Life Science News

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

A live audio webcast can be accessed by visiting the Investors section of the Company's website on the Events page . An archived webcast will be available on the website approximately two hours after the event.

About CNM-Au8®
CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to protect 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.

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; 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

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 Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

  • Treatment with CNM-Au8 significantly improved long-term survival with approximately a 70% decreased risk of mortality vs. original placebo randomization
  • Comparable survival benefits were also shown compared to ENCALS predicted median survival
  • C NM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

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 presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.

The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .

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Ginkgo Bioworks Provides Compensation Information Related to Recent Acquisitions

Ginkgo Bioworks Provides Compensation Information Related to Recent Acquisitions

Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), which is building the leading platform for cell programming and biosecurity, today announced that in connection with its transaction with Bayer CropScience LP ("Bayer") on October 17, 2022 Ginkgo granted 9,868,143 restricted stock units to 139 new employees, and in connection with its acquisition of Zymergen Inc. ("Zymergen") on October 19, 2022 Ginkgo granted 8,305,110 restricted stock units to 179 new employees. The restricted stock units were granted without stockholder approval as material inducements to the employees entering into employment with Ginkgo pursuant to NYSE Listed Company Manual Section 303A.08 and were approved by Ginkgo's compensation committee.

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Mindset Pharma CEO, James Lanthier Issues Letter to Shareholders

Mindset Pharma CEO, James Lanthier Issues Letter to Shareholders

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Dear Fellow Shareholders:

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Interim Data from Ambrx's Study of ARX788 selected for Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium

Interim Data from Ambrx's Study of ARX788 selected for Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium

ARX788 is an anti-HER2 antibody drug conjugate currently being studied in several registrational trials in breast cancer and gastric/GEJ cancer by Ambrx's partner, NovoCodex Biopharmaceuticals, in China. Pursuant to its recently announced strategic reprioritization, Ambrx has paused the internal development of ARX788 and is seeking to partner ARX788 outside of China.

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Ginkgo Announces Public Offering of Class A Common Stock

Ginkgo Announces Public Offering of Class A Common Stock

Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), which is building the leading platform for cell programing and biosecurity, today announced the sale of shares of  its Class A common stock for gross proceeds of approximately $100 million to BTIG, LLC, as the underwriter in the registered public offering of those shares. In connection with this offering, Ginkgo has granted the underwriter a 30-day option to purchase up to an additional $15 million of  shares of Class A common stock.

(PRNewsfoto/Ginkgo Bioworks)

The last reported sale price of Ginkgo's Class A common stock on November 15, 2022 was $2.67 per share.  The underwriter proposes to offer for sale the shares of common stock from time to time in one or more transactions on the New York Stock Exchange, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to the prevailing market prices or at negotiated prices, subject to receipt and acceptance by it and subject to its right to reject any order in whole or in part.

BTIG, LLC is acting as the sole book-running manager for the offering. The offering is expected to close on or about November 18, 2022 , subject to the satisfaction of customary closing conditions.

Ginkgo intends to use the net proceeds from the offering to offset the cash used to finance the acquisition of certain assets and liabilities of Bayer CropScience LP and for other general corporate purposes. The shares described above are being offered by Ginkgo pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the "SEC") on October 4, 2022 and declared effective by the SEC on October 14, 2022 . A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 15, 2022 . The final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus can be obtained at the SEC's website http://www.sec.gov or from BTIG, LLC at 65 East 55th Street New York, NY , 10022 or by e-mail at ProspectusDelivery@btig.com .

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

About Ginkgo

Ginkgo is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.

Forward-Looking Statements of Ginkgo

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the use of proceeds from the sale of Class A common stock and the expected closing of the offering. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (vi) our ability to realize the expected benefits of merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's annual report on Form 10-K, most recent quarterly report on Form 10-Q filed with the SEC on November 14, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

GINKGO BIOWORKS INVESTOR CONTACT:

investors@ginkgobioworks.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/ginkgo-announces-public-offering-of-class-a-common-stock-301679941.html

SOURCE Ginkgo Bioworks

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Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, and PharmAla Biotech Holdings Inc. ("PharmAla")(CSE: MDMA) a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, today announced that they have entered into an exclusive sales agreement. Under the sales agreement, PharmAla will be the exclusive global reseller of Mindset's cGMP (i.e. pharmaceutical grade) psilocybin to appropriately licensed clinical researchers.

"In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers," said James Lanthier, CEO of Mindset. "We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It's also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations."

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Mindset Pharma and PharmAla Biotech Enter into Exclusive Sales Agreement

Mindset Pharma and PharmAla Biotech Enter into Exclusive Sales Agreement

PharmAla Biotech Holdings Inc. ("PharmAla")(CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset"), a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that they have entered into an exclusive sales agreement. Under the sales agreement, PharmAla will be the exclusive global reseller of Mindset's cGMP (i.e. pharmaceutical grade) psilocybin to appropriately licensed clinical researchers.

"In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers," said James Lanthier, CEO of Mindset. "We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It's also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations."

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