S&P 500 7,623.68 −0.52%
Nasdaq 25,955.34 −0.21%
S&P/TSX 35,788.18 −0.52%
Apple 347.73 −0.14%
Nvidia 210.96 −0.59%
Microsoft 524.51 +0.66%
Shopify 236.24 −0.07%
Royal Bank 281.77 −0.36%
CAD/USD 0.7141 −0.01%
CLOSED · 03:15 ET
Market ClerkRecap
Sun Oct 25 · markets closed1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 30The week ahead

CLNN

Clene Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
3.88
+0.00 +0.00%
USD · close Oct 23
WatchTime Machine

A free account adds a watchlist, alerts when insiders, Congress or short sellers move on your tickers, and a morning brief. Sign up

Work order
61
WATCH · shorts 61
Insiders, 90 days
0
no open-market filings in 90 days
Congress, 90 days
0 / 0
no disclosures naming it
Big money
0 / 15
none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $49.9MP/E —DIV YIELD —FCF YIELD —REV TTM $197K −31.1%NET INCOME −$39.5MNET DEBT $7.9M52W 3.10 – 12.50SEC XBRL · TTM TO Invalid Date

How CLNN rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
87%
of sentences unchanged
Added
71
new sentences
Dropped
70
sentences removed
Length
+204
words, now 38,687

New in FY2025

  • We believe that CNM-Au8’s core effects of remyelination and neuroprotection provide us a globally unique first-mover advantage for the treatment of central nervous system diseases.
  • As of December 31, 2025, we have over 160 issued patents worldwide with approximately 5 patents pending worldwide.
  • We have worldwide rights to protect and thus commercialize our CSN therapeutics and believe that our issued, and pending patents, provide sufficient protection to secure the future commercial potential of our CSN therapeutics.
  • We have filed and obtained patents in the United States (U.S.), Australia (AU), Brazil (BR), Canada (CA), China (CN), Egypt (EG), Indonesia (ID), Israel (IL), India (IN), Japan (JP), Korea (KR), Mexico (MX), New Zealand (NZ), Philippines (PH), Russia (RU), Seychelles (SC), Singapore (SG), the United Arab Emirates (UAE), and the European Patent Office (EP) including Belgium (BE), Switzerland (CH), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), Great Britain (GB), Hungary (HU), Ireland (IE), Iceland (IS), Italy (IT), Netherlands (NL), Norway (NO), Poland (PL), Portugal (PT), Sweden (SE), Slovenia (SI), and Turkey (TR), with multiple fundamental patent families protecting our CSN therapeutics.
  • (5), AU (3), BE, CA (2), CH, CN, DE, DK, ES, FI, FR, GB, HU, ID, IE, IL, IN, IT, JP (2), KR, MX, NL, NO, PH, PL, PT, SE, SI, TR Pending: EP July 11, 2007 December 31, 2013 August 29, 2017 October 9, 2018 May 11, 2021 Expiration dates for these patents will occur in 2028 in the applicable foreign jurisdictions and in 2030 in the U.S.* Continuous methods for treating liquids and manufacturing certain constituents (e.g., nanoparticles) in liquids, apparatuses and nanoparticles and nanoparticle/ liquid solution(s) therefrom Issued: U.S.
  • Description Jurisdiction Application Date (U.S.) Grant Date (U.S.) Continuous, semi-continuous and batch methods for treating liquids and manufacturing certain constituents (e.g., nanoparticles) in liquids, apparatuses and nanoparticles and nanoparticle/liquid solution(s) and colloids resulting therefrom (these patents relate to CNM-Au8 and ZnAg) Issued: U.S.
  • (3), AU, CA, CH, CN, DE, DK, FI, FR, GB, IE, IL, IN, IS, JP, KR, NL, NO, SE Pending: EP January 15, 2009 June 30, 2015 July 31, 2018 May 18, 2021 Expiration dates for these patents will occur in 2030 in the U.S. and the applicable foreign jurisdictions* Novel gold-based nanocrystals for medical treatments and electrochemical manufacturing processes therefor (these patents relate to CNM-Au8) Issued: U.S.
  • (3), AU (6), BR, CA, CH, CN, DE, DK, ES, FI, FR, GB, ID, IE, IL, IN, IT, JP (4), KR (3), MX (2), NL, NO, PH (2), RU, SE, SG (3), UAE Pending: U.S.
  • (2), MX July 8, 2009 March 28, 2017 October 22, 2019 April 20, 2021 Expiration dates for these patents will occur in 2030 in the U.S. and the applicable foreign jurisdictions* Novel gold-platinum based bi-metallic nanocrystal suspensions, electrochemical manufacturing processes therefor and uses for the same (these patents do not relate to any specifically named product candidates herein) Issued: U.S., AU, CA, CH, CN, DE, DK, ES, FI, FR, GB, ID, IE, IL, IN, IT, JP, KR (2), MX, NL, NO, NZ, PH, RU, SE, SG, UAE March 30, 2011 July 12, 2016 Expiration dates for these patents will occur in 2030 in the U.S. and in 2032 in the applicable foreign jurisdictions* Methods and treatment for certain demyelination and dysmyelination-based disorders and/or promoting remyelination (these patents relate to CNM-Au8) Issued: AU, BE, BR, CA, CH, DE, DK, ES, FI, FR, GB, HU, ID, IE, IL, IT, JP, KR, MX, NL, NO, NZ (2), PH, PT, RU, SE, SG (2), SI, TR NA NA Expiration dates for these patents will occur in 2033 in the U.S. and the applicable foreign jurisdictions* * Expiration dates do not include possible patent extensions for certain countries.
  • Expedited Development and Review Programs A marketing application for a drug candidate submitted to the FDA for approval may be eligible for FDA programs intended to expedite the FDA review and approval process, such as priority review, fast track designation, breakthrough therapy, accelerated approval, and the Commissioner’s National Priority Voucher program.
  • A new program launched by the FDA in June 2025, the Commissioner’s National Priority Voucher program, shortens the review process from 10-12 months to 1-2 months from the time of a sponsor’s final NDA submission for products that meet four criteria outlined by the FDA: (1) addressing a health crisis in the U.S.; (2) delivering more innovative cures for the American people; (3) addressing unmet public health needs; and (4) increasing domestic drug manufacturing as a national security issue.
  • To qualify for a voucher, FDA requires sponsors to submit the CMC portion of the NDA and the draft labeling at least 60 days before submitting the final NDA submission.
  • The review process is expedited by convening experts from FDA offices who pre-review the submission and convene for a 1-day “tumor board style” meeting.
  • Sponsors granted a voucher under this program may also be granted accelerated approval if a product also meets the standards for accelerated approval.
  • The program has not been authorized by statute and has received scrutiny from Democratic members of Congress.
  • Furthermore, priority review, fast track designation, breakthrough therapy designation, accelerated approval, and the Commissioner’s National Priority Voucher program do not change the standards for approval but may expedite the development or approval process.
  • For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2032 unless additional Congressional action is taken, with COVID-19 relief legislation suspending the 2% Medicare sequester from May 1, 2020 through December 31, 2021.
  • The second Trump administration has launched multiple initiatives aimed at lowering the cost of prescription drugs, including the Global Benchmark for Efficient Drug Pricing Model, that would require drug manufacturers to issue rebates to the Medicare Part B program when U.S. prices exceed those offered to comparable countries.
  • Medicare Against Rising Drug Costs Model, would create the same rebate obligation for Medicare Part D.
  • Another initiative, TrumpRX, aims to use the direct-to-consumer model to lower prescription drug costs by working with drug manufacturers to provide drugs directly from the government to consumers.
  • Smaller Reporting Company Status We are a “smaller reporting company” because the market value of our stock held by non-affiliates was less than $250 million as of June 30, 2025.
  • Employees and Human Capital Resources As of December 31, 2025, we had a total of 79 employees, 76 of which were full-time and 3 were part-time, primarily located in Utah and Maryland.
  • The principal purposes of our equity incentive plans are to attract, retain, and motivate selected employees, consultants, and directors through the granting of equity compensation awards and cash-based performance bonus awards.
  • We currently do not have any drugs available for commercial sale, nor do we have any drugs that have been approved for sale by applicable regulatory authorities.
  • Our main business is research and development, and, if our research and development activities are successful, sales of drug candidates.
  • Research and development expenses totaled $14.0 million and $20.1 million for the years ended December 31, 2025 and 2024, respectively.
  • We incurred a loss from operations of $23.1 million and $33.1 million for the years ended December 31, 2025 and 2024, respectively, and a net loss of $26.2 million and $39.4 million for the years ended December 31, 2025 and 2024, respectively.
  • Our accumulated deficit was $308.3 million and $282.1 million as of December 31, 2025 and 2024, respectively.
  • Our cash and cash equivalents totaled $5.2 million and $12.2 million as of December 31, 2025 and 2024, respectively, and net cash used in operating activities was $18.5 million and $21.3 million for the years ended December 31, 2025 and 2024, respectively.
  • Additionally, pursuant to our senior secured convertible promissory notes issued in December 2024 (the “2024 SSCP Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8 to the consolidated financial statements).
  • To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and potential proceeds from the exercise of outstanding warrants and stock options.
  • During the year ended December 31, 2025, we generated $10.6 million of gross proceeds from our equity distribution agreement and $1.5 million from the issuance of senior secured convertible promissory notes (see Note 8 to the consolidated financial statements).
  • Subsequent to December 31, 2025, we generated $6.0 million of gross proceeds from the issuance of Common Stock and warrants in a registered direct offering.
  • While we have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts, reducing employee compensation, and eliminating certain staff positions, we have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the consolidated financial statements are issued.
  • We have not had any product approved for commercial sale and have not generated any revenue from pharmaceutical product sales.
  • If a material breach of our information technology (“IT”) systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.
  • Such disclosures are costly, could lead to negative publicity, may cause our customers or collaborators or other relevant stakeholders to lose confidence in the effectiveness of our security measures and require us to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security incident.
  • Unauthorized access to our IT systems could result in litigation with our customers, collaborators, or other relevant stakeholders, or regulatory actions by government entities.
  • Our manufacturing facilities will be subject to ongoing, periodic inspection by various regulatory authorities, including the FDA, EMA, China’s National Medical Products Administration (“NMPA”), Health Canada, and the TGA or other comparable regulatory agencies to ensure compliance with GMP.
  • Current or future tax treatments, tax concessions, tax allowances and financial incentives applicable to us may be changed, terminated, or otherwise become unavailable due to many factors, including changes in government policy or administrative decisions by the relevant government authorities.

and 31 more.

Gone since FY2024

  • CNM-Au8’s core effects of remyelination and neuroprotection provide us a globally unique first-mover-advantage for the treatment of central nervous system diseases.
  • As of December 31, 2024, we have over 150 issued patents worldwide and approximately 20 patents pending worldwide.
  • We have world-wide rights to protect and thus commercialize our CSN therapeutics and believe that our issued, and pending patents, provide sufficient protection to secure the future commercial potential of our CSN therapeutics.
  • We have filed and obtained patents in the United States (U.S.); Australia (AU); Brazil (BR); Canada (CA); China (CN); European Patent Office (EP), including Belgium (BE), Switzerland (CH), Germany (DE), Denmark (DK), Finland (FI), France (FR), Great Britain (GB), Iceland (IS), Ireland (IE), Italy (IT), Hungary (HU), Netherlands (NL), Norway (NO), Poland (PL), Portugal (PT), Spain (ES), Sweden (SE), Slovenia (SI), and Turkey (TR); Egypt (EG); India (IN); Indonesia (ID); Israel (IL); Japan (JP); Korea (KR); Mexico (MX); New Zealand (NZ); Philippines (PH); Russia (RU); Seychelles (SC), Singapore (SG); and the United Arab Emirates (AE); with multiple fundamental patent families protecting our CSN therapeutics.
  • (4), AU (3), CA (2), CN, ID, IL, IN, JP (2), KR, MX, PH; BE, DK, ES, FI, FR, DE, HU, IE, IT, NL, NO, PL, PT, SE, SI, CH, TR, GB Pending: U.S., EP July 11, 2007 December 31, 2013 August 29, 2017 October 9, 2018 May 11, 2021 Expiration dates for these patents will occur in 2028 in the applicable foreign jurisdictions and in 2030 in the U.S.* Continuous methods for treating liquids and manufacturing certain constituents (e.g., nanoparticles) in liquids, apparatuses and nanoparticles and nanoparticle/ liquid solution(s) therefrom Issued: U.S.
  • Continuous, semi-continuous and batch methods for treating liquids and manufacturing certain constituents (e.g., nanoparticles) in liquids, apparatuses and nanoparticles and nanoparticle/liquid solution(s) and colloids resulting therefrom (these patents relate to CNM-Au8 and ZnAg) Issued: U.S.
  • (3), AU, CA, CN, IL, IN, IS, JP, KR; CH, DE, DK, FI, FR, IE, NL, NO, SE, GB Pending: EP January 15, 2009 June 30, 2015 July 31, 2018 May 18, 2021 Expiration dates for these patents will occur in 2030 in the U.S. and the applicable foreign jurisdictions* Novel gold-based nanocrystals for medical treatments and electrochemical manufacturing processes therefor (these patents relate to CNM-Au8) Issued: U.S.
  • (3), AE, AU (6), BR, CA, CN, ID, IN, IL, JP (4), KR (3), MX (2), PH, RU, SG (3); CH, DE, DK, ES, FI, FR, GB, IE, IT, NL, NO, SE Pending: MX, PH, U.S.
  • (2) July 8, 2009 March 28, 2017 October 22, 2019 April 20, 2021 Expiration dates for these patents will occur in 2030 in the U.S. and the applicable foreign jurisdictions* Description Jurisdiction Application Date (U.S.) Grant Date (U.S.) Novel gold-platinum based bi-metallic nanocrystal suspensions, electrochemical manufacturing processes therefor and uses for the same (these patents do not relate to any specifically named product candidates herein) Issued: U.S., AE, AU, CA, CN, ID, IL, IN, JP, KR (2), MX, NZ, PH, RU, SG; CH, DE, DK, ES, FI, FR, GB, IE, IT, NL, NO, SE.
  • Pending: BR March 30, 2011 July 12, 2016 Expiration dates for these patents will occur in 2030 in the U.S. and in 2032 in the applicable foreign jurisdictions* Methods and treatment for certain demyelination and dysmyelination-based disorders and/or promoting remyelination (these patents relate to CNM-Au8) Issued: AU, BR, CA, ID, IL, JP, KR, MX, NZ (2), PH, RU, SG (2); BE, DK, FI, FR, DE, HU, IE, IT, NL, NO, PT, SE, ES, SI, CH, TR, GB Pending: IN NA NA Expiration dates for these patents will occur in 2033 in the U.S. and the applicable foreign jurisdictions* * Expiration dates do not include possible patent extensions for certain countries.
  • Expedited Development and Review Programs A marketing application for a drug candidate submitted to the FDA for approval may be eligible for FDA programs intended to expedite the FDA review and approval process, such as priority review, fast track designation, breakthrough therapy, and accelerated approval.
  • Furthermore, priority review, fast track designation, breakthrough therapy designation, and accelerated approval do not change the standards for approval but may expedite the development or approval process.
  • For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2030 unless additional Congressional action is taken, with COVID-19 relief legislation suspending the 2% Medicare sequester from May 1, 2020 through December 31, 2021.
  • In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue to as well as potential administrative actions HHS can take to advance these principles.
  • Smaller Reporting Company Status We are a “smaller reporting company” because the market value of our stock held by non-affiliates was less than $250 million as of June 30, 2024.
  • Employees and Human Capital Resources As of December 31, 2024, we had a total of 76 employees, 75 of which were full-time and 1 was part-time, primarily located in Utah and Maryland.
  • The principal purposes of our equity incentive plans are to attract, retain, and motivate selected employees, consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards.
  • We currently do not have any drugs available for commercial sales nor do we have any drugs that have been approved for sale by the regulatory authorities.
  • Our main business is research and development, and if successful, sales of drug candidates.
  • Research and development expenses totaled $20.1 million and $26.7 million for the years ended December 31, 2024 and 2023, respectively.
  • We incurred a loss from operations of $33.1 million and $40.5 million for the years ended December 31, 2024 and 2023, respectively, and a net loss of $39.4 million and $49.5 million for the years ended December 31, 2024 and 2023, respectively.
  • Our accumulated deficit was $282.1 million and $242.7 million as of December 31, 2024 and 2023, respectively.
  • Our cash, cash equivalents, and marketable securities totaled $12.2 million and $35.0 million as of December 31, 2024 and 2023, respectively, and net cash used in operating activities was $21.3 million and $30.2 million for the years ended December 31, 2024 and 2023, respectively.
  • Additionally, pursuant to our senior secured convertible promissory notes (the “2024 SSCP Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8 to the consolidated financial statements).
  • To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from the exercise of outstanding warrants and stock options.
  • During the year ended December 31, 2024, we generated $2.7 million of gross proceeds from our equity distribution agreement (the “ATM Agreement”), raised $3.5 million from a registered direct offering of equity securities and an additional $3.8 million from separate, concurrent private placements of equity securities, and raised $10.0 million from the issuance of the 2024 SSCP Notes of which $7.9 million was used to repay the remaining balance of our obligations under a term loan with Avenue Venture Opportunities Fund, L.P.
  • Additionally, subsequent to December 31, 2024, we generated $2.5 million of gross proceeds from our ATM Agreement.
  • We have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts and elimination of certain staff positions.
  • We have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the consolidated financial statements are issued.
  • We have not had any product approved for commercial sale and have not generated any revenue from product sales.
  • If a material breach of our information technology systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.
  • Such disclosures are costly, could lead to negative publicity, may cause our customer or collaborators or other relevant stakeholders to lose confidence in the effectiveness of our security measures and require us to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security incident.
  • Unauthorized access to our information technology systems could result in litigation with our customers, collaborators, or other relevant stakeholders, or regulatory actions by government entities.
  • Our manufacturing facilities will be subject to ongoing, periodic inspection by various regulatory authorities, including the FDA, EMA, China’s National Medical Products Administration (“NMPA”), Health Canada, and the Australian Therapeutics Goods Administration (“TGA”) or other comparable regulatory agencies to ensure compliance with GMP.
  • In addition, current or future tax treatments, tax concessions, tax allowances and financial incentives applicable to us may be changed, terminated, or otherwise become unavailable due to many factors, including changes in government policy or administrative decisions by the relevant government authorities.
  • Our post-tax profitability and cash flows may be adversely affected as a result of one or more of these or other factors.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
  • As of December 31, 2024, we had U.S. federal net operating loss (“NOL”) carryforwards of $170.1 million, of which $136.7 million may be carried forward indefinitely to reduce future taxable income but utilization is limited to 80% of our annual taxable income in any given year based on current federal tax laws.
  • As of December 31, 2024, we had state NOL carryforwards of $116.1 million, of which $103.2 million may be carried forward indefinitely to reduce future taxable income but utilization is limited to 80% of our taxable income in any given tax year based on current tax laws.
  • As of December 31, 2024, we had research and development tax credit carryforwards of $6.4 million, which may be available to reduce future tax liabilities and expire at various dates beginning after 2032.

and 30 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch CLNN. Know when insiders buy.
One email the day a filing lands. Free.