IGM Biosciences Announces First Quarter 2023 Financial Results and Provides Corporate Update
12 May 2023 - 11:05PM
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 first
quarter ended March 31, 2023 and provided an update on recent
developments.
“We are pleased to be underway in our randomized clinical trial
of IGM-8444 in combination with standard of care FOLFIRI
chemotherapy and bevacizumab in second line metastatic colorectal
cancer patients, and we look forward to presenting additional
clinical data in the middle of 2023 from our non-randomized Phase 1
clinical study of 3 mg/kg of IGM-8444 plus FOLFIRI, with and
without bevacizumab,” said Fred Schwarzer, Chief Executive Officer
of IGM Biosciences. “We are also looking forward to the start of
clinical testing of imvotamab in autoimmune diseases, where we
believe the clinical safety and efficacy profile of imvotamab
positions us very well for the exciting new area of treating
autoimmune disease with T cell engagers.”
Pipeline Updates
IGM-8444 (DR5)
- Clinical development of IGM-8444 advances. The
Company continues to advance the clinical development of IGM-8444,
the Company’s IgM agonist antibody targeting death receptor 5
(DR5).
- Dosing ongoing in the randomized colorectal cancer
clinical trial. The Company is currently treating patients
in a randomized clinical trial of IGM-8444 plus FOLFIRI and
bevacizumab in second line metastatic colorectal cancer. The
Company plans to assess both the 3 mg/kg and 10 mg/kg dose
levels of IGM-8444 with a primary endpoint of progression free
survival and secondary endpoints of overall response rate and
overall survival as compared to the current standard of care
treatment arm.
- Dosing ongoing in the venetoclax combination.
The Company is currently treating patients with acute myeloid
leukemia in its IGM-8444 plus venetoclax and azacytidine Phase 1
combination cohort.
- Dosing ongoing in the fifth birinapant dose
cohort. The Company is also currently treating patients in
its fifth birinapant Phase 1 combination dose escalation
cohort.
- Additional clinical data expected in middle of
2023. The Company plans to present additional clinical
data from the 3 mg/kg of IGM-8444 plus FOLFIRI cohort, with and
without bevacizumab, of its non-randomized Phase 1 clinical trial
in the middle of 2023.
- Presented preclinical data. In April 2023, the
Company presented preclinical data on IGM-8444 at the American
Association for Cancer Research (AACR) Annual Meeting. The data was
featured in a poster presentation titled “Characterization of the
synergistic tumor cytotoxicity of agonist DR5 IgM antibody IGM-8444
with chemotherapeutic agents”.
Imvotamab (CD20 x CD3)
- Advancing into multiple autoimmune clinical
trials. The Company is planning to begin clinical testing
of imvotamab in severe systemic lupus erythematosus and severe
rheumatoid arthritis, subject to IND clearance.
- Presented preclinical data. In April 2023, the
Company presented preclinical data on imvotamab at the American
Association for Cancer Research (AACR) Annual Meeting. The data was
featured in a poster presentation titled “Depletion of
tissue-resident B cells by a CD20xCD3 IgM bispecific T cell engager
in cynomolgus monkeys demonstrates effective tissue penetration and
potent target cell killing”.
IGM-7354 (IL-15 x PD-L1)
- Phase 1 trial. The Company continues enrolling
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.
- Presented preclinical data. In April 2023, the
Company presented preclinical data on IGM-7354 at the American
Association for Cancer Research (AACR) Annual Meeting. The data was
featured in a poster presentation titled “IGM-7354, an
immunocytokine with IL-15 fused to an anti-PD-L1 IgM, induces NK
and CD8+ T cell-mediated cytotoxicity of PD-L1-positive tumor
cells”.
IGM-2644 (CD38 x CD3)
- Phase 1 trial. The Company is initiating a
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.
- Presented preclinical data. In April 2023, IGM
presented preclinical data evaluating IGM-2644 at the American
Association for Cancer Research (AACR) Annual Meeting. The data was
featured in a poster presentation titled “Novel CD38xCD3 Bispecific
IgM T Cell Engager, IGM-2644, Potently Kills Multiple Myeloma Cells
Though Complement and T Cell Dependent Mechanisms”.
First Quarter 2023 Financial Results
- Cash and Investments: Cash and investments as
of March 31, 2023 were $373.4 million, compared to $427.2
million as of December 31, 2022.
- Collaboration Revenue: For the first quarter
of 2023, collaboration revenues were $0.5 million, compared to
no revenue for the same period in 2022.
- Research and Development (R&D) Expenses:
For the first quarter of 2023, R&D expenses were $50.9 million,
compared to $38.9 million for the same period in 2022.
- General and Administrative (G&A) Expenses:
For the first quarter of 2023, G&A expenses were $13.0 million,
compared to $13.1 million for the same period in 2022.
- Net Loss: For the first quarter of 2023, net
loss was $59.3 million, or a loss of $1.33 per share, compared to a
net loss of $51.9 million, or a loss of $1.53 per share, for the
same period in 2022.
2023 Financial GuidanceThe Company expects full
year 2023 GAAP operating expenses of $275 million to $285 million,
including estimated non-cash stock-based compensation expense of
approximately $45 million, and full year collaboration revenue of
approximately $3 million related to the Sanofi agreement. The
Company expects to end 2023 with a balance of more than $200
million in cash and investments, and for the balance to enable it
to fund its operating expenses and capital expenditure requirements
into the fourth quarter of 2024.
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. The
Company’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. The Company
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, including statements relating to the Company’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, the Company’s technology
platform and its IgM antibodies and product candidates, including
IGM-8444, imvotamab, IGM-7354 and IGM-2644; the Company’s plans and
expectations regarding its clinical development efforts and
activities; statements regarding the clinical development of
IGM-8444, imvotamab, IGM-7354 and IGM-2644, including the timing of
initiation of clinical trials, patient enrollment and release of
clinical data; the Company’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 the
Company’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: the Company’s early stages of clinical drug
development; risks related to the use of engineered IgM antibodies,
which is a novel and unproven therapeutic approach; the Company’s
ability to demonstrate the safety and efficacy of its product
candidates; the Company’s ability to successfully and timely
advance its product candidates through preclinical studies and
clinical trials; the Company’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; the Company’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
the Company’s product candidates, and the progress and success of
alternative therapeutics currently available or in development; the
Company’s ability to obtain additional capital to finance its
operations, if needed; uncertainties related to the projections of
the size of patient populations suffering from the diseases the
Company is targeting; the Company’s ability to obtain, maintain and
protect its intellectual property rights; developments relating to
the Company’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 the
Company’s filings with the Securities and Exchange Commission
(SEC), including the Company’s Quarterly Report on Form 10-Q filed
with the SEC on May 12, 2023 and in the Company’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 the
Company 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, |
|
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
522 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development (1) |
|
|
50,894 |
|
|
|
38,875 |
|
General and administrative (1) |
|
|
13,002 |
|
|
|
13,081 |
|
Total operating expenses |
|
|
63,896 |
|
|
|
51,956 |
|
Loss from operations |
|
|
(63,374 |
) |
|
|
(51,956 |
) |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
4,172 |
|
|
|
54 |
|
Other income (expense) |
|
|
(20 |
) |
|
|
8 |
|
Total other income (expense) |
|
|
4,152 |
|
|
|
62 |
|
Loss before income tax
expense |
|
|
(59,222 |
) |
|
|
(51,894 |
) |
Income tax expense |
|
|
(87 |
) |
|
|
— |
|
Net loss |
|
$ |
(59,309 |
) |
|
$ |
(51,894 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(1.33 |
) |
|
$ |
(1.53 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
44,466,764 |
|
|
|
33,838,895 |
|
(1) Amounts
include stock-based compensation expense as follows: |
Research and development |
|
$ |
6,439 |
|
|
$ |
6,607 |
|
General and administrative |
|
|
4,608 |
|
|
|
4,892 |
|
Total stock-based compensation expense |
|
$ |
11,047 |
|
|
$ |
11,499 |
|
IGM Biosciences, Inc. |
Selected Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash and investments |
|
$ |
373,396 |
|
|
$ |
427,162 |
|
Total assets |
|
|
462,742 |
|
|
|
513,499 |
|
Accounts payable |
|
|
3,972 |
|
|
|
2,512 |
|
Accrued liabilities |
|
|
29,637 |
|
|
|
33,621 |
|
Deferred revenue |
|
|
148,409 |
|
|
|
148,931 |
|
Total liabilities |
|
|
223,312 |
|
|
|
226,236 |
|
Accumulated deficit |
|
|
(634,135 |
) |
|
|
(574,826 |
) |
Total stockholders'
equity |
|
|
239,430 |
|
|
|
287,263 |
|
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