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REDWOOD CITY, Calif.--( BUSINESS WIRE )--Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of ascites due to all etiologies except cancer. “The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio. “This milestone serves as a catalyst as we work with patients, healthcare professionals and health authorities to pave a brighter path forward for these patients who have limited treatment options. We are well positioned to further advance our clinical development program for OCE-205 and look forward to progressing this program in ascites.” Ascites is the abnormal accumulation of fluid within the peritoneal cavity of the abdomen and the hallmark of progression into the decompensated phase of cirrhosis. Data suggest that approximately 400,000 people live with ascites, with 60,000 refractory to standard-of-care treatment and who require much more aggressive treatment approaches. 1,2 Current treatments for ascites are limited, are often invasive procedures and may come with significant risks and burden for patients, underscoring the critical need for novel advancements that improve outcomes for those suffering from this devastating condition. Ocelot Bio plans to initiate clinical studies of OCE-205 in refractory ascites in 2024. The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication. This is the second Orphan Drug Designation for OCE-205, which previously received the designation in hepatorenal syndrome. About OCE-205 Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has potential for improving outcomes for patients with complications of end-stage liver disease (ESLD). OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in treating ESLD. By virtue of its mixed V1a agonist/antagonist activity, OCE-205 treatment is designed to relieve portal hypertension while offering a capped maximal efficacy that avoids excessive vasoconstriction seen with full agonists, that leads to ischemic injury and potentially other serious adverse events such as respiratory failure. By eliminating V2 activity, OCE-205 treatment is designed to avoid fluid retention and overload. A Phase 2 clinical trial has completed enrollment to evaluate OCE-205 for the treatment of hepatorenal syndrome with acute kidney injury (HRS-AKI) ( NCT05309200 ), and clinical studies for ascites are expected to initiate in 2024. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome in 2022 and in ascites in 2023. About Ocelot Bio Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease. The company’s lead clinical candidate, OCE-205, is a peptide therapeutic with a mechanism of action designed to selectively target complications of portal hypertension, such as hepatorenal syndrome with acute kidney injury (HRS-AKI) and ascites, serious and life-threatening consequences of end-stage liver disease (ESLD). The company was founded by leading experts in peptide therapeutic development and is backed by a strong syndicate of investors including Venrock, RA Capital Management and Vivo Capital. For more information, visit www.ocelotbio.com . References 1 Siqueira F, et al. Gastroenterol Hepatol (N Y) . 2009;5(9):647-656. 2 Orman, et al. JAMA Netw Open . 2019;2;2(10):e1913673.

Investors Claim Significant Losses Following Product Failures ONTARIO, Nov. 10, 2022 /PRNewswire/ -- McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt APC (MLG) – a national law firm specializing in Securities Litigation , Commercial Litigation, and Class Actions – informs investors that a class action lawsuit has been filed in the United States District Court for the Central District of California (captioned Fernandes v. Centessa Pharmaceuticals plc, No. 22-cv-07030 (C.D. Cal.)) on behalf of investors who purchased and/or acquired (1) Centessa Pharmaceuticals (NASDAQ: CNTA) ("Centessa" or the "Company") American Depositary Shares ("ADSs") pursuant and/or traceable to the Offering Documents issued in connection with Centessa's initial public offering conducted on or about May 28, 2021 (the "IPO"); and/or (2) Centessa securities between May 28, 2021 and June 1, 2022, inclusive (the "Class Period"). Investors have until November 28, 2022, to seek appointment as lead plaintiff in the action. Centessa Pharmaceuticals develops multiple medical products such as lixivaptan, a vasopressin V2 receptor small molecule inhibitor in Phase 3 clinical development for the treatment of autosomal dominant polycystic kidney disease. Centessa also is developing a small molecule pharmacological chaperon folding corrector of the Z variant of the DNA encoding protein alpha-1-antitrypsin, ZF874, which is in Phase 1 clinical development for the treatment of A1AT deficiency. On May 28, 2021, Centessa conducted the Initial Public Offering, issuing 16.5 million of its securities to the public at the price of $20 per ADS. The claims under investigation are whether Centessa made false and/or misleading statements and/or concealed that : (1) the company's product, lixivaptan, was less safe than Centessa had represented; (2) Centessa overstated lixivaptan's clinical and commercial prospects; (3) another Centessa product, ZF874, was less safe than it had been represented; (4) Centessa overstated ZF874's clinical and commercial prospects while downplaying the drug's safety issues; and (5) as a result, documents issued in connection with Centessa's initial public offering and the company's public statements throughout the class period were materially false and/or misleading and failed to state information required. On November 1, 2021, Centessa announced results from a Phase 1 study evaluating ZF874's in treating AATD. Centessa announced, among other things, potential safety issues related to increases in liver enzymes alanine aminotransferase ("ALT") and aspartate aminotransferase ("AST") in one of the study subjects. On this news, Centessa's ADS price fell by more than 18%. Then, on June 2, 2022, Centessa announced "it has made the strategic decision to discontinue development of lixivaptan for [ADPKD]," citing "a recent observation of [ALT] and [AST] elevations in one subject" from a Phase 3 study of lixivaptan that was designed to assess liver and non-liver safety in certain subjects. On this news, Centessa's ADS price fell by nearly 28%. Last, on August 10, 2022, Centessa announced "its decision to discontinue development of ZF874 following a recent report of an adverse event (AE) involving elevated liver enzymes (AST/ALT) in a . . . subject dosed with 5 mg/kg BID of ZF874 in the Phase 1 study." Centessa stated that "[b]ased on the results observed to date, [Centessa] concluded that ZF874 was unlikely to achieve the desired target product profile." On this news, Centessa's ADSs price fell by an additional 5.19%, further harming investors. McCune Law Group hopes to leverage its Securities Litigation practice area to protect investors from dishonest or misleading business practices that take advantage of their investors. "Centessa talked up their products while understating or ignoring the problems they faced," says MLG Partner Elaine. S Kusel , "Without the proper understanding of the situation at Centessa, investors were blindsided by these poor performance results and safety concerns. They deserve better from the businesses they support." About the Lead Plaintiff Process : The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or otherwise acquired Centessa ADSs pursuant and/or traceable to the Offering Documents issued in connection with the IPO and/or Centessa securities during the Class Period to seek appointment as lead plaintiff. The lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. The lead plaintiff acts on behalf of all other class members in directing the Centessa class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Centessa class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Centessa class action lawsuit. About MLG's Securities Litigation Practice: The Securities Litigation attorneys of MLG provide representation for investors who have been wronged through fraud, scams, and schemes. Our team has many years of experience bringing claims on behalf of investors and pursues all avenues of compensation to maximize our clients' recovery as they navigate this tumultuous time. With hard-hitting tactics and dedicated legal professionals protecting our clients' interests, MLG's Securities Litigation Practice Group hopes to hold companies accountable for their unfair or illegal financial practices. About McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt APC: McCune Law Group has a deep history of success for its clients, including a $203 million verdict against Wells Fargo Bank, recovery of over $1 billion for its clients, and over 100 contingency cases with recovery of $1 million or more. MLG maintains California offices in Ontario, San Bernardino, Calimesa, Palm Desert, and Irvine and supports its national practice with offices in Illinois and New Jersey. For over 30 years, MLG has successfully represented Southern California residents and grown to be the largest Inland Empire consumer rights firm. Visit  mccunewright.com  for more information.  CONTACT: [email protected] SOURCE McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt, APC

In healthy volunteers, OCE-205 administration led to increases in mean arterial pressure with promising safety pro > Study findings support clinical program for OCE-205 in End-Stage Liver Disease focused on treating consequences associated with complications of portal hypertension, such as HRS-AKI and ascites SAN DIEGO--(BUSINESS WIRE)-- Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announces results from the completed Phase 1 healthy volunteer clinical trial for its lead candidate, OCE-205, via a poster presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®, taking place in Washington, DC. OCE-205 is an investigational vasopressin (V1a) receptor mixed agonist-antagonist therapeutic peptide that has a mechanism of action designed to selectively target consequences of the systemic hemodynamic complications associated with decompensated liver cirrhosis, or ESLD. In the double-blinded, placebo-controlled Phase 1 study, 64 healthy volunteers ages 18-45 were randomized to placebo or one of five OCE-205 doses (0.1 mg, 0.3 mg, 0.45 mg, 0.6 mg or 0.9 mg). OCE-205 was administered as a six-hour constant rate intravenous infusion. Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional. OCE-205 administration also led to increases in mean arterial pressure (ranging from 12 to 14 mmHg) at every dose level, but the increases were not dose-proportional. The drug was well tolerated across all doses. During the study, no serious adverse events (SAEs) occurred, and most adverse events (AEs) were gastrointestinal in nature and generally mild or moderate in severity. “The Phase 1 data presented at AASLD provide valuable information that will inform our clinical development strategy for OCE-205. These data that demonstrate the investigational compound’s unique potential of a selective V1a receptor agonism that has a therapeutic window that is capped below maximal vasoconstrictive effects,” said Stan Bukofzer, M.D., chief scientific and medical officer at Ocelot Bio. “Ultimately, our goal is to meaningfully improve treatment options for common systemic hemodynamic complications associated with ESLD. These data support further clinical development of OCE-205 as a potential treatment for conditions such as HRS-AKI and ascites.” Titled “OCE-205, a Novel, Selective Vasopressin (V1a) Receptor Mixed Agonist-Antagonist: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics from a Phase 1 Study” (#3622), Ocelot Bio’s poster will be presented by Geoff Harris, DVM, Ph.D., founder of Ocelot Bio, on Sunday, November 6, 2022, at 1:00 p.m. Additionally, the poster has been selected for inclusion in the Portal Hypertension Special Interest Group (SIG) poster debrief on Sunday, November 6, at 8:00 a.m. The full poster presentation will also be made available to registered meeting attendees via The Liver Meeting Digital Experience™ within 72 hours of presentation, and the poster is now available online on the Publications page at Ocelot Bio’s website. About OCE-205 Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has potential for improving outcomes for patients with complications of ESLD. OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in treating ESLD. By virtue of its mixed V1a agonist/antagonist activity, OCE-205 treatment is designed to relieve portal hypertension while offering a capped maximal efficacy that avoids excessive vasoconstriction seen with full agonists, that leads to ischemic injury and potentially other serious adverse events such as respiratory failure. By eliminating V2 activity, OCE-205 treatment is designed to avoid fluid retention and overload. Ocelot Bio is currently enrolling patients in its Phase 2 clinical trial evaluating OCE-205 for the treatment of HRS-AKI (NCT05309200) and has received Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome from the U.S. Food and Drug Administration (FDA). OCE-205 is also in early-stage development for the treatment of ascites, a complication of ESLD-induced portal hypertension that leads to the accumulation of fluid in the peritoneal cavity. About Ocelot Bio Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease. The company’s lead clinical candidate, OCE-205, is a peptide therapeutic with a mechanism of action designed to selectively target complications of portal hypertension, such as hepatorenal syndrome with acute kidney injury (HRS-AKI), a serious and life-threatening consequence of end-stage liver disease (ESLD). The company was founded by leading experts in peptide therapeutic development and is backed by a strong syndicate of investors including Venrock, RA Capital Management and Vivo Capital. For more information, visit .