UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On June 1, 2022, Clene Inc. (the “Company”) presented new data from the RESCUE-ALS clinical trial and long-term open-label extension study in three posters in the Emerging Science Program at European Network to Cure ALS (“ENCALS”) Meeting 2022, taking place June 1-3, 2022. A copy of the posters are furnished as Exhibit 99.1, Exhibit 99.2, and Exhibit 99.3 to this Current Report on Form 8-K and are incorporated herein by reference.
The information furnished in this Item 7.01, including Exhibit 99.1, Exhibit 99.2, and Exhibit 99.3, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
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99.2 |
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99.3 |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
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CLENE INC. |
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Date: June 1, 2022 |
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/s/ Robert Etherington |
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Robert Etherington |
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President and Chief Executive Officer |
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Evidence for an ALS Survival Benefit with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS Trial Long-Term Open Label Extension Long Term Vital Status All Randomized | Active vs. Placebo Original Treatment vs. No OLE or OLE Delayed Start All OLE Participants Observed vs. ENCALS Predicted Median Survival Steve Vucic PhD, DSc, FRACP, FAHMS1, Parvathi Menon PhD, FRACP1, William Huynh PhD, FRACP2, Colin Mahoney, PhD, MB, MRCPI2, Karen S. Ho, PhD MSc3, Austin Rynders, RN3, Jacob Evan3, Jeremy Evan, PA-C3, Robert Glanzman, MD FAAN3, Michael T. Hotchkin3, Matthew C. Kiernan PhD, DSc, MBBS, FRACP, FAHMS 1Concord Repatriation General Hospital, University of Sydney, Australia; 2Brain and Mind Centre, University of Sydney, Australia; 3Clene Nanomedicine, Salt Lake City, UT, USA CONCLUSION: CNM-Au8 treatment impacts long-term survival with decreased mortality risk >60% vs. original placebo randomization, and compared to ENCALS predicted median survival Long-Term OLE Participant Vital Status by Treatment Group Notes: Interim data cut as of 24-May-2022. All current active OLE subjects are censored as of 24-May-2022. Vital status and date of death (as applicable) captured for all subjects withdrawn from the study. Lost-to-follow-up (active, n=1; placebo, n=1) censored as of the date of last study contact (Active: Feb-2021; Placebo: Feb-2022). Acknowledgements: We thank the ALS study patients and their families for their support and willingness to engage in clinical research. We thank the site investigators for their research excellence and dedication to patients. We thank FightMND of Australia for substantially funding the RESCUE-ALS trial. Study Design Scheme 36-Week Blinded Treatment Period with Long Term OLE Screening (4-weeks) Baseline Wk12 Wk36 Wk24 Wk48 Wk60 Wk72 Wk84 Wk96 Wk108+ Double-Blind Period Long-Term Open Label Extension Early symptomatic ALS (within 2-years onset or 1-year diagnosis) Randomized (1:1, CNM-Au8 30 mg or placebo) 36-week treatment period with long-term open label extension 1st EP: MUNIX(4) summed %change of 4-spinal cord innervated muscles 2nd EPs: absolute MUNIX change, % FVC Exploratory EPs: disease progression, 6-pt decline in ALSFRS-R, ALSSQOL-SF, & other neurophysiology endpoints Exhibit 99.1
Steve Vucic PhD, DSc, FRACP, FAHMS1, Parvathi Menon PhD, FRACP1, William Huynh PhD, FRACP2, Colin Mahoney, PhD, MB, MRCPI2, Karen S. Ho, PhD MSc3, Austin Rynders, RN3, Jacob Evan3, Jeremy Evan, PA-C3, Robert Glanzman, MD FAAN3, Michael T. Hotchkin3, Matthew C. Kiernan PhD, DSc, MBBS, FRACP, FAHMS 1Concord Repatriation General Hospital, University of Sydney, Australia; 2Brain and Mind Centre, University of Sydney, Australia; 3Clene Nanomedicine, Salt Lake City, UT, USA Evidence for Continuing Quality of Life Benefit Following CNM-Au8 ALS Treatment Preliminary Analyses of the RESCUE-ALS Long Term OLE Design Scheme Early symptomatic ALS (within 2-years onset or 1-year diagnosis) Randomized (1:1, CNM-Au8 30 mg or placebo) 36-week treatment period with long-term open label extension 1st EP: MUNIX(4) summed %change of 4-spinal cord innervated muscles 2nd EPs: absolute MUNIX change, % FVC Exploratory EPs: disease progression, 6-pt decline in ALSFRS-R, ALSSQOL-SF, & other neurophysiology endpoints CONCLUSION: In RESCUE-ALS, CNM-Au8 treatment stabilised ALS-Specific QoL decline during the double-blind period, which was maintained for up to 84 weeks post-randomisation 36-Week Blinded Treatment Period with Long-Term Open-Label Extension Screening (4-weeks) Baseline Wk12 Wk36 Wk24 Wk48 Wk60 Wk72 Wk84 Wk96 Wk108+ Double-Blind Period Long-Term Open Label Extension Long-Term OLE Notes: Interim data cut as of 15-March-2022. Data include all reported values without imputation for missing data. Acknowledgements: We thank the ALS study patients and their families for their support and willingness to engage in clinical research. We thank the site investigators for their research excellence and dedication to patients. We thank FightMND of Australia for substantially funding the RESCUE-ALS trial. Original Placebo to OLE CNM-Au8 Treatment Original Placebo | 36-Week Randomized Period Original Active to OLE CNM-Au8 Treatment Original Active | 36-Week Randomized Period Week 36 Unblinded ALSSQOL Results Ex-Placebo OLE CNM-Au8 treated participants stabilized ALS Specific QOL decline during OLE Original CNM-Au8 treated participants maintained ALS Specific QOL values during OLE treatment Average slope decline/week, mean (sd) = -0.008 (0.03) Average slope decline/week, mean (sd) = -0.004 (0.02) n=22 n=16 n=23 n=20 Average slope decline/week, mean (sd) = -0.05 (0.07) Average slope decline/week, mean (sd) = -0.005 (0.03) Exhibit 99.2
Steve Vucic PhD, DSc, FRACP, FAHMS1, Parvathi Menon PhD, FRACP1, William Huynh PhD, FRACP2, Colin Mahoney, PhD, MB, MRCPI2, Karen S. Ho, PhD MSc3, Austin Rynders, RN3, Jacob Evan3, Jeremy Evan, PA-C3, Robert Glanzman, MD FAAN3, Michael T. Hotchkin3, Matthew C. Kiernan PhD, DSc, MBBS, FRACP, FAHMS 1Concord Repatriation General Hospital, University of Sydney, Australia; 2Brain and Mind Centre, University of Sydney, Australia; 3Clene Nanomedicine, Salt Lake City, UT, USA Preliminary Biomarker Findings from the RESCUE-ALS Trial | A Phase 2 Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS Baseline Value mean (sd) Age (yrs) Sex n, (%) Male | Female Onset Site n, (%) Limb | Bulbar Months from Onset FVC (% pred.) ALSFRS-R Score ENCALS Risk Profile1 MUNIX Sum All (n=45) 59.1 (12.3) M: 26 (58%) F: 19 (42%) L: 33 (73%) B: 12 (27%) 15.8 (9.3) 81.5 (16.7) 38.7 (6.0) -4.4 (1.8) 378.2 (175.3) CNM-Au8 30mg (n=23) 57.0 (13.3) M: 13 (57%) F: 10 (43%) L: 16 (70%) B: 7 (30%) 15.5 (7.6) 84.5 (18.3) 38.6 (6.6) -4.6 (1.7) 380.2 (198.0) Placebo (n=22) 61.3 (10.9) M: 13 (59%) F: 9 (41%) L: 17 (77%) B: 5 (23%) 16.1 (10.9) 78.2 (14.5) 38.8 (5.4) -4.2 (1.8) 376.2 (152.7) Baseline Demographics 1Urinary p75ECD Results: CNM-Au8 treatment demonstrated trend for decreased p75ECD (ELISA, M. Rodgers, U. Flinders) Early symptomatic ALS Randomized (1:1, CNM-Au8 30 mg or placebo) 36-week treatment period with open label extension 1st EP: MUNIX(4) summed %change of ADM, APB, BB, & TA Exploratory pharmacodynamic markers: p75ECD, NfL, UCHL1, GFAP, untargeted proteomics, untargeted metabolomics Design Summary CONCLUSION: CNM-Au8 treatment decreased urinary p75 and plasma UCHL1 levels during the double-blind period; plasma NfL levels were predominantly stable in this early ALS population Acknowledgements: We thank the ALS study patients and their families for their support and willingness to engage in clinical research. We thank the site investigators for their research excellence and dedication to patients. We thank FightMND of Australia for substantially funding the RESCUE-ALS trial. 1. Sheapheard et al. 2020 Neurology 2017, 88 (12), 1137–1143. 2. Li et al. 2020 Ann. Clin. Transl. Neurol. 2020, 7 (8), 1420–1428. Plasma NfL Results: Levels were predominantly stable across both treatment groups (Quanterix, Simoa Assay) 2Plasma UCHL1 Results: CNM-Au8 treatment blunted increased UCHL1 vs. placebo (Quanterix, Simoa Assay) (n=21) (n=19) (n=22) (n=19) (n=23) (n=23) (n=22) (n=22) (n=23) (n=23) (n=22) (n=22) Exhibit 99.3