CinRx Pharma LLC

Late-Breaking Poster of interim single-ascending dose data for CIN-110, a potent and highly selective peptide YY (PYY 3-36 ) analog Results from a Phase I Study of CIN-109, a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) CINCINNATI--(BUSINESS WIRE)--CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity, will present two posters at ObesityWeek® 2024, held at the Henry B. Gonzalez Convention Center in San Antonio from November 2 nd to 6 th . Poster Presentations: Title: Safety, Pharmacokinetics, and Effect of Novel PYY Analog CIN-110 on Weight in Subjects with Obesity Date: Tuesday, November 5, 2024 Time: 2:30 – 3:30pm CST Location: Exhibit Hall 4B Title: Effect of CIN-109, a Novel GDF-15 Analog, on Body Weight and Composition in Subjects with Obesity Date: Tuesday, November 5, 2024 Time: 2:30 – 3:30pm CST Location: Exhibit Hall 4B About CIN-110: CIN-110 is a potent, highly selective peptide YY (PYY 3-36 ) analog with an extended half-life, designed to significantly reduce the nausea and vomiting which has been observed with other PYY molecules while promoting effective, long-term weight loss. It is currently being evaluated in clinical trials to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The trials include single ascending dose (SAD) and multiple ascending dose (MAD) studies, with the MAD study building on the encouraging safety and tolerability data from the SAD study. About CIN-109: CIN-109 is a Phase 2 ready, a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) analog for the treatment of obesity. CIN-109 is a Phase 2 ready candidate after successfully completing a randomized, double-blind, placebo-controlled multiple-ascending-dose study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity delivered subcutaneously. About CinFina Pharma: CinFina Pharma, a CinRx portfolio company, is expanding the treatment options for obesity and its associated comorbidities with a pipeline of therapeutic candidates designed to be safe, tolerable, and durable to help people lose weight and keep it off to improve their overall health. CinFina’s four therapeutic candidates are naturally occurring peptides engineered for prolonged activity that send signals to the body to control insulin secretion or feelings of satiety. Learn more at . About CinRx Pharma: CinRx Pharma is a biotech company advancing a diverse portfolio of high-impact medicines through clinical development with a unique hub-and-spoke business model. CinRx’s approach combines financing with the efficient progression of therapeutic candidates within its portfolio, each managed by CinRx’s central infrastructure and operating team. Current CinCos address areas of high unmet medical need, including metabolic, gastrointestinal, and oncology. Differentiated by an asset selection process agnostic to therapeutic area, a strategic CRO partnership, and insights from thousands of development programs, CinRx identifies, funds, and accelerates promising drugs with the potential to have the highest impact on patients’ quality of life. CinRx Pharma is headquartered in Cincinnati, Ohio. For more information, please visit or follow the company on X and LinkedIn . Contacts Media Contact: Katherine Beach Oltsik Account Director, Communications katherine.beach@inizioevoke.com CinRx Pharma Contact: Jason Westerheide Executive Director, Business Development jwesterheide@CinRx.com

Neurogastrx believes its drug could treat one of the most troublesome side effects of one of the industry’s biggest blockbusters. On Wednesday, the Boston-area biotech said that its experimental drug, NG101, reduced the incidence of nausea by 40% and cut vomiting by 56% in adults taking Novo Nordisk’s semaglutide, which is marketed as Wegovy for obesity and Ozempic for type 2 diabetes. In the Phase 2 trial, about 90 adults received a single subcutaneous dose of semaglutide, at 0.5 mg, and then for five days, they took two capsules of NG101 or placebo each day. The results were statistically significant. Neurogastrx sees a market opportunity worth “billions of dollars,” CEO James O’Mara told Endpoints News. “The GLP-1s are miracle drugs,” O’Mara said. But many patients stop taking the medicines within a year, and a lot of them cite the gastrointestinal side effects as a key reason, he said. The news is Neurogastrx’s first major step since 2021, when it outlined a $60 million Series B and unveiled a partnership with Daewoong Pharmaceutical, which it then terminated in mid-2023. NG101 is a dopamine D2 antagonist, and it affects the area postrema, or the “nausea center of the brain,” O’Mara said. That region is outside the blood-brain barrier, meaning it might allow the medicine to avoid CNS side effects that come with some other dopamine modulators, the CEO said. Neurogastrx will have to test NG101 in larger studies and for a longer duration before seeking regulatory approval, and the company aims to start either a Phase 2 or a Phase 2/3 trial next year, the CEO said. “Whether it’s registrational, we’ll have to see,” O’Mara said. A Phase 3 would likely involve both semaglutide and Eli Lilly’s related drug tirzepatide. “I think you would have to include both eventually in order to get them in the label,” O’Mara said. The company thinks it can raise the money it needs to get into later-stage testing, O’Mara said, noting Neurogastrx is starting discussions with potential partners and funding sources. In February 2023, Neurogastrx completed a Phase 2 of NG101 in patients with gastroparesis, in which the body struggles to empty food, but the company has yet to announce the results. O’Mara said the results have been submitted for publication and described the data as “interesting.” “We had endpoints which looked good and others which we were disappointed in,” he said. In May, another biotech in the space, CinDome Pharma, announced a $40 million funding extension to finish its Phase 2 in diabetic gastroparesis. It anticipates results next year and will likely seek a pharma partner or acquirer to bring it into Phase 3, CinDome creator CinRx CEO Jon Isaacsohn told Endpoints in May . O’Mara also gave more details of the company’s terminated pact with South Korea’s Daewoong. Under the deal, Neurogastrx was to have developed Daewoong’s investigational acid blocker fexuprazan for GERD and other acid-related conditions. The US and Canada-focused agreement was terminated last year. “We did a deal for fexuprazan when there was a lot of money flowing into biotech, and very shortly, frankly, after we closed that deal, it was just harder to raise capital,” O’Mara said. “We wanted to be fair with our collaborator and give them the opportunity to find another company that could better escort the drug forward.”

CINCINNATI--( BUSINESS WIRE )--CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity and metabolic diseases, today announced the initiation of the Phase 1 MAD clinical trial for CIN-110, a novel, highly selective PYY 3-36 analog for the treatment of obesity. This Phase 1 MAD clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CIN-110 in adults with obesity. The initiation of this MAD trial follows the ongoing SAD study, where CIN-110 was well-tolerated with noteworthy reductions in caloric intake and body weight. The SAD study will be used to inform dosing decisions in the current MAD study. “ To date, CIN-110 has demonstrated very strong safety and pharmacokinetic profiles in its single dose study, as well as encouraging pharmacodynamic data,” said Mary Bond, M.S., M.B.A., Chief Translational Science Officer of CinRx Pharma. “ We are excited to see this promising asset advance into this next clinical assessment where we will gain an even greater understanding of its potential to provide a safe and effective obesity treatment option for physicians and their patients.” As a potent and highly selective PYY 3-36 analog with an extended half-life, CIN-110 has the potential to be durable and well-tolerated without the significant nausea and emesis seen in previous attempts to develop PYY-focused therapies. PYY 3-36 is an endogenous hormone secreted from endocrine L-cells in the gut in response to food, particularly fat ingestion, acting as a selective agonist of the neuropeptide Y2 receptor (Y2R) and safely decreasing food intake by reducing appetite. About CIN-110 Phase 1 MAD Study: The multiple ascending dose (MAD) study is designed as a randomized, placebo-controlled clinical trial that will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CIN-110 delivered subcutaneously (SC) in study subjects with obesity over 12 weeks. Trial participants are males and females, ages 18-55, with a body mass index between 30.0 and 44.9 kg/m2. The study is planned to include multiple cohorts, each with 12 subjects randomized in a 3:1 ratio to receive SC CIN-110 or a matched placebo, respectively. About CinFina Pharma: CinFina Pharma, a CinRx portfolio company, is expanding the treatment options for obesity and its associated comorbidities with a pipeline of therapeutic candidates designed to be safe, tolerable and durable to help people lose weight and keep it off to improve their overall health. CinFina’s four therapeutic candidates are naturally occurring peptides engineered for prolonged activity which send signals in the body to control insulin secretion or feelings of satiety. Learn more at www.CinFina.com . About CinRx Pharma: CinRx Pharma is a biotech company advancing a diverse portfolio of high-impact medicines through clinical development with a unique hub-and-spoke business model. CinRx’s approach combines financing with the efficient progression of therapeutic candidates within its portfolio, each managed by CinRx’s central infrastructure and operating team. Current CinCos address areas of high unmet medical need including metabolic, gastrointestinal and oncology. Differentiated by an asset selection process agnostic to therapeutic area, a strategic CRO partnership, and insights from thousands of development programs, CinRx identifies, funds and accelerates promising drugs with the potential to have the highest impact on patients’ quality of life. CinRx Pharma is headquartered in Cincinnati, Ohio. For more information, please visit www.CinRx.com or follow the company on X and LinkedIn .