IGM Biosciences Announces First Quarter 2020 Financial Results and Provides Corporate Update
May 07 2020 - 4:03PM
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, 2020 and provided an update on recent
developments.
“While these unprecedented times have presented many unique
challenges, thanks to the hard work and dedication of the entire
IGM team, we continue to make good progress,” said Fred Schwarzer,
Chief Executive Officer of IGM Biosciences. “Notably, we recently
announced a collaboration with Atreca and BeiGene which will allow
us to evaluate the potential of our novel IgM and IgA antibodies
for the treatment of COVID-19. Beyond this exciting new program, we
continue to expect initial data from our Phase 1 trial of IGM-2323
in relapsed/refractory NHL in the second half of 2020, as well as
the filing of an IND for IGM-8444 later this year.”
Recent Highlights and Pipeline Updates:
Collaboration with Atreca and BeiGene for
COVID-19: In April 2020, IGM, Atreca, Inc., and BeiGene,
Ltd. announced plans to collaborate to help address the COVID-19
pandemic. The companies will leverage their combined technology and
expertise in an effort to discover, develop, and manufacture novel
IgM and IgA antibodies targeting SARS-CoV-2 for the potential
treatment of COVID-19. If research, manufacturing, and regulatory
activities proceed very well, then the companies believe that an
antibody may be ready to begin clinical testing in the first half
of 2021.
IGM-2323
- Phase 1 data expected in the second half of
2020: IGM continues to expect to report initial data from
the Phase 1 trial evaluating IGM-2323 in patients with
relapsed/refractory B cell NHL, the first-in-human application of
IGM’s engineered IgM antibody technology, in the second half of
2020.
IGM-8444
- IGM-8444 data to be presented at the ASCO Annual
Meeting. The poster, titled “IGM-8444 as a potent
agonistic Death Receptor 5 (DR5) IgM antibody: Induction of tumor
cytotoxicity, combination with chemotherapy and in vitro safety
profile,” will be made available online via the ASCO20 Virtual
Scientific Program beginning on Friday, May 29, at 8:00 a.m.
ET.
- IND filing in 2020: IGM continues to expect to
file an IND with the FDA for IGM-8444 in 2020, initially for the
treatment of patients with solid tumors. IGM-8444 is an IgM
antibody targeting the Death Receptor 5 (DR5) protein, which is
broadly expressed on a broad range of solid and hematologic
malignancies.
IGM-7354
- IND filing in 2021: IGM continues to expect to
file an IND with the FDA for IGM-7354, the Company’s third clinical
candidate, in 2021. IGM-7354 is a targeted IL-15 immune stimulating
antibody which demonstrates another use of IGM’s novel J chain
based bispecific technology. In this case, the immune stimulating
IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody,
which serves to display the immune stimulating IL-15 on the surface
of PD-L1 positive cells, such as cancer cells.
First Quarter 2020 Financial Results:
- Cash and Investments: Cash and
investments as of March 31, 2020 were $219.0 million,
compared to $236.6 million as of December 31, 2019.
- Research and Development (R&D)
Expenses: For the first quarter of 2020, R&D
expenses were $14.6 million, compared to $5.9 million for the same
period in 2019.
- General and Administrative (G&A)
Expenses: For the first quarter of 2020, G&A
expenses were $4.0 million, compared to $1.4 million for the same
period in 2019.
- Net Loss: For the first quarter of 2020,
net loss was $17.6 million, or a loss of $0.58 per
share, compared with a net loss of $7.5 million, or a loss of
$16.86 per share, for the same period in 2019.
- Shares Outstanding: Weighted-average shares
outstanding for the first quarter of 2020 were 30.5 million,
compared to 0.4 million for the same period in 2019.
2020 Financial Guidance:
IGM reiterates its previously issued financial guidance which
consisted of non-GAAP operating expenses for 2020 of approximately
$75 - $85 million, excluding estimated non-cash stock-based
compensation expense of approximately $8 million. Including
non-cash stock-based compensation expense, IGM estimates GAAP
operating expenses for 2020 of $83 - $93 million. IGM also expects
to end 2020 with a balance of over $140 million in cash and
investments.
About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a
clinical-stage biotechnology company focused on creating and
developing engineered IgM antibodies. Since 2010, IGM Biosciences
has worked to overcome the manufacturing and protein engineering
hurdles that have limited the therapeutic use of IgM antibodies.
Through its efforts, IGM Biosciences has created a proprietary IgM
technology platform for the development of IgM antibodies for those
clinical indications where their inherent properties may provide
advantages as compared to IgG antibodies.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements,
including statements relating to IGM’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 IgM technology platform, statements
regarding the Company’s Phase 1 clinical trial of IGM-2323,
including the timing of reporting initial data from the clinical
trial, the timing of filing an IND for IGM-8444, the timing of
filing an IND for IGM-7354, the Company’s future financial and
operating performance, including its guidance for the full year
2020 and year end 2020 cash and investments balance, statements
relating to the collaboration among IGM, Atreca and BeiGene, the
possible nature and scope of any such collaboration, statements
regarding the potential timing of clinical testing of an antibody
for the potential treatment of COVID-19, 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: potential delays and disruption resulting from the COVID-19
coronavirus pandemic and governmental responses to the pandemic,
including any future impacts to IGM’s operations, the manufacturing
of its product candidates, the progression of its current clinical
trials, enrollment in its current and future clinical trials
and on the collaboration and related efforts; the risks that IGM,
Atreca and/or BeiGene may ultimately decide to not pursue the
collaboration, that one or more of them decide to leave the
collaboration or that they do not reach agreement on the definitive
terms and conditions of such collaboration; the risks that
antibodies with the desired characteristics cannot be isolated from
the COVID-19 patient samples obtained by Atreca, that any
antibodies developed are not safe and effective in treating
COVID-19 or that such antibodies are not safer and/or more
effective than alternatives to treating or otherwise addressing
COVID-19; the potential benefits of the collaboration and these
efforts do not outweigh their costs; 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 advance product candidates into, and successfully
complete, clinical trials on the timelines it projects; IGM’s
ability to adequately demonstrate sufficient safety and efficacy of
its product candidates; IGM’s ability to enroll patients in its
ongoing and future clinical trials; IGM’s ability to successfully
manufacture and supply its product candidates for clinical trials;
IGM’s ability to accurately forecast future financial results in
the current environment; 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; general economic and market conditions;
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 26, 2020, IGM’s Quarterly Report on
Form 10-Q filed with the SEC on May 7, 2020 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.
IGM Biosciences, Inc. |
Selected Statement of Operations Data |
(unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development (1) |
$ |
14,583 |
|
|
$ |
5,912 |
|
General and administrative (1) |
|
3,990 |
|
|
|
1,445 |
|
Total operating expenses |
|
18,573 |
|
|
|
7,357 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(18,573 |
) |
|
|
(7,357 |
) |
Other income (expense),
net |
|
949 |
|
|
|
(113 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(17,624 |
) |
|
$ |
(7,470 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(16.86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic and
diluted |
|
30,491,463 |
|
|
|
443,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Amounts include stock-based
compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
666 |
|
|
$ |
105 |
|
General and administrative |
|
657 |
|
|
|
34 |
|
Total stock-based compensation expense |
$ |
1,323 |
|
|
$ |
139 |
|
|
|
|
|
IGM Biosciences, Inc. |
Selected Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash and investments |
$ |
218,964 |
|
|
$ |
236,607 |
|
Total assets |
|
243,150 |
|
|
|
261,350 |
|
Accrued liabilities |
|
3,031 |
|
|
|
3,305 |
|
Total liabilities |
|
19,139 |
|
|
|
21,119 |
|
Accumulated deficit |
|
(124,829 |
) |
|
|
(107,205 |
) |
Total stockholders'
equity |
|
224,011 |
|
|
|
240,231 |
|
Contact:Argot Partners David Pitts212-600-1902
igmbio@argotpartners.com
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