- Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)
- Peer-reviewed publication characterized the protein corona of CNM-Au8
- Company received sub-award of
$7.3 million fromNIH grant for ALS Expanded Access Program - Cash, cash equivalents and marketable securities of
$27.9 million as ofMarch 31, 2024
“In the first quarter our team worked diligently to advance our FDA discussions in ALS while continuing to generate more data supporting the neurological benefits and mechanism of action of CNM-Au8,” said
First Quarter 2024 and Recent Operating Highlights
CNM-Au8 for the treatment of MS
- In April, the Company announced at the 2024
American Academy of Neurology (AAN) Annual Meeting clinical data demonstrating that long-term CNM-Au8 treatment produced significant evidence of repair and remyelination across multiple paraclinical endpoints. Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity. More than half of participants improved by 10 or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (mixed model repeat measures, or MMRM vs. original baseline, p < 0.001). Study participants treated with CNM-Au8 also experienced up to 29 points of significant improvement (max score =110) in cognition and working memory as measured by the Symbol Digit Modality Test (SDMT) (MMRM vs. original baseline, p < 0.001). Study participants treated with CNM-Au8 also demonstrated functional and structural evidence of repair and remyelination.
The presentation of Visionary-MS long-term extension results presented at the 2024 AAN Annual Meeting is available here.
Corporate Updates
- In April, the Company entered into a grant sub-award agreement with
Columbia University pursuant to theNational Institute of Health (NIH) Grant that includes reimbursement of Company expenses for the NIH Expanded Access Program (EAP) in an amount up to$7.3 million during the period fromSeptember 25, 2023 toAugust 31, 2024 . InOctober 2023 , the Company announced a four-year,$45.1 million grant from theNIH in collaboration withColumbia University and Synapticure, a neurology specialty health clinic, that is intended to support an EAP for CNM-Au8 treatment of ALS. Disbursement of funds will be paid toClene based on invoice submissions for reimbursement on a monthly or quarterly basis.
- In March,
Clene announced the publication “Protein Corona Composition of Gold Nanocatalysts” in the journal ACS Pharmacology & Translational Science, a journal of theAmerican Chemical Society that publishes innovative and impactful research with translational relevance across a broad spectrum of biological sciences. This corona is an important feature of CNM-Au8’s neuroprotective mechanism of action and enables the drug’s longevity in circulation without provoking an inflammatory response.
The full publication can be accessed here: https://pubs.acs.org/doi/10.1021/acsptsci.4c00028
First Quarter 2024 Financial Results
Clene’s cash, cash equivalents and marketable securities totaled
Research and development expenses were
General and administrative expenses were
Total other expense was
About
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
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 our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “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, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include 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, the development and commercialization of our drug candidates; changes in government regulation or in practices relating to the pharmaceutical and biotechnology industries, including potential healthcare reform, which could decrease the need for our drug candidates, or make it more difficult to obtain regulatory approvals for our drug candidates and commercialize them; our substantial dependence on the successful commercialization of our drug candidates in the future, which may fail to materialize or may experience significant delays; our limited operating history, which may make it difficult to evaluate our current business and predict our future performance; and our ability to continue as a going concern, which requires that we obtain sufficient funding to finance our operations, which financing may not be available on acceptable terms, or at all, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce, or terminate our drug development or commercialization efforts; 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@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310 | Investor Contact kgardner@lifesciadvisors.com (617) 283-2856 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended | |||||||
2024 | 2023 | ||||||
Revenue: | |||||||
Product revenue | $ | 44 | $ | 64 | |||
Royalty revenue | 29 | 43 | |||||
Total revenue | 73 | 107 | |||||
Operating expenses: | |||||||
Cost of revenue | 16 | 5 | |||||
Research and development | 5,869 | 7,395 | |||||
General and administrative | 3,420 | 3,439 | |||||
Total operating expenses | 9,305 | 10,839 | |||||
Loss from operations | (9,232 | ) | (10,732 | ) | |||
Other income (expense), net: | |||||||
Interest income | 359 | 172 | |||||
Interest expense | (1,244 | ) | (1,066 | ) | |||
Commitment share expense | — | (399 | ) | ||||
Change in fair value of common stock warrant liabilities | (1,309 | ) | — | ||||
Change in fair value of Clene Nanomedicine contingent earn-out liability | 53 | (55 | ) | ||||
Change in fair value of Initial Stockholders contingent earn-out liability | 7 | (7 | ) | ||||
Research and development tax credits and unrestricted grants | 286 | 314 | |||||
Other income, net | — | 3 | |||||
Total other income (expense), net | (1,848 | ) | (1,038 | ) | |||
Net loss before income taxes | (11,080 | ) | (11,770 | ) | |||
Income tax benefit | — | — | |||||
Net loss | (11,080 | ) | (11,770 | ) | |||
Other comprehensive income (loss): | |||||||
Unrealized gain (loss) on available-for-sale securities | (4 | ) | 14 | ||||
Foreign currency translation adjustments | (55 | ) | 4 | ||||
Total other comprehensive income (loss) | (59 | ) | 18 | ||||
Comprehensive loss | $ | (11,139 | ) | $ | (11,752 | ) | |
Net loss per share – basic and diluted | $ | (0.09 | ) | $ | (0.15 | ) | |
Weighted average common shares used to compute basic and diluted net loss per share | 128,427,231 | 76,049,665 | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
2024 | 2023 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 21,732 | $ | 28,821 | |||
Marketable securities | 6,178 | 6,179 | |||||
Accounts receivable | 64 | 143 | |||||
Inventory | 37 | 37 | |||||
Prepaid expenses and other current assets | 4,100 | 3,672 | |||||
Total current assets | 32,111 | 38,852 | |||||
Restricted cash | 58 | 58 | |||||
Operating lease right-of-use assets | 4,046 | 4,168 | |||||
Property and equipment, net | 8,854 | 9,263 | |||||
TOTAL ASSETS | $ | 45,069 | $ | 52,341 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,645 | $ | 1,504 | |||
Accrued liabilities | 3,905 | 3,720 | |||||
Operating lease obligations, current portion | 599 | 576 | |||||
Finance lease obligations, current portion | 7 | 27 | |||||
Notes payable, current portion | 14,987 | 14,627 | |||||
Convertible notes payable, current portion | 5,042 | 4,876 | |||||
Total current liabilities | 26,185 | 25,330 | |||||
Operating lease obligations, net of current portion | 4,720 | 4,903 | |||||
Notes payable, net of current portion | 1,820 | 1,894 | |||||
Convertible notes payable, net of current portion | 5,265 | 5,258 | |||||
Common stock warrant liabilities | 2,790 | 1,481 | |||||
Clene Nanomedicine contingent earn-out liability | 22 | 75 | |||||
Initial Stockholders contingent earn-out liability | 3 | 10 | |||||
TOTAL LIABILITIES | 40,805 | 38,951 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock, | 13 | 13 | |||||
Additional paid-in capital | 257,914 | 255,901 | |||||
Accumulated deficit | (253,803 | ) | (242,723 | ) | |||
Accumulated other comprehensive income | 140 | 199 | |||||
TOTAL STOCKHOLDERS’ EQUITY | 4,264 | 13,390 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 45,069 | $ | 52,341 |
Source:
2024 GlobeNewswire, Inc., source