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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

Key Takeaway: 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

Full Press Release Details

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 an ongoing
Phase 3 study in amyotrophic lateral sclerosis (ALS) and four concurrent Phase 2 studies in ALS, multiple sclerosis and Parkinson's
Proceeds from the transaction totaled
approximately $31.9 million, combining funds held in Tottenham's trust account and a concurrent $22.4 million PIPE financing
SALT LAKE CITY, December 30, 2020 - Clene Nanomedicine,
Inc. ("Clene") (NASDAQ: CLNN), a clinical-stage biopharmaceutical company, today announced the closing of a merger
with Tottenham Acquisition I Limited ("Tottenham") and provided a corporate update. Proceeds from this transaction
totaled approximately $31.9 million, which included funds held in Tottenham's trust account and a concurrent private placement
investment in public equity (PIPE) financing led by existing Clene shareholders. Tottenham shareholders approved the transaction
on December 30, 2020. The combined, publicly traded company will operate under the name Clene Inc., and its common stock will commence
trading on the NASDAQ Capital Market on December 31, 2020, under the ticker symbol "CLNN." Clene's management
team will continue leading the merged company following this transaction.
"Since its inception, Clene has sought to revolutionize
the treatment of neurodegenerative disease by leveraging the power of neuro-reparative nanocatalysis to enhance cellular bioenergetic
mechanisms," said Rob Etherington, president and chief executive officer of Clene. "Through the successful execution
of this strategy, we have advanced our lead asset, CNM-Au8, into Phase 2 and 3 clinical studies that aim to address neurodegenerative
diseases of high unmet medical need, such as multiple sclerosis, Parkinson's disease, and amyotrophic lateral sclerosis.
We are thrilled to have the added financial flexibility provided by Tottenham, our PIPE investors and existing shareholders as
we advance these trials and the rest of our nanotherapeutic pipeline as a public company. This, combined with our interim clinical
data set, leaves us well-positioned to deliver multiple value-creating milestones as we seek to shift the paradigm of neurodegenerative
disease treatment and improve the lives of patients."
Recent Achievements and Outlook
CNM-Au8 for the treatment of amyotrophic lateral sclerosis
Blinded interim data from the Phase 2 RESCUE-ALS trial,
as presented at the 31st International Symposium on ALS/MND:
Rescue-ALS is a Phase 2, multi-center, randomized, double-blind,
placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8, a neuro-reparative
nanocatalyst, in early symptomatic ALS patients. Enrollment in the trial was completed ahead of schedule in September 2020. Preliminary
blinded data presented at the 31st International Symposium on ALS/MND show that more than 40% of enrolled patients with
completed 12-week data experienced improvements in motor neuron function as assessed by the mean motor unit number index-4 [MUNIX(4)]
score, the study's primary endpoint. Compared to baseline values, the average MUNIX(4) score of the overall trial population
(including both active CNM-Au8 and placebo) showed an absolute increase. This increase exceeded the expectations of the statistical
models on which the study was based, which predicted a continuing linear decrease in average MUNIX(4) score from study onset (Neuwirth
et al. JNNP 2015). These data, though blinded, suggest that CNM-Au8 may have neuro-reparative potential in ALS patients. Clene
expects to report the complete, unblinded results from the RESCUE-ALS study in the second half of 2021.
Launched patient enrollment in the HEALEY ALS Platform
CNM-Au8 was selected as one of the first drug regimens to be
evaluated in the HEALEY ALS Platform Trial, a multi-center, multi-regimen, placebo-controlled, Phase 3 registration trial evaluating
the safety and efficacy of investigational products for the treatment of ALS. This first-ever ALS platform trial is designed to
reduce trial time, reduce costs and increase patient participation in developing novel therapies for ALS. It includes substantial
financial support from philanthropic donors and foundations and provides access to 54 expert ALS clinical trial sites across the
U.S. Dosing was initiated in the Clene-specific portion of the platform trial in July 2020 and full enrollment is expected by the
end of Q2 2021, with top-line data available in the first half of 2022.
CNM-Au8 for the treatment of multiple sclerosis (MS):
Blinded interim data from the Phase 2 VISIONARY-MS trial,
as presented at the MSVirtual2020 Meeting:
VISIONARY-MS is a Phase 2, multi-center, double-blind, randomized,
placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in stable
relapsing MS patients with chronic visual impairment. Preliminary blinded data presented at the MSVirtual2020 Meeting demonstrated
notable, exposure-related median improvements in low contrast letter acuity (the study's primary endpoint), as well as the
three remaining sub-scales of the modified MS Functional Composite: Symbol Digit Modalities Test (cognition), 9-Hole Peg Test (upper
extremity function) and Timed 25-foot Walk (gait). The available safety data indicate that CNM-Au8 is well-tolerated with no drug-related
serious adverse events reported to date. These data, though blinded, together provide support for the potential of CNM-Au8 to drive
clinically meaningful improvements in MS visual and functional endpoints. Full enrollment in VISIONARY-MS is expected by the end
of 2021, subject to ongoing COVID-19 related site research restrictions generally implemented to protect MS patients taking standard-of-care
immunosuppressive therapies.
Interim data from the Phase 2 REPAIR-MS trial, as presented
at the MSVirtual2020 Meeting:
REPAIR-MS is a single-center, active-only, sequential group,
investigator-blinded study to assess the central nervous system (CNS) metabolic effects, safety, pharmacokinetics, and pharmacodynamics
of CNM-Au8 in MS patients. An analysis of combined, interim results from REPAIR-MS and the concurrent REPAIR-PD trial demonstrate
significant CNS target engagement of orally dosed CNM-Au8. The data also show improvements across important CNS bioenergetic metabolites,
including total nicotinamide adenine dinucleotide (NAD+) levels, NAD+/NADH ratio, and adenosine triphosphate (ATP) levels, indicating
a homeostatic effect of CNM-Au8 on brain bioenergetics. Such data provide evidence for the ability of CNM-Au8 to positively affect
key metabolic markers in the human brain and highlight its potential to enhance fundamental cell processes through broadly applicable
bioenergetic mechanisms. Clene expects to report additional data from REPAIR-MS in the second half of 2021.
CNM-Au8 for the treatment of Parkinson's disease
Interim data from the Phase 2 REPAIR-PD trial, as presented
at the MSVirtual2020 Meeting:
REPAIR-PD is a single-center, active-only, sequential group,
investigator-blinded study to assess the CNS metabolic effects, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in PD
patients. As discussed above, an analysis of combined, interim results from REPAIR-PD and REPAIR-MS studies were presented during
the joint MSVirtual2020 Meeting. Clene expects to report additional data from REPAIR-PD in the first half of 2021 and to launch
an additional Phase 2 PD efficacy trial by the end of 2021.
CNM-AgZn17 for the treatment of infectious diseases, including
Launching a Phase 2 trial in COVID-19 patients in Brazil:
CNM-AgZn17 is Clene's second key asset intended for broad
anti-viral and anti-microbial use. A Phase 2 study is planned for conduct in Brazil to treat acutely symptomatic non-hospitalized
patients with COVID-19. This study will evaluate time to symptomatic improvement (up to 28 days) and prevention of hospitalization.
This study is anticipated to launch in the first half of 2021.
Corporate Milestones:
Appointed Ted Jeong as Chief
Earlier this month, Clene appointed
Dr. Ted (Tae Heum) Jeong as the company's chief financial officer (CFO). Dr. Jeong has more than 20 years of experience as
a financial executive and venture capitalist. He is a Managing Partner at Kensington-SV Global Innovations LP, a growth-stage investment
firm which he co-founded in 2018. Dr. Jeong also serves on the Board of Directors of Neurobo Pharmaceuticals, Inc. as chair of
the audit committee. From 2002 to 2018, he was the CFO of Rexahn Pharmaceuticals, Inc., an oncology and CNS-focused biopharmaceutical
company. At Rexahn, Dr. Jeong completed equity financings totaling more than $170 million and was also responsible for forming
strategic alliances and executing license deals in the U.S., Europe, and Asia. From 1997 to 2002, he served as the Senior Investment
Manager at Hyundai Venture Investment Corporation, a subsidiary of the Hyundai Motors conglomerate and one of the largest venture
capital firms in South Korea, where he operated two of the country's first healthcare venture capital funds. Dr. Jeong received
his B.S. and M.S. in Chemistry from Pohang University of Science & Technology. He also holds an M.S. in Finance from Johns
Hopkins University, and a Doctor of Management from the University of Maryland.
Matt Gardner, who has led the Clene
finance team for the past five years, is Vice President of Finance.
About this Transaction
Last updated: Dec 31, 2020