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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.

Mark Mortenson, Founder and Chief Science Officer of Clene, commented, "We are immensely appreciative of the financial support from the State of Maryland and DHCD. This Loan is a good example of an effective public-private partnership that supports 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."

Maryland Governor Larry Hogan said, "Providing funds for Clene Nanomedicine to expand demonstrates the importance of working with the private sector to improve the lives of Marylanders. I congratulate Clene Nanomedicine and look forward to the creation of pharmaceutical manufacturing jobs thanks to the SSBCI programs."

Rob Etherington, CEO and President of Clene, added, "These funds will be important in Clene's efforts to advance its lead asset CMN-Au8, targeting neurodegenerative diseases with our initial focus on ALS. We are excited to have Maryland as the epicenter for our research, development, and production activities."

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. 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; 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.


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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.

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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."

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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 ® .

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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.

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Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3

Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3

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 will report topline results of the CNM-Au8® regimen of the HEALEY ALS Platform Trial on Monday, Oct. 3. Clene's management team will host a conference call and webcast to discuss the results.

Conference Call and Webcast Details
Time and Date: 8:30 a.m. EDT on Oct. 3, 2022
Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll)
Conference ID: 5318408
Webcast Link

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Eupraxia Pharmaceuticals Reports Fourth Quarter and 2022 Financial Results

Eupraxia Pharmaceuticals Reports Fourth Quarter and 2022 Financial Results

Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced its audited financial results (prepared in accordance with International Financial Reporting Standards or "IFRS") and operational highlights for the fourth quarter and year ended December 31, 2022 . All amounts are expressed in Canadian dollars unless otherwise indicated.

"The fourth quarter of 2022 was a period of accelerated progress for Eupraxia," said Dr. James Helliwell , CEO of Eupraxia. "We advanced our innovative drug delivery technology platform during the reporting period with the commencement of a Phase 1b /2a trial of EP-104GI in eosinophilic esophagitis. This open-label study is on track to generate interim data readouts in the second quarter of 2023, with complete top-line data anticipated in the second half of 2023. We also continued to make strong progress with our Phase 2 trial of EP-104AR in osteoarthritis, with top-line data readout expected in the second quarter of this year. In parallel with our ongoing pipeline progress, we recently announced the appointment of Paul Brennan as Chief Business Officer as we look to fully resource and fund each of our high-potential clinical programs."

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Ocumetics Announces Advertising Campaign with Investing News Network

Ocumetics Announces Advertising Campaign with Investing News Network

(TheNewswire)

Ocumetics Technology Corp.

Calgary, Alberta TheNewswire - March 3, 2023 - Ocumetics Technology Corp. (" Ocumetics " or the " Company ") ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) has retained Dig Media Inc. dba Investing News Network ("INN") to assist in an advertising and investor awareness campaign.

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Plant-based Food Stocks: 10 Biggest Companies in 2023

The plant-based food industry has attracted a lot of interest in the past few years. Consumers are hungry for more plant-based diets, and their enthusiasm is creating a juicy growth market that investors can really sink their teeth into.

In 2021, several companies garnered more than US$100 million in 13 separate funding rounds. One of the biggest winners was privately held Impossible Foods, which completed a US$500 million raise for lifetime funding of over US$2 billion.

One of 2022's key financings was the US$400 million Series C round for cultured meat company Upside Foods, which included Tyson (NYSE:TSN), Cargill and Givaudan (SWX:GIVN). The money is to help build a commercial-scale manufacturing facility and a solid supply chain for cell growth media, as well as to fund more research and development on cell-based meat.

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Ocumetics Announces Successful Completion of Animal Studies

Ocumetics Announces Successful Completion of Animal Studies

(TheNewswire)

Ocumetics Technology Corp.

Ocumetics Technology Corp. (" Ocumetics " or the " Company ") ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) is pleased to announce the successful completion of its latest animal studies. "The purpose of these studies was to test our latest design," said Dr. Garth Webb, Ocumetics' Founder and Chief Scientific Officer.  "The lens design met and exceeded our expectations.  It is exciting to see the technology we have developed over the years coming to fruition

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Ginkgo Bioworks and the Ministry of Health of the Republic of Botswana Announce Plans to Develop and Implement New Biosecurity Capabilities in Botswana

Ginkgo Bioworks and the Ministry of Health of the Republic of Botswana Announce Plans to Develop and Implement New Biosecurity Capabilities in Botswana

Collaboration aims to leverage innovative biosecurity capabilities to promote public health, global health security, and the development of the bioeconomy

Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, and the Ministry of Health ("MoH"), representing the Government of the Republic of Botswana today announced that they have entered into a Memorandum of Understanding ("MoU") with the intent of developing and implementing new biosecurity capabilities in Botswana .

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Ambrx Biopharma Inc. Announces Receipt of NYSE Non-Compliance Letter Regarding ADS Trading Price

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Ambrx Biopharma Inc. (Ambrx) (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics platform to create antibody drug conjugates, announced today that it received a notice (the Notice) on November 23, 2022 from the New York Stock Exchange (NYSE) that it was not in compliance with the NYSE's continued listing standards because the average closing price of Ambrx's American Depositary Shares (ADS), each representing seven ordinary shares, had fallen below $1.00 per ADS (Minimum Stock Price) over a period of 30 consecutive trading days, which is the minimum average closing price per ADS required to maintain continued listing on the NYSE.

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