Immuneering Reports Third Quarter 2021 Financial Results and Recent Business Highlights
November 09 2021 - 6:30AM
Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company
advancing a robust pipeline of oncology and neuroscience product
candidates that are designed to uniquely disrupt cellular signaling
dynamics, today reported financial results for the third quarter
ended September 30, 2021 and provided recent business highlights.
“We made notable progress in the third quarter, including
completing our IPO, and are well-funded to support the continued
development of our robust pipeline of oncology and neuroscience
drug programs. In the near term, we anticipate filing our
Investigational New Drug (IND) application for IMM-1-104, our
dual-MEK inhibitor, targeting RAS mutant tumors, in the first
quarter of 2022,” said Ben Zeskind, Ph.D., MBA, chief executive
officer of Immuneering Corporation.
Corporate Highlights
- IMM-1-104 Preclinical Data
Presented at EORTC 2021: Immuneering presented data from
three posters showcasing IMM-1-104 at the recent AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics that took place virtually from October 7-10, 2021. The
study authors concluded that IMM-1-104 displayed broad activity
across a wide range of animal tumor models with diverse RAS and RAF
mutations including KRAS-G12C, KRAS-G12D, KRAS-G12S, NRAS-Q61R, and
BRAF-V600E. In addition, IMM-1-104 prompted tumor regressions
similar to sotorasib in a KRAS-G12C mutant pancreatic xenograft
model (MIA PaCa-2) and led to deeper durable tumor regressions in
combination with sotorasib when compared to either drug alone.
Transcriptomic data that was presented confirmed IMM-1-104’s deep
cyclic inhibition by demonstrating strong MAPK pathway inhibition
at two hours post-treatment, with a near complete release at 12
hours post-treatment. Through its short half-life, IMM-1-104
observes an encouraging tolerability profile across animal models
that may provide differentiation from FDA-approved MEK inhibitors.
A replay of all three presentations can be accessed at:
www.immuneering.com/publications.
- Company Held Its First Key
Opinion Leader Event: Immuneering held its first key
opinion leader event titled “Better Medicines for MEK, RAS and
Beyond Through Signaling Dynamics” on October 12, 2021 where
participating key experts reviewed the RAS mutant tumor treatment
landscape and noted the need for development of therapies outside
of the KRAS-G12C mutant tumor setting. A replay of the event can be
accessed at:
https://ir.immuneering.com/news-events/events-presentations.
- Completed Initial Public
Offering: On August 3, 2021, Immuneering announced the
closing of its upsized initial public offering of 8,625,000 shares
of Class A common stock, including the full exercise by the
underwriters of their overallotment option to purchase 1,125,000
shares of Class A common stock, at a public offering price of
$15.00 per share, for total gross proceeds of approximately $129.4
million, before deducting underwriting discounts and commissions
and estimated offering expenses payable by Immuneering.
- Strengthened Leadership
Team and Board of Directors: Immuneering strengthened its
management team with the appointment of Michael Bookman as the
company’s General Counsel and Secretary in July 2021. Immuneering
also appointed Ann Berman to its board of directors in July
2021.
Key Development Highlights
- IMM-1-104 IND submission
expected in Q1 2022: Immuneering expects to file the IND
for IMM-1-104 in Q1 2022 and expects to initiate its Phase 1 trial
evaluating IMM-1-104 in 1H 2022. IMM-1-104 is a highly selective
dual-MEK inhibitor that has been designed to overcome MAPK-feedback
loops and exhibits deep cyclic inhibition through its targeted
potency and short half-life. As a result, Immuneering believes
IMM-1-104 has the potential to become an important new treatment
option for advanced solid tumors in patients with a broad spectrum
of mutations in genes, such as KRAS and NRAS, that activate the
MAPK pathway.
Third Quarter 2021 Financial Highlights
- Cash Position: Cash and cash
equivalents and marketable securities as of September 30, 2021 were
$159.6 million, compared with $37.1 million as of December 31,
2020.
- Research and Development (R&D)
Expenses: R&D expenses for the third quarter of 2021 were $6.2
million, compared with $4.1 million for the third quarter of 2020.
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 third quarter of 2021
were $2.6 million, compared with $0.7 million for the same period
of 2020. 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 preparing for the Company’s initial public
offering.
- Net Loss: Net loss attributable to
common stockholders was $8.5 million, or $0.47 per share, for the
quarter ended September 30, 2021, compared to $4.4 million, or
$0.89 per share, for the quarter ended September 30, 2020.
About Immuneering
Corporation
Immuneering is a biopharmaceutical company with
an emerging pipeline focused on improving patient outcomes across a
spectrum of debilitating oncologic and neurologic diseases by
applying its deep knowledge of translational bioinformatics to
every stage of the drug development process. Immuneering has more
than a decade of experience in translational bioinformatics and
generating insights into drug mechanisms of action and patient
treatment responses. Building on this experience, Immuneering has
developed a disease-agnostic platform that enables the company to
utilize human data, novel biology and chemistry, and translational
planning to create and advance its wholly owned pipeline.
Immuneering’s current development programs in oncology are focused
on providing potential treatments for patients with solid tumors
caused by mutations of oncologic signaling pathways, including the
MAPK pathway. Immuneering’s lead product candidate, IMM-1-104, is
designed to be a highly selective dual-MEK inhibitor that further
disrupts KSR for the treatment of advanced solid tumors in patients
harboring RAS mutant tumors. Additionally, Immuneering has six
other oncology programs in the discovery stage that are designed to
target either the MAPK or mTOR pathway, and two neuroscience
programs in the discovery stage.
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 and cash
equivalents and marketable securities, the treatment potential of
IMM-1-104, the timing of submission of the IND and commencement of
clinical trials for IMM-1-104 and Immuneering’s ability to advance
its pipeline and further diversify its portfolio. 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 Corporation617-500-8080rkusko@immuneering.com
Investor Contact:Anne Marie FieldsManaging
DirectorRx Communications afields@rxir.com
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
482,130 |
|
|
$ |
682,570 |
|
|
$ |
1,890,370 |
|
|
$ |
1,646,455 |
|
Cost of
revenue |
|
|
219,088 |
|
|
|
315,002 |
|
|
|
946,852 |
|
|
|
807,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
263,042 |
|
|
|
367,568 |
|
|
|
943,518 |
|
|
|
839,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,207,486 |
|
|
|
4,069,037 |
|
|
|
18,590,471 |
|
|
|
10,113,291 |
|
General and administrative |
|
|
2,598,940 |
|
|
|
698,760 |
|
|
|
5,123,361 |
|
|
|
1,972,171 |
|
Total operating expenses |
|
|
8,806,426 |
|
|
|
4,767,797 |
|
|
|
23,713,832 |
|
|
|
12,085,462 |
|
Loss from operations |
|
|
(8,543,384 |
) |
|
|
(4,400,229 |
) |
|
|
(22,770,314 |
) |
|
|
(11,246,099 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
17,400 |
|
|
|
1,150 |
|
|
|
27,014 |
|
|
|
42,138 |
|
Other expense |
|
|
(8,089 |
) |
|
|
- |
|
|
|
(8,089 |
) |
|
|
- |
|
Net loss |
|
$ |
(8,534,073 |
) |
|
$ |
(4,399,079 |
) |
|
$ |
(22,751,389 |
) |
|
$ |
(11,203,961 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.89 |
) |
|
$ |
(2.41 |
) |
|
$ |
(2.26 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
18,286,352 |
|
|
|
4,950,129 |
|
|
|
9,445,862 |
|
|
|
4,950,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses from marketable securities |
|
|
(4,751 |
) |
|
|
— |
|
|
|
(4,751 |
) |
|
|
— |
|
Comprehensive
Loss |
|
$ |
(8,538,824 |
) |
|
$ |
(4,399,079 |
) |
|
$ |
(22,756,140 |
) |
|
$ |
(11,203,961 |
) |
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited)
|
|
September 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
106,927,550 |
|
|
$ |
37,090,151 |
|
Marketable securities |
|
|
42,550,420 |
|
|
|
— |
|
Accounts receivable |
|
|
471,375 |
|
|
|
500,110 |
|
Prepaids and other current assets |
|
|
3,361,471 |
|
|
|
140,958 |
|
Total current assets |
|
|
153,310,816 |
|
|
|
37,731,219 |
|
|
|
|
|
|
|
|
Marketable securities, non-current |
|
|
10,098,616 |
|
|
|
— |
|
Property
and equipment, net |
|
|
81,445 |
|
|
|
64,363 |
|
Right-of-use asset, net |
|
|
537,181 |
|
|
|
613,103 |
|
Other
assets |
|
|
14,333 |
|
|
|
14,333 |
|
Total assets |
|
$ |
164,042,391 |
|
|
$ |
38,423,018 |
|
|
|
|
|
|
|
|
Liabilities, Convertible Preferred Stock and Stockholders'
Deficit |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,795,153 |
|
|
$ |
1,480,537 |
|
Accrued expenses |
|
|
3,388,853 |
|
|
|
698,992 |
|
Lease liability, current |
|
|
82,795 |
|
|
|
76,322 |
|
Total current liabilities |
|
|
5,266,801 |
|
|
|
2,255,851 |
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
Lease
liability, non-current |
|
|
481,965 |
|
|
|
544,767 |
|
Total liabilities |
|
|
5,748,766 |
|
|
|
2,800,618 |
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
Convertible preferred stock: |
|
|
|
|
|
|
Series B
preferred stock, $0.001 par value, 0 and 6,032,183 shares
authorized at September 30, 2021 and December 31, 2020, 0 and
3,619,292 shares issued and outstanding at
September 30, 2021 and December 31, 2020 |
|
|
— |
|
|
|
36,983,910 |
|
Series A
preferred stock, $0.001 par value, 0 and 2,495,933 shares
authorized at September 30, 2021 and December 31, 2020, 0 and
2,495,933 shares issued and outstanding at
September 30, 2021 and December 31, 2020 |
|
|
— |
|
|
|
21,119,940 |
|
Total
convertible preferred stock |
|
|
— |
|
|
|
58,103,850 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 and 0 shares
authorized at September 30, 2021 and December 31, 2020,
respectively; No shares issued or outstanding |
|
|
— |
|
|
|
— |
|
Class A
common stock, $0.001 par value, 200,000,000 and 22,026,200 shares
authorized at September 30, 2021 and December 31, 2020
respectively; 25,938,064 and 4,950,129 shares issued and
outstanding at September 30, 2021 and
December 31, 2020 |
|
|
25,938 |
|
|
|
4,950 |
|
Class B
common stock, $0.001 par value, 20,000,000 and 6,032,183 shares
authorized at September 30, 2021 and December 31, 2020
respectively; 0 shares issued and outstanding at
September 30, 2021 and December 31, 2020 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
206,761,467 |
|
|
|
3,251,240 |
|
Accumulated other comprehensive loss |
|
|
(4,751 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(48,489,029 |
) |
|
|
(25,737,640 |
) |
Total stockholders' equity (deficit) |
|
|
158,293,625 |
|
|
|
(22,481,450 |
) |
Total liabilities, convertible preferred stock and
stockholders' equity (deficit) |
|
$ |
164,042,391 |
|
|
$ |
38,423,018 |
|
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