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Excellent progress on late-stage scientific packages

Lyme Disease Vaccine Candidate VLA15

Phase 3 research initiated in August 20221Further optimistic Phase 2 outcomes reported, together with first pediatric data2

Single-Shot Chikungunya Vaccine Candidate VLA1553

Initiation of rolling submission for Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) imminentFinal optimistic pivotal Phase 3 outcomes reported3Final optimistic lot-to-lot consistency Phase 3 outcomes reported4

Four advertising authorizations granted for inactivated COVID-19 vaccine

First Standard Marketing Authorization granted in Europe by the European Medicines Agency (EMA)5Conditional Marketing Authorization granted within the United Kingdom (UK) by the Medicines and Healthcare merchandise Regulatory Agency (MHRA)6 and Emergency Use Authorizations granted within the Kingdom of Bahrain7 and the United Arab Emirates (UAE)8

H1 income and money

Total income of €93.2 million within the first half of 2022 in comparison with €47.5 million within the first half of 2021 Includes product gross sales of €33.3 million (vs €31.8 million within the first half of 2021) with first COVID-19 vaccine gross sales of €3.8 million€59.9 million of different revenues (vs €15.7 million within the first half of 2021) Cash place of €336.2 million as of June 30, 2022 Includes €90.5 ($95) million of proceeds from Pfizer’s funding in Valneva through an fairness subscription agreement9

Updated FY 2022 Financial Guidance

Valneva expects whole revenues to succeed in €340 million to €360 million in 2022 noting the continued restoration of journey vaccine gross sales, the income recognition linked to the EC and UK provide contracts and the lately revised Advance Purchase Agreement (APA) with the European Commission for the Company’s COVID-19 vaccine.Product gross sales of the Company’s journey vaccine franchise are anticipated to succeed in €70 million to €80 million whereas COVID-19 product gross sales are anticipated to succeed in €30 million to €40 million. Other Revenues are anticipated to succeed in roughly €240 million and might be primarily COVID-19 associated. Other non-COVID-19 associated revenues might be unfavorable in 2022 because of the elevated refund legal responsibility linked to the modification of the VLA15 collaboration and license settlement with Pfizer. COVID-19 associated Other Revenues could have no money influence in 2022 and relate to revenues acknowledged in relation to the UK and EC Advance Purchase Agreements.Valneva expects R&D bills of €120 million to €135 million in 2022. The Company will proceed investing in progressing its two main, late-stage investigational vaccines towards Lyme illness and chikungunya within the second half of 2022. Valneva will put money into additional improvement of its present or any potential second-generation COVID-19 vaccine provided that it receives the required funding or commitments to such funding through the third quarter of 2022. The Company additionally stays dedicated to additional increasing its R&D pipeline, together with via the development of a number of the Company´s pre-clinical candidates in direction of scientific entry.

Financial Information
(unaudited outcomes, consolidated per IFRS)

€ in million6 months ending June 30 20222021Total revenues93.247.5Product sales33.331.8Net loss (171.5) (86.4)Adjusted EBITDA loss (136.0) (80.1)Cash (at finish of interval) 336.2 346.7

Saint-Herblain (France), August 11, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine firm, at this time reported consolidated monetary outcomes for the primary half of the yr, ended June 30, 2022. The half yr monetary report, together with the condensed consolidated interim monetary report and the half yr administration report, is accessible on the Company’s web site (Financial Reports – Valneva).

Valneva will present a dwell webcast of its half yr monetary outcomes convention name starting at
3 p.m. CEST or 9 a.m. EDT at this time. This webcast may also be out there on the Company’s web site. Please seek advice from this hyperlink: https://edge.media-server.com/mmc/p/gpxqaier

Thomas Lingelbach, Valneva’s Chief Executive Officer, commented, “Valneva continued to attain vital R&D milestones within the first half of the yr. Our up to date Lyme illness collaboration settlement with Pfizer included a considerable fairness funding which we see as a powerful signal of confidence and recognition of our vaccine experience, and the current Phase 3 initiation brings us a step nearer to a possible vaccine answer towards Lyme illness. Our chikungunya vaccine program efficiently met all Phase 3 scientific endpoints, readying us for BLA submission. Our COVID-19 vaccine grew to become the primary to obtain full advertising authorization in Europe, and we stay up for delivering the primary doses in Europe within the coming weeks. However, given the revised quantity of orders from the EU Member States, we’re evaluating how one can re-shape our operations. Looking at our different business merchandise, we’re seeing a quicker restoration than anticipated within the journey vaccine market and demand could even exceed our present provide capability within the later a part of the yr. I wish to take this chance to thank our shareholders, companions and workers for his or her ongoing help and contribution.”

Clinical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE – VLA15
Phase 3 research initiated

Valneva and Pfizer are growing VLA15, a Lyme illness vaccine candidate that targets the outer floor protein A (OspA) of Borrelia burgdorferi, the micro organism that trigger Lyme illness. The vaccine candidate covers the six OspA serotypes expressed by Borrelia burgdorferi sensu lato species which can be prevalent in North America and Europe.

In August 2022, Valneva and Pfizer introduced the initiation of a Phase 3 scientific research, “Vaccine Against Lyme for Outdoor Recreationists (VALOR)” (NCT NCT05477524), to research the efficacy, security and immunogenicity of VLA15 in roughly 6,000 individuals 5 years of age and older in extremely endemic areas within the United States and Europe. As per the phrases of the collaboration settlement between the 2 corporations, Valneva will obtain a $25 million milestone cost from Pfizer inside 60 days following initiation of the Phase 3 research.

Pending profitable Phase 3 completion, Pfizer may probably submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2025.

Valneva and Pfizer entered right into a collaboration settlement in April 2020 to co-develop VLA1510. In June 2022, the phrases of this collaboration had been up to date, and Pfizer invested €90.5 ($95) million in Valneva as a part of an Equity Subscription Agreement11. If accredited, Pfizer will commercialize VLA15 and Valneva might be eligible to obtain substantial milestone and royalty funds.

CHIKUNGUNYA VACCINE CANDIDATE – VLA1553
Initiation of BLA rolling submission with U.S. FDA imminent

VLA1553 is a live-attenuated, single-dose vaccine candidate towards the chikungunya virus, a mosquito-borne virus that has unfold to greater than 100 nations with the potential to quickly increase additional. There are presently no preventive vaccines or efficient remedies for the chikungunya virus out there and VLA1553 is presently the one chikungunya vaccine candidate that efficiently accomplished major evaluation in a pivotal Phase 3 research.

Valneva reported last pivotal Phase 3 knowledge in March 202212 and last lot-to-lot consistency leads to May 202213, enabling BLA submission with the FDA. Valneva expects initiation of the rolling submission for approval of VLA1553 in individuals aged 18 years and above imminently. This rolling BLA submission might be a part of the accelerated approval pathway agreed upon with the FDA in 202014.

Valneva is presently focusing on the top of 2022 for completion of the BLA submission. Once all parts of the applying have been submitted and if the FDA has accepted the submitting, the FDA will decide precedence assessment eligibility and the motion date upon which the FDA will full its analysis. The program acquired FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was additionally granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva presently plans to make regulatory submissions for VLA1553 in Europe within the first half of 2023.  

A scientific trial of VLA1553 in adolescents is presently ongoing in Brazil15, which can help future regulatory submissions and label extensions following a possible preliminary regulatory approval in adults within the US. Conducted by Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the trial can be anticipated to help licensure of the vaccine in Brazil, which might be the primary potential approval to be used in an endemic area.

Pre-Clinical Vaccine Candidates

The Company plans to advance analysis and improvement actions relating to 2 of its pre-clinical property, VLA1554 and VLA2112. VLA1554 is a vaccine candidate focusing on the human metapneumovirus (hMPV), which is a serious worldwide respiratory pathogen that causes acute higher and decrease respiratory tract an infection in kids and can be a typical explanation for morbidity and mortality in immunocompromised sufferers and older adults. VLA1554 is presently in pre-clinical proof of idea research. VLA2112 is a vaccine candidate focusing on the Epstein-Barr virus, which is without doubt one of the commonest human viruses and may trigger infectious mononucleosis and different diseases. VLA2112 is presently in a late-stage analysis part.

Marketed Vaccines

JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®)
IXIARO® is the one Japanese encephalitis vaccine licensed and out there within the U.S., Canada and Europe.

In the primary half of 2022, IXIARO®/JESPECT® gross sales had been €12.3 million in comparison with €25.4 million within the first half of 2021, because of the deliberate supply schedule to the U.S. Department of Defense. This lower was partly offset by the non-public journey markets, which confirmed vital restoration with IXIARO®/JESPECT® gross sales reaching €11.3 million within the first half of 2022 in comparison with €3.1 million within the first half of 2021.

CHOLERA / ETEC16-DIARRHEA VACCINE (DUKORAL®)

DUKORAL® is an oral vaccine for the prevention of diarrhea attributable to Vibrio cholerae and/or heat-labile toxin producing ETEC17, the main explanation for vacationers’ diarrhea. DUKORAL® is permitted to be used within the European Union and Australia to guard towards cholera, and in Canada, Switzerland, New Zealand and Thailand to guard towards cholera and ETEC.

In the primary half of 2022, DUKORAL® gross sales elevated to €5.8 million in comparison with €0.4 million within the first half of 2021, additionally benefitting from the numerous restoration within the non-public journey markets.

SARS-CoV-2 INACTIVATED WHOLE-VIRUS VACCINE

Valneva’s COVID-19 vaccine is the one inactivated whole-virus COVID-19 vaccine to obtain advertising authorization in Europe18 and the one COVID-19 vaccine to obtain a full advertising authorization in Europe. It is produced utilizing Valneva’s established Vero-cell platform, leveraging the manufacturing know-how for the Company’s business Japanese encephalitis vaccine, IXIARO®.

During the primary half of the yr, Valneva’s COVID-19 vaccine was additionally granted conditional advertising authorization within the United Kingdom19 and emergency use authorization within the United Arab Emirates20 and Kingdom of Bahrain21. The vaccine generated gross sales of €3.8 million through the first six months of 2022.

In July 2022, Valneva introduced an modification to the APA it signed with the EC in November 202122. The amended APA contains orders of 1.25 million doses of the vaccine, with the choice to buy an equal amount later this yr for supply in 2022. This modification adopted remediation discussions based mostly on the EC’s discover of intent23 to terminate the preliminary APA for doses in 2022 and optionally available doses for 2023.

First vaccine doses are presently anticipated to be delivered to collaborating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in August 2022. Valneva will retain stock for potential extra provide to those EU Member States ought to demand enhance and, in parallel, Valneva will proceed discussions on potential extra provide and financing agreements with varied different governments around the globe. Valneva will intention to deploy roughly eight to 10 million doses of remaining stock into worldwide markets. Given that the vaccine’s shelf life is anticipated to be progressively prolonged from the present 15 months to a minimum of 24 months over time, the Company will search to deploy its stock doses within the subsequent six to 12 months.

In mild of the lowered order quantity from EU Member States, Valneva has suspended manufacturing of the vaccine and acknowledged write-downs of €100.6 million as of June 30, 2022 referring to current stock acquired to provide and provide volumes beneath the unique EC APA. Valneva can be evaluating its COVID-19 program and related actions and can re-shape its operations accordingly. In addition, Valneva and IDT Biologika (IDT) are discussing potential methods of terminating their drug substance manufacturing settlement in mild of the suspended manufacturing of Valneva’s COVID-19 vaccine. Valneva will proceed sure ongoing scientific trials, specifically on the potential use of the vaccine as a booster. Valneva will put money into additional improvement of the vaccine or second-generation COVID-19 vaccine candidate provided that it receives the required funding or commitments to such funding through the third quarter of 2022.

THIRD-PARTY DISTRIBUTION
Valneva distributes sure third-party vaccines in nations the place it operates its personal advertising and gross sales infrastructure. In June 2020, the Company entered right into a distribution settlement with Bavarian Nordic, pursuant to which it agreed to commercialize Bavarian Nordic’s marketed vaccines for rabies (Rabipur®/RabAvert®) and tick-borne encephalitis, leveraging its business infrastructure in Canada, the United Kingdom, France and Austria.

In the primary half of 2022, third social gathering product gross sales elevated by 93.5% to €11.5 million from €5.9 million within the first half of 2021.

First Half 2022 Financial Review24
(Unaudited, consolidated beneath IFRS)

Revenues

Valneva’s whole revenues had been €93.2 million within the first half of 2022 in comparison with €47.5 million within the first half of 2021, a rise of 96.3%.

Product gross sales, together with COVID-19 vaccine gross sales, elevated by 5.0% to €33.3 million within the first half of 2022 in comparison with €31.8 million within the first half of 2021. Foreign forex fluctuations contributed positively to €2.6 million of the change in product gross sales. Product gross sales from our business merchandise amounted to €29.5 million within the first half of 2022, a lower of seven.0% in comparison with the primary half of 2021. Product gross sales associated to COVID-19 amounted to €3.8 million.

IXIARO®/JESPECT® gross sales decreased by 51.7% to €12.3 million within the first half of 2022 in comparison with €25.4 million within the first half of 2021, primarily because of the deliberate supply schedule to the DoD through the interval. Foreign forex fluctuations contributed positively to €2.4 million of the change in IXIARO® product gross sales. This was partly offset by the non-public journey markets, which confirmed vital restoration with IXIARO®/JESPECT® gross sales reaching €11.3 million within the first half of 2022 in comparison with €3.1 million within the first half of 2021. DUKORAL® additionally benefited from this restoration as gross sales elevated considerably to €5.8 million within the first half of 2022 in comparison with €0.4 million within the first half of 2021. COVID-19 vaccine gross sales amounted to €3.8 million ensuing from shipments of the vaccine to Bahrain. Third Party product gross sales elevated by 93.5% to €11.5 million within the first half of 2022 from €5.9 million within the first half of 2021, pushed by progress associated to Valneva’s distribution settlement with Bavarian Nordic for the gross sales of Rabipur®/RabAvert® and Encepur®.

Other revenues, together with revenues from collaborations, licensing and providers, amounted to €59.9 million within the first half of 2022 in comparison with €15.7 million within the first half of 2021. This enhance is attributable to €89.4 million launched from the refund legal responsibility because of the settlement with the UK authorities achieved within the second quarter of 2022, partially offset by €36.1 million of unfavorable income ensuing from a rise within the refund legal responsibility linked to the modification to the VLA15 collaboration and license settlement with Pfizer.

Operating Result and adjusted EBITDA

Costs of products and providers offered (COGS) had been €171.5 million within the first half of 2022. The gross margin on business product gross sales amounted to 58.3% in comparison with 39.2% within the first half of 2021. COGS of €3.6 million had been associated to IXIARO® product gross sales, yielding a product gross margin of 70.4%. COGS of €1.3 million had been associated to DUKORAL® product gross sales, yielding a product gross margin of 77.8%, which was positively impacted by provision releases ensuing from lowered expiry dangers on stock. Of the remaining COGS within the first half of 2022, €7.4 million had been associated to the Third Party merchandise distribution enterprise, €154.9 million to the COVID-19 vaccine enterprise and €4.3 million to value of providers. COGS of the COVID-19 vaccine program included results from the numerous discount of gross sales volumes to EC Member States. In the primary half of 2021, general COGS had been €34.8 million, of which €23.5 million associated to value of products and €11.3 million associated to value of providers.

Research and improvement bills amounted to €51.9 million within the first half of 2022, in comparison with €78.7 million within the first half of 2021. This lower was primarily pushed by decrease scientific trials prices for Valneva’s chikungunya and COVID-19 vaccine program as these superior in direction of licensure. Marketing and distribution bills within the first half of 2022 amounted to €7.8 million in comparison with €9.6 million within the first half of 2021. Marketing and distribution bills within the first half of 2022 notably included €2.2 million of bills associated to the launch preparation prices for Valneva’s chikungunya vaccine candidate, VLA1553, in comparison with €2.0 million within the first half of 2021. In the primary half of 2022, normal and administrative bills declined to €16.0 million from €20.9 million within the first half of 2021. COGS, analysis and improvement, advertising and distribution in addition to normal and administrative bills benefited from a non-cash accrual adjustment to revenue of €17.8 million associated to the optimistic impact of the Company’s share value improvement on the worker share-based compensation packages. This revenue compares to a price of €7.3 million within the first half of 2021.

Other revenue, internet of different bills, lowered to €3.6 million within the first half of 2022 from €10.4 million within the first half of 2021. This lower was primarily pushed by lowered R&D tax credit instantly ensuing from decrease R&D spending and a rise of bills associated to the supply for the continuing merger litigation proceedings.

Valneva recorded an working lack of €150.4 million within the first half of 2022 in comparison with €86.2 million within the first half of 2021, of which the COVID-19 working loss represented €110.7 million and €55.5 million as of June 30, 2022 and 2021 respectively and the opposite segments represented €39.7 million within the first half of 2022 in comparison with €30.7 million within the first half of 2021. Adjusted EBITDA (as outlined under) loss within the first half of 2022 was €136.0 million in comparison with an adjusted EBITDA lack of €80.1 million within the first half of 2021.

Net Result

In the primary half of 2022, Valneva generated a internet lack of €171.5 million in comparison with a internet lack of €86.4 million within the first half of 2021.

Finance expense and forex results within the first half of 2022 resulted in a internet finance expense of €18.8 million, in comparison with a internet finance revenue of €0.5 million within the first half of 2021. This was primarily a results of a international trade loss amounting to €10.7 million within the first half of 2022, primarily pushed by revaluation outcomes of non-Euro denominated steadiness sheet positions, in comparison with a internet international trade acquire of €8.7 million within the first half of 2021. Interest bills internet of curiosity revenue had been €8.2 million within the first half of 2022 in comparison with €8.2 million within the first half of 2021.
        
Cash Flow and Liquidity

Net money utilized in working actions amounted to €100.2 million within the first half of 2022 in comparison with €84.2 million of money generated by working actions within the first half of 2021. Cash outflows within the first half of 2022 had been primarily associated to the working loss generated within the interval, whereas through the first half of 2021 money inflows primarily resulted from pre-payments acquired associated to the vaccine provide settlement signed with the UK authorities.

Cash outflows from investing actions amounted to €16.0 million within the first half of 2022 in comparison with €39.9 million within the first half of 2021, each primarily a results of COVID-19-related building actions throughout manufacturing websites in Scotland and Sweden, in addition to gear purchases.

Net money generated from financing actions amounted to €105.0 million within the first half of 2022, which was primarily a results of proceeds from the fairness subscription settlement with Pfizer in addition to disbursements from the credit score facility supplied by Deerfield & Orbimed. Cash inflows within the first half of 2021 amounted to €78.7 million which was primarily a results of proceeds from issuance of latest shares within the U.S. preliminary public providing and European non-public placement (Global Offering).

Cash and money equivalents decreased to €336.2 million as of June 30, 2022, in comparison with €346.7 million as of December 31, 2021. The money lower primarily resulted from ongoing COVID-19-related investments into mounted property and R&D bills.

Non-IFRS Financial Measures

Management makes use of and presents IFRS outcomes, in addition to the non-IFRS measure of Adjusted EBITDA to guage and talk its efficiency. While non-IFRS measures shouldn’t be construed as alternate options to IFRS measures, administration believes non-IFRS measures are helpful to additional perceive Valneva’s present efficiency, efficiency developments, and monetary situation.

Adjusted EBITDA is a typical supplemental measure of efficiency utilized by buyers and monetary analysts. Management believes this measure gives extra analytical instruments. Adjusted EBITDA is outlined as earnings (loss) for the interval earlier than revenue tax, finance revenue/expense, international trade acquire/(loss), outcomes from investments in associates, amortization, depreciation, and impairment.

A reconciliation of Adjusted EBITDA to internet loss for the interval, which is essentially the most instantly comparable IFRS measure, is ready forth under:

€ in million6 months ending June 30(unaudited outcomes, consolidated per IFRS)20222021Loss for the interval(171.5)(86.4)Add:  Income tax expense2.30.7Total Finance revenue(0.0)(0.2)Total Finance expense8.28.4Foreign trade acquire/(loss) – net10.7(8.7)Result from investments in associates(0.0)0.1Amortization3.53.1Depreciation7.73.0Impairment3.3-Adjusted EBITDA(136.0)(80.1)

About Valneva SE        
Valneva is a specialty vaccine firm centered on the event, manufacturing and commercialization of prophylactic vaccines for infectious illnesses with vital unmet medical want. The Company takes a extremely specialised and focused strategy to vaccine improvement after which applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these illnesses. Valneva has leveraged its experience and capabilities each to efficiently commercialize two vaccines and to quickly advance a broad vary of vaccine candidates into and thru the clinic, together with candidates towards Lyme illness, the chikungunya virus and COVID-19, which was accredited by the EMA and MHRA through the second quarter of 2022.

 

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
buyers@valneva.com
        

 

 

Joshua Drumm, Ph.D.
VP, Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com

 

 

        

 

 

Forward-Looking Statements
This press launch accommodates sure forward-looking statements referring to the enterprise of Valneva, together with however not restricted to statements relating to anticipated whole revenues and R&D spending for full fiscal yr 2022, product gross sales, doable regulatory approvals of product candidates, the re-shaping of the Company’s operations, and initiation of scientific trials. In addition, even when the precise outcomes or improvement of Valneva are according to the forward-looking statements contained on this press launch, these outcomes or developments of Valneva might not be indicative of future outcomes. In some circumstances, you possibly can establish forward-looking statements by phrases similar to “may,” “ought to,” “could,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “goals,” “targets,” or related phrases. These forward-looking statements are based mostly on the present expectations of Valneva as of the date of this press launch and are topic to a variety of identified and unknown dangers and uncertainties and different elements that will trigger precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievement expressed or implied by these forward-looking statements. In specific, the expectations of Valneva could possibly be affected by, amongst different issues, uncertainties concerned within the improvement and manufacture of vaccines, sudden scientific trial outcomes, regulatory actions or delays, competitors normally, forex fluctuations, the influence of the worldwide and European credit score disaster, the flexibility to acquire or preserve patent or different proprietary mental property safety, the cancellation of current contracts, and the influence of the COVID-19 pandemic, the incidence of any of which may considerably hurt Valneva’s enterprise, monetary situation, prospects and outcomes of operations. In mild of those dangers and uncertainties, there might be no assurance that the forward-looking statements made throughout this presentation will in reality be realized. Valneva is offering the knowledge on this press launch as of the date hereof and disclaims any intention or obligation to publicly replace or revise any forward-looking statements, whether or not because of new data, future occasions, or in any other case.

1 Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15
2 Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate – Valneva
3 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva
4 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
5 Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001
6 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine – Valneva
7 Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001 – Valneva
8Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine
9 Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
10 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15
11 Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
12 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva
13 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
14 Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage for Phase 3 Study
15 Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
16 Indications differ by nation – Please seek advice from Product / Prescribing Information (PI) / Medication Guide accredited in your respective nations for full data, incl. dosing, security and age teams wherein this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.
17 Enterotoxigenic Escherichia coli (ETEC) is a sort of Escherichia coli and one of many main bacterial causes of diarrhea within the growing world,[1] in addition to the commonest explanation for vacationers’ diarrhea.
18 Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001
19 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine – Valneva
20 Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine
21 Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001 – Valneva
22 Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001
23 Valneva Receives Notice of European Commission’s Intent to Terminate COVID-19 Vaccine Purchase Agreement – Valneva
24 Further particulars in regards to the outcomes offered under can be found within the Company’s half yr report

2022_08_11_VLA_HY_2022_PR_EN_Final

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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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