List of Peptide Therapies Companies with Phase 3 Active Clinical Trial - 20

Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the development of therapeutic compounds through the inhibition of the complement system for autoimmune and inflammatory diseases. Its lead product candidate is pegcetacoplan that is in Phase III clinical trials for the treatment of geographic atrophy in age-related macular degeneration and paroxysmal nocturnal hemoglobinuria diseases; and in Phase II clinical trials for the treatment of cold agglutinin disease, C3 glomerulopathy, IgA nephropathy, primary membranous nephropathy, and lupus nephritis. The company is also developing APL-9, which is in single ascending dose Phase I randomized, double-blind, and placebo-controlled clinical trials for the prevention of immune system activation coincident with adeno-associated virus for intravenous administration. Apellis Pharmaceuticals, Inc. has a strategic collaboration with Swedish Orphan Biovitrum AB (publ) for the advancement of pegcetacoplan, a C3 therapy for the treatment of multiple rare diseases, including paroxysmal nocturnal hemoglobinuria. The company was founded in 2009 and is based in Waltham, Massachusetts.

Ascendis Pharma A/S, a biopharmaceutical company, develops various prodrug therapies for unmet medical needs. The company develops TransCon growth hormone, which has completed Phase III clinical study in children to treat growth hormone deficiency; TransCon parathyroid hormone which is in Phase II clinical study for treating hypoparathyroidism; and TransCon CNP, a long-acting prodrug of C-type natriuretic peptide which is in Phase II clinical for the treatment of achondroplasia. It is also developing preclinical studies in the field of oncology for potential product candidates and evaluate systemic and localized delivery systems using its TransCon technologies. It also has strategic collaborations with Sanofi to develop TransCon technologies for the treatment of diabetes. The company was founded in 2006 and is headquartered in Hellerup, Denmark.

Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines to improve the lives of patients with systemic amyloidosis. Our proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the universal disease-causing pathology in all systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis.

Avidity Biosciences, Inc., a biopharmaceutical company, engages in the development of oligonucleotide-based therapies. It develops antibody oligonucleotide conjugates (AOC) that are designed to treat a range of serious diseases. The company’s lead product candidate AOC 1001 is used for the treatment of myotonic dystrophy type 1, a rare monogenic muscle disease; and to design, engineer, and develop therapeutics that combine tissue selectivity of monoclonal antibodies and the precision of oligonucleotide therapies to access previously undruggable tissue and cell types, and target underlying genetic drivers of diseases. In addition, it develops muscle programs, which focuses on the treatment of facioscapulohumeral muscular dystrophy, Duchenne muscular dystrophy, muscle atrophy, and Pompe diseases.

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company that is harnessing the power of bicyclic peptides and leveraging Nobel Prize-winning science to develop a new and differentiated class of medicines to treat cancer and other diseases. Bicycle® molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin, previously BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.

BioLineRx Ltd., a clinical-stage biopharmaceutical development company, focuses on oncology. Its development pipeline consists of clinical-stage therapeutic candidates, which include BL-8040, a peptide for the treatment of solid tumors, hematological malignancies, and stem cell mobilization; AGI-134, an immuno-oncology agent in the development for solid tumors; and BL-5010, a customized, proprietary, pen-like applicator for the non-surgical removal of skin lesions. The company has collaboration agreement with MSD for the cancer immunotherapy field; MD Anderson Cancer Center to investigate the combination of BL-8040 with KEYTRUDA (pembrolizumab) in pancreatic cancer; and Genentech Inc. to investigate the combination of BL-8040 for solid tumors. BioLineRx Ltd. was founded in 2003 and is headquartered in Hevel Modi'in, Israel.

Cerium Pharmaceuticals is dedicated to creating efficacious therapies for patients with kidney diseases. Cerium is currently focused on developing the first drug approved for a very rare kidney disease called Primary Membranous Nephropathy (PMN). There are approximately 75,000 PMN patients in the US and approximately 3,000 newly diagnosed PMN patients per year.

Dong-A ST is a company established in March 2013 following the restructuring of the former Dong-A Pharmaceutical into a holding company. Our company focuses on the development and sale of specialized pharmaceuticals (ETC) and is dedicated to the philosophy of "Our company's social contribution is in new drug development." With state-of-the-art research facilities such as the Yongin Research Center established in 1977 and the completion of the Songdo Research Center in 2021, Dong-A ST has been striving for innovative global new drug development with excellent research and development capabilities. For many years, by consistently investing more than 10% of its revenue in R&D, we have successfully developed multiple proprietary novel drugs, including Stillen, Zydena, Motilitone, Sivextro, and Suganon/Sugamet.

Eusol Biotech was founded in March 2005 in Taipei, Taiwan. The company is involved in the R&D and GMP process development of recombinant human acid fibroblast.

MAIA Biotechnology is a targeted therapy, immune-oncology company, focused on development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. A publicly traded company based in Chicago, MAIA (NYSE American: MAIA) is led by a passionate, principled and highly experienced Management Team with significant drug development experience, committed to advancing promising agents into human clinical trials. MAIA’s business strategy is designed to advance a strong value proposition for its portfolio of potentially novel compounds. MAIA controls risk and enhances its opportunity for success by diversifying and generating this portfolio of assets with a variety of compounds with novel mechanisms of action which have potential activity in multiple tumor types. MAIA’s business model involves placing drug candidates in their own dedicated, R&D focused subsidiary company, which is supported by the common infrastructure, management team, and resources of the MAIA enterprise. This model allows MAIA to provide more focused R&D support to each drug candidate, while also distributing shared central resources among subsidiary companies to maintain a lean, capital-efficient operating structure.

Phoenix Nest Biotech is a biotechnology company that focuses on treating Sanfilippo Syndrome by collaborating with leading academics and utilizing licensed key technologies.

Polaris Pharmaceuticals, is a biopharmaceutical development and manufacturing organization (CDMO) specializing in biologics derived from microbial systems. We have manufactured clinical material for trials in the United States, Europe, China, Taiwan, Australia, and Korea. Polaris Pharma offers a comprehensive range of process and analytical development and high-quality cGMP pre-clinical and clinical manufacturing services. We offer services for the following: • Process Development • Master and Working Cell Bank Propagation • Pre-Clinical/Clinical Manufacturing • QC Method Development • In Process Testing • Release Testing • Stability Storage and Testing • Availability to provide high purity WFI and PW • Custom Buffer and Media Manufacturing • Contract Filling, Labeling, Inspection • Microbial Based Fermentation Products

Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform focused on discovering and developing peptide-based new chemical entities (NCEs) that can potentially transform existing treatment paradigms in disease areas with significant unmet medical needs. Our platform enables us to discover peptides in a de novo fashion with the desired degree of potency, specificity and selectivity, and also engineer oral stability with specific peptidomimetic and chemical modifications. We have successfully utilized this platform to discover PN-943 and PTG-200 which are oral, GI-restricted peptides for inflammatory bowel diseases (IBD), as well as PTG-300, an injectable peptide for rare blood disorders.

Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company recently announced topline results from pivotal Phase 3 clinical trials in POMC deficiency obesity and LEPR deficiency obesity. Rhythm is also conducting a pivotal Phase 3 trial in Bardet-Biedl syndrome and Alström syndrome. The company is leveraging the Rhythm Engine -- comprised of its Phase 2 basket study in additional rare genetic disorders of obesity, TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of these disorders. For healthcare professionals, visit www.UNcommonObesity.com for more information.

SELLAS Life Sciences Group, Inc., a late-stage biopharmaceutical company, focuses on the development of novel cancer immunotherapies for various cancer indications in the United States. The company's lead product candidate is galinpepimut-S (GPS), a wilms tumor 1 targeting peptide-based cancer immunotherapeutic agent, which is in Phase III clinical trials for the treatment of acute myeloid leukemia; and in Phase 1/2 clinical trials for the treatment for ovarian cancer. It also develops nelipepimut-S, a cancer immunotherapy that is in Phase 2b clinical trials for the treatment of early stage breast cancer. The company has strategic collaboration with Merck & Co., Inc. to evaluate GPS as it is administered in combination with PD1 blocker pembrolizumab in a Phase 1/2 clinical trial enrolling patients in up to five cancer indications, including hematologic malignancies and solid tumors. SELLAS Life Sciences Group, Inc. was founded in 2012 and is headquartered in New York, New York.

Patients around the world are struggling with debilitating back pain, trying to avoid invasive surgeries and the potential of opioid addiction. Spine Biopharma has developed a non-surgical solution that will remove pain and restore functionality, without having to use opioids.

Stuart Therapeutics (Stuart) is a clinical stage biopharmaceutical company focused on the development of a unique tissue reparative platform for eye diseases called PolyColTM (PolyCol). PolyCol is a family of synthesized polypeptide sequences that are specifically designed to repair damaged extracellular matrix (ECM) helical collagen. Helical collagen structures play an important role in healthy tissues and they are damaged in chronic and acute/traumatic disease processes and injuries. Stuart was founded in 2018 to champion a new approach to the treatment of chronic diseases. Each of our founders has been affected directly or indirectly by chronic eye disease, and we have a passion for the pursuit of new and effective solutions for these indications. Stuart’s areas of interest are Dry Eye Disease, Glaucoma, and Dry Age-Related Macular Degeneration.

Vigeo is focusing on tumors that are largely refractory to approved therapies. Our approach to drug development and treatment is based on targeting both the tumor and the genetically normal cells that comprise the microenvironment, which are less likely to develop mutation-based resistance. Therefore, we believe Vigeo’s therapies can have a significant impact on cancers where other types of therapy have been unsuccessful. Vigeo is the first, and only, company developing therapies designed to stimulate Tsp-1 expression by replicating the biological activity of prosaposin (PSAP). By triggering the production of TSP-1 and downstream activities via CD36 and CD47, we are reprogramming the tumor microenvironment from one that is immunosuppressive and tumor-promoting, to one that activates the immune system and is tumor-inhibiting.

Xiamen Amoytop Biotech Co., Ltd., founded in 1996, is an innovative biopharmaceutical company in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop Biotech is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for unmet medical needs, such as viral hepatitis and malignant tumors, and immunotherapy. Looking into the future, Amoytop Biotech is especially focusing on CHB (chronic hepatitis B) treatment and will keep advancing the clinical research progress of multiple ongoing pipeline programs aiming to achieve breakthroughs in the clinical cure of CHB.

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or bond with us through LinkedIn.