Immuneering Reports Third Quarter 2023 Financial Results and Provides Business Updates
2023年11月10日 - 6:05AM
Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company seeking to develop medicines for broad populations of
cancer patients with an initial aim to develop a universal-RAS
therapy, today reported financial results for the third quarter
ended September 30, 2023, and provided business updates.
“We believe that every cancer patient deserves a
durable complete response, and that the first step towards this
long-term goal is to safely and durably deprive tumors of sustained
signaling on the MAPK pathway, cancer’s superhighway,” said Ben
Zeskind, Ph.D., Co-founder and Chief Executive Officer of
Immuneering. “Completing our Phase 1 dose escalation of IMM-1-104
with no observed dose-limiting toxicities was an important step in
that direction. We have made rapid progress in the Phase 1 dose
evaluation portion of the study and are preparing to hit the ground
running with the expanded Phase 2a development plan we are
announcing today.”
“We look forward to assessing IMM-1-104
monotherapy in melanoma and lung cancer. In pancreatic cancer, we
plan to assess IMM-1-104 as monotherapy in a first- or second-line
setting, and as combination therapy in a first-line setting with
chemotherapy, for which we shared promising preclinical data at the
AACR-NCI-EORTC Conference last month. The Phase 2a portion of the
study will also include the addition of new sites and investigators
focused on these cancer types. We expect to announce initial Phase
2a data from multiple arms in 2024. We believe the important
progress we have made in the third quarter of 2023, and are
continuing to make on both IMM-1-104 and IMM-6-415, lays a strong
foundation for the year ahead.”
Corporate Highlights
- Continued progress on Phase 1 portion of the Phase 1/2a
trial for IMM-1-104
- Approximately two thirds of planned patients (20 per arm) now
enrolled in the Phase 1 dose evaluation portion of the Phase 1/2a
trial, comparing 240mg and 320mg of IMM-1-104 as monotherapy, with
no dose limiting toxicities having been observed in the Phase 1
dose escalation portion of the study completed in June 2023.
- The Company’s recommendation for a Phase 2 dose, based on
safety, tolerability, PK/PD, circulating tumor DNA, and initial
activity readouts from the Phase 1 portion of the study, expected
to be shared in early 2024.
- Expanded clinical development plan for
IMM-1-104
- Immuneering is expanding its clinical development plan for the
Phase 1/2a study of IMM-1-104 to include 5 arms and additional
clinical sites and investigators.
- Phase 2a portion of the trial is now expected to evaluate
IMM-1-104 as a single-agent in approximately 90 patients across
three arms:
- IMM-1-104 monotherapy in patients with pancreatic ductal
adenocarcinoma (PDAC) in the first- or second-line setting
(n=30).
- IMM-1-104 monotherapy in RAS-mutant melanoma in the second- or
third-line setting after patients have received immunotherapy
(n=30), or in the first-line setting for patients who are not
candidates for existing therapies.
- IMM-1-104 monotherapy in RAS-mutant non-small cell lung cancer
(NSCLC) in the second- or third-line setting (n=30).
- The Phase 1b/2a combination portion of the trial is expected to
include approximately 60 PDAC patients in the first-line setting
across two arms:
- IMM-1-104 in combination with mFOLFIRINOX (n=30).
- IMM-1-104 in combination with modified
gemcitabine/nab-paclitaxel (n=30).
- First patient in the Phase 2a portion of the study expected to
be dosed in early 2024, with initial data from multiple arms
expected in 2024.
- Presented preclinical data demonstrating encouraging
anti-tumor activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC
conference held in October 2023
- Expanded benchmarking of IMM-1-104 as a single agent across 193
patient-aligned models in humanized 3D-tumor growth assays
demonstrated high sensitivity in a wide range of MAPK-driven
tumors, including melanoma, pancreatic cancer and lung cancer.
- IMM-1-104 in combination with gemcitabine or paclitaxel drove
enhanced anti-tumor activity in humanized 3D-tumor growth assays
across multiple pancreatic cancer models.
- Benchmarking of IMM-6-415 as a single agent across more than 60
patient-aligned models in humanized 3D-tumor growth assays
demonstrated high sensitivity in a wide range of MAPK-driven
tumors, including models of RAS and RAF mutant disease.
- IMM-6-415 in combination with encorafenib drove deeper
regressions and superior durability compared to binimetinib plus
encorafenib in a head-to-head study in animal models of RAF mutant
melanoma and colorectal cancer.
- Advanced IMM-6-415 with planned IND on track for filing
in Q4 2023
- Phase 1/2a study planned to include both RAS and RAF mutant
disease.
Near-Term Milestone
Expectations
IMM-1-104
- The Company’s recommendation for a
Phase 2 dose, based on safety, tolerability, PK/PD, circulating
tumor DNA, and initial activity readouts from the Phase 1 portion
of the study, expected to be shared in early 2024.
- First Phase 2a patient expected to
be dosed in early 2024, with initial data from multiple arms
expected in 2024.
- Additional trial updates expected
on a periodic basis.
IMM-6-415
- IND filing expected in the fourth
quarter of 2023.
Third Quarter 2023 Financial
Highlights
- Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2023 were $97.2 million,
compared with $105.5 million as of December 31, 2022.
- Research and Development (R&D) Expenses:
R&D expenses for the quarter ended September 30, 2023 were
$10.1 million, compared with $9.4 million for the quarter ended
September 30, 2022. The increase in R&D expenses was primarily
attributable to higher clinical costs related to the company’s lead
program.
- General and Administrative (G&A) Expenses:
G&A expenses for the quarter ended September 30, 2023 were $3.9
million, compared with $3.8 million for the quarter ended September
30, 2022. The increase in G&A expenses was primarily
attributable to an increase in headcount to support the company’s
business operations which was partially offset by a decrease in
professional services fees.
- Net Loss: Net loss attributable to common
stockholders was $12.6 million, or $0.43 per share, for the quarter
ended September 30, 2023, compared to $12.8 million, or $0.49 per
share, for the quarter ended September 30, 2022.
2023 Financial Guidance
Based on cash, cash equivalents and marketable
securities as of September 30, 2023, and current operating plans,
the company expects its cash runway to extend into 2025.
About Immuneering
Corporation
Immuneering is a clinical-stage oncology company
seeking to develop potential 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, a universal-MAPK program, as well as
several early-stage programs. For more information, please visit
www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements contained in this
press release that do not relate to matters of historical fact
should be considered forward-looking statements, including without
limitation statements concerning: the expected design, timing,
enrollment and advancement of, and data results from, preclinical
studies and clinical trials involving our product candidates; the
potential of our product candidates to be used as monotherapies and
/ or in combination with other therapeutic agents, including to
treat RAS or RAF mutant diseases; and the clinical development of
IMM-1-104 and anticipated filing of an IND for IMM-6-415.
These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: the risks inherent in oncology drug
research and development, including target discovery, target
validation, lead compound identification, and lead compound
optimization; we have incurred significant losses, are not
currently profitable and may never become profitable; our projected
cash runway; our need for additional funding; our unproven approach
to therapeutic intervention; our ability to address regulatory
questions and the uncertainties relating to regulatory filings,
reviews and approvals; the lengthy, expensive, and uncertain
process of clinical drug development, including potential delays in
or failure to obtain regulatory approvals; our reliance on third
parties and collaborators to conduct our clinical trials,
manufacture our product candidates, and develop and commercialize
our product candidates, if approved; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; costs and resources of operating as a public
company; and unfavorable or no analyst research or reports.
These and other important factors discussed
under the caption "Risk Factors" in our Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2023, and our
other reports filed with the United States Securities and Exchange
Commission, could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, except as required by law, we disclaim any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing our views as of any date subsequent to the date of
this press release.
Media Contact:Gina NugentNugent
Communications617-460-3579gina@nugentcommunications.com
Investor Contacts:Laurence WattsGilmartin
Group619-916-7620laurence@gilmartinir.com or
Kiki Patel, PharmDGilmartin
Group332-895-3225kiki@gilmartinir.com
|
IMMUNEERING
CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
38,380 |
|
|
$ |
- |
|
|
$ |
316,497 |
|
Cost of revenue |
|
- |
|
|
|
19,343 |
|
|
|
- |
|
|
|
158,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
- |
|
|
|
19,037 |
|
|
|
- |
|
|
|
158,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
10,050,198 |
|
|
|
9,363,838 |
|
|
|
29,713,835 |
|
|
|
26,395,355 |
|
General and administrative |
|
3,868,823 |
|
|
|
3,836,032 |
|
|
|
12,375,114 |
|
|
|
11,500,144 |
|
Amortization of intangible asset |
|
7,317 |
|
|
|
7,317 |
|
|
|
21,950 |
|
|
|
22,737 |
|
Total operating expenses |
|
13,926,338 |
|
|
|
13,207,187 |
|
|
|
42,110,899 |
|
|
|
37,918,236 |
|
Loss from operations |
|
(13,926,338 |
) |
|
|
(13,188,150 |
) |
|
|
(42,110,899 |
) |
|
|
(37,759,861 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
855,532 |
|
|
|
222,985 |
|
|
|
2,852,852 |
|
|
|
498,288 |
|
Other income (expense) |
|
475,595 |
|
|
|
120,835 |
|
|
|
869,917 |
|
|
|
(6,434 |
) |
Net loss |
$ |
(12,595,211 |
) |
|
$ |
(12,844,330 |
) |
|
$ |
(38,388,130 |
) |
|
$ |
(37,268,007 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.43 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.36 |
) |
|
$ |
(1.41 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
29,266,309 |
|
|
|
26,394,490 |
|
|
|
28,129,005 |
|
|
|
26,380,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses) from marketable securities |
|
7,825 |
|
|
|
39,088 |
|
|
|
35,727 |
|
|
|
(93,464 |
) |
Comprehensive Loss |
$ |
(12,587,386 |
) |
|
$ |
(12,805,242 |
) |
|
$ |
(38,352,403 |
) |
|
$ |
(37,361,471 |
) |
The accompanying notes are an integral part of
these condensed consolidated financial statements.
|
IMMUNEERING
CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited) |
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
68,040,264 |
|
|
$ |
72,636,886 |
|
Marketable securities, current |
|
29,202,248 |
|
|
|
32,887,970 |
|
Accounts receivable |
|
- |
|
|
|
12,417 |
|
Prepaids and other current assets |
|
3,340,248 |
|
|
|
3,209,536 |
|
Total current assets |
|
100,582,760 |
|
|
|
108,746,809 |
|
|
|
|
Property and equipment, net |
|
1,393,173 |
|
|
|
1,369,608 |
|
Goodwill |
|
6,690,431 |
|
|
|
6,690,431 |
|
Intangible asset, net |
|
386,997 |
|
|
|
408,947 |
|
Right-of-use assets, net |
|
4,083,875 |
|
|
|
4,407,785 |
|
Other assets |
|
743,703 |
|
|
|
743,703 |
|
Total assets |
$ |
113,880,939 |
|
|
$ |
122,367,283 |
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
1,941,099 |
|
|
$ |
3,154,557 |
|
Accrued expenses |
|
3,299,053 |
|
|
|
4,500,993 |
|
Other liabilities, current |
|
80,497 |
|
|
|
19,796 |
|
Lease liabilities, current |
|
301,633 |
|
|
|
378,723 |
|
Total current liabilities |
|
5,622,282 |
|
|
|
8,054,069 |
|
|
|
|
Long-term liabilities: |
|
|
Lease liabilities, non-current |
|
4,241,020 |
|
|
|
4,462,959 |
|
Total liabilities |
|
9,863,302 |
|
|
|
12,517,028 |
|
Commitments and contingencies (Note 10) |
|
|
Stockholders’ equity: |
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
September 30, 2022 and December 31, 2022; 0 shares issued or
outstanding at June 30, 2023 and December 31, 2021 |
|
- |
|
|
|
- |
|
Class A common stock, $0.001 par value, 200,000,000 shares
authorized at June 30, 2023 and December 31, 2022; 26,404,732 and
26,320,199 shares issued and outstanding at June 30, 2023 and
December 31, 2021, respectively |
|
29,269 |
|
|
|
26,419 |
|
Class B common stock, $0.001 par value, 20,000,000 shares
authorized at June 30, 2023 and December 31, 2022; 0 shares issued
and outstanding at June 30, 2023 and December 31, 2022 |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
252,157,847 |
|
|
|
219,640,912 |
|
Accumulated other comprehensive income (loss) |
|
5,607 |
|
|
|
(30,120 |
) |
Accumulated deficit |
|
(148,175,086 |
) |
|
|
(109,786,956 |
) |
Total stockholders' equity |
|
104,017,637 |
|
|
|
109,850,255 |
|
Total liabilities and stockholders' equity |
$ |
113,880,939 |
|
|
$ |
122,367,283 |
|
Immuneering (NASDAQ:IMRX)
過去 株価チャート
から 4 2024 まで 5 2024
Immuneering (NASDAQ:IMRX)
過去 株価チャート
から 5 2023 まで 5 2024