Immuneering Reports First Quarter 2022 Financial Results and Recent Business Highlights
May 10 2022 - 6:30AM
Immuneering Corporation (NASDAQ: IMRX), a biopharmaceutical company
using translational bioinformatics to advance a pipeline of product
candidates designed to benefit large populations of patients with
cancer and other diseases, today reported financial results for the
first quarter ended March 31, 2022 and provided recent business
highlights.
“We believe IMM-1-104 has great potential to benefit the many
cancer patients with tumors driven by RAS mutations. We are
thrilled to be gearing up to file our IND for IMM-1-104, which
remains on track to be filed in the third quarter of 2022, and we
expect to enroll our first patient in the Phase 1 trial in the
fourth quarter of 2022. To date, we have generated compelling
preclinical results across a broad range of animal tumor models
including KRAS-G12C, KRAS-G12D, KRAS-G12S, NRAS-Q61R, and
BRAF-V600E mutations. In totality, this compelling preclinical
data package demonstrates IMM-1-104’s potential to have broad
activity that is independent of the specific mutation activating
the MAPK pathway.” said Ben Zeskind, Ph.D., MBA, chief executive
officer of Immuneering Corporation.
Corporate Highlights
- IMM-1-104 Observed Greater Tumor Growth Inhibition
Compared to Binimetinib in a NRAS Mutant Melanoma Model:
In January 2022, Immuneering presented preclinical data in a
presentation titled “Head-to-Head Comparison of the Dual-MEK
Inhibitor IMM-1-104 Versus Binimetinib in NRAS Mutant Melanoma
Models,” by Peter King, PhD, Vice President and Head of Discovery.
In the SK-MEL-2 melanoma xenograft mouse model exhibiting the
NRAS-Q61R mutation, IMM-1-104 demonstrated superior tumor growth
inhibition relative to binimetinib (binimetinib was tested versus
dacarbazine in the Phase 3 NEMO trial). Immuneering also hosted a
key expert event with Dr. Anna Pavlick, a leading melanoma expert,
to discuss the NRAS mutant melanoma treatment landscape. A replay
of the key expert event can be accessed at:
https://ir.immuneering.com/news-events/events-presentations.
- Diana F. Hausman, M.D. Joins
Immuneering’s Board of Directors: Immuneering appointed
Diana F. Hausman, M.D. to its board of directors in January 2022.
Dr. Hausman is currently the Chief Medical Officer of Link
Immunotherapeutics and was the former Chief Medical Officer of
Lengo Therapeutics. As a board member of Immuneering, Dr. Hausman
will leverage her more than two decades of clinical drug
development experience to help advance Immuneering’s
pipeline.
- Immuneering Published Its First Environmental, Social,
and Governance (ESG) Report on March 31, 2022: The company
published its first annual ESG report which highlights the
company’s commitment to corporate social responsibility. The 2021
ESG report was guided by standards established by the
Sustainability Accounting Standards Board (SASB). The report is
available at:
https://ir.immuneering.com/environment-social-and-governance-esg.
Key Development Highlights
- IMM-1-104 IND submission expected in Q3 2022:
Immuneering expects to file the IND for IMM-1-104 in the third
quarter of 2022 and expects to enroll the first patient in its
Phase 1 trial evaluating IMM-1-104 in the fourth quarter of
2022.
- Second IND, IMM-6-415, submission expected in
2023: IMM-6-415, the company’s MEK-io program, is
currently in IND-enabling studies. Immuneering expects to file an
IND application for IMM-6-415 in 2023. IMM-6-415 is a dual-MEK
inhibitor that has drug-like properties optimized for immune
modulation and may enhance and/or expand clinical responses to
checkpoint inhibitors.
First Quarter 2022 Financial
Highlights
- Cash Position: Cash and cash equivalents and marketable
securities as of March 31, 2022 were $137.8 million, compared with
$150.2 million as of December 31, 2021.
- Research and Development (R&D) Expenses: R&D expenses
for the first quarter of 2022 were $9.1 million, compared with $5.4
million for the same period in 2021. The increase in R&D
expenses was primarily attributable to higher preclinical costs
related to the company’s lead programs and increased personnel to
support ongoing research and development activities.
- General and Administrative (G&A) Expenses: G&A expenses
for the first quarter of 2022 were $4.0 million, compared with $1.2
million for the same period of 2021. The increase in G&A
expenses was primarily attributable to an increase in headcount in
our general and administrative functions to support the company’s
business and to costs related to operating as a public
company.
- Net Loss: Net loss attributable to common stockholders was
$12.9 million, or $0.49 per share, for the quarter ended March 31,
2022, compared to $6.2 million, or $1.26 per share, for the quarter
ended March 31, 2021.
2022 Financial Guidance
- Immuneering reiterates full year GAAP operating expenses to be
between $55.0 million and $60.0 million including estimated
non-cash stock-based compensation. Based on cash, cash equivalents
and marketable securities as of March 31, 2022, the company expects
its cash runway to extend into the third quarter of
2024.
About Immuneering
Corporation Immuneering aims to improve patient
outcomes by advancing a unique pipeline of oncology and
neuroscience product candidates developed using its translational
bioinformatics platform. Immuneering has more than a decade of
experience applying translational bioinformatics to generate
insights into drug mechanism of action and patient treatment
response. Building on this experience, Immuneering’s
disease-agnostic discovery platform enables the company to create
product candidates based on 1) biological insights that are both
counterintuitive and deeply rooted in data, and 2) novel chemistry.
Immuneering’s lead product candidate IMM-1-104 is designed to be a
highly selective dual-MEK inhibitor that further disrupts KSR to
modulate the signaling dynamics of the MAPK pathway. Specifically,
it is designed to drive deep cyclic inhibition that deprives tumor
cells of the sustained proliferative signaling required for rapid
growth, while providing a cadenced, moderate level of signaling
sufficient to spare healthy cells. IMM-1-104 is being developed to
treat advanced solid tumors in patients harboring RAS mutations,
and is translationally guided by Immuneering’s proprietary,
human-aligned 3D tumor modeling platform combined with
patient-aligned bioinformatics. In addition to IMM-1-104,
Immuneering is evaluating its MEK-io product candidate, IMM-6-415,
in IND-enabling studies, and has five other oncology programs in
the discovery stage that are designed to target components of the
MAPK or mTOR pathway, as well as two discovery stage neuroscience
programs.
Forward-Looking
Statements This press release includes certain
disclosures that contain "forward-looking statements," including,
without limitation, statements regarding Immuneering’s expectations
regarding the sufficiency of Immuneering’s cash, cash equivalents
and marketable securities, its full year GAAP operating expenses
for 2022, Immuneering’s commitment to corporate social
responsibility, the treatment potential of IMM-1-104 and IMM-6-415,
the timing of submission of the IND and commencement of clinical
trials for IMM-1-104 and IMM-6-415, and Immuneering’s ability to
advance its pipeline and further diversify its portfolio and make
progress towards its longstanding goal of creating better medicines
for cancer patients. Forward-looking statements are based on
Immuneering’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Factors that could cause actual results to differ include, but are
not limited to, the risks inherent in oncology and neuroscience
drug development, including target discovery, target validation,
lead compound identification, lead compound optimization,
preclinical studies and clinical trials. These and other risks and
uncertainties are described more fully in the section titled "Risk
Factors" in Immuneering’s most recent Form 10-Q filed with the U.S.
Securities and Exchange Commission. Forward-looking statements
contained in this announcement are made as of this date, and
Immuneering undertakes no duty to update such information except as
required under applicable law.
Corporate Contact: Rebecca Kusko,
Ph.D. Immuneering
Corporation 617-500-8080 rkusko@immuneering.com
Investor Contact: Susan A. NoonanS.A.
Noonan Communicationssusan@sanoonan.com 917-513-5303
IMMUNEERING
CORPORATIONCONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Revenue |
|
$ |
183,698 |
|
|
$ |
748,200 |
|
Cost of
revenue |
|
|
90,846 |
|
|
|
409,163 |
|
|
|
|
|
|
|
|
Gross
profit |
|
|
92,852 |
|
|
|
339,037 |
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
Research and development |
|
|
9,058,545 |
|
|
|
5,391,020 |
|
General and administrative |
|
|
3,951,866 |
|
|
|
1,184,023 |
|
Amortization of intangible asset |
|
|
8,103 |
|
|
|
— |
|
Total operating expenses |
|
|
13,018,514 |
|
|
|
6,575,043 |
|
Loss from operations |
|
|
(12,925,662 |
) |
|
|
(6,236,006 |
) |
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
Interest income |
|
|
132,506 |
|
|
|
6,355 |
|
Other expense |
|
|
(103,218 |
) |
|
|
— |
|
Net loss |
|
$ |
(12,896,374 |
) |
|
$ |
(6,229,651 |
) |
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(1.26 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
26,359,080 |
|
|
|
4,950,129 |
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized losses from marketable securities |
|
|
(118,386 |
) |
|
|
— |
|
Comprehensive
Loss |
|
$ |
(13,014,760 |
) |
|
$ |
(6,229,651 |
) |
IMMUNEERING
CORPORATIONCONSOLIDATED BALANCE
SHEETS(Unaudited)
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
75,205,060 |
|
|
$ |
74,888,145 |
|
Marketable securities, current |
|
|
62,565,953 |
|
|
|
74,311,203 |
|
Accounts receivable |
|
|
279,614 |
|
|
|
246,040 |
|
Prepaids and other current assets |
|
|
1,479,592 |
|
|
|
2,888,608 |
|
Total current assets |
|
|
139,530,219 |
|
|
|
152,333,996 |
|
|
|
|
|
|
|
|
Marketable securities,
non-current |
|
|
— |
|
|
|
996,560 |
|
Property and equipment,
net |
|
|
874,569 |
|
|
|
807,223 |
|
Goodwill |
|
|
6,690,431 |
|
|
|
6,701,726 |
|
Intangible asset |
|
|
430,897 |
|
|
|
439,000 |
|
Right-of-use assets, net |
|
|
4,831,639 |
|
|
|
5,324,198 |
|
Other assets |
|
|
89,579 |
|
|
|
102,129 |
|
Total assets |
|
$ |
152,447,334 |
|
|
$ |
166,704,832 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,642,364 |
|
|
$ |
1,394,340 |
|
Accrued expenses |
|
|
1,718,804 |
|
|
|
3,965,447 |
|
Other liabilities, current |
|
|
47,213 |
|
|
|
— |
|
Lease liabilities, current |
|
|
265,419 |
|
|
|
274,039 |
|
Total current liabilities |
|
|
3,673,800 |
|
|
|
5,633,826 |
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
Other liabilities, non-current |
|
|
9,898 |
|
|
|
— |
|
Lease liabilities, non-current |
|
|
4,707,526 |
|
|
|
5,090,897 |
|
Total liabilities |
|
|
8,391,224 |
|
|
|
10,724,723 |
|
Commitments and contingencies
(Note 12) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized at March 31, 2022 and December
31, 2021, respectively; 0 shares issued or outstanding at March 31,
2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Class A common stock, $0.001
par value, 200,000,000 shares authorized at March 31, 2022 and
December 31, 2021; 26,383,299 and 26,320,199 shares issued and
outstanding at March 31, 2022 and
December 31, 2021, respectively |
|
|
26,383 |
|
|
|
26,320 |
|
Class B common stock, $0.001
par value, 20,000,000 shares authorized at March 31, 2022 and
December 31, 2021; 0 shares issued and outstanding at
March 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
|
216,366,884 |
|
|
|
215,276,186 |
|
Accumulated other
comprehensive loss |
|
|
(167,395 |
) |
|
|
(49,009 |
) |
Accumulated deficit |
|
|
(72,169,762 |
) |
|
|
(59,273,388 |
) |
Total stockholders' equity |
|
|
144,056,110 |
|
|
|
155,980,109 |
|
Total liabilities and stockholders' equity |
|
$ |
152,447,334 |
|
|
$ |
166,704,832 |
|
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