Major Estimate Revision • Jun 11
Consensus revenue estimates fall by 28% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from €8.68m to €6.25m. Forecast losses increased from -€1.11 to -€1.30 per share. Biotechs industry in France expected to see average net income growth of 6.0% next year. Consensus price target of €14.07 unchanged from last update. Share price rose 18% to €4.38 over the past week. New Risk • Apr 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 9.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (9.0% average weekly change). Revenue is less than US$5m (€1.8m revenue, or US$2.1m). Market cap is less than US$100m (€82.0m market cap, or US$96.1m). Annuncio • Apr 23
OSE Immunotherapeutics Announces Presentation Of Tedopi Phase 2 Topline Results In Ovarian Cancer OSE Immunotherapeutics SA announced that topline results from the TEDOVA Phase 2 international clinical trial of Tedopi in Ovarian Cancer sponsored by ARCAGY-GINECO have been selected for an oral presentation at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, United States (May 29 - June 2, 2026). The TEDOVA trial evaluates Tedopi as a maintenance treatment of ovarian cancer. The neo-epitope-based vaccine OSE-2101 with or without pembrolizumab versus best supportive care as maintenance in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy: The academic randomized TEDOVA/GINECO-OV244b/ENGOT-ov58 trial. Rapid Oral Abstract. Session: Gynecologic Cancer – Subtrack: Ovarian Cancer. Abstract 5510. Room: E450. May 30, 2026, 8:06-8:12am CDT (3:06-3:12pm EST). TEDOVA is a three-arm Phase 2 study evaluating Tedopi as a maintenance treatment, alone or in combination with anti-PD1 immune checkpoint inhibitor Keytruda (pembrolizumab), versus best supportive care in 185 patients in platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor. The primary endpoint is the Progression Free Survival (PFS) of the maintenance of Tedopi, with a PD1 inhibitor, after platinum-based chemotherapy in relapsed ovarian cancer. (NCT04713514). Annuncio • Apr 16
OSE Immunotherapeutics SA Announces Appointment of Thomas Gidoin as Deputy CEO and Aurore Morello as Chief Scientific Officer OSE Immunotherapeutics SA announced the appointment of Thomas Gidoin as Deputy Chief Executive Officer (Directeur Général Adjoint), in addition to his current duties, to support Marc Le Bozec in implementing OSE’s strategic plan. In his new role as Deputy CEO and CFO, he will notably drive the Company’s financial strategy, develop investor relations, and oversee corporate communications, as well as legal and corporate affairs. Thomas Gidoin is an experienced biopharma executive with a strong expertise in strategic financial leadership, capital markets and corporate affairs, both in private and listed companies on Euronext Paris and the US NASDAQ. He joined OSE Immunotherapeutics in June 2025 and has demonstrated significant contribution to defining and implementing the new 2026-2028 strategic plan. OSE Immunotherapeutics SA also announced the appointment of Aurore Morello, PhD, previously Head of Research and Director of R&D Programs, as Chief Scientific Officer. In her new role, she will oversee OSE’s research strategy, drive R&D innovation, and lead the Company’s scientific teams developing monoclonal antibodies, immunocytokines, and RNA-based immunotherapies. Dr Morello will also lead OSE’s Scientific Advisory Board, contributing to the strategic guidance of the Company’s scientific roadmap. Dr. Morello earned her PhD in Immunology and Oncology from the University of Bordeaux, France and completed a prestigious postdoctoral fellowship at Memorial Sloan Kettering Cancer Center (MSKCC) in New York, where her work focused on CAR T-cell therapies for solid tumors. She is the author of numerous publications in high-impact journals, and recipient of several scientific awards, including the MSKCC Young Researcher Award. Dr Morello joined OSE Immunotherapeutics in 2016. Price Target Changed • Mar 26
Price target decreased by 12% to €14.07 Down from €16.04, the current price target is an average from 3 analysts. New target price is 366% above last closing price of €3.02. Stock is down 51% over the past year. The company is forecast to post a net loss per share of €1.04 next year compared to a net loss per share of €1.48 last year. Annuncio • Mar 17
OSE Immunotherapeutics SA, Annual General Meeting, Jun 24, 2026 OSE Immunotherapeutics SA, Annual General Meeting, Jun 24, 2026. New Risk • Mar 12
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €85.3m (US$98.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Revenue is less than US$5m (€1.8m revenue, or US$2.1m). Market cap is less than US$100m (€85.3m market cap, or US$98.3m). Annuncio • Mar 10
OSE Immunotherapeutics SA Confirms Marc Le Bozec as Chief Executive Officer ,Effective March 10, 2026 OSE Immunotherapeutics SA announced the transition of Marc Le Bozec from interim to permanent Chief Executive Officer, effective March 10, 2026. Mr. Le Bozec had served as interim CEO since October 2, 2025. Following a thorough review of internal and external candidates and upon recommendation of the Nomination and Compensation Committee, the Board of Directors unanimously confirmed Marc Le Bozec's transition from interim to permanent CEO. New Risk • Jan 19
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: €33m Forecast net loss in 2 years: €19m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€19m net loss in 2 years). Revenue is less than US$5m (€1.8m revenue, or US$2.1m). New Risk • Jan 09
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 92% per year for the foreseeable future. Minor Risk Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Board Change • Nov 03
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO & Director Marc Le Bozec was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Annuncio • Oct 03
OSE Immunotherapeutics SA Announces Management Changes OSE Immunotherapeutics announced the termination of the position as chief executive officer of Mr. Nicolas Poirier and the appointment of Mr. Marc Le Bozec as interim CEO, as decided on October 2, 2025 by the Board of Directors. The Board of Directors has commenced a formal search for a new permanent Chief Executive Officer. The Board of Directors has empowered Marc Le Bozec to lead a strategic evaluation of OSE's business, with a focus on maximizing value across partnerships, finances, and clinical development programs. Nicolas Poirier will retain his position as Chief Scientific Officer at OSE. The termination of Mr. Nicolas Poirier's duties as Chief Executive Officer will not result in the payment of any compensation or indemnity, given that Mr. Nicolas Poirier is remunerated exclusively under his employment contract with the Company. The compensation of the new Chief Executive Officer will be reviewed by the Nomination and Compensation Committee and submitted to a vote at the next shareholders' general meeting, given the absence of a compensation policy for the Chief Executive Officer. Marc Le Bozec currently advises numerous biotech companies as a consultant, board member, and investor. He has extensive experience in interim management. Between 2015 and 2023, he created and managed two biotech investment funds at Financière Arbevel. He made 11 investments and facilitated two exits: TransCure bioServices, sold to Cathay Capital in early 2022, and Imactis, sold to GE Healthcare in early 2023. Previously, he was CFO of Cellectis, where he raised €120 million and prepared the company for its Nasdaq listing. He also led and successfully restructured CYTOO. A graduate of HEC Paris (1992), Marc Le Bozec began his career in organizational consulting (Bossard Consultants), then in strategy consulting (Arthur D. Little). He founded his first biotech company, BioProtein Technologies, in 1998. Annuncio • Oct 01
OSE Immunotherapeutics Approves Board Appointments OSE Immunotherapeutics at its Annual General Meeting held on September 30, 2025, shareholders notably voted in favor of the appointment of the following directors: Caroline Mary, as representative of employee shareholders. Pascale Briand, Markus Cappel, Jonathan Cool, Marc Le Bozec, Shihong Nicolaou and Alexis Peyroles. Following the General Meeting, the new Board of Directors held its first meeting and elected Dr. Markus Cappel as Chairman. Biographical highlights on Dr. Markus Cappel: Dr. Markus Cappel has over thirty years of experience in the biotechnology sector. He is widely recognized for his entrepreneurial spirit and for his outstanding achievements. As Chief Business Officer of ChemoCentryx, he led product development and key initiatives supporting the commercialization of TAVNEOS® across seven market countries. He also led multi-party negotiations with major pharmaceutical companies, securing agreements that preserved commercial rights and development control in the United States. He played a pivotal role in the acquisition of ChemoCentryx by Amgen for $4 billion, representing a 116% premium, after having raised $435 million at the IPO, $138 million through private equity fundraising, and over $250 million in non-dilutive financing. Prior to ChemoCentryx, Dr. Cappel served as Vice-President of Business Development at Advanced Inhalation Research (AIR), where he negotiated an exclusive agreement with Eli Lilly and built a strategic alliance with GlaxoSmithKline, securing an upfront payment of $125 million. Dr. Cappel holds an MBA from Harvard Business School and a PhD in Pharmaceutical Sciences from J.W. Goethe University in Germany. Valuation Update With 7 Day Price Move • Sep 30
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €6.76, the stock trades at a forward P/E ratio of 7x. Average trailing P/E is 21x in the Biotechs industry in Europe. Total returns to shareholders of 31% over the past three years. Major Estimate Revision • Sep 29
Consensus revenue estimates decrease by 15% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from €56.7m to €48.2m. EPS estimate unchanged from €0.91 per share at last update. Biotechs industry in France expected to see average net income growth of 23% next year. Consensus price target of €16.00 unchanged from last update. Share price fell 2.1% to €5.88 over the past week. New Risk • Sep 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 83% per year for the foreseeable future. Minor Risk Share price has been volatile over the past 3 months (6.7% average weekly change). Annuncio • Sep 13
OSE Immunotherapeutics and the FoRT Foundation Announces Completion of Enrollment in Combi-TED, a Phase 2 Clinical Trial Evaluating Tedopi in Combination with Nivolumab or Docetaxel in Patients with Non-Small Cell Cancer OSE Immunotherapeutics SA the FoRT Foundation (Fondazione Ricerca Traslazionale) today announced the completion of patient enrollment in a Phase 2 clinical trial evaluating the neoepitope-based therapeutic cancer vaccine Tedopi® in combination with nivolumab or docetaxel in patients with Non-Small Cell Lung Cancer (NSCLC). The clinical trial (NCT04884282) is sponsored and conducted by the Italian Foundation FoRT across sites in Italy, France and Spain. Combi-TED is an open label, randomized, three-arm Phase 2 study evaluating Tedopi® in combination with the anti-PD1 immune checkpoint inhibitor Opdivo® (nivolumab) or Tedopi® plus docetaxel or docetaxel alone (reference arm) as second-line treatment in HLA-A2 positive patients with metastatic NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangement, after first-line chemo-immunotherapy. The primary endpoint is 1-year survival rate. As planned, 105 patients were enrolled in the clinical study, and the readouts are expected in the second half of 2026 (Presentation at the ESMO 17-21 Oct. 2025: 2085eTrial in Progress (TiP): OSE2101 plus docetaxel or nivolumab as second line therapy in metastatic non-small-cell lung cancer (mNSCLC) progressing after first line chemoimmunotherapy (Combi-TED). Annuncio • Sep 10
OSE Immunotherapeutics SA to Report First Half, 2025 Results on Sep 30, 2025 OSE Immunotherapeutics SA announced that they will report first half, 2025 results on Sep 30, 2025 Major Estimate Revision • Sep 02
Consensus revenue estimates increase by 18% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from €48.2m to €56.7m. EPS estimate unchanged from €0.91 at last update. Biotechs industry in France expected to see average net income growth of 2.2% next year. Consensus price target of €17.50 unchanged from last update. Share price was steady at €6.19 over the past week. Annuncio • Aug 21
OSE Immunotherapeutics SA Announces Chief Financial Officer Changes OSE Immunotherapeutics SA announced the appointment of Thomas Gidoin as Chief Financial Officer. Thomas joins the Executive Committee, bringing over 15 years of deep international expertise in capital markets, financial strategy, and governance to the company. Thomas Gidoin is an experienced biopharma finance executive with a strong track record in strategic financial leadership, both in private and public companies. Prior to joining OSE Immunotherapeutics, he served as Chief Financial Officer at Advesya, a privately held Franco-Swiss clinical-stage biotech company in oncology and autoimmune diseases, after having spent 8 years as CFO of GenSight Biologics, where he led the company’s financing strategy from the Series B to the IPO on Euronext Paris and a number of follow-on transactions and structured financings. Previously, Thomas was Vice President of Finance at DBV Technologies, where he led the Corporate Finance team and contributed to public offerings and private placements, including the dual listing of the company on the US NASDAQ. Prior to this, Thomas served as Northern Europe Business Controller at PregLem in London, held several positions at Ipsen, including UK Operations Controller in London and Senior Financial Analyst in the Global Operations division in Paris. He started his career in audit at Ernst & Young in Paris. He holds master’s degrees in international finance from ESGF Paris and in international management from NEOMA Business School. Thomas succeeds Anne-Laure Autret-Cornet, marking a new phase in the company’s financial leadership. Valuation Update With 7 Day Price Move • Aug 18
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €6.91, the stock trades at a forward P/E ratio of 8x. Average trailing P/E is 15x in the Biotechs industry in France. Total loss to shareholders of 6.4% over the past three years. Valuation Update With 7 Day Price Move • Jul 25
Investor sentiment improves as stock rises 18% After last week's 18% share price gain to €6.28, the stock trades at a forward P/E ratio of 7x. Average trailing P/E is 15x in the Biotechs industry in France. Total loss to shareholders of 3.4% over the past three years. Valuation Update With 7 Day Price Move • Jun 11
Investor sentiment deteriorates as stock falls 15% After last week's 15% share price decline to €5.29, the stock trades at a forward P/E ratio of 6x. Average trailing P/E is 18x in the Biotechs industry in France. Total loss to shareholders of 15% over the past three years. Annuncio • Jun 02
Ose Immunotherapeutics Sa Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi®? in Pancreatic Cancer and Non-Small Cell Lung Cancer OSE Immunotherapeutics SA provided clinical updates on Tedopi®?, the "off-the-shelf" neo-epitope-based therapeutic cancer vaccine under evaluation in both monotherapy and combination therapy across five clinical trials in several cancer indications. Tedopi®? combines 10 neo-epitopes derived from five tumor antigens, selected for their presence in a range of tumors, offering a multi-target "pipeline in a product" approach for HLA-A2 positive patients to address unmet needs in oncology. The positive results for Tedopi®? in pancreatic cancer are promising for this devastating disease with a poor progosis. In lung cancer, patient recruitment is progressing per plan in the Artemia Phase 3 registration study, a key milestone bringing one step closer to the registration of Tedopi®? for NSCLC. As previously communicated, the readouts of the combination Phase 2 trials, CombiTED for NSCLC and TEDOVA for ovarian cancer, are expected in 2026. TEDOPaM - An oral communication, titled "Maintenance with OSE2101 plus FOLFIRI vs FOLFIRI alone after FOLFIRI reduction in patients with advanced pancreatic ductal adenocarcinoma (PDAC): Primary endpoint results of a randomized randomized TEDOPAM GERCOR D17-01 PRODIGE 63 trial" (abstract 4009) featuring positive topline Phase 2 results for the clinical trial TEDOPaM was presented by the GERCOR Oncology Group at ASCO 2025. TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI1 (Arm A) and cancer vaccine Tedopi®? (OSE2101) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patient with advanced or metastatic Pancreatic Ductal Adenocarcinoma (PD AC) with no progression after eight cycles of FOLFIRI reduction chemotherapy2. No new safety signal was observed. Prof. Cindy Neuzillet, MD, PhD (Curie Cancer Research Institute, Saint-Cloud), Principal Investigator of the Tedopi®? in combination therapy in advanced pancreatic cancer. The company now need more mature data on overall survival over a longer period. ARTEMIA - A "Trial in Progress" poster titled: Phase 3 trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy" was also presented at ASCO 2025. The Phase 3 pivotal clinical trial aims to support the registration of Tedopi as a second-line treatment in HLA-A 2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy. This pivotal trial is conducted in 14 countries across the United States, Canada, Europe, and United Kingdom. However, long-term survival rates remain low, underscores the need for continued research and development of more effective systemic therapies to improve outcomes for patients with resected PD-PD-(L)1. Annuncio • May 22
OSE Immunotherapeutics SA, Annual General Meeting, Jun 25, 2025 OSE Immunotherapeutics SA, Annual General Meeting, Jun 25, 2025. Location: hotel drawing house, 21 rue vercingetorix, paris France Annuncio • May 06
OSE Immunotherapeutics SA Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab OSE Immunotherapeutics SA announced that over >90% of people living with ulcerative colitis (UC) who achieved a clinical response after 10 weeks of treatment with Lusvertikimab maintained symptomatic remission for an additional 24 weeks. Of the participants who did not reach symptomatic remission in the first 10 weeks of treatment with either dose of Lusvertikimab, 61% had achieved remission after a further 24 weeks on the 850 mg dose. Lusvertikimab was well tolerated over the 24-week extended treatment period. These findings from the open-label extension (OLE) of the Phase 2 CoTikiS study of the anti-IL-7 receptor monoclonal antibody Lusvertikimab in UC were presented at Digestive Disease Week in San Diego (May 3 - 6, 2025). These build on results from the earlier induction phase presented at the ECCO 2025 congress in February. Findings from the OLE period, extending from Week 10 to Week 34, complete the CoTikiS dataset which provides a compelling Phase 2 efficacy and safety data package for Lusvertikimab In UC. OverVIEW OF COTIKIS EXTENSION PERIOD (OLE) FINDINGS1 Lusvertikimab demonstrated a deepening of treatment response and durable response, with a high rate of symptomatic remission. 89% of participants entered the OLE period and 87% of them completed the study. Rates of symptomatic remission6 improved for all dose groups in the OLE period, suggesting a deepening of efficacy. For participants who had received the 850 mg dose from the beginning of the study, rates plateaued already after Week 14; rates of symptomatic remission continued to improve through week 26 for the 450 mg induction group (10 weeks of 450 mg, 16 weeks of 850 mg dosing) and through week 34 for the group receiving placebo in the induction phase (10 weeks of placebo, 14 weeks of 850 mg Lusvertikimab). A 24-week OLE period in which all participants received Lusvertikimab 850 mg infusions every four weeks; and A 16-week safety follow-up period without treatment. Findings from the induction phase of the CoTikiS study were presented in February at the 2025 ECCO congress. Both doses met the primary efficacy endpoint (improvement in Modified Mayo Score at Week 10) and demonstrated statistically significant and clinically meaningful results on secondary clinical, endoscopy and histology endpoints. Valuation Update With 7 Day Price Move • May 02
Investor sentiment improves as stock rises 18% After last week's 18% share price gain to €6.76, the stock trades at a forward P/E ratio of 7x. Average trailing P/E is 28x in the Biotechs industry in Europe. Total loss to shareholders of 1.5% over the past three years. Annuncio • Apr 30
Ose Immunotherapeutics Sa Reports on an Oral Presentation from Research Collaboration with the Leon Berard Cancer Center At the American Association for Cancer Research Annual Meeting Held April 25 - 30, 2025 OSE Immunotherapeutics SA reported on an oral presentation from a research collaboration with the renowned Leon Berard Cancer Center in Lyon at the American Association for Cancer Research (AACR) Annual Meeting held April 25 - 30, 2025, in Chicago. Immune checkpoint blockade (ICB) therapies, targeting PD-1, PD-L1, and CTLA-4, have revolutionized cancer treatment by helping the immune system recognize and attack cancer cells more effectively. These therapies offer lasting responses and significant survival benefits across various cancers. However, current biomarkers like PD-L1 expression and tumor mutational burden (TMB) are not always reliable. PD-L1 expression can vary within tumors and between patients, making predictions inconsistent. Therefore, more universally applicable biomarkers are needed to predict patient responses and guide treatment decisions. While RNA sequencing has created detailed gene expression signatures (GES) that describe the tumor environment, their use in everyday clinical practice is limited due to their specificity and lack of widespread adoption. The presentation, entitled "A tumor agnostic composite gene expression signature identifies three groups of patients treated with immune checkpoint blockade with distinct clinical outcome", reported on the development and validation of a robust and tumor-agnostic composite gene expression signature (cGES) that can predict overall survival and progression free survival in cancer patients treated with immune checkpoint blockers (e.g. Anti PD-L1, Anti PD-1 and Anti CTLA-4). This signature could be useful in clinical practice to better stratify patients on risk and potentially guide treatment decisions of multiple cancer types. Valuation Update With 7 Day Price Move • Apr 16
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €5.96, the stock trades at a forward P/E ratio of 7x. Average trailing P/E is 22x in the Biotechs industry in Europe. Total loss to shareholders of 23% over the past three years. Reported Earnings • Mar 27
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: EPS: €1.72 (up from €1.18 loss in FY 2023). Revenue: €83.4m (up €81.2m from FY 2023). Net income: €37.4m (up €60.4m from FY 2023). Profit margin: 45% (up from net loss in FY 2023). The move to profitability was driven by higher revenue. Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 48%. Revenue is expected to decline by 50% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 27%. Over the last 3 years on average, earnings per share has increased by 79% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Annuncio • Mar 12
OSE Immunotherapeutics SA and GERCOR Announce Positive Topline Phase 2 Result for Clinical Trial TEDOPaM Evaluating OSE2101 in Advanced Pancreatic Cancer OSE Immunotherapeutics SA and the GERCOR Group announced that the primary endpoint has been reached in TEDOPaM (GERCOR D17-01 PRODIGE 63 trial), a Phase 2 clinical trial sponsored and conducted by the French GERCOR Oncology Clinician Group, evaluating OSE2101 (Tedopi), the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC). TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI (Arm A) and cancer vaccine OSE2101 (Tedopi) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with PDAC with no progression after eight cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). 107 patients were enrolled with a 1:1 ratio. The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with minimal toxicity for OSE2101 (Tedopi®) combined with FOLFIRI as maintenance treatment. Further follow-up and translational analyses are ongoing, with detailed results to be presented at upcoming medical congresses. PDAC is a highly aggressive form of cancer originating in the ducts of the pancreas. It represents about 95% of all pancreatic cancers. The global burden of pancreatic cancer has more than doubled in recent decades. It is now the sixth leading cause of cancer-related death worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The incidence of the disease continues to rise annually, with projections indicating a 95.4% increase in new cases by 2050. The overall five-year survival rate for pancreatic cancer is 10% worldwide, showing only a modest improvement over the past decade. More than 67,000 Americans will be diagnosed with pancreatic cancer in 2025, which is the equivalent of 184 people being diagnosed every day. Pancreatic cancer is now the 10 most found cancer in the US and represents about 3.5% of all new cancer diagnoses, and 7.1% of all cancer deaths in the EU. Price Target Changed • Feb 10
Price target increased by 22% to €15.37 Up from €12.60, the current price target is an average from 3 analysts. New target price is 145% above last closing price of €6.28. Stock is up 72% over the past year. The company is forecast to post earnings per share of €2.89 next year compared to a net loss per share of €1.18 last year. Annuncio • Jan 14
OSE Immunotherapeutics SA Appoints Dr. Sonya Montgomery as Chief Development Officer OSE Immunotherapeutics SA announced the appointment of Dr. Sonya Montgomery as Chief Development Officer. Sonya will serve on the OSE Immunotherapeutics Executive Committee in a strategic move that will enhance the company’s development capabilities. Dr. Montgomerybrings over two decades of experience leading R&D strategies at major life science companies. She will oversee development activities for the company’s key assets and the strategic development of the preclinical and clinical product portfolio, and coordinate development efforts across manufacturing, supply, translational & biomarker development, alliance, and medico-marketing teams. Dr. Montgomery’s expertise extends to defining and executing development strategies across various therapeutic areas and modalities. She is skilled in designing innovative and efficient development plans for biologics, advanced therapies, and small molecules. She has successfully partnered various clinical assets to large pharma, secured financing for pipeline programs, and led programs from discovery through registration in Europe and the United States. Dr. Montgomery started her career in Canada, later holding various global leadership positions, including Director and Clinical Lead at Pfizer (Connecticut and Cambridge, US), Executive Director Clinical Development at Relypsa (California, US), Vice President Clinical Development at ProQR (Netherlands), Vice President and Head of Clinical Development at Gyroscope Therapeutics (London, UK), and more recently Chief Medical Officer at Evox Therapeutics (Oxford, UK). She has also been an advisor on development strategy for early-stage biotech companies and supported their financing strategy. Valuation Update With 7 Day Price Move • Dec 02
Investor sentiment deteriorates as stock falls 18% After last week's 18% share price decline to €7.33, the stock trades at a forward P/E ratio of 3x. Average trailing P/E is 28x in the Biotechs industry in Europe. Total loss to shareholders of 26% over the past three years. Valuation Update With 7 Day Price Move • Oct 21
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to €10.36, the stock trades at a forward P/E ratio of 5x. Average trailing P/E is 24x in the Biotechs industry in Europe. Total returns to shareholders of 10% over the past three years. Reported Earnings • Sep 29
First half 2024 earnings released: EPS: €2.63 (vs €0.64 loss in 1H 2023) First half 2024 results: EPS: €2.63 (up from €0.64 loss in 1H 2023). Revenue: €82.6m (up €81.2m from 1H 2023). Net income: €57.2m (up €69.0m from 1H 2023). Profit margin: 69% (up from net loss in 1H 2023). The move to profitability was driven by higher revenue. Revenue is expected to decline by 46% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 32%. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. New Risk • Sep 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 58% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 58% per year for the foreseeable future. Minor Risk Shareholders have been diluted in the past year (16% increase in shares outstanding). Price Target Changed • Jul 05
Price target increased by 42% to €10.15 Up from €7.15, the current price target is an average from 2 analysts. New target price is 57% above last closing price of €6.48. Stock is up 74% over the past year. The company is forecast to post earnings per share of €3.40 next year compared to a net loss per share of €1.18 last year. New Risk • Jul 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 9.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 9.1% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-€20m). Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (€2.2m revenue, or US$2.4m). Annuncio • Jun 20
OSE Immunotherapeutics Presents Preclinical Data on Mrna Therapeutic Platform for the Treatment of Inflammatory and Autoimmune Disorders At the Focis Annual Meeting, San Francisco OSE Immunotherapeutics SA presented a poster on preclinical data on its mRNA (messenger RiboNucleic Acid) therapeutic platform for the treatment of inflammatory and autoimmune disorders at the Federation of Clinical Immunology Societies (FOCIS) annual meeting held in San Francisco (June 18 – 21, 2024). IL-35 (Interleukin-35) is an immunosuppressive cytokine capable of potently inhibiting immune- related inflammation by acting on multiple immune cells (T cells, Myeloid cells, B cells). IL-35 can promote differentiation of T and B cells into regulatory functional state to limit inflammatory response. IL-35 has demonstrated in preclinical studies a key role in controlling several immune related disorders including autoimmune diseases, infectious diseases, and cancer. OSE Immunotherapeutics’ mRNA therapeutic platform has been designed for the local delivery of mRNA into inflammatory tissue using lipid nanoparticles. mRNA encodes for immunotherapy to locally suppress immune response for the treatment of inflammatory and autoimmune diseases. This platform has the potential to deliver innovative immunotherapeutic drugs and to address new biology that cannot be targeted with standard biologic treatments. Breakeven Date Change • Jun 06
Forecast breakeven date moved forward to 2024 The 3 analysts covering OSE Immunotherapeutics previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of €17.5m in 2024. Earnings growth of 79% is required to achieve expected profit on schedule. Annuncio • May 09
OSE Immunotherapeutics SA, Annual General Meeting, Jun 19, 2024 OSE Immunotherapeutics SA, Annual General Meeting, Jun 19, 2024. Location: 21 rue vercingetorix, paris France Major Estimate Revision • Apr 03
Consensus revenue estimates increase by 59% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from €23.9m to €37.8m. Forecast losses expected to reduce from -€0.463 to -€0.43 per share. Biotechs industry in France expected to see average net income decline 8.4% next year. Consensus price target of €7.15 unchanged from last update. Share price was steady at €4.87 over the past week. Reported Earnings • Mar 31
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2023 results: €1.18 loss per share (further deteriorated from €0.96 loss in FY 2022). Net loss: €23.0m (loss widened 30% from FY 2022). Revenue missed analyst estimates by 26%. Earnings per share (EPS) exceeded analyst estimates by 29%. Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 36% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 27% per year, which means it is performing significantly worse than earnings. Breakeven Date Change • Mar 18
Forecast to breakeven in 2025 The 3 analysts covering OSE Immunotherapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €51.7m in 2025. Average annual earnings growth of 81% is required to achieve expected profit on schedule. Annuncio • Feb 27
OSE Immunotherapeutics Provides Update on Clinical Results With OSE-279 in Advanced Solid Tumors OSE Immunotherapeutics SA presented an update on the positive results of OSE-279 in the Phase 1/2 clinical evaluation in advanced solid tumors at the 2024 ESMO Targeted Anticancer Therapies Congress [1] (ESMO TAT) held in Paris, France (February 26 – 28, Abstract #368; FPN 30P). The ESMO-TAT communication reported on the positive results from the Phase 1/2 clinical trial (NCT05751798 [2]) evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available. The updated data show a good pharmacokinetic/pharmacodynamic (PK/PD) and manageable safety profile in line with previous anti-PD1 development and with a high signal of efficacy in the first 20 patients representing 13 different tumor types. Four confirmed ongoing partial responses (PR) with 600 mg every six weeks (q6w), with a response rate of 36%, were reported in patients with anal squamous cell carcinoma, undifferentiated pleomorphic sarcoma, oncocytic thyroid cancer, and alveolar soft part sarcoma. One still ongoing confirmed PR (81% reduction of target lesions) has been observed in a patient with hepatocellular carcinoma after one single dose of OSE-279 300 mg. Five stable diseases (SD) were reported at multiple dose levels. Treatment is ongoing in seven patients. Pharmacokinetic (PK) showed dose-proportionality and favorable exposure. Receptor occupancy (RO) was maintained. At 600 mg q6w, no dose-limiting toxicities (DLTs) were reported in 10 patients. Further to the recommendation of a Phase 2 dose (RP2D) of 300 mg q3w, the dose of 600 mg q6w has been selected as the second RP2D. OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. Overexpression of PD-L1 and PD-L2 on tumor and myeloid cells in the tumor microenvironment is a mechanism of tumor immune escape. The first-in-human open label Phase 1/2 dose escalation and expansion study, initiated in December 2022, aims to determine the Maximum Tolerated Dose (MTD) and/or the RP2D of OSE-279 as a monotherapy in advanced solid tumors with two possible administration regimens. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile. New Risk • Jan 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-€28m free cash flow). Minor Risks Shareholders have been diluted in the past year (17% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.9m). Market cap is less than US$100m (€83.8m market cap, or US$91.3m). Annuncio • Dec 11
OSE Immunotherapeutics SA and Nantes University Hospital Presents Positive Interim Data Analysis from the FIRsT Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplant OSE Immunotherapeutics SA and Nantes University Hospital presented positive interim data analysis from first use of anti-CD28 FR104/VEL-101 in kidney transplantation at the Annual Meeting of the Francophone Society of Transplantation(SFT, Société Francophone de Transplantation) held in Brest, France (December 5 – 8, 2023). The oral communication, entitled “First use of FR104, an anti-CD28 molecule in human kidney transplantation, interim analysis”, reported on the first data from the Phase 1/2 clinical trial FIRsT evaluating FR104/VEL-101(emerging locally from the ITUN/CR2TI*) in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics. The purpose of the FIRsT Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment is performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 is evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events. Ten patient candidates to a first kidney transplant at low risk of rejection, as planned in the protocol, have been included in the FIRsT study for eight analyzable patients (two patients were screened and enrolled but not transplanted for technical reasons). Tacrolimus (a calcineurin inhibitor) was withdrawn after 6 months post-transplantation. Seven patients completed 1-year treatment with FR104/VEL-101 and one is ongoing (Month 4). At this interim analysis, no safety alert was detected for FR104/VEL-101. Adverse events were those conventionally observed in kidney transplantation. Pharmacological monitoring made it possible to optimize exposure to FR104/VEL-101 and to maintain high receptor occupancy during the one-year follow-up. No acute rejection under FR104/VEL-101 was observed, especially after discontinuation of Tacrolimus. One of the key challenges in organ transplantation remains to replace calcineurin inhibitors with efficient immunosuppressive treatments with minimal side effects, particularly on renal function in order to preserve patients’ quality of life, and long-term control of post-transplant immune reaction. Annuncio • Oct 24
Ose Immunotherapeutics Sa Announces First Clinical Results for Bi 770371, A Novel Anti-Sirpa Monoclonal Antibody OSE Immunotherapeutics SA announced that first Phase 1 results for BI 770371, a novel anti-SIRPa monoclonal antibody evaluated in advanced solid tumors, have been presented, at the European Society for Medical Oncology conference, held in Madrid, Spain (October 20 - 24, 2023). The BI 770371 development program will extend the therapeutic potential of selective SIRPa antagonists in various diseases or disorders, covering the most prevalent allelic variants of SIRPa, V1 SIRPa and V2 SIRPa expressed on myeloid cells. Boehringer Ingelheim is currently evaluating BI 770371 as monotherapy and in combination with ezabenlimab, a PD1 inhibitor (BI 754091), in an open-label, dose escalation/dose expansion Phase I clinical trial (NCT05327946) conducted in Canada, USA and Japan in patients with advanced solid tumours. The first clinical results of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract #697P) showed that adverse events were manageable during the on-treatment period, Maximal Tolerated Dose (MTD) has not been reached. This clinical trial is ongoing. Boehringer IngELheim is also evaluating BI 765063 (formerly OSE-172) in different combinations with patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC) in a Phase 1b trial conducted in the United States, Europe and Asia (NCT05249426). Major Estimate Revision • Oct 04
Consensus revenue estimates fall by 73% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from €11.5m to €3.15m. Forecast losses increased from -€1.10 to -€1.14 per share. Biotechs industry in France expected to see average net income growth of 9.4% next year. Consensus price target down from €11.10 to €7.35. Share price rose 2.5% to €4.60 over the past week. Reported Earnings • Sep 29
First half 2023 earnings released: €0.64 loss per share (vs €0.11 loss in 1H 2022) First half 2023 results: €0.64 loss per share (further deteriorated from €0.11 loss in 1H 2022). Net loss: €11.9m (loss widened 499% from 1H 2022). Revenue is forecast to grow 103% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 13% per year, which means it is performing significantly worse than earnings. New Risk • Sep 28
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€19m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Minor Risks Revenue is less than US$5m (€3.6m revenue, or US$3.8m). Market cap is less than US$100m (€84.4m market cap, or US$89.3m). Breakeven Date Change • Sep 28
Forecast breakeven date moved forward to 2024 The 2 analysts covering OSE Immunotherapeutics previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of €3.57m in 2024. Average annual earnings growth of 135% is required to achieve expected profit on schedule. Annuncio • Jul 22
OSE Immunotherapeutics SA Announces Publication in Frontiers in Immunology on Ose-230, Its Novel Agonist Therapy in Chronic Inflammation OSE Immunotherapeutics SA announced the publication of its latest peer-reviewed results on pro-resolutive monoclonal antibody OSE-230, a novel and innovative approach in the management of the resolution of chronic and severe inflammation, in the leading journal Frontiers in Immunology. The article, entitled: "ChemR23 activation reprograms macrophages toward a less inflammatory phenotype and dampens carcinoma progression", reports on ChemR23 expression by Tumor-Associated Macrophages (TAM) and the use of tumor models to explore OSE-230's pro-resolutive and non-immunosuppressive activity in a chronic severe inflammatory situation associated with cancer and metastasis. OSE-230's target, ChemR23, also known as chemerin chemokine-like receptor 1 (CMKLR1), a G-protein coupled receptor (GPCR), is expressed by human TAM, the most frequent infiltrating immune cells in tumors known to modulate pro-tumoral chronic inflammation. The research demonstrated the reprogramming of TAM through the activation of ChemR23 by OSE-230. ChemR23 receptor strongly controls macrophage phenotype and its activation by OSE-230 results in major remodeling of the tumor immune microenvironment by limiting macrophages' immunosuppressive functions, activating T lymphocyte activity as well as modifying the metastatic niche. The research conducted jointly with the CRCI2NA laboratory (Nantes, Principal investigators: Christophe Blanquart and Sophie Barille) has demonstrated the long-term efficacy of OSE-230 based on the strong expression of ChemR23 in a high inflammatory and severe chronic model. With occurrence of metastases reduced and overall survival extended, these data support the durability of OSE-230's agonist effect on chronic and severe inflammation. This makes OSE-230 a first-in-class candidate for IND-enabling studies and opens its development pathway in various chronic inflammatory diseases with significant advantage over immunosuppressive therapies". ChemR23 activation reprograms Macrophages toward a less inflammatory disease and dampens carcinoma progression, Frontiers Immunology Frontiers, Front. Immunol., 19 July 2023, Sec. Cancer Immunity and Immunotherapy, Volume 14 - 2023. Annuncio • Jul 12
OSE Immunotherapeutics and Nantes University Hospital Announce Completion of Patient Enrollment in the FIRsT Clinical Trial, a Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplantation OSE Immunotherapeutics and Nantes University Hospital announced the completion of patient enrollment in the FIRsT Study. This Phase 1/2 clinical trial is the first study to evaluate the immunotherapy FR104/VEL-101, a monoclonal antibody fragment CD28 antagonist, in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics. The purpose of this Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment will be performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 will be evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events. Price Target Changed • Jul 10
Price target decreased by 14% to €10.80 Down from €12.50, the current price target is an average from 2 analysts. New target price is 200% above last closing price of €3.60. Stock is down 44% over the past year. The company is forecast to post a net loss per share of €1.48 next year compared to a net loss per share of €0.96 last year. Board Change • Jul 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Employee Shareholder Representative Director & CFO Anne-Laure Autret-Cornet was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Jun 29
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Bernard Malissen was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Jun 16
Price target decreased by 7.7% to €12.00 Down from €13.00, the current price target is an average from 2 analysts. New target price is 244% above last closing price of €3.49. Stock is down 44% over the past year. The company is forecast to post a net loss per share of €1.68 next year compared to a net loss per share of €0.96 last year. Annuncio • Jun 06
OSE Immunotherapeutics SA Presents Clinical Abstracts on Tedopi at the ASCO 2023 Annual Meeting OSE Immunotherapeutics SA presented a poster and a publication in abstract book featuring Tedopi, an immunotherapy activating tumor specific T-cells, in non-small cell lung cancer (NSCLC) and in ovarian cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6. AddITIONAL data from the POSITIVE PHASE 3 CLINICAL TRIAL IN NSCLC, ATALANTE-1 randomized trial", reported an analysis performed to identify the prognostic factors of overall survival (OS) in each treatment group of the Phase 3 clinical trial of Tedopi®? (Atalante-1) in HLA-A2+ patients with advanced or metastatic non-small cell lung cancer, led by Pr. Benjamin Besse, Gustave Roussy cancer center, Principal Investigator of the study. Tedopi®? is the first cancer vaccine that has shown positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to immune checkpoint inhibitors in advanced or metastatic NSCLC (Phase 3 trial ATALANTE-1). Classical baseline factors (disease stage, histology) and treatment effect including best response, safety and ECOG Performance Status (PS) deterioration were studied in this analysis and correlated to OS. These results support the mechanism of action of Tedopi®? in improving OS by controlling tumor growth regardless of best response. Annuncio • Jun 01
OSE Immunotherapeutics SA, Annual General Meeting, Jun 22, 2023 OSE Immunotherapeutics SA, Annual General Meeting, Jun 22, 2023. Annuncio • May 25
OSE Immunotherapeutics and GERCOR Oncology Clinician Group Announces Completion of Patient Enrollment in TEDOPaM Phase 2 Clinical Trial with Tedopi in Advanced Pancreatic Cancer OSE Immunotherapeutics SA announced completion of patient enrollment in the Phase 2 clinical trial TEDOPaM sponsored and conducted by the GERCOR Group and evaluating Tedopi in advanced or metastatic pancreatic ductal adenocarcinoma. This randomized, non-comparative Phase 2 trial is designed to evaluate Tedopi plus FOLFIRI chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after 8 cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis =25%; alternative hypothesis = 50%), and the key secondary endpoint is the progression-free survival [TEDOPaM GERCOR D17-01 PRODIGE 63 study: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma NCT03806309]. The interim results from the TEDOPaM Phase 2 trial presented at the 2022 ASCO (American Society of Clinical Oncology) meeting referred to the first 29 randomized HLA-A2 positive patients with no progression after 8 cycles of FOLFIRINOX: 9 patients included in standard arm A (FOLFIRI) with a 1-year OS rate of 44% and one partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with a similar 1-year OS rate of 40% and one partial response (10%); and 10 patients in experimental arm C (nivolumab + Tedopi) with a 1-year OS rate of 30% and no partial response. Tedopi as maintenance monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. Nivolumab + Tedopi was associated with poorer outcomes leading to the closing of this arm. Following an Independent Data Monitoring Committee (IDMC) recommendation, the study continued with an amended protocol comparing a maintenance treatment Tedopi in combination with FOLFIRI versus FOLFIRI chemotherapy after treatment with FOLFIRINOX. A total of 107 patients were enrolled in this second part. Breakeven Date Change • May 23
Forecast to breakeven in 2025 The analyst covering OSE Immunotherapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of €37.2m in 2025. Average annual earnings growth of 34% is required to achieve expected profit on schedule. Reported Earnings • Apr 30
Full year 2022 earnings: EPS and revenues exceed analyst expectations Full year 2022 results: €0.96 loss per share (further deteriorated from €0.93 loss in FY 2021). Revenue: €18.3m (down 30% from FY 2021). Net loss: €17.8m (loss widened 5.4% from FY 2021). Revenue exceeded analyst estimates by 14%. Earnings per share (EPS) also surpassed analyst estimates by 32%. Revenue is expected to decline by 50% p.a. on average during the next 2 years, while revenues in the Biotechs industry in France are expected to grow by 18%. Over the last 3 years on average, earnings per share has fallen by 10% per year whereas the company’s share price has fallen by 12% per year. Annuncio • Feb 16
OSE Immunotherapeutics SA Provides Regulatory Update on Tedopi®, a Cancer Vaccine at a Late-Stage Clinical Development in Lung Cancer After Failure to Immunotherapies OSE Immunotherapeutics SA provided a regulatory update on the clinical development plan of Tedopi®, an immunotherapy activating tumor specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. Both Agencies supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second line treatment for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC). OSE Immunotherapeutics is thus progressing on the protocol development for the next confirmatory phase 3 pivotal trial to support the regulatory registration of Tedopi® in second line. This upcoming phase 3 is planned for HLA-A2+ patients with secondary resistance to immunotherapy (IO) after a first line of chemo-IO followed by failure to maintenance IO of at least 12 weeks (defined as the threshold for secondary/acquired resistance by international expert consensus recommendations). The protocol design is developed with the support of the international NSCLC clinician experts’ group which were already involved in the previous phase 3 ATALANTE trial. Tedopi® is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to ICI in advanced or metastatic NSCLC. Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi® versus 27.5% with chemotherapy; - Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi® versus 35% with chemotherapy, p<0.05); - Significant better quality of life (Global health status: p=0.045; Role Functioning: p=0.025). The results from the first phase 3 trial (ATALANTE) in a clearly defined target population are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi®’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi® differs from ICI releasing the break of immune response. OSE Immunotherapeutics is committed to provide Tedopi® through cohort early access and nominative compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement. The French National Authority for Health issued a negative decision on the cohort early access program in third line treatment related to the COVID crisis which led to the suspension of patient inclusion in the previous phase 3 ATALANTE and the consecutive primary analysis on a population of interest with secondary resistance. Patients can benefit from Tedopi® through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives. Major Estimate Revision • Dec 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from €15.5m to €15.7m. Forecast EPS reduced from -€1.08 to -€1.24 per share. Biotechs industry in France expected to see average net income growth of 1.6% next year. Consensus price target of €15.03 unchanged from last update. Share price fell 6.1% to €6.50 over the past week. Price Target Changed • Dec 14
Price target decreased to €15.03 Down from €16.78, the current price target is an average from 2 analysts. New target price is 117% above last closing price of €6.92. Stock is down 30% over the past year. The company is forecast to post a net loss per share of €1.09 next year compared to a net loss per share of €0.93 last year. Reported Earnings • Sep 23
First half 2022 earnings released: €0.11 loss per share (vs €0.64 loss in 1H 2021) First half 2022 results: €0.11 loss per share (improved from €0.64 loss in 1H 2021). Revenue: €16.0m (up 79% from 1H 2021). Net loss: €1.98m (loss narrowed 83% from 1H 2021). Revenue is expected to decline by 25% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 30%. Over the last 3 years on average, earnings per share has fallen by 31% per year but the company’s share price has increased by 10% per year, which means it is well ahead of earnings. Major Estimate Revision • May 04
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -€1.12 to -€1.42 per share. Revenue forecast of €24.2m unchanged since last update. Biotechs industry in France expected to see average net income growth of 1.6% next year. Consensus price target of €16.73 unchanged from last update. Share price rose 4.0% to €7.20 over the past week. Breakeven Date Change • Apr 01
No longer forecast to breakeven The 4 analysts covering OSE Immunotherapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €3.45m in 2023. New consensus forecast suggests the company will make a loss of €13.3m in 2024. Reported Earnings • Sep 23
First half 2021 earnings released: €0.64 loss per share (vs €0.21 loss in 1H 2020) The company reported a mediocre first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: €8.98m (up 53% from 1H 2020). Net loss: €11.5m (loss widened 269% from 1H 2020). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 147 percentage points per year, which is a significant difference in performance. Price Target Changed • Apr 25
Price target increased to €16.33 Up from €14.80, the current price target is an average from 3 analysts. New target price is 47% above last closing price of €11.12. Stock is up 122% over the past year. Reported Earnings • Mar 29
Full year 2020 earnings released: €1.06 loss per share (vs €0.31 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €10.4m (down 60% from FY 2019). Net loss: €16.6m (loss widened 256% from FY 2019). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 118 percentage points per year, which is a significant difference in performance. Major Estimate Revision • Feb 19
Analysts increase EPS estimates to -€0.54 The 2020 consensus revenue estimate increased from €12.5m to €13.7m. Analysts raised their EPS forecasts from -€0.64 to -€0.54 in 2020. The Biotechs industry in France is expected to see an average net income growth of 8.7% next year. The consensus price target increased from €10.80 to €14.80. Share price is down by 4.2% to €12.70 over the past week. Price Target Changed • Feb 18
Price target raised to €12.80 Up from €10.80, the current price target is an average from 5 analysts. The new target price is close to the current share price of €13.25. As of last close, the stock is up 233% over the past year.