Clene Reports Second Quarter 2023 Financial Results and Operating Highlights
- Statistically significant reductions in plasma neurofilament light chain levels
- Strong financial position with $49.2 million in cash, cash equivalents, and marketable securities as of June 30, 2023
- Net loss of $25.1 million for the quarter ended June 30, 2023
- Reported statistically significant reductions in plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) in patients treated with CNM-Au8® in the HEALEY ALS Platform trial
- Announced publication of the results of the Phase 2 RESCUE ALS study and its open-label extension in the Lancet journal, eClinicalMedicine
- Received one-year grant from the National Multiple Sclerosis Society (NMSS) that will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS
- Company expects multiple near-term data announcements that will further support benefit and safety of CNM-Au8 in people living with ALS
- Company is preparing for upcoming ALS regulatory discussions with FDA
- Cash, cash equivalents and marketable securities of
$49.2 million as of June 30, 2023, which includes gross proceeds of$40 million from a recent public offering and that may provide additional capital up to$130 million through future warrant exercises
SALT LAKE CITY, Aug. 14, 2023 (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 2023 financial results and provided recent operating highlights for the clinical programs in ALS and MS.
“Our recent financing has strengthened our capital position and provided the runway needed to advance our ALS clinical program with upcoming engagement with regulatory agencies, the initiation of our global Phase 3 in ALS (RESTORE-ALS), and additional clinical trial data read-outs,” said Rob Etherington, President and CEO of Clene. “We look forward to additional long-term clinical data, including survival, time-to-clinical-worsening and additional biomarker data, from the HEALEY ALS Platform trial. We are actively preparing for ALS regulatory discussions with the FDA and EMA, with meetings anticipated later this year. Additionally, we plan to continue advancing our clinical program in MS, while pursuing prospective partnering opportunities in parallel.”
Second Quarter 2023 and Recent Operating Highlights
CNM-Au8, a gold nanocrystal suspension, for the treatment of ALS
- Results of the Phase 2 RESCUE ALS study and its open-label extension trial were published in the Lancet journal, eClinicalMedicine. The article can be accessed via the following link: https://authors.elsevier.com/sd/article/S2589537023002134.
- Clene reported that CNM-Au8 treatment demonstrated significantly reduced plasma NfL levels compared to placebo at 24 weeks (p=0.04). The results are based on an analysis of the plasma NfL biomarker across all Regimen C participants (CNM-Au8 or placebo, n=161) from the HEALEY ALS Platform trial.
CNM-Au8 for the treatment of MS
Clene received a one-year grant from NMSS that will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS. Using non-invasive brain imaging, the study will enroll up to 15 individuals with primary progressive or non-active secondary progressive MS and determine the effects of 12 weeks of daily oral dosing with CNM-Au8 on critical brain energy metabolites that have been shown to be compromised in individuals with MS.
Corporate Updates
On June 21, 2023, Clene announced the closing of its underwritten public offering. This financing raised gross proceeds of
Second Quarter 2023 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
Clene reported a net loss of
About Clene
Clene is a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including ALS and MS, 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.
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,” “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 our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our 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; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our 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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 226 | $ | 2 | $ | 290 | $ | 9 | ||||||||
| Royalty revenue | 43 | 33 | 86 | 56 | ||||||||||||
| Total revenue | 269 | 35 | 376 | 65 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | 66 | — | 71 | — | ||||||||||||
| Research and development | 6,615 | 9,166 | 14,010 | 17,746 | ||||||||||||
| General and administrative | 3,924 | 4,464 | 7,363 | 9,250 | ||||||||||||
| Total operating expenses | 10,605 | 13,630 | 21,444 | 26,996 | ||||||||||||
| Loss from operations | (10,336 | ) | (13,595 | ) | (21,068 | ) | (26,931 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 213 | 61 | 385 | 85 | ||||||||||||
| Interest expense | (1,104 | ) | (751 | ) | (2,170 | ) | (1,533 | ) | ||||||||
| Gain on termination of lease | — | — | — | 420 | ||||||||||||
| Commitment share expense | (3 | ) | — | (402 | ) | — | ||||||||||
| Issuance costs for common stock warrant liability | (333 | ) | — | (333 | ) | — | ||||||||||
| Loss on initial issuance of equity | (14,840 | ) | — | (14,840 | ) | — | ||||||||||
| Change in fair value of common stock warrant liabilities | (383 | ) | 20 | (383 | ) | 2 | ||||||||||
| Change in fair value of Clene Nanomedicine contingent earn-out liability | 1,165 | 8,310 | 1,110 | 8,253 | ||||||||||||
| Change in fair value of Initial Stockholders contingent earn-out liability | 150 | 1,066 | 143 | 1,054 | ||||||||||||
| Research and development tax credits and unrestricted grants | 341 | 356 | 655 | 655 | ||||||||||||
| Other income (expense), net | (13 | ) | (1 | ) | (10 | ) | 107 | |||||||||
| Total other income (expense), net | (14,807 | ) | 9,061 | (15,845 | ) | 9,043 | ||||||||||
| Net loss before income taxes | (25,143 | ) | (4,534 | ) | (36,913 | ) | (17,888 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net loss | (25,143 | ) | (4,534 | ) | (36,913 | ) | (17,888 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | 6 | (37 | ) | 20 | (87 | ) | ||||||||||
| Foreign currency translation adjustments | (53 | ) | (110 | ) | (49 | ) | (60 | ) | ||||||||
| Total other comprehensive loss | (47 | ) | (147 | ) | (29 | ) | (147 | ) | ||||||||
| Comprehensive loss | $ | (25,190 | ) | $ | (4,681 | ) | $ | (36,942 | ) | $ | (18,035 | ) | ||||
| Net loss per share – basic and diluted | $ | (0.29 | ) | $ | (0.07 | ) | $ | (0.46 | ) | $ | (0.28 | ) | ||||
| Weighted average common shares used to compute basic and diluted net loss per share | 86,050,405 | 63,335,271 | 81,077,661 | 63,095,400 | ||||||||||||
| CLENE INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 49,243 | $ | 18,332 | ||||
| Marketable securities | — | 4,983 | ||||||
| Accounts receivable | 161 | 189 | ||||||
| Inventory | 52 | 43 | ||||||
| Prepaid expenses and other current assets | 3,915 | 5,648 | ||||||
| Total current assets | 53,371 | 29,195 | ||||||
| Restricted cash | 58 | 58 | ||||||
| Operating lease right-of-use assets | 4,383 | 4,602 | ||||||
| Property and equipment, net | 10,033 | 10,638 | ||||||
| TOTAL ASSETS | $ | 67,845 | $ | 44,493 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 846 | $ | 3,014 | ||||
| Accrued liabilities | 4,298 | 3,863 | ||||||
| Operating lease obligations, current portion | 529 | 488 | ||||||
| Finance lease obligations, current portion | 62 | 74 | ||||||
| Notes payable, current portion | — | 6,418 | ||||||
| Total current liabilities | 5,735 | 13,857 | ||||||
| Operating lease obligations, net of current portion | 5,235 | 5,557 | ||||||
| Finance lease obligations, net of current portion | — | 34 | ||||||
| Notes payable, net of current portion | 16,017 | 9,483 | ||||||
| Convertible notes payable | 9,822 | 9,770 | ||||||
| Common stock warrant liabilities | 8,201 | — | ||||||
| Clene Nanomedicine contingent earn-out liability | 1,154 | 2,264 | ||||||
| Initial Stockholders contingent earn-out liability | 148 | 291 | ||||||
| TOTAL LIABILITIES | 46,312 | 41,256 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 13 | 7 | ||||||
| Additional paid-in capital | 251,478 | 196,246 | ||||||
| Accumulated deficit | (230,132 | ) | (193,219 | ) | ||||
| Accumulated other comprehensive income | 174 | 203 | ||||||
| TOTAL STOCKHOLDERS’ EQUITY | 21,533 | 3,237 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 67,845 | $ | 44,493 | ||||
FAQ
What did Clene Inc. announce regarding the HEALEY ALS Platform trial?
What is the company's financial position as of June 30, 2023?
What grant did Clene Inc. receive and what will it fund?
What is the net loss reported by Clene Inc. for the quarter ended June 30, 2023?
