IGM Biosciences Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
– Announced Global Collaboration Agreement with Sanofi for Oncology, Autoimmune and Inflammation Targets; IGM to Receive
– Ongoing Progress in Clinical Programs with Two Phase 2 Studies of Two Doses of IGM-2323, 100 mg and 300 mg, in Patients with DLBCL and FL Initiated –
– Company to Host Conference Call and Webcast Today at
“IGM continues to make progress in creating a new class of antibody medicines, which strengthens our commitment to use our expertise to develop and improve upon the inherent qualities of IgM antibodies,” said
Global R&D Collaboration with Sanofi
- An exclusive worldwide collaboration agreement with Sanofi for multiple oncology, autoimmune and inflammation targets was announced.
- IGM and Sanofi will leverage IGM’s proprietary IgM antibody technology platform to discover IgM antibody agonists against three oncology targets and three autoimmune/inflammation targets.
- IGM will receive a
$150 millionupfront payment and potentially over $6 billionin aggregate development, regulatory and commercial milestones. A 50:50 profit share in certain major market countries and tiered royalties in the rest of world is planned for oncology targets, and IGM will receive tiered royalties for autoimmune/inflammation targets. Sanofi has also expressed an interest in purchasing up to $100 millionof IGM non-voting common stock in a public financing.
- Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the
U.S., and other customary closing conditions.
IGM-2323 (CD20 x CD3)
- Phase 2 studies initiated. IGM announced the initiation of two Phase 2 studies to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (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.
- Presented Phase 1 clinical results: In
December 2021, IGM presented clinical results from its Phase 1 trial evaluating IGM-2323 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”.
- Clinical development of IGM-8444 advances. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase I study of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid and hematologic cancers. IGM expects to report initial monotherapy and combination data in solid tumors from the dose escalation portion of this Phase 1 trial in 2022.
- Third FOLFIRI dose cohort successfully completed. IGM announced that it has cleared the third of four planned FOLFIRI combination dose escalation cohorts (3.0 mg/kg Q2W) with no dose limiting toxicities (DLTs) and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the final planned FOLFIRI combination dose escalation cohort (10.0 mg/kg Q2W).
- First birinapant dose cohort successfully completed. IGM also announced that it has cleared the first of four planned birinapant combination dose escalation cohorts with no DLTs and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the second planned birinapant combination dose escalation cohort.
IGM-7354 (IL-15 x PD-L1)
- IND filing expected in 2022. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, in solid tumors in 2022.
IGM-2644 (CD38 x CD3)
- IND filing expected in 2022. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma in 2022.
- Announced grant agreement with the
Bill & Melinda Gates Foundation. The agreement aims to leverage IGM’s engineered IgM and IgA antibodies for the potential prevention of malaria, a significant driver of morbidity and mortality in low- and middle-income countries. Carrie Brodmerkel, Ph.D., appointed Chief Scientific Officer of IGM Autoimmunity and Inflammation. Dr. Brodmerkelbrings extensive experience across a broad range of disciplines to this role. Most recently, she served as Vice President and Global Head of Exploratory Biology and Scientific Strategy at Janssen R&D, a division of Johnson & Johnson, where she was responsible for scientific and strategic leadership of the biotherapeutics portfolio, functional planning and execution, computational sciences, and exploratory biology across therapeutic areas including immunology, hematology, and oncology.
Fourth Quarter and Full Year 2021 Financial Results
- Cash and Investments: Cash and investments as of December 31, 2021 were $229.5 million, compared to
$366.3 millionas of December 31, 2020.
- Research and Development (R&D) Expenses: For the fourth quarter and year ended 2021, R&D expenses were
$39.2 millionand $127.0 million, respectively, compared to $19.6 millionand $65.0 millionfor the fourth quarter and year ended 2020, respectively.
- General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2021, G&A expenses were
$11.5 millionand $38.3 million, respectively, compared to $5.1 millionand $18.3 millionfor the fourth quarter and year ended 2020, respectively.
- Net Loss: For the fourth quarter of 2021, net loss was $50.6 million, or a loss of $1.50 per share, compared to a net loss of
$24.6 million, or a loss of $0.79per share, for the fourth quarter of 2020. For the year ended 2021, net loss was $165.2 million, or a loss of $4.93per share, compared to a net loss of $81.4 million, or a loss of $2.65per share, for the year ended 2020.
2022 Financial Guidance:
IGM expects full year GAAP operating expenses of
Conference Call and Webcast
IGM will host a conference call and webcast to discuss the Sanofi R&D collaboration announcement today,
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM and IgA antibodies and product candidates, including IGM-2323, IGM-8444, IGM-7354 and IGM-2644; expectations regarding the transaction with Sanofi, including all financial aspects of the collaboration and an equity investment; the potential benefits and results of the transaction with Sanofi, including goals of the collaboration and the potential for accelerated development of IGM’s platform; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of IGM-2323, including the potential for the Phase 2 studies to potentially serve as the basis for a regulatory filing and accelerated review and approval of IGM-2323; statements regarding the clinical development of IGM-8444, including timing for data and the safety profile of IGM-8444; the expected timing of filing INDs with for IGM-7354 and IGM-2644; IGM’s expectations regarding a grant agreement with the
|Selected Statement of Operations Data|
|(in thousands, except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|Research and development (1)||$||39,169||$||19,599||$||127,026||$||65,030|
|General and administrative (1)||11,511||5,140||38,297||18,250|
|Total operating expenses||50,680||24,739||165,323||83,280|
|Loss from operations||(50,680||)||(24,739||)||(165,323||)||(83,280||)|
|Other income, net||38||117||159||1,925|
|Net loss per share, basic and diluted||$||(1.50||)||$||(0.79||)||$||(4.93||)||$||(2.65||)|
|Weighted-average common shares outstanding, basic and diluted|
|(1)Amounts include stock-based compensation expense as follows:|
|Research and development||$||4,659||$||1,203||$||12,264||$||4,160|
|General and administrative||3,889||1,379||13,609||4,294|
|Total stock-based compensation expense||$||8,548||$||2,582||$||25,873||$||8,454|
|Selected Balance Sheet Data|
|Cash and investments||$||229,542||$||366,269|
|Total stockholders' equity||244,908||381,815|
Source: IGM Biosciences, Inc.