Immuneering Reports Second Quarter 2021 Financial Results and Provides Business Updates
September 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 second quarter
ended June 30, 2021 and provided a corporate update.
“We continue to make significant progress across all aspects of
our organization and with the recent IPO proceeds and the additions
to our management team and board of directors, we plan to advance
our pipeline and strive to bring novel medicines to patients,” said
Ben Zeskind, chief executive officer of Immuneering Corporation.
“In the near term, we remain focused on continuing to advance
IMM-1-104, our RAF-MEK inhibitor, targeting RAS mutant tumors into
the clinic and anticipate filing our IND in Q1 2022.”
Corporate Highlights
- 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, commissions and
estimated offering expenses payable by Immuneering.
- Strengthened Leadership
Team: Immuneering further strengthened its management team
with the appointment of Biren Amin as its Chief Financial Officer
in April 2021 and Michael Bookman as the company’s General Counsel
and Secretary in July 2021.
- Enhanced and Expanded
Board of Directors: Immuneering also welcomed new
additions to the board of directors with the appointments of Laurie
Keating in April 2021, and Ann Berman in July 2021.
- Completed Series B
Financing in 1H 2021: Immuneering raised
$62 million in a Series B financing led by Cormorant Asset
Management, Surveyor Capital (a Citadel company), Rock Springs
Capital, funds and accounts advised by T. Rowe Price Associates,
Inc., funds and accounts managed by Blackrock, Perceptive Advisors,
and LYFE Capital.
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 start 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 can target patients with a broad spectrum of mutations,
such as KRAS and NRAS, that activate the MAPK pathway.
Second Quarter 2021 Financial Highlights
- Cash Position: Cash and cash
equivalents as of June 30, 2021 were $50.2 million, compared
with $37.1 million as of December 31, 2020. The June 30,
2021 cash and equivalents excludes $118.3 million in net proceeds
from the Company’s initial public offering, which was completed in
August 2021.
- Research and Development (R&D)
Expenses: R&D expenses for the second quarter of 2021 were $7.0
million, compared with $3.2 million for the second 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 second quarter of 2021
were $1.3 million, compared with $0.6 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 $7.9 million, or $1.61 per share, for the
quarter ended June 30, 2021, compared to $3.6 million, or
$0.73 per share, for the quarter ended June 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 anticipated use of net proceeds from its initial
public offering, the sufficiency of Immuneering’s cash and cash
equivalents, 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 June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
660,040 |
|
|
$ |
480,835 |
|
|
$ |
1,408,240 |
|
|
$ |
963,885 |
|
Cost of
revenue |
|
|
318,601 |
|
|
|
237,062 |
|
|
|
727,763 |
|
|
|
492,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
341,439 |
|
|
|
243,773 |
|
|
|
680,477 |
|
|
|
471,796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,991,965 |
|
|
|
3,221,000 |
|
|
|
12,382,985 |
|
|
|
6,044,254 |
|
General and administrative |
|
|
1,340,398 |
|
|
|
629,403 |
|
|
|
2,524,422 |
|
|
|
1,273,412 |
|
Total operating expenses |
|
|
8,332,363 |
|
|
|
3,850,403 |
|
|
|
14,907,407 |
|
|
|
7,317,666 |
|
Loss from operations |
|
|
(7,990,924 |
) |
|
|
(3,606,630 |
) |
|
|
(14,226,930 |
) |
|
|
(6,845,870 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,259 |
|
|
|
2,468 |
|
|
|
9,614 |
|
|
|
40,988 |
|
Net loss |
|
$ |
(7,987,665 |
) |
|
$ |
(3,604,162 |
) |
|
$ |
(14,217,316 |
) |
|
$ |
(6,804,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(1.61 |
) |
|
$ |
(0.73 |
) |
|
$ |
(2.87 |
) |
|
$ |
(1.37 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
4,954,553 |
|
|
|
4,950,129 |
|
|
|
4,952,352 |
|
|
|
4,950,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited)
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
50,245,103 |
|
|
$ |
37,090,151 |
|
Accounts receivable |
|
|
495,105 |
|
|
|
500,110 |
|
Prepaids and other current assets |
|
|
696,684 |
|
|
|
140,958 |
|
Total current assets |
|
|
51,436,892 |
|
|
|
37,731,219 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
82,077 |
|
|
|
64,363 |
|
Right-of-use asset, net |
|
|
562,770 |
|
|
|
613,103 |
|
Other
assets |
|
|
960,386 |
|
|
|
14,333 |
|
Total assets |
|
$ |
53,042,125 |
|
|
$ |
38,423,018 |
|
|
|
|
|
|
|
|
Liabilities, Convertible Preferred Stock and Stockholders'
Deficit |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,432,516 |
|
|
$ |
1,480,537 |
|
Accrued expenses |
|
|
3,318,870 |
|
|
|
698,992 |
|
Lease liability, current |
|
|
80,605 |
|
|
|
76,322 |
|
Total current liabilities |
|
|
4,831,991 |
|
|
|
2,255,851 |
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
Lease
liability, noncurrent |
|
|
503,213 |
|
|
|
544,767 |
|
Total liabilities |
|
|
5,335,204 |
|
|
|
2,800,618 |
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
Convertible preferred stock: |
|
|
|
|
|
|
Series B
preferred stock, $0.001 par value, 6,032,183 shares authorized,
6,032,145 and 3,619,292 shares issued and outstanding at
June 30, 2021 and December 31, 2020 |
|
|
61,772,761 |
|
|
|
36,983,910 |
|
Series A
preferred stock, $0.001 par value, 2,495,933 shares authorized,
2,495,933 shares issued and outstanding at June 30, 2021
and December 31, 2020 |
|
|
21,119,940 |
|
|
|
21,119,940 |
|
Total
convertible preferred stock |
|
|
82,892,701 |
|
|
|
58,103,850 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
Class A
common stock, $0.001 par value, 22,026,200 shares authorized,
5,275,936 and 4,950,129 shares issued and outstanding at
June 30, 2021 and December 31, 2020 |
|
|
5,276 |
|
|
|
4,950 |
|
Class B
common stock, $0.001 par value, 6,032,183 shares authorized, 0
shares issued and outstanding at June 30, 2021 and
December 31, 2020 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
4,763,900 |
|
|
|
3,251,240 |
|
Accumulated deficit |
|
|
(39,954,956 |
) |
|
|
(25,737,640 |
) |
Total stockholders' deficit |
|
|
(35,185,780 |
) |
|
|
(22,481,450 |
) |
Total liabilities, convertible preferred stock and
stockholders' deficit |
|
$ |
53,042,125 |
|
|
$ |
38,423,018 |
|
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