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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in bluebird bio, Inc. of Class Action Lawsuit and Upcoming Deadline – BLUE

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against bluebird bio, Inc. (“bluebird” or the “Company”) (NASDAQ: BLUE) and certain of its officers.  The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 21-cv-00777, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired bluebird securities between May 11, 2020 and November 4, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased bluebird securities during the Class Period, you have until April 13, 2021 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

bluebird is a biotechnology company that engages in researching, developing, and commercializing transformative gene therapies for severe genetic diseases and cancer.  The Company’s gene therapy programs include, among others, LentiGlobin (bb1111) for the treatment of sickle cell disease (“SCD”).

In May 2020, in the midst of the COVID-19 pandemic, bluebird announced that the Company expected to submit a U.S. Biologics Licensing Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for LentiGlobin for SCD in the second half of 2021.

Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) data supporting bluebird’s BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability; (ii) Defendants downplayed the foreseeable impact of disruptions related to the COVID-19 pandemic on the Company’s BLA submission schedule for LentiGlobin for SCD, particularly with respect to manufacturing; (iii) as a result of all the foregoing, it was foreseeable that the Company would not submit the BLA for LentiGlobin for SCD in the second half of 2021; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On November 4, 2020, post-market, bluebird disclosed that it would no longer apply for FDA approval of its LentiGlobin product as a treatment for SCD in the second half of 2021 as expected.  Instead, citing “feedback” from the FDA requiring the Company to provide additional data “to demonstrate drug product comparability” for LentiGlobin for SCD, “alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts,” bluebird adjusted its submission timing to late 2022.

On this news, bluebird’s stock price fell $9.72 per share, or 16.6%, to close at $48.83 per share on November 5, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]  
888-476-6529 ext. 7980

Cision View original content:http://www.prnewswire.com/news-releases/shareholder-alert–pomerantz-law-firm-reminds-shareholders-with-losses-on-their-investment-in-bluebird-bio-inc-of-class-action-lawsuit-and-upcoming-deadline—blue-301262553.html

SOURCE Pomerantz LLP

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in EHang Holdings Limited of Class Action Lawsuit and Upcoming Deadline- EH

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against EHang Holdings Limited (“EHang” or the “Company”) (NASDAQ: EH) and certain of its officers.  The class action, filed in the United States District Court for the Central District of California, and docketed under 21-cv-01811, is on behalf of a class consisting of all investors who purchased or otherwise acquired EHang securities between December 12, 2019 and February 16, 2021, inclusive (the “Class Period”).  The action is brought on behalf of the class for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5.

If you are a shareholder who purchased EHang securities during the Class Period, you have until April 19, 2021 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.  To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

EHang purports to be an autonomous aerial vehicle (“AAV”) technology platform company.  The Company has stated that it is “pioneering the future of transportation through our proprietarily developed AAVs and related commercial solutions.  We believe we are the first in the world to launch passenger-grade AAVs, setting a new milestone in AAV technology.”  EHang’s purported flagship, passenger-grade AAV is the “EH216.”

In recent press releases and other public statements, Defendants have lauded EHang’s AAV business and prospects, including announcing numerous “flight certifications” and “long-term” approvals for its “passenger-grade” EH216 in the United States, Canada, and various European countries.  As alleged in the Complaint, Defendants have repeatedly asserted that EHang is “the world’s leading [AAV] technology platform company.”

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements, and failed to disclose material adverse facts about the Company’s business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and failed to disclose to investors that: (i) the Company’s purported regulatory approvals in Europe and North America for its EH216 were for use as a drone, and not for carrying passengers; (ii) EHang’s relationship with its purported primary customer is a sham; (iii) EHang has only collected on a fraction of its reported sales since its American depository shares (“ADSs”) began trading on the NASDAQ stock exchange in December 2019; (iv) the Company’s manufacturing facilities were practically empty and lacked evidence of advanced manufacturing equipment or employees; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.

During the trading day on February 16, 2021, analyst Wolfpack Research (“Wolfpack”) published a scathing report entitled “EHang: A Stock Promotion Destined to Crash and Burn.”  In this report, and as further alleged in the Complaint, Wolfpack wrote that EHang is “an elaborate stock promotion, built on largely fabricated revenues based on sham sales contracts with a customer [Shanghai Kunxiang Intelligent Technology Co., Ltd.] who appears to us to be more interested in helping inflate the value of its investment in EH[ang] . . . than about buying its products.”  Wolfpack wrote that it had “gathered extensive evidence” to support its report, “including behind-the-scenes photographs, recorded phone calls, and videos of on-site visits to EH[ang]’s various facilities.”  Wolfpack also noted that “in just 14 months as a publicly traded company, EH[ang]’s PR team has put out 50 press releases . . . . However, EH[ang]’s constant stream of press releases are easily proven untrue.”  Finally, Wolfpack wrote that it “obtained Chinese court records which show that EH[ang]’s [American Depository Receipts—i.e., ADSs] may already be in serious jeopardy due to legal issues in China.”

On this news, the price of EHang ADSs fell from their February 12, 2021 close of $124.09 per share to a February 16, 2021 close of $46.30 per share, a one day drop of $77.79 per share, or approximately 62.7%.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:

Robert S. Willoughby

Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

Cision View original content:http://www.prnewswire.com/news-releases/shareholder-alert–pomerantz-law-firm-reminds-shareholders-with-losses-on-their-investment-in-ehang-holdings-limited-of-class-action-lawsuit-and-upcoming-deadline-eh-301262546.html

SOURCE Pomerantz LLP

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Oxurion NV enters into a Capital Commitment of up to €30 Million with Negma Group

Leuven, BE, Boston, MA, US – April 6, 2021 – 7.30 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care back of the eye therapies, today announces that is has agreed to a capital commitment of up to €30 Million with Negma Group.

Negma Group is a Paris-based leading financial institution focused on supporting growth and capturing value through a multi-strategy approach.

Negma Group has committed to subscribe to up to €30 million in equity in tranches over a 12-month period through mandatory convertible bonds at Oxurion’s sole discretion.

Oxurion anticipates initial clinical data from its lead drug candidate THR-149 later this year. THR-149 is a plasma kallikrein inhibitor being developed as a potential new standard of care for diabetic macular edema (DME) patients, who respond sub-optimally to anti-VEGF therapy.  

Oxurion also expects to initiate a Phase 2 clinical trial with THR-687 in DME by mid-year. THR-687 is a pan-RGD integrin inhibitor that is being developed as a potential first line therapy for all DME patients. THR-687 also holds potential to deliver improved treatment outcomes for patients with wet Age-related Macular Degeneration (wet AMD) and Retinal Vein Occlusion (RVO).

Patrik De Haes, M.D., CEO of Oxurion, says: “I am happy that we have been able to agree on this flexible financing agreement, which is under our control and can be exercised at our discretion. Access to these funds will allow us to focus on progressing our two exciting novel and differentiated back of the eye drug candidates that are targeting potential market opportunities of over $12 billion, beyond key value inflection points in 2021 and 2022.”

“We are excited to collaborate with Oxurion. At Negma Group, we invest in people and have been very impressed by both the scientific rigor and clinical experience of the Oxurion team. We are proud to partner with this team while they advance two very distinct and innovative programs that have great potential to deliver much improved clinical outcomes to patients suffering from debilitating retinal vascular disorders such as DME, wet AMD and RVO”, says Sophie Villedieu, Equity Capital Market Associate of Negma Group.

END

For further information please contact:

Oxurion NV

Wouter Piepers,
Global Head of Investor Relations
& Corporate Communications
Tel: +32 478 33 56 32
[email protected]

 

Negma Group
Anthony de Rauville, CIO
Tel : +33 (0)6 48 10 16 41
[email protected]

 

Sophie Villedieu, ECM Associate
Tel: +33 (0)6 24 48 07 94
[email protected]

 

EU

Citigate Dewe Rogerson

David Dible/ Sylvie Berrebi/Frazer Hall
Tel: +44 20 7638 9571
[email protected]

 

US
Westwicke, an ICR Company
Christopher Brinzey
Tel: +1 617 835 9304
[email protected]


 

About Oxurion

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with Diabetic Macular Edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet Age-related Macular Degeneration (AMD) and Retinal Vein Occlusion (RVO).

Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

  • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 in DME-patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ: BCYC).
     
  • THR-687 is a pan-RGD integrin inhibitor that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, which is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV (Euronext & NASDAQ: GLPG), also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.

Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.  More information is available at www.oxurion.com.


Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

 



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OSE Immunotherapeutics Announces First Peer-Reviewed Publication in “Science Advances” on OSE-230, its Novel Monoclonal Antibody Agonist Therapy Triggering Resolution of Chronic Inflammation

NANTES, France, April 06, 2021 (GLOBE NEWSWIRE) — OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announced the first peer-reviewed publication on OSE-230, a novel and innovative approach in the management of the resolution of chronic and severe inflammation, in Science Advances.

The article, entitled: “Agonist anti-ChemR23 mAb reduces tissue neutrophil accumulation and triggers chronic inflammation resolution” (1) reports on the discovery and preclinical data for OSE-230, an innovative agonist antibody against ChemR23, also known as chemerin chemokine-like receptor 1 (CMKLR1), a G-protein coupled receptor (GPCR) expressed on myeloid immune cells known to modulate inflammation.

OSE Immunotherapeutics’ R&D team identified ChemR23 as a GPCR receptor of the resolution program overexpressed in the inflamed tissues of patients unresponsive to anti-TNFα or anti-α4β7 therapies with high unmet medical needs.

The preclinical results demonstrate that OSE-230 accelerates inflammation resolution and tissue hemostasis in severe inflammatory models. Most importantly, OSE-230 triggers pro-resolutive actions resulting in the resolution of chronic inflammation in models where such recovery is deficient or missing. The direct consequence of OSE-230 pro-resolutive actions is a marked reduction of fibrosis in inflamed tissues and a significant reduction in the development of inflammation-driven tumors.

Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, comments: “We are very pleased with this publication on OSE-230 in ‘Science Advances’, a journal of highest scientific level which recognizes the disruptive innovation of our research program. This is the first peer-reviewed publication to describe an agonist monoclonal antibody, which triggers pro-resolutive mechanisms in macrophages and neutrophils in chronic inflammatory condition. This breakthrough discovery opens the development pathway of OSE-230 in various chronic inflammations such as inflammatory bowel diseases, arthritis, type 1 diabetes, lung or kidney inflammatory diseases. We believe this discovery suggests OSE-230 could also be used as a treatment in severe COVID-19 patients where excessive inflammation has a key role in the physiopathology of the disease”.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, adds: “OSE-230 is an additional program that positions OSE as a true leader in innovation and discovery of new pathways. Based on the strong potential of OSE-230, we look forward to initiating an ambitious development plan to address the numerous patients’ need for disruptive innovations to manage complex inflammatory diseases.”

This research was the result of a productive collaboration between the OSE R&D team and scientific partners at Ambiotis, a French Contract Research Organization specialized in the active resolution of inflammation, MAbSilico, a deep technology innovative French TechBio specialized in Artificial Intelligence and the CRTI (Center for Research in Transplantation and Immunology, UMR1064, INSERM, Nantes University based at the University Hospital of Nantes).

(1)

Agonist anti-ChemR23 mAb reduces tissue neutrophil


1


accumulation and triggers chronic inflammation resolution


Trilleaud C., Gauttier V., Biteau K., Girault I., Belarif L., Mary C., Pengam S., Teppaz G., Thepenier V., Danger R., Robert-Siegwald G., Néel M., Bruneau S., Glemain A., Néel A., Poupon A., Mosnier JF., Chêne G., Dubourdeau M., Blancho G., Vanhove B., Poirier N.

ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Vaccine platform

  • Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure.
    In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR)
    In Phase 2 in ovary cancer (TEDOVA, sponsor ARCAGY-GINECO)
    Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.
  • CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results in August 2020. In clinical Phase 1.

Immuno-oncology platform

  • BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors.
  • CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.
  • BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.

Auto-immunity and inflammation platform

  • FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; ongoing Phase 1/2 in renal transplant, Phase 2-ready asset in a niche indication in autoimmune diseases.
  • OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2 planned in Sjögren’s syndrome (Servier sponsor).
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
    Due to the COVID-19 crisis, accrual of new patients in the clinical trial TEDOPaM is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127/S95011 could be impacted during the coming months.

For more information:

Click and follow us on Twitter and Linkedln
https://twitter.com/OSEIMMUNO
https://www.linkedin.com/company/10929673

Contacts  
OSE Immunotherapeutics

Sylvie Détry
[email protected]
+33 153 198 757		 U.S. Media: LifeSci Communications

Darren Opland, Ph.D.
[email protected]
+1 646 627 8387
   
French Media: FP2COM
Florence Portejoie
[email protected]
+33 607 768 283		 U.S. and European Investors
Chris Maggos
[email protected]
+41 79 367 6254

Forward-looking statements

This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.



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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in SOS Limited of Class Action Lawsuit and Upcoming Deadline – SOS

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against SOS Limited (“SOS” or the “Company”)  (NYSE: SOS), and certain of its officers.  The class action, filed in the United States (“U.S.”) District Court for the District of New Jersey, and docketed under 21-cv-07454, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired SOS American depository shares (“ADSs”) between July 22, 2020 and February 25, 2021, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission (“SEC”), against the Company and certain of its top officials.

If you are a shareholder who purchased SOS ADSs during the Class Period, you have until May 31, 2021 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

SOS is a technology company that purportedly provides marketing data, technology, and solutions for emergency rescue services.  When the Company went public in April 2017, it was known as “China Rapid Finance Limited” and claimed to focus on a peer-to-peer, micro-lending business.  The Company later changed its name to “SOS Limited” in July 2020 and sold its peer-to-peer, micro-lending business in August 2020, rebranding itself into an emergency services business.  In January 2021, the Company again shifted its business focus, this time to cryptocurrency mining.

Critical to SOS’s purportedly successful transition into a cryptocurrency mining business were the Company’s claims to have entered into an agreement with HY International Group New York Inc. (“HY”), which calls itself the “world’s largest mining machine matchmaker,” to acquire 15,645 mining rigs—i.e., personal computing machines built specifically for cryptocurrency mining—for $20 million, and the Company’s plans to purchase FXK Technology Corporation (“FXK”), a purported Canadian cryptocurrency technology firm.

In addition to rapidly changing its business focus, SOS has also rapidly changed the location of its headquarters.  According to the Company’s SEC filings, the address of the Company’s principal executive offices has changed no less than five times since the Company went public in April 2017.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) SOS had misrepresented the true nature, location, and/or existence of at least one of the principal executive offices listed in its SEC filings; (ii) HY and FXK were either undisclosed related parties and/or entities fabricated by the Company; (iii) the Company had misrepresented the type and/or existence of the mining rigs that it claimed to have purchased; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On February 26, 2021, Hindenburg Research (“Hindenburg”) and Culper Research (“Culper”) released commentary on SOS, claiming that the Company was an intricate “pump and dump” scheme that used fake addresses and doctored photos of crypto mining rigs to create an illusion of success.  The analysts noted, for example, that SOS’s SEC filings listed a hotel room as the Company’s headquarters.  The analysts also questioned whether SOS had actually purchased mining rigs that it claimed to own, as the entity from which SOS purportedly bought the mining rigs appeared to be a fake shell company.  The analysts further alleged that the photos SOS had published of their purported “mining rigs” were phony.  Culper noted that photographs of SOS’s “miners” did not depict the A10 Pro machines that the Company claimed to own and instead appeared to show different devices altogether.  Hindenburg, for its part, found that the original images from SOS’s website actually belonged to another company.

On this news, SOS’s American depositary share (“ADS”) price fell $1.27 per share, or 21.03%, to close at $4.77 per ADS on February 26, 2021.

After the end of the Class Period, between February 27 and March 3, 2021, Hindenburg subsequently provided additional information on SOS that further supported its earlier allegations, including pictures, highlighting, inter alia, how SOS had allegedly taken steps to hide the misconduct noted in the February 26, 2021 corrective disclosures.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

Contact:

Robert S. Willoughby

Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

Cision View original content:http://www.prnewswire.com/news-releases/shareholder-alert–pomerantz-law-firm-reminds-shareholders-with-losses-on-their-investment-in-sos-limited-of-class-action-lawsuit-and-upcoming-deadline–sos-301262554.html

SOURCE Pomerantz LLP

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their investment in Clover Health Investments, Corp. f/k/a Social Capital Hedosophia Holdings Corp. III of Class Action Lawsuit and Upcoming Deadline – CLOV; CLOVW; IPOC.U; IPOC; IPOC WS

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Clover Health Investments, Corp. f/k/a Social Capital Hedosophia Holdings Corp. III (“SCH”, “Clover”, or the “Company”) (NASDAQ: CLOV) (NASDAQ: CLOVW) (NYSE: IPOC.U) (NASDAQ: IPOC) (NASDQ: IPOC WS), and certain of its officers and directors. The class action, filed in the United States District Court for the Middle District of Tennessee, and docketed under 21-cv-00138, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Clover securities between October 6, 2020 and February 3, 2021, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Clover securities during the Class Period, you have until April 6, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

SCH was a publicly-traded blank check company, also known as a special purpose acquisition company (“SPAC”), formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses.

On October 6, 2020, SCH and a private health insurance company, Clover Health Investments, Corp. (“Legacy Clover”), issued a press release announcing their plan to bring Legacy Clover public via a merger between SCH and Legacy Clover (the “Business Combination”). That press release described Legacy Clover as “a next-generation Medicare Advantage insurance company offering best-in-class plans that combine wide access to healthcare and rich supplemental benefits with low out-of-pocket expenses[.]”

Legacy Clover’s (and following the Business Combination, Clover’s) flagship platform, the Clover Assistant, purportedly aggregates millions of relevant health data points—including claims, medical charts, and diagnostics—and uses machine learning to synthesize that data with member-specific information. This purportedly provides physicians with actionable and personalized insights at the point of care, offering suggestions for medications and dosages as well as the need for, among other things, tests or referrals, to ultimately improve health outcomes.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) SCH had performed inadequate due diligence into Legacy Clover prior to the Business Combination, or else ignored and/or failed to disclose multiple red flags concerning Legacy Clover’s business and operations; (ii) since before the Business Combination, Legacy Clover and/or Clover have been under active investigation by the U.S. Department of Justice (“DOJ”) for multiple issues ranging from kickbacks to marketing practices to undisclosed third-party deals; (iii) Legacy Clover’s and/or Clover’s sales were, and/or are, driven in large part by an undisclosed related party deal, misleading marketing targeting the elderly, and other illicit practices; (iv) Defendants overstated the capabilities of the Company’s technology; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On February 4, 2021, Hindenburg Research (“Hindenburg”) issued a report on Clover entitled “Clover Health: How the ‘King of SPACs’ Lured Retail Investors Into a Broken Business Facing an Active, Undisclosed DOJ Investigation.” Citing “more than a dozen interviews with former employees, competitors, and industry experts, dozens of calls to doctor’s offices, and a review of thousands of pages of government reports, insurance filings, regulatory filings, and company marketing materials,” Hindenburg claimed that “Clover Health and its Wall Street celebrity promoter, Chamath Palihapitiya, misled investors about critical aspects of Clover’s business in the run-up to the company’s SPAC go-public transaction last month.” 

Specifically, the Hindenburg report concluded, among other things, that the Company and Clover Assistant “are under active investigation by the [DOJ]” for “at least 12 issues ranging from kickbacks to marketing practices to undisclosed third-party deals”; that “Clover’s sales are driven by a major undisclosed related party deal and misleading marketing targeting the elderly”; that “Clover’s software is primarily a tool to help the company increase coding reimbursement”; that doctors at key Clover providers view Clover Assistant as “embarrassingly rudimentary”, “a waste of . . . time”, and just another administrative hassle to deal with; and that Clover pays physicians “$200 per visit to use the software, twice the normal reimbursement rate for a Medicare visit.”

On this news, Clover’s stock price fell $1.72 per share, or 12.33%, to close at $12.23 per share on February 4, 2021, representing a loss of approximately $700 million in market capitalization. Moreover, shares traded as low as $11.86 per share intraday on February 4, 2021.  Additionally, Clover warrants fell $0.18 per warrant, or 5.04%, to close at $3.39 per warrant on February 4, 2021.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:

Robert S. Willoughby

Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

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SOURCE Pomerantz LLP

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Kadmon Holdings, Inc., of Class Action Lawsuit and Upcoming Deadline – KDMN

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. (“Kadmon” or the “Company”) (NASDAQ: KDMN) and certain of its officers.  The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 21-cv-01797, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired  Kadmon securities between October 1, 2020 and March 10, 2021, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Kadmon securities during the Class Period, you have until June 2, 2021 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Kadmon is a biopharmaceutical company that discovers, develops, and commercializes small molecules and biologics primarily for the treatment of inflammatory and fibrotic diseases.  The Company’s lead product candidates include, among others, belumosudil (KD025), an orally administered selective inhibitor of the rho-associated coiled-coil kinase 2 (“ROCK2”), which is in Phase II clinical development for the treatment of chronic graft-versus-host disease (“cGVHD”).

On September 30, 2020, post-market, Kadmon announced the submission of a New Drug Application (“NDA”) for belumosudil for the treatment of cGVHD (the “Belumosudil NDA”) with the U.S. Food and Drug Administration (“FDA”).

Then, on November 30, 2020, Kadmon announced the FDA’s acceptance of the Belumosudil NDA, and that the FDA had assigned the NDA a Prescription Drug User Fee Act (“PDUFA”) target action date of May 30, 2021.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Belumosudil NDA was incomplete and/or deficient; (ii) the additional new data that the Company submitted in support of the Belumosudil NDA in response to an information request from the FDA materially altered the NDA submission; (iii) accordingly, the initial Belumosudil NDA submission lacked the degree of support that the Company had led investors to believe; (iv) accordingly, the FDA was likely to extend the PDUFA target action date to review the Belumosudil NDA; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On March 10, 2021, Kadmon issued a press release “announc[ing] that the [FDA] has extended the review period” for the Belumosudil NDA and that, “[i]n a notice received from the FDA on March 9, 2021, the Company was informed that the [PDUFA] goal date for its Priority Review of belumosudil has been extended to August 30, 2021.”  Kadmon advised investors that “[t]he FDA extended the PDUFA date to allow time to review additional information submitted by Kadmon in response to a recent FDA information request,” and that “[t]he submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA date by three months.”

On this news, Kadmon’s stock price fell $0.52 per share, or 10.57%, to close at $4.40 per share on March 11, 2021.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]  
888-476-6529 ext. 7980

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SOURCE Pomerantz LLP

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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors Amdocs Limited – DOX

PR Newswire

NEW YORK, April 6, 2021 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of Amdocs Limited (“Amdocs” or the “Company”) (NASDAQ: DOX). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Amdocs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

[Click here for information about joining the class action] 

On March 31, 2021, pre-market, Jehoshaphat Research published a short-seller report addressing Amdocs, which alleged, among other things, that: (1) Amdocs overstated its profits, evidenced by steady parent profits despite declining subsidiary profits; (2) there was a concerning pattern of reputable auditors resigning, only to be replaced by “scandal-plagued or tiny shops”; (3) Amdocs “window-dressed” its balance sheets to keep its large borrowing a secret; and (4) all of the foregoing was corroborated by former employees and direct competitors of the Company, including a former American Amdocs executive, who stated that the Company’s “US business was declining at a rate of [around] 7% annually . . . but then we would see the company [publish results that] say North America is stable.” On this news, Amdocs’ stock price fell sharply during intraday trading on March 31, 2021.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:

Robert S. Willoughby

Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

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SOURCE Pomerantz LLP

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NeuroRx Announces Zyesami™ (Aviptadil) Has Been Selected for Inclusion in NIH-Sponsored Global Clinical Trial to Include Aviptadil and Remdesivir

PR Newswire

RADNOR, Pa., April 6, 2021 /PRNewswire/ — NeuroRx, Inc. reports today that Aviptadil, to be supplied by NeuroRx, has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in a phase III multicenter clinical trial that will include the United States and multiple foreign countries. Aviptadil is being developed by NeuroRx as ZYESAMI™ in collaboration with Relief Therapeutics Holding, AG (SIX: RLF, OTCQB: RLFTF). The trial, designated as TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), is funded by the US Government COVID-19 Therapeutics Response and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The TESICO protocol has been reviewed and approved as a phase III trial by the US Food and Drug Administration and will randomly allocate 640 participants to Aviptadil, Remdesivir, the combination of both drugs and placebo. Remdesivir is currently marketed as Veklury© by Gilead Sciences (Nasdaq: GILD). The primary endpoint of the trial will be participant recovery from respiratory failure over 90 days. Additional information will be supplied by the NIH when the trial randomizes its first patients.

About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on Aviptadil, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division.  NeuroRx recently announced a plan to complete a business combination with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) (“BRPA”), and intends to apply for listing on the NASDAQ under the proposed symbol “NRXP”.


Cautionary Note Regarding Forward Looking Statements

Statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or NeuroRx’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern NeuroRx’s expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other things, the outcome of any discussions or applications for the future use of ZYESAMI, the approvals, timing, and ability to complete the proposed business combination with BRPA, and the combined company’s ability to continue listing on Nasdaq after closing the proposed business combination. Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties. NeuroRx does not undertake any obligation to update forward-looking statements as a result of new information, future events or developments or otherwise.


Additional Information and Where to Find It

This press release relates to a proposed business combination and related transactions (the “Transactions”) between NeuroRx and BRPA. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. BRPA has filed a registration statement on Form S-4 (“Registration Statement”), which includes a preliminary proxy statement for the solicitation of the approval of BRPA’s stockholders, a preliminary prospectus for the offer and sale of BRPA’s securities in the Transactions and a preliminary consent solicitation statement of NeuroRx, and other relevant documents with the SEC. The proxy statement/prospectus/consent solicitation statement will be mailed to stockholders of NeuroRx and BRPA as of a record date to be established for voting on the proposed business combination. INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Investors and security holders will be able to obtain free copies of the registration statement, proxy statement, prospectus and other documents containing important information about NeuroRx and BRPA once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, copies of the documents filed with the SEC by BRPA can be obtained free of charge on BRPA’s website at www.bigrockpartners.com or by directing a written request to BRPA at 2645 N. Federal Highway, Suite 230 Delray Beach, FL 33483.


Participants in the Solicitation

NeuroRx, BRPA and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of BRPA’s stockholders in connection with the proposed Transactions. Investors and securityholders may obtain more detailed information regarding the names and interests in the proposed Transactions of NeuroRx’s and BRPA’s respective directors and officers in BRPA’s filings with the SEC, including the proxy statement/consent solicitation statement/prospectus statement. You may obtain a free copy of these documents as described in the preceding paragraph.

CORPORATE CONTACT

Jonathan C. Javitt, M.D., MPH
Chairman & Chief Executive Officer
[email protected]   

INVESTOR RELATIONS

Ryan Sheffield

[email protected]

(484) 254-6134, ext. 723

MEDIA RELATIONS

Greg Parasmo

[email protected]

(484) 254-6134, ext. 724

 

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SOURCE NeuroRx

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Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001


 

  • VLA2001 was well tolerated with no safety concerns identified
     
  • In the high dose group :
     
    • IgG seroconversion rate of 100%
       
    • Neutralizing antibody titres at or above levels generally seen in convalescent sera.

Saint-Herblain (France), April 6, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

In study VLA2001-201, three dose levels of VLA2001 (low, medium, high), based on a schedule of two doses with vaccinations three weeks apart, were evaluated in 153 healthy adults aged 18 to 55 years.

VLA2001 was generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board. There were no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity. The majority of Adverse Events (AEs) were mild or moderate and only two subjects reported severe solicited AEs (headache and fatigue). All solicited AEs were transient. Only 17.6% of unsolicited AEs up to day 36 were considered related to the vaccine and no severe unsolicited AEs were reported. No serious related AEs were reported.

VLA2001 was highly immunogenic with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. Seroconversion Rates (SCR) for S-protein binding IgG antibodies were 89.8% in the medium dose and 100% in the high dose group. Two weeks after completion of the two dose schedule, Geometric Mean Fold Rise (GMFR) from baseline were 26 in the medium dose and 86 in the high dose group.

Of note, the IgG antibody response was highly correlated with neutralization titres in a micro-neutralization assay (MNA50) (r=0.79, p<0.001).

VLA2001 induced a dose dependent response with statistically significant higher Geometric Mean Titres (GMTs) for both IgG and neutralizing antibodies in the high dose group compared to the low and medium dose groups. In the high dose group, the GMT of neutralizing antibody titres measured two weeks after completion of the two-dose schedule was at or above levels for a panel of convalescent sera (GMT 530.4 (95% CI: 421.49, 667.52)).

With a GMT ratio of vaccine vs. convalescent sera ≥ 1, vaccine efficacy has been reported above 80% for other vaccines1.

VLA2001 induced broad T-cell responses across participants with antigen-specific IFN-gamma producing T-cells against the S-protein, M and N protein detected in 75.6 %, 35.6% and 48.9% of study participants, respectively.

Thomas Lingelbach, Chief Executive Officer of Valneva, said: “We are extremely pleased with these results which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19. The world needs multiple vaccines as well as booster options. Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process. I want to thank everyone involved in the ongoing work. We could not have achieved this milestone without them.”

Health and Social Care Secretary, Matt Hancock said: “The U.K. government has funded these clinical trials and it is fantastic to see Valneva’s vaccine produces a strong immune response. This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved will play an important role in protecting our communities. I look forward to seeing the results of the upcoming phase 3 trial.”

Vaccines Minister Nadhim Zahawi said:  “These results are very promising and provide renewed hope that a vaccine using a whole inactivated virus might provide strong protection against variants. If the results from the phase 3 clinical trials are positive and the vaccine meets the robust standards of safety, quality and effectiveness of our medicines regulator, the MHRA, this will be another powerful weapon in our arsenal to beat this pandemic. The government has funded the clinical trials for this promising vaccine and, if approved, it will be manufactured in Scotland, boosting the UK’s ability to become more self-sufficient in the future.”

Clive Dix, Chair of the Vaccines Taskforce said: “These are great results from Valneva, particularly around the antibody and cellular responses generated and low numbers of adverse events, as these indicate good levels of immune responses among the participants to date. The findings of 100% levels of immunogenicity against the viral spike protein in the high-dose group is also encouraging. Inactivated virus vaccines are proven technologies that are often able to induce wide-ranging immune responses, and these promising data indicate that VLA2001 may continue this trend. We are hopeful of seeing good results from the upcoming Phase 3 trials, and look forward to continuing working closely with Valneva on their vaccine.”

Based on the data assessed, the Company has decided to advance the high dose into the Phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

The Company continues to work closely with the UK Government to review plans including potential variant vaccine development and supply as well as meeting the UK’s booster campaign requirements acknowledging the ongoing vaccine roll out in the UK. As a result, Valneva now believes that the timeline for delivery of 60 million doses of vaccine to the UK Government will extend into the first quarter of 2022. Based on the Phase 1/2 data, the Company is also investigating antigen sparing options for booster strategies. Overall capacity and delivery schedule will be dependent on the UK’s vaccine requirements and production related factors.

Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial by the end of April 2021 with the aim of making a regulatory licensure submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in the autumn 2021. Discussions with other regulatory bodies are ongoing.

In parallel, Valneva has initiated the development of new variant based viral seed banks.

About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally2. It has been declared a pandemic by the World Health Organization (WHO).

About VLA2001-201

VLA2001-201 is a randomized, dose-finding study to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001, against COVID-19 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years have been recruited in the study. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).
This report is independent research paid for by the Department of Health and Social Care. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health and Social Care.

About VLA2001

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX),  is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

About Valneva SE

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

 

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
Director Investor Relations & Corporate Communications
M +33 (0)6 4516 7099
[email protected]

 

           

 

 

  

  
Dan Sharp
Government & Public Affairs Manager
T +44-(0)7436-244309
[email protected]
         

 

 

Valneva Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, timing and volume expectations with respect to the manufacture of our product candidates; the ability to market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

1
Earle et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.17.20200246); Khoury et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.09.21252641)

2


https://www.worldometers.info/coronavirus/

 

 

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