Polycystic Liver Disease

—Proteomic Analysis of Human Samples Highlights the Unique Role of CCL24 in Activating Key PSC-related Disease Mechanisms Involving Immune Cell Trafficking and HSC Activation, Further Confirming the Potential of Chemomab's CCL24-Neutralizing Antibody CM-101 as a Promising Therapy for PSC— —CM-101 Phase 2 PSC Trial Has Completed Patient Enrollment with Topline Data Readout Targeted for Midyear 2024— TEL AVIV, Israel, Jan. 30, 2024 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced publication of proteomic analyses that further demonstrate the unique role of the soluble protein CCL24 in driving pathologies associated with the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new studies reinforce the extensive existing evidence showing that Chemomab's first-in-class CCL24-neutralizing antibody CM-101 can interrupt these destructive processes. The study, "The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data" 1 has been published in the current online version of the peer-reviewed journal Cells. "The patient sample and other proteomic analyses reported in this publication add to the large and growing body of data showing that CCL24 is a major driver of PSC pathology, providing more detail about its central role in orchestrating the fibrosis and inflammation underlying PSC progression," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "These new data further validating our CCL24 target and the clinical rationale for our CCL24-neutralizing antibody are especially timely as we look forward to our CM-101 Phase 2 topline readout expected midyear, which has the potential to deliver the first significant clinical proof-of-concept of CM-101's therapeutic activity in PSC, a lethal disease with no FDA approved therapies." The studies included advanced proteomic analyses of serum samples from PSC patients and healthy controls to further investigate the involvement of CCL24 in PSC and its association with specific disease-related pathways. They confirmed the exclusive association of CCL24 with fundamental PSC mechanisms, with no similar association seen with two other related proteins (CCL11 and CCL26) sharing the same receptor, emphasizing CCL24's unique potential as a target for PSC therapies. Additional studies showed that CCL24 directly contributes to the development of fibrosis and inflammation in PSC via recruitment of monocytes and neutrophils and activation of hepatic stellate cells (HSCs), a major source of the myofibroblasts that are a key driver of liver fibrogenesis. Notably, an invitro analysis pinpointed a CCL24-dependant proteomic signature in HSCs treated with CCL24 that is capable of stratifying PSC patients based on disease severity, offering promise for future disease activity monitoring. CM-101 is a first-in-class CCL24-neutralizing monoclonal antibody whose dual anti-inflammatory and anti-fibrotic activity has demonstrated disease modifying potential in nonclinical studies of PSC and other fibro-inflammatory disorders. CM-101 has Orphan Drug designation for PSC in the U.S. and the European Union and was recently awarded Fast Track designation by the FDA for the treatment of PSC in adults. About Primary Sclerosing Cholangitis PSC is a rare, progressive liver disease characterized by inflammation and fibrosis (scarring) of the bile ducts that can lead to cirrhosis of the liver, liver failure and death. PSC also increases the risk of various cancers, which account for about half of PSC-related mortality. PSC affects an estimated 30,000 patients in the U.S. and about 80,000 worldwide. The underlying cause of PSC is unknown, but about 75% of patients also have inflammatory bowel disease. Currently there are no approved therapies for PSC. Liver transplantation is common in advanced cases, but even then, PSC re-occurs in about 20% of transplanted patients. There is a high unmet need for therapeutic options to address the symptoms and modify the progression of this devastating illness. 1 Greenman, R.; Snir, T.; Katav, A.; Aricha, R.; Mishalian, I.; Hay, O.; Frankel, M.; Lawler, J.; Saffioti, F.; Pinzani, M.; et al. The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data. Cells 2024, 13, 209. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the expectation that Chemomab will report topline data from the PSC clinical trial by mid-year 2024; the length, duration and impact of the war in Israel on Chemomab's business and operations; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab's current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including those found under the caption "Risk Factors" and elsewhere in Chemomab's filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law. About Chemomab Therapeutics Ltd. Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody that neutralizes CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. The CM-101 program for the treatment of systemic sclerosis is Phase 2-ready. A Phase 2 trial in primary sclerosing cholangitis has completed patient enrollment, with topline data expected midyear 2024. For more information about Chemomab, visit chemomab.com. Contacts: Media and Investors: Barbara Lindheim Consulting Vice President, Investor & Public Relations, Strategic Communications Phone: +1 917-355-9234 [email protected] IR@chemomab.com SOURCE Chemomab Therapeutics, Ltd.

Favorable safety profile and effective biochemical control in 52-week trial Significant improvement of acromegaly symptoms vs. standard of care at baseline Improved patient reported treatment satisfaction, convenience, and quality of life LUND, Sweden, July 17, 2023 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced topline, interim data from an open-label, long-term safety and extension trial, ACROINNOVA 2, assessing CAM2029, octreotide subcutaneous (SC) depot, in 135 adult patients with acromegaly. These include both new patients and roll-over patients from the previous randomized controlled trial, ACROINNOVA 1, where they received treatment with CAM2029 or placebo ('treatment naïve' patients). The Phase 3 data show a favorable safety profile and robust long-term efficacy over 52 weeks of treatment with CAM2029. "We are very pleased with the Phase 3 data from ACROINNOVA 2 which shows improved biochemical and symptom control after treatment with CAM2029 versus standard of care as well as improved quality of life of patients. The new data reinforces the recent positive results from ACROINNOVA 1 and the potential of CAM2029 as a new treatment option for patients with acromegaly," says Fredrik Tiberg, Camurus' President & CEO, CSO. Acromegaly is a rare and severe chronic disease caused by a benign pituitary tumor causing excess levels of growth hormone (GH), leading to increased levels of insulin-like growth factor-1 (IGF-1). The disease causes significant morbidity, physical changes, burdensome symptoms, and diminished quality of life of patients.1-3 First-line medical treatment of acromegaly is represented by first-generation injectable somatostatin receptor ligands (SRL), octreotide and lanreotide. Interim topline data from ACROINNOVA 2 show that CAM2029 is well tolerated with a safety profile comparable to current standard of care (SoC) with first-generation SRLs. There were no severe adverse events related to CAM2029. One patient had a related serious adverse event of cholelithiasis, which resolved, and the patient continued in the trial. Two patients discontinued treatment due to adverse reactions, and one patient had an adverse reaction leading to dose reduction. In addition to a beneficial safety profile, ACROINNOVA 2 shows statistically significant improvements for multiple endpoints from baseline, with SoC and placebo (in treatment naïve patients), to the end of study treatment with CAM2029 at week 52. These improvements include: Increased IGF-1 response rate [mean (95% CI) IGF-1≤1xULN] for Full population from 49.7% to 58.4% with a difference of 8.7% [0.6%, 16.8%] New patients from 12.0% to 30.3% with a difference of 18.3% [6.5%, 30.1%] Treatment naïve patients from 20.2% to 93.8% with a difference of 73.7% [51.5%, 95.8%] CAM2029 patients had stable response rate from 92.8% to 89.4% Reduced acromegaly symptom burden during treatment with CAM2029 as measured by proportion of patients with any acromegaly symptom and the Acromegaly Index of Severity (AIS) score (sum of scores of the six acromegaly symptoms of headache, sweating, fatigue, joint pain, paresthesia, and soft tissue swelling) Increased patient and treatment satisfaction as measured by the Patient Satisfaction score and Treatment Satisfaction Questionnaire for Medication (TSQM) scores Improved quality of life as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL) scores and the EuroQoL 5D-5L VAS "The data from ACROINNOVA 2 are impressive and indicate that CAM2029 has the potential to address key unmet medical needs of patients with acromegaly, including improving biochemical control, symptoms, and quality of life of patients. We also see high patient satisfaction related to the convenience of the prefilled pen and syringe and option for easy self-administration by patients", says Prof. Diego Ferone, Endocrinologist, Head of Department of Internal Medicine & Medical Specialties, IRCCS Ospedale Policlinico San Martino, University of Genova, Italy, and coordinating investigator in the trial. The interim results of ACROINNOVA 2 will be part of the regulatory submissions for CAM2029 and presented at upcoming medical meetings and in a scientific publication. About the ACROINNOVA clinical program ACROINNOVA comprises two Phase 3 studies evaluating efficacy and safety of octreotide SC depot (CAM2029). The first trial (ACROINNOVA 1, NCT04076462) is a 24-week, randomized, double-blind, multi-center, placebo-controlled Phase 3 trial that randomized 72 adult patients with acromegaly, who were on stable treatment with octreotide LAR4 or lanreotide ATG5 at enrollment. Topline results from ACROINNOVA 1 were announced on 20 June, 2023.6 Additionally, Camurus is conducting an open-label, Phase 3 long-term safety and extension trial of octreotide SC depot (ACROINNOVA 2, NCT04125836). 81 new participants have been enrolled in the trial and 54 patients have rolled over from ACROINNOVA 1 from 24 weeks treatment with CAM2029 or placebo (treatment naïve patients) to the extension part of the trial. Complete results from the 52 weeks treatment period are expected in Q2 2024. The study has been extended with an additional year of treatment and is expected to continue until 2025. About acromegaly and octreotide subcutaneous (SC) depot (CAM2029) Acromegaly is a rare, slowly progressive, and serious condition typically caused by a tumor of the pituitary gland, resulting in overproduction of growth hormone and insulin growth factor 1. This may cause physiological changes, disease symptoms, diminished quality of life, and, if untreated, premature death.7-10 The prevalence of acromegaly is estimated at about 60 cases per million.11 Octreotide SC depot is a ready-to-use octreotide for subcutaneous administration under development for treatment of acromegaly as well as gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). The product is designed for convenient, once-monthly administration using an injection pen to facilitate easy administration by patients themselves. CAM2029 has been evaluated in five completed clinical Phase 1 and 2 studies and has demonstrated an approximate five-fold increase in dose-adjusted plasma exposure compared to octreotide LAR 4. Combined with the convenience of administering CAM2029, this may offer the potential for improved efficacy, convenience, and quality of life compared to current first-line medical treatments of acromegaly, with octreotide LAR and lanreotide ATG5. These aspects are assessed in the Phase 3 ACROINNOVA program. About Camurus Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus' clinical pipeline includes products for the treatment of dependence, pain, cancer, and endocrine disease, developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit . References Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111. Strasburger CJ, et al. Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016 Mar;174(3):355-62. Prescribing Information SANDOSTATIN® LAR, Prescribing Information SOMATULINE®, Press release: Camurus' octreotide SC depot (CAM2029) achieves superior treatment response compared to placebo in Phase 3 acromegaly trial. 20 June, 2023. Melmed S., et al. Causes and clinical manifestations of acromegaly, UpToDate, last updated May 2020, accessed May 2023. Melmed S., et al. Diagnosis of acromegaly, UpToDate, last updated Dec 2021, accessed May 2023. Katznelson L., et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-51. Holdaway IM, et al. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004;89(2):667-74 Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 [email protected] Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 [email protected] This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 7:00 am CET on 17 July 2023. The following files are available for download: SOURCE Camurus AB