Semaglutide (Novo Nordisk)

KEY BUSINESS HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025.New Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board (SAB) was formed in October 2024 to support development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications.Two obesity proof-of-concept studies with IC 100 in diet-induced obesity (DIO) mouse models are planned, which will include assessment of various metabolic parameters. At least one of the studies is targeted to begin Q4-2024.IC 100 Investigational New Drug (IND) submission is planned for Q2-2025, and once cleared, will be followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk for certain metabolic complications (Q2/Q3-2025), with safety data expected H2-2025.Raised approximately $3.9 million from the beginning of Q3-2024 to present. WESTON, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for the quarter ended September 30, 2024, and provides business update. “We are pleased to announce the progress that ZyVersa has made toward achieving our key near-term development milestones,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our Phase 2a clinical trial with Cholesterol Efflux Mediator™ VAR 200 in diabetic kidney disease is expected to begin Q1-2025, with an initial data read-out around mid-year 2025. In preparation for an IND submission for Inflammasome ASC Inhibitor IC 100 and a subsequent Phase 1 trial in healthy overweight subjects at risk for certain metabolic complications, we are initiating two proof-of-concept studies with IC 100 in obesity DIO models. At least one of the studies is expected to begin in Q4-2024. One study will evaluate IC 100 as monotherapy compared to semaglutide, and the other will evaluate IC 100 in combination with semaglutide. Our newly formed Obesity, Metabolic & Inflammatory Disease SAB has been instrumental in designing these two studies to optimize the parameters to be evaluated. We are pleased with the level of scientific evidence from our preclinical program and published third party data that support the potential of IC 100 to control the damaging obesity-driven inflammation and its associated comorbidities. Unlike NLRP3 inhibitors in development for obesity with metabolic complications, IC 100 targets ASC to inhibit multiple inflammasomes, including NLRP3 and AIM2 associated with obesity. More importantly, IC 100 uniquely disrupts the function of ASC specks to attenuate chronic, systemic inflammation leading to obesity comorbidities. We are excited about the promise of our two lead compounds in development to improve health and transform lives. We believe our near-term milestone achievement will be a key inflection point for ZyVersa that will drive shareholder value.” BUSINESS UPDATE CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 FOR RENAL DISEASE Phase 2a clinical trial in diabetic kidney disease planned to begin Q1-2025. All necessary regulatory preparation has been completed by ZyVersa, our CRO, George Clinical, and our two clinical sites who are gearing up for site initiation and patient recruitment in the new year. INFLAMMASOME ASC INHIBITOR IC 100 FOR OBESITY WITH METABOLIC COMPLICATIONS IC 100 IND submission planned for Q2-2025, to be followed by initiation of a Phase 1 clinical trial in healthy overweight patients at risk for certain metabolic complications. Safety data expected before year end 2025. New Obesity, Metabolic & Inflammatory Disease SAB established to provide expert advice on IC 100’s obesity clinical program. SAB comprised of five top tier experts in the areas of obesity and metabolic diseases, and four world-renowned inflammasome experts and inventors of IC 100 from University of Miami Miller School of Medicine who have provided advisory support for IC 100 since its license. Two IC 100 obesity proof-of-concept studies in DIO mouse models designed with expert advice from SAB. One will evaluate IC 100 monotherapy in comparison to semaglutide, and the other will evaluate IC 100 in combination with semaglutide.At least one of the DIO model studies is planned to begin Q4-2024.Data read-outs expected within six months of initiation. IC 100 GLP toxicology studies are anticipated to begin Q4-2024/Q1-2025 THIRD QUARTER FINANCIAL RESULTS Net losses were approximately $2.4 million for the three months ended September 30, 2024, with an improvement of approximately $0.5 million or 17.3% compared to a net loss of approximately $2.9 million for the three months ended September 30, 2023. Based on its current operating plan, ZyVersa expects its cash of approximately $0.1 million as of September 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations and to meet its stated milestones. ZyVersa will seek to fund its operations and clinical activity through public or private equity or debt financings or other sources, which may include government grants, collaborations with third parties or outstanding warrant exercises. Research and development expenses were approximately $0.4 million for the three months ended September 30, 2024, a decrease of approximately $0.2 million or 35.3% from the three months ended September 30, 2023. The decrease is primarily attributable to a decrease of approximately $0.2 million in the costs of manufacturing, pre-clinical costs for IC 100, and clinical costs for VAR 200. General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2024, a decrease of approximately $0.4 million or 17.7% from the three months ended September 30, 2023. The decrease is attributable to an approximate $0.1 million decrease in professional fees due to reduced fees of public auditors and legal counsel, an approximate $0.2 million decrease in director and officer insurance due to reduced costs in the second year of being a public company, and an approximate $0.1 million decrease in stock-based compensation as a result of options becoming fully amortized in 2024. About ZyVersa Therapeutics, Inc. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com. Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing, as well as ZyVersa’s ability to successfully complete any such financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, Media, IR Contact Karen CashmereChief Commercial Officerkcashmere@zyversa.com786-251-9641 ZYVERSA THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2024 2023 (Unaudited) Assets Current Assets: Cash$122,921 $3,137,674 Prepaid expenses and other current assets 267,494 215,459 Total Current Assets 390,415 3,353,133 Equipment, net - 6,933 In-process research and development 18,647,903 18,647,903 Vendor deposit 178,476 98,476 Deferred offering costs 207,130 - Operating lease right-of-use asset - 7,839 Total Assets$19,423,924 $22,114,284 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable$9,284,631 $8,431,583 Accrued expenses and other current liabilities 2,257,372 1,754,533 Operating lease liability - 8,656 Total Current Liabilities 11,542,003 10,194,772 Deferred tax liability 854,621 844,914 Total Liabilities 12,396,624 11,039,686 Stockholders' Equity: Preferred stock, $0.0001 par value, 1,000,000 shares authorized: Series A preferred stock, 8,635 shares designated, 50 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively - - Series B preferred stock, 5,062 shares designated, 5,062 shares issued and outstanding as of September 30, 2024 and December 31, 2023 1 1 Common stock, $0.0001 par value, 250,000,000 shares authorized; 1,074,203 and 405,212 shares issued at September 30, 2024 and December 31, 2023, respectively, and 1,074,196 and 402,205 shares outstanding as of September 30, 2024 and December 31, 2023, respectively 107 40 Additional paid-in-capital 118,245,220 114,300,849 Accumulated deficit (111,210,860) (103,219,124) Treasury stock, at cost, 7 shares at September 30, 2024 and December 31, 2023, respectively (7,168) (7,168) Total Stockholders' Equity 7,027,300 11,074,598 Total Liabilities and Stockholders' Equity$19,423,924 $22,114,284 ZYVERSA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023Operating Expenses: Research and development$436,043 $673,943 $1,658,030 $2,950,462 General and administrative 1,833,578 2,228,735 6,192,205 9,694,097 Impairment of in-process research and development - - - 69,280,171 Impairment of goodwill - - - 11,895,033 Total Operating Expenses 2,269,621 2,902,678 7,850,235 93,819,763 Loss From Operations (2,269,621) (2,902,678) (7,850,235) (93,819,763) Other Income (Expense): Interest (income) expense 131,635 210 131,794 (555) Pre-Tax Net Loss (2,401,256) (2,902,888) (7,982,029) (93,819,208) Income tax (provision) benefit - 485 (9,707) 8,859,762 Net Loss (2,401,256) (2,902,403) (7,991,736) (84,959,446) Deemed dividend to preferred stockholders - (32,373) - (7,948,209) Net Loss Attributable to Common Stockholders$(2,401,256) $(2,934,776) $(7,991,736) $(92,907,655) Net Loss Per Share - Basic and Diluted$(2.43) $(30.18) $(9.79) $(1,591.46) Weighted Average Number of Common Shares Outstanding - Basic and Diluted 988,378 97,252 816,293 58,379

SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced that it has achieved more than 50% of targeted patient enrollment for its CBeyond™ Phase 2 clinical trial assessing nimacimab, a differentiated CB1 inhibitor, in patients with overweight or obesity. Skye expects to report interim data for the CBeyond™ Phase 2 clinical trial in Q2 2025 after this initial set of enrolled patients has completed the 26-week treatment period. “We are grateful for the amazing motivation and responsiveness shown by our study participants and clinical investigators in the assessment of this first-in-class drug candidate for weight loss. The current pace of patient enrollment may also shorten our timeline to topline data next year. We will provide a further update after reaching full enrollment,” said Puneet Arora, MD, Skye’s Chief Medical Officer. “This is a rigorous clinical trial evaluating multiple important parameters. We look forward to advancing nimacimab through this program and getting this Phase 2 data next year.” “CB1 inhibition has been shown in preclinical and clinical studies to have attributes with the potential to play a distinct role in achieving the goal of healthier, more sustainable anti-obesity drug regimens,” said Punit Dhillon, President & Chief Executive Officer. “Within the class, our monoclonal antibody, nimacimab, is the most peripherally restricted CB1 inhibitor, even compared to the most peripherally restricted small molecules. Importantly, our recently announced preclinical diet-induced obesity model data provides evidence for sufficiency of CB1 inhibition outside the brain to drive meaningful weight loss. We believe the effects of nimacimab in the periphery cause metabolic gains and directly cause fat loss, while modulating hunger and increasing satiety without the need to inhibit CB1 receptors in the brain. Mr. Dhillon added: “With virtually undetectable accumulation in the brain, we believe nimacimab has the best safety profile among CB1 inhibitors. In Phase 1 and preclinical studies of nimacimab, there were no observations of neuropsychiatric adverse events, a risk and outcome that plagues small-molecule CB1 inhibitors with their to-date unavoidable engagement with CB1 in the brain. Notably, nimacimab’s gastrointestinal tolerability far exceeds GLP-1 receptor agonists, and CB1 inhibition has displayed favorable outcomes with respect to lean mass preservation. With these attributes, we believe nimacimab is well-positioned to play a breakthrough role in realizing the therapeutic benefits of CB1 inhibition as an important non-incretin alternative.” CBeyond™ Phase 2 Clinical Trial Design This clinical trial is a randomized, double-blind study designed to enroll 120 patients across four treatment groups. The primary endpoint will evaluate the difference in weight loss of nimacimab compared to placebo. An exploratory endpoint will assess a combination of nimacimab and Wegovy® compared to placebo and Wegovy®. Secondary and other exploratory endpoints will assess safety and tolerability; neuropsychiatric and cognitive outcomes; change in body composition by dual-energy X-ray absorptiometry (DEXA); metabolic parameters; and improvement in sleep. About Skye Bioscience Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. CONTACTS Investor Relationsir@skyebioscience.com(858) 410-0266 LifeSci Advisors, Mike Moyermmoyer@lifesciadvisors.com(617) 308-4306 Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@lifescicomms.com(628) 234-3889 FORWARD LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. These forward looking statements include, but are not limited to: statements regarding our product development, statements regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors, statements relating to any expectations regarding the safety, including lack of neuropsychiatric effects, efficacy, tolerability or dosing of nimacimab, including based on preclinical models and the clinical information from the nimacimab Phase 1 study in NAFLD, statements regarding the ability of nimacimab to treat obesity or related indications, statements regarding the timing of receipt of interim and final data from Skye’s Phase 2 obesity study of nimacimab and statements regarding the therapeutic potential of nimacimab. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.