DR5

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc., (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments. “We made significant progress during 2023 in the clinical development of our two lead product candidates in therapeutic areas that we believe have the greatest potential to produce significant near-term value,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Enrollment in our randomized clinical trial of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer continues to be encouraging, and we expect to expeditiously complete our target enrollment of 110 patients. If the control arm of this randomized study demonstrates the expected median progression free survival of approximately six months, we will be able to begin evaluating the benefit of aplitabart in enhancing progression free survival by the end of this year." Mr. Schwarzer continued, “We also initiated two Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and in severe rheumatoid arthritis. We are encouraged by the initial level of investigator and patient interest that we have seen in these clinical trials, and we are optimistic that we will be able to generate meaningful initial clinical data by the end of 2024.” Pipeline Updates Aplitabart (DR5 agonist) Clinical development of aplitabart advances. Enrollment ongoing in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. In addition to clinical trial sites in the United States, this study includes multiple clinical trial sites in Asia and Europe. This randomized trial is designed to assess the additional benefit of 3 mg/kg of aplitabart when administered in combination with the current standard of care treatment arm of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). Evaluating 10 mg/kg dose in single arm colorectal cancer clinical trial. The Company also continues to evaluate a dose of 10 mg/kg of aplitabart in combination with FOLFIRI and bevacizumab in the treatment of later line colorectal cancer patients in its single arm combination clinical trial. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination dose cohort in the first half of 2024. Imvotamab (CD20 x CD3) Clinical development of imvotamab in autoimmune diseases advances. The Company currently has two Phase 1b clinical trials underway for imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody: one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also received clearance in late 2023 from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and the Company is currently making preparations to initiate this clinical trial. IGM-2644 (CD38 x CD3) Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company is currently making plans to begin clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. Fourth Quarter and Full Year 2023 Financial Results Cash and Investments: Cash and investments as of December 31, 2023 were $337.7 million, compared to $427.2 million as of December 31, 2022. Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively. Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively. General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively. Net Loss: For the fourth quarter of 2023, net loss was $60.7 million, or a loss of $1.01 per share, compared to a net loss of $52.6 million, or a loss of $1.19 per share, for the fourth quarter of 2022. For the year ended 2023, net loss was $246.4 million, or a loss of $4.71 per share, compared to a net loss of $221.1 million, or a loss of $5.32 per share, for the year ended 2022. 2024 Financial Guidance The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million, including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026. About IGM Biosciences, Inc. IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including the timing of clinical trial initiation and patient enrollment; IGM’s expectations regarding its financial position and guidance, including non-cash stock-based compensation expense, collaboration revenue, ending 2024 cash and investments and projected cash runway; and statements by IGM’s Chief Executive Officer. 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 its product candidates; IGM’s ability to successfully and timely advance its product candidates through 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, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties; 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, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations; 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; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; 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 7, 2024 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, Inc. Selected Statement of Operations Data (in thousands, except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2023 2022 2023 2022 Collaboration revenue $ 651 $ 372 $ 2,130 $ 1,069 Operating expenses: Research and development (1) 54,190 45,018 215,519 179,289 General and administrative (1) 11,580 11,618 50,072 49,736 Total operating expenses 65,770 56,636 265,591 229,025 Loss from operations (65,119 ) (56,264 ) (263,461 ) (227,956 ) Other income (expense) Interest income 4,666 3,746 17,743 7,035 Other expense — (58 ) (20 ) (181 ) Total other income (expense) 4,666 3,688 17,723 6,854 Loss before income tax expense (60,453 ) (52,576 ) (245,738 ) (221,102 ) Income tax expense (242 ) — (678 ) — Net Loss $ (60,695 ) $ (52,576 ) $ (246,416 ) $ (221,102 ) Net loss per share, basic and diluted $ (1.01 ) $ (1.19 ) $ (4.71 ) $ (5.32 ) Weighted-average common shares outstanding, basic and diluted 59,829,077 44,241,491 52,311,958 41,543,954 (!)Amounts include stock-based compensation expense as follows: Research and development $ 5,421 $ 6,582 $ 27,499 $ 25,620 General and administrative 3,816 4,527 19,048 19,090 Total stock-based compensation expense $ 9,237 $ 11,109 $ 46,547 $ 44,710 IGM Biosciences, Inc. Selected Balance Sheet Data (in thousands) December 31, 2023 2022 Cash and investments $ 337,677 $ 427,162 Total assets 423,411 513,499 Accounts payable 1,326 2,512 Accrued liabilities 31,544 33,621 Deferred revenue 146,801 148,931 Total liabilities 220,177 226,236 Accumulated deficit (821,242 ) (574,826 ) Total stockholders' equity 203,234 287,263

IGM ended September with 290 full-time employees. How much money does a biotech need to feel comfortable in today’s market? IGM Biosciences added to evidence that the number is big after the market closed Tuesday, when it revealed a 22% reduction in its headcount and prioritization of its pipeline to make the hundreds of millions in its bank go further.  Talking at an investor event last month, IGM CEO Fred Schwarzer gave an upbeat answer to a question about the biotech’s financial footing, telling attendees that it had “plenty of cash to get through into the second half of 2025.” The cash pile stood at $387 million at the end of September. Yet, while IGM has a bank balance to turn some biotechs green with envy, it has decided it needs to cut costs.   IGM ended September with 290 full-time employees. The decision to reduce that figure by 22% is part of a set of changes intended to keep IGM going into the second quarter of 2026. Through the changes, IGM is focusing its resources on colorectal cancer and autoimmune diseases. The biotech is halting work on two assets, the CD123xCD3 bispecific IGM-2537 and IL-15xPD-L1 candidate IGM-7354, and cutting the list of the indications targeted by two other molecules. Work on aplitabart in acute myeloid leukemia and in combination with birinapant is stopping, as is development of IGM-2644 in multiple myeloma. In a statement, Schwarzer said IGM is “very encouraged by the clinical and preclinical data that we have generated for the programs” but is halting work in response to “the difficult conditions in the capital markets for our industry.” The changes are intended to narrow IGM’s focus on opportunities with “the most potential to produce significant near-term value,” the CEO said. IGM will continue to study aplitabart, a DR5 agonist, in colorectal cancer, forging toward the goal of enrolling 110 patients in a randomized trial by the end of the first quarter of next year. Development of the CD38xCD3 bispecific IGM-2644 is continuing in autoimmune diseases. IGM aims to file to test the drug candidate in humans next year. Work on the CD20xCD3 bispecific imvotamab is continuing too.

ONK Therapeutics and NAYA Biosciences to assess proof-of-concept and establish activity and feasibility of the combination of ONK’s optimally engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies for the treatment of cancerPartnership may be expanded to joint clinical development following successful completion of the initial researchCombination therapy expected to improve response rate and address significant unmet medical need in hepatocellular carcinoma (HCC) GALWAY, Ireland and SAN DIEGO and AVENTURA, Fla. and SARASOTA, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) -- ONK Therapeutics (“ONK”), an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf natural killer (NK) cell therapies, and NAYA Biosciences Inc. ("NAYA"), a company dedicated to increasing patient access to breakthrough treatments in fertility, oncology, and regenerative medicine, today announced that they have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies. Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody. “We are impressed with the data ONK has generated using its differentiated editing of NK cells, which may further enhance the efficacy of our FLEX-NK™ bispecific antibodies,” commented NAYA’s CEO Dr. Daniel Teper. “The future development of this combination therapy alongside our monotherapy clinical trials will help expand patient options and narrow the gap towards improving the long-term survival of patients with hepatocellular carcinoma.” ONK’s CEO Chris Nowers added, “The opportunity to partner with NAYA to evaluate the activity of our optimally gene-edited, non-CAR directed, allogeneic NK cell therapies in combination with its exciting FLEX-NK™ bispecific antibodies offers an opportunity to further improve response rates and durability of NK cell therapy. We believe this therapeutic combination represents a broadly applicable and versatile approach to treat patients with cancer and autoimmune diseases, where additional treatment options are needed.” ONK and NAYA plan to assess several combination therapies in preclinical cancer models in 2024 prior to subsequently exploring initiating clinical trials. The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development. Both companies will share the costs of manufacturing and preclinical assessments. ONK Therapeutics employs an innovative gene editing strategy to engineer NK cell therapies that are fit for purpose and optimally engineered, depending on the indication and intent for use alone (CAR NK), or in combination with targeting monoclonal antibody or NK cell engager therapies. All of ONK’s allogeneic NK cell therapy products candidates include the foundational CISH KO gene edit, to allow for enhanced metabolic properties and improved in vivo persistence. ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells. Additional gene edits, such as the KO of immunosuppressive checkpoints such as TGFβR2, as well as gene knock-ins (KIs), such as sIL-15, are included to further armor the NK cell therapies for maximal activity within the tumor microenvironment. NAYA’s FLEX-NK bispecific antibodies are built on a proprietary tetravalent, multifunctional format with flexible linker, facilitating simultaneous binding to different antigens on one or multiple cells. They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors. NKp46 mediates NK-cell lysis in both autologous and allogeneic cells and shows sustained expression on NK cells in the tumor microenvironment. NY-303 targets GPC3 for the treatment of HCC and other solid tumors and has demonstrated enhanced tumor growth inhibition when combined with NK cells in data presented at leading conferences including the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC). About ONK Therapeutics – www.onktherapeutics.com ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its two lead programs, ONKT105, a highly functional, multi gene edited NK cell therapy for use either alone or in combination with monoclonal antibodies or NK cell engagers, and ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/refractory multiple myeloma. Read about the pipeline here. The company’s optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize NK cell metabolic health, persistence and anti-tumor effect of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here. Follow us on Twitter and LinkedIn. About NAYA Biosciences NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to increasing patient access to life-transforming treatments in oncology, fertility, and regenerative medicine. NAYA's capabilities in biology, cell and gene therapy, and artificial intelligence (AI) provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments. NAYA Oncology aims to achieve clinical proof-of-concept for its two bispecific antibodies acquired from Cytovia Therapeutics, with the goal of advancing towards breakthrough outcomes for Hepatocellular Carcinoma and Multiple Myeloma patients. Clinical trials are expected to start in 2024. NAYA Fertility aims to increase accessibility to advanced fertility care through a growing network of INVO-owned and affiliated clinics and the commercialization of INVO's unique FDA-cleared INVOcell® device. NAYA Regenerative Medicine is evaluating the acquisition of clinic-stage assets aiming to restore biological function in patients with damaged tissues and organs. On October 22, 2023, NAYA and INVO announced a merger agreement, which is expected to close in Q1 2024. For additional details, see Inline XBRL Viewer (sec.gov). For more information, please visit www.nayabiosciences.com. Media enquiries ONK Therapeutics – International:Sue Charles (Charles Consultants)+44 7968 726585 sue@charles-consultants.com ONK Therapeutics – Ireland:Ray Gordon (Gordon MRM)+353 87 2417373 ray@gordonmrm.ie NAYA Biosciences:Anna Baran-Djokovic305-615-9162anna@nayabiosciences.com INVO Bioscience:Steve Shum978-878-9505sshum@invobio.com; INVO Investor Contact:Robert Blum (Lytham Partners, LLC)602-889-9700INVO@lythampartners.com