Annuncio • Jul 17
IGM Biosciences, Inc.(NasdaqGS:IGMS) dropped from NASDAQ Biotechnology Index IGM Biosciences, Inc. has been dropped from the NASDAQ Biotechnology Index. Annuncio • Jul 02
Concentra Biosciences, LLC agreed to acquire IGM Biosciences, Inc. (NasdaqGS:IGMS) for $76.3 million. Concentra Biosciences, LLC agreed to acquire IGM Biosciences, Inc. (NasdaqGS:IGMS) for $76.3 million on July 1, 2025. A cash consideration valued at $1.247 per share will be paid by Concentra Biosciences, LLC. The consideration consists of contingent value rights of Concentra Biosciences, LLC to be issued for common equity of IGM Biosciences, Inc. As part of consideration, an undisclosed value is paid towards Restricted Stock Units common equity, an undisclosed value is paid towards common equity and an undisclosed value is paid towards options of IGM Biosciences, Inc. In case of termination of transaction, Concentra Biosciences, LLC will pay a termination fee of $0.50 million and IGM will pay a termination fee of $2.42 million.
The transaction subjected to IGM shareholders approval and minimum tender. The deal has been unanimously approved by the board. The expected completion of the transaction in August 2025. Pursuant and subject to the terms of the Merger Agreement, Concentra will commence a tender offer by July 16, 2025.
Tony Jeffries, Robert Ishii and Ethan Lutske of Wilson Sonsini Goodrich & Rosati, P.C. acted as legal advisor for IGM Biosciences, Inc. Ryan A. Murr of Gibson, Dunn & Crutcher LLP acted as legal advisor for Concentra Biosciences, LLC. Annuncio • Jun 12
IGM Biosciences Receives Nasdaq Non-Compliance Notice Regarding MVLS Requirement On June 6, 2025, IGM Biosciences, Inc. (the Company") received written notice (the Notice") from The Nasdaq Stock Market LLC (Nasdaq") indicating that the Company is no longer in compliance with the minimum Market Value of Listed Securities (MVLS") of $50,000,000 required for continued listing on The Nasdaq Global Select Market, as set in Nasdaq Listing Rule 5450(b)(2)(A) (the MVLS Requirement"). The Notice has no effect at this time on the listing of the Company's common stock (the Common Stock"), which continues to trade on The Nasdaq Global Select Market under the symbol IGMS". In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has a period of 180 calendar days, or until December 3, 2025 (the Compliance Date"), to regain compliance with the MVLS Requirement. To regain compliance, the Company's MVLS must close at $50,000,000 or more for a minimum of 10 consecutive business days prior to the Compliance Date. In the event the Company does not regain compliance with the MVLS Requirement prior to the Compliance Date, Nasdaq will notify the Company that its securities are subject to delisting, at which point the Company may appeal the delisting determination to a Nasdaq hearings panel. The Company intends to actively monitor its MVLS and may, if appropriate, consider implementing available options to regain compliance with the MVLS Requirement. The Company may also choose to transfer the listing of its Common Stock to The Nasdaq Capital Market. There can be no assurance that the Company will be able to regain compliance with Nasdaq Listing Rule 5450(b)(2)(A), or maintain compliance with any other listing requirements, or satisfy the requirements necessary to transfer the listing of its Common Stock to The Nasdaq Capital Market. Annuncio • May 10
IGM Biosciences, Inc. Announces Workforce Reduction and Closure of Remaining Lab and Office Facilities IGM Biosciences, Inc. announced that in connection with the Agreement termination, the Company implemented an approximately 80% reduction in its remaining workforce and closed most of its remaining lab and office facilities to preserve cash. The Company continues to evaluate potential strategic alternatives and reorganization options. Annuncio • Jan 10
IGM Biosciences, Inc. Provides Strategic Update on Autoimmunity Pipeline Programs IGM Biosciences, Inc. announced a strategic update to halt further development of imvotamab, an IgM-based CD20 X CD3 bispecific antibody T cell engager, and IGM-2644, an IgM-basedCD38 X CD3 bispecific antibodies T cell engager, for autoimmune diseases. Interim data from the Phase 1b studies of imvotamab in rheumatoid arthritis and systemic lupus erythematosus show that the depth and consistency of B cell depletion is insufficient to meet high bar for success. The Company is currently evaluating internal options as well as potential strategic alternatives with the goal of maximizing value for its shareholders. While this internal evaluation and strategic exploration are ongoing, the Company is immediately taking steps, including an approximately 73% reduction in force, to preserve cash. Reported Earnings • Nov 10
Third quarter 2024 earnings released: US$1.01 loss per share (vs US$1.04 loss in 3Q 2023) Third quarter 2024 results: US$1.01 loss per share (improved from US$1.04 loss in 3Q 2023). Net loss: US$61.4m (flat on 3Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 15
Second quarter 2024 earnings released: US$0.79 loss per share (vs US$1.43 loss in 2Q 2023) Second quarter 2024 results: US$0.79 loss per share (improved from US$1.43 loss in 2Q 2023). Net loss: US$47.9m (loss narrowed 26% from 2Q 2023). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Reported Earnings • May 09
First quarter 2024 earnings released: US$0.83 loss per share (vs US$1.33 loss in 1Q 2023) First quarter 2024 results: US$0.83 loss per share (improved from US$1.33 loss in 1Q 2023). Net loss: US$49.8m (loss narrowed 16% from 1Q 2023). Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 45% per year, which means it is performing significantly worse than earnings. Annuncio • May 09
IGM Biosciences, Inc. Provides Revenue Guidance for the Second Quarter and Full Year 2024 IGM Biosciences, Inc. provided revenue guidance for the second quarter and full year 2024. Collaboration revenue of $62 million is expected to be recognized in the second quarter of 2024. The Company expects to recognize full year collaboration revenue of approximately $63 million. Annuncio • Apr 28
IGM Biosciences, Inc., Annual General Meeting, Jun 11, 2024 IGM Biosciences, Inc., Annual General Meeting, Jun 11, 2024, at 08:00 Pacific Standard Time. Agenda: To elect three Class II directors to serve until the 2027 annual meeting of stockholders or until their successors are duly elected and qualified; to ratify the appointment of Deloitte & Touche LLP as the company's independent registered public accounting firm for the company's fiscal year ending December 31, 2024; to approve an amendment to the company's amended and restated certificate of incorporation to limit the liability of certain officers as permitted by Delaware law; to approve a stock option exchange program for employees (excluding the company's chief executive officer and nonemployee directors); and to transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Recent Insider Transactions • Mar 18
CEO, President & Director recently sold €82k worth of stock On the 14th of March, Fred Schwarzer sold around 9k shares on-market at roughly €9.19 per share. This transaction amounted to 3.6% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Fred has been a net seller over the last 12 months, reducing personal holdings by €197k. Reported Earnings • Mar 08
Full year 2023 earnings released: US$4.71 loss per share (vs US$5.32 loss in FY 2022) Full year 2023 results: US$4.71 loss per share. Net loss: US$246.4m (loss widened 11% from FY 2022). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Board Change • Mar 06
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 10 experienced directors. 1 highly experienced director. Director Elizabeth Thompson was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 14
Third quarter 2023 earnings released: US$1.04 loss per share (vs US$1.32 loss in 3Q 2022) Third quarter 2023 results: US$1.04 loss per share. Net loss: US$62.0m (loss widened 6.8% from 3Q 2022). Revenue is forecast to grow 71% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Annuncio • Oct 05
IGM Biosciences, Inc. Announces Board Changes IGM Biosciences, Inc. announced that Michael Loberg, Ph.D. has retired from its Board of Directors, including as Chairman, effective October 3, 2023. Dr. Loberg has served as a member of the IGM Biosciences Board of Directors since 2015 and as Chairman of the Board since 2018. IGM Biosciences announced the appointment of Elizabeth H.Z. Thompson, Ph.D. to its Board of Directors. Dr. Thompson is an accomplished drug development professional who has been involved in the development of important marketed medicines, most recently as the Executive Vice President of Research and Development at Horizon Therapeutics. Dr. Thompson currently serves as Executive Vice President of Research and Development at Horizon Therapeutics. She is also a member of the board of California Life Sciences, an influential life sciences membership organization. At Horizon, Dr. Thompson is responsible for overseeing all research and development activities across the company's preclinical, clinical and marketed products. She played an important role in the acquisition and integration of Viela Bio as well as the expedited filing and approval of TEPEZZA®, along with its successful FDA Advisory Committee meeting. Dr. Thompson previously served as a Group Scientific Director in pharmaceutical development at AbbVie, acting as clinical lead and supporting global submissions and approvals for SKYRIZI®. She previously held positions across the clinical development, business development and medical communications fields as Search and Evaluation Lead at Raptor Pharmaceuticals, Head of Scientific Communications and Publications at InterMune and Development Clinical Director and Licensing Director at Amgen. Dr. Thompson holds a Ph.D. in Macromolecular and Cellular Structure and Chemistry from the Scripps Research Institute and a B.S. in Chemistry from Harvey Mudd College. New Risk • Jul 04
New major risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 41% 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 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 (US$260m net loss in 3 years). Shareholders have been diluted in the past year (41% increase in shares outstanding). Revenue is less than US$5m (US$1.6m revenue). New Risk • Jun 23
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 33% 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 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 (US$260m net loss in 3 years). Shareholders have been diluted in the past year (33% increase in shares outstanding). Significant insider selling over the past 3 months (€83k sold). Revenue is less than US$5m (US$1.6m revenue). Annuncio • Jun 23
IGM Biosciences, Inc. announced a financing transaction IGM Biosciences, Inc. announced that it will raise an equity round of funding on June 21, 2023. The company will issue non-voting common shares in the transaction. Annuncio • Jun 01
IGM Biosciences, Inc. Announces FDA Clearance to Begin Clinical Studies of Imvotamab in Lupus and Rheumatoid Arthritis IGM Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications for imvotamab, an IgM-based CD20 X CD3 bispecific antibody T cell engager, enabling the initiation of Phase 1b studies in both severe systemic lupuserythematosus (SLE) and severe rheumatoid arthritis (RA). The Company plans to begin patient enrollment in both multicenter clinical studies in the third quarter of 2023. The data from non-Hodgkin's lymphoma clinical studies indicate that imvotamab can deplete CD20 expressing B cells, even rapidly growing lymphomacells, with a favorable safety profile as compared with other T cell engaging CD20 x CD3 antibodies. Emerging data with cell-based therapies suggest that deep B cell depletion may have the potential to reset the immune system in patients with certain autoimmune diseases. Imvotamab has also demonstrated in preclinical in vitro studies that it can be more effective in depleting B cells with low levels of CD20 expression as compared to rituximab. Annuncio • Jan 18
IGM Biosciences Initiates First-In-Human Clinical Trial of Igm-7354 in Solid Tumors IGM Biosciences, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-7354, a targeted IL-15/IL-15R IgM antibody whichcould potentially be used for the treatment of patients with solid and hematologic malignancies. The multicenter, open-label, dose escalation Phase 1 clinical trial will evaluate IGM-7354 intravenously administered as a monotherapy in patients with relapsed and/or refractory solid tumor cancers. The key objectives of this trial are to provide an initial assessment of pharmacokinetics, safety and immune cell proliferation. If IGM-7354 shows an encouraging safety profile and significant increases in T cells and natural killer (NK) cells in this clinical trial, the Company may begin combination studies of IGM-7354 with T cell engaging antibodies in 2024. The Company may also decide to pursue combination studies with CAR-T or CAR-NK cells with a partner. Annuncio • Jan 10
IGM Biosciences Announces Update on Igm-8444 Phase 1 Trial and Future Clinical Development IGM Biosciences, Inc. announced an update on its clinical development program for IGM-8444, a novel multivalent DR5 agonist, and announced plans for a new randomized combination trial in patients with metastatic colorectal cancer. Initial Phase 1 data reported from a cohort of patients with combination treatment of IGM-8444 and FOLFIRI showed an encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, there was no drug related clinically significant hepatotoxicity, with only grade 1 and grade 2 transient liver enzyme elevations observed. In patients with metastatic colorectal cancer, the combination of IGM-8444 and FOLFIRI showed promising activity, with multiple confirmed responses observed even in patients who had previously progressed on FOLFIRI. In 13 metastatic patients treated with doses of IGM-8444 from 1 to 10 mg/kg plus standard doses of FOLFIRI chemotherapy, there were four responses observed (three confirmed at 3mg/kg), and one additional patient had substantial tumor shrinkage allowing for subsequent complete surgical resection. Responses occurred in patients with KRAS wild type and mutated tumors and in patients with or without liver metastases. The majority of patients were on their third line of treatment or beyond and 10 of the 13 patients had previously been treated with FOLFIRI chemotherapy. Median progression free survival (PFS) among nine 3L+ patients was 5.5 months, with the longest observed PFS extending beyond 12 months. Recent Insider Transactions • Dec 22
CEO, President & Director recently sold €221k worth of stock On the 16th of December, Fred Schwarzer sold around 12k shares on-market at roughly €17.90 per share. This transaction amounted to 5.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Fred has been a net seller over the last 12 months, reducing personal holdings by €269k. Recent Insider Transactions • Nov 16
Independent Director recently bought €1.0m worth of stock On the 8th of November, M. Behrens bought around 60k shares on-market at roughly €17.01 per share. This transaction amounted to 27% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €3.3m more in shares than they have sold in the last 12 months. Board Change • Nov 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 10 experienced directors. 1 highly experienced director. Independent Director Felix Baker was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Nov 12
Independent Director recently bought €1.0m worth of stock On the 8th of November, M. Behrens bought around 60k shares on-market at roughly €17.01 per share. This transaction amounted to 27% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €3.3m more in shares than they have sold in the last 12 months. Recent Insider Transactions • Oct 01
Independent Chairman of the Board recently bought €145k worth of stock On the 28th of September, Michael Loberg bought around 7k shares on-market at roughly €21.67 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Michael has been a buyer over the last 12 months, purchasing a net total of €598k worth in shares. Board Change • Aug 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 10 experienced directors. 1 highly experienced director. Independent Director Felix Baker was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Jun 04
IGM Biosciences, Inc. Appoints Steven Weber as Principal Accounting Officer On May 25, 2022, the board of directors of IGM Biosciences, Inc. appointed Steven Weber as the company’s principal accounting officer, effective immediately. Mr. Weber will also continue to serve as the company’s senior vice president and corporate controller. Mr. Weber, 46, has served as its Senior Vice President and Corporate Controller since March 2022. Previously, Mr. Weber served at Aeglea BioTherapeutics, Inc. as Vice President and Principal Accounting Officer from February 2021 to March 2022, Senior Director and Corporate Controller from July 2015 to January 2021, and Director and Corporate Controller from 2014 to 2015. He began his career at PricewaterhouseCoopers LLP. Mr. Weber is a certified public accountant in the State of Texas and received a B.B.A. in Accounting and a M.P.A. in Professional Accounting from the McCombs School of Business at the University of Texas at Austin. Recent Insider Transactions • May 18
Independent Director recently bought €224k worth of stock On the 13th of May, Jakob Topsøe bought around 16k shares on-market at roughly €13.94 per share. In the last 3 months, there was an even bigger purchase from another insider worth €1.3m. Insiders have collectively bought €1.9m more in shares than they have sold in the last 12 months. Recent Insider Transactions • Apr 08
Independent Director recently bought €1.3m worth of stock On the 1st of April, M. Behrens bought around 61k shares on-market at roughly €20.84 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €1.7m more in shares than they have sold in the last 12 months. Annuncio • Feb 10
IGM Biosciences, Inc. Advances Novel Antibody IGM-6268 into Clinical Trials for the Treatment and Prevention of COVID-19 IGM Biosciences, Inc. announced its progress in two Phase 1 clinical trials evaluating IGM-6268, an anti-SARS-CoV-2 IgM monoclonal antibody, for the treatment and prevention of COVID-19. The first, a Phase 1 clinical trial in the U.S., is a multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics of IGM-6268 administered intranasally in healthy volunteers. The first two dose cohorts of healthy volunteers have been successfully cleared in the U.S., and data from the study are expected in the first half of 2022. The second, a Phase 1a/1b clinical trial in South Africa, is a multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IGM-6268 administered intranasally first in healthy volunteers, once an appropriate dose cohort has been cleared, in outpatients with mild to moderate COVID-19. The first dose cohort of healthy volunteers has been cleared in the South Africa study, and data from the study are expected in mid-2022. IGM also announced that results from in vitro pseudovirus testing conducted by a widely recognized, commercial laboratory indicate that IGM-6268 exhibits neutralization of the Omicron (B.1.1.529) variant at an IC50 of 230 ng/mL, as well as potent in vitro neutralization activity against all other SARS-CoV-2 Variants of Concern (VoC) and Variants of Interest (VoI) tested to date, including the Delta variant. This indicated IC50 for the Omicron variant is expected to be well below the concentrations achievable by intranasal administration in key sites of infection and viral replication, based on previous observations from animal studies. These results expand upon data previously published in Nature, in which IGM-6268 exhibited significantly increased potency against wild type SARS-CoV-2 relative to an IgG antibody with the same binding domains and exhibited potent neutralization against the Alpha (B.1.1.7), Gamma (P.1), and Beta (B.1.351) variants, as well as other receptor-binding domain mutants that conferred resistance to several IgG antibodies authorized for emergency use. Annuncio • Dec 12
IGM Biosciences, Inc. Presents Clinical Data from IGM-2323 in Patients with Advanced B Cell Malignancies at 2021 American Society of Hematology Annual Meeting IGM Biosciences, Inc. announced the presentation of clinical results from the Company’s Phase 1 trial evaluating IGM-2323, a novel bispecific IgM antibody targeting CD20 x CD3, at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. The data was featured in an oral presentation titled “A Phase 1 Dose Escalation Study of IGM-2323, a Novel Anti-CD20 x Anti-CD3 IgM T Cell Engager (TCE) in Patients with Advanced B-Cell Malignancies”. The multicenter, open-label Phase 1 dose escalation trial was intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with advanced B cell malignancies. As of September 10, 2021, the data cutoff date for the presentation, 40 patients were enrolled and treated at escalating dose levels of IGM-2323. All 40 patients received at least one dose and were evaluable for safety. There were no dose limiting toxicities (DLTs), no neurotoxicity adverse events (AEs), a relatively low rate of cytokine release syndrome (CRS) and no patients discontinued due to an AE. Of the 10 patients treated in the 100 mg cohort, 3 of 6 diffuse large B cell lymphoma (DLBCL) patients had a complete response and 2 of 3 follicular lymphoma (FL) patients had a complete response. Additionally, the one mantle cell patient treated in the 100 mg dose cohort had a partial response. Overall, of the 38 patients evaluable for efficacy, 11 patients showed a response, 8 of which were complete responses. Based on these promising results, two Phase 2 studies are being initiated to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with DLBCL and FL. If supportive, the data from this Phase 2 multicenter, open-label study could potentially be used as the basis for accelerated review and approval of IGM-2323. About IGM-2323: IGM-2323 is a CD20 x CD3 bispecific IgM antibody designed to treat patients with B cell non-Hodgkin’s lymphoma (NHL) and other B cell malignancies. CD20 is a protein that is frequently expressed on the surface of malignant B cells, while CD3 is a protein that is expressed on the surface of T cells and is an essential activating molecule of the T cell. IGM-2323 has 10 binding domains to CD20 and a single binding domain to CD3 (specifically CD3?). IGM-2323 is designed to simultaneously and stably bind a CD20 expressing cancer cell as well as CD3 on a cytotoxic T cell, bringing both cells into close proximity. This interaction mimics the normal T cell activation pathway leading the T cell to recognize and kill the cancer cell by releasing cytotoxic biochemicals (perforins and granzymes) that penetrate and perforate the cancer cell. In contrast to other bispecific antibody formats that bind to one or two CD20 molecules on the surface of the cancer cell and to one CD3 molecule on the surface of the T cell, IGM-2323 has 10 binding units to CD20 and one binding unit to CD3. The Company believes that IGM-2323 with its 10 binding units for CD20 may successfully bind to CD20 expressing cancer cells with more avidity compared to an IgG bispecific antibody with only one binding unit for CD20. IGM-2323 also employs an additional mechanism to kill CD20 expressing cancer cells, known as complement dependent cytotoxicity (CDC). CDC is a mechanism by which antibodies can mediate specific targeted cell killing by activating the complement system. Components of the complement system are naturally present in humans, and IgM antibodies are the most efficient antibodies at engaging the complement system for CDC, with an approximately 100-fold increase in CDC relative to comparable IgG CD20 antibodies. Annuncio • Jun 04
IGM Biosciences Announces Expansion of IgM Platform into Infectious Diseases, Publication of Preclinical Data in Nature Demonstrating Engineered IgM Antibody Antiviral Activity for the Treatment and Prevention of COVID-19 IGM Biosciences, Inc. announced the expansion of its IgM antibody platform into infectious diseases, with the anticipated advancement of a new pipeline candidate, IGM-6268, into the clinic in the third quarter of 2021. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody being developed as an intranasally administered agent for the treatment and prevention of COVID-19. The announcement coincides with the publication in Nature of an article entitled Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants, which is available now online and will be published in a future print issue of Nature. The article describes results from preclinical studies demonstrating significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all evaluated mutant Variants of Concern (VoC) and Variants of Interest (VoI), and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The work described in the paper was performed in collaboration with The University of Texas Medical Branch at Galveston (UTMB), and The University of Texas Health Science Center at Houston (UTHealth). IGM has exclusively licensed the rights to the antibodies used to generate IGM-6268 and related intellectual property from the University of Texas System. Annuncio • Mar 16
IGM Biosciences Appoints Lisa Decker, Ph.D., as Chief Business Officer IGM Biosciences, Inc. announced the appointment of Lisa L. Decker, Ph.D., to the newly created position of Chief Business Officer. Ms. Decker joins IGM with twenty years of experience in business development strategy, transactions and alliance management. Most recently, Ms. Decker was Chief Business Officer at Atreca, Inc., where she led business development, including the portfolio and alliance management functions. Is New 90 Day High Low • Feb 10
New 90-day high: €94.00 The company is up 103% from its price of €46.20 on 11 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 11% over the same period. Executive Departure • Feb 05
Independent Director has left the company On the 26th of January, Kelvin Neu's tenure as Independent Director ended after 1.7 years in the role. We don't have any record of a personal shareholding under Kelvin's name. Kelvin is the only executive to leave the company over the last 12 months. Annuncio • Jan 29
IGM Biosciences, Inc. Announces Board Changes On January 23, 2021, Kelvin Neu notified IGM Biosciences, Inc. of his resignation from the Company's board of directors, which resignation was effective as of January 26, 2021 and was not due to any disagreement with the Company on any matter related to the Company's operations, policies or practices. On January 24, 2021, Felix J. Baker, Ph.D. was appointed to the Board to serve as a Class III director, with a term beginning on January 26, 2021 and expiring at the Company's 2022 annual meeting of the stockholders. Dr. Baker will serve on the Board as the designee of 667, L.P. and Baker Brothers Life Sciences, L.P. pursuant to that certain Nominating Agreement, dated as of June 28, 2019, by and between the Company and the Baker Bros. Annuncio • Jan 12
IGM Biosciences, Inc. Enters into Exclusive Licensing Agreement with Medivir for Birinapant vIGM Biosciences, Inc. announced that it has entered into an exclusive license agreement with Medivir AB, through which IGM will receive global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically. Under terms of the agreement, Medivir will receive an upfront payment of $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in clinical Phase I studies. The terms of the agreement also entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately $350 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales. In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a Phase 1 dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM plans to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid tumors later this year. Recent Insider Transactions • Dec 17
Independent Director recently bought €3.3m worth of stock On the 11th of December, M. Behrens bought around 44k shares on-market at roughly €74.30 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €4.8m more in shares than they have sold in the last 12 months. Is New 90 Day High Low • Dec 10
New 90-day high: €88.50 The company is up 80% from its price of €49.20 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Dec 06
IGM Biosciences, Inc. Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma IGM Biosciences, Inc. announced the presentation of preliminary clinical results from the Company’s Phase 1 trial evaluating IGM-2323, a bispecific IgM antibody targeting CD20 x CD3, at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The multicenter, open-label Phase 1 dose escalation trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell non-Hodgkin’s lymphoma (NHL). As of October 30, 2020, the data cutoff date for the presentation, 16 patients were enrolled and treated at escalating dose levels of IGM-2323. Dose escalation continues in the study toward the anticipated recommended Phase 2 dose (RP2D) range of between 100 and 1000 mg. Of the 14 patients treated in the 0.5, 2.5, 10, 30 and 50/100 mg dose cohorts, nine showed evidence of tumor size reduction and two patients showed partial responses (PRs), including a patient with follicular lymphoma (50/100 mg dose level) and a patient with diffuse large B cell lymphoma (DLBCL) who had failed CAR-T therapy (30 mg dose level). Subsequent to the data cutoff, the two patients with follicular lymphoma treated at the 50/100 mg titration dose converted to complete responses (CRs). Dose titration has been introduced at the higher dose levels to provide NHL patients with optimal and repeatable immune activity. The study is currently enrolling for the 50/300 mg titration dose cohort. Of the three patients at the 50/100 mg titration dose and one patient at the 50/300 mg titration dose, none have exhibited fever, chills, cytokine release syndrome (CRS) or neurotoxicity to date. Among all patients, IGM-2323 was found to be generally well tolerated, with no dose limiting toxicities, no Grade 3 or higher CRS and no evidence of neurotoxicity observed, despite less steroid pretreatment than used in studies of most other T cell engagers. Three Grade 1 CRS events (low-grade fever/chills) were reported in the lower dose groups, and one Grade 2 CRS event was observed at the first infusion in the non-titrated 100 mg dose level in a patient with pre-existing severe hypertension who was receiving four anti-hypertensive medications. IFN-dominant cytokine secretion with little to no measurable circulating IL-6 or TNFa was observed in most patients treated at = 10 mg of IGM-2323, an observation that contrasts with studies of most other T cell engagers. No drug-induced anti-drug antibodies were observed, and preliminary PK results were consistent with preclinical data. Annuncio • Nov 06
IGM Biosciences to Present First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting IGM Biosciences, Inc. announced that it expects the first clinical data from its Phase 1 trial evaluating IGM-2323 will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held virtually. IGM-2323 is a bispecific IgM antibody targeting the CD20 protein on the surface of lymphoma cells and the CD3protein on the surface of T cells in order to kill lymphoma cells in patients with non-Hodgkin’s lymphoma(NHL). The Company’s multicenter, open-label Phase 1 clinical trial is intended to assess the safety,pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cellNHL. The preliminary results are expected to be presented on Saturday, December 5, 2020, at 7:00 a.m. PT, in an oral poster presentation titled “Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class IgM
Based Bispecific Antibody IGM-2323 (anti-CD20 x anti-CD3) in Patients with Advanced B-Cell Malignancies.” At the time of the ASH Annual Meeting, IGM plans to present additional safety, pharmacokinetic, biomarker and efficacy data from the eight patients described in the abstract released on November 4, 2020 (Budde et. al., abstract #134983) and from additional patients treated subsequent to the data cut-off for the abstract. IGM is currently enrolling patients for treatment with 300 mg, but data from this dose cohort will not be available by the time of the ASH Annual Meeting. As described in the abstract, as of June 12, 2020, eight patients had been treated at 4 dose levels (0.5, 2.5, 10, and 30 mg). The eight patients had received an average of four prior therapies before treatment with IGM-2323. Six of the eight patients remained on active treatment as of the data cut-off for the abstract. No dose limiting toxicities (DLTs) or drug related serious adverse events (SAEs) had been observed among the eight patients. Two patients had experienced low-grade transient fevers, but no grade 2 or higher cytokine release syndrome had been observed among the eight patients. When cytokines were detectable following dosing, they were transient and had returned to baseline at less than 6-12 hours. Interferon-gamma (IFNg) was the primary cytokine observed, with significant levels of IL-6 detected in only one patient. Preliminary results from this first-in-human T cell engaging antibody study show an improved safety and tolerability profile. There is also evidence of a novel mechanism of action based on repeatable T cell activation and preservation of T cell function compared with other T cell engaging antibodies. Annuncio • Oct 04
IGM Biosciences, Inc. Initiates First-In-Human Clinical Trial of IGM-8444 for the Treatment of Solid Cancers and Non-Hodgkin’S Lymphoma IGM Biosciences, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, in patients with solid cancers and non-Hodgkin’s lymphoma. The multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers and non-Hodgkin’s lymphoma. The key objectives of this trial are to provide an initial assessment of the pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy. IGM expects to report initial data from this Phase 1 trial in 2021. Annuncio • Sep 26
AbCellera Biologics Inc. and IGM Biosciences, Inc. Announce Multi-Year Antibody Discovery Collaboration AbCellera and IGM Biosciences, Inc. announced that they have entered into a multi-year, multi-target strategic research collaboration and license agreement to facilitate the discovery and development of novel IgM antibodies. AbCellera will generate panels of antibodies for multiple therapeutic targets identified by IGM using its full-stack, AI-powered antibody discovery technology, and IGM will have the rights to develop and commercialize the novel antibodies resulting from this collaboration. Financial terms of the collaboration were not disclosed. AbCellera sources, searches, decodes and analyzes natural immune responses to identify antibodies for next-generation therapeutics. A modern operating system for antibody discovery, the platform integrates patented and proprietary technologies to advance the development of existing and new biological modalities, from monoclonal, multi-specific, and single-domain antibodies, to bioconjugates, gene-encoded biologics, and cell therapies. IGM’s proprietary platform expands upon the inherent characteristics of IgM and IgA antibodies and is designed to enable the rapid development of engineered therapeutic antibodies. IGM’s technology allows it to create IgM and IgA antibodies with higher affinity and avidity than naturally occurring IgM and IgA antibodies, and is designed to overcome the historical difficulties in recombinantly expressing and manufacturing IgM and IgA antibodies. Is New 90 Day High Low • Sep 22
New 90-day high: €69.50 The company is up 10.0% from its price of €63.00 on 24 June 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Jul 03
IGM Biosciences, Inc.(NasdaqGS:IGMS) dropped from Russell 3000 Value Index IGM Biosciences, Inc.(NasdaqGS:IGMS) dropped from Russell 3000 Value Index