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Clene Reports Third Quarter 2024 Financial Results and Recent Operating Highlights

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Clene Inc. (NASDAQ: CLNN) reported Q3 2024 financial results with cash and equivalents of $14.6 million as of September 30, 2024. The company completed a $7.3 million registered direct offering in October 2024 and amended its debt agreement with Avenue Capital, extending maturity to Q2 2025. R&D expenses decreased to $4.5 million from $6.0 million year-over-year, while G&A expenses reduced to $3.4 million from $3.7 million. The company reported a net loss of $8.0 million ($1.22 per share) compared to $2.4 million ($0.38 per share) in Q3 2023.

Clene Inc. (NASDAQ: CLNN) ha riportato i risultati finanziari del terzo trimestre 2024, con disponibilità liquide e equivalenti di $14,6 milioni al 30 settembre 2024. L'azienda ha completato un'offerta diretta registrata di $7,3 milioni nell'ottobre 2024 e ha modificato il suo accordo di debito con Avenue Capital, prorogando la scadenza al secondo trimestre 2025. Le spese per R&D sono diminuite a $4,5 milioni rispetto ai $6,0 milioni dell'anno precedente, mentre le spese generali e amministrative sono scese a $3,4 milioni da $3,7 milioni. L'azienda ha riportato una perdita netta di $8,0 milioni ($1,22 per azione) rispetto a $2,4 milioni ($0,38 per azione) nel terzo trimestre 2023.

Clene Inc. (NASDAQ: CLNN) informó los resultados financieros del tercer trimestre de 2024, con efectivo y equivalentes de $14,6 millones al 30 de septiembre de 2024. La compañía completó una oferta directa registrada de $7,3 millones en octubre de 2024 y modificó su acuerdo de deuda con Avenue Capital, extendiendo el vencimiento al segundo trimestre de 2025. Los gastos de I+D disminuyeron a $4,5 millones desde $6,0 millones en comparación con el año anterior, mientras que los gastos generales y administrativos se redujeron a $3,4 millones desde $3,7 millones. La compañía reportó una pérdida neta de $8,0 millones ($1,22 por acción) en comparación con $2,4 millones ($0,38 por acción) en el tercer trimestre de 2023.

클리니 Inc. (NASDAQ: CLNN)은 2024년 3분기 재무 결과를 보고했으며, 2024년 9월 30일 기준으로 현금 및 현금성 자산은 $14.6 백만입니다. 회사는 2024년 10월에 $7.3 백만의 등록 직접 공모를 완료했으며, 에비뉴 캐피탈과의 부채 계약을 수정하여 만기를 2025년 2분기로 연장했습니다. 연구 및 개발 비용은 지난해 $6.0 백만에서 $4.5 백만으로 감소하였고, 일반 관리비용은 $3.7 백만에서 $3.4 백만으로 줄었습니다. 회사는 2023년 3분기에 비해 $8.0 백만의 순손실을 보고했습니다 ($1.22 per 주식), 이는 2023년 3분기의 $2.4 백만 ($0.38 per 주식)에 해당합니다.

Clene Inc. (NASDAQ: CLNN) a publié les résultats financiers du troisième trimestre 2024, avec des liquidités et équivalents de $14,6 millions au 30 septembre 2024. L'entreprise a complété une offre directe enregistrée de $7,3 millions en octobre 2024 et a modifié son accord de dette avec Avenue Capital, prolongeant l'échéance jusqu'au deuxième trimestre 2025. Les dépenses en R&D ont diminué à $4,5 millions contre $6,0 millions d'une année sur l'autre, tandis que les frais généraux et administratifs ont été réduits à $3,4 millions contre $3,7 millions. L'entreprise a enregistré une perte nette de $8,0 millions ($1,22 par action) contre $2,4 millions ($0,38 par action) au troisième trimestre 2023.

Clene Inc. (NASDAQ: CLNN) hat die finanziellen Ergebnisse des dritten Quartals 2024 bekannt gegeben, mit liquiden Mitteln und Gleichwerten in Höhe von $14,6 Millionen zum 30. September 2024. Das Unternehmen hat im Oktober 2024 eine registrierte Direktplatzierung in Höhe von $7,3 Millionen abgeschlossen und seinen Schuldenvertrag mit Avenue Capital geändert, wodurch die Fälligkeit auf das zweite Quartal 2025 verlängert wurde. Die F&E-Ausgaben sanken von $6,0 Millionen auf $4,5 Millionen im Vergleich zum Vorjahr, während die allgemeinen und Verwaltungskosten von $3,7 Millionen auf $3,4 Millionen reduziert wurden. Das Unternehmen berichtete von einem Nettoverlust von $8,0 Millionen ($1,22 pro Aktie) im Vergleich zu $2,4 Millionen ($0,38 pro Aktie) im dritten Quartal 2023.

Positive
  • Successfully raised $7.3 million through registered direct offering and private placements
  • Extended debt maturity to Q2 2025 through amended agreement with Avenue Capital
  • Reduced R&D expenses by 25% year-over-year
  • Decreased G&A expenses by 8% year-over-year
Negative
  • Cash position decreased to $14.6 million from $35.0 million at end of 2023
  • Net loss increased to $8.0 million from $2.4 million year-over-year
  • Current funding only sufficient until Q1 2025
  • Implemented 1-for-20 reverse stock split to maintain Nasdaq listing compliance

Insights

The Q3 results reveal concerning financial metrics. $14.6M cash position represents a significant 58% decline from $35M at 2023 year-end. Despite raising $7.3M through offerings and restructuring debt with Avenue Capital, runway only extends into Q1 2025, suggesting potential near-term financing needs.

R&D expenses decreased to $4.5M from $6M YoY, primarily due to completed trials. Net loss widened to $8M ($1.22/share) compared to $2.4M ($0.38/share) in Q3 2023, largely due to absence of non-cash gains from warrant and contingent liability valuations. The 1-for-20 reverse stock split maintains Nasdaq compliance but indicates capital structure challenges.

The FDA Type C meeting for CNM-Au8's accelerated approval pathway in ALS represents a critical regulatory milestone. However, pending meeting minutes and lack of disclosed biomarker data make immediate implications unclear. The company's focus on two expanded ALS EAPs with Massachusetts General Hospital shows continued clinical development despite reduced R&D spending across other programs.

The launch of RESTORE-ALS Phase 3 trial demonstrates pipeline progression, but cash runway raises concerns about the ability to fully execute clinical development plans without additional financing. The reduction in clinical trial expenses across multiple programs suggests a strategic narrowing of focus to conserve resources.

  • 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 minutes
  • Cash, cash equivalents and marketable securities of $14.6 million as of September 30, 2024
  • Amended debt agreement with Avenue Capital to defer principal payments and extend maturity of facility to second quarter of 2025
  • Completed 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 Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its third quarter 2024 financial results and provided recent updates on its CNM-Au8 programs.

Third Quarter 2024 and Recent Operating Highlights

CNM-Au8 for the treatment of ALS

On November 1, 2024, the Company met with the FDA in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS for CNM-Au8, including biomarker and related clinical and survival data, and are currently awaiting meeting minutes from this meeting.

Corporate Update

In July, Clene announced a 1-for-20 reverse stock split. Clene’s common stock now trades on the Nasdaq Capital Market on a split-adjusted basis under a new CUSIP number 185634201 and the Company’s existing trading symbol “CLNN.” The reverse stock split enabled Clene to regain compliance with the $1.00 minimum closing bid price required for continued listing on the Nasdaq Capital Market. All outstanding stock options, warrants, rights to restricted stock awards, convertible debt, and contingent earn-out shares entitling their holders to purchase or receive shares of Common Stock were adjusted as a result of the reverse stock split as required by the terms of each security.

In September, Clene amended its existing debt facility with Avenue Venture Opportunities Fund, L.P. in which the parties agreed to reduce or defer future monthly principal payments and extend the principal amortization period and maturity date into the second quarter of 2025.

In October, Clene announced the closing of a registered direct offering and concurrent private placements of common stock and warrants with a healthcare-focused institutional investor and existing shareholders, including insiders, with total gross proceeds of $7.3 million and the potential for additional capital in the future through the exercise of warrants. The offering was led by a 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.

The October offering, combined with the amendment to the debt facility with Avenue, is expected to enable the Company to fund its operations into the first quarter of 2025. We believe that this funding enables runway for key inflection points.

In October, Clene presented the design for RESTORE-ALS, its potentially confirmatory international Phase 3 clinical trial of CNMAu8 30 mg, at the 2024 Annual Northeast Amyotrophic Lateral Sclerosis Consortium.

Third Quarter 2024 Financial Results

Clene’s cash, cash equivalents and marketable securities totaled $14.6 million as of September 30, 2024, compared to $35.0 million as of December 31, 2023. Clene expects that its resources as of September 30, 2024 combined with gross proceeds raised in the October offering, will be sufficient to fund its operations into the first quarter of 2025.

Research and development expenses were $4.5 million for the quarter ended September 30, 2024, compared to $6.0 million for the same period in 2023. The year-over-year decrease was primarily related to a decrease in expenses in the HEALEY ALS Platform Trial, RESCUE-ALS, REPAIR-MS, and VISIONARY-MS clinical trials due to the previous completion of the blinded period of each trial; a decrease in expenses for the VISIONARY-MS LTE due to its completion; and a decrease in non-clinical and pre-clinical activities; partially offset by an increase in expenses related to our two ALS EAPs with Massachusetts General Hospital due to increased enrollment and expansion of one EAP.

General and administrative expenses were $3.4 million for the quarter ended September 30, 2024, compared to $3.7 million for the same period in 2023. The year-over-year decrease was primarily related to decreases in directors’ and officers’ insurance premiums, decreases in finance and accounting fees, primarily due to a decrease in fees from consultants, advisors, and other financial vendors, and decreases in stock-based compensation expense; partially offset by an increase in legal fees, primarily related to regulatory activities, and an increase in other general and administrative fees associated primarily with lobbying activities.

Total other expense was $0.2 million for the quarter ended September 30, 2024, compared to total other income of $7.1 million for the same period in 2023. During 2023, Clene recorded significant non-cash gains from the change in the fair value of the common stock warrant liability related to the 2023 Avenue Warrants and Tranche A Warrants as well as significant non-cash gains from the change in fair value of the Clene Nanomedicine Contingent Earn-out liability and the Initial Stockholders Contingent Earn-out liability. Similar large non-cash gains were not recorded in 2024. Additionally, interest expense was less in 2024 due to reduced interest rates and outstanding principal balances.

Clene reported a net loss of $8.0 million, or $1.22 per share, for the quarter ended September 30, 2024, compared to a net loss of $2.4 million, or $0.38 per share, for the same period in 2023.

About Clene
Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. 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 X (formerly Twitter) and LinkedIn.

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.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding Clene’s expectations that its resources are sufficient to fund operations into the first quarter of 2025 and the availability of an accelerated approval regulatory pathway. In addition, any statements that refer to characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, Clene’s expectations that its resources are sufficient to fund operations into the first quarter of 2025, and the availability of an accelerated approval regulatory pathway may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions; whether clinical trials of our drug candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, or do not otherwise produce positive results, which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete; 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 drug candidates, if approved; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. 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
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310
Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
617-283-2856


CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)

 Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
 2024  2023  2024  2023 
Revenue:               
Product revenue$65  $65  $173  $355 
Royalty revenue 22   43   78   129 
Total revenue 87   108   251   484 
Operating expenses:               
Cost of revenue 18   12   52   83 
Research and development 4,471   5,972   14,490   19,982 
General and administrative 3,413   3,666   10,147   11,029 
Total operating expenses 7,902   9,650   24,689   31,094 
Loss from operations (7,815)  (9,542)  (24,438)  (30,610)
Other income (expense), net:               
Interest income 127   546   755   931 
Interest expense (1,022)  (1,188)  (3,548)  (3,358)
Commitment share expense          (402)
Issuance costs for common stock warrant liabilities          (333)
Loss on initial issuance of equity          (14,840)
Change in fair value of common stock warrant liabilities 697   6,341   956   5,958 
Change in fair value of Clene Nanomedicine contingent
earn-out liability
    1,004   75   2,114 
Change in fair value of Initial Stockholders contingent
earn-out liability
    129   10   272 
Research and development tax credits and unrestricted
grants
 27   247   339   902 
Other income, net    45      35 
Total other income (expense), net (171)  7,124   (1,413)  (8,721)
Net loss before income taxes (7,986)  (2,418)  (25,851)  (39,331)
Income tax expense           
Net loss (7,986)  (2,418)  (25,851)  (39,331)
                
Other comprehensive income (loss):               
Unrealized gain (loss) on available-for-sale securities 1   (4)  (1)  16 
Foreign currency translation adjustments 52   (81)  25   (130)
Total other comprehensive income (loss) 53   (85)  24   (114)
Comprehensive loss$(7,933) $(2,503) $(25,827) $(39,445)
                
Net loss per share – basic and diluted$(1.22) $(0.38) $(4.00) $(8.11)
Weighted average common shares used to compute basic
and diluted net loss per share
 6,557,839   6,420,274   6,467,771   4,851,348 
                

CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)

 September 30,  December 31, 
 2024  2023 
ASSETS       
Current assets:       
Cash and cash equivalents$14,645  $28,821 
Marketable securities    6,179 
Accounts receivable    143 
Inventory 128   37 
Prepaid expenses and other current assets 4,925   3,672 
Total current assets 19,698   38,852 
Restricted cash 58   58 
Operating lease right-of-use assets 3,776   4,168 
Property and equipment, net 8,037   9,263 
TOTAL ASSETS$31,569  $52,341 
        
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)       
Current liabilities:       
Accounts payable$1,678  $1,504 
Accrued liabilities 6,733   3,720 
Share subscriptions payable 3,810    
Operating lease obligations, current portion 732   576 
Finance lease obligations, current portion    27 
Notes payable, current portion 10,875   14,627 
Convertible notes payable, current portion    4,876 
Total current liabilities 23,828   25,330 
Operating lease obligations, net of current portion 4,335   4,903 
Notes payable, net of current portion 1,668   1,894 
Convertible notes payable, net of current portion 5,271   5,258 
Common stock warrant liabilities 592   1,481 
Clene Nanomedicine contingent earn-out liability    75 
Initial Stockholders contingent earn-out liability    10 
TOTAL LIABILITIES 35,694   38,951 
Commitments and contingencies       
Stockholders’ equity (deficit):       
Common stock, $0.0001 par value: 600,000,000 and 300,000,000 shares
authorized at September 30, 2024 and December 31, 2023, respectively;
6,857,170 and 6,421,084 shares issued and outstanding at September 30,
2024 and December 31, 2023, respectively
 1   1 
Additional paid-in capital 264,225   255,913 
Accumulated deficit (268,574)  (242,723)
Accumulated other comprehensive income 223   199 
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) (4,125)  13,390 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)$31,569  $52,341 

FAQ

What were Clene's (CLNN) Q3 2024 financial results?

Clene reported a net loss of $8.0 million ($1.22 per share) with cash and equivalents of $14.6 million. R&D expenses were $4.5 million and G&A expenses were $3.4 million.

How much did Clene (CLNN) raise in its October 2024 offering?

Clene raised $7.3 million in gross proceeds through a registered direct offering and concurrent private placements with healthcare-focused institutional investors and existing shareholders.

When did Clene (CLNN) implement its reverse stock split?

Clene implemented a 1-for-20 reverse stock split in July 2024 to regain compliance with Nasdaq's minimum $1.00 closing bid price requirement.

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