Annual financial report 2020

Annual financial report 2020




Annual financial report 2020

FINANCIERE DE TUBIZE SA/NV

Allée de la Recherche 60, 1070 Brussels

Contact: Anne Sophie Pijcke, directeur, aspijcke@financiere-tubize.be

Annual financial report 2020

Regulated information
27 February 2021

The board of directors of Financière de Tubize has established the 2020 annual financial report. This report is available on the website www.financiere-tubize.be

  • Dividend received from UCB: € 84,4 million (against € 82.4 million in 2019)
  • Profit of € 81,0 million (against € 80.0 million in 2019)
  • Decrease of outstanding debt from € 86.5 million at 31 December 2019 to € 33,5 million at 31 December 2020.

If the general shareholders meeting of 30 April 2021 approves the 2020 annual accounts, including the proposed result appropriation, a dividend of € 0,68 will be payable as from 6th of May 2021 onwards at the offices, seats and branches of BNP Paribas Fortis, in exchange of coupon n° 16.

Ex-dividend                     4 May 2021
Record date                     4 May 2021
Payment date                  6 May 2021

In addition, the company Other Look SRL (Ol2EF) represented by Mrs Anne-Sophie Pijcke has given its resignation with effect at the end of the Ordinary General Assembly on 30 April 2021. The new Director of the Company will, from that date, be the company ENRE SRL, represented by its director Mr. Eric Nys, whose head office is established Place Obert de Thieusies at 7830 Silly, which will carry out missions similar to those previously devolved to Ol2EF SRL.

Imara to Webcast Conference Call of Full Year 2020 Financial Results and Business Highlights

Imara to Webcast Conference Call of Full Year 2020 Financial Results and Business Highlights




Imara to Webcast Conference Call of Full Year 2020 Financial Results and Business Highlights

BOSTON, Feb. 26, 2021 (GLOBE NEWSWIRE) — Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced that the company will host a conference call and live webcast on Friday, March 5, 2021 at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020 and review recent business highlights.

A live webcast will be available under “Events and Presentations” in the Investors section of the company’s website. The conference call can be accessed by dialing +1 (833) 519-1307 (U.S. domestic) or (914) 800-3873 (international) and referring to conference ID 1368162. A replay of the webcast will be archived on the Imara website following the presentation.

About Imara
Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin. Imara is currently advancing IMR-687, a highly selective, potent small molecule inhibitor of PDE9 that is an oral, once-a-day, potentially disease-modifying treatment for sickle cell disease and beta-thalassemia. IMR-687 is being designed to have a multimodal mechanism of action that acts on red blood cells, white blood cells, adhesion mediators and other cell types. For more information, please visit www.imaratx.com

Media Contact:
Gina Nugent
Ten Bridge Communications
617-460-3579
gina@tenbridgecommunications.com

Investor Contact:
Michael Gray
617-835-4061
mgray@imaratx.com

GENFIT: Revenues and Cash Position as of December 31, 2020

GENFIT: Revenues and Cash Position as of December 31, 2020




GENFIT: Revenues and Cash Position as of December 31, 2020

  • Cash and cash equivalents totaled €171 million as of December 31, 2020
  • The announced cash position omits the partial buyback of the OCEANEs convertible bonds by GENFIT, for €47.48 million1, completed in January 2021

Lille, France; Cambridge, MA; February 26, 2021GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced its cash position as of December 31, 2020 and revenues for 20202.

Financials

As of December 31, 2020, the Company’s cash and cash equivalents amounted to €171.0 million compared with €276.7 million, as of December 31, 2019.

As of June 30, 2020, cash and cash equivalents amounted to €225.7 million.

The cash position as of December 31, 2020 omits the cost of the partial buyback by the Company for its convertible bonds (OCEANEs) issued in October 2017 and amounting to approximately €180 million. Following the completion of this transaction, €85.7 million of convertible debt was canceled by spending a gross amount of only €47.48 million.

Given the conversions of bonds into shares in January 2021, which led to the creation of 3,037,309 new shares in February 2021, the residual convertible debt, initially reduced to a nominal amount of €94.3 million through the partial buyback transaction, was further reduced by a nominal amount of €16.3 million, with approximately €78 million outstanding as of February 18, 2021.

Pascal Prigent, CEO of GENFIT, commented: “Since the announcement of our new corporate strategy in the Fall of 2020, GENFIT has achieved a significant amount and I’m satisfied with the early direction of 2021. ELATIVETM, our Phase 3 clinical trial in PBC, is on track, and we recently organized a KOL event on this disease, which highlighted the potential of elafibranor in this market already worth >$300M in 2020, and expected to reach $1bn in 2025, at the time we hope to launch. Next to this, we successfully restructured the convertible debt at the end of January 2021, with a maturity extended to October 2025. Some bondholders have since converted their OCEANEs, further reducing the outstanding debt to approximately €78 million. We will present advances on our R&D programs at the next corporate update, to take place before the summer.


Revenues
3

Revenues for 2020 amounted to €765 thousand compared to €31 million for 2019.

Revenues included revenues from the licensing agreements with Covance/Labcorp to roll out the NIS4™ diagnostic technology in NASH  and the sale of goods and services provided pursuant to the collaboration and license agreement with Terns Pharmaceuticals.  As a comparison, revenues for 2019 mainly consisted of the $35 million upfront payment received from Terns Pharmaceuticals as part of the collaboration and license agreement.

Reminder

On September 30, 2020, GENFIT announced its plan to reduce its cash burn by 50% by 2022 compared to the cash burn before the publication of the RESOLVE-IT Phase 3 data readout.

The Company reiterates its goal to reduce the cash burn rate from €110 million annually before our Phase 3 data, to approximately €45 million annually, beginning in 2022. 2021 will be a transition year with a cash burn of approximately €75 million (excluding the partial OCEANEs buyback transaction for €47.48 million in cash) mainly due to the residual expenses related to the termination of the RESOLVE-IT clinical trial, and to costs associated with the workforce reduction plan.

Upcoming Financial Communications

The Company will release its full-year 2020 financial results on April 1, 2021. The 2020 Universal Registration Document, the 2021 Annual Financial Report (included in the 2020 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2021.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with cholestatic and metabolic chronic liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT is currently enrolling in ELATIVE™, a Phase 3 clinical trial evaluating elafibranor in patients with Primary Biliary Cholangitis (PBC). Elafibranor is an investigational compound that has not been reviewed and has not received approval by any regulatory authority. As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which could enable easier identification of patients with at-risk NASH.  NIS4™ technology has been licensed to LabCorp® in the U.S. and Canada for the development and commercialization of a blood-based molecular diagnostic test powered by NIS4™ technology. GENFIT has facilities in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including statements regarding the Company’s ability to meet clinical, regulatory and commercial milestones and timelines in our PBC program, expectations for disease prevalence, growth and size of the PBC market, including GENFIT’s potential market share and revenues and projected cash burn. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe”, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “have confidence” or (as the case may be) the negative forms of such terms or any other variant of such terms or other terms similar to them in meaning is intended to identify forward-looking statements. Although the Company believes its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, exchange rate fluctuations and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Main Risks and Uncertainties” of the Company’s 2019 Universal Registration Document filed with the AMF on 27 May 2020 under n° D.20-0503 and in Section 2 “Risk Factors” of the Company’s Amendment to the Universal Registration Document filed with the AMF on 22 December 2020 under n° D.20-0503-A01, which are available on the Company’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”) including the Company’s 2019 Annual Report on Form 20-F filed with the SEC on May 27, 2020. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods.  These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Naomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.com

PRESS RELATIONS | Media

Hélène LAVIN – Press relations | Tel: +333 2016 4000 | helene.lavin@genfit.com


 

1Excluding transaction-related costs

2Unaudited financial information under IFRS
3Revenues recognized under IFRS 15

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com        

 

Attachment

Grant of Restricted Stock Units to Management and Employees and Grant of Warrants to Employees in Genmab

Grant of Restricted Stock Units to Management and Employees and Grant of Warrants to Employees in Genmab




Grant of Restricted Stock Units to Management and Employees and Grant of Warrants to Employees in Genmab

Company Announcement

COPENHAGEN, Denmark; February 26, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the board decided to grant 123,949 restricted stock units to four members of management and employees of the company as well as the company’s subsidiaries and 99,938 warrants to employees of the company and the company’s subsidiaries.

Each restricted stock unit is awarded cost-free and provides the owner with a right and obligation to receive one share in Genmab A/S of nominally DKK 1. The vesting of the restricted stock units granted to the members of executive management will be subject to forward looking performance criteria. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,070.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Stock information > Restricted stock units.

The exercise price for each warrant is DKK 2,070. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 647.32.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Stock information > Warrants.

About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab’s proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

Contact:          
Marisol Peron, Senior Vice President, Global Investor Relations & Communications
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Senior Director, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.

Company Announcement no. 13
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

Attachment

Xtant Medical Comments on Trading Activity of its Stock

Xtant Medical Comments on Trading Activity of its Stock




Xtant Medical Comments on Trading Activity of its Stock

BELGRADE, Mont., Feb. 26, 2021 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT, the “Company”), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced that it is not aware of any material, undisclosed corporate developments or material change in its business or affairs that has not been publicly disclosed that would account for the recent increase in the market price or trading volume of its shares.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant’s people are dedicated and talented, operating with the highest integrity to serve our customers.

The symbols ™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Investor Relations Contact

David Carey
Lazar FINN
Ph: 212-867-1762
Email: david.carey@finnpartners.com

Pacific Biosciences of California, Inc. to Present at Upcoming Investor Conferences

Pacific Biosciences of California, Inc. to Present at Upcoming Investor Conferences




Pacific Biosciences of California, Inc. to Present at Upcoming Investor Conferences

MENLO PARK, Calif., Feb. 26, 2021 (GLOBE NEWSWIRE) — Pacific Biosciences of California, Inc. (NASDAQ: PACB) announced today that its executives will be speaking at the following investor conferences:

Cowen Annual Health Care Conference on Monday, March 1, 2021 at 1:20 p.m. EST

Barclays Global Healthcare Conference on Wednesday, March 10, 2021 at 2:25 p.m. EST

The live webcasts can be accessed at the company’s investors page at investor.pacificbiosciences.com. The replays will be available for at least 30 days following the presentation.

About Pacific Biosciences

Pacific Biosciences of California, Inc. (NASDAQ: PACB) is empowering life scientists with highly accurate long-read sequencing. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology. For more information please visit www.pacb.com and follow @PacBio.

Contacts

Investors:
Todd Friedman
650.521.8450
ir@pacificbiosciences.com

Orphazyme announces participation in upcoming virtual investor conferences

Orphazyme announces participation in upcoming virtual investor conferences




Orphazyme announces participation in upcoming virtual investor conferences

Orphazyme A/S
Investor news                                                                                                       

No. 04/2021                                                                                                           
Company Registration No. 32266355

Copenhagen, Denmark and Chicago, IL, February 26, 2021 – Orphazyme A/S (ORPHA.CO; ORPH) (“the Company”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative rare diseases, today announced that Anders Vadsholt, interim CEO and CFO of Orphazyme, will be participating in the following upcoming investor conferences:

  • Cowen Healthcare Conference, March 1-3, 2021:
    • Panel discussion moderated by Cowen analysts Phil Nadeau, Ritu Baral and Boris Peaker entitled “New Drug Launches Panel” on Wednesday, March 3, 2021 from 10:20-11:20 AM EST
       
  • Guggenheim Healthcare Talks, 2021 Genomic Medicines & Rare Diseases Conference, April 1, 2021:
    • Orphazyme will participate in 1x1s and small group meetings with investors

A live webcast of the panel will be available on the Orphazyme global website under the Investor Relations section.


For additional information, please contact
Orphazyme A/S

Anders Vadsholt, Interim CEO and CFO                               +45 28 98 90 55


About Orphazyme A/S 
Orphazyme is a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative rare diseases. The company is harnessing amplification of Heat-Shock Proteins (or HSPs) in order to develop and commercialize novel therapeutics for diseases caused by protein misfolding, protein aggregation, and lysosomal dysfunction, including lysosomal storage diseases and neuromuscular degenerative diseases. Arimoclomol, the company’s lead candidate, is in clinical development for four orphan diseases: Niemann-Pick disease Type C (NPC), Amyotrophic Lateral Sclerosis (ALS), sporadic Inclusion Body Myositis (sIBM) and Gaucher disease. Orphazyme is headquartered in Denmark and has operations in the U.S. and Switzerland. Orphazyme’s shares are listed on Nasdaq U.S. (ORPH) and Nasdaq Copenhagen (ORPHA). 

About arimoclomol 
Arimoclomol is an investigational drug candidate that amplifies the production of Heat-Shock Proteins (HSPs). HSPs can rescue defective misfolded proteins, clear protein aggregates, and improve the function of lysosomes. Arimoclomol is administered orally and has now been studied in seven phase 1, four phase 2 and one pivotal phase 2/3 trial. Arimoclomol is in clinical development for NPC, Gaucher Disease, sIBM, and ALS. Arimoclomol has received orphan drug designation (ODD) for NPC, sIBM, and ALS in the US and EU. Arimoclomol has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for NPC, sIBM and ALS. In addition, arimoclomol has received breakthrough therapy designation (BTD) and rare-pediatric disease designation (RPDD) from the FDA for NPC.

Forward-looking statement 
This company announcement may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this company announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.  

Attachment

Adial Receives $1.425 Million in Net Proceeds from Exercise of Warrants

Adial Receives $1.425 Million in Net Proceeds from Exercise of Warrants




Adial Receives $1.425 Million in Net Proceeds from Exercise of Warrants

CHARLOTTESVILLE, Va., Feb. 26, 2021 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced the exercise of 712,500 warrants from its June 2020 financing for net proceeds to the company of $1,425,000.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity, and the Company develops adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.

About the Landmark ONWARD™ Pivotal Phase 3 Clinical Trial

The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.

Forward Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to enroll patients within the timelines anticipated and complete clinical trials on time and achieve desired results and benefits as expected, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:
Crescendo Communications, LLC
David Waldman / Natalya Rudman
Tel: 212-671-1021
Email: adil@crescendo-ir.com

UPDATE — Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Planned Completion and Emergency Use Authorization Request

UPDATE — Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Planned Completion and Emergency Use Authorization Request




UPDATE — Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Planned Completion and Emergency Use Authorization Request

TORONTO, Feb. 26, 2021 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.

With its recent $23 million dollar financing, the Company plans to aggressively expand from 14 clinical sites to up to 50 clinical sites to meet the next enrollment goals for the Study in Q2-2021. The Study is a randomized, double-blinded, placebo-controlled trial and the safety and efficacy data analyzed at each interim analysis timepoint of 210, 400, 600 and 800 completed patients are only made available to the Independent Data and Safety Monitoring Board (“DSMB”) for review and recommendations on continuation, stopping or changes to the conduct of the Study. In the event of any serious safety concerns, the DSMB would be notified to determine any risks and provide its recommendations. To date, in this initial 210 interim point there have been no serious safety concerns that required the DSMB to be notified.

Further to the DSMB review and recommendations on each interim analysis periods, the Company aims to approach the FDA to obtain agreement on filing an Emergency Use Authorization (“EUA”) for Bucillamine to treat mild to moderate COVID-19.

“With our funding completed we are adding more clinical sites to meet our enrollment goals and be in a position to meet with the FDA to determine the best path forward for EUA approval,” said Michael Frank, CEO of Revive. “We are committed to achieving our mission in making Bucillamine the first orally administered drug to obtain FDA approval and EUA to treat mild to moderate COVID-19.”

About the Phase 3 Clinical Trial (ClinicalTrials.gov Identifier: NCT04504734)

The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized to either Bucillamine or placebo for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID-19 between patients receiving standard-of-care plus Bucillamine and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Genetic Technologies Limited Interview to Air on Bloomberg TV in the US on the RedChip Money Report®

Genetic Technologies Limited Interview to Air on Bloomberg TV in the US on the RedChip Money Report®




Genetic Technologies Limited Interview to Air on Bloomberg TV in the US on the RedChip Money Report®

MELBOURNE, Australia, Feb. 26, 2021 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) (the “Company”), a leader in the development of genetic risk assessment tests, today announced an interview with Dr. George Muchnicki, Chief Medical Officer and Executive Director, will air on The RedChip Money Report® on Bloomberg TV in the US on Saturday, February 27, at 7 p.m. local time in 73M homes across the United States. The RedChip Money Report® also airs on Bloomberg International in Europe in 100M homes at 6 pm local time on Sundays.

In the exclusive interview, Dr. Muchnicki discusses the Company’s cancer predictive testing and assessment tools to help physicians proactively manage patient health. Also discussed is the global market opportunity, upcoming predictive testing milestones and the capacity for Covid-19 (SDR) serious disease risk testing and the company’s developing pipeline of risk assessment products including guideline driven reimbursable Germline panel testing for cancers, heart disease and metabolic diseases such as Type 2 Diabetes.

To view the interview segment, please visit: https://youtu.be/D7Rk9ezrWGM

“The RedChip Money Report” delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG offers, and soon to be released Cardiovascular and Metabolic predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer for non-hereditary breast cancer and GeneType for non-hereditary Colorectal Cancers are clinically validated risk assessment tests and are first in class.

Genetic Technologies has capacity for Covid-19 testing and is growing its pipeline of risk assessment and stratification products.

For more information, please visit www.gtglabs.com

Forward-Looking Statements
This press release may contain forward-looking statements about the Company’s expectations, beliefs or intentions regarding, among other things, statements regarding the expected use of proceeds. In addition, from time to time, the Company or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by the Company with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of the Company’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause the Company’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause the Company’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements as detailed in the Company’s filings with the Securities and Exchange Commission and in its periodic filings in Australia and the risks and risk factors included therein. In addition, the Company operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. The Company does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations and Media (US)
Dave Gentry, CEO
RedChip Companies
Office: 1 800 RED CHIP (733 2447)
Cell: US 407 491 4498
dave@redchip.com