EX-99.1 2 clnn-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

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 Phase 2 Trial top-line results expected mid-year 2022

 

SALT LAKE CITY, March 11, 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 the treatment of neurodegenerative disease, today reported its full year 2021 operating and financial results, as well as an overview of fourth quarter 2021 and recent operating highlights.

 

“We exited 2021 with significant momentum, having made substantial clinical advancement across our portfolio of first-in-class nanotherapeutics,” said Rob Etherington, President and CEO of Clene. “This progress now has Clene positioned to achieve multiple clinical milestones in 2022, highlighted by the upcoming results from the HEALEY ALS Platform Trial. Positive results for CNM-Au8® in this study would be transformative for Clene, and more importantly, for people living with ALS.”

 

Fourth Quarter 2021 and Recent Operating Highlights

 

CNM-Au8®, a gold nanocrystal suspension, for the treatment of amyotrophic lateral sclerosis (ALS)

 

Enrollment in the HEALEY ALS Platform Trial, led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, was completed in November 2021, and top-line data are expected in the second half of this year.
Top-line results from the RESCUE-ALS Phase 2 clinical trial were reported in November 2021. Results demonstrated clinically meaningful benefits in people with early ALS, including:
o
Results showed the slowing of disease progression and improvements to patients’ quality of life. In addition, RESCUE-ALS demonstrated evidence for a potential long-term survival benefit from CNM-Au8®.
o
Data from RESCUE-ALS were presented in the fourth quarter of 2021 at the 4th Annual ALS ONE Research Symposium and at a late-breaking session at the 32nd International Symposium on ALS/MND.
Additional data including the significant survival benefit from the RESCUE-ALS open label extension will be presented at the upcoming Muscular Dystrophy Association Clinical & Scientific Conference this month and at a late breaker session at the upcoming American Academy of Neurology Annual Meeting in April.
Clene continues to support expanded access programs, providing CNM-Au8® treatment at four clinical sites to more than 50 participants with ALS.

 

CNM-Au8® for the treatment of multiple sclerosis (MS)

 

Clene has initiated a second cohort of the more severe non-active, progressive MS population in the REPAIR-MS Phase 2 clinical trial to confirm the robust target engagement demonstrated in the first cohort of relapsing MS patients in this trial.
The VISIONARY-MS Phase 2 clinical trial will conclude early due to pandemic-related enrollment challenges. Clene will utilize the available data collected from up to 48 weeks of clinical visits to better understand the efficacy and safety profile of CNM-Au8® and to inform further clinical development in MS.
o
Unblinded VISIONARY-MS data are targeted for the second half of 2022.
o
Updated blinded interim data from VISIONARY-MS and results from REPAIR-MS Phase 2 trials were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2022 in February 2022.

 

CNM-ZnAg for the treatment of COVID-19

 

The CNM-ZnAg COVID Phase 2 clinical trial achieved full enrollment in acutely symptomatic, non-hospitalized COVID-19 patients in Brazil. Top-line results are expected mid-year 2022.

 

 


 

Corporate Updates

 

Morgan Brown was appointed Chief Financial Officer (CFO) effective February 1, 2022. Mr. Brown’s extensive experience in executive finance roles includes four publicly traded life science companies, three as CFO, and experience as the CFO of a privately held clinical research organization.
Two key patents were granted and validated in Europe that protect Clene’s breakthrough processes, devices and methods for treating certain disease indications for its nanotherapeutic drugs. Clene was also granted a patent from the U.S. Patent and Trademark Office for CNM-Au8 for the treatment of MS.
Clene announced a $1 million grant award from the Maryland Department of Housing and Community Development in support of the redevelopment of a 72,000 ft2 manufacturing facility in Elkton, Maryland, in anticipation of product commercialization.

 

Full Year 2021 Financial Results

 

Clene’s cash and restricted cash totaled $50.3 million as of December 31, 2021, compared to $59.3 million as of December 31, 2020. Clene expects that its resources as of December 31, 2021, will be sufficient to fund its operations into the second quarter of 2023.

 

Research and development expenses were $28.4 million for the year ended December 31, 2021, compared to $15.2 million for the same period in 2020. The year-over-year increase was primarily related to the development of CNM-Au8, rent expense for the newly-leased facility in Elkton, Maryland, and personnel and stock-based compensation due to increased headcount, partially offset by decreased manufacturing and materials expense.

 

General and administrative expenses were $22.0 million for the year ended December 31, 2021, compared to $5.2 million for the same period in 2020. The year-over-year increase was primarily attributable to costs related to being a public company and fees for professional services, technology services, and pre-commercialization activities for CNM-Au8, and personnel and stock-based compensation due to increased headcount.

 

Clene reported a net loss of $9.7 million, or $0.16 per share, for the year ended December 31, 2021, compared to a net loss of $19.3 million, or $1.10 per share, for the same period in 2020. Included in net loss for the year ended December 31, 2021, was an unrealized gain from the change in fair value of contingent earn-out liabilities of $37.5 million, compared to $14.1 million in the prior year period.

 

About Clene

Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

 

About CNM-Au8®

CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

 

About CNM-ZnAg

CNM-ZnAg, a proprietary zinc-silver ionic solution, has demonstrated broad antiviral and antimicrobial activity.

 

Forward-Looking Statements

This press release contains “forward-looking statements” which are intended to be covered by the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Clene’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,”

 


 

“potential,” “might” and “continues,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene’s reliance on third parties to conduct drug development, manufacturing and other services; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

 

Media Contact

Investor Contact

Erica Fiorini, Ph.D., or David Schull

John Woolford

Russo Partners, LLC

Managing Director, Westwicke

Erica.fiorini@russopartnersllc.com

clene@westwicke.com

David.schull@russopartnersllc.com

+1-443-213-0506

+1-212-845-4253

 

 

Source: Clene Inc.

 

 


 

CLENE INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Audited)

 

 

Year Ended December 31,

 

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

Product revenue

 

$

570

 

 

$

176

 

Royalty revenue

 

 

153

 

 

 

30

 

Total revenue

 

 

723

 

 

 

206

 

Operating expenses:

 

 

 

 

 

 

Cost of revenue

 

 

289

 

 

 

65

 

Research and development

 

 

28,416

 

 

 

15,204

 

General and administrative

 

 

21,996

 

 

 

5,151

 

Total operating expenses

 

 

50,701

 

 

 

20,420

 

Loss from operations

 

 

(49,978

)

 

 

(20,214

)

Other income (expense), net:

 

 

 

 

 

 

Interest expense

 

 

(870

)

 

 

(950

)

Gain on extinguishment of notes payable

 

 

648

 

 

 

 

Loss on extinguishment of convertibles notes payable

 

 

 

 

 

(540

)

Gain on termination of lease

 

 

 

 

 

51

 

Change in fair value of preferred stock warrant liability

 

 

 

 

 

(14,615

)

Change in fair value of common stock warrant liability

 

 

983

 

 

 

 

Change in fair value of derivative liability

 

 

 

 

 

29

 

Change in fair value of Clene Nanomedicine contingent earn-out

 

 

33,953

 

 

 

12,659

 

Change in fair value of Initial Stockholders contingent earn-out

 

 

3,589

 

 

 

1,465

 

Australia research and development credit

 

 

1,519

 

 

 

3,210

 

Other income (expense), net

 

 

(12

)

 

 

34

 

Total other income (expense), net

 

 

39,810

 

 

 

1,343

 

Net loss before income taxes

 

 

(10,168

)

 

 

(18,871

)

Income tax benefit (expense)

 

 

428

 

 

 

(406

)

Net loss

 

 

(9,740

)

 

 

(19,277

)

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(92

)

 

 

284

 

Total other comprehensive income (loss)

 

 

(92

)

 

 

284

 

Comprehensive loss

 

$

(9,832

)

 

$

(18,993

)

 

 

 

 

 

 

 

Net loss per share-- basic and diluted

 

$

(0.16

)

 

$

(1.10

)

Weighted average common shares used to compute basic and diluted net loss
   per share

 

 

61,558,455

 

 

 

17,503,992

 

 

 


 

CLENE INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Audited)

 

 

December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

50,288

 

 

$

59,275

 

Accounts receivable

 

 

49

 

 

 

21

 

Inventory

 

 

41

 

 

 

191

 

Prepaid expenses and other current assets

 

 

4,205

 

 

 

3,502

 

Total current assets

 

 

54,583

 

 

 

62,989

 

Restricted cash

 

 

58

 

 

 

 

Right-of-use assets

 

 

3,250

 

 

 

1,029

 

Property and equipment, net

 

 

5,172

 

 

 

4,225

 

TOTAL ASSETS

 

$

63,063

 

 

$

68,243

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,923

 

 

$

1,124

 

Accrued liabilities

 

 

3,610

 

 

 

3,960

 

Income tax payable

 

 

 

 

 

164

 

Deferred revenue from related parties

 

 

 

 

 

112

 

Operating lease obligations, current portion

 

 

347

 

 

 

194

 

Finance lease obligations, current portion

 

 

146

 

 

 

190

 

Clene Nanomedicine contingent earn-out, current portion

 

 

 

 

 

5,924

 

Total current liabilities

 

 

6,026

 

 

 

11,668

 

Operating lease obligations, net of current portion

 

 

4,370

 

 

 

1,785

 

Finance lease obligations, net of current portion

 

 

97

 

 

 

205

 

Notes payable

 

 

14,484

 

 

 

1,949

 

Convertible notes payable

 

 

4,598

 

 

 

 

Deferred income tax

 

 

 

 

 

260

 

Common stock warrant liability

 

 

474

 

 

 

 

Clene Nanomedicine contingent earn-out, net of current portion

 

 

18,100

 

 

 

46,129

 

Initial Stockholders contingent earn-out

 

 

2,317

 

 

 

5,906

 

TOTAL LIABILITIES

 

 

50,466

 

 

 

67,902

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.0001 par value: 150,000,000 and 100,000,000 shares authorized at December 31, 2021 and December 31, 2020, respectively; 62,312,097 and 59,526,171 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively

 

 

6

 

 

 

6

 

Additional paid-in capital

 

 

175,659

 

 

 

153,571

 

Accumulated deficit

 

 

(163,301

)

 

 

(153,561

)

Accumulated other comprehensive income

 

 

233

 

 

 

325

 

TOTAL STOCKHOLDERS’ EQUITY

 

 

12,597

 

 

 

341

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

63,063

 

 

$

68,243