Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights
Rhea-AI Summary
Clene Inc. (Nasdaq: CLNN) reported its Q2 2024 financial results and updates on CNM-Au8® programs. Key highlights:
1. Improved survival in CNM-Au8 30 mg treated ALS patients compared to controls.
2. Significant clinical improvements in CNM-Au8 NfL Responders.
3. Neuroprotective effects demonstrated in Rett Syndrome model.
4. First ALS patient enrolled in NIH-funded Expanded Access Program.
5. Regained Nasdaq listing compliance.
6. FDA Type C interaction scheduled for Q3 2024.
Financial results: Cash and equivalents of $21.7M as of June 30, 2024. Q2 net loss of $6.8M ($1.06 per share), compared to $25.1M ($5.84 per share) in Q2 2023. R&D expenses decreased to $4.2M from $6.6M year-over-year.
Positive
- Improved survival in CNM-Au8 30 mg treated ALS patients with 60% decreased risk of death compared to controls
- Significant clinical improvements in CNM-Au8 NfL Responders, including survival, functional status, and combined function and survival
- Neuroprotective effects demonstrated in Rett Syndrome model, expanding potential applications
- Regained compliance with Nasdaq listing requirements
- Reduced net loss from $25.1M in Q2 2023 to $6.8M in Q2 2024
- Decreased R&D expenses from $6.6M to $4.2M year-over-year
Negative
- Cash and cash equivalents decreased from $35.0M (Dec 31, 2023) to $21.7M (Jun 30, 2024)
- Current cash resources only sufficient to fund operations into Q4 2024
- Ongoing net losses, with Q2 2024 net loss of $6.8M
Insights
Clene's Q2 2024 results reveal a mixed financial picture. The company's cash position of
Positively, the company has reduced its net loss to
The recent 1-for-20 reverse stock split to regain Nasdaq compliance is a short-term fix but doesn't address underlying financial challenges. Investors should closely monitor Clene's burn rate and potential funding sources in the coming quarters.
Clene's CNM-Au8 shows promising results in ALS treatment, with significant survival improvements compared to matched controls. The
The expansion into Rett Syndrome treatment is an interesting development, with preliminary data showing improvements in neuronal health and mitochondrial function. This could diversify Clene's pipeline and open new therapeutic avenues.
However, it's important to note that these are mostly post-hoc analyses and preliminary findings. The upcoming FDA Type C interaction will be critical in determining the regulatory path forward. Investors should await the FDA's feedback before drawing firm conclusions about CNM-Au8's potential market approval.
- Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline
- CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-responders
- CNM-Au8 demonstrated neuroprotective effects in an in vitro model of Rett Syndrome, a rare pediatric neurodevelopmental disease
- Enrolled first ALS patient in NIH-funded Expanded Access Program (EAP) in June
- Regained compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq
- Submitted briefing book to the U.S. Food and Drug Administration (FDA) in advance of granted Type C interaction to occur in the third quarter of 2024
- Cash and cash equivalents of
$21.7 million as of June 30, 2024
SALT LAKE CITY, Aug. 07, 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 second quarter 2024 financial results and provided recent updates on its CNM-Au8® programs.
“We are approaching our next FDA interaction focused on the regulatory path forward to potentially bring CNM-Au8 to people living with ALS,” said Rob Etherington, President and CEO of Clene. “With this imminent timing, we are optimistic about the possibility of submitting a new drug application later this year. Our utmost priority is to help patients and their families for whom time is critical.”
Second Quarter 2024 and Recent Operating Highlights
CNM-Au8 for the treatment of ALS
In June, the Company presented new long-term CNM-Au8 treatment results for survival and neurofilament light (NfL) levels from the HEALEY ALS Platform Trial open label extension (OLE) at the European Network for the Cure of ALS (ENCALS) meeting in Stockholm, Sweden. The data highlights up to 42 months of survival follow-up and 76 weeks of long-term NfL biomarker results, including a NfL responder subset (CNM-Au8 NfL Responders) from the HEALEY ALS Platform Trial who had consistent and sustained NfL reductions, comprising nearly half of all CNM-Au8 patients.
The data demonstrated improved survival compared to matched PRO-ACT controls as well as continued significant decline in plasma NfL levels in CNM-Au8 treated patients.
Improved Survival Compared to Matched PRO-ACT Controls: Survival analyses of participants originally randomized to CNM-Au8 30 mg treatment (n=59) and ex-placebo to CNM-Au8 (n=11) compared to matched PRO-ACT controls up to 3.5 years post-baseline.
- Approximately
60% decreased risk of death in CNM-Au8 30 mg treated patients compared to matched PRO-ACT controls up to 3.5 years of follow-up; covariate-adjusted hazard ratio (HR): 0.431 (95% CI: 0.276-0.672), p-value = 0.0002.
Reduced NfL Biomarker Levels in CNM-Au8 NfL Responders: CNM-Au8 NfL Responder Subset: The CNM-Au8 NfL Responder analysis was completed to identify NfL decreases in participants who showed consistent NfL declines (n=55). CNM-Au8 NfL Responders were defined as participants who had all post-baseline measures with an NfL decrease or repeated declines of at least 10 pg/mL following the start of CNM-Au8 treatment.
- CNM-Au8 NfL Responders demonstrated an average NfL reduction of
28% , which is suggestive of decreased axonal loss on an ongoing basis; geometric mean ratio (GMR) at week 76 change vs. baseline: 0.72, (95% CI: 0.67 – 0.79), p < 0.0001. - The NfL results are based on earlier announced analyses of plasma NfL collected from participants (n=99) in the OLE who were treated with CNM-Au8 30 mg through week 76 compared to participants treated with placebo for 24 weeks prior to crossing over to active treatment for up to 52 weeks. Long-term treatment with CNM-Au8 30 mg resulted in continued significant decline of plasma NfL levels. The GMR vs. placebo at week 76 was 0.841,
95% CI: 0.73 – 0.98, p = 0.023.
On July 13, 2024, the Company submitted a briefing book to FDA in advance of a granted Type C interaction expected to occur in the third quarter of 2024. The briefing book contains new post-hoc analyses from two independently conducted Phase 2 clinical trials of CNM-Au8 for the treatment for ALS. This new information supplements the original data previously discussed with the FDA in late 2023 and is intended to guide the planned FDA Type C interaction to discuss an accelerated approval regulatory pathway. The Company plans to publicly announce the topline FDA feedback following the conclusion of the Type C interaction. CNM-Au8 NfL Responders demonstrated a
Late last year, Clene, in collaboration with Columbia University and Synapticure, announced the award of a four-year grant from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), to support an EAP for the Company’s investigational drug, CNM-Au8 in ALS. The Company enrolled its first EAP patient in June.
CNM-Au8 for the treatment of Rett Syndrome
In June, Clene presented new, preliminary data demonstrating the potential of CNM-Au8 as a treatment for Rett Syndrome. at the International Rett Syndrome Foundation 2024 Annual Meeting. The presentation was titled, “CNM-Au8, a Candidate First-in-Class Nanotherapeutic for Treatment of Rett Syndrome.” Key findings included:
- Statistically significant improvement in neuronal health (p<0.01), neuron survival (p<0.0001), and neurite lengths (p<0.05) in an in vitro model of Rett Syndrome, and;
- Improvements in the mitochondrial respiration deficits associated with Rett patient-derived astrocytes with CNM-Au8 treatment in vitro, with full rescue (p<0.0001) of both basal and ATP-linked respiration observed in one Rett line, and partial rescue observed in a second Rett line (ns change in basal respiration; p<0.001 improvement in ATP-linked respiration) at one concentration of CNM-Au8 treatment for 24 hours.
Corporate Update
In July, Clene completed 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
Second 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 income was
Clene reported a net loss of
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 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 fourth quarter of 2024, the timing of Clene’s public announcement of topline FDA feedback, the timing of Clene’s submission of a new drug application 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 fourth quarter of 2024, the timing of Clene’s public announcement of topline FDA feedback, the timing of Clene’s submission of a new drug application 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, 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 64 | $ | 226 | $ | 108 | $ | 290 | ||||||||
| Royalty revenue | 27 | 43 | 56 | 86 | ||||||||||||
| Total revenue | 91 | 269 | 164 | 376 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | 18 | 66 | 34 | 71 | ||||||||||||
| Research and development | 4,150 | 6,615 | 10,019 | 14,010 | ||||||||||||
| General and administrative | 3,314 | 3,924 | 6,734 | 7,363 | ||||||||||||
| Total operating expenses | 7,482 | 10,605 | 16,787 | 21,444 | ||||||||||||
| Loss from operations | (7,391 | ) | (10,336 | ) | (16,623 | ) | (21,068 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 269 | 213 | 628 | 385 | ||||||||||||
| Interest expense | (1,282 | ) | (1,104 | ) | (2,526 | ) | (2,170 | ) | ||||||||
| Commitment share expense | — | (3 | ) | — | (402 | ) | ||||||||||
| Issuance costs for common stock warrant liabilities | — | (333 | ) | — | (333 | ) | ||||||||||
| Loss on initial issuance of equity | — | (14,840 | ) | — | (14,840 | ) | ||||||||||
| Change in fair value of common stock warrant liabilities | 1,568 | (383 | ) | 259 | (383 | ) | ||||||||||
| Change in fair value of Clene Nanomedicine contingent earn-out liability | 22 | 1,165 | 75 | 1,110 | ||||||||||||
| Change in fair value of Initial Stockholders contingent earn-out liability | 3 | 150 | 10 | 143 | ||||||||||||
| Research and development tax credits and unrestricted grants | 26 | 341 | 312 | 655 | ||||||||||||
| Other expense, net | — | (13 | ) | — | (10 | ) | ||||||||||
| Total other income (expense), net | 606 | (14,807 | ) | (1,242 | ) | (15,845 | ) | |||||||||
| Net loss before income taxes | (6,785 | ) | (25,143 | ) | (17,865 | ) | (36,913 | ) | ||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net loss | (6,785 | ) | (25,143 | ) | (17,865 | ) | (36,913 | ) | ||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | 2 | 6 | (2 | ) | 20 | |||||||||||
| Foreign currency translation adjustments | 28 | (53 | ) | (27 | ) | (49 | ) | |||||||||
| Total other comprehensive income (loss) | 30 | (47 | ) | (29 | ) | (29 | ) | |||||||||
| Comprehensive loss | $ | (6,755 | ) | $ | (25,190 | ) | $ | (17,894 | ) | $ | (36,942 | ) | ||||
| Net loss per share – basic and diluted | $ | (1.06 | ) | $ | (5.84 | ) | $ | (2.78 | ) | $ | (9.11 | ) | ||||
| Weighted average common shares used to compute basic and diluted net loss per share | 6,423,182 | 4,302,520 | 6,422,242 | 4,053,883 | ||||||||||||
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,682 | $ | 28,821 | ||||
| Marketable securities | — | 6,179 | ||||||
| Accounts receivable | — | 143 | ||||||
| Inventory | 37 | 37 | ||||||
| Prepaid expenses and other current assets | 6,191 | 3,672 | ||||||
| Total current assets | 27,910 | 38,852 | ||||||
| Restricted cash | 58 | 58 | ||||||
| Operating lease right-of-use assets | 3,920 | 4,168 | ||||||
| Property and equipment, net | 8,442 | 9,263 | ||||||
| TOTAL ASSETS | $ | 40,330 | $ | 52,341 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,066 | $ | 1,504 | ||||
| Accrued liabilities | 5,927 | 3,720 | ||||||
| Operating lease obligations, current portion | 623 | 576 | ||||||
| Finance lease obligations, current portion | — | 27 | ||||||
| Notes payable, current portion | 20,453 | 14,627 | ||||||
| Convertible notes payable, current portion | — | 4,876 | ||||||
| Total current liabilities | 28,069 | 25,330 | ||||||
| Operating lease obligations, net of current portion | 4,530 | 4,903 | ||||||
| Notes payable, net of current portion | 1,745 | 1,894 | ||||||
| Convertible notes payable, net of current portion | 5,268 | 5,258 | ||||||
| Common stock warrant liabilities | 1,222 | 1,481 | ||||||
| Clene Nanomedicine contingent earn-out liability | — | 75 | ||||||
| Initial Stockholders contingent earn-out liability | — | 10 | ||||||
| TOTAL LIABILITIES | 40,834 | 38,951 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 259,913 | 255,913 | ||||||
| Accumulated deficit | (260,588 | ) | (242,723 | ) | ||||
| Accumulated other comprehensive income | 170 | 199 | ||||||
| TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | (504 | ) | 13,390 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | 40,330 | $ | 52,341 | ||||
FAQ
What were Clene's (CLNN) key financial results for Q2 2024?
What significant clinical results did Clene (CLNN) report for CNM-Au8 in ALS treatment?
When is Clene's (CLNN) FDA Type C interaction scheduled for CNM-Au8 in ALS?
How long can Clene (CLNN) fund its operations with current cash resources as of Q2 2024?
