SCYNEXIS, Inc.

16 October 2024 Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials 26 March 2025 assigned as action date for FDA decision Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs). The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. Over half of all women are affected by uUTIs in their lifetime1, with approximately 30% suffering from recurrent disease which can cause significant patient burden, including discomfort and restriction of daily activities.2 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.3 Gepotidacin is a late-stage antibiotic in GSK’s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years. The NDA is supported by positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95% CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI (-3.6, 12.1)). The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the maximum severity were mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (gepotidacin and nitrofurantoin) across the two trials. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III programme The global phase III clinical programme for gepotidacin in adults and adolescents consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and adolescents with uncomplicated urinary tract infections, respectively. Across both trials, the duration of follow-up for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. About gepotidacin Gepotidacin, discovered by GSK scientists, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhoea phase III clinical trials, including those with drug-resistant pathogens. Due to the well-balanced inhibition, gepotidacin target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin. Therefore, leading to a lower potential for resistance development. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. GSK’s expertise and capabilities in innovation, access and stewardship position the Company uniquely to help prevent and mitigate the challenge of antimicrobial resistance. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like

JERSEY CITY, N.J., Oct. 10, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced David Angulo, M.D., President and Chief Executive Officer, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, at 11:30 A.M. ET. Maxim Healthcare Virtual Summit Details: Format:Fireside chatDate:Thursday, October 17, 2024Time:11:30 A.M. ETLocation:Virtual To sign up to view the presentation, click here. 1x1 investor meetings will be available after the event upon request through the following link or by contacting your Maxim representative. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps”. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com. CONTACT: Investor RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

10 October 2024 60 abstracts to be presented across broad and growing portfolio of vaccines and medicines aimed at getting ahead of infectious disease New data to be shared on GSK’s RSV vaccine across different age groups of patients at increased risk Efficacy data for gepotidacin in patients with a high unmet need suffering from uUTIs to be shared against a backdrop of rising antimicrobial resistance New evidence to be shared on real-world impact of ViiV Healthcare’s innovative, long-acting HIV prevention and treatment portfolio GSK plc (LSE/NYSE: GSK) and ViiV Healthcare will share new data from their industry-leading, prevention-focused infectious disease pipeline and portfolio at the Infectious Disease Society of America’s IDWeek 2024 annual meeting in Los Angeles from 16-19 October 2024. 60 abstracts will be presented, showcasing data for vaccines and medicines across a range of infectious diseases including respiratory syncytial virus (RSV), herpes zoster, uncomplicated urinary tract infections (uUTI) and HIV. Vaccines 22 abstracts from GSK’s vaccines pipeline and portfolio have been accepted, including new data for Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) and Shingrix (Zoster Vaccine Recombinant, Adjuvanted). Presentations on GSK’s RSV vaccine will include data across different age ranges in older adults and post-marketing safety data, plus 10 other abstracts featuring evidence across comorbidities of interest, seasons and geographies. Additional presentations include overviews of GSK's 5-in-1 meningococcal ABCWY vaccine candidate and the risks of invasive meningococcal disease in young children. Medicines Among the abstracts from GSK’s infectious disease therapeutics portfolio, 13 abstracts will highlight data for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for uUTI and urogenital gonorrhoea (GC). This includes an oral presentation of clinical data from the EAGLE-2 and EAGLE-3 phase III trials, examining the efficacy of gepotidacin in patient subgroups with uUTIs with a high unmet need in the context of rising antimicrobial resistance (AMR). Additional data on surveillance and the burden of AMR in uUTIs and treatment failure in uUTIs will also be highlighted. HIV prevention and treatments Additionally, ViiV Healthcare will present 22 abstracts from its innovative HIV treatment and prevention portfolio. Two oral presentations will share real-world evidence from the OPERA and TRIO studies, evaluating the effectiveness of, adherence to and persistence in the use of Apretude (cabotegravir long-acting (LA)) for HIV pre-exposure prophylaxis (PrEP) across diverse populations. Findings from the PILLAR study will highlight the impact of cabotegravir LA for PrEP on common challenges associated with daily oral PrEP, such as stigma and anxiety. Additional abstracts highlight ViiV’s industry-leading long-acting and two-drug regimens for the treatment of HIV including treatment benefits, satisfaction and preference, offering new insights for healthcare providers seeking to optimise care to suit individual needs and circumstances. Tony Wood, Chief Scientific Officer, GSK said: “Infectious diseases represent a major threat to human health, which is why two-thirds of our pipeline focuses on pioneering new technologies to deliver preventative options – like vaccines and HIV PrEP – plus therapeutic solutions. At IDWeek 2024, we’re proud to share data highlighting our scientific developments in the prevention and treatment of diseases like RSV, herpes zoster, uUTI and HIV, while also working to tackle the challenge of antimicrobial resistance.” For more than 70 years, GSK has been advancing a comprehensive portfolio of medicines and vaccines for infectious diseases. Considerable progress has been made, but there remains significant work to do to address the burden of infectious diseases on individuals, society and healthcare systems: More than one billion people are infected annually by seasonal respiratory viruses such as influenza and RSV.1,2 People living with certain underlying health conditions are at increased risk of hospitalisation or death due to RSV.3 About 40 million people live with HIV worldwide, many of whom still face stigma and do not have adequate access to care.4 AMR threatens to undermine the progress that has been made to date and prevent further gains. Without action, AMR could contribute to 40 million deaths by 2050.5 In support of its ambition to get ahead of disease, GSK continues to advance the science, pursuing new solutions while continuing to build the evidence base for its vaccines and treatments. With the breadth of data presented at IDWeek, GSK and ViiV Healthcare highlight their goal to pioneer a new range of first- or best-in-class options to close the gap in prevention and treatment for patients who deserve more. Full list of GSK and ViiV Healthcare’s presentations at IDWeek 2024: GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. With our infectious disease innovation, we’re also helping address the growing number of infections which are resistant to existing medicines. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE), dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like