Tick-Borne Diseases

Reimbursements deferred by 18 months to start in January 2026 instead of July 2024 Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed to extend the interest-only period of its existing loan by eighteen months. Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024. Maturity of this first tranche will remain in the first quarter of 2027. The terms of the second $100 million tranche remain unchanged. Peter Bühler, Chief Financial Officer of Valneva, said, “We greatly appreciate the continued support from Deerfield and OrbiMed. This extension further strengthens our cash position and contributes to our runway towards expected sustained profitability on the back of a successful commercial launch of the Lyme program. The original loan agreement was signed in February 20201. Valneva announced amendments to the terms in January 20212 and upsizing in April 20223 and August 20234. About DeerfieldDeerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. The Firm works across the healthcare ecosystem to connect people, capital, ideas and technology in bold, collaborative and inclusive ways. About OrbiMedOrbiMed is a leading healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, through private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to expected cash position, including as a result of other potential business developments, including results of ongoing clinical trials, the timing and possible occurrence of further or initial regulatory approvals of its product candidates, the anticipated size of markets for its approved products and sales of those products, receipt of funding from external sources, supply of products sold by Valneva, and relationships with current business partners. 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 indicative of future results. 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 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. These risks and uncertainties include those developed or identified in any public documents filed with the French financial markets authority (Autorité des marchés financiers) and the U.S. Securities and Exchange Commission made or to be made by Valneva. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines (including in relation to organic or strategic expansion of Valneva’s clinical pipeline), unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis and other global economic or political events, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, the impact of a pandemic, and changes in the regulatory environment in which Valneva operates. The occurrence of any of these risks and uncertainties could substantially harm Valneva’s business, financial condition, prospects and results of operations. 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 this press release as of the date hereof and disclaims 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 Valneva Announces New $85 Million Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed2 Valneva Announces Amendment to Deerfield and OrbiMed Debt Facility Terms3 Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed4 Valneva Provides Updated 2023 Financial Guidance - Valneva Attachment 2024_03_18_VLA_D&O_PR_EN_Final

26 submissions selected from a total of 281 applications from 47 countries to diagnose infectious and vector-borne diseases Awardees representing 12 countries in Europe, the Americas, Asia and Africa, will receive research grants of up to USD 600,000 per project As part of the Seegene's technology-sharing initiative, SG OneSystem Business™ aims to promote participation from the global scientific community, laying the groundwork to 'realize a world free from all diseases' SEOUL, South Korea, March 15, 2024 /PRNewswire/ -- Seegene Inc. (KQ096530), a leading South Korean company providing a total solution for PCR molecular diagnostics, and Springer Nature, a world-leading provider of services to the research community, unveiled the final list of participants for the diagnostic reagent development project on March 15, 2024(GMT), through the online platform of the Open Innovation Program (). Continue Reading Seegene and Springer Nature Announce Awardees for the Open Innovation Program In September 2023, Seegene and Springer Nature opened applications to scientists and experts across the global community to conduct research for the 15 designated projects to develop Seegene's syndromic qPCR diagnostics assay reagents for the Open Innovation Program. During the initial stage of document screening, a total of 281 applications were submitted from 47 different countries, demonstrating worldwide interest in the program. Two rounds of evaluations, which included document assessment and on-site evaluations specific to each country were conducted. Following the rigorous assessment process, a total of 26 applications were selected. The total number of selected awardees is 17, including those who applied for more than one project. Selected designated projects and the final number of awardees are as follows: Urinary Tract Infection (UTI): 3 projects, 9 awardees Dermatophyte: 1 project, 3 awardees Sexually Transmitted Infections (STI): 1 project, 2 awardees Vaginitis Screening: 1 project, 1 awardee Respiratory Panel (viral and bacterial respiratory infections): 2 projects, 2 awardees Nontuberculous Mycobacteria Typing: 1 project, 2 awardees Tick-borne Diseases: 1 project, 1 awardee Tropical Fever Virus (mosquito-borne tropical fever viruses): 1 project, 2 awardees Methicillin-resistant Staphylococcus aureus (MRSA): 1 project, 3 awardees Multidrug-resistant Organisms: 1 project, 1 awardee The Open Innovation Program resulted in awardees from a total of 12 countries with the following distribution: Belgium (3), the Netherlands (1), Germany (2), Italy (3), Portugal (1), Canada (3), the United States (3), Mexico (2), Argentina (1), UAE (3), South Korea (3), and Kenya (1). (Figures in parenthesis denote the number of projects selected) The awardees will receive research grants of up to USD 600,000 per project. Furthermore, Seegene will provide syndromic qPCR reagents, extraction reagents, development system (SGDDS), test instrument (AIOS), and related software free of charge throughout the collaboration period. Developing products that encapsulate the knowledge and experience of scientists from around the globe is essential to achieve the overarching vision: 'A World Free from All Diseases.' The inaugural Open Innovation Program marks the initial step in this endeavor. "Attracting numerous exceptional applicants from diverse backgrounds, the evaluations present an invaluable opportunity to cultivate a robust global network of clinical trial collaborations." said Dr. Jik Young Park, Head of Seegene's Development Automation. Dr. Park served as a member of the panel responsible for reviewing the submitted applications. The Open Innovation Program forms an integral part of Seegene's broader technology-sharing initiative, the SG OneSystem Business™ which debuted in 2023 and aligns with the company's vision of realizing a "world free from all diseases." The SG OneSystem Business™ involves the dissemination of Seegene's extensive expertise and knowledge accumulated over 20 years. The initiative includes collaborating with representative institutions from each country, to effectively develop diagnostic products tailored to meet the needs of the local market. In pursuit of this vision, Seegene has further bolstered its SG OneSystem Business™ through the strategic collaboration with Microsoft in January 2024, marking a significant milestone in its commitment to advancing global healthcare solutions. Seegene's Digitalized Development System (SGDDS), which enables less experienced researchers to develop assays, will integrate Microsoft Azure services, including Azure OpenAI Service. About Seegene Seegene has 23 years of dedicated R&D, manufacturing and business experience around syndromic quantitative PCR technologies, which was highlighted during the COVID-19 pandemic when it provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene's unique syndromic PCR technologies is the ability to simultaneously test 14 pathogens that cause similar symptoms in a single tube and provide quantitative information on the infectivity profile to correlate with the severity of illness. SOURCE Seegene Inc.

WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ: SXTP, SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame. The Company is continuing preparations for a June 1, 2024 start date as previously communicated. Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less frequent dosing for prophylaxis for malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. ARAKODA® (tafenoquine) Important Safety Information ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Contraindications ARAKODA® should not be administered to: Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status. Lactating women who are breastfeeding when the infant is found to be G6PD deficient or if G6PD status is unknown. Patients with a history of psychotic disorders or current psychotic symptoms. Patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA®. Warnings and Precautions Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins. Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible. Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy. Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia and hypersensitivity reactions may be delayed in onset and/or duration. Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams and anxiety. Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1- 888-834-0225 or FDA at 1-800-FDA-1088 or . ARAKODA® full prescribing information is here. About 60 Degrees Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals achieved FDA approval of its lead product, ARAKODA® (tafenoquine) for malaria prevention, in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the United States Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at . Cautionary Note Regarding Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts: Sheila A. Burke SheilaBurke-consultant@60degreespharma.com (484) 667-6330 Investor Contact: Patrick Gaynes patrickgaynes@60degreespharma.com (310) 989-5666