IGM Biosciences Announces Second Quarter 2023 Financial Results
04 August 2023 - 6:10AM
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 June 30, 2023.
“We continued to make good progress in the
development of our IgM platform in the second quarter, as reflected
in our announcement of encouraging data from the clinical trials of
IGM-8444, now known as aplitabart, and in the clearance by the FDA
of two Investigational New Drug applications to begin clinical
trials of imvotamab, our IgM-based CD20 x CD3 bispecific antibody T
cell engager, in severe systemic lupus erythematosus and severe
rheumatoid arthritis,” said Fred Schwarzer, Chief Executive Officer
of IGM Biosciences. “Building on this progress, during the third
quarter we expect to initiate these two Phase 1b autoimmune
clinical trials and to continue to build enrollment in our
randomized clinical trial of aplitabart in combination with
standard of care FOLFIRI chemotherapy and bevacizumab in
second-line metastatic colorectal cancer patients.”
Pipeline Progress
Aplitabart (IGM-8444) (DR5 agonist)
- Clinical data with 3 mg/kg
of aplitabart plus FOLFIRI from a non-randomized Phase 1 clinical
trial. In June 2023, the Company reported Phase 1 data
from a cohort of patients treated with aplitabart, the Company’s
IgM agonist antibody targeting death receptor 5 (DR5), in
combination with FOLFIRI through a data cut-off date of April 12,
2023.
- In 51 CRC patients treated with the
combination regimens, no drug related clinically significant
hepatotoxicity was observed, with only grade 1 and grade 2
transient liver enzyme elevations noted as of the data cut-off
date.
- In these predominantly third-line
metastatic colorectal cancer patients, the combination of
aplitabart dosed at 3 mg/kg and FOLFIRI showed promising activity
in terms of progression-free survival.
- Multiple confirmed partial
responses were observed among the patients treated with 3 mg/kg of
aplitabart and FOLFIRI, including some patients who had previously
progressed on FOLFIRI treatment.
- Clinical development of
aplitabart advances. The Company continues to advance the
clinical development of aplitabart.
- Dosing ongoing in the
randomized colorectal cancer clinical trial. The Company
is currently enrolling patients in an open-label randomized
clinical trial of aplitabart plus FOLFIRI and bevacizumab in
second-line metastatic colorectal cancer. This randomized trial
will assess the additional benefit of 3 mg/kg of aplitabart with a
primary endpoint of progression-free survival (PFS) and secondary
endpoints of overall response rate and overall survival as compared
to the current standard of care treatment arm of FOLFIRI and
bevacizumab. The Company’s goal is to have enrolled approximately
110 patients in the trial by the end of the first quarter of 2024
and to have median PFS data from these patients by the end of
2024.
- Dosing at 10 mg/kg ongoing
in the single arm colorectal cancer clinical trial. The
Company has also begun dosing additional colorectal cancer patients
at 10 mg/kg of aplitabart in its single arm FOLFIRI combination
clinical trial.
- Dosing ongoing in the
venetoclax combination. The Company is currently treating
patients with acute myeloid leukemia in its aplitabart plus
venetoclax and azacytidine Phase 1 combination cohort.
- Dosing ongoing in
birinapant combination. The Company is also currently
treating patients in its aplitabart plus birinapant Phase 1
combination cohort.
Imvotamab (CD20 x CD3)
- FDA clearance to begin
autoimmune clinical trials. In the second quarter, the
Company received clearance of 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, which will enable the initiation of two Phase 1b clinical
trials, one in severe systemic lupus erythematosus (SLE) and one in
severe rheumatoid arthritis (RA), during third quarter 2023.
IGM-7354 (IL-15 x PD-L1)
- Phase 1 trial
continues. The Company continues to enroll 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
initiated. The Company has initiated 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.
Financing
- Completed underwritten
public offering of common stock and concurrent private
placement. As previously announced, the Company recently
closed a public offering of its voting and non-voting common stock
and concurrent private placement of non-voting common stock, with
total gross proceeds of $120.0 million and net proceeds of $113.5
million, after deducting underwriting discounts and commissions and
estimated offering expenses payable by the Company, of which $68.5
million had been received by the Company as of June 30, 2023 and
$45.0 million was received on July 3, 2023.
Second Quarter 2023 Financial
Results
- Cash and
Investments: Cash and investments as of June 30, 2023
were $386.9 million (which amount does not include an
additional $45.0 million from the public equity offering received
on July 3, 2023), compared to $427.2 million as of December 31,
2022.
- Collaboration
Revenue: For the second quarter of 2023, collaboration
revenues were $0.4 million, compared to $0.4 million for the
same period in 2022.
- Research and Development
(R&D) Expenses: For the second quarter of 2023,
R&D expenses were $55.7 million, compared to $47.2 million for
the same period in 2022.
- General and Administrative
(G&A) Expenses: For the second quarter of 2023,
G&A expenses were $13.0 million, compared to $12.4 million for
the same period in 2022.
- Net Loss: For the
second quarter of 2023, net loss was $64.4 million, or a loss of
$1.43 per share, compared to a net loss of $58.6 million, or a loss
of $1.33 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 $45 million, and full year collaboration revenue of
approximately $3 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 and
imvotamab; 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 the timing of initiation of clinical trials,
patient enrollment and availability of clinical data; 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, if needed; 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 August 3, 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 |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Collaboration revenue |
|
$ |
448 |
|
|
$ |
366 |
|
|
$ |
970 |
|
|
$ |
366 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
|
55,673 |
|
|
|
47,218 |
|
|
|
106,567 |
|
|
|
86,093 |
|
|
General and administrative (1) |
|
|
12,983 |
|
|
|
12,372 |
|
|
|
25,985 |
|
|
|
25,453 |
|
|
Total operating expenses |
|
|
68,656 |
|
|
|
59,590 |
|
|
|
132,552 |
|
|
|
111,546 |
|
|
Loss from operations |
|
|
(68,208 |
) |
|
|
(59,224 |
) |
|
|
(131,582 |
) |
|
|
(111,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,894 |
|
|
|
760 |
|
|
|
8,066 |
|
|
|
814 |
|
|
Other expense |
|
|
— |
|
|
|
(131 |
) |
|
|
(20 |
) |
|
|
(123 |
) |
|
Total other income
(expense) |
|
|
3,894 |
|
|
|
629 |
|
|
|
8,046 |
|
|
|
691 |
|
|
Loss before income tax expense |
|
|
(64,314 |
) |
|
|
(58,595 |
) |
|
|
(123,536 |
) |
|
|
(110,489 |
) |
|
Income tax expense |
|
|
(109 |
) |
|
|
— |
|
|
|
(196 |
) |
|
|
— |
|
|
Net loss |
|
$ |
(64,423 |
) |
|
$ |
(58,595 |
) |
|
$ |
(123,732 |
) |
|
$ |
(110,489 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(1.43 |
) |
|
$ |
(1.33 |
) |
|
$ |
(2.76 |
) |
|
$ |
(2.84 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
|
45,122,900 |
|
|
|
43,919,092 |
|
|
|
44,796,644 |
|
|
|
38,906,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,248 |
|
|
$ |
6,335 |
|
|
$ |
14,687 |
|
|
$ |
12,942 |
|
|
General and administrative |
|
|
6,061 |
|
|
|
4,951 |
|
|
|
10,669 |
|
|
|
9,843 |
|
|
Total stock-based compensation expense |
|
$ |
14,309 |
|
|
$ |
11,286 |
|
|
$ |
25,356 |
|
|
$ |
22,785 |
|
IGM Biosciences, Inc. |
Selected Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Cash and investments |
|
$ |
386,869 |
|
|
$ |
427,162 |
|
|
Total assets |
|
|
480,658 |
|
|
|
513,499 |
|
|
Accounts payable |
|
|
4,936 |
|
|
|
2,512 |
|
|
Accrued liabilities |
|
|
27,737 |
|
|
|
33,621 |
|
|
Deferred revenue |
|
|
147,961 |
|
|
|
148,931 |
|
|
Total liabilities |
|
|
222,051 |
|
|
|
226,236 |
|
|
Accumulated deficit |
|
|
(698,558 |
) |
|
|
(574,826 |
) |
|
Total stockholders'
equity |
|
|
258,607 |
|
|
|
287,263 |
|
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