IGM Biosciences Announces Second Quarter 2024 Financial Results and Provides Corporate Update
14 8월 2024 - 8:00PM
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 June 30, 2024 and provided an update on recent
developments.
“We continue to make significant progress in the
clinical development of our two lead product candidates,” said Fred
Schwarzer, Chief Executive Officer of IGM Biosciences. “We are
pleased to have completed enrollment of 127 patients in our
randomized study of 3mg/kg of aplitabart plus FOLFIRI and
bevacizumab in second line colorectal cancer. We are also pleased
to have successfully cleared the first two cohorts of our clinical
trial of imvotamab in severe rheumatoid arthritis as well as the
first cohort of our clinical trial of imvotamab in severe systemic
lupus erythematosus.”
Pipeline Updates
Aplitabart (death receptor 5
agonist)
- Clinical development of
aplitabart advances.
- Enrollment completed in
randomized colorectal cancer clinical trial. The
Company announced that it has completed enrollment in its
randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and
bevacizumab in second-line metastatic colorectal cancer. A total of
127 patients, exceeding the trial design target of 110 patients,
were 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 depend on 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.
Imvotamab (CD20 x CD3 T cell
engager)
- Clinical development of
imvotamab in autoimmune diseases advances.
- First and second dose
cohorts in rheumatoid arthritis successfully completed.
The Company announced that it has cleared both the first and second
dose cohorts of its placebo-controlled clinical study testing
imvotamab in severe rheumatoid arthritis and is currently enrolling
the third cohort. This study is designed to evaluate three cohorts
of progressively higher dose regimens of imvotamab, with each
cohort designed to recruit eight patients, six of whom receive
imvotamab and two of whom receive placebo.
- First dose cohort in
systemic lupus erythematosus successfully completed. The
Company announced that it has cleared the first dose cohort of its
open-label clinical study testing imvotamab in severe systemic
lupus erythematosus (SLE), with each dose cohort designed to
recruit six patients, all of whom are to be treated with imvotamab.
The Company is currently enrolling patients in a second dose cohort
and plans to enroll a third dose cohort, with each cohort at
progressively higher dose regimens of imvotamab.
- Enrollment initiated in
myositis. The Company has initiated recruitment of
patients in its single arm, open-label clinical study testing
imvotamab in moderate-severe idiopathic inflammatory myopathies
(myositis).
IGM-2644 (CD38 x CD3 T cell
engager)
- Clinical development of
IGM-2644 in autoimmune diseases to be initiated. The
Company has made significant progress towards initiating clinical
development of IGM-2644, a CD38 x CD3 T cell engager antibody, in
the treatment of autoimmune diseases. The Company currently expects
to begin enrolling patients in a single arm, open-label clinical
study testing IGM-2644 in generalized myasthenia gravis (gMG) by
the end of 2024.
Second Quarter 2024 Financial
Results
- Cash and
Investments: Cash and investments as of June 30, 2024
were $256.4 million, compared to $337.7 million as of December 31,
2023.
- Collaboration
Revenue: For the second quarter of 2024, collaboration
revenues were $1.3 million compared to $0.4 million for the second
quarter of 2023.
- Research and Development
(R&D) Expenses: For the second quarter of 2024,
R&D expenses were $42.0 million, compared to $55.7 million for
the second quarter of 2023.
- General and Administrative
(G&A) Expenses: For the second quarter of 2024,
G&A expenses were $10.6 million, compared to $13.0 million for
the second quarter of 2023.
- Net Loss: For the
second quarter of 2024, net loss was $47.9 million, or a loss of
$0.79 per share, compared to a net loss of $64.4 million, or a loss
of $1.43 per share, for the second 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, and full year
collaboration revenue of approximately $2 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
immunology and inflammation targets. For more information, please
visit www.igmbio.com.
Cautionary Note Regarding
Forward-Looking StatementsThis 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 with respect to patient
enrollment, dosing, and the timing of the release of data; IGM’s
expectations regarding its financial position and results,
including its stock-based compensation expense and collaboration
revenue, 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; 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
August 14, 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 Partners David Pitts
212-600-1902 igmbio@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, |
|
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| Collaboration revenue |
|
$ |
1,254 |
|
|
$ |
448 |
|
|
$ |
1,751 |
|
|
$ |
970 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
|
41,962 |
|
|
|
55,673 |
|
|
|
85,777 |
|
|
|
106,567 |
|
|
General and administrative (1) |
|
|
10,649 |
|
|
|
12,983 |
|
|
|
21,187 |
|
|
|
25,985 |
|
|
Total operating expenses |
|
|
52,611 |
|
|
|
68,656 |
|
|
|
106,964 |
|
|
|
132,552 |
|
| Loss from operations |
|
|
(51,357 |
) |
|
|
(68,208 |
) |
|
|
(105,213 |
) |
|
|
(131,582 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,455 |
|
|
|
3,894 |
|
|
|
7,495 |
|
|
|
8,066 |
|
|
Other expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(20 |
) |
|
Total other income (expense) |
|
|
3,455 |
|
|
|
3,894 |
|
|
|
7,495 |
|
|
|
8,046 |
|
| Loss before income tax
expense |
|
|
(47,902 |
) |
|
|
(64,314 |
) |
|
|
(97,718 |
) |
|
|
(123,536 |
) |
|
Income tax expense |
|
|
— |
|
|
|
(109 |
) |
|
|
— |
|
|
|
(196 |
) |
| Net loss |
|
$ |
(47,902 |
) |
|
$ |
(64,423 |
) |
|
$ |
(97,718 |
) |
|
$ |
(123,732 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss per share, basic and
diluted |
|
$ |
(0.79 |
) |
|
$ |
(1.43 |
) |
|
$ |
(1.62 |
) |
|
$ |
(2.76 |
) |
| Weighted-average common shares
outstanding, basic and diluted |
|
|
60,434,161 |
|
|
|
45,122,900 |
|
|
|
60,274,285 |
|
|
|
44,796,644 |
|
(1) Amounts include stock-based compensation expense as
follows:
|
Research and development |
|
$ |
4,807 |
|
|
$ |
8,248 |
|
|
$ |
9,169 |
|
|
$ |
14,687 |
|
|
General and administrative |
|
|
3,621 |
|
|
|
6,061 |
|
|
|
7,181 |
|
|
|
10,669 |
|
|
Total stock-based compensation expense |
|
$ |
8,428 |
|
|
$ |
14,309 |
|
|
$ |
16,350 |
|
|
$ |
25,356 |
|
|
IGM Biosciences, Inc. Selected Balance Sheet
Data
(unaudited)(in
thousands) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
|
2024 |
|
|
2023 |
|
| Cash and investments |
|
$ |
256,381 |
|
|
$ |
337,677 |
|
| Total assets |
|
|
336,501 |
|
|
|
423,411 |
|
| Accounts payable |
|
|
3,259 |
|
|
|
1,326 |
|
| Accrued liabilities |
|
|
26,461 |
|
|
|
31,544 |
|
| Deferred revenue |
|
|
145,050 |
|
|
|
146,801 |
|
| Total liabilities |
|
|
214,143 |
|
|
|
220,177 |
|
| Accumulated deficit |
|
|
(918,960 |
) |
|
|
(821,242 |
) |
| Total stockholders' equity |
|
|
122,358 |
|
|
|
203,234 |
|
IGM Biosciences (NASDAQ:IGMS)
과거 데이터 주식 차트
부터 9월(9) 2024 으로 10월(10) 2024
IGM Biosciences (NASDAQ:IGMS)
과거 데이터 주식 차트
부터 10월(10) 2023 으로 10월(10) 2024
