Clene Announces $10.8 Million Registered Direct Offering and $5 Million Debt Facility from the State of Maryland

Clene Announces $10.8 Million Registered Direct Offering and $5 Million Debt Facility from the State of Maryland

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it has entered into a securities purchase agreement with certain existing stockholders, including existing stockholders affiliated with Clene's board of directors, for the purchase and sale of 10,723,926 shares of the Company's common stock at a purchase price per share of $1.01, priced at-the-market based on the October 28, 2022 closing stock price, in a registered direct offering.

The closing of the registered direct offering is expected to occur on or about November 2, 2022, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10.8 million. The registered direct offering is being made without a placement agent, underwriter, broker or dealer and, as a result, Clene is not paying any underwriter commission or discount. Clene intends to use the proceeds from this offering together with its existing cash for expenses primarily related to general corporate purposes, including to fund the clinical development of its lead drug candidate, CNM-Au8 ® .

The shares were offered pursuant to an effective shelf registration statement on Form S-3 (No. 333-264299) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on April 26, 2022. A final prospectus supplement and accompanying prospectus (collectively, the "Prospectus") containing additional information relating to the offering will be filed with the SEC and will be available on the SEC's website located at https://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Clene also announced that it has executed a Commitment Letter with the Maryland Department of Housing and Community Development ("DHCD") to borrow $5 million (the "Loan Facility"). The State Small Business Credit Initiative ("SSBCI") program within DHCD was provided the source funds for the Loan Facility by the U.S. Department of Treasury. The Loan Facility is conditioned on Clene matching the $5 million loan with at least $5 million of new equity capital. The closing of the registered direct offering referenced above will satisfy that condition of the Loan Facility. Clene is targeting December 1, 2022, as the tentative closing date for the Loan Facility.

Mark Mortenson, Founder & Chief Science Officer of Clene Nanomedicine, added, "We greatly appreciate the continued financial support from the State of Maryland and DHCD. This offered Loan Facility is another great example of effective public-private partnerships that support continued investment in activities that create high-value pharmaceutical manufacturing jobs, specifically producing nanotherapeutics at Clene that have the potential to improve the lives of people living with neurodegenerative diseases."

Rob Etherington, CEO and President of Clene, commented, "These funds, along with existing cash-on-hand, enable Clene to advance its pipeline in difficult-to-treat neurodegenerative diseases, focusing immediately on ALS. The proceeds from these two financings, once closed, one of which is non-dilutive, will further strengthen our balance sheet, enable sufficient capital to fund our operations into the third quarter 2023, and support the regulatory path to potential marketing authorization for CNM-Au8 in the treatment of ALS."

About Clene

Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease 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 .

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; uncertainty regarding whether potential strategic partnerships will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms; 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 filings with the SEC, including 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
David Schull
Russo Partners, LLC
David.schull@russopartnersllc.com
(858) 717-2310

Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
617-283-2856

Source: Clene Inc.


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

CLNN
The Conversation (0)
Presenting on Emerging Growth Conference 81 Day 1 on April 16; Register to live stream

Presenting on Emerging Growth Conference 81 Day 1 on April 16; Register to live stream

EmergingGrowth.com a leading independent small cap media portal announces the schedule of the 81 th Emerging Growth Conference on April 16 & 17, 2025.

The Emerging Growth Conference identifies companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long-term growth.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene Announces Closing of $5 Million Debt Facility from the State of Maryland

Clene Announces Closing of $5 Million Debt Facility from the State of Maryland

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced the closing of a $5 million debt facility (the "Loan") with the Maryland Department of Housing and Community Development ("DHCD").

The State Small Business Credit Initiative ("SSBCI") program within DHCD sourced the funds for the Loan from the U.S. Department of Treasury. All conditions related to the Loan were satisfied by Clene. The Loan bears interest at a rate of 6% per annum and has a maturity date 60 months from the first day of the second full month following the date the Loan closes.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
VISIONARY-MS Trial Results Featured in Platform Presentation at PACTRIMS 2022: CNM-Au8® Demonstrated Global Neurological Improvement in Stable MS Patients as Adjunct to Background Disease Modifying Therapies

VISIONARY-MS Trial Results Featured in Platform Presentation at PACTRIMS 2022: CNM-Au8® Demonstrated Global Neurological Improvement in Stable MS Patients as Adjunct to Background Disease Modifying Therapies

  • CNM-Au8 demonstrated low contrast vision improvement and global neurological improvement (low contrast vision, cognition, upper extremity function, and walking speed) in stable MS patients as adjunct to background immunomodulating disease modifying therapies (DMTs)
  • No approved MS DMTs have shown global neurological improvement in stable MS patients, a significant unmet medical need in MS
  • CNM-Au8 treatment was well-tolerated, and no significant safety findings were observed

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that the VISIONARY-MS trial results were featured as a platform presentation by Professor Michael Barnett, MBBS FRACP PhD at the 14th Annual Singapore Pan-Asian Committee on Treatment and Research in Multiple Sclerosis (PACTRIMS) Congress held November 24-26.

The platform presentation titled, " VISIONARY-MS Top-line Results: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety and Efficacy of CNM-Au8, a Catalytically Active Gold Nanocrystal Suspension in Relapsing Multiple Sclerosis ," provided proof-of-concept evidence for global neurological improvement as assessed by the modified Multiple Sclerosis Functional Composite (mMSFC), evaluating low contrast vision, cognition, upper extremity function, and walking speed with CNM-Au8 as adjunct to approved background immunomodulatory disease modifying therapies (DMTs) in stable MS patients.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene Reports Third Quarter 2022 Financial Results and Recent Operating Highlights

Clene Reports Third Quarter 2022 Financial Results and Recent Operating Highlights

  • Secondary survival endpoint for the   CNM-Au8 ®   30 mg dose investigated in the Healey ALS Platform Trial demonstrated a >90% reduction in the risk of death or death equivalent (permanently assisted ventilation) and risk of death alone at 24 weeks . This survival benefit was consistent with prior results reported from the Phase 2 RESCUE-ALS trial long term open-label extension.
  • Topline results from the Phase 2 VISIONARY-MS clinical trial of   CNM-Au8 ® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and global neurological improvement measured by the modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the modified intent to treat (mITT) population   .
  • Cash, cash equivalents, and marketable securities of $16.2 million as of September 30, 2022.
  • Closed a registered direct offering of $10.8 million with certain existing stockholders, including existing stockholders affiliated with Clene's board of directors, for the purchase and sale of 10,723,926 shares of the Company's common stock at a purchase price per share of $1.01, priced at-the-market based on the October 28, 2022, closing stock price, in a registered direct offering.
  • Executed a Commitment Letter with the Maryland Department of Housing and Community Development to borrow $5.0 million.

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today reported its third quarter 2022 financial results and recent operating highlights.

"Clene was pleased to report the significant survival benefit in people living with ALS in the Healey ALS Platform Trial at six months with the CNM-Au8 ® 30 mg dose. To our knowledge, this is the only study to show a survival benefit at 6-months in ALS," said Rob Etherington, President and CEO of Clene. "Subsequent to the Healey data read-out, we have been able to secure sufficient capital to further strengthen our balance sheet, extend our financial runway, and support the regulatory path to potential marketing authorization. We remain in active discussions with potential strategic partners regarding CNM-Au8. We are also looking forward to the further results from the full Healey data set, including biomarker data and exploratory endpoints, during the coming months."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene Reports Topline Results Demonstrating Survival Signal for CNM-Au8® in Healey ALS Platform Trial

Clene Reports Topline Results Demonstrating Survival Signal for CNM-Au8® in Healey ALS Platform Trial

  • The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeks
  • Prespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks
  • Survival signal consistent with prior results from the Phase 2 RESCUE-ALS trial
  • Clene will continue the open-label extension of CNM-Au8 in the Healey ALS Platform Trial and is in discussions with the Healey & AMG ALS Center to design and offer an Expanded Access Protocol (EAP) of CNM-Au8 30mg for eligible participants of closed regimens and others
  • Clene is pursuing multiple paths, including ongoing discussions with potential strategic partners, in its goal of marketing authorization
  • Clene to host investor call and webcast at 8:30 am EDT today

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced topline study results showing a survival benefit in the Healey ALS Platform trial of CNM-Au8®, an investigational gold nanocrystal suspension, in participants with amyotrophic lateral sclerosis (ALS).

The primary endpoint of slope of change in ALS Functional Rating Scale Revised (ALSFRS-R) scores adjusted for mortality was not significant (2% slowing, 95% CI: -20% to +19%) at 24 weeks. Secondary endpoints of Combined Assessment of Function and Survival (CAFS) and slow vital capacity (SVC) were also not met at 24 weeks across the combined 30 mg and 60 mg CNM-Au8 doses.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Emyria Limited

Medibank to Fund Emyria’s PTSD Program at Perth Clinic

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) a leader in developing and delivering innovative mental health treatments, is pleased to announce that Medibank Private Limited (“Medibank”), Australia’s largest private health insurer, has commenced funding for eligible customers to access Emyria’s Empax PTSD care program delivered in association with Perth Clinic.

Keep reading...Show less
ASX:HIQ

HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard

Common Shareholder Questions – Entitlement Offer

HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.

Keep reading...Show less
HeartSciences Inc

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

Keep reading...Show less
Zoono Group

Exclusive UK Packaging Agreement signed between Sharpak Aylesham Limited, Zoono, and OSY

Zoono Group Limited (Company) (ASX: ZNO) is pleased to update the market on an exclusive contract signed with Sharpak Aylesham Limited (Sharpak) and the Company’s partner in the food supply chain sector, OSY Group Limited (OSY).

Keep reading...Show less
Amplia Therapeutics

Accent Trial Data Demonstrates that Narmafotinib + Chemotherapy Combination Superior to Chemotherapy Alone

Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce important new data from our ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane. Fifteen (15) confirmed partial responses (PRs) have now been recorded in the trial, a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone.
Keep reading...Show less
Nutritional Growth Solutions Limited

Binding Commitments Received for A$1.0 Million under Convertible Note Placement

Nutritional Growth Solutions Limited (ASX:NGS) ("NGS" or "the Company"), is pleased to announce that it has received binding commitments for the issue of 1,000,000 convertible notes (Placement CNs), to be issued at $1.00 each (CN Placement).

Keep reading...Show less

Latest Press Releases

Related News

×