- Clinical data from May 2024 on
ACTengine® IMA203 targeting PRAME in 30 heavily pre-treated
metastatic melanoma patients at RP2D: 55% confirmed objective
response rate, median duration of response of 13.5 months; IMA203
continues to maintain a favorable tolerability profile
- Registration-enabling randomized
Phase 2/3 trial for ACTengine® IMA203 in 2L+ melanoma planned to
commence in 2024
- Next data update on IMA203 and
IMA203CD8 (GEN2) to be presented at medical conferences in 2H
2024
- First Phase 1 dose escalation
clinical data from Immatics’ next-generation, half-life extended
TCR Bispecific, TCER® IMA401 (MAGEA4/8), to be presented as an oral
presentation at the European Society for Medical Oncology (ESMO)
Congress 2024
- First next-generation, half-life
extended TCER® IMA402 (PRAME) dose escalation data to be announced
later in 2H 2024
- Appointment of Alise Reicin M.D. to
Board of Directors
- Cash and cash equivalents as well
as other financial assets amount to $568.5 million1 (€531.1
million) as of June 30, 2024, funding company operations into
2027
Houston, Texas and Tuebingen, Germany,
August 13, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics”
or the “Company”), a clinical-stage biopharmaceutical company
active in the discovery and development of T cell-redirecting
cancer immunotherapies, today provided a business update and
reported financial results for the quarter ended June 30, 2024.
“It is an exciting time for Immatics as we
prepare to reach several major clinical milestones in the second
half of the year. Starting with the presentation of the first
clinical data on our TCR Bispecific, TCER® IMA401, at ESMO,
followed by further data updates from our cell therapy pipeline and
the initiation of the IMA203 registration-enabling clinical trial,
we look forward to the continued advancement of our product
candidates in the coming months,” said Harpreet Singh, Ph.D., CEO
and Co-Founder of Immatics. “Patients with advanced solid tumors
are in need of transformative therapies that make a meaningful
difference in their quality of life. With each clinical milestone
we reach, we move one step closer to making an impact in the lives
of these patients.”
Second Quarter 2024 and Subsequent
Company Progress
ACTengine® Cell Therapy
Program
ACTengine® IMA203 and IMA203CD8 (GEN2)
monotherapy
On May 14, 2024, Immatics provided a data update
on IMA203 monotherapy targeting PRAME from the ongoing Phase 1
trial at the recommended Phase 2 dose (RP2D, 1 to 10 billion total
TCR-T cells) in 30 heavily pretreated metastatic melanoma patients
evaluable for efficacy.
As of the data cut-off on April 25, 2024,
treatment with IMA203 monotherapy in the efficacy population has
demonstrated a confirmed objective response rate (cORR) of 55%
(16/29), a disease control rate of 90% (27/30) and tumor shrinkage
in 87% (26/30) of patients.
Median duration of response (mDOR) was 13.5
months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed
objective responses ongoing at data cut-off and longest duration of
response ongoing at >21 months after infusion.
Confirmed response rates are similar across all
melanoma subtypes (56% (9/16) in cutaneous melanoma and 54% (7/13)
in other melanoma subtypes). IMA203 has exhibited a favorable
tolerability profile (N=65 patients across all dose levels and all
tumor types).
The next data update, which will include
translational and clinical data for IMA203, as well as further
details on the clinical trial design for the planned IMA203 Phase
2/3 study, will be presented in 2H 2024 at a medical
conference.
Immatics is continuing dose escalation of
IMA203CD8 (GEN2) with the goal of defining the optimal dose for
further development. The next data update for IMA203CD8 (GEN2) is
planned for 2H 2024 with a focus on continued dose escalation data
in melanoma patients. In addition to treating melanoma patients,
Immatics has also started to expand its clinical footprint outside
of melanoma to address a broader patient population with a
particular focus on ovarian and uterine cancers.
TCR Bispecifics Programs
Immatics’ T cell engaging receptor (TCER®)
candidates are next-generation, half-life extended TCR Bispecific
molecules. They are designed to maximize efficacy while minimizing
toxicities and provide a patient-convenient dosing schedule through
the proprietary format consisting of a high-affinity TCR domain
against the tumor target and a low-affinity T cell recruiter
binding to the T cell.
Upcoming milestones for Immatics’
clinical TCER® pipeline
Martin Wermke, M.D. will present the first
clinical data from Immatics’ IMA401 (MAGEA4/8) at the ESMO Congress
during an oral presentation titled, Initial safety,
pharmacokinetics, and anti-tumor activity data of TCER IMA401, a
MAGEA4/8-directed half-life extended TCR Bispecific, in Phase 1
dose escalation, on September 16, 2024, at 11:25 CEST.
Data from approximately 30 patients from the
dose escalation phase will be presented. Key objectives include:
(1) Demonstrating tolerability of the novel, next-generation,
half-life extended TCR Bispecifics format; (2) optimizing dosing
schedule to a less frequent regimen during dose escalation, based
on pharmacokinetics data; and (3) demonstrating initial clinical
anti-tumor activity.
IMA402 (PRAME) data are planned to be announced
later in 2H 2024 and will include data from at least 15 patients in
early stages of dose escalation across multiple solid cancers, but
initially focused on melanoma.
TCER® IMA401 (MAGEA4/8)
The Phase 1 dose escalation basket trial to
evaluate safety, tolerability and initial anti-tumor activity of
TCER® IMA401 in patients with recurrent and/or refractory solid
tumors is ongoing. IMA401 targets an HLA-A*02:01-presented peptide
that occurs identically in two different proteins, MAGEA4 and
MAGEA8. This target peptide has been selected based on natural
expression in native solid tumors at particularly high target
density (peptide copy number per tumor cell identified by Immatics’
proprietary quantitative mass spectrometry engine XPRESIDENT® is
>5x higher than for a MAGEA4 peptide target used in other
clinical trials). MAGEA4 and MAGEA8 are expressed in multiple solid
cancers including lung cancer, head and neck cancer, melanoma,
ovarian cancer, sarcoma and others.
IMA401 is being developed in collaboration with
Bristol Myers Squibb.
TCER® IMA402 (PRAME)
Immatics initiated the Phase 1/2 trial
investigating the Company’s fully owned TCER® candidate IMA402 in
patients with recurrent and/or refractory solid tumors in August
2023. Initial focus indications are ovarian cancer, lung cancer,
uterine cancer and cutaneous and uveal melanoma, among others.
IMA402 targets an HLA-A*02:01-presented peptide derived from the
tumor antigen PRAME. This target peptide has been selected based on
natural expression in native solid primary tumors and metastases at
particularly high target density (peptide copy number per tumor
cell identified by Immatics’ proprietary quantitative mass
spectrometry engine XPRESIDENT®).
Corporate Development
In July 2024, Alise Reicin, M.D., was appointed
to Immatics’ Board of Directors as the Company is advancing its
pipeline of TCR-based cell therapy and bispecific product
candidates into the next phase of development. Dr. Reicin brings
extensive experience in early- and late-stage clinical development
and has led the successful development of multiple important new
therapies, including Keytruda®.
Second Quarter 2024 Financial
Results
Cash Position: Cash and cash equivalents as well
as other financial assets total €531.1 million ($568.5 million1) as
of June 30, 2024, compared to €425.9 million ($455.9 million1) as
of December 31, 2023. The increase is mainly due to the public
offering in January 2024, partly offset by ongoing research and
development activities. The Company projects a cash runway into
2027.
Revenue: Total revenue, consisting of revenue
from collaboration agreements, was €18.8 million ($20.1 million1)
for the three months ended June 30, 2024, compared to €22.4 million
($24.0 million1) for the three months ended June 30, 2023. The
decrease is mainly the result of a one-time revenue of €13.7
million associated with an opt-in payment by BMS during the three
months ended June 30, 2023.
Research and Development Expenses: R&D
expenses were €35.2 million ($37.7 million1) for the three months
ended June 30, 2024, compared to €27.3 million ($29.2 million1) for
the three months ended June 30, 2023. The increase mainly resulted
from costs associated with the advancement of the clinical pipeline
candidates.General and Administrative Expenses: G&A expenses
were €10.1 million ($10.8 million1) for the three months ended June
30, 2024, compared to €9.4 million ($10.1 million1) for the three
months ended June 30, 2023.
Net Profit and Loss: Net loss was €18.0 million
($19.3 million1) for the three months ended June 30, 2024, compared
to a net loss of €24.6 million ($26.3 million1) for the three
months ended June 30, 2023. The decrease in net loss despite
decreased revenue and increased operating expenses is driven by an
increased financial result.
Full financial statements can be found in the
6-K filed with the Securities and Exchange Commission (SEC) on
August 13, 2024, and published on the SEC website under
www.sec.gov.
Upcoming Investor
Conferences
Jefferies London Healthcare Conference, London,
United Kingdom – November 19 – 21, 2024
To see the full list of events and
presentations, visit
www.investors.immatics.com/events-presentations.
- END -
About ImmaticsImmatics combines
the discovery of true targets for cancer immunotherapies with the
development of the right T cell receptors with the goal of enabling
a robust and specific T cell response against these targets. This
deep know-how is the foundation for our pipeline of Adoptive Cell
Therapies and TCR Bispecifics as well as our partnerships with
global leaders in the pharmaceutical industry. We are committed to
delivering the power of T cells and to unlocking new avenues for
patients in their fight against cancer.
Immatics intends to use its website
www.immatics.com as a means of disclosing material non-public
information. For regular updates you can also follow us on X,
Instagram and LinkedIn.
Forward-Looking
StatementsCertain statements in this press release may be
considered forward-looking statements. Forward-looking statements
generally relate to future events or the Company’s future financial
or operating performance. For example, statements concerning timing
of data read-outs for product candidates, the timing, outcome and
design of clinical trials, the nature of clinical trials (including
whether such clinical trials will be registration-enabling), the
timing of IND or CTA filing for pre-clinical stage product
candidates, estimated market opportunities of product candidates,
the Company’s focus on partnerships to advance its strategy, and
other metrics are forward-looking statements. In some cases, you
can identify forward-looking statements by terminology such as
“may”, “should”, “expect”, “plan”, “target”, “intend”, “will”,
“estimate”, “anticipate”, “believe”, “predict”, “potential” or
“continue”, or the negatives of these terms or variations of them
or similar terminology. Such forward-looking statements are subject
to risks, uncertainties, and other factors which could cause actual
results to differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon estimates and assumptions that, while considered
reasonable by Immatics and its management, are inherently
uncertain. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to, various factors beyond management's control including general
economic conditions and other risks, uncertainties and factors set
forth in the Company’s Annual Report on Form 20-F and other filings
with the Securities and Exchange Commission (SEC). Nothing in this
press release should be regarded as a representation by any person
that the forward-looking statements set forth herein will be
achieved or that any of the contemplated results of such
forward-looking statements will be achieved. You should not place
undue reliance on forward-looking statements, which speak only as
of the date they are made. The Company undertakes no duty to update
these forward-looking statements. All the scientific and clinical
data presented within this press release are – by definition prior
to completion of the clinical trial and a clinical study report –
preliminary in nature and subject to further quality checks
including customary source data verification.
For more information, please contact:
Media |
|
Trophic Communications |
|
Phone: +49 171 3512733 |
|
immatics@trophic.eu |
|
Immatics N.V. |
|
Jordan Silverstein |
|
Head of Strategy |
|
Phone: +1 346 319-3325 |
|
InvestorRelations@immatics.com |
|
Immatics N.V. and
subsidiariesCondensed Consolidated Statement of
Loss of Immatics N.V.
|
Three months ended June 30,
|
Six months ended June 30,
|
|
2024 |
2023 |
2024 |
2023 |
|
(Euros in thousands, exceptper share
data) |
(Euros in thousands, exceptper
share data) |
Revenue from collaboration
agreements |
18,755 |
22,354 |
49,024 |
32,150 |
Research and development
expenses |
(35,216) |
(27,317) |
(67,324) |
(54,898) |
General and administrative
expenses |
(10,128) |
(9,358) |
(21,770) |
(18,944) |
Other income |
25 |
6 |
37 |
948 |
|
|
|
|
|
Operating
result |
(26,564) |
(14,315) |
(40,033) |
(40,744) |
Change in fair value of liabilities for
warrants |
(648) |
(13,105) |
395 |
(5,708) |
Other financial
income |
9,665 |
3,954 |
20,580 |
6,748 |
Other financial
expenses |
(305) |
(1,144) |
(515) |
(4,653) |
|
|
|
|
|
Financial
result |
8,712 |
(10,295) |
20,460 |
(3,613) |
|
|
|
|
|
Loss before
taxes |
(17,852) |
(24,610) |
(19,573) |
(44,357) |
Taxes on
income |
(170) |
— |
(1,503) |
— |
Net
loss |
(18,022) |
(24,610) |
(21,076) |
(44,357) |
|
|
|
|
|
Net loss per
share: |
|
|
|
|
Basic |
(0.17) |
(0.32) |
(0.21) |
(0.58) |
Diluted |
(0.17) |
(0.32) |
(0.21) |
(0.58) |
Immatics N.V. and
subsidiariesCondensed Consolidated Statement of
Comprehensive Loss of Immatics N.V.
|
Three months ended June 30,
|
Six months ended June 30,
|
|
2024 |
2023 |
2024 |
2023 |
|
(Euros in thousands) |
(Euros in thousands) |
Net
loss |
(18,022) |
(24,610) |
(21,076) |
(44,357) |
Other comprehensive income |
|
|
|
|
Items that may be reclassified subsequently to profit or
loss |
|
|
|
|
Currency translation differences from foreign
operations |
462 |
(224) |
798 |
340 |
|
|
|
|
|
Total comprehensive loss for the
year |
(17,560) |
(24,834) |
(20,278) |
(44,017) |
|
|
|
|
|
Immatics N.V. and
subsidiariesCondensed Consolidated Statement of
Financial Position of Immatics N.V.
|
As of |
|
June 30,2024
|
December 31,2023
|
|
|
|
|
(Euros in thousands) |
Assets |
|
|
Current assets |
|
|
Cash and cash
equivalents |
158,143 |
218,472 |
Other financial
assets |
372,964 |
207,423 |
Accounts
receivables |
2,811 |
4,093 |
Other current
assets |
25,200 |
19,382 |
|
|
|
Total current assets |
559,118 |
449,370 |
Non-current assets |
|
|
Property, plant and
equipment |
50,289 |
43,747 |
Intangible
assets |
1,608 |
1,523 |
Right-of-use assets
|
14,616 |
13,308 |
Other non-current
assets |
1,336 |
2,017 |
|
|
|
Total non-current
assets |
67,849 |
60,595 |
|
|
|
Total assets |
626,967 |
509,965 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Provisions |
3,437 |
— |
Accounts
payables |
18,791 |
25,206 |
Deferred
revenue |
95,521 |
100,401 |
Liabilities for
warrants |
18,598 |
18,993 |
Lease
liabilities |
3,178 |
2,604 |
Other current
liabilities |
10,021 |
9,348 |
|
|
|
Total current liabilities |
149,546 |
156,552 |
Non-current liabilities |
|
|
Deferred
revenue |
75,298 |
115,527 |
Lease
liabilities |
14,235 |
12,798 |
Other non-current
liabilities |
— |
4 |
|
|
|
Total non-current liabilities |
89,533 |
128,329 |
Shareholders’ equity |
|
|
Share capital |
1,031 |
847 |
Share premium |
1,006,064 |
823,166 |
Accumulated
deficit |
(618,369) |
(597,293) |
Other reserves |
(838) |
(1,636) |
|
|
|
Total shareholders’ equity |
387,888 |
225,084 |
|
|
|
Total liabilities and shareholders’ equity |
626,967 |
509,965 |
|
|
|
Immatics N.V. and
subsidiariesCondensed Consolidated Statement of
Cash Flows of Immatics N.V.
|
|
|
|
Six months ended June 30,
|
|
2024 |
2023 |
|
|
|
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
Net loss |
(21,076) |
(44,357) |
Taxes on
income |
1,503 |
— |
Loss before
tax |
(19,573) |
(44,357) |
Adjustments for: |
|
|
Interest
income |
(12,660) |
(4,999) |
Depreciation and
amortization |
6,116 |
3,666 |
Interest
expenses |
420 |
401 |
Equity-settled share-based
payment |
8,605 |
11,615 |
Loss from disposal of fixed
assets |
1 |
|
Net foreign exchange differences and expected credit
losses |
(7,723) |
4,081 |
Change in fair value of liabilities for
warrants |
(395) |
5,708 |
Changes in: |
|
|
Decrease in accounts
receivables |
1,283 |
781 |
Decrease/(increase) in other
assets |
(1,246) |
765 |
(Decrease) in deferred revenue, accounts payables and other
liabilities |
(48,493) |
(9,889) |
Interest
received |
8,260 |
2,051 |
Interest paid |
(420) |
(146) |
Income tax
paid |
— |
— |
|
|
|
Net cash used in operating
activities |
(65,825) |
(30,323) |
|
|
|
Cash flows from investing activities |
|
|
Payments for property, plant and
equipment |
(11,797) |
(15,004) |
Payments for intangible
assets |
(148) |
(154) |
Payments for investments classified in other financial
assets |
(356,596) |
(170,326) |
Proceeds from maturity of investments classified in other financial
assets |
196,548 |
164,929 |
|
— |
— |
Net cash used in investing
activities |
(171,993) |
(20,555) |
|
|
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares to equity
holders |
174,476 |
38,608 |
Transaction costs deducted from
equity |
|
(1,157) |
Repayments related to lease
liabilities |
(397) |
(1,866) |
|
|
|
Net cash provided by financing
activities |
174,079 |
35,585 |
|
|
|
Net decrease in cash and cash
equivalents |
(63,739) |
(15,293) |
|
|
|
Cash and cash equivalents at beginning of the
year |
218,472 |
148,519 |
|
|
|
Effects of exchange rate changes and expected credit losses on cash
and cash
equivalents |
3,410 |
(2,821) |
|
|
|
Cash and cash equivalents at end of the
year |
158,143 |
130,405 |
|
|
|
Immatics N.V. and
subsidiariesCondensed Consolidated Statement of
Changes in Shareholders’ Equity of Immatics N.V.
(Euros in thousands)
|
Sharecapital
|
Sharepremium
|
Accumulateddeficit
|
Otherreserves
|
Totalshare-holders’equity
|
Balance as of January 1,
2023 |
767 |
714,177 |
(500,299) |
(1,481) |
213,164 |
Other comprehensive
income |
— |
— |
— |
340 |
340 |
Net loss |
— |
— |
(44,357) |
— |
(44,357) |
Comprehensive loss for the
year |
— |
— |
(44,357) |
340 |
(44,017) |
Equity-settled share-based
compensation |
— |
11,615 |
— |
— |
11,615 |
Share options
exercised |
— |
40 |
— |
— |
40 |
Issue of share capital – net of transaction
costs |
37 |
37,374 |
— |
— |
37,411 |
|
|
|
|
|
|
Balance as of June 30, 2023 |
804 |
763,206 |
(544,656) |
(1,141) |
218,213 |
|
|
|
|
|
|
Balance as of January 1,
2024 |
847 |
823,166 |
(597,293) |
(1,636) |
225,084 |
Other comprehensive
income |
— |
— |
— |
798 |
798 |
Net loss |
— |
— |
(21,076) |
— |
(21,076) |
Comprehensive loss for the
year |
— |
— |
(21,076) |
798 |
(20,278) |
Equity-settled share-based
compensation |
— |
8,605 |
— |
— |
8,605 |
Share options
exercised |
1 |
1,036 |
— |
— |
1,037 |
Issue of share capital – net of transaction
costs |
183 |
173,257 |
— |
— |
173,440 |
|
|
|
|
|
|
Balance as of June 30, 2024 |
1,031 |
1,006,064 |
(618,369) |
(838) |
387,888 |
|
|
|
|
|
|
1 All amounts translated using the exchange rate published by
the European Central Bank in effect as of June 30, 2024 (1 EUR =
1.0705 USD).
Immatics NV (NASDAQ:IMTX)
過去 株価チャート
から 12 2024 まで 1 2025
Immatics NV (NASDAQ:IMTX)
過去 株価チャート
から 1 2024 まで 1 2025