GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that it has submitted the Marketing Authorisation Application (MAA) for its lead product LUMEVOQ® to the European Medicines Agency (EMA), seeking approval for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene.
"This first regulatory submission for GenSight is a major milestone in our progression from a pure research organization to one with commercial capabilities. It validates a technology platform that has the potential to address the high unmet medical needs of patients suffering from a range of rare diseases. I would like to thank all GenSight employees and partners whose motivation, focus and effort made this submission possible,” said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight Biologics.
LHON is a rare, mitochondrial genetic disease, mainly affecting young males. The ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There continues to be a high unmet medical need for the 800-1200 new LHON patients in Europe and the U.S. each year, particularly those who are struck blind in their prime working years.
Lenadogene nolparvovec (tradename: LUMEVOQ®) is a recombinant adeno-associated viral vector, serotype 2 (rAAV2/2), containing a cDNA encoding the human wild-type mitochondrial NADH dehydrogenase 4 protein (ND4), which has been specifically developed for the treatment of LHON associated with mutation in the ND4 gene. It received orphan drug designation status for the treatment of LHON from the EMA in 2011 and from the U.S. Food and Drug Administration (FDA) in 2013.
GenSight submitted the MAA based on the benefit-risk balance established by results from a Phase-I/IIa study (CLIN-01), two pivotal Phase-III efficacy studies (CLIN-03A: RESCUE, and CLIN-03B: REVERSE) and the long-term follow up study of RESCUE and REVERSE (CLIN 06 - readout at Year 3 post injection). To demonstrate the efficacy of LUMEVOQ® in the context of a contralateral effect, the Company used a statistics-based indirect comparison methodology to assess the visual outcomes in LUMEVOQ®-treated patients (from LUMEVOQ® efficacy studies) against those in untreated patients from Natural History studies and GenSight’s REALITY Natural History Registry.
GenSight expects to submit the Biologics License Application (BLA) for LUMEVOQ® to the FDA in H2 2021. First-in-human data from GenSight’s second clinical stage program, GS030, are expected to be available in H2 2021.
About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to the eye by intravitreal injection to offer patients a sustainable functional visual recovery.
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Viad Corp (NYSE: VVI) announced today that President and Chief Executive Officer Steve Moster and Chief Financial Officer Ellen Ingersoll will be available for investor meetings at the following virtual conferences in September 2020:
The 3rd Annual Wells Fargo Consumer Conference on Wednesday, September 16th and Thursday, September 17th.
The Sidoti Fall 2020 Investor Conference on Wednesday, September 23rd and Thursday, September 24th.
An updated investor presentation will be posted on our website at www.viad.com on Wednesday, September 16th by 7 a.m. Eastern Time.
Viad (NYSE: VVI) generates revenue and shareholder value through two businesses: GES and Pursuit. Pursuit is a collection of inspiring and unforgettable travel experiences in Alaska, Montana, the Canadian Rockies, Vancouver and Reykjavik, as well as new experiences in development in Las Vegas and Toronto. Pursuit’s collection includes attractions, lodges and hotels, and sightseeing tours that connect guests with iconic places. GES is a global, full-service live events company offering a comprehensive range of services to the world's leading brands and event organizers. Our business strategy focuses on providing superior experiential services to our customers and sustainable returns on invested capital to our shareholders. Viad is an S&P SmallCap 600 company. For more information, visit www.viad.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200910005974/en/
In the news release "Dizun Announces Closing of $750,000 Private Placement and Letter of Intent With Maitri Health for Reverse Takeover", issued 24-Jul-2020 by Dizun International Enterprises Inc. over CNW, we are advised by the company that in the previous version of the news release, under the terms of the reverse takeover ("RTO"), Dizun International Enterprises Inc.("Dizun") announced that as part of the RTO, the Maitri Health Corp. ("Maitri") Shareholders will receive an aggregate of 25,000,000 common shares of Dizun. The correct amount is 250,000,000 common shares of Dizun. The complete release follows:
Dizun Announces Closing of $750,000 Private Placement and Letter of Intent With Maitri Health for Reverse Takeover
VANCOUVER, BC, July 24, 2020 /CNW/ - Dizun International Enterprises Inc. (CSE: KDZ) ("Dizun" or the "Company") is pleased to announce the closing of a $750,000 non-brokered private placement (the "Private Placement") of units of the Company (each a "Unit") and that it has entered into a non-binding letter of intent (the "LOI") with Maitri Health Corp. ("Maitri") to complete a business combination by way of a reverse takeover (the "RTO") of Dizun by the shareholders of Maitri. Upon completion of the RTO, the combined entity (the "Resulting Issuer") will continue to carry on the business of Maitri. The closing of the RTO is subject to the receipt of all necessary approvals, including without limitation regulatory approval for the listing of the common shares of the Resulting Issuer (the "Resulting Issuer Shares") on the Canadian Securities Exchange (the "Exchange"). The LOI was negotiated at arm's length and is effective July 23, 2020.
Pursuant to the Private Placement, Dizun issued 30,000,000 Units at a price of $0.025 per Unit for aggregate gross proceeds of $750,000.
Each Unit consists of one common share in the capital of Dizun (a "Dizun Share") and one Dizun Share purchase warrant (a "Warrant"). Each Warrant will entitle the holder to purchase one additional Dizun Share at an exercise price of $0.025 per share for a period of two years from the date of issuance.
The Private Placement is subject to the approval of the Exchange and the securities will be subject to a four-month hold period under securities laws.
In connection with the Private Placement, Dizun paid a cash finder's fee of $1,850 and issued 70,000 Finder's Warrants. The Finder's Warrants have the same terms as the Warrants and will be subject to a four-month hold period under securities laws.
Description of Maitri
Maitri is a coordinated global platform that delivers reliable, high quality health care supplies with transparent supply chains. The Covid-19 pandemic has exposed a need for a new way to manufacture and manage healthcare and PPE materials. Businesses need new protocols to keep workers safe and healthcare needs to equip first responders. Created by industry leaders, Maitri's mission is to bring a stable supply of materials to enable businesses and healthcare to function efficiently. Maitri is securing strategic on-shore manufacturing and licensing agreements. Clients of Maitri have a system that ensures medical supplies are available, reliable, consistent and sustainable. With advanced protocols for production, logistics, advanced technology and strict quality control, Maitri will ensure our global community is able to navigate every biomedical emergency. For further information, refer to Maitri's website at www.maitrihealth.ca.
Terms of the RTO
The RTO is expected to be completed by way of a share exchange between the shareholders of Maitri (the "Maitri Shareholders") and Dizun, following which the Resulting Issuer will continue the business of Maitri. In exchange for 100% of the issued and outstanding shares of Maitri (the "Maitri Shares"), the Maitri Shareholders will receive an aggregate of 250,000,000 Dizun Shares.
The Parties anticipate entering into a definitive amalgamation agreement (the "Definitive Agreement") by the end of August 2020, following the completion of satisfactory due diligence. The RTO constitutes an Arm's Length Transaction under the policies of the Exchange.
As of the date hereof, Dizun has 41,605,880 Dizun Shares outstanding, as well as an aggregate of 30,070,000 warrants.
As of the date hereof, Maitri has 25,000,000 Maitri Shares outstanding and no convertible securities.
Management and Directors of the Resulting Issuer
When the RTO is completed, it is anticipated that the board of directors of the Resulting Issuer shall be reconstituted to consist of such directors as Maitri shall determine, and each of the officers of Dizun shall resign and be replaced with officers appointed by the new board of directors.
It is anticipated that the directors of the Resulting Issuer will be Sav DiPasquale, Tony Clement, Dr. Solomon (Sam) Pillersdorf and Gavin Cooper, and the officers will be Andrew Morton and Marlis Yassin.
Sav DiPasquale: Board ChairMr. DiPasquale is a senior executive with over 30 years of experience in the pharmaceutical, biotechnology and transportation industries, and he is currently President of the Canadian Pharmaceutical Distribution Network ("CPDN"). At CPDN, Mr. DiPasquale is responsible for overall operations, including the development and implementation of strategies to grow the organization's membership and extend its unique service offering. Previously Mr. DiPasquale spent almost seventeen years at Glaxo Smith Kline in various senior positions, including VP Business Development and CIO.
Tony Clement: DirectorMr. Clement is a former Canadian federal politician and former Member of Parliament. Mr. Clement served as an Ontario cabinet minister, including as Federal Minister of Health and Long-Term Care as well as President of the Treasury.
Dr. Solomon (Sam) Pillersdorf: DirectorDr. Pillersdorf has been involved in the mining sector for over 10 years, including funding start-up mining companies and sourcing and funding resource claims. Dr. Pillersdorf was Head of Rheumatology Outpatients and Head of Rheumatology training at the McMaster University Medical Center.
Gavin Cooper: DirectorMr. Cooper is a Chartered Accountant with extensive experience in all aspects of corporate and financial management. For the past 35 years, Mr. Cooper has been providing strategic and financial advice and corporate administration services, and has held senior positions with a number of public and private companies with local and international operations
Andrew Morton: CEO and DirectorMr. Morton is a seasoned global technology executive with a track record of successfully building and running innovative companies. Mr. Morton was SVP Global Sales for Zodiac Interactive, a private equity held software company focused on advanced software for Tier 1 Cable and Telecom providers. He headed up Broadband TV for Entone where he launched successful operations on multiple continents. Entone was acquired by Amino Communications (LON: AMO) where he served for several years post transaction on the senior executive team. Earlier in his career, Mr. Morton co-launched global operations for Comtrend Corporation, a leader in telecom hardware and software.
Marlis Yassin: CFO and Corporate SecretaryMs. Yassin is a CPA, CA with over 15 years experience working with publicly listed companies. She has held finance management positions at various public companies, including an international industrial products company and mid-tier mining companies. Ms. Yassin gained extensive experience through her client engagements at Deloitte providing reporting, advisory and assurance services to publicly traded companies, primarily in the natural resources sector.
Conditions to the RTO
The RTO is subject to the satisfaction of customary closing conditions, including as follows:
each of Dizun and Maitri obtaining any requisite director and shareholder approvals;
the completion of due diligence investigations to the satisfaction of each of Dizun and Maitri;
Dizun and Maitri entering into the Definitive Agreement; and
all requisite regulatory and stock exchange approvals relating to the RTO and Exchange approval for the listing of the Resulting Issuer Shares having been obtained.
Additional Information Regarding the RTO
The RTO will constitute a change of business under the rules of the Exchange. The final legal structure for the RTO will be determined after the parties have considered all applicable tax, securities law and accounting efficiencies.
Dizun and Maitri expect to complete the RTO in the fall of 2020.
On behalf of the Board,
Dizun International Enterprises Inc.
Hani Zabaneh, Director and CEO
Completion of the RTO is subject to a number of conditions, including but not limited to, Exchange acceptance. The RTO cannot close until the required shareholder approvals are obtained. There can be no assurance that the RTO will be completed as proposed or at all. Investors are cautioned that, except as disclosed in the management information circular or listing statement to be prepared in connection with the transaction, any information released or received with respect to the transaction may not be accurate or complete and should not be relied upon. Trading in the securities of Dizun should be considered highly speculative. The Canadian Securities Exchange has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this news release.
Neither the Canadian Securities Exchange nor its regulation services provider has reviewed or accepts responsibility for the adequacy or accuracy of this news release.
All information contained in this press release with respect to Dizun and Maitri was supplied by the parties respectively for inclusion herein, and each party and its directors and officers have relied entirely on the other party for any information concerning the other party. Dizun has not conducted due diligence on the information provided by Maitri and does not assume any responsibility for the accuracy or completeness of such information.
This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities described herein in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws, and may not be offered or sold within the United States or to U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
This press release contains certain forward-looking statements that reflect the current views and/or expectations of management of Dizun and Maitri, respectively, with respect to performance, business and future events, including but not limited to express or implied statements and assumptions regarding the intention of Dizun and Maitri to negotiate for or complete the RTO, the change of directors, as proposed or at all. Forward-looking statements are based on the current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which Dizun and Maitri operate. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions, which are difficult to predict. In particular, there is no guarantee that the parties will successfully negotiate and enter into the Definitive Agreement or complete the RTO contemplated herein; that the due diligence of Dizun and/or Maitri will be satisfactory; or that Dizun and Maitri will obtain any required shareholder or regulatory approvals, including the listing of the Resulting Issuer Shares on the Exchange. Accordingly, readers should not place undue reliance on forward-looking statements and information herein, which are qualified in their entirety by this cautionary statement. Neither Dizun nor Maitri undertakes any obligation to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.
SOURCE Dizun International Enterprises Inc.