New Risk • Apr 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €2.93m (US$3.21m) This is considered a major 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: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Market cap is less than US$10m (€2.93m market cap, or US$3.21m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (€7.1m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Aankondiging • Mar 14
Medigene Files Patent for Unique NK-Specific TCR Construct with European Patent Office Medigene AG announced the submission of a patent for a novel natural killer (NK) cell-specific TCR construct to the European Patent Office. With that, Medigene is advancing its TCR-guided strategy by expanding the application of its proprietary 3S (sensitive, specific, and safe) TCRs into NK cells. This patent application marks a major expansion of Medigene's intellectual property portfolio, broadening its therapeutic reach and reinforcing its commitment to developing innovative, off-the-shelf immunotherapies for cancer treatment. To enable this innovation, Medigene combined TCR-guided precision targeting with innate NK cell killing. The Company has developed a proprietary universal scaffold that allows its 3S TCRs to function in NK cells without requiring CD3 co-expression. This novel NK-TCR system enhances NK cell production and therapeutic potential by facilitating the efficient transfer of all 3S TCRs into NK cells, streamlining the manufacturing process for future allogeneic TCR-NK therapies. By eliminating CD3 dependency, this approach overcomes a critical limitation in TCR-based NK cell therapy development, delivering a scalable, clinically viable solution that accelerates therapeutic timelines and reduces costs. New Risk • Mar 02
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (€7.1m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€24.3m market cap, or US$25.2m). Price Target Changed • Feb 26
Price target increased by 190% to €2.90 Up from €1.00, the current price target is an average from 2 analysts. New target price is 79% above last closing price of €1.62. Stock is down 44% over the past year. The company is forecast to post a net loss per share of €1.02 next year compared to a net loss per share of €1.32 last year. Aankondiging • Feb 19
Medigene Ag Expands Patent Portfolio with Patent Grant for Its Jovi Technology in the U.S Medigene AG announced that the Company has been issued a patent by the U.S. Patent Office protecting its JOVI technology, a method allowing the enrichment of T cells using a specific anti-Cb antibody. The U.S. patent for the JOVI technology was granted at the end of last year with the official notification received by Medigene in 2025. The selection of optimal 3S TCRs is crucial for developing TCR-guided therapies, such as off-the-shelf TCR-TCE and TCR-NK therapies, with enhanced safety and efficacy. The Company's innovative JOVI technology employs a high-throughput comparison approach, facilitating the enrichment of recombinant TCR-expressing T cells. This allows for straightforward comparison of their efficacy and safety profiles, ensuring the generation of superior TCR-guided therapies. Medigene continuously strengthens and expands its patent portfolio by developing new 3S TCRs, integrating advanced technologies, and extending its existing patents to new regions. The Company now owns over 29 unique patent families worldwide, protecting its 3S TCRs and proprietary E2E Platform technologies. Aankondiging • Dec 09
Medigene AG Announces KRAS G12V as First Target for TCR-guided T Cell Engagers Medigene AG announced the selection of Kirsten rat sarcoma viral oncogene homologue (KRAS) G12V, in the context of HLA*A11, as the initial target for the co-development of T cell receptor-guided T cell engagers (TCR-TCEs) with WuXi Biologics. The selection of this first target is a key step for the partnership between Medigene and WuXi Biologics, which aims to advance multiple TCR-TCEs over the next three years. The collaboration seeks to harness Medigene’s expertise in the generation and characterization of highly sensitive, specific and safe (3S) TCRs with WuXi Biologics’ unique anti-CD3 monoclonal antibody (mAb), its TCE platform and proprietary bispecific antibody platform WuXiBody™. KRAS mutations are widely recognized as the most common oncogene mutations and play a significant role in indications that affect a large number of patients, such as pancreatic, small bowel, colorectal, and lung cancers. In pancreatic cancer, KRAS mutations are among the earliest and most critical genetic alterations, present in over 95% of cases; here, G12D and G12V are the most frequent (~65%). In 2020, pancreatic cancer was the seventh leading cause of cancer-related deaths globally for both men and women, with nearly as many newly diagnosed patients (496,000) as deaths (466,000) from this single indication. The bispecific therapies market offers a significant opportunity in the fight against cancer, addressing the unmet need in both solid and hematologic tumors. Over 5 million cancer patients worldwide face low five-year survival rates, highlighting the urgent demand for innovative treatments. Bispecific TCR-TCEs, which harness the immune system to target cancer cells more precisely, are projected to grow at a compound annual rate of 40.9% from 2023 to 2030. By 2030, the market is expected to surpass USD 80 billion5, reflecting its potential to transform cancer treatment and improve patient outcomes. Aankondiging • Nov 08
Medigene AG Presents Unique Approach for Use of Optimal T Cell Receptors in TCR-Guided Modalities At Cell 2024 Medigene AG highlighted recent advances in its proprietary End-to-End Platform to create optimal safe, sensitive, and specific (3S) T cell receptors that can be applied in various modalities, including therapies utilizing T cell receptor engineered T (TCR-T) cells, TCR-guided T cell engagers (TCR-TCEs) and TCR-natural killer cell therapies (TCR-NK) at the Cell 2024 Conference by Oxford Global taking place in London, UK from November 6-8, 2024. Aankondiging • Sep 16
Medigene AG Presents Progress on KRAS Library and UniTope & TraCR Technology at ESMO 2024 Medigene AG presented updates for its T cell receptor (TCR) library targeting the Kirsten rat sarcoma viral oncogene homolog (KRAS) and also highlighted advancements of its UniTope and TraCR technology, which serves as a universal system for tagging and tracking recombinant TCRs (rTCRs) across multiple modalities, including T cell receptor engineered T cell (TCR-T) therapies, at the ESMO Congress 2024 taking place in Barcelona from September 13-17, 2024. The first data presented showcased recent advancements in the expansion of the Company's KRAS library, using a high-throughput approach to develop optimal affinity TCRs targeting the mKRAS G12D neoantigen in the context of HLA-A11 via Medigene’s proprietary E2E Platform. Further in vitro studies characterized the lead TCR candidate in terms of specificity, sensitivity, and safety (3S) while incorporating the PD1-41BB CSP. TCR-expressing T cells, when stimulated by mKRAS G12D-positive tumor cells, showed increased interferon gamma (IFN?) release. Reduced cancer cell survival was observed when mKRAS G12D-positive tumor cell lines from various origins were exposed to T cells co-expressing the rTCR mKRAS G12D-HLA-A11 and PD1-41BB CSP. These effects were specific to mKRAS G12D, with no impact on wild-type KRAS cells. The TCR demonstrated an excellent safety profile, with no off-target toxicity against an extensive panel of healthy cell types. Finally, in vitro data showed that co-expression of PD1-41BB CSP enhanced and sustained T cell function in an rTCR-specific manner, with gated activation that only occurred when the specific peptide-HLA complex was present on target cells, and not through PD-L1 expression alone. The second poster displayed the Company´s recently introduced universal TCR tagging and tracking combination technology UniTope & TraCR. Bioinformatic alignment of T cell receptor beta variable sequences enabled a six-amino-acid peptide (UniTope) to be predicted that is not found in natural TCR beta chains and has low immunogenicity. In parallel, an antibody was developed to specifically target this short aminbo acid peptide (TraCR) and further in vitro experiments demonstrated that TCR-T cells containing the UniTope sequence exhibited similar effects to those of TCR-T cells without the UniTope sequence. Integration of the UniTope sequence in a rTCR guarantees 100% co-expression of the tag and provides a significant advancement over current methods of detection of rTCRs in TCR-guided therapeutics. In vitro studies confirmed that insertion of UniTope did not alter expression or functionality of rTCRs. In addition, safety assessments confirmed that UniTope-modified rTCRs displayed the same high safety profile as un-modified rTCRs with respect to lack of recognition and killing of 16 healthy cell types. New Risk • Sep 11
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 German stocks, typically moving 6.8% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-€15m free cash flow). Earnings are forecast to decline by an average of 4.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€12m net loss in 3 years). Share price has been volatile over the past 3 months (6.8% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€26.6m market cap, or US$29.4m). Major Estimate Revision • Sep 06
Consensus EPS estimates fall by 18% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -€0.76 to -€0.90 per share. Revenue forecast of €11.0m unchanged since last update. Biotechs industry in Germany expected to see average net income growth of 3.8% next year. Consensus price target of €6.00 unchanged from last update. Share price fell 12% to €1.78 over the past week. Reported Earnings • Aug 16
Second quarter 2024 earnings released: €0.15 loss per share (vs €0.17 loss in 2Q 2023) Second quarter 2024 results: €0.15 loss per share. Revenue: €1.46m (down 6.0% from 2Q 2023). Net loss: €4.08m (flat on 2Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Aankondiging • Aug 14
Medigene AG Reaffirms Revenue Guidance for the Year 2024 Medigene AG reaffirmed revenue guidance for the year 2024. The company maintained its guidance on expected revenues to be between EUR 9.0 million and EUR 11.0 million (unchanged) in 2024. Aankondiging • Jul 04
Medigene AG Expands Patent Portfolio with the Patent Grant for its NY-ESO-1/LAGE 1a Targeted T Cell Receptor in China Medigene AG announced that the Company has been issued a patent by the Chinese Patent Office protecting its T cell receptor (TCR) targeting NY-ESO-1 (New York esophageal squamous cell carcinoma 1) and LAGE 1a (L Antigen Family Member-1a), both being well-recognized and validated cancer-testis antigens, expressed in multiple tumor types. Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains over 20 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies. New Risk • Jul 01
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: -€16m 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 (-€16m free cash flow). Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€13m net loss in 3 years). Share price has been volatile over the past 3 months (8.9% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€33.5m market cap, or US$35.8m). Aankondiging • Jun 29
Medigene AG to Report First Half, 2024 Results on Aug 14, 2024 Medigene AG announced that they will report first half, 2024 results on Aug 14, 2024 Aankondiging • Jun 27
Medigene Presents Efficient 6-Day TCR-T Therapy Production Process with High Stemness Medigene AG provided a detailed overview of its lead candidate MDG1015, a first-in-class 3rd generation T cell receptor engineered T cell (TCR-T) therapy, at the 7th Cell and Gene Therapy In-Depth Focus Summit from June 27-28, 2024, in Beijing, China. MDG1015 advances towards the clinic and targets the cancer-testisantigens (CTA) NY-ESO-1 /LAGE-1a (New York esophageal squamous cell carcinoma 1 /L Antigen Family Member-1a) and is armored and enhanced by the Company’s PD1-41BB costimulatory switch protein (CSP). Targeting tumors expressing CTAs has shown promising clinical benefits, yet there remains a need to enhance efficacy, safety, and response durability not only in orphan indications but also in more common solid tumor types. Tackle these issues with a comprehensive strategy, starting with the development of a best-in-class TCR that is sensitive, specific, and safe (3S TCR). Further, innovative approach not only armors and enhances the TCR-T cell functionality by combining 3S TCRs with the PD1-41BB CSP but also places a significant emphasis on the drug product (DP) manufacturing process. This process is vital for producing effective, safe, and durable TCR-T therapies. A benefit of adding the PD1-41BB CSP to the Company´s 3S TCRs has been shown in multiple in vitro assays displaying elevated TCR-T cell proliferation, superior TCR-T cell functionality as well as quick and consistent elimination of tumor cells when compared to TCR-T cells lacking the CSP. It has been demonstrated this effect is “”gated” in that the enhancement occurs only after the 3S TCR binds to its specific target antigen. This is an important safety feature of Medigene’s 3rd generation TCR-T programs. In addition, Medigene devised an efficient 6-day manufacturing process that emphasizes enriching CD8+ T cells while preserving their stem-like properties. Research studies indicates that DPs with more stem-like characteristics demonstrate increased effectiveness and longer-lasting responses. By incorporating the PD1-41BB CSP, the necessity for CD4+ T cells within the DP is eliminated, allowing CD8+ T cells to independently produce the necessary cytokines that would have been provided by the CD4+ cells. This approach mitigates potential risks associated with CD4+ T cells, potentially enhancing both the safety and therapeutic benefits of the treatment. Medigene's lead TCR-T program, MDG1015, is scheduled for IND submission in the third quarter of 2024 and CTA submission in the fourth quarter of 2024. MDG1015's clinical indications were selected due to significant unmet medical needs, the presence of the target antigen, and/or PD-L1 expression. This decision resulted in the initial focus on evaluating gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. Subject to additional financing, the first patient enrollment is anticipated by the end of 2024. Based on this timeline, the Company aims to unveil early data from the dose escalation phase in the fourth quarter of 2025. MDG1015 is a first-in-class, 3rd generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1 /LAGE-1a, a well-recognized and validated cancer testis antigen, which is expressed in multiple tumor types. MDG1015 contains our optimal affinity 3S (sensitive, specific and safe) NY-ESO-1 /LAGE-1a TCR combined with our proprietary PD1-41BB costimulatory switch protein that blocks the PD1/PD-L1 inhibitory axis while simultaneously activating the T cell through the well described -41BB pathway further enhancing the activity and persistence of the TCR-T cell in the hostile tumor microenvironment (TME). MDG1015 is currently undergoing IND/CTA enabling studies with IND approval expected in Third Quarter 2024 and CTA approval in Fourth Quarter 2024. New Risk • May 26
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% 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 Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€13m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€36.0m market cap, or US$39.0m). Aankondiging • May 22
Medigene AG, Annual General Meeting, Jun 24, 2024 Medigene AG, Annual General Meeting, Jun 24, 2024, at 11:00 W. Europe Standard Time. Aankondiging • May 16
Medigene AG Presents Preclinical Data on Optimal Affinity TCRs Targeting the Neoantigen Mutant KRAS Medigene AG presents the company's proprietary T cell receptor (TCR) discovery process to obtain optimal Affinity 3S (sensitive, specific and safe) TCRs at the 21thAss Association for Cancer Immunotherapy (CIMT) Annual Meeting in Mainz from May 15 - 17, 2024. Data presented also shows the clear benefit of adding the PD1-41BB costimulatory switch protein (CSP) to further armor and enhance these 3S TCR-T cells, which enables them to overcome the immunosuppressive tumor microenvironment. The poster with the title "Selection of superior KRAS G12V mutation-specific T cell receptors with unique characteristics for 3rd generation armored and enhanced T cell therapy" will be available on May 15, 2024, following the presentation on Medigene's website: <URL> The presented data highlighted the specificity and sensitivity of TCR-T cells co-expressing the PD1-41BB CSP alongside one of three distinct 3S TCRs targeting the mKRAS G12V neoantigen. These TCR-T cells displayed markedly increased secretion of interferon gamma (IFNg) observed upon TCR-T cell stimulation with mKRAS G12V-positive tumor cells, contrasting with the absence of IFN g secretion upon stimulation with any tumor or healthy cell expressing naturally occurring wild-type KRAS protein. All three 3S TCRs also demonstrated high sensitivity to the mKRAS G 12V neoantigen, as demonstrated by their activation in response to extremely low levels of mKRAS-G12V peptide. Conc Concurrent expression of the PD1-41 BB CSP significantly augmented TCR-T cell functionality, enabling sustained cytotoxicity targeting 3D tumor spheroids across multiple rounds of tumor exposure. This underscores the potent anti-cancer efficacy of the TCR-T cells. From a safety perspective, all three 3S TCRs combined with the PD1-41BBCSP demonstrated favorable safety profiles, with no IFNg secretion or cytotoxicity when exposed to healthy cells from major tissues or organs, confirming their selective cytotoxicity towards cancer cells while sparing healthy tissue from toxicity. Aankondiging • May 15
Medigene Ag Maintains Earnings Guidance for 2024 Medigene AG maintained earnings guidance for 2024. For the year, company expects revenue to be between EUR 9 Million and 11 Million (unchanged) in 2024. Aankondiging • Apr 26
Medigene AG Presents Streamlined 6-Day, High Stemness Tcr-T Therapy Production Process Medigene AG presented a comprehensive overview of its lead candidate MDG1015, a first-in-class 3rd generation T cell receptor engineered T cell (TCR-T) therapy, at CHI's 8th Annual Immuno-Oncology Summit Europe from April 23-25, 2024, in London. MDG1015, which is advancing towards the clinic, targets NY-ESO-1 /LAGE-1a (New York esophageal squamous cell carcinoma 1 /L Antigen Family Member-1a) and is armored and enhanced by the PD1-41BB costimulatory switch protein The presentation with the title “MDG1015: a 3rd Generation TCR-T Therapy Incorporating the PD1-41BB Costimulatory Switch Protein, Advancing to the Clinic” is available on Medigene’s website: https://medigene.com/science/abstracts/Targeting tumors expressing cancer-testis antigens (CTAs) shows promising clinical benefits. However, improving efficacy, safety, and ensuring a sustained response are areas needing improvement. Medigene tackles these challenges with a comprehensive approach, which starts with the development of a potential best-in-class, 3S (sensitive, specific, and safe) TCR. Next, the 3S TCR is enhanced with the Company’s exclusive PD1-41BB costimulatory switch protein (CSP) on the engineered TCR-T cells. Finally, Medigene generates a meticulously customized drug product (DP) composition. Medigene has developed a streamlined 6-day manufacturing process that focuses on the enrichment of CD8+ T cells whilst simultaneously maintaining a high degree of stemness. This allows for creating highly effective DPs, as the field has shown that more stem-like DPs exhibit greater potency and durability of response. The inclusion of the PD1-41BB CSP eliminates the need for CD4+ T cells within the DP, as CD8+ T cells are empowered to autonomously produce supporting cytokines. By doing so, the potential risks posed by CD4+ T cells can be circumvented and therefore potentially enhance both clinical safety and therapeutic efficacy. Multiple in vitro studies for MDG1015 have clearly demonstrated enhanced anti-tumor immune responses for MDG1015 in comparison to TCRs without the CSP. This enhancement is evidenced by increased TCR-T cell proliferation and marked augmentation of Interferon ? (IFN?) release, serving as a reliable indicator of superior TCR-T cell functionality. Furthermore, MDG1015 showed elevated polyfunctionality and clear durability of effect, with rapid and sustained tumor cell eradication upon multiple serial rechallenges of CTA /PD-L1 positive cells. IND/CTA approval for MDG1015 is expected in the second half of 2024. Clinical indications for MDG1015 were primarily chosen based on the high unmet medical need, expression of the target antigen and/or PD-L1. This led to the selection of gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma as the initial focus areas for clinical evaluation. First patient enrolment will follow by the end of 2024, subject to financing. Based on this, the Company expects to present early data from the dose escalation phase in the fourth quarter of 2025. Aankondiging • Apr 10
Medigene AG Presents Favorable Safety Profile of TCR-T Cells with Costimulatory Switch Protein at AACR Annual Meeting 2024 Medigene AG presents superior recombinant T cell receptor (rTCR) engineered T cell functionality as well as a favorable safety profile when rTCR-T cells are armored and enhanced with the PD1-41BB costimulatory switch protein (CSP) at the American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024, in San Diego, USA. The data presented in the poster demonstrated that the CSP-mediated costimulatory signal is TCR-gated, such that costimulation only takes place when a specific peptide-human leukocyte antigen (pHLA) complex is present on a tumor cell and triggers a signal through the rTCR expressed by the TCR-T cells. Enhanced, gated T cell functionality of CSP-armored rTCR-T cells increased secretion of interferon-? (IFN?) only when tumor cells simultaneously expressed the pHLA target antigen and PD-L1. In addition, CSP-armored rTCR-T cells showed high sensitivity in recognition of diverse tumor cell lines of different tissue origin, such as melanoma, sarcoma, and gastric cancer which varied in levels of pHLA and PD-L1 in vitro. Rapid and sustained killing of 3D tumor cell-derived spheroids only occurred when PD-L1-positive tumor cells simultaneously expressed the specific pHLA target antigen. Importantly, no recognition of healthy cells occurred if they lacked the pHLA target antigen, irrespective of PD-L1 expression, underpinning the safety of combining the CSP with a rTCR to generate rTCR-T cells that displayed no signs of toxicity for diverse healthy tissues in vitro. Aankondiging • Apr 05
Medigene AG Secures European Patent for Its iM-TCR Technology Medigene AG announced that the Company has been issued a patent by the European Patent Office protecting its inducible Medigene T cell receptor (iM-TCR) technology, which contains a control mechanism to regulate efficacy and improve safety of its T cell receptor engineered T cell (TCR-T) therapies. TCR-T therapies have demonstrated that they can effectively kill tumor cells. However, excessive activation of T cells may lead to premature exhaustion or cell death, as well as unwanted overactivity and the potential development of inflammatory responses in the body. The iM-TCR technology modifies the TCR to achieve control of TCR surface expression, allowing for fine-tuning of activity against tumor cells and thereby reducing potential inflammatory responses in the body. This property is of potential benefit not only to current autologous TCR-T therapy assets, but potentially also applicable to other TCR-T based modalities. Additionally, the iM-TCR technology can potentially expand the range of targets and indications of vital or more sensitive tissue origin and provide additional safety when expanding to other disease areas beyond oncology. The T cell receptor (TCR) assembly is a complex process. In humans, TCRs consist of an alpha (a) chain and a beta (ß) chain and each chain possesses a constant and a variable part. Medigene´s proprietary iM-TCR technology prevents the normal pairing of the a and the ß chains by introduction of specific engineered sequences into the constant part of each TCR chain. Each engineered chain is linked to an estrogen receptor sequence, which only allows the two iM-TCR chains to pair (dimerize) in the presence of Tamoxifen, and be expressed and function at the surface of TCR-T cells in a normal manner. Consequentially, to enable the iM-TCR-T cells to function in tumor cell recognition and killing, Tamoxifen administration is required but the levels required for dimerization and TCR-T function are orders of magnitude lower than the commonly used therapeutic doses. Any TCR from Medigene’s broad library of 3S TCRs can be equipped with the proprietary iM-TCR technology, which enables the function of tumor-specific TCR-T cell therapies to be finely tuned for safety and efficacy according to clinical needs. Reported Earnings • Mar 31
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: €0.66 loss per share (further deteriorated from €0.34 loss in FY 2022). Revenue: €6.03m (down 81% from FY 2022). Net loss: €16.2m (loss widened 94% from FY 2022). Revenue exceeded analyst estimates by 9.7%. Earnings per share (EPS) also surpassed analyst estimates by 16%. Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings. Aankondiging • Mar 28
Medigene Ag Provides Earnings Guidance for 2024 Medigene AG provided earnings guidance for 2024. For the year, company expects revenue to be between EUR 9 Million and 11 Million. Aankondiging • Mar 19
Medigene AG to Report Fiscal Year 2023 Results on Mar 28, 2024 Medigene AG announced that they will report fiscal year 2023 results on Mar 28, 2024 New Risk • Mar 04
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. 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: Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (€17m net loss in 3 years). Share price has been volatile over the past 3 months (8.0% average weekly change). Market cap is less than US$100m (€37.3m market cap, or US$40.5m). Aankondiging • Feb 12
Medigene AG Announces Indication Selection for the Clinical Development of Its Lead 3Rd Generation Tcr-T Therapy Program in Solid Tumors Medigene AG announced the selection of gastric cancer, ovarian cancer and two types of soft tissue sarcomas, myxoid/round cell liposarcoma and synovial sarcoma, as the initial clinical indications for its lead candidate MDG1015. MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a (New York esophageal squamous cell carcinoma1 /L Antigen Family Member-1a), armored and enhanced by costimulatory switch protein PD1-41BB in the context of HLA-A*02 (HLA, human leukocyte antigen). Preclinical data presented in 2023 at the AACR and ESMO conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors. The indications were selected predominantly based on target and/or PD-L1 expression, with 34-60%, 35-55% and 75-80% of gastric cancer, ovarian Cancer and the two subtypes of soft tissue sarcoma expressing NY-ESO-1 /LAGE-1a, respectively. Aankondiging • Nov 22
Medigene AG Maintains Financial Guidance for the Fiscal Year 2023 Medigene AG maintained financial guidance for the fiscal year 2023. The Company maintains its guidance on expected revenues to be between EUR 5 and 7 million in 2023 (unchanged). Aankondiging • Oct 24
Medigene AG Presents First Pre-Clinical Data of Optimal Affinity TCR Targeting mKRAS G12V Combined with a PD1-41BB Costimulatory Switch Protein Showing Medigene AG presented data showing significantly enhanced T cell activity when combining the PD1-41BB costimulatory switch protein (CSP) with recombinant T cell receptors (rTCR) not only when directed at the cancer-testis antigen (CTA) New York esophageal squamous cell carcinoma-1 (NY-ESO-1)/L Antigen Family Member-1a (LAGE-1a), but also, presented here for the first time, against the neoantigen mutant Kirsten rat sarcoma virus (mKRAS) G12V at the ESMO Congress 2023 held October 20-24, 2023, in Madrid, Spain. Within the solid tumor microenvironment (TME) T cell functionality is strongly impaired by the expression of the programmed cell death 1 ligand 1 (PD-L1) on tumor cells. The engagement of PD-L1 on tumor cells with PD-1 on T cells prevents specific killing of tumor cells. Moreover, PD-L1 signalling to T cells via the PD-1 receptor limits proliferation, cytokine secretion and cytotoxic response, while exhaustion is induced by repetitive TCR signalling in the absence of T cell costimulation. The presented data showed that by combining optimal affinity TCRs with a PD1-41BB CSP, not only is the PD-1/PD-L1 axis blocked, but also T cell proliferation, cytokine secretion and cytotoxic response are increased through positive 4-1BB signaling, resulting in mitigation of the immunosuppressive TME through enhanced T cell functionality. Robust expression of rTCR directed against NY-ESO-1/LAGE-1a and/or the neoantigen mKRAS G12V as well as the PD1-41BB CSP was demonstrated in TCR-T cells. The combination of NY-ESO-1/LAGE-1a or mKRAS G12V-specific rTCRs with PD1-41BB CSP displayed elevated polyfunctionality by increased levels of effector, stimulatory and chemoattractive cytokines as compared to TCR-T cells without PD1-41BB CSP in melanoma and pancreatic tumor cell lines. Interferon-gamma (IFN?) release measured in several tumor cell lines of different origin was enhanced in TCR-T cells co-expressing the rTCR and PD1-41BB CSP as compared to TCR-T cells lacking PD1-41BB CSP. The co-stimulatory effects of PD1-41BB were highly dependent on the rTCR-mediated recognition of the specific tumor-antigen NY-ESO-1/LAGE-1a or mKRAS G12V, respectively, and on the expression of the inhibitory ligand PD-L1 on tumor cells. Elevated and sustained killing of 3D tumor spheroids was observed with TCR-T cells co-expressing the rTCR targeting mKRAS G12V and PD1-41BB CSP compared to TCR-T cells without the PD1-41BB CSP. Additional data on Medigene’s library of KRAS mutation-specific TCRs will be presented at the Society of Immunotherapy of Cancer (SITC) 38th Annual Meeting held in San Diego, November 1 to 5, 2023. Aankondiging • Oct 17
Medigene to Present New Pre-Clinical Data for Pipeline TCR-T Therapies At the ESMO Congress 2023 Medigene AG will be presenting at the ESMO Congress 2023 being held on October 20-24, 2023, in Madrid, Spain. The data to be presented shows that optimal affinity T cell receptors (TCRs) when combined with Medigene’s PD1-41BB costimulatory switch protein (CSP), provides strong protection of T cell receptor engineered T cells (TCR-T) against multiple mechanisms of solid tumor microenvironment immunosuppression, including CSP-enhanced poly-cytokine secretion, proliferation and mitigation against exhaustion of the TCR-T in vitro. Details on the poster presentation are as follows: Abstract and title: “Mitigation of Tumor Microenvironment-Mediated Immunosuppression Using a PD1-41BB Switch Protein with Optimal Affinity TCRs for First-In-Class, 3rd Generation TCR-T Therapies.” Authors: Kirsty Crame, Giulia Longinotti, Mario Catarinella, Petra U Prinz, Stefanie Tippmer, Kathrin Mutze, Andrea Coluccio, Melanie Salvermoser, Julia Bittmann, Maja Buerdek, Barbara Loesch, Christiane Geiger, Kathrin Davari and Dolores J Schendel Final presentation number: 2249P Date/time: Saturday October 21, 2023, Poster lunch session from 12 to 1 pm CEST, poster will be on display from 9 am to 6.30 pm CEST Category: Translational Research (Agnostic). Aankondiging • Aug 19
Medigene AG Provides Revenue Guidance for 2023 Medigene AG announced that the Executive Management Board expects revenue in 2023 to be between EUR 5 million and EUR 7 million. New Risk • Aug 18
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: -€15m 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 (-€15m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€17m net loss in 3 years). Market cap is less than US$100m (€47.8m market cap, or US$52.0m). Reported Earnings • Aug 18
Second quarter 2023 earnings released: €0.17 loss per share (vs €0.097 loss in 2Q 2022) Second quarter 2023 results: €0.17 loss per share (further deteriorated from €0.097 loss in 2Q 2022). Revenue: €1.55m (down 31% from 2Q 2022). Net loss: €4.06m (loss widened 70% from 2Q 2022). Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. New Risk • Jun 15
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 German stocks, typically moving 10% 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 10% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€20m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (€52.8m market cap, or US$57.3m). Reported Earnings • Mar 31
Full year 2022 earnings released: €0.34 loss per share (vs €0.41 loss in FY 2021) Full year 2022 results: €0.34 loss per share (improved from €0.41 loss in FY 2021). Revenue: €31.2m (up 199% from FY 2021). Net loss: €8.33m (loss narrowed 17% from FY 2021). Over the last 3 years on average, earnings per share has increased by 58% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Price Target Changed • Nov 16
Price target decreased to €3.90 Down from €6.73, the current price target is provided by 1 analyst. New target price is 71% above last closing price of €2.28. Stock is down 36% over the past year. The company is forecast to post earnings per share of €0.03 next year compared to a net loss per share of €0.41 last year. Price Target Changed • Aug 09
Price target decreased to €5.95 Down from €6.73, the current price target is an average from 2 analysts. New target price is 142% above last closing price of €2.46. Stock is down 36% over the past year. The company is forecast to post earnings per share of €0.03 next year compared to a net loss per share of €0.41 last year. Breakeven Date Change • Feb 23
No longer forecast to breakeven The 3 analysts covering Medigene no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €12.6m in 2022. New consensus forecast suggests the company will make a loss of €21.5m in 2023. Major Estimate Revision • Dec 10
Consensus revenue estimates increase to €10.5m The consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from €9.10m to €10.5m. Forecast losses expected to reduce from -€0.56 to -€0.48 per share. Biotechs industry in Germany expected to see average net income growth of 3.4% next year. Consensus price target of €6.73 unchanged from last update. Share price rose 6.7% to €3.10 over the past week. Price Target Changed • Nov 11
Price target decreased to €6.73 Down from €8.35, the current price target is an average from 3 analysts. New target price is 90% above last closing price of €3.54. Stock is down 3.9% over the past year. The company is forecast to post a net loss per share of €0.56 next year compared to a net loss per share of €1.18 last year. Price Target Changed • Sep 16
Price target decreased to €6.80 Down from €8.35, the current price target is an average from 4 analysts. New target price is 70% above last closing price of €3.99. Stock is down 12% over the past year. Major Estimate Revision • Apr 04
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 losses forecast to reduce from -€1.32 to -€0.97 per share. Revenue forecast steady at €15.2m. Biotechs industry in Germany expected to see average net income growth of 9.8% next year. Consensus price target broadly unchanged at €8.35. Share price was steady at €3.86 over the past week. Executive Departure • Apr 02
Advisor has left the company On the 31st of March, Kai Pinkernell's tenure as Advisor ended after 3.0 years in the role. We don't have any record of a personal shareholding under Kai's name. A total of 3 executives have left over the last 12 months. Reported Earnings • Mar 28
Full year 2020 earnings released: €1.18 loss per share (vs €0.81 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: €8.00m (down 24% from FY 2019). Net loss: €28.9m (loss widened 45% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 1 Over the last 3 years on average, earnings per share has fallen by 12% per year but the company’s share price has fallen by 36% per year, which means it is performing significantly worse than earnings. Price Target Changed • Feb 25
Price target raised to €8.51 Up from €6.87, the current price target is an average from 4 analysts. The new target price is 113% above the current share price of €3.99. As of last close, the stock is down 12% over the past year. Is New 90 Day High Low • Jan 06
New 90-day high: €3.92 The company is up 6.0% from its price of €3.70 on 08 October 2020. The German market is up 7.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €37.44 per share. Price Target Changed • Dec 23
Price target lowered to €6.87 Down from €7.60, the current price target is an average from 3 analysts. The new target price is 92% above the current share price of €3.58. As of last close, the stock is down 12% over the past year.