Gram-Negative Bacterial Infections

SAN DIEGO, March 19, 2024 /PRNewswire/ -- Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing medicines targeting metalloenzymes, announced today that it will present a talk and poster highlighting its novel chemistry technology platform for metalloenzyme inhibitors of LpxC for the treatment of infections caused by multidrug-resistant Gram-negative bacteria at the New Antibacterial Discovery and Development Gordon Research Conference (GRC): Innovative Approaches in Antibacterial Research and Development to Fight the Antibiotic Resistance Crisis being held March 17-22, 2024, in Ventura, CA. "We are looking forward to attending the GRC and presenting an overview of Blacksmith's discovery platform along with a progress update on our novel class small-molecule antibacterial targeting LpxC," said Andrew Tomaras, Ph.D., Senior Vice President of Blacksmith. "Our lead candidate, currently undergoing IND-enabling studies, has demonstrated activity against susceptible and multidrug-resistant Gram-negative organisms included on the WHO and CDC bacterial threat lists, and is currently being pursued using both IV and oral routes of administration for indications such as UTI." Talk Presentation Details: Title: "Anti-Infective Candidates with Novel Targets Using the Blacksmith Discovery Platform" Category: Discovery Pipelines, Hits, Leads and Candidates Date and Time: Tuesday, March 19 at 11:05am – 11:25am Pacific Poster Presentation Details: Title: "Advanced preclinical in vitro and in vivo characterization of a novel, non-hydroxamate-based LpxC inhibitor for the intravenous and oral treatment of multidrug-resistant Enterobacterales" Date and Time: Thursday, March 21 at 4:00pm – 6:00pm Pacific Poster Board Number: 13 More information can be found on the meeting website at 2024 New Antibacterial Discovery and Development GRC and, following the presentation, a version of the poster will be made available on the Blacksmith Medicines website About LpxC LpxC, a zinc hydrolase, is an attractive and highly sought-after antibiotic target – it is conserved across Gram-negative bacteria and not found in Gram-positive bacteria or human cells. Inhibiting LpxC results in potent killing of Gram-negative bacteria with the benefit of sparing Gram-positive bacteria such as those residing in the protective microbiome of the gut which help to deter opportunistic C. difficile infections. Other LpxC inhibitors have been evaluated by biopharma in the past but chemistry limitations (e.g. hydroxamic acid) have yielded ineffective compounds that suffer from poor drug-like properties. Thus, there are no approved therapeutics targeting LpxC. Blacksmith, using its proprietary chemistry platform, has developed novel non-hydroxamate inhibitors of LpxC that are safe and effective in animal models of Gram-negative infection and are able to kill Gram-negative 'superbugs' where other antibiotics are ineffective. About metalloenzymes and the Blacksmith platform Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following: A large proprietary fragment library of metal-binding pharmacophores (MBPs); A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease; A first-of-its-kind metallo-CRISPR library of custom single guide RNAs; An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines. About Blacksmith Medicines At Blacksmith Medicines, we are developing medicines targeting metal-dependent enzymes. Over 30% of known enzymes are metalloenzymes, covering all major enzyme classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Metal ions, including magnesium, zinc, iron, manganese and copper, are the essential ingredient in these metalloenzymes. We recognized a large unmet need for new chemical matter and innovative approaches to drug this important class of enzymes. Our purpose-built platform for metalloenzyme-targeted medicines combines, for the first time in industry, a focused library of metal-binding pharmacophores with proprietary computational modeling approaches to rapidly and rationally design small molecule inhibitors that interact with key metal ions in the enzyme's active site. Our comprehensive knowledge of the metal environment and key active site interactions enables Blacksmith to rapidly build potent and selective inhibitors in a stepwise and predictable manner. Blacksmith has executed strategic drug discovery collaborations with Basilea Pharmaceutica International Ltd., Cyteir Therapeutics Inc., Eli Lilly and Company (Lilly), Hoffmann-La Roche Ltd., and Zoetis LLC., and has been awarded non-dilutive Federal funding agreements with CARB-X and NIH/NIAID. Blacksmith investors include Lilly, Evotec A.G., MP Healthcare Partners, MagnaSci Ventures, and Alexandria Venture Investments. For further information, please visit the company's website and LinkedIn. Media Contact: Amy Conrad Juniper Point [email protected] 858-366-3243 SOURCE Blacksmith Medicines

The collaboration exemplifies DDF's commitment to advancing gastrointestinal cancer research and treatment options for patients. FORT LAUDERDALE, Fla., March 19, 2024 /PRNewswire/ -- Debbie's Dream Foundation: Curing Stomach Cancer (DDF) announces an unprecedented collaboration with Memorial Sloan Kettering Cancer Center (MSK) that marks a significant leap forward in the field of gastric cancer research. Through the visionary efforts and support of DDF, a research fellowship grant has been established at MSK under the guidance of Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology Service at MSK. The "Debbie's Dream Foundation Gastric Cancer Investigator" fellowship will focus on patient care, research, and education specifically for esophageal and gastric cancers. The collaboration is a testament to the shared commitment of DDF and MSK to fueling groundbreaking research and providing top-notch cancer care. Continue Reading Debbie's Dream Foundation: Curing Stomach Cancer Dr. Yelena Janjigian, a distinguished member of DDF's Scientific Medical Advisory Board, emphasized the importance of the DDF and MSK's partnership in shaping the future of gastric cancer research. "This fellowship signifies a commitment to excellence in gastroesophageal cancer research. With the support of DDF, we can provide dedicated time and resources to focus on advancing translational studies. This collaboration is pivotal in our collective efforts to better understand and treat esophageal and gastric cancers." Andrea Eidelman, Chief Executive Officer of DDF, expressed her pride in continuing to fund research that propels the organization's mission forward. "At DDF, we are deeply committed to advancing the landscape of gastric cancer research. This partnership with MSK is a significant step towards realizing our vision of a world without stomach cancer. Through the 'Debbie's Dream Foundation Gastric Cancer Investigator fellowship, we aim to make impactful strides in biomarker development, laboratory research, and translational studies in gastroesophageal cancer." DDF plans to contribute nearly $600,000 to fund this initiative over a three-year period, reinforcing the commitment to long-term support for innovative research. MSK will provide regular progress reports, ensuring transparency and accountability throughout the fellowship. Upon completion of the funding, MSK will recognize DDF for its invaluable contribution to advancing cancer research and patient care. Since 2014, DDF, in partnership with the American Association for Cancer Research (AACR), has invested $1.45 million in research grants to pioneering scientists in the United States. The 2023 AACR-Debbie's Dream Foundation Innovation and Discovery Grant recipients include Drs. Eunyoung Choi, Brent Allen Hanks, and Ryan H. Moy are exploring new targets and biomarkers for gastric cancer. Highlighting a significant milestone, DDF also celebrated Dr. Valerie O'Brien's recent discovery, funded by the 2018 Debbie's Dream Foundation-AACR Fellowship, of a precancerous cell type linked to H. pylori infection, offering new insights and therapeutic directions for gastric cancer. For more information about DDF programs and initiatives, please visit . About Debbie's Dream Foundation: Curing Stomach Cancer DDF is a 501(c)(3) non-profit organization dedicated to raising awareness about gastric cancer, advancing research funding, and providing international education and support to patients, families, and caregivers. DDF's ultimate goal is to make the cure for stomach cancer a reality. DDF was founded in 2009 by Debbie Zelman after she was diagnosed with stage IV incurable gastric cancer in 2008 and given only weeks to live. Debbie is considered a pioneer by many for bringing awareness to the plight of stomach cancer patients worldwide, as well as to the lack of federal funding for stomach cancer research. She did all of this while receiving hundreds of rounds of chemo and daily oral treatments. Debbie passed away on December 23, 2017, at 50, almost a decade later. As a result of her leadership, DDF now has a Scientific and Medical Advisory Board of world-renowned doctors and chapters throughout Canada and Germany. DDF strives to continue Debbie's mission to make her dream a reality. To learn more, visit . Media Contact Brittnay Starks, Communications Director Debbie's Dream Foundation: Curing Stomach Cancer (954) 475-1200 [email protected] SOURCE Debbie's Dream Foundation: Curing Stomach Cancer

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