue reliance upon any forward-looking statements, which converse solely as of the date made. Neither Tottenham or Clene undertakes or accepts any obligation or endeavor to launch publicly any updates or revisions to any forward-looking statements to replicate any change in its expectations or any change in occasions, circumstances or circumstances on which any such assertion is predicated, topic to relevant legislation. All info on this press launch is as of the date of this press launch. The knowledge contained in any web site referenced herein is just not, and shall not be deemed to be, a part of or included into this press launch.
LifeSci Advisors, LLC
Supply: Clene Inc.