IL-7

-- Novel approach to directly target local tissue complement dysregulation resulted in durable and efficacious complement blockade without systemic inhibition in preclinical studies -- -- Company is planning to evaluate ADX-097 in a Phase 2 clinical trial of complement-mediated renal diseases, with initial data expected by year-end 2024 and topline results in 2025, and a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV) -- WALTHAM, Mass., Feb. 21, 2024 /PRNewswire/ -- Q32 Bio Inc., a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, today announced the publication of preclinical data in Molecular Therapy that further validates the therapeutic potential of ADX-097, a tissue-targeted complement inhibitor. The paper, titled "C3d-Targeted factor H inhibits tissue complement in disease models and reduces glomerular injury without affecting circulating complement," was co-authored by Q32 Bio scientists Fei Liu, Ph.D., and Sarah Ryan, with Chief Scientific Officer Shelia Violette, Ph.D., and Stefan Wawersik, Ph.D., Vice President and Head of Research at Q32 Bio as senior authors. ADX-097 is Q32 Bio's lead program from its tissue-targeted complement inhibitor platform. Q32 Bio has completed a Phase 1 clinical trial of ADX-097 and expects to initiate an open-label Phase 2 renal basket clinical trial this year as well as a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV). Initial data from the renal basket trial is expected by year-end and topline results from both Phase 2 trials are expected in 2025. "These data described in the Molecular Therapy paper underscore the transformative potential which a tissue-targeting approach may provide, representing an exciting next generation evolution within the complement therapeutics field," said Michael Holers, M.D., University of Colorado Smyth Professor of Rheumatology and a co-founder of Q32 Bio. "Although systemic inhibitors can be leveraged to treat diseases of complement hyperactivity, complete and highly effective inhibition in tissues is very difficult to achieve due to high circulating concentrations and rapid turnover of complement components, and local complement factor production. Systemic treatments also increase infection risk because of complement's essential role in innate immunity." Q32 Bio explored the biodistribution and pharmacology of fusion proteins containing a C3d antibody and a fragment of the complement negative regulator factor H (fH) in various animal models. The findings supported C3d as an effective localization target to deliver a novel and potent tissue-targeted approach to complement inhibition as demonstrated in mouse, rat and non-human primate models of complement activation. Additionally, in the Passive Heymann Nephritis model of membranous nephropathy in rats, researchers found that local complement inhibition is sufficient to modulate disease progression in vivo. Notably, without requiring systemic complement inhibition, C3d-mAb-fH fusion proteins in this model reduced glomerular complement, as measured in kidney tissue via immunostaining, as well as urinary complement activation biomarkers including the soluble C5b-9 complex. The fusion proteins also inhibited progression of renal injury and preserved podocyte architecture, suggesting disease-modifying efficacy. "These preclinical data support Q32 Bio's novel approach to tissue-targeted regulation of the complement system and the potential of ADX-097 across multiple complement-mediated diseases," said Dr. Violette. "Together with the promising results from our Phase 1 clinical trial in healthy volunteers, which demonstrated a favorable tolerability and immunogenicity profile across all single and multiple dose cohorts, we are excited to advance ADX-097 into a Phase 2 basket clinical trial in multiple renal disease indications this year." "The data presented indicate that tissue C3d deposition is a feature of several autoimmune diseases affecting multiple organs, co-localizing with active complement, and that C3d-targeting could be a means of locally delivering a complement inhibitor for these indications," added Dr. Wawersik. "These results suggest C3d-directed targeting as a strategy for potent, localized complement inhibitors, demonstrating that targeting local tissue complement results in durable and efficacious complement blockade while avoiding systemic inhibition. This has long been a goal in treating patients with autoimmune and inflammatory disorders." About ADX-097 ADX-097 is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade, a key differentiator from current complement therapeutics. Q32 Bio recently completed a first-in-human, Phase 1 ascending dose clinical study of ADX-097 in healthy volunteers. Results from the Phase 1 clinical trial demonstrated a favorable tolerability and immunogenicity profile across all single and multiple dose cohorts and weekly subcutaneous dosing met exposures for predicted complete complement inhibition in the tissue with no systemic inhibition. Q32 Bio expects to initiate an open-label Phase 2 basket clinical trial, with initial data expected by year-end 2024, and a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV), with topline results from the AAV and basket trials expected in the second half of 2025. About Q32 Bio Q32 Bio is a clinical stage biotechnology company developing biologic therapeutics targeting potent regulators of the innate and adaptive immune systems to re-balance immunity in autoimmune and inflammatory diseases. Q32 Bio's lead programs, focused on the IL-7 / TSLP receptor pathways and complement system, address immune dysregulation to help patients take back control of their lives. Q32 Bio's program for adaptive immunity, bempikibart (ADX-914), is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases. It is being evaluated in two Phase 2 trials for the treatment of atopic dermatitis and alopecia areata. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases. Q32 Bio's program for innate immunity, ADX-097, is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade – a key differentiator versus current complement therapeutics. Q32 Bio has recently completed a first-in-human, Phase 1 ascending dose clinical study of ADX-097 in healthy volunteers. Cautionary Statement Regarding Forward-Looking Statements This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of Q32 Bio's product candidates, including ADX-097, and anticipated milestones and timing, among others. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) potential unforeseen events during clinical trials could cause delays or other adverse consequences; (ii) risks relating to the regulatory approval process; (iii) interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; (iv) Q32 Bio's product candidates may cause serious adverse side effects; (v) the potential for ADX-097 to provide therapeutic benefit in complement mediated diseases; (vi) the company's reliance on third parties, including for the manufacture of materials for our research programs, preclinical and clinical studies; (vii) failure to obtain U.S. or international marketing approval; (viii) ongoing regulatory obligations; effects of significant competition; (ix) unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; (x) product liability lawsuits; (xi) securities class action litigation; (xii) the impact of the COVID-19 pandemic and general economic conditions on our business and operations, including the combined company's preclinical studies and clinical trials; (xiii) the possibility of system failures or security breaches; risks relating to intellectual property; Except as required by applicable law, Q32 Bio undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Important Information about the Merger and Where to Find It This communication relates to a proposed transaction between Homology Medicines and Q32 Bio. In connection with the proposed transaction, Homology Medicines has filed with the SEC a registration statement on Form S-4 that includes a proxy statement of Homology Medicines and that constitutes a prospectus with respect to shares of Homology Medicines' common stock to be issued in the proposed transaction (Proxy Statement/Prospectus). Homology Medicines may also file other documents with the SEC regarding the proposed transaction. This document is not a substitute for the Proxy Statement/Prospectus or any other document which Homology Medicines may file with the SEC. INVESTORS, Q32 BIO STOCKHOLDERS AND HOMOLOGY MEDICINES STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY HOMOLOGY MEDICINES WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors, Q32 Bio stockholders and Homology Medicines stockholders will also be able to obtain free copies of the Proxy Statement/Prospectus and other documents containing important information about Homology Medicines, Q32 Bio and the proposed transaction that are or will be filed with the SEC by Homology Medicines through the website maintained by the SEC at . Copies of the documents filed with the SEC by Homology Medicines will also be available free of charge on Homology Medicines' website at or by contacting Homology Medicines' investor relations department by email at [email protected]. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. Participants in the Solicitation Homology Medicines and certain of its directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies of Homology Medicines stockholders in connection with the proposed transaction. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to Homology Medicines stockholders in connection with the proposed transaction are set forth in the Proxy Statement/Prospectus on Form S-4 for the proposed transaction, has been filed with the SEC by Homology Medicines. Investors and security holders of Q32 Bio and Homology Medicines are urged to read the Proxy Statement/Prospectus and other relevant documents that are or will be filed with the SEC by Homology Medicines carefully and in their entirety when they become available because they contain, or will contain, important information about the proposed transaction. Investors and security holders will be able to obtain free copies of the Proxy Statement/Prospectus and other documents containing important information about Q32 Bio and Homology Medicines through the website maintained by the SEC at . Copies of the documents filed with the SEC by Homology Medicines can be obtained free of charge by directing a written request to Homology Medicines, Inc., One Patriots Park, Bedford, MA 01730. Contacts: Investors: Brendan Burns Media: Sarah Sutton Argot Partners 212.600.1902 [email protected] SOURCE Q32 Bio

Pancreatic cancer has the highest mortality rate of all major cancers with only a 3% relative-survival-rate at 5-years for the advanced form. [1], [2] Pancreatic tumors are highly resistant to chemotherapy and radiation and there are limited treatment options[2] FDA ODD designation bolsters NeoImmuneTech's determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat cancer ROCKVILLE, Md. , Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.[3] Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.2 Dr. Luke Oh, Ph.D., President of NeoImmuneTech, Inc. said: "We are excited that the FDA granted NT-I7 an ODD in the treatment of pancreatic cancer. This decision adds further credibility to our existing evidence that NT-I7 has the potential to bring a much-needed therapy option to people suffering from pancreatic cancer. We look forward to continuing our collaboration with FDA, as we explore the therapeutic benefits of combining NT-I7 with other anti-cancer treatments such as immunotherapies for patients with pancreatic cancer." NT-I7 has been studied in several robust phase I and II clinical trials and has demonstrated the potential to amplify T cells across the subsets, boost the immune system, and enhance the anti-tumor response in people with pancreatic cancer and other solid tumors.[5] The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent. About Pancreatic Cancer Pancreatic cancer is a malignant, aggressive tumor of the pancreas. More than 90% of cases develop in the exocrine tissue of the pancreas, which makes enzymes to digest food. The less common endocrine tumors, commonly referred to as pancreatic neuroendocrine tumors (NETs), develop in hormone-producing cells.[1} Whilst pancreatic cancer's low prevalence rate qualifies it as a rare cancer, the aggressiveness of the disease and its high death rate means that patients diagnosed have a very poor prognosis. Every year, 157,107 new patients are diagnosed with pancreatic cancer in the US and Europe Union combined. [1],[4] About NT-I7 (efineptakin alfa) (rhIL-7-hyFc) NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety pro making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. About NeoImmuneTech, Inc. NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit . Forward-looking Statements The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the "Company") that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company's control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein. Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties, and is subject to change based on various factors. [1] American Cancer Society 'Cancer Facts and Figures 2022' Last accessed: March 2022 [2] UEG Public Affaires 'Pancreatic Cancer Across Europe – Taking a United Stand' Last accessed: March 2022 [3] FDA letter [4] European Commission . (2018). European Cancer Information System. Last accessed: March 2022 [5] Naing A, Kim R, Barve M, et al408 Preliminary biomarker and clinical ata of a phase 2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab: cohort of subjects with checkpoint inhibitor-naïve advanced pancreatic cancer Journal for ImmunoTherapy of Cancer 2021;9:

NANTES, France--(BUSINESS WIRE)-- Regulatory News: OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024. Our preclinical programs are focused on 3 immunotherapy platforms, a source of innovation in immuno-oncology and inflammatory diseases linked to myeloid cells or T lymphocytes. Part of the portfolio generates revenues from existing industrial agreements and the progress of proprietary products, in clinical and preclinical stages, is a source of potential future revenue in markets with high medical needs. Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement. Moreover, we will reinforce the partnership and recurrent revenue strategy by relying on pharmaceutical partners recognized in the relevant markets for our other first-in-class innovative programs. All of which has been put in place over the last 12 months will help advance the Company’s growth path in the coming weeks and months.” Proprietary programs: a broad portfolio of advanced products Tedopi®, optimized epitope-based cancer vaccine Dossier and protocol approved by the FDA (Food and Drug Administration) in mid-January to launch a new confirmatory Phase 3 clinical trial in second-line lung cancer In September 2023, the positive results from the first Phase 3 clinical trial in third-line lung cancer with secondary resistance to immune checkpoint inhibitors (ICI) were published in Annals of Oncology. In March 2023, based on these results, compassionate use programs had been approved in France and Italy as well as an extended access made available in Spain. In July 2023, a patent was granted in the United States for the use of Tedopi® in cancer after failure with ICI. Based on the positive recommendations from the US FDA and from the European Medicines Agency (EMA) in early 2023, the Company filed a dossier to the FDA to continue the development of Tedopi® in the same patient population in secondary resistance, but in second-line treatment (due to changing medical practice and earlier administration of ICI, now used in first-line treatment in combination with chemotherapy). Moreover, a specific dossier was filed to the FDA to validate a companion diagnostic test to identify HLA-A2-positive cancer patients eligible for treatment with Tedopi®. This test, currently under evaluation, has been developed in close collaboration with GenDx (as part of funding from Bpifrance received in June 2023). The full dossier to initiate the new confirmatory Phase 3 trial of Tedopi® was filed to the FDA end of 2023. Both dossiers have just received a positive review from the American Agency that should enable trial initiation in the US in Q2 2024, and extension to Europe in S2 2024. In parallel, three exploratory Phase 2 clinical trials, sponsored by cooperative clinical oncology groups, explored the interest of Tedopi® in combination in several types of solid tumors: Pancreatic cancer: results expected in 2024, in combination with chemotherapy by FOLFIRI (sponsor: GERCOR); Ovarian cancer: results expected in 2025, in combination with an anti-PD1, pembrolizumab (sponsor: ARCAGY-GINECO); in lung cancer: results expected in 2025, in combination with an anti-PDA, nivolumab (sponsor: FoRT). OSE-127/Lusvertikimab: anti-IL-7 Receptor monoclonal antibody Phase 2 clinical trial ongoing in ulcerative colitis; end of patient enrollment expected in Q1 2024 An article published in The Journal of Immunology (February 2023), reported on the positive Phase 1 clinical results with a tolerability pro pharmacodynamic parameters determining the recommended dose in Phase 2. A decreased IL-7 pathway gene signature in human peripheral blood cells has been demonstrated confirming the efficient blockade of the target. In May 2023, OSE retained global and full rights on Lusvertikimab to continue its strategic development in ulcerative colitis. Further to a mutual agreement between both companies, Servier decided not to continue the clinical development of its program after an exploratory negative trial (a phase 2 in a complex and rare systemic disease: the Sjögren syndrome) and a review of its portfolio. The ongoing Phase 2 trial (CoTikiS trial: NCT04882007), a randomized, double-blind versus placebo study, is evaluating the efficacy and safety of Lusvertikimab in patients with moderate to severe active Ulcerative Colitis, naïve of any treatment or who previously failed or lost response or were intolerant to previous treatment(s) including biotherapies and immunosuppressive treatments. In July 2023, based on regular positive reviews, the study’s Drug Monitoring Board recommended continuing the trial until its completion. Another recommendation from the Committee was implemented to strengthen the recruitment planned after the failure of biological treatments (biotherapies of the anti-TNF type or other biological classes), due to patients naive to biotherapies (having not previously received biotherapies). Due to this recommendation, as well as to the geopolitical context, the trial was redirected towards new clinical centers in countries further west in Europe, concerning patients naive to biological treatments, who are much more numerous in the countries from Eastern Europe. Due to this rebalancing, the end of recruitment is now expected in Q1 2024, and the first results (from induction to week 10 and after 6 months of maintenance) are expected in mid-2024. Moreover, in July 2023, the EMA provided a positive opinion on Orphan Drug Designation for Lusvertikimab for the treatment of Acute Lymphoblastic Leukemia (ALL), opening future potential new indications in ALL, rare diseases with limited treatment options. OSE-279: proprietary anti-PD1 Phase 1/2 clinical trial ongoing in solid tumors The first positive clinical results of the trial initiated in December 2022, and announced in October 2023, show several confirmed antitumor responses in patients with solid tumors. An updated presentation of these results is planned for the end of February 2024 (ESMO-TAT conference). Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials. OSE-279, a potentially “best-in-class” product, represents a strategic opportunity currently being evaluated allowing continued development as a monotherapy in pre-identified niche indications in cancers with high medical need, and/or to explore combinations with other OSE drug candidates or with external active ingredients that could open the way to new potential partnerships. Industrial partnerships programs: important steps achieved OSE-172/BI 765063, selective SIRPα antagonist (that recognizes the V1 variant) and BI 770371 (that recognizes both the V1 and V2 variants), developed in partnership with Boehringer Ingelheim Clinical advancement of SIRPα selective inhibitors in solid tumors BI 765063 is being evaluated by Boehringer Ingelheim in different combinations in patients with metastatic or recurrent head and neck squamous cell carcinoma (HCC) or hepatocellular carcinoma (HCC) in an international study phase 1b initiated in May 2022 and conducted in the United States, Europe and Asia (NCT05249426). Promising results from the first Phase 1a study of early clinical efficacy data and biomarkers predictive of response and survival (on SIRPα, not CD47) were presented at the AACR Annual Meeting (American Association for Cancer Research) in April 2023 BI 770371 is a new selective anti-SIRPα monoclonal antibody (co-owned by OSE and Boehringer Ingelheim) recognizing both the V1 and V2 variants of SIRPα (the V2 allele being more common in Asian countries). It is currently being studied as a monotherapy and in combination with a PD1 inhibitor (BI 754091) in an international phase 1 dose escalation/expansion clinical trial (NCT05327946) conducted in Canada, the United States, and Japan in patients with solid tumors. The first clinical results of BI 770371, showing a manageable safety pro a maximum tolerated dose not reached, were presented at the ESMO (European Society for Medical Oncology) conference in October 2023. FR104/VEL-101: anti-CD28 selective monoclonal antibody, developed in partnership with Veloxis Pharmaceuticals, Inc. Two clinical trials, a phase 1/2 and a phase 1, completed in 2023 – Results expected in 2024 The ongoing phase 1/2 clinical trial, conducted and sponsored by the University Hospital Center of Nantes, evaluates the first use of FR104/VEL-101 intravenously in patients who have received a kidney transplant. After the end of recruitment was announced in July 2023, a positive interim analysis of the study was presented in December 2023 at the annual congress of the Société Francophone de Transplantation, showing the safety of the product used in combination and the first signals of efficacy in these kidney transplant recipients. Another phase 1 clinical trial was conducted and sponsored by Veloxis to evaluate FR104/VEL-101 subcutaneously. This trial was successfully completed in early 2023. Veloxis also obtained a “Fast Track” designation from the FDA for the development of FR104/VEL-101 for prophylaxis against transplant rejection. Following on from these two results, Veloxis plans to continue developing the product subcutaneously in an international phase 2 study in kidney transplantation. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation. The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-279 is the backbone therapy of the BiCKI® platform. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.). BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Myeloid checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in immuno-oncology. - CLEC-1 (a C-type lectin receptor) is a myeloid checkpoint and a novel therapeutic target of interest in immuno-oncology. Pro-resolutive antibody platform focused on controlling myeloid cell-mediated inflammation. - OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by this platform with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity. Increased cytokine platform focused on delivering the potential of modified cytokine in immuno-oncology or in auto-immune diseases. - The most advanced candidate is BiCKI®-IL-7 targeting anti-PD1xIL-7 in immuno-oncology. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: Click and follow us on Twitter and LinkedIn Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. View source version on businesswire.com: Contacts OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 U.S. Media Contact RooneyPartners LLC Kate Barrette kbarrette@rooneypartners.com +1 212 223 0561 Source: OSE Immunotherapeutics View this news release online at: