Mycovia Pharmaceuticals, Inc. Announces Publication of Partner Jiangsu Hengrui Pharmaceuticals’ Phase 3 Clinical Study Evaluating the Efficacy and Safety of VIVJOA® (Oteseconazole) Versus Fluconazole in Women with Vulvovaginal Candidiasis (VVC) in the Journal Antimicrobial Agents and Chemotherapy

Mycovia Pharmaceu�cals, Inc. Announces Publica�on of Partner Jiangsu Hengrui Pharmaceu�cals’ Phase 3 Clinical Study Evalua�ng the Efficacy and Safety of VIVJOA® (Oteseconazole) Versus Fluconazole in Women with Vulvovaginal Candidiasis (VVC) in the Journal An�microbial Agents and Chemotherapy - VIVJOA demonstrated statistically significant and clinically meaningful superiority to fluconazole, the current standard-of-care, in treating women with severe VVC - Treatment-emergent adverse events were similar between patients treated either with VIVJOA or fluconazole Durham, N.C. – January 31, 2024 – Mycovia Pharmaceu�cals, Inc. (“Mycovia”), an emerging biopharmaceu�cal company, today announced that its partner Jiangsu Hengrui Pharmaceu�cals Co., Ltd (“Hengrui”) has published its phase 3 study evalua�ng the efficacy and safety of VIVJOA® (oteseconazole) capsules versus fluconazole in the treatment of severe vulvovaginal candidiasis (VVC) in Chinese women in the journal An�microbial Agents and Chemotherapy. The peer-reviewed ar�cle describes the results of a mul�-center, randomized, double-blinded, phase 3 study designed to evaluate efficacy and safety of VIVJOA as a two-day dosing regimen versus fluconazole in women with severe VVC. The authors concluded that VIVJOA was sta�s�cally superior to fluconazole in trea�ng severe VVC. At Day 28, 66.88% of pa�ents treated with VIVJOA had therapeu�c cure (absence of signs and symptoms of VVC and nega�ve culture of Candida species), compared to 45.91% of pa�ents treated with fluconazole (p = 0.0002). Mycological cure (nega�ve culture of Candida species) and clinical cure (absence of signs and symptoms of VVC) at Day 28 was higher in the pa�ents treated with VIVJOA compared to pa�ents treated with fluconazole (82.50% vs. 59.12%, p < 0.0001 and 71.25% vs. 55.97%, p = 0.0046, respec�vely). At Day 14, therapeu�c cure and mycological cure were superior for pa�ents treated with VIVJOA compared to those treated with fluconazole (52.50% vs. 38.36%, p = 0.0112 and 81.88% vs. 66.67%, p = 0.0019, respec�vely. The rates of pa�ents who had at least one treatment-emergent adverse event (TEAE) were similar in both groups (51.3% of pa�ents in the VIVJOA group and 42.9% of pa�ents in the fluconazole group). Of the pa�ents experiencing a TEAE, similar rates of treatment-related adverse events were reported (21.9% in the VIVJOA group and 19.9% in the fluconazole group). The most commonly reported TEAEs were urinary tract infection and bacterial vulvovaginitis. “These clinical data describe the first head-to-head study of VIVJOA versus fluconazole, considered to be the standard-of-care for trea�ng VVC for over 30 years. Following its recent approval in China , VIVJOA offers health care providers and their appropriate pa�ents with a novel, safe and efficacious oral treatment op�on,” said Stephen Brand PhD, Chief Development Officer at Mycovia. “ The results also expand on available clinical suscep�bility data by demonstra�ng potent MIC ac�vity of oteseconazole against wild- type and resistant Candida albicans isolates from this pa�ent popula�on, in addi�on to clinical isolates resistant to fluconazole, including Candida glabrata.” Vulvovaginal candidiasis is an exceedingly common mucosal infec�on usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts. Typical symptoms include vulvovaginal itching, irrita�on, burning, soreness, fissuring, redness, vaginal discharge, and dyspareunia. Approximately 70% to 75% of women in all strata of the society will experience at least one episode during their life�me. Oteseconazole is designed to selec�vely inhibit fungal CYP51, which is required for fungal cell wall integrity, and this interac�on is also toxic to fungi, resul�ng in the inhibi�on of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. In April 2022, the U.S. Food and Drug Administra�on (FDA) approved VIVJOA (oteseconazole) Capsules, as the first medica�on for Recurrent Vulvovaginal Candidiasis (chronic yeast infec�on). In June 2023, VIVJOA received approval in China from the Na�onal Medical Products Administra�on and is indicated for the treatment of severe VVC. About VIVJOA® VIVJOA® (oteseconazole) is an azole an�fungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproduc�ve poten�al. VIVJOA is the first FDA-approved medica�on that provides sustained efficacy demonstrated by significant long- term reduc�on of RVVC recurrence through 50 weeks versus comparators. Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selec�ve interac�on is also toxic to fungi, resul�ng in the inhibi�on of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. The FDA approved VIVJOA based upon the posi�ve results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 pa�ents at 232 sites across 11 countries. Please click here for full Prescribing Informa�on. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VIVJOA is contraindicated in females of reproduc�ve poten�al. Females who are NOT of reproduc�ve poten�al are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infer�lity (e.g., tubal liga�on, hysterectomy, salpingo-oophorectomy). VIVJOA is contraindicated in pregnant and lacta�ng women. VIVJOA is contraindicated in pa�ents with known hypersensi�vity to oteseconazole. WARNINGS AND PRECAUTIONS Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 �mes the half -life of oteseconazole) precludes adequate mi�ga�on of the embryofetal toxicity risks. Advise pa�ents that VIVJOA is contr aindicated in females of reproduc�ve poten�al, and in pregnant and lacta�ng women because of poten�al risks to a fetus or breas�ed infant. ADVERSE REACTIONS The most frequently reported adverse reac�ons among VIVJOA-treated pa�ents in clinical studies included headache (7.4%) and nausea (3.6%). DRUG INTERACTIONS VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvasta�n) may increase the exposure of BCRP substrates, which may increase the risk of adverse reac�ons associated with these drugs. Please see full Prescribing Information and Patient Information. To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceu�cals, Inc. at 1 -855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Mycovia Pharmaceu�cals, Inc. Mycovia Pharmaceu�cals, Inc. is an emerging biopharmaceu�cal company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. VIVJOA® (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole an�fungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproduc�ve poten�al. Oteseconazole received FDA Qualified Infec�ous Disease Product and Fast-Track designa�ons to become the first FDA -approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceu�cals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan. Mycovia also recognizes a tremendous poten�al for its oral fungal inhibitors and a growing need to treat a range of mul�-drug resistant fungal pathogens. For more informa�on, please visit www.mycovia.com. About Jiangsu Hengrui Pharmaceu�cals Co., Ltd. Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 21st among the top 1,000 global pharmaceutical companies in 2021. 1 Hengrui Pharma has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 2021.2 1. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf; page 49 and 56. 2. https://www.pharmexec.com/view/2022-pharm-exec-top-50-companies; page 24

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