IGM Biosciences Announces Third Quarter 2023 Financial Results
13 Noviembre 2023 - 3:10PM
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
quarter ended September 30, 2023.
“During the third quarter, we continued to
execute across our clinical development pipeline,” said Fred
Schwarzer, Chief Executive Officer of IGM Biosciences. “We have
significantly expanded the number of active sites for our
aplitabart randomized study, including multiple international
sites, begun our Phase 1b clinical trials of imvotamab in severe
systemic lupus erythematosus and severe rheumatoid arthritis and
received FDA clearance of our IND application to begin a third
Phase 1b autoimmune clinical trial of imvotamab. Our progress in
the clinical development of these pipeline product candidates
reinforces our commitment to the broad development of our Death
Receptor 5 agonist platform and our T cell engager platform for
autoimmune diseases.”
Pipeline Progress
Aplitabart (DR5 agonist)
- Clinical development of
aplitabart advances.
- Enrollment ongoing in the
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, with a
goal of enrolling approximately 110 patients by the end of the
first quarter of 2024. In addition to clinical sites in the United
States, this study will include multiple sites in Asia and Europe.
This randomized trial is designed to assess the additional benefit
of 3 mg/kg of aplitabart to the current standard of care treatment
arm of FOLFIRI and bevacizumab, with a primary endpoint of
progression-free survival and secondary endpoints of overall
response rate and overall survival.
- Dosing at 10 mg/kg ongoing
in the single arm colorectal cancer clinical trial. The
Company continues to treat later line colorectal cancer patients in
its single arm combination clinical trial of 10 mg/kg of aplitabart
and FOLFIRI. The Company expects to complete enrollment of patients
in this 10 mg/kg single arm combination study in the first half of
2024.
- Ongoing venetoclax
combination. The Company continues to treat patients in
its initial Phase 1 single arm study of aplitabart in acute myeloid
leukemia in combination with venetoclax and azacytidine.
- Ongoing birinapant
combination. The Company continues to treat patients in
its aplitabart plus birinapant Phase 1 combination
cohort.
Imvotamab (CD20 x CD3)
- Two autoimmune clinical
trials ongoing. Following the clearance of the Company’s
two Investigational New Drug (IND) applications with the U.S. Food
and Drug Administration (FDA) for imvotamab, an IgM-based CD20 x
CD3 bispecific antibody T cell engager, the Company has begun two
Phase 1b clinical trials, one in severe systemic lupus
erythematosus (SLE) and one in severe rheumatoid arthritis
(RA).
- FDA clearance to begin
third autoimmune clinical trial. In the third quarter, the
Company received clearance from the FDA of its IND application for
the use of imvotamab in treating idiopathic inflammatory myopathies
(myositis).
- Imvotamab preclinical
data. In November 2023, the Company presented
preclinical data for imvotamab at the American College of
Rheumatology Annual Meeting. The results were featured in a poster
presentation titled “Therapeutic Potential of Imvotamab, a
CD20-Targeted Bispecific IgM T Cell Engager, for the Treatment of
Refractory Autoimmune Disease Patients”, which highlighted the
ability of imvotamab to effectively deplete CD20+ B cells in tissue
as well as to deplete low expressing CD20+ cells. These
preclinical results support the advancement of imvotamab into Phase
1b clinical trials in autoimmune disease and may indicate
differentiated activity as compared to anti-CD20 IgG1
antibodies.
IGM-7354 (IL-15 x PD-L1)
- Phase 1 trial
continues. The Company continues to treat patients in a
Phase 1 clinical trial exploring the safety, efficacy, and
biomarker activity of IGM-7354, an IgM-targeted immunostimulatory
IL-15 cytokine, in the treatment of patients with solid
tumors.
IGM-2644 (CD38 x CD3)
- Phase 1 trial
continues. The Company continues to treat patients in a
Phase 1 clinical trial exploring the safety and efficacy of
IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients
with recurrent or refractory multiple myeloma.
Third Quarter 2023 Financial Results
- Cash and Investments: Cash and investments as
of September 30, 2023 were $387.0 million, compared to
$427.2 million as of December 31, 2022.
- Collaboration Revenue: For the third quarter
of 2023, collaboration revenues were $0.5 million, compared to
$0.3 million for the same period in 2022.
- Research and Development (R&D) Expenses:
For the third quarter of 2023, R&D expenses were $54.8 million,
compared to $48.2 million for the same period in 2022.
- General and Administrative (G&A) Expenses:
For the third quarter of 2023, G&A expenses were $12.5 million,
compared to $12.7 million for the same period in 2022.
- Net Loss: For the third quarter of 2023, net
loss was $62.0 million, or a loss of $1.04 per share, compared to a
net loss of $58.0 million, or a loss of $1.32 per share, for the
same period in 2022.
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of
$275 million to $285 million, including estimated non-cash
stock-based compensation expense of approximately $50 million, and
full year collaboration revenue of approximately $2 million related
to the Sanofi agreement. The Company expects to end 2023 with more
than $325 million in cash and investments, and the Company expects
its existing cash and investments and anticipated collaboration
payments to fund operations into the second half of 2025.
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, autoimmune and inflammatory diseases
and infectious 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 www.igmbio.com.
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, IGM-7354 and
IGM-2644; IGM’s plans and expectations regarding its clinical
development efforts and activities; statements regarding the
clinical development of aplitabart, imvotamab, IGM-7354 and
IGM-2644, including patient enrollment; IGM’s expectations
regarding its financial position and guidance, including
collaboration revenue, operating expenses, stock-based compensation
expense, ending 2023 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; 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 Quarterly Report on Form 10-Q filed with the SEC on
November 13, 2023 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 PartnersDavid
Pitts212-600-1902igmbio@argotpartners.com
|
|
IGM Biosciences, Inc. |
Selected Statement of Operations Data |
(unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
509 |
|
|
$ |
331 |
|
|
$ |
1,479 |
|
|
$ |
697 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development (1) |
|
54,762 |
|
|
|
48,179 |
|
|
|
161,329 |
|
|
|
134,272 |
|
General and administrative (1) |
|
12,507 |
|
|
|
12,664 |
|
|
|
38,492 |
|
|
|
38,117 |
|
Total operating expenses |
|
67,269 |
|
|
|
60,843 |
|
|
|
199,821 |
|
|
|
172,389 |
|
Loss from operations |
|
(66,760 |
) |
|
|
(60,512 |
) |
|
|
(198,342 |
) |
|
|
(171,692 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
|
5,011 |
|
|
|
2,475 |
|
|
|
13,077 |
|
|
|
3,289 |
|
Other expense |
|
— |
|
|
|
— |
|
|
|
(20 |
) |
|
|
(123 |
) |
Total other income (expense) |
|
5,011 |
|
|
|
2,475 |
|
|
|
13,057 |
|
|
|
3,166 |
|
Loss before income tax expense |
|
(61,749 |
) |
|
|
(58,037 |
) |
|
|
(185,285 |
) |
|
|
(168,526 |
) |
Income tax expense |
|
(240 |
) |
|
|
— |
|
|
|
(436 |
) |
|
|
— |
|
Net Loss |
$ |
(61,989 |
) |
|
$ |
(58,037 |
) |
|
$ |
(185,721 |
) |
|
$ |
(168,526 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(1.04 |
) |
|
$ |
(1.32 |
) |
|
$ |
(3.73 |
) |
|
$ |
(4.15 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
59,580,402 |
|
|
|
44,034,652 |
|
|
|
49,778,716 |
|
|
|
40,634,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
Research and development |
$ |
7,391 |
|
|
$ |
6,096 |
|
|
$ |
22,078 |
|
|
$ |
19,038 |
|
General and administrative |
|
4,563 |
|
|
|
4,720 |
|
|
|
15,232 |
|
|
|
14,563 |
|
Total stock-based compensation expense |
$ |
11,954 |
|
|
$ |
10,816 |
|
|
$ |
37,310 |
|
|
$ |
33,601 |
|
|
|
|
|
|
|
|
|
IGM Biosciences, Inc. |
Selected Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
Cash and investments |
$ |
386,991 |
|
|
$ |
427,162 |
|
Total assets |
|
474,350 |
|
|
|
513,499 |
|
Accounts payable |
|
3,913 |
|
|
|
2,512 |
|
Accrued liabilities |
|
27,933 |
|
|
|
33,621 |
|
Deferred revenue |
|
147,452 |
|
|
|
148,931 |
|
Total liabilities |
|
220,488 |
|
|
|
226,236 |
|
Accumulated deficit |
|
(760,547 |
) |
|
|
(574,826 |
) |
Total stockholders' equity |
|
253,862 |
|
|
|
287,263 |
|
|
|
|
|
IGM Biosciences (NASDAQ:IGMS)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
IGM Biosciences (NASDAQ:IGMS)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024