IGM Biosciences Announces Leadership Appointments and Formation of IGM Infectious Diseases and IGM Autoimmunity and Inflammation Business Units

– John Shiver, Ph.D., and Tong-Ming Fu, M.D., Ph.D., Appointed as Chief Strategy Officer and Chief Scientific Officer, Respectively, of IGM Infectious Diseases –

– Mary Beth Harler, M.D., Appointed as President of IGM Autoimmunity and Inflammation –

IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced the formation of two business units: IGM Infectious Diseases and IGM Autoimmunity and Inflammation. These new business units will utilize and build upon IGM’s platform technology to create and develop novel IgM and IgA antibodies to address infectious diseases, autoimmunity and inflammation. Both business units will be headquartered in the greater Philadelphia area of Pennsylvania.

“We believe the successes we have achieved clinically and preclinically this year, together with our successes with engineering and manufacturing IgM antibodies, provide a strong basis for the expansion of our research and development efforts beyond oncology,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We are very excited that Drs. Shiver, Fu and Harler have decided to bring their decades of experience as successful drug developers and thought leaders in infectious diseases, autoimmunity and inflammation to help develop the potential of the IGM technology across a broad range of disease areas that may be transformed by therapeutic IgM and IgA antibodies.”

To lead the IGM Autoimmunity and Inflammation business unit, IGM today announced the appointment of Mary Beth Harler, M.D., as President. Dr. Harler served most recently as Senior Vice President, Head of Immunology and Fibrosis Development at Bristol Myers Squibb, where she oversaw late-stage development of assets with the potential to become approved treatment options for patients with diseases such as psoriasis, inflammatory bowel disease (IBD) and nonalcoholic steatohepatitis (NASH), among others. Dr. Harler also oversaw approved medicines that sit within the immunology and fibrosis  portfolios, such as Orencia and Zeposia. Prior to being appointed to that position, Dr. Harler served in positions of increasing responsibility at Bristol Myers Squibb for almost 10 years. Notably, Dr. Harler served as Head of Innovative Medicines Development and Head of Innovative Clinical Development in the cardiovascular, fibrosis, immunoscience and genetically-defined diseases group.

Prior to joining Bristol Myers Squibb, Dr. Harler worked in both medical affairs and clinical research at Wyeth Pharmaceuticals (now part of Pfizer). Dr. Harler received a B.S. from Wheeling University in West Virginia and an M.D. from Marshall University. She then went on to complete training as a general surgeon at Brown University’s Rhode Island Hospital, where she was also a research fellow with a focus on the role of immune cells in wound healing.

“As the global leader in the development of engineered IgM antibodies, I believe IGM Biosciences has the potential to create exciting new therapies for patients with autoimmune and inflammatory diseases,” said Dr. Harler. “The IGM Autoimmunity and Inflammation business unit will be dedicated to rapidly and efficiently establishing our platform’s full potential in these therapeutic areas, and I look forward to building and leading the team in these efforts.”

To lead the IGM Infectious Diseases business unit, IGM today also announced the appointments of John Shiver, Ph.D. and Tong-Ming Fu, M.D., Ph.D., as Chief Strategy Officer and Chief Scientific Officer, respectively.

Dr. Shiver was most recently Senior Vice President, Vaccine Research and Development at Sanofi Pasteur. Prior to joining Sanofi, Dr. Shiver held positions of increasing responsibility at Merck & Co., most recently as Vice President, Vaccine and Biologics Basic Research and Global Vaccine Research Franchise Head. He has also served as an Adjunct Professor at the University of Pennsylvania College of Medicine for ten years. Over the course of his career, he has contributed leadership towards the approval of ten novel pharmaceutical products and has worked on product candidates addressing more than forty infectious and noninfectious diseases. He received a Ph.D. in Chemistry from the University of Florida and a B.S. in Chemistry and Mathematics from Wofford College.

“IgM antibodies are nature’s first line of defense against pathogens, and the preclinical data to date suggest that engineered IgM antibodies could be very helpful in treating and preventing COVID-19 and other infectious diseases,” said Dr. Shiver. “Following the expansion of the IgM platform into infectious diseases with our intranasally delivered IgM antibody, IGM-6268, for the treatment and prevention of COVID-19, as described in a recent Nature publication, IGM has been advancing its understanding of the potential of IgM antibodies in other infectious diseases. I am very excited that the IGM Infectious Diseases business unit has been established, and I look forward to helping to build and lead the team working to broadly develop this potential in infectious diseases.”

Dr. Fu served most recently as Head of Vaccine Research, North America, at Sanofi Pasteur, where he led a group of over 40 scientists working on multiple vaccine projects, including respiratory syncytial virus, influenza virus, SARS-CoV-2, chlamydia and pertussis, and novel vaccine or technology platforms including mRNA and recombinant human antibodies. Prior to his time at Sanofi, Dr. Fu was a research scientist in vaccines and biologics at Merck & Co. Dr. Fu is also an Adjunct Professor at the Texas Therapeutic Institute, Texas Health Science Center. Dr. Fu received a Ph.D. from the Milton S. Hershey Medical Center at the Pennsylvania State University College of Medicine and an M.D. from Peking University Health Science Center, formerly Beijing Medical University.

“Based on IGM’s preclinical work demonstrating that IgM antibodies can be more effective at neutralizing viruses, including SARS-CoV-2, as compared with traditional IgG antibodies, we feel it is important to expand the scope of research and development to explore the use of IgM antibodies in a variety of infectious diseases where there is unmet need,” said Dr. Fu. “I am very excited to help build the team and lead the work at IGM Infectious Diseases to develop new antibody therapies that can provide exciting new medicines to treat and prevent infectious diseases.”   

About IGM Biosciences, Inc. 

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies. 

Cautionary Note Regarding Forward-Looking Statements  

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its IgM and IgA antibodies and product candidates, its expansion into infectious diseases and autoimmunity and inflammation, and its newly created infectious diseases and autoimmunity and inflammation business units; the Company’s research and development strategy and statements by the Chief Executive Officer of IGM, the Chief Strategy Officer and Chief Scientific Officer of IGM’s Infectious Diseases business unit and the President of IGM’s Autoimmunity and Inflammation business unit. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, the potential diminishing need for therapeutics to address COVID-19, particularly in the United States and other major markets, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact 

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

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IGM Biosciences to Present at the 2021 Cantor Virtual Global Healthcare Conference

MOUNTAIN VIEW, Calif., September 23, 2021 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that management will present at the 2021 Cantor Virtual Global Healthcare Conference on September 29, 2021 at 3:20 p.m. EDT.

A live webcast of the event will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

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IGM Biosciences to Participate in Three Upcoming Investor Conferences

MOUNTAIN VIEW, Calif., September 7, 2021 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that management will participate in three upcoming investor conferences:

  • Citi 16th Annual BioPharma Virtual Conference on Thursday, September 9
  • Fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, September 13 at 2:45 p.m. EDT
  • Fireside chat at Baird’s 2021 Global Consumer, Technology & Services Conference on Tuesday, September 14 at 2:35 p.m. EDT

A live webcast of the Morgan Stanley fireside chat will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

###

IGM Biosciences Announces Second Quarter 2021 Financial Results and Provides Corporate Update

– Recommended Phase 2 Dose of IGM-2323 Expected in 2021 –

– Initial Data from Phase 1 Trial of IGM-8444 in Solid Cancers Expected in 2021 –

– Expansion of IgM Platform into Infectious Diseases –

MOUNTAIN VIEW, Calif., August 9, 2021 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the second quarter ended June 30, 2021 and provided an update on recent developments.

“We continue to make steady progress in the development of our innovative product pipeline, including the successful completion of the initial dose escalation portion of our IGM-2323 Phase 1 clinical trial,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We look forward to announcing a recommended Phase 2 dose for IGM-2323, presenting initial dose escalation data from the Phase 1 trial of IGM-8444, initiating a Phase 1 trial for IGM-6268 and filing an IND for IGM-7354 this year. “

Pipeline Updates

IGM-2323 

  • Phase 1 dose escalation completed; dose expansion continues. IGM continues to advance the clinical development of IGM-2323, the Company’s IgM-based CD20 x CD3 bispecific antibody, for the treatment of non-Hodgkin’s lymphoma (NHL). The Company cleared its highest planned dose escalation cohort, a top dose of 1000 mg, without a dose limiting toxicity, and is currently treating additional patients in four Phase 1 dose cohorts with top doses of 100 mg, 300 mg, 600 mg and 1000 mg, respectively. IGM expects to select a recommended Phase 2 dose in 2021.

IGM-8444 

  • Additional dose cohorts cleared in Phase 1. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM Death Receptor 5 (DR5) agonist, for the treatment of a potentially broad range of solid tumors and hematologic malignancies. IGM has cleared its third dose cohort (3 mg/kg) of the single-agent portion of its Phase 1 clinical study and is currently treating patients in its highest dose escalation cohort (10 mg/kg) with every two-week single agent dosing. IGM has also cleared the first dose cohort of the FOLFIRI combination portion of the Phase 1 study and is currently treating patients in the second of four planned FOLFIRI combination dose escalation cohorts. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in 2021. 
  • Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 in 2021.

IGM-6268  

  • New pipeline candidate for the treatment and prevention of COVID-19 expected to advance into the clinic this year. In June 2021, IGM announced IGM-6268, which represents the expansion of the Company’s IgM platform into infectious diseases. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody and is being developed as an intranasally administered agent for the treatment and prevention of COVID-19. IGM expects to initiate a Phase 1 clinical trial of IGM-6268 in 2021. 
  • Nature manuscript published. In June 2021, Nature published an article entitled “Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants”. 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 and Variants of Interest, and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The article was co-authored by researchers at IGM, The University of Texas Medical Branch at Galveston and The University of Texas Health Science Center at Houston. 

IGM-7354

  • Investigational New Drug (IND) application expected to be filed this year. IGM plans to file an IND application with the U.S. Food and Drug Administration (FDA) for IGM-7354, the Company’s IL‑15 x PD‑L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies.

Corporate Updates

  • Chris Takimoto appointed Chief Medical Officer. Dr. Takimoto brings 30 years of experience in cancer research and development. Most recently, Dr. Takimoto was Senior Vice President, Oncology at Gilead Sciences, Inc. Prior to Gilead, he served as Chief Medical Officer of Forty Seven, Inc., a biotechnology company formed out of Stanford University and acquired by Gilead Sciences in 2020.

Second Quarter 2021 Financial Results 

  • Cash and Investments: Cash and investments as of June 30, 2021 were $301.8 million, compared to $366.3 million as of December 31, 2020.
  • Research and Development (R&D) Expenses:  For the second quarter of 2021, R&D expenses were $30.1 million, compared to $15.0 million for the same period in 2020.
  • General and Administrative (G&A) Expenses:  For the second quarter of 2021, G&A expenses were $8.6 million, compared to $4.4 million for the same period in 2020.
  • Net Loss: For the second quarter of 2021, net loss was $38.7 million, or a loss of $1.16 per share, compared to a net loss of $18.8 million, or a loss of $0.62 per share, for the same period in 2020.

2021 Financial Guidance

IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments. 

About IGM Biosciences, Inc. 

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies. 

Cautionary Note Regarding Forward-Looking Statements 

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its antibody drug candidates and birinapant; statements regarding IGM’s Phase 1 clinical trials of IGM-2323 and IGM-8444; the anticipated timing of the selection of a recommended Phase 2 dose for IGM-2323, the reporting of initial data from the dose escalation portion of the Phase 1 trial of IGM-8444, the initiation of clinical testing of birinapant in combination with IGM-8444, the initiation of a Phase 1 trial for IGM-6268 and an IND filing for IGM-7354; IGM’s expectations regarding its financial position, including operating expenses, cash and investments and non-cash stock-based compensation; and statements by the Chief Executive Officer of IGM. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the risk that all necessary regulatory approvals cannot be obtained; the risk that the potential benefits of combination therapies do not outweigh their costs; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact 

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

 

IGM Biosciences Announces the Appointment of Chris H. Takimoto, M.D., Ph.D., F.A.C.P., as Chief Medical Officer

IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced the appointment of Chris H. Takimoto, M.D., Ph.D., F.A.C.P., to the role of Chief Medical Officer, effective today. Dr. Takimoto will be responsible for global development of IGM’s clinical pipeline of proprietary IgM antibodies. He joins IGM with 30 years of experience in cancer research and development, most recently as Senior Vice President, Oncology, Gilead Sciences, Inc. Daniel S. Chen, M.D., Ph.D., will continue to assist the Company in a consulting capacity.

“Dr. Takimoto has a proven track record of shepherding novel oncology product candidates through clinical development together with broad expertise in oncology and pharmacology gained through a distinguished industry, academic, and public service career,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We look forward to working with him and our clinical team in continuing to advance our growing clinical pipeline of IgM antibodies. We would also like to thank Dr. Chen for the significant contributions he has made to the Company, including managing the initial dose escalation portion of our Phase 1 clinical trial of IGM-2323, our CD20 x CD3 T cell engager IgM antibody for non-Hodgkin’s lymphoma, and successfully launching our Phase 1 clinical trial of IGM-8444, our Death Receptor 5 agonist IGM antibody for solid and liquid tumors, and we sincerely wish him continued success in his career.”

“As the pioneers of a groundbreaking new technology, IGM Biosciences has the potential to make a real difference for patients in therapeutic areas from oncology to infectious diseases to immunology and inflammation by harnessing the power of nature’s strongest antibodies, IgMs,” said Dr. Takimoto. “IGM Biosciences has solved many of the challenges historically associated with engineering and manufacturing these complex molecules, and I look forward to participating in their clinical development and helping to demonstrate their full potential.”

Prior to Gilead, Dr. Takimoto served as Chief Medical Officer, since February 2016, of Forty Seven, Inc., a biotechnology company formed out of Stanford University and acquired by Gilead Sciences in 2020. From September 2010 to January 2016, Dr. Takimoto served as Vice President of Experimental Medicine Early Development, Oncology Therapeutic Area for Janssen Research and Development, LLC. From 2008 to 2010, Dr. Takimoto served as Senior Director of Translational Medicine of Ortho Biotech Oncology Research and Development. He has over thirty years of experience in industry and academia, including academic positions at the University of Texas Health Science Center at San Antonio, the National Cancer Institute, and the Uniformed Services University of the Health Sciences. He also served as a Commissioned Officer in the U.S. Public Health Service. Dr. Takimoto received a B.S. in Chemistry from Stanford University, a Ph.D. in Pharmacology from Yale University, and an M.D. from Yale University School of Medicine.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its product candidates and clinical pipeline; statements regarding IGM’s Phase 1 clinical trials of IGM-2323 and IGM-8444; and statements by Mr. Schwarzer and Dr. Takimoto. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the risk that all necessary regulatory approvals cannot be obtained; the risk that the potential benefits of combination therapies do not outweigh their costs; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGM’s Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

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

Company Expects to Advance First Intranasally Administered IgM Antibody, IGM-6268, into the Clinic in Third Quarter of 2021

MOUNTAIN VIEW, Calif., June 03, 2021 — IGM Biosciences, Inc. (Nasdaq: IGMS) a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today 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.

“High viral load in the respiratory tract correlates with severe illness and mortality in patients with COVID-19,” said Dr. Zhiqiang An, Director of the UTHealth Texas Therapeutics Institute, Professor of Molecular Medicine at McGovern Medical School at UTHealth, and one of the corresponding authors on the publication. “Respiratory mucosal antibodies are key to clearing SARS-CoV-2 infection and reducing viral transmission and IgM antibodies are nature’s first line of defense against pathogens such as viruses. The current EUA antibodies, which are all IgG antibodies, are administered intravenously at high doses and don’t directly target the main sites of infection. Moreover, SARS-CoV-2 has evolved mutations that severely compromise the neutralizing activities of multiple IgG monoclonal antibodies, including those under clinical trials and authorized for emergency use. Therefore, developing new antibody therapies that can overcome these challenges is an urgent unmet need, and we are pleased with the data published today.”

Results from the study published in Nature found that, among the anti-SARS-CoV-2 IgG, IgA, and IgM antibodies screened, IgM antibodies were in all cases significantly more potent than IgG and IgA antibodies in neutralizing virus. IGM-6268, described as IgM-14 in the publication, was shown to be effective for prophylaxis and treatment in animal models when administered intranasally, and also demonstrated significantly increased potency against wild type SARS-CoV-2 and emerging natural viral variants, such as the current UK, South African and Brazilian VoC strains, VoIs, as well as the antibody escape mutants for the current Emergency Use Authorized antibodies.

“The ability to transform IgG antibodies into potently neutralizing IgM antibodies for the possible prevention and treatment of COVID-19 with broad coverage of VoCs, VoIs and viral escape mutants is a very exciting application of our IgM platform that could address an urgent unmet medical need,” said Fred Schwarzer, CEO of IGM Biosciences. “We look forward to advancing IGM-6268 as quickly as possible and plan to initiate a clinical study in the third quarter of this year, marking the expansion of our IgM antibody platform from oncology into infectious diseases. We are grateful to our collaborators at UTMB and UTHealth and our scientists at IGM for the exceptional work described in Nature today.”

About IGM-6268
IGM-6268, an engineered human IgM monoclonal antibody designed for the treatment and prevention of COVID-19, has been shown in preclinical studies to be highly effective in preventing and treating COVID-19 after intranasal administration. Due to its ability to bind to SARS-CoV-2 with greater strength, IGM-6268 offers advantages over current IgG treatments, including 100x to 1,000x greater neutralizing potency than comparable IgG antibodies, and the ability to effectively neutralize Variants of Concern and Variants of Interest. In our in vivo models, IGM-6286 appeared to be well-tolerated, did not appear to present any adverse safety signals, and demonstrated good persistence in the sinus following intranasal administration.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, IGM-6268, the Company’s IgM technology platform and its expansion into infectious diseases, statements regarding the timing of the Company’s planned clinical trials of IGM-6268, the Company’s development strategy for IGM-6268, and statements by Dr. An and Mr. Schwarzer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of IGM-6268; IGM’s ability to successfully and timely advance IGM-6268 through clinical studies; the risk that all necessary regulatory approvals cannot be obtained; IGM’s ability to enroll patients in clinical studies; the potential for the results of clinical studies of IGM-6268 to differ from preclinical, preliminary or expected results; the risk that IGM-6268 may cause significant adverse events, toxicities or other undesirable side effects; the risk that initial, interim, topline or preliminary data from IGM’s clinical studies may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the later or final data; IGM’s ability to successfully manufacture and supply IGM-6268 for clinical studies; potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical studies, enrollment in its current and future clinical studies and progression of its collaborations and related efforts; the potential market for IGM-6268, the potential diminishing need for therapeutics to address COVID-19, particularly in the United States and other major markets, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations, licenses or agreements with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaborations, licenses or agreements; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGM’s Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

IGM Biosciences to Present at the Jefferies Virtual Healthcare Conference

MOUNTAIN VIEW, Calif., May 26, 2021IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 2, 2021 at 1:00 p.m. EDT.

A live webcast of the event will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of multiple diseases. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com