IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
March 07 2024 - 4:10PM
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 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 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.
ContactArgot PartnersDavid
Pitts212-600-1902igmbio@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 |
|
|
|
|
|
|
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