IGM Biosciences Announces First Quarter 2024 Financial Results and Provides Corporate Update
08 Maggio 2024 - 10:10PM
IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage
biotechnology company creating and developing engineered IgM
antibodies, today announced its financial results for the fiscal
quarter ended March 31, 2024 and provided an update on recent
developments.
“We are pleased to have exceeded our enrollment
target of 110 patients in our randomized study of 3 mg/kg of
aplitabart plus FOLFIRI and bevacizumab in second line colorectal
cancer,” said Fred Schwarzer, Chief Executive Officer of IGM
Biosciences. “While we are still scheduling first doses for a few
patients, we expect that final enrollment in this clinical trial
will exceed 120 patients. We are also pleased that we have
completed enrollment in the first dose cohort of our clinical trial
of imvotamab in severe rheumatoid arthritis.”
Pipeline Updates
Aplitabart (DR5 agonist)
- Clinical development of aplitabart advances.
- Enrollment target exceeded
in ongoing randomized colorectal cancer clinical
trial. The Company has exceeded its target of
enrolling 110 patients in its randomized clinical trial of 3 mg/kg
of aplitabart, a death receptor 5 agonist, plus FOLFIRI and
bevacizumab in second-line metastatic colorectal cancer. Patients
have been enrolled across multiple clinical trial sites in the
United States, Asia and Europe. This randomized trial is designed
to assess the benefit of 3 mg/kg of aplitabart when administered in
combination with FOLFIRI and bevacizumab compared to the current
standard of care treatment of FOLFIRI and bevacizumab, with a
primary endpoint of progression-free survival (PFS). The release of
data from this randomized clinical trial will be dependent upon the
timing of PFS events in both the control and the experimental arms
of this study. Based on its assumptions as to the
timing of PFS events, the Company expects to be able to release
top-line PFS results from this study by the end of the first
quarter of 2025.
- Enrollment target met in 10 mg/kg dose single arm
colorectal cancer clinical trial. The Company has also met
its target of enrolling 20 patients in its single arm clinical
study of 10 mg/kg of aplitabart in combination with FOLFIRI and
bevacizumab in the treatment of later line colorectal cancer
patients.
Imvotamab (CD20 x CD3)
- Clinical development of imvotamab in autoimmune
diseases advances.
- Enrollment completed in first dose cohort of imvotamab
in rheumatoid arthritis. The Company has completed
enrollment in the first dose cohort of its placebo-controlled
clinical study testing imvotamab in severe rheumatoid arthritis. In
this first dose cohort, the Company treated six patients with
imvotamab and two patients with a placebo. The Company plans to
enroll two additional dose cohorts, each consisting of six patients
treated with imvotamab and two patients treated with a placebo. The
doses of imvotamab received in the second dose cohort are planned
to be higher than those received in the first dose cohort, and the
doses of imvotamab received in the third dose cohort are planned to
be higher than those received in the second dose cohort. This
clinical study is now being expanded to include international
clinical trial sites, in addition to sites in the United
States.
- Enrollment continues in first dose cohort of imvotamab
in severe systemic lupus erythematosus. The Company also
continues to enroll patients in the first dose cohort of its single
arm, open-label clinical study testing imvotamab in severe systemic
lupus erythematosus (SLE). All six patients treated in the first
SLE dose cohort will receive imvotamab. The Company also plans to
enroll two additional dose cohorts, each consisting of six patients
treated with imvotamab. The doses of imvotamab received in the
second dose cohort are planned to be higher than those received in
the first dose cohort, and the doses of imvotamab received in the
third dose cohort are planned to be higher than those received in
the second dose cohort.
- Enrollment to begin in myositis.
The Company is currently initiating a clinical trial of imvotamab
in idiopathic inflammatory myopathies (myositis). The Company
expects to begin recruiting patients for this clinical trial in the
current quarter.
IGM-2644 (CD38 x CD3)
- Clinical development of
IGM-2644 in autoimmune diseases to be initiated. The
Company continues to make plans to begin clinical development of
IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of
autoimmune diseases.
First Quarter 2024 Financial Results
- Cash and
Investments: Cash and investments as of March 31, 2024
were $293.8 million, compared to $337.7 million as of December 31,
2023.
- Collaboration
Revenue: For the first quarter of 2024 and 2023,
collaboration revenues were $0.5 million in each quarter.
- Research and Development
(R&D) Expenses: For the first quarter of 2024, R&D
expenses were $43.8 million, compared to $50.9 million for the
first quarter of 2023.
- General and Administrative
(G&A) Expenses: For the first quarter of 2024, G&A
expenses were $10.5 million, compared to $13.0 million for the
first quarter of 2023.
- Net Loss: For the
first quarter of 2024, net loss was $49.8 million, or a loss of
$0.83 per share, compared to a net loss of $59.3 million, or a loss
of $1.33 per share, for the first quarter of 2023.
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. As a result of the refocusing of the
Sanofi collaboration announced in April 2024, the Company expects
to recognize full year collaboration revenue of approximately $63
million, of which $62 million is expected to be recognized in the
second quarter of 2024. This collaboration revenue relates to
accounting recognition of the upfront $150 million payment received
from Sanofi in 2022 and will not impact the Company’s cash balance
or runway. 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 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, 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, expected patient
enrollment, expected dosing, expected expansion to international
clinical trial sites, and the timing of the release of data; IGM’s
expectations regarding its financial position and projected cash
runway; expected impact of the refocusing of the Sanofi
collaboration on the Company’s recognition of revenue; 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;
uncertainties related to IGM’s ability to realize the contemplated
benefits of its pipeline prioritization efforts and related
reduction in force; 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 May 8, 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 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 |
|
March 31, |
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue |
$ |
497 |
|
|
$ |
522 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development(1) |
|
43,815 |
|
|
|
50,894 |
|
General and administrative(1) |
|
10,538 |
|
|
|
13,002 |
|
Total operating expenses |
|
54,353 |
|
|
|
63,896 |
|
Loss from
operations |
|
(53,856 |
) |
|
|
(63,374 |
) |
|
|
|
|
Other income
(expense): |
|
|
|
Interest income |
|
4,040 |
|
|
|
4,172 |
|
Other expense |
|
— |
|
|
|
(20 |
) |
Total other income (expense) |
|
4,040 |
|
|
|
4,152 |
|
Loss before
income tax expense |
|
(49,816 |
) |
|
|
(59,222 |
) |
Income tax expense |
|
— |
|
|
|
(87 |
) |
Net
loss |
$ |
(49,816 |
) |
|
$ |
(59,309 |
) |
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.83 |
) |
|
$ |
(1.33 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
60,114,409 |
|
|
|
44,466,764 |
|
|
|
|
|
|
|
|
|
(1)Amounts
include stock-based compensation expense as follows: |
|
|
|
Research and development |
$ |
4,362 |
|
|
$ |
6,439 |
|
General and administrative |
|
3,560 |
|
|
|
4,608 |
|
Total stock-based compensation expense |
$ |
7,922 |
|
|
$ |
11,047 |
|
|
|
|
|
IGM
Biosciences, Inc. |
Selected
Balance Sheet Data |
(unaudited) |
(in
thousands) |
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
2024 |
|
|
|
2023 |
|
Cash and
investments |
$ |
293,768 |
|
|
$ |
337,677 |
|
Total
assets |
|
376,132 |
|
|
|
423,411 |
|
Accounts
payable |
|
3,995 |
|
|
|
1,326 |
|
Accrued
liabilities |
|
23,652 |
|
|
|
31,544 |
|
Deferred
revenue |
|
146,304 |
|
|
|
146,801 |
|
Total
liabilities |
|
214,879 |
|
|
|
220,177 |
|
Accumulated
deficit |
|
(871,058 |
) |
|
|
(821,242 |
) |
Total
stockholders' equity |
|
161,253 |
|
|
|
203,234 |
|
|
|
|
|
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