- ACTengine® TCR-T cell
therapy targeting PRAME
is enrolling patients in
all three Phase
1b cohorts:
IMA203 monotherapy at provisional
recommended Phase 2 dose (RP2D) (Cohort
A),
IMA203/nivolumab
checkpoint inhibitor combination (Cohort
B) and IMA203CD8
2nd
generation
monotherapy (Cohort C)
- TCR Bispecific candidate
TCER® IMA401 targeting
MAGEA4/A8 Phase
1a clinical trial
initiated in patients with recurrent
and/or refractory solid tumors
- New multi-program
collaboration initiated with
Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T
programs using Immatics’
proprietary ACTallo® platform; Immatics
received $60 million upfront payment and
is eligible for
up to $700 million per program in milestone payments as
well as tiered royalties
-
Autologous TCR-T
collaboration with Bristol Myers
Squibb from 2019 expanded to
include one additional target;
Immatics received $20 million
upfront payment and is eligible for milestone
payments and royalties
-
CRISPR-based gene editing:
Strategic research collaboration and
licensing agreement with Editas
Medicine, Inc.
signed
- Cash and
cash equivalents as well as other
financial assets of
$337.0
million1
(€324.4 million) as
of June 30,
2022, funding company operations
into second half of
2024
Tuebingen,
Germany and Houston,
Texas, August
9, 2022 –
Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage
biopharmaceutical company active in the discovery and development
of T cell-redirecting cancer immunotherapies, today reported
financial results and provided a business update for the quarter
ended June 30, 2022.
“Immatics has now initiated all three IMA203
TCR-T Phase 1b expansion cohorts with the objective to deliver
durable objective responses in heavily pre-treated solid cancer
patients. Our IMA203 TCR-T therapy as well as IMA402, our TCR
Bispecific, both target a PRAME peptide which represents one of the
most promising and prevalent targets in the solid cancer space,”
commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.
“We are also very excited to have recently announced two new
agreements with Bristol Myers Squibb and Editas Medicine that
strengthen our capabilities in the field of allogeneic gamma delta
T cell therapies. By combining our strengths through such
partnerships, we can accelerate the development of our pipeline and
increase its potential to deliver a meaningful impact on the lives
of cancer patients.”
Second Quarter 2022 and
Subsequent Company Progress
Adoptive Cell Therapy
Programs
- ACTengine® IMA203
(PRAME) – Following interim results from the IMA203
monotherapy during Phase 1a dose escalation, Immatics has extended
the clinical trial to three Phase 1b expansion cohorts to realize a
high rate of durable responses with TCR-T against PRAME.
- Cohort A – IMA203 as monotherapy at
the provisional recommended Phase 2 dose (RP2D) plus exploration of
a higher dose level (dose level 5, DL5; up to 4.7 billion
transduced CD8 T cells per m² body surface area)
- Cohort B – IMA203 in combination
with the PD-1 immune checkpoint inhibitor Opdivo® (nivolumab)
- Cohort C – IMA203CD8, a 2nd
generation monotherapy where IMA203 is co-expressed with a CD8
co-receptor to leverage functional CD4 T cells in addition to CD8 T
cells in the anti-tumor response
As per the respective announcements made in
March and May, the first patients have been treated in Cohort A and
Cohort B, with the first patient expected to be treated in Cohort C
in August, 2022. The next data readout for the IMA203 monotherapy
cohort at RP2D is expected for 2H 2022 and an initial data readout
for Cohort B and Cohort C is planned for YE2022.
- ACTallo® – On June
2nd, 2022, Immatics announced a multi-program collaboration with
Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs.
Immatics received an upfront payment of $60 million and is eligible
for up to $700 million per Bristol Myers Squibb program through
milestone payments and tiered royalties. Under the collaboration
agreement, Bristol Myers Squibb receives access to Immatics’
proprietary gamma delta T cell-derived allogeneic Adoptive Cell
Therapy (ACT) platform, ACTallo®, and can bring in up to 4 TCR-T
targets based on the 2019 collaboration agreement or CAR-T targets.
Immatics receives access to Bristol Myers Squibb’s next-generation
technologies. The companies will work together to develop and
commercialize two of Bristol Myers Squibb’s allogeneic TCR-T/CAR-T
programs. Under the terms of the collaboration, both companies have
an option to develop up to four additional programs each. Immatics
may also develop additional allogeneic programs based on its
ACTallo® platform outside of the collaboration.
- ACTallo® –
Immatics entered a strategic research collaboration and licensing
agreement with Editas Medicine, Inc., combining gamma delta T cell
adoptive cell therapies and gene editing to develop medicines for
the treatment of cancer. As part of the agreement, Immatics gains
non-exclusive rights to Editas Medicine’s CRISPR technology and
intellectual property.
- Autologous TCR-T –
Immatics and Bristol Myers Squibb expanded their autologous T cell
receptor-based therapy (TCR-T) collaboration signed in 2019 by
including one additional TCR-T target discovered by Immatics.
Immatics received a payment of $20 million and is eligible for
milestone payments as well as royalties.
- ACTengine® IMA201
(MAGEA4/A8) – The Phase 1a dose escalation cohort is
ongoing and is expected to be completed by YE2022.
TCR Bispecifics Programs
Immatics’ TCER® candidates are next-generation,
half-life extended TCR Bispecific molecules designed to maximize
efficacy while minimizing toxicities in patients through its
proprietary format using a low-affinity T cell recruiter and a
high-affinity TCR domain.
- TCER® IMA401
(MAGEA4/8) – On May 10, 2022, Immatics announced the
initiation of its Phase 1 trial evaluating the company’s most
advanced T cell engaging receptor (TCER®) IMA401 in patients with
recurrent and/or refractory solid tumors. The Phase 1 clinical
trial is expected to include approximately 50 patients at up to 15
centers in Germany. IMA401 is developed in collaboration with
Bristol Myers Squibb.
- TCER® IMA402
(PRAME) – A preclinical data update will be presented at
the European Society for Medical Oncology (ESMO) Annual Meeting
(September 9-13, 2022). Manufacturing of the clinical batch is on
track for 2H 2022 and initiation of the Phase 1 trial is planned in
2023.
Corporate
Developments
Board of Directors Update
- At Immatics’ Annual General Meeting
in June 2022, Nancy Valente, M.D., was elected as a member of the
company’s Board of Directors. Dr. Valente brings over 20 years of
experience in oncology and hematology drug development. In her last
position at Genentech/Roche, she was Senior Vice President,
Oncology Product Development, where she helped to build a diverse
portfolio of new oncology therapies encompassing small molecules,
antibodies, bispecific antibodies and antibody drug conjugates.
Additional information on all members of Immatics’ Board of
Directors can be found on the Immatics website.
Second Quarter 2022
Financial Results
Cash Position: Cash and cash equivalents as well
as other financial assets total €324.4 million ($337.0 million1) as
of June 30, 2022, compared to €252.7 million ($262.5 million1) as
of March 31, 2022. The increase is mainly due to the receipt of the
upfront payment in connection with the collaboration agreement with
Bristol Myers Squibb on allogeneic ACT as well as the addition of
one additional autologous TCR-T target as part of a 2019
collaboration agreement, partly offset by the financing of our
ongoing research and development activities. With the addition of
these upfront payments, the Company projects a cash runway into 2H
2024.
Revenue: Total revenue, consisting of revenue
from collaboration agreements, was €17.2 million ($17.9 million1)
for the three months ended June 30, 2022, compared to €5.2 million
($5.4 million1) for the three months ended June 30, 2021. The
increase is mainly related to the increased recognition of revenue
for the multiple collaboration agreements Immatics has in
place.
Research and Development Expenses: R&D
expenses were €25.2 million ($26.2 million1) for the three months
ended June 30, 2022, compared to €20.3 million ($21.1 million1) for
the three months ended June 30, 2021. The increase is mainly
related to increased spending on clinical trials.
General and Administrative Expenses: G&A
expenses were €8.7 million ($9.0 million1) for the three months
ended June 30, 2022, compared to €8.3 million ($8.6 million1) for
the three months ended June 30, 2021.
Net Income/Loss: Net loss was €14.0 million
($14.5 million1) for the three months ended June 30, 2022, compared
to a net loss of €26.5 million ($27.5 million1) for the three
months ended June 30, 2021. The decrease was primarily the result
of the increased revenue from multiple collaboration
agreements.
Full financial statements can be found in the
current report on Form 6-K filed with the Securities and Exchange
Commission (SEC) and published on the SEC website under
www.sec.gov.
1 All amounts translated using the exchange rate
published by the European Central Bank in effect as of June 30,
2022 (1 EUR = 1.0387 USD).
Upcoming Investor Conferences
- Jefferies Cell and Genetic Medicine
Summit, New York – September 29-30, 2022
- Jefferies London Healthcare
Conference, London, U.K. – November 15-17, 2022
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.
For regular updates about Immatics, visit www.immatics.com. You
can also follow us on Instagram, Twitter and LinkedIn.
Forward-Looking
Statements:Certain statements in this press release may be
considered forward-looking statements. Forward-looking statements
generally relate to future events or Immatics’ future financial or
operating performance. For example, statements concerning the
timing of product candidates and Immatics’ focus on partnerships to
advance its strategy are forward-looking statements. In some cases,
you can identify forward-looking statements by terminology such as
“may”, “should”, “expect”, “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 filings with the SEC. Nothing in this presentation 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. Immatics 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 and Investor Relations Contact |
Jacob Verghese or Eva Mulder |
Trophic Communications |
Phone: +49 89 2070 89831 or +31 6 52 33 1579 |
immatics@trophic.eu |
Immatics N.V. |
|
Anja Heuer |
Jordan Silverstein |
Director, Corporate Communications |
Head of Strategy |
Phone: +49 89 540415-606 |
Phone: +1 281 810 7545 |
media@immatics.com |
InvestorRelations@immatics.com |
Unaudited Condensed Consolidated Statement of Financial
Position of Immatics N.V.
|
|
|
|
As of |
|
June 30,2022 |
December 31,2021 |
|
|
|
|
(Euros in thousands) |
Assets |
|
|
Current assets |
|
|
Cash and cash
equivalents |
265,125 |
132,994 |
Other financial
assets |
59,253 |
12,123 |
Accounts
receivable |
961 |
682 |
Other current
assets |
10,686 |
6,408 |
|
|
|
Total current
assets |
336,025 |
152,207 |
Non-current assets |
|
|
Property, plant and
equipment |
11,271 |
10,506 |
Intangible
assets |
1,309 |
1,315 |
Right-of-use assets
|
15,016 |
9,982 |
Other non-current
assets |
4,678 |
636 |
|
|
|
Total non-current
assets |
32,274 |
22,439 |
|
|
|
Total
assets |
368,299 |
174,646 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Provisions |
2,858 |
51 |
Accounts
payable |
13,284 |
11,624 |
Deferred
revenue |
78,394 |
50,402 |
Other financial
liabilities |
14,116 |
27,859 |
Lease
liabilities |
2,429 |
2,711 |
Other current
liabilities |
2,913 |
2,501 |
|
|
|
Total current
liabilities |
113,994 |
95,148 |
Non-current liabilities |
|
|
Deferred
revenue |
115,321 |
48,225 |
Lease
liabilities |
13,984 |
7,142 |
Other non-current
liabilities |
59 |
68 |
|
|
|
Total non-current
liabilities |
129,364 |
55,435 |
Shareholders’ equity |
|
|
Share capital |
653 |
629 |
Share premium |
593,026 |
565,192 |
Accumulated
deficit |
(466,131) |
(537,813) |
Other reserves |
(2,607) |
(3,945) |
|
|
|
Total shareholders’
equity |
124,941 |
24,063 |
|
|
|
Total liabilities and shareholders’
equity |
368,299 |
174,646 |
|
|
|
Unaudited Condensed Consolidated Statement of
Income/(Loss) of Immatics N.V.
|
|
|
|
|
|
Three months ended June 30,
|
Six months ended June 30, |
|
2022 |
2021 |
2022 |
2021 |
|
(Euros in thousands, exceptshare and per
share data) |
(Euros in thousands, exceptshare
and per share data) |
Revenue from collaboration
agreements |
17,215 |
5,189 |
120,123 |
12,592 |
Research and development
expenses |
(25,216) |
(20,340) |
(50,360) |
(43,389) |
General and administrative
expenses |
(8,683) |
(8,271) |
(17,961) |
(16,702) |
Other income |
27 |
26 |
32 |
265 |
|
|
|
|
|
Operating
result |
(16,657) |
(23,396) |
51,834 |
(47,234) |
Financial
income |
7,015 |
213 |
8,774 |
3,101 |
Financial
expenses |
(407) |
(629) |
(1,524) |
(1,277) |
Change in fair value of warrant
liabilities |
(2,786) |
(2,722) |
13,743 |
(3,936) |
|
|
|
|
|
Financial
result |
3,822 |
(3,138) |
20,993 |
(2,112) |
|
|
|
|
|
Profit/(loss) before
taxes |
(12,835) |
(26,534) |
72,827 |
(49,346) |
Taxes on
income |
(1,145) |
— |
(1,145) |
— |
Net
profit/(loss) |
(13,980) |
(26,534) |
71,682 |
(49,346) |
|
|
|
|
|
Net profit/(loss) per
share: |
|
|
|
|
Basic |
(0.22) |
(0.42) |
1.12 |
(0.78) |
Diluted |
(0.22) |
(0.42) |
1.11 |
(0.78) |
Weighted average shares
outstanding: |
|
|
|
|
Basic |
64,915,600 |
62,909,095 |
63,932,449 |
62,908,945 |
Diluted |
64,915,600 |
62,909,095 |
64,477,256 |
62,908,945 |
Unaudited Condensed Consolidated Statement of
Comprehensive Income/(Loss) of Immatics N.V.
|
Three months ended June 30,
|
Six months ended June 30,
|
|
2022 |
2021 |
2022 |
2021 |
|
(Euros in thousands) |
(Euros in thousands) |
Net
profit/(loss) |
(13,980) |
(26,534) |
71,682 |
(49,346) |
Other comprehensive income/(loss) |
|
|
|
|
Items that may be reclassified subsequently to profit or loss, net
of tax |
|
|
|
|
Currency translation differences from foreign
operations |
778 |
(1,401) |
1,338 |
1,324 |
|
|
|
|
|
Total comprehensive income/(loss) for the
period |
(13,202) |
(27,935) |
73,020 |
(48,022) |
|
|
|
|
|
Unaudited Condensed Consolidated Statement of Cash Flows
of Immatics N.V.
|
|
|
|
Six months ended June 30, |
|
2022 |
2021 |
|
|
|
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
Net
profit/(loss) |
71,682 |
(49,346) |
Adjustments for: |
|
|
Interest
income |
(23) |
(87) |
Depreciation and
amortization |
3,407 |
2,264 |
Interest
expense |
538 |
140 |
Equity settled share-based
payment |
11,262 |
16,270 |
Net foreign exchange
differences |
115 |
236 |
Change in fair value of warrant
liabilities |
(13,743) |
3,936 |
Changes in: |
|
|
(Increase)/decrease in accounts
receivable |
(280) |
532 |
(Increase)/decrease in other
assets |
(6,903) |
902 |
Increase/(decrease) in accounts payable and other
liabilities |
98,078 |
(11,363) |
Interest
received |
23 |
54 |
Interest paid |
(434) |
(140) |
|
|
|
Net cash provided
by/(used in) operating
activities |
163,722 |
(36,602) |
|
|
|
Cash flows from investing activities |
|
|
Payments for property, plant and
equipment |
(1,965) |
(1,912) |
Cash paid for investments classified in Other financial
assets |
(59,253) |
(11,423) |
Cash received from maturity of investments classified in Other
financial
assets |
12,695 |
3,411 |
Payments for intangible
assets |
(6) |
(390) |
Proceeds from disposal of property, plant and
equipment |
1 |
8 |
|
|
|
Net cash (used in)/provided by investing
activities |
(48,528) |
(10,306) |
|
|
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares to equity
holders |
17,112 |
— |
Transaction costs deducted from
equity |
(515) |
— |
Payments for
leases |
(1,394) |
(1,348) |
|
|
|
Net cash provided
by/(used in)
financing
activities |
15,203 |
(1,348) |
|
|
|
Net increase/(decrease) in cash and cash
equivalents |
130,397 |
(48,256) |
|
|
|
Cash and cash equivalents at beginning of
period |
132,994 |
207,530 |
|
|
|
Effects of exchange rate changes on cash and cash
equivalents |
1,734 |
819 |
|
|
|
Cash and cash equivalents at end of
period |
265,125 |
160,093 |
|
|
|
Unaudited Condensed 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,
2021 |
629 |
538,695 |
(444,478) |
(7,459) |
87,387 |
|
Other comprehensive
income |
— |
— |
— |
1,324 |
1,324 |
|
Net loss |
— |
— |
(49,346) |
— |
(49,346) |
|
Comprehensive income/(loss) for the
year |
— |
— |
(49,346) |
1,324 |
(48,022) |
|
Equity-settled share-based
compensation |
— |
16,270 |
— |
— |
16,270 |
|
|
|
|
|
|
|
|
Balance as of June 30,
2021 |
629 |
554,965 |
(493,824) |
(6,135) |
55,635 |
|
|
|
|
|
|
|
|
Balance as of January 1,
2022 |
629 |
565,192 |
(537,813) |
(3,945) |
24,063 |
|
Other comprehensive
income |
— |
— |
— |
1,338 |
1,338 |
|
Net profit |
— |
— |
71,682 |
— |
71,682 |
|
Comprehensive income for the
year |
— |
— |
71,682 |
1,338 |
73,020 |
|
Equity-settled share-based
compensation |
— |
11,262 |
— |
— |
11,262 |
|
Share options
exercised |
— |
1 |
— |
— |
1 |
|
Issue of share capital – net of transaction costs |
24 |
16,571 |
— |
— |
16,595 |
|
|
|
|
|
|
|
|
Balance as of June 30,
2022 |
653 |
593,026 |
(466,131) |
(2,607) |
124,941 |
|
|
|
|
|
|
|
|
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