- ACTengine® IMA203: First patients treated at RP2D in Phase 1b
cohort A with IMA203 monotherapy as well as Phase 1b cohort B with
IMA203/checkpoint inhibitor combination. IND for Phase 1b cohort C
with 2nd-generation IMA203CD8 granted
- Phase 1 clinical trial initiated with the first T cell engaging
receptor TCER® IMA401 targeting MAGEA4/8 for patients with
recurrent and/or refractory solid tumors
- New multi-program collaboration with Bristol Myers Squibb to
develop allogeneic TCR-T/CAR-T programs; agreement includes $60
million upfront payment to Immatics and up to $700 million per
program in milestone payments as well as tiered royalties
- Bristol Myers Squibb and Immatics are also including an
additional target to their autologous TCR-T collaboration signed in
2019, Immatics to receive an upfront payment of $20 million and
eligibility for milestone payments and royalties
- Cash and cash equivalents as well as other financial assets of
$280.5 million1 (€252.7 million) as of March 31, 2022. With the
upfront payment from the new collaboration agreement with Bristol
Myers Squibb, cash reach into 2H 2024
Tuebingen, Germany and
Houston, Texas, June
2, 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 March
31, 2022.
Harpreet Singh, Ph.D., CEO and Co-Founder of
Immatics commented, “Immatics has continued to build positive
momentum in the first quarter of 2022. We have started treatment in
two of three Phase 1b cohorts advancing our IMA203 TCR-T studies
targeting PRAME. We have reached a key milestone by entering the
first-in-human trial with our first TCR Bispecifics candidate
directed against MAGEA4/A8 and have set the stage for further
advancing our TCER® pipeline. We have also further strengthened our
pipeline portfolio to address the needs of cancer patients by
joining forces with Bristol Myers Squibb to develop multiple
off-the-shelf TCR-T and/or CAR-T programs based on our allogeneic
gamma-delta cell therapy platform ACTallo®.”
First Quarter 2022 and Subsequent
Company Progress
Adoptive Cell Therapy
Programs
- ACTallo® and Autologous
TCR-T – Immatics entered into a strategic multi-program
collaboration with Bristol Myers Squibb to develop allogeneic
TCR-T/CAR-T programs combining Immatics’ proprietary gamma-delta T
cell-derived, allogeneic Adoptive Cell Therapy (ACT) platform
ACTallo®, with a suite of next-generation technologies developed by
Bristol Myers Squibb. Immatics will receive an upfront payment of
$60 million and is eligible for up to $700 million per Bristol
Myers Squibb program through development, regulatory and commercial
milestone payments and tiered royalty payments up to low
double-digit percentages on net sales. The new collaboration covers
development and commercialization of two programs for Bristol Myers
Squibb. Both companies have an option to develop up to four
additional programs each. In addition, Bristol Myers Squibb and
Immatics will expand their autologous T cell receptor-based therapy
(TCR-T) collaboration signed in 2019 by including one additional
TCR-T target discovered by Immatics. Immatics will receive a
payment of $20 million and eligibility for milestone payments as
well as tiered royalties.
- ACTengine® IMA203
(PRAME) – Update on Phase 1b expansion cohorts:
- Cohort A – IMA203 as monotherapy:
First patient treated at provisional Recommended Phase 2 Dose
(RP2D) in March
- Cohort B – IMA203 in combination
with an immune checkpoint inhibitor: First patient treated at RP2D
in May
- Cohort C – IMA203CD8, a 2nd
generation monotherapy where IMA203 is co-transduced with a CD8
co-receptor: IND granted by FDA, patient enrollment planned for Q2
2022
The next data read-out for the IMA203
monotherapy cohort is planned for 2H 2022. An initial data read-out
for the IMA203/immune checkpoint inhibitor combination therapy
cohort and the IMA203CD8 cohort is planned for YE2022.
- ACTengine® IMA201
(MAGEA4/A8) – Dose escalation is ongoing, target dose
level to commence.
- ACTengine®
IMA202 (MAGEA1) – A preliminary interim analysis
from 16 patients treated in the dose escalation cohort demonstrated
a favorable tolerability profile for IMA202. Signs of clinical and
biological activity were observed, but were not reaching the
threshold of objective responses as per RECIST1.1.
Treatment-emergent adverse events for IMA202 were transient and
manageable. No dose-limiting toxicities or signs of auto-immune
toxicities were observed. 11 out of 16 patients (69%) showed
disease control and 5 out of 16 patients (31%) showed tumor
shrinkage. Maximum change of target lesion was minus 35%. Following
final evaluation, Immatics plans to present the full data set at a
later timepoint. Immatics management has decided not to further
progress the IMA202 program into Phase 1b dose expansion and is
evaluating development options and partnering opportunities for the
program and the target MAGEA1.
TCR Bispecifics Programs
- TCER® IMA401 (MAGEA4/8) – Immatics initiated a
Phase 1 clinical trial with its T cell engaging receptor (TCER®)
IMA401 for patients with recurrent and/or refractory solid tumors.
IMA401 is the most advanced TCER® candidate and targets an
HLA-A*02-presented peptide derived from both MAGEA4 and/or MAGEA8.
TCER® IMA401 is being developed in collaboration with Bristol Myers
Squibb. Immatics is responsible for conducting the Phase 1 clinical
trial with approximately 50 patients at up to 15 centers in
Germany.
- TCER® IMA402 (PRAME) – Manufacturing of the
clinical batch is on track for the 2H 2022 and initiation of the
Phase 1 trial is planned in 2023.
Corporate
Developments
Board of Directors Update
- Nancy Valente, M.D., was appointed
to Immatics’ Board of Directors in March 2022 and will be nominated
for election at Immatics’ Annual General Meeting in June 2022. She
brings over 20 years of experience in oncology and hematology drug
development. Additional information on all members of Immatics’
Board of Directors can be found on the Immatics website.
First Quarter 2022
Financial Results
Cash Position: Cash and cash equivalents as well
as other financial assets total €252.7 million ($280.5 million1) as
of March 31, 2022 compared to €145.1 million ($161.1 million1) as
of December 31, 2021. The increase is mainly due to the receipt of
the upfront payment in connection with the collaboration agreement
with Bristol Myers Squibb on IMA401, partly offset by the financing
of our ongoing research and development activities. This does not
include $60 million cash to be received from the collaboration
agreement signed with Bristol Myers Squibb in May 2022 or the $20
million cash to be received as a result of Bristol Myers Squibb’s
decision to add one additional autologous TCR-T target as part of a
2019 collaboration agreement. 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 €102.9 million ($114.2 million1)
for the three months ended March 31, 2022, compared to €7.4 million
($8.2 million1) for the three months ended March 31, 2021. The
increase is mainly related to the recognition of revenue for the
license portion of the collaboration agreement with Bristol Myers
Squibb on IMA401.
Research and Development Expenses: R&D
expenses were €25.1 million ($27.9 million1) for the three months
ended March 31, 2022, compared to €23.0 million ($25.5 million1)
for the three months ended March 31, 2021.
General and Administrative Expenses: G&A
expenses were €9.3 million ($10.3 million1) for the three months
ended March 31, 2022, compared to €8.4 million ($9.3 million1) for
the three months ended March 31, 2021.
Net Income/Loss: Net income was €85.7 million
($95.1 million1) for the three months ended March 31, 2022,
compared to a net loss of €22.8 million ($25.3 million1) for the
three months ended March 31, 2021. The increase mainly resulted
from a one-time revenue in connection with the partial recognition
of the upfront payment from the collaboration with Bristol Myers
Squibb on IMA401.
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 March 31,
2022 (1 EUR = 1.1101 USD).
Upcoming Investor Conferences
- Jefferies Global Healthcare
Conference (in-person) New York, NY – June 8-10, 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 |
|
March 31,2022 |
December 31,2021 |
|
|
|
|
(Euros in thousands) |
Assets |
|
|
Current assets |
|
|
Cash and cash
equivalents |
247,316 |
132,994 |
Other financial
assets |
5,428 |
12,123 |
Accounts
receivable |
742 |
682 |
Other current
assets |
6,432 |
6,408 |
|
|
|
Total current
assets |
259,918 |
152,207 |
Non-current assets |
|
|
Property, plant and
equipment |
10,801 |
10,506 |
Intangible
assets |
1,287 |
1,315 |
Right-of-use assets
|
9,297 |
9,982 |
Other non-current
assets |
879 |
636 |
|
|
|
Total non-current
assets |
22,264 |
22,439 |
|
|
|
Total
assets |
282,182 |
174,646 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Provisions |
1,405 |
51 |
Accounts
payable |
13,304 |
11,624 |
Deferred
revenue |
61,444 |
50,402 |
Other financial
liabilities |
11,331 |
27,859 |
Lease
liabilities |
2,770 |
2,711 |
Other current
liabilities |
1,600 |
2,501 |
|
|
|
Total current
liabilities |
91,854 |
95,148 |
Non-current liabilities |
|
|
Deferred
revenue |
67,787 |
48,225 |
Lease
liabilities |
6,491 |
7,142 |
Other non-current
liabilities |
63 |
68 |
|
|
|
Total non-current
liabilities |
74,341 |
55,435 |
Shareholders’ equity |
|
|
Share capital |
629 |
629 |
Share premium |
570,894 |
565,192 |
Accumulated
deficit |
(452,151) |
(537,813) |
Other reserves |
(3,385) |
(3,945) |
|
|
|
Total shareholders’
equity |
115,987 |
24,063 |
|
|
|
Total liabilities and shareholders’
equity |
282,182 |
174,646 |
Unaudited Condensed Consolidated Statement of
Income/(Loss) of Immatics N.V.
|
|
|
|
|
Three months ended March 31, |
|
|
2022 |
2021 |
|
|
(Euros in thousands, except share and
pershare data) |
|
|
|
|
|
Revenue from collaboration
agreements |
102,907 |
7,403 |
|
Research and development
expenses |
(25,144) |
(23,049) |
|
General and administrative
expenses |
(9,278) |
(8,431) |
|
Other income |
7 |
239 |
|
|
|
|
|
Operating
result |
68,492 |
(23,838) |
|
Financial
income |
1,759 |
3,464 |
|
Financial
expenses |
(1,117) |
(1,224) |
|
Change in fair value of warrant
liabilities |
16,528 |
(1,215) |
|
|
|
|
|
Financial
result |
17,170 |
1,025 |
|
|
|
|
|
Income/(loss) before
taxes |
85,662 |
(22,813) |
|
Taxes on
income |
— |
— |
|
|
|
|
|
|
|
|
|
|
Net
income/(loss) |
85,662 |
(22,813) |
|
|
|
|
|
Net income/(loss) per
share: |
|
|
|
Basic |
1.36 |
(0.36) |
|
Diluted |
1.35 |
(0.36) |
|
Weighted average shares
outstanding: |
|
|
|
Basic |
62,927,205 |
62,908,791 |
|
Diluted |
63,402,023 |
62,908,791 |
|
Unaudited Condensed Consolidated Statement of
Comprehensive Income/(Loss) of Immatics N.V.
|
Three months ended March 31,
|
|
2022 |
2021 |
|
|
|
|
(Euros in thousands) |
Net
income/(loss) |
85,662 |
(22,813) |
Other comprehensive income/(loss) |
|
|
Items that may be reclassified subsequently to profit or loss, net
of tax |
|
|
Currency translation differences from foreign
operations |
560 |
2,725 |
|
|
|
Total comprehensive income/(loss) for the
period |
86,222 |
(20,088) |
|
|
|
Unaudited Condensed Consolidated Statement of Cash Flows
of Immatics N.V.
|
Three months ended March 31,
|
|
2022 |
2021 |
|
|
|
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
Income/(loss) before
taxation |
85,662 |
(22,813) |
Adjustments for: |
|
|
Interest
income |
(6) |
(49) |
Depreciation and
amortization |
1,636 |
1,094 |
Interest
expense |
162 |
70 |
Equity settled share-based
payment |
5,702 |
8,304 |
Net foreign exchange
differences |
126 |
318 |
Change in fair value of warrant
liabilities |
(16,528) |
1,215 |
Changes in: |
|
|
(Increase)/decrease in accounts
receivable |
(61) |
676 |
(Increase)/decrease in other
assets |
(235) |
1,207 |
Increase/(decrease) in accounts payable and other current
liabilities |
32,800 |
(6,645) |
Interest
received |
6 |
36 |
Interest paid |
(162) |
(70) |
|
|
|
Net cash (used in)/provided by operating
activities |
109,102 |
(16,657) |
|
|
|
Cash flows from investing activities |
|
|
Payments for property, plant and
equipment |
(1,156) |
(565) |
Cash paid for investments classified in Other financial
assets |
— |
— |
Cash received from maturity of investments classified in Other
financial
assets |
6,993 |
3,126 |
Payments for intangible
assets |
(2) |
(6) |
Proceeds from disposal of property, plant and
equipment |
1 |
4 |
|
|
|
Net cash (used in)/provided by investing
activities |
5,836 |
2,559 |
|
|
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares to equity holders of the
parent |
— |
— |
Payments for
leases |
(689) |
(482) |
|
|
|
Net cash (used in)/provided by financing
activities |
(689) |
(482) |
|
|
|
Net increase/(decrease) in cash and cash
equivalents |
114,249 |
(14,580) |
|
|
|
Cash and cash equivalents at beginning of
period |
132,994 |
207,530 |
|
|
|
Effects of exchange rate changes on cash and cash
equivalents |
73 |
2,383 |
|
|
|
Cash and cash equivalents at end of
period |
247,316 |
195,333 |
|
|
|
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 |
— |
— |
— |
2,725 |
2,725 |
Net loss |
— |
— |
(22,813) |
— |
(22,813) |
Comprehensive income/(loss) for the
year |
— |
— |
(22,813) |
2,725 |
(20,088) |
Equity-settled share-based
compensation |
— |
8,304 |
— |
— |
8,304 |
|
|
|
|
|
|
Balance as of March 31,
2021 |
629 |
546,999 |
(467,291) |
(4,734) |
75,603 |
|
|
|
|
|
|
Balance as of January 1,
2022 |
629 |
565,192 |
(537,813) |
(3,945) |
24,063 |
Other comprehensive
income |
— |
— |
— |
560 |
560 |
Net loss |
— |
— |
85,662 |
— |
85,662 |
Comprehensive income/(loss) for the
year |
— |
— |
85,662 |
560 |
86,222 |
Equity-settled share-based
compensation |
— |
5,702 |
— |
— |
5,702 |
Share options
exercised |
— |
— |
— |
— |
— |
|
|
|
|
|
|
Balance as of March 31,
2022 |
629 |
570,894 |
(452,151) |
(3,385) |
115,987 |
|
|
|
|
|
|
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