Immuneering Reports First Quarter 2023 Financial Results and Provides Business Updates
05 5월 2023 - 5:05AM
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 first quarter ended
March 31, 2023, and provided business updates.
“2023 has already been transformative for Immuneering, headlined
by initial Phase 1 PK, PD, and safety data for IMM-1-104 presented
at AACR, which we believe demonstrated the profile necessary for
deep cyclic inhibition for the first time in humans. We are excited
by the data, which we believe de-risks key elements of our
universal-RAS program,” said Ben Zeskind, Ph.D., Co-founder, and
Chief Executive Officer of Immuneering. “In addition, we are
delighted to have achieved significant levels of PK Cmax earlier
than expected, which has enabled us to accelerate our study
timeline. We now expect to announce a recommended Phase 2 dose in
early 2024, which provides us an opportunity to assess potential
preliminary efficacy earlier than anticipated. In connection with
our initial data announcement at AACR, we were also pleased to
announce the completion of a successful $30 million financing,
which extends our cash runway into 2025. 2023 is shaping up to be a
breakout year for Immuneering as we continue to expeditiously
advance IMM-1-104 in the clinic. We look forward to providing
further updates later in the year.”
Corporate Highlights
- Positive Initial Phase 1 Pharmacokinetic,
Pharmacodynamic and Safety Data for IMM-1-104 Universal-RAS Program
presented at American Association for Cancer Research (AACR) annual
meeting: In April 2023, Immuneering presented initial
Phase 1 PK, PD and safety data for IMM-1-104 at the AACR annual
meeting. Data presented at AACR (as of the April 10, 2023 cutoff
date) support IMM-1-104’s potential to address a broad population
of patients with RAS mutant tumors and provide the first
demonstration of the profile necessary for its novel deep cyclic
inhibition mechanism in humans, with IMM-1-104 achieving
significant levels of PK Cmax and a half-life of approximately two
hours as predicted. IMM-1-104 was well tolerated with no dose
limiting toxicities or serious adverse events observed. In
addition, the pharmacodynamic data supports the potential to
evaluate preliminary efficacy sooner than expected and RP2D is now
expected in early 2024.
- Preclinical data on lead program IMM-1-104 presented at
AACR annual meeting: Immuneering also presented
preclinical data at AACR in which the antitumor activity of
IMM-1-104 was evaluated in 132 tumor models spanning 12 distinct
tumor types utilizing its proprietary humanized 3D tumor growth
assay (3D-TGA). Based on drug-response sensitivity and resistance
profiles, a biomarker signature for IMM-1-104 was developed to
project potential therapeutic response in more than 100,000 cancer
patients found in the AACR Project GENIE® database. Mutational
landscapes of patients within GENIE helped identify preclinical
models that represent patient profiles likely to be encountered in
the clinic. These results were utilized in prioritizing indications
for the planned Phase 2a clinical trial.
- Preclinical data on lead program IMM-1-104 presented at
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.
- $30 Million Underwritten Offering: In April
2023, Immuneering completed an underwritten offering of 2,727,273
shares of its Class A common stock at an offering price of $11.00
per share. The net proceeds from the offering are expected to be
$27.8 million, after deducting underwriting discounts and
commissions and estimated offering expenses payable by Immuneering.
Immuneering intends to use the net proceeds of the offering to
advance the preclinical and clinical development of its product
candidates and for working capital and other general corporate
purposes.
- Chief Business Officer appointed: In March
2023, the company announced the appointment of Harold E. Brakewood
(“E.B.”) as its Chief Business Officer. Mr. Brakewood, who has more
than 25 years of experience as a senior executive in the
biotechnology and pharmaceutical industry, will be responsible for
corporate and business development, new product planning, and
commercial strategy.
Near-Term Milestone
Expectations
IMM-1-104
- Additional trial updates expected
on a periodic basis.
- RP2D and additional safety data
expected in early 2024.
IMM-6-415
- IND filing expected in the fourth
quarter of 2023.
First Quarter 2023 Financial
Highlights
- Cash Position: Cash and cash equivalents and
marketable securities as of March 31, 2023 were $91.5 million,
compared with $105.5 million as of December 31,
2022.
- Research and Development (R&D) Expenses:
R&D expenses for the first quarter ended 2023, were $10.2
million compared with $9.1 million for the first quarter of 2022.
The increase in R&D expenses 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 first quarter of 2023 were $4.5 million
compared with $4.0 million for the same period of 2022. The
increase in G&A is primarily attributed 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 $13.6 million, or $0.51 per share, for the first
quarter ended March 31, 2023, compared to $12.9 million, or
$0.49 per share, for the first quarter ended March 31,
2022.
2023 Financial Guidance
Based on cash, cash equivalents and marketable
securities, as of March 31, 2023, including estimated net
proceeds from the April 2023 underwritten offering, and current
operating plans, the company expects its cash runway to extend into
2025.
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, 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 includes certain disclosures
that contain "forward-looking statements," including, without
limitation, statements regarding Immuneering’s expectations
regarding the treatment potential of IMM-1-104, the design,
enrollment criteria and conduct of the Phase 1/2a clinical trial,
the translation of preclinical data into human clinical data, the
ability of initial clinical data to de-risk IMM-1-104 and be
confirmed as the study progresses, including the safety,
tolerability, pharmacokinetics, pharmacodynamics and potential
efficacy of IMM-1-104; the potential advantages and effectiveness
of the company’s clinical and preclinical candidates, the timing of
additional trial updates, recommended phase 2 dose and additional
safety data, the indications to be pursued by Immuneering in the
Phase 2a portion of the study, the timing of submission of the IND
for IMM-6-415, the sufficiency of its cash, cash equivalents and
marketable securities, its current business plans and cash runway,
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 research and 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.
Media Contact:Gina NugentNugent
Communications617-460-3579gina@nugentcommunications.com
Investor Contacts:Laurence WattsGilmartin
Group619-916-7620laurence@gilmartinir.com
or
Kiki Patel, PharmDGilmartin Group
332-895-3225kiki@gilmartinir.com
IMMUNEERING CORPORATION |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(Unaudited) |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Revenue |
$ |
— |
|
|
$ |
183,698 |
|
Cost of
revenue |
|
— |
|
|
|
90,846 |
|
|
|
|
|
Gross
profit |
|
— |
|
|
|
92,852 |
|
|
|
|
|
Operating
expenses |
|
|
|
Research and development |
|
10,210,926 |
|
|
|
9,058,545 |
|
General and administrative |
|
4,461,331 |
|
|
|
3,951,866 |
|
Amortization of intangible asset |
|
7,317 |
|
|
|
8,103 |
|
Total operating expenses |
|
14,679,574 |
|
|
|
13,018,514 |
|
Loss from operations |
|
(14,679,574 |
) |
|
|
(12,925,662 |
) |
|
|
|
|
Other income
(expense) |
|
|
|
Interest income |
|
831,274 |
|
|
|
132,506 |
|
Other income (expense) |
|
244,129 |
|
|
|
(103,218 |
) |
Net loss |
$ |
(13,604,171 |
) |
|
$ |
(12,896,374 |
) |
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.51 |
) |
|
$ |
(0.49 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
26,442,216 |
|
|
|
26,359,080 |
|
|
|
|
|
Other comprehensive loss: |
|
|
|
Unrealized gains (losses) from marketable securities |
|
30,626 |
|
|
|
(118,386 |
) |
Comprehensive
Loss |
$ |
(13,573,545 |
) |
|
$ |
(13,014,760 |
) |
|
|
|
|
|
|
|
|
IMMUNEERING CORPORATION |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(Unaudited) |
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
77,430,283 |
|
|
$ |
72,636,886 |
|
Marketable securities, current |
|
14,105,560 |
|
|
|
32,887,970 |
|
Accounts receivable |
|
1,046 |
|
|
|
12,417 |
|
Prepaids and other current assets |
|
2,696,640 |
|
|
|
3,209,536 |
|
Total current assets |
|
94,233,529 |
|
|
|
108,746,809 |
|
|
|
|
|
Property and equipment, net |
|
1,325,192 |
|
|
|
1,369,608 |
|
Goodwill |
|
6,690,431 |
|
|
|
6,690,431 |
|
Intangible asset, net |
|
401,630 |
|
|
|
408,947 |
|
Right-of-use assets, net |
|
4,301,999 |
|
|
|
4,407,785 |
|
Other assets |
|
743,703 |
|
|
|
743,703 |
|
Total assets |
$ |
107,696,484 |
|
|
$ |
122,367,283 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,723,624 |
|
|
$ |
3,154,557 |
|
Accrued expenses |
|
2,412,413 |
|
|
|
4,500,993 |
|
Other liabilities, current |
|
26,333 |
|
|
|
19,796 |
|
Lease liabilities, current |
|
363,238 |
|
|
|
378,723 |
|
Total current liabilities |
|
5,525,608 |
|
|
|
8,054,069 |
|
|
|
|
|
Long-term liabilities: |
|
|
|
Lease liabilities, non-current |
|
4,381,252 |
|
|
|
4,462,959 |
|
Total liabilities |
|
9,906,860 |
|
|
|
12,517,028 |
|
Commitments and contingencies
(Note 10) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized at March 31, 2023 and
December 31, 2022; 0 shares issued or outstanding at
March 31, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Class A common stock, $0.001 par
value, 200,000,000 shares authorized at March 31, 2023 and
December 31, 2022; 26,495,797 and 26,418,732 shares issued and
outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
26,496 |
|
|
|
26,419 |
|
Class B common stock, $0.001 par
value, 20,000,000 shares authorized at March 31, 2023 and
December 31, 2022; 0 shares issued and outstanding at
March 31, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
221,153,749 |
|
|
|
219,640,912 |
|
Accumulated other comprehensive
gain (loss) |
|
506 |
|
|
|
(30,120 |
) |
Accumulated deficit |
|
(123,391,127 |
) |
|
|
(109,786,956 |
) |
Total stockholders' equity |
|
97,789,624 |
|
|
|
109,850,255 |
|
Total liabilities and stockholders' equity |
$ |
107,696,484 |
|
|
$ |
122,367,283 |
|
Immuneering (NASDAQ:IMRX)
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부터 4월(4) 2024 으로 5월(5) 2024
Immuneering (NASDAQ:IMRX)
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부터 5월(5) 2023 으로 5월(5) 2024