Immuneering Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates
March 06 2023 - 4:05PM
Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company developing medicines for broad populations of cancer
patients with an initial aim to develop a universal-RAS therapy,
today reported financial results for the fourth quarter and full
year ended December 31, 2022, and provided recent business updates.
“2022 was a year of important progress towards
our goal of creating impactful new medicines for cancer patients,”
said Ben Zeskind, Ph.D., MBA, Co-founder, and Chief Executive
Officer of Immuneering. “IMM-1-104, the first and only MAPK pathway
inhibitor with the potential for universal-RAS activity, entered
the clinic as we dosed the first patient in our Phase 1/2a clinical
trial in November, enrolling patients with advanced solid tumors
harboring RAS mutations. With a unique and counterintuitive
mechanism of deep cyclic inhibition, IMM-1-104 was designed to
limit toxicity and maximize therapeutic activity by selectively
targeting cancer cells based on their increased need for sustained
MAPK pathway signaling, while sparing healthy cells which are less
dependent on continuous pathway signaling. IMM-1-104 is being
evaluated as an oral, once-daily monotherapy. Our goal is to
provide newer and better treatment options for patients with tumors
driven by any mutation in KRAS, NRAS, or HRAS.”
Dr. Zeskind continued: “We are very pleased with
the progress of our trial, which enables us today to provide debut
guidance on when investors can expect to see initial data from our
ongoing IMM-1-104 Phase 1/2a clinical trial. Currently, we plan to
share (1) initial Phase 1 pharmacokinetic (PK) and safety data in
mid-2023, followed by (2) initial Phase 1 pharmacodynamic (PD)
modeling and additional PK and safety data in the second half of
2023 and (3) the announcement of a recommended Phase 2 dose and
additional safety data in mid-2024. We also plan to provide
additional trial updates on a periodic basis. Because observing a
unique PK profile in humans is a fundamental aspect of our
counterintuitive deep cyclic inhibition mechanism, we believe these
initial readouts could provide particularly impactful early
validation for our approach and the potential universal-RAS
activity of IMM-1-104. With our clinical trial rapidly advancing
and continued progress accelerating IMM-6-415 toward an IND filing
later this year, we have also taken the opportunity to sharpen our
focus exclusively to oncology, by suspending our neuroscience
programs. This change as well as other non-core adjustments extend
our projected cash runway by an additional quarter, into Q4
2024.”
Corporate Highlights
- Preclinical data on lead
program IMM-1-104 presented at American Association for Cancer
Research (AACR) special conference targeting RAS: In March
2023, Immuneering presented preclinical data in a poster titled,
“Pan-RAS IMM-1-104 activity in humanized 3D tumor models is
independent of specific amino acid substitution.” IMM-1-104
demonstrated response across RAS mutant preclinical models
regardless of mutation position or amino acid substitution,
suggesting potential relevance to a broad universal-RAS-driven
patient population.
- Cash runway extended into Q4
2024 with sharpened focus on oncology pipeline: In March
2023, Immuneering announced the company would sharpen its focus
exclusively to its oncology pipeline, suspending its
discovery-stage neuroscience programs. With this change, and other
non-core adjustments, based on cash, cash equivalents and
marketable securities and current operating plans, the company now
expects its cash runway to extend into the fourth quarter of
2024.
- First patient dosed in
Phase 1/2a Clinical Trial of IMM-1-104 in advanced solid tumors
with RAS mutations: In September 2022,
Immuneering received FDA clearance of the IND application for
IMM-1-104 and in November 2022, commenced dosing in a Phase 1/2a
open-label study designed to evaluate the safety, tolerability,
pharmacokinetics, and preliminary efficacy of IMM-1-104 as an oral,
once-daily monotherapy in patients with advanced RAS mutant solid
tumors. To the company’s knowledge, this is the first and only
clinical trial for which patients with any mutation in KRAS, NRAS,
or HRAS are eligible to be screened for other enrollment criteria.
The Phase 1 portion of the study, which is being conducted at five
clinical sites in the United States, includes a dose escalation
phase and dose evaluation phase in order to establish an optimized
Recommended Phase 2 Dose (RP2D) candidate. Subject to Phase 1
results, the Company currently expects to conduct a Phase 2a dose
expansion phase in order to assess the safety and efficacy of
IMM-1-104 at the RP2D in RAS mutated pancreatic, melanoma, lung,
and colorectal cancers. The Company is currently in the dose
escalation phase of the trial.
- Preclinical data on its
second program IMM-6-415 presented at the 37th Annual Meeting of
SITC: In November 2022, Immuneering presented preclinical
data in a presentation titled, “Cyclic disruption of the
mitogen-activated protein kinase (MAPK) pathway by the Dual MEK
inhibitor, IMM-6-415, enhances PD1 and CTLA4 checkpoint blockade in
RAS mutant tumors.” IMM-6-415 exhibited preclinical activity as a
single-agent in RAF and RAS mutant tumor models, as well as
enhanced activity in combination with checkpoint inhibitors (CPIs)
in RAS-mutant colorectal cancer (CRC) and non-small cell lung
cancer (NSCLC) models driven by diverse MAPK pathway
mutations.
- Chief People Officer
appointed: In October 2022, the company announced the
appointment of Leah R. Neufeld to the newly created Chief People
Officer position. Ms. Neufeld brings decades of experience in life
sciences as well as human resources and will join the senior
leadership team in continuing to make the company a great place for
the all-star team of Immuneers to work and grow, while also helping
to add new talent as the company advances a robust pipeline of
novel product candidates.
- Preclinical data presented
at ASCO 2022 Annual Meeting highlighting pan-KRAS/NRAS activity of
IMM-1-104: In May 2022, Immuneering presented two
preclinical abstracts. The first abstract, titled “Head-to-head
comparison of the dual-MEK inhibitor IMM-1-104 versus sotorasib or
adagrasib in KRAS mutant pancreatic tumors,” demonstrated a lack of
Tumor Growth Inhibition (TGI) by sotorasib and adagrasib in
KRAS-G12V mutant Capan-2 PDAC tumors. In contrast, IMM-1-104
observed TGIs of 49-84% across all doses and schedules tested.
Consistent with other IMM-1-104 in vivo studies, median body weight
loss was no more than 3-5% at top doses. The second abstract titled
“Translational modeling for patients with RAS mutant tumors:
Profiling the dual-MEK inhibitor IMM-1-104 in a humanized 3D
assay,” found KRAS mutant pancreatic cancer and NRAS mutant
melanoma were the most broadly sensitive patient-aligned models in
the 3D-tumor growth assay and are expected to be included among the
target indications planned for the Phase 2a portion of
Immuneering’s ongoing Phase 1/2a clinical trial.
Near-Term Milestone
Expectations
IMM-1-104
- Initial Phase 1 PK and safety data
expected in mid-2023
- Initial Phase 1 PD modeling data
and additional PK and safety data expected in the second half of
2023
- Recommended Phase 2 dose and
additional safety data expected in mid-2024
- Additional trial updates expected
on a periodic basis
IMM-6-415
- IND filing expected in the fourth
quarter of 2023
Fourth Quarter and Full Year 2022
Financial Highlights
- Cash
Position: Cash, cash equivalents and marketable
securities as of December 31, 2022 were $105.5 million, compared
with $150.2 million as of December 31, 2021.
-
Research and Development (R&D)
Expenses: R&D expenses for the fourth quarter of
2022 were $9.9 million compared with $7.9 million for the fourth
quarter of 2021. Full year 2022 R&D expenses were $36.3 million
compared to $26.5 million for full year 2021. The increase in
R&D expenses from both periods of 2021 was primarily
attributable to higher clinical costs related to the company’s lead
program and increased personnel to support ongoing research and
development activities.
- General
and Administrative (G&A) Expenses: G&A
expenses for the fourth quarter of 2022 were $4.1 million compared
with $3.1 million for the same period of 2021. Full year 2022
G&A expenses were $15.6 million compared to $8.3 million for
full year 2021. The increase in G&A expenses for both periods
of 2022 was primarily attributable to an increase in headcount in
the company’s general and administrative functions to support the
business, and costs related to operating as a public company.
- Net
Loss: Net loss attributable to common stockholders
was $13.2 million, or $0.50 per share, for the quarter ended
December 31, 2022, compared to $10.8 million, or $0.42 per share,
for the quarter ended December 31, 2021. Net loss attributable to
common stockholders for full year 2022 was $50.5 million, or $1.91
per share compared to $33.5 million, or $2.46 per share, for full
year 2021.
2023 Financial Guidance
- Based on cash,
cash equivalents and marketable securities, as of December 31,
2022, and current operating plans, the company expects its cash
runway to extend into the fourth quarter of 2024.
Conference Call
Immuneering will host a corresponding conference
call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on March 6,
2023, to discuss the results and provide a business and pipeline
update. To access the call by phone, please use this
registration link, and you will be provided with dial in
details. To avoid delays, we encourage participants to dial into
the conference call fifteen minutes ahead of the scheduled start
time. After the live webcast, the event will be archived for
90 days in the Investor Relations section of Immuneering’s website
at Events & Presentations.
About Immuneering
Corporation
Immuneering is a clinical-stage oncology company
developing medicines for broad populations of cancer patients with
an initial aim to develop a universal-RAS therapy. The company aims
to achieve universal activity through deep cyclic inhibition of the
MAPK pathway, impacting cancer cells while sparing healthy cells.
Immuneering’s lead product candidate, IMM-1-104, is in a Phase 1/2a
study in patients with advanced solid tumors harboring RAS
mutations. The company’s development pipeline also includes
IMM-6-415, our universal-MAPK inhibitor, as well as several
early-stage programs. For more information, please visit
www.immuneering.com.
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, current operating plans and cash runway,
the treatment potential of IMM-1-104 and IMM-6-415, including
estimates of the patient population that may ultimately benefit
from treatment, statements regarding the design, enrollment and
conduct of the Phase 1/2a clinical trial for IMM-1-104, the timing
of initial Phase 1 PK and safety data, initial PD modeling data and
additional PK and safety data, additional trial updates,
recommended phase 2 dose and additional safety data, the ability of
initial readouts to validate the company’s therapeutic approach,
the timing of submission of the IND for 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 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-K 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.
Media Contact:Gina NugentNugent
Communications617-460-3579gina@nugentcommunications.com
Investor Contact:Laurence WattsGilmartin
Group619-916-7620laurence@gilmartinir.com
IMMUNEERING
CORPORATIONCONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
|
|
Three Months Ended December 31 |
|
Twelve Months Ended December 31 |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
456 |
|
|
$ |
189,591 |
|
|
$ |
316,952 |
|
|
$ |
2,079,961 |
|
Cost
of revenue |
|
|
— |
|
|
|
206,221 |
|
|
|
158,122 |
|
|
|
1,153,073 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
456 |
|
|
|
(16,630 |
) |
|
|
158,830 |
|
|
|
926,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
9,871,761 |
|
|
|
7,950,488 |
|
|
|
36,267,116 |
|
|
|
26,540,959 |
|
General and
administrative |
|
|
4,106,385 |
|
|
|
3,148,637 |
|
|
|
15,606,529 |
|
|
|
8,271,998 |
|
Amortization
of intangible asset |
|
|
7,317 |
|
|
|
— |
|
|
|
30,053 |
|
|
|
— |
|
Total
operating expenses |
|
|
13,985,463 |
|
|
|
11,099,125 |
|
|
|
51,903,698 |
|
|
|
34,812,957 |
|
Loss
from operations |
|
|
(13,985,007 |
) |
|
|
(11,115,755 |
) |
|
|
(51,744,868 |
) |
|
|
(33,886,069 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
516,167 |
|
|
|
142,885 |
|
|
|
1,014,456 |
|
|
|
169,899 |
|
Other income
(expense) |
|
|
223,278 |
|
|
|
(118,974 |
) |
|
|
216,844 |
|
|
|
(127,063 |
) |
Loss
before income taxes |
|
|
(13,245,562 |
) |
|
|
(11,091,844 |
) |
|
|
(50,513,568 |
) |
|
|
(33,843,233 |
) |
Income tax
benefit |
|
|
— |
|
|
|
307,485 |
|
|
|
— |
|
|
|
307,485 |
|
Net
loss |
|
$ |
(13,245,562 |
) |
|
$ |
(10,784,359 |
) |
|
$ |
(50,513,568 |
) |
|
$ |
(33,535,748 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share attributable to common stockholders, basic and diluted |
|
|
(0.50 |
) |
|
|
(0.42 |
) |
|
|
(1.91 |
) |
|
|
(2.46 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
26,406,933 |
|
|
|
25,977,246 |
|
|
|
26,386,864 |
|
|
|
13,612,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
losses from marketable securities |
|
|
112,353 |
|
|
|
(44,258 |
) |
|
|
18,889 |
|
|
|
(49,009 |
) |
Comprehensive Loss |
|
$ |
(13,133,209 |
) |
|
$ |
(10,828,617 |
) |
|
$ |
(50,494,679 |
) |
|
$ |
(33,584,757 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
IMMUNEERING
CORPORATIONCONSOLIDATED BALANCE
SHEETS(Unaudited)
|
|
December 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
72,636,886 |
|
|
$ |
74,888,145 |
|
Marketable
securities, current |
|
|
32,887,970 |
|
|
|
74,311,203 |
|
Accounts
receivable |
|
|
12,417 |
|
|
|
246,040 |
|
Prepaids and
other current assets |
|
|
3,209,536 |
|
|
|
2,888,608 |
|
Total
current assets |
|
|
108,746,809 |
|
|
|
152,333,996 |
|
|
|
|
|
|
|
|
Marketable
securities, non-current |
|
|
— |
|
|
|
996,560 |
|
Property and
equipment, net |
|
|
1,369,608 |
|
|
|
807,223 |
|
Goodwill |
|
|
6,690,431 |
|
|
|
6,701,726 |
|
Intangible
asset |
|
|
408,947 |
|
|
|
439,000 |
|
Right-of-use
assets, net |
|
|
4,407,785 |
|
|
|
5,324,198 |
|
Other
assets |
|
|
743,703 |
|
|
|
102,129 |
|
Total assets |
|
$ |
122,367,283 |
|
|
$ |
166,704,832 |
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock and stockholders'
equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
3,154,557 |
|
|
$ |
1,394,340 |
|
Accrued
expenses |
|
|
4,500,993 |
|
|
|
3,965,447 |
|
Other
liabilities, current |
|
|
19,796 |
|
|
|
— |
|
Lease
liabilities, current |
|
|
378,723 |
|
|
|
274,039 |
|
Total
current liabilities |
|
|
8,054,069 |
|
|
|
5,633,826 |
|
|
|
|
|
|
|
|
Long-term
liabilities: |
|
|
|
|
|
|
Lease
liabilities, non-current |
|
|
4,462,959 |
|
|
|
5,090,897 |
|
Total
liabilities |
|
|
12,517,028 |
|
|
|
10,724,723 |
|
Commitments
and contingencies (Note 13) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized at December
31, 2022 and December 31, 2021; No shares issued or
outstanding |
|
|
— |
|
|
|
— |
|
Class A
common stock, $0.001 par value, 200,000,000 shares authorized at
December 31, 2022 and December 31, 2021;
26,418,732 and 26,320,199 shares issued and outstanding at
December 31, 2022 and December 31, 2021,
respectively |
|
|
26,419 |
|
|
|
26,320 |
|
Class B
common stock, $0.001 par value, 20,000,000 shares authorized at
December 31, 2022 and December 31, 2021; 0
shares issued and outstanding at December 31, 2022 and
December 31, 2021 |
|
|
— |
|
|
|
— |
|
Additional
paid-in capital |
|
|
219,640,912 |
|
|
|
215,276,186 |
|
Accumulated
other comprehensive loss |
|
|
(30,120 |
) |
|
|
(49,009 |
) |
Accumulated
deficit |
|
|
(109,786,956 |
) |
|
|
(59,273,388 |
) |
Total
stockholders' equity |
|
|
109,850,255 |
|
|
|
155,980,109 |
|
Total liabilities, convertible preferred stock and
stockholders' equity |
|
$ |
122,367,283 |
|
|
$ |
166,704,832 |
|
|
|
|
|
|
|
|
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