Anidulafungin

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups. The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, "We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.” She added, "Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses." Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma. About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . About Melinta Therapeutics, LLC Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit .

SCY-247’s IND-enabling activities continue to progress, with initiation of Phase I anticipated in the second half of 2024 Clinical study reports for the FURI, CARES and NATURE trials in refractory invasive fungal infections remain on track for delivery to GSK in mid 2024, which would trigger a $10 million development milestone payment to SCYNEXIS SCYNEXIS ended Q1 2024 with cash, cash equivalents and investments of $94.2 million and projects a cash runway of more than two years JERSEY CITY, N.J., May 08, 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 reported financial results for the first quarter ended March 31, 2024. “We continue to be impressed by the highly promising preclinical results of our next generation compound SCY-247,” said David Angulo, M.D., President and Chief Executive Officer. “SCY-247 consistently demonstrates potent activity against a broad range of invasive fungal pathogens, including resistant species for whom there are few or no treatment options. We plan to begin a Phase I trial by year-end. In response to the hold on clinical studies of ibrexafungerp due to possible beta-lactam cross contamination, we have entered into certain new manufacturing agreements with third-party contract manufacturers to begin producing new batches of ibrexafungerp. We believe this new material will allow us to lift the clinical hold and restart the Phase 3 MARIO study evaluating ibrexafungerp in patients with invasive candidiasis." SCY-247 Preclinical Development Program Phase I-enabling development activities for SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, continue to progress. A portion of these activities, including assessing SCY-247 efficacy against Candida auris and Mucorales, are being supported by National Institute of Health (NIH) grants. Phase I initiation is anticipated in the second half of 2024. Presented preclinical efficacy data on SCY-247 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global, formerly ECCMID) in Barcelona, Spain from April 27-30, 2024. An oral presentation presented by Nathan Wiederhold, Ph.D. featured an in vivo study that demonstrated significant fungal burden reduction in the kidneys and lungs of mice with Candida glabrata invasive candidiasis treated with SCY-247. Additional poster presentations highlighted potent in vitro activity of SCY-247 on a broad range of susceptible and multidrug-resistant pathogenic fungi. Ibrexafungerp Clinical and Regulatory Updates Final study reports from the completed FURI, CARES, NATURE, SCYNERGIA, and VANQUISH studies are anticipated to be delivered to partner GSK in mid 2024, delivery of the first three of which would trigger a $10 million development milestone payment to SCYNEXIS. Data analysis for the FURI study is ongoing, and top line data from the CARES study are positive and consistent with previously disclosed results from interim analyses. First Quarter 2024 Financial Results For the three months ended March 31, 2024, revenue consists of the $1.4 million in license agreement revenue associated with the license agreement with GSK. For the three months ended March 31, 2023, revenue consisted of $1.1 million product sales of BREXAFEMME. Research and development expense for the quarter ended March 31, 2024 was $7.2 million compared to $6.8 million for the same period in 2023. The increase of $0.4 million, or 6%, for the three months ended March 31, 2024, was primarily driven by an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) expense and a $0.3 million increase in preclinical expense, offset in part by a $0.8 million decrease in clinical expense and a decrease of $0.5 million in salaries primarily associated with medical affairs. SG&A expense for the quarter ended March 31, 2024 decreased to $3.7 million from $4.8 million for the same period in 2023. The decrease of $1.2 million, or 24%, for the three months ended March 31, 2024, was primarily driven by a decrease of $0.8 million in professional fees and a decrease of $0.4 million in commercial expense due to the costs incurred in the prior comparable period associated with BREXAFEMME. Total other income was $10.5 million for the quarter ended March 31, 2024, versus total other expense of $23.2 million for the same period in 2023. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended March 31, 2024 and 2023, we recognized a gain of $9.6 million and a loss of $21.7 million, respectively, on fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively. Net income for the quarter ended March 31, 2024, was $0.4 million, or $0.01 basic income per share, compared to a net loss of $33.9 million, or $0.71 basic loss per share for the same period in 2023. Cash Balance Cash, cash equivalents and investments totaled $94.2 million on March 31, 2024, compared to $98.0 million on December 31, 2023. Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments provide a cash runway beyond two years. About Triterpenoid Antifungals Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage of development for invasive candidiasis and other indications. SCY-247 is a next generation fungerp in pre-clinical development for the treatment of life-threatening and often multi-drug resistant fungal diseases including Candida auris infections. 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 . Forward-Looking Statements Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’s expectation that it will have a cash runway of more than two years; delivery of clinical study reports to GSK in the first half of 2024, anticipated initiation of Phase I clinical studies of SCY-247 in the second half of 2024; and the resumption of the MARIO study. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, and form 10-Q for the quarter ending March 31, 2024, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT: Investor Relations Irina Koffler LifeSci Advisors Tel: (646) 970-4681 ikoffler@lifesciadvisors.com SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Revenue: Product revenue, net $ — $ 1,130 License agreement revenue 1,373 — Total revenue 1,373 1,130 Operating expenses: Cost of product revenue — 137 Research and development 7,212 6,835 Selling, general and administrative 3,669 4,840 Total operating expenses 10,881 11,812 Loss from operations (9,508 ) (10,682 ) Other (income) expense: Amortization of debt issuance costs and discount 401 255 Interest income (1,280 ) (587 ) Interest expense 205 1,447 Warrant liabilities fair value adjustment (9,608 ) 21,673 Derivative liabilities fair value adjustment (168 ) 406 Total other (income) expense (10,450 ) 23,194 Income (loss) before taxes 942 (33,876 ) Income tax expense (531 ) — Net income (loss) $ 411 $ (33,876 ) Net income (loss) per share attributable to common stockholders – basic Net income (loss) per share – basic $ 0.01 $ (0.71 ) Net income (loss) per share attributable to common stockholders – diluted Net income (loss) per share – diluted $ 0.01 $ (0.71 ) Weighted average common shares outstanding – basic and diluted Basic 48,245,559 47,757,246 Diluted 48,565,051 47,757,246 SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) March 31, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $ 35,482 $ 34,050 Short-term investments 44,762 40,312 Prepaid expenses and other current assets 1,583 5,548 License agreement receivable — 2,463 License agreement contract asset 19,466 19,363 Restricted cash 380 380 Total current assets 101,673 102,116 Investments 13,943 23,594 Deferred offering costs 175 175 Restricted cash 163 163 Operating lease right-of-use asset 2,300 2,364 Total assets $ 118,254 $ 128,412 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 8,918 $ 7,149 Accrued expenses 4,601 7,495 Deferred revenue, current portion 1,083 1,189 Operating lease liability, current portion 356 340 Warrant liabilities — 130 Convertible debt and derivative liability 12,391 — Total current liabilities 27,349 16,303 Deferred revenue 2,111 2,727 Warrant liabilities 12,202 21,680 Convertible debt and derivative liability — 12,159 Operating lease liability 2,487 2,581 Total liabilities 44,149 55,450 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 — — Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 37,779,796 and 37,207,799 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 41 40 Additional paid-in capital 428,900 428,169 Accumulated deficit (354,836 ) (355,247 ) Total stockholders’ equity 74,105 72,962 Total liabilities and stockholders’ equity $ 118,254 $ 128,412