Immuneering Reports Second Quarter 2023 Financial Results and Provides Business Updates
03 Agosto 2023 - 3:05PM
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 second quarter ended
June 30, 2023, and provided business updates.
“We are delighted with our progress this
quarter, as we finished the Phase 1a dose escalation portion of our
Phase 1/2a trial for IMM-1-104 ahead of schedule and completed a
successful financing with a syndicate of top tier investors,” said
Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of
Immuneering. “Importantly the initial PK, PD, and safety data we
presented at AACR reinforce the potential of IMM-1-104 to drive
deep cyclic inhibition of the MAPK pathway, which we believe has
significant advantages over conventional chronic inhibition
approaches. Our Phase 1b dose evaluation is enrolling patients with
advanced RAS mutant solid tumors including pancreatic cancer,
melanoma, lung cancer and colorectal cancer. We are grateful to the
patients, their families, and our investigators for participating
in our trial. We expect the coming months to be data-rich, with
additional updates to be provided as the trial progresses, and we
remain on track to select our recommended Phase 2 dose in early
2024.”
Corporate Highlights
- Completed dose escalation in
the IMM-1-104 Phase 1/2a clinical trial for RAS-mutant, Advanced
Solid Tumors: In June 2023, the study’s Safety Review
Committee (SRC) completed its evaluation and observed that doses up
to and including 320 mg once daily are tolerable with no
dose-limiting toxicities. Enrollment in the Phase 1b dose
evaluation portion of the study is underway and is designed to
evaluate two dosing cohorts of approximately 12 patients each at an
oral dose of 240mg or 320mg once daily.
- Reported positive initial
Phase 1 pharmacokinetic, pharmacodynamic, and safety data for
IMM-1-104 Universal-RAS program: In April 2023,
Immuneering presented initial Phase 1 PK, PD, and safety data for
IMM-1-104 at the American Association for Cancer Research (AACR)
annual meeting. IMM-1-104 achieved significant levels of PK Cmax,
demonstrated a half-life of approximately two hours, as predicted,
and was well tolerated with no dose-limiting toxicities. These data
support the potential of IMM-1-104 to drive deep cyclic inhibition
of the MAPK pathway. The findings also may make it possible to
evaluate preliminary efficacy sooner than previously expected, such
that a recommended Phase 2 dose (RP2D) determination is now
expected in early 2024.
- Presented additional
preclinical data on lead program IMM-1-104 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. 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.
- Completed $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
aggregate net proceeds from the offering were approximately $28.2
million, after deducting underwriting discounts and commissions,
but before deducting 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.
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.
Second Quarter
2023 Financial Highlights
- Cash Position: Cash,
cash equivalents and marketable securities as of June 30, 2023
were $109.0 million, compared with $105.5 million as of
December 31, 2022.
- Research and Development
(R&D) Expenses: R&D expenses for the quarter ended
June 30, 2023 were $9.5 million, compared with $8.0 million
for the quarter ended June 30, 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 quarter ended
June 30, 2023 were $4.0 million, compared with $3.7 million
for the quarter ended June 30, 2022. The increase in G&A
expenses was primarily attributable to an increase in headcount to
support the company’s business operations.
- Net Loss: Net loss
attributable to common stockholders was $12.2 million, or $0.43 per
share, for the quarter ended June 30, 2023, compared to $11.5
million, or $0.44 per share, for the quarter ended June 30,
2022.
2023 Financial
Guidance
Based on cash, cash equivalents and marketable
securities as of June 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
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 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; our
anticipated cash runway; 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 June 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 Group
332-895-3225kiki@gilmartinir.com
IMMUNEERING CORPORATION |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
|
(Unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
— |
|
|
$ |
94,419 |
|
|
$ |
— |
|
|
$ |
278,117 |
|
Cost of revenue |
|
— |
|
|
|
47,933 |
|
|
|
— |
|
|
|
138,778 |
|
|
|
|
|
|
|
|
|
Gross profit |
|
— |
|
|
|
46,486 |
|
|
|
— |
|
|
|
139,339 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
|
9,452,711 |
|
|
|
7,981,075 |
|
|
|
19,663,637 |
|
|
|
17,031,517 |
|
General and administrative |
|
4,044,960 |
|
|
|
3,704,143 |
|
|
|
8,506,291 |
|
|
|
7,664,112 |
|
Amortization of intangible asset |
|
7,317 |
|
|
|
7,317 |
|
|
|
14,633 |
|
|
|
15,420 |
|
Total operating expenses |
|
13,504,988 |
|
|
|
11,692,535 |
|
|
|
28,184,561 |
|
|
|
24,711,049 |
|
Loss from operations |
|
(13,504,988 |
) |
|
|
(11,646,049 |
) |
|
|
(28,184,561 |
) |
|
|
(24,571,710 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
|
1,166,047 |
|
|
|
142,799 |
|
|
|
1,997,321 |
|
|
|
275,304 |
|
Other income (expense) |
|
150,193 |
|
|
|
(24,053 |
) |
|
|
394,322 |
|
|
|
(127,271 |
) |
Net loss |
$ |
(12,188,748 |
) |
|
$ |
(11,527,303 |
) |
|
$ |
(25,792,918 |
) |
|
$ |
(24,423,677 |
) |
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.43 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.93 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
28,647,450 |
|
|
|
26,386,343 |
|
|
|
27,550,922 |
|
|
|
26,372,787 |
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gains (losses) from marketable securities |
|
(2,724 |
) |
|
|
(14,166 |
) |
|
|
27,902 |
|
|
|
(132,552 |
) |
Comprehensive Loss |
$ |
(12,191,472 |
) |
|
$ |
(11,541,469 |
) |
|
$ |
(25,765,016 |
) |
|
$ |
(24,556,229 |
) |
|
IMMUNEERING CORPORATION |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(Unaudited) |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
104,017,496 |
|
|
$ |
72,636,886 |
|
Marketable securities, current |
|
4,967,840 |
|
|
|
32,887,970 |
|
Accounts receivable |
|
— |
|
|
|
12,417 |
|
Prepaids and other current assets |
|
2,521,757 |
|
|
|
3,209,536 |
|
Total current assets |
|
111,507,093 |
|
|
|
108,746,809 |
|
|
|
|
|
Property and equipment, net |
|
1,365,741 |
|
|
|
1,369,608 |
|
Goodwill |
|
6,690,431 |
|
|
|
6,690,431 |
|
Intangible asset, net |
|
394,313 |
|
|
|
408,947 |
|
Right-of-use assets, net |
|
4,194,049 |
|
|
|
4,407,785 |
|
Other assets |
|
743,703 |
|
|
|
743,703 |
|
Total assets |
$ |
124,895,330 |
|
|
$ |
122,367,283 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,693,000 |
|
|
$ |
3,154,557 |
|
Accrued expenses |
|
2,426,899 |
|
|
|
4,500,993 |
|
Other liabilities, current |
|
26,333 |
|
|
|
19,796 |
|
Lease liabilities, current |
|
332,675 |
|
|
|
378,723 |
|
Total current liabilities |
|
5,478,907 |
|
|
|
8,054,069 |
|
|
|
|
|
Long-term liabilities: |
|
|
|
Lease liabilities, non-current |
|
4,312,008 |
|
|
|
4,462,959 |
|
Total liabilities |
|
9,790,915 |
|
|
|
12,517,028 |
|
Commitments and contingencies (Note 10) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
June 30, 2023 and December 31, 2022; 0 shares issued or
outstanding at June 30, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Class A common stock, $0.001 par value, 200,000,000 shares
authorized at June 30, 2023 and December 31, 2022;
29,263,028 and 26,418,732 shares issued and outstanding at
June 30, 2023 and December 31, 2022, respectively |
|
29,263 |
|
|
|
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 |
|
250,657,245 |
|
|
|
219,640,912 |
|
Accumulated other comprehensive loss |
|
(2,218 |
) |
|
|
(30,120 |
) |
Accumulated deficit |
|
(135,579,875 |
) |
|
|
(109,786,956 |
) |
Total stockholders' equity |
|
115,104,415 |
|
|
|
109,850,255 |
|
Total liabilities and stockholders' equity |
$ |
124,895,330 |
|
|
$ |
122,367,283 |
|
Immuneering (NASDAQ:IMRX)
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De Abr 2024 a May 2024
Immuneering (NASDAQ:IMRX)
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De May 2023 a May 2024