-
ACTengine® IMA200 clinical trial series continues scaling
globally; initial analysis for patients in ACTengine® dose
escalation is on track for Q1 2021
- Expansion of UTHealth partnership secures cell therapy
manufacturing capacities until end of 2024
- Positive pre-clinical data updates on ACTengine® IMA204
and first TCR Bispecifics (TCER™) program IMA401
- Strengthened leadership team with appointment of Arnd
Christ as Chief Financial Officer and addition of Eliot Forster to
Immatics’ Board of Directors
- Cash and cash equivalents as well as other financial
assets of €259.3 million ($303.6 million1) as of September 30, 2020
provide cash reach into 2023
Tuebingen, Germany and Houston, TX,
December 2, 2020 – 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 September 30, 2020.
“The third quarter was highlighted by meaningful
progress in our ACTengine® IMA200 clinical trial series. Seven
clinical sites in Germany and the US are now initiated and
screening patients. These advancements mark critical steps towards
delivering our clinical milestones for the coming year including
reporting on initial data for ACTengine® patients in dose
escalation in Q1,” said Harpreet Singh, Ph.D., CEO of Immatics. “In
conjunction with our clinical and operational progress, we are
pleased to further strengthen the Company’s capabilities with the
appointments of both Eliot Forster to the Board and Arnd Christ as
Chief Financial Officer.”
Third Quarter 2020 and Subsequent
Company Progress
Adoptive Cell Therapy Programs
- ACTengine® IMA200 Series – Immatics continued to select and
initiate additional clinical trial sites in Germany and the US. The
increased patient enrollment seen at sites in Germany was able to
mitigate the impact of the global COVID-19 pandemic at US sites.
These patients are expected to be treated within the fourth quarter
this year, moving Immatics towards delivering the clinical
milestones for ACTengine® in the coming year. Combined initial data
readout for ACTengine® programs, IMA201, IMA202 and IMA203,
continues to be expected in Q1 2021. Reported initial data will
focus on safety and pharmacodynamic data including engraftment
level, persistence and molecular phenotype of infused T cells as
well as clinical change of target tumor lesions.
- ACTengine® IMA204 – Immatics presented preclinical data from
the ACTengine® cell therapy program targeting the tumor
microenvironment on September 10. IMA204 is directed at a novel
target, COL6A3 exon 6, which is highly expressed in the tumor
stroma of a variety of solid cancers. An affinity-enhanced TCR
candidate directed to this target demonstrated full functionality
in CD8+ and CD4+ T cells indicating that this TCR could be employed
in a next-generation ACTengine® approach without the need of CD8
co-receptor transduction. Submission of an Investigational New Drug
(IND) application to the US Food and Drug Administration (FDA) for
IMA204 remains anticipated for 2021.
- ACTolog® IMA101 – On November 10, Immatics presented topline
data from its clinical pilot trial IMA101, a personalized
multi-target ACT approach using the patient’s own, non-engineered T
cells. The trial demonstrated feasibility and tolerability of this
approach as well as very high persistence of endogenous T cells
directed against defined pHLA targets. Clinical course observations
in patients treated with T cells directed at the tumor stroma
target COL6A3 exon 6 warrant further exploration of this target
within ACTengine®. The results also support further development of
a multi-target approach using multiple engineered TCRs
simultaneously in ACTengine®.
TCR
Bispecifics Programs
- IMA401 – A preclinical data update from Immatics’ first TCR
Bispecifics (TCER™) program on October 29, delivered pre-clinical
proof-of-concept for IMA401 demonstrating complete remission of
transplanted human tumors in mice as well as favorable CMC
characteristics. The IMA401 cancer target, an HLA-A*02-bound
peptide derived from both MAGEA4 and MAGEA8, showed more than
5-fold higher target copy numbers per tumor cell than a commonly
used target peptide derived from MAGEA4. Submission of the IMA401
IND/IMPD application remains expected by the end of 2021.
Corporate Development
Management and Board of Directors Updates
- Eliot Forster, Ph.D., joined Immatics’ Board of Directors as a
new member in September 2020. He brings to Immatics extensive
experience, including leadership of trailblazing biopharmaceutical
companies in the field of immuno-oncology as well as other
therapeutic areas.
- In October 2020, Arnd Christ joined Immatics’ leadership team
as Chief Financial Officer (CFO). He was previously the CFO of
Nasdaq-listed InflaRx and brings nearly two decades of experience
serving as the CFO of both private and public biotechnology
companies.
Collaborations and Strategic Alliances
- On August 6, Immatics announced the extension of its strategic
alliance with UTHealth. The continued collaboration will provide
Immatics exclusive access to three cGMP suites enabling
manufacturing and supply of its ACT products for current and
upcoming Phase 1 clinical trials in the US and Europe for an
additional four years until end of 2024.
Third Quarter 2020 Financial
Results
Cash Position: Cash and cash equivalents as well
as other financial assets sum up to €259.3 million ($303.6
million1) as of September 30, 2020 compared to €86.1 million
($100.8 million1) as of June 30. The increase is mainly due to the
business combination with ARYA Sciences Acquisition Corporation
completed in July 2020 (ARYA merger) and the concurrent PIPE
Financing.
Revenue: Total revenue, consisting of revenue
from collaboration agreements, was €7.8 million ($9.1 million1) for
the three months ended September 30, 2020, compared to €5.1 million
($6.0 million1) for the three months ended September 30, 2019.
Research and Development Expenses: R&D
expenses were €17.5 million ($20.5 million1) for the three months
ended September 30, 2020, compared to €10.2 million ($11.9
million1) for the three months ended September 30, 2019. The
increase is mainly due to increased share-based compensation (€4.6
million; $5.4 million1).
General and Administrative Expenses: G&A
expenses were €9.2 million ($10.8 million1) for the three months
ended September 30, 2020, compared to €2.7 million ($3.2 million1)
for the three months ended September 30, 2019. The increase is
mainly due to increased share-based compensation (€3.6 million;
$4.2 million1) as well as one-time transaction costs of the NASDAQ
listing in connection with the ARYA merger in July.
Net Loss: Net loss was €177.1 million ($207.3
million1) for the three months ended September 30, 2020, compared
to €5.0 million ($5.9 million1) for the three months ended
September 30, 2019 of which €152.8 million ($178.9 million1)
resulted from a one-time, non-cash expense in connection with the
ARYA merger. The main part of this €152.8 million ($178.9 million1)
non-cash expense resulted from the share price increase between
signing and closing of the ARYA merger. For detailed information,
please refer to Note 9 of the Notes to the Financial
Statements.
Upcoming Investor Conferences
- Piper Sandler Healthcare Conference – December 1-3, 2020
- 10th Annual SVB Leerink Global Healthcare Conference – February
24-26, 2021
To see the full list of events and
presentations, visit
www.investors.immatics.com/events-presentations.
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
https://www.sec.gov/.
1 All amounts translated using the exchange rate
published by the European Central Bank in effect as of September
30, 2020 (1 EUR = 1.1708 USD).
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 Twitter
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 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.
For more information, please
contact:
For Media Inquiries |
Investor
Relations Contact |
Jacob Verghese or Stephanie May |
John
Graziano |
Trophic Communications |
Solebury
Trout |
Phone: +49 89 2388 7731 |
Phone: +1 646 378
2942 |
immatics@trophic.eu |
jgraziano@soleburytrout.com |
Immatics N.V. |
|
Anja Heuer |
Jordan Silverstein |
Corporate Communications |
Head of Strategy |
Phone: +49 89 540415-606 |
Phone: +1 281 810
7545 |
media@immatics.com |
InvestorRelations@immatics.com |
Immatics N.V. and subsidiariesUnaudited
Condensed Consolidated Statement of Financial Position of Immatics
N.V.
|
|
|
As of |
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
(Euros in thousands) |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
|
|
233,676 |
|
103,353 |
Other financial assets |
|
|
25,624 |
|
16,023 |
Accounts receivable |
|
|
1,049 |
|
957 |
Other current assets |
|
|
6,518 |
|
3,667 |
Total current assets |
|
|
266,867 |
|
124,000 |
Non-current assets |
|
|
|
|
|
Property, plant and equipment |
|
|
7,753 |
|
4,720 |
Intangible assets |
|
|
969 |
|
1,008 |
Right-of-use assets |
|
|
6,814 |
|
3,287 |
Other non-current assets |
|
|
632 |
|
1,262 |
Total non-current assets |
|
|
16,168 |
|
10,277 |
Total assets |
|
|
283,035 |
|
134,277 |
Liabilities and shareholders' deficit |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Provisions |
|
|
2,038 |
|
50 |
Accounts payable |
|
|
9,743 |
|
7,082 |
Deferred revenue |
|
|
60,614 |
|
59,465 |
Lease liabilities |
|
|
1,939 |
|
1,411 |
Other current liabilities |
|
|
1,856 |
|
1,288 |
Total current liabilities |
|
|
76,190 |
|
69,296 |
Non-current liabilities |
|
|
|
|
|
Deferred revenue |
|
|
80,295 |
|
101,909 |
Lease liabilities |
|
|
4,891 |
|
1,823 |
Other non-current liabilities |
|
|
- |
|
2,084 |
Total non-current liabilities |
|
|
85,186 |
|
105,816 |
Shareholders' equity (deficit) |
|
|
|
|
|
Share capital |
|
|
629 |
|
1,164 |
Share premium |
|
|
564,852 |
|
190,945 |
Accumulated deficit |
|
|
(439,665) |
|
(233,194) |
Other reserves |
|
|
(4,157) |
|
(770) |
Total equity (deficit) attributable to shareholders of the
parent |
|
121,659 |
|
(41,855) |
Non-controlling interest |
|
|
- |
|
1,020 |
Total shareholders' equity (deficit) |
|
|
121,659 |
|
(40,835) |
Total liabilities and shareholders' equity
(deficit) |
|
|
283,035 |
|
134,277 |
Immatics N.V. and subsidiariesUnaudited
Condensed Consolidated Statement of Loss of Immatics
N.V.
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
(Euros in thousands, except share and per share
data) |
|
|
(Euros in thousands, except share and per share
data) |
|
Revenue from collaboration agreements |
|
|
|
|
|
|
7,871 |
|
|
|
5,056 |
|
|
|
21,807 |
|
|
14,065 |
|
|
|
Research and development expenses |
|
|
|
|
|
|
(17,485) |
|
|
|
(10,233) |
|
|
|
(46,236) |
|
|
(27,964) |
|
|
|
General and administrative expenses |
|
|
|
|
|
|
(9,215) |
|
|
|
(2,769) |
|
|
|
(25,488) |
|
|
(7,147) |
|
|
|
Other income |
|
|
|
|
|
|
32 |
|
|
|
190 |
|
|
|
232 |
|
|
315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating result |
|
|
|
|
|
|
(18,797) |
|
|
|
(7,756) |
|
|
|
(49,685) |
|
|
(20,731) |
|
|
|
Financial income |
|
|
|
|
|
|
1,188 |
|
|
|
2,844 |
|
|
|
1,943 |
|
|
3,339 |
|
|
|
Financial expenses |
|
|
|
|
|
|
(6,717) |
|
|
|
(61) |
|
|
|
(6,499) |
|
|
(158) |
|
|
|
Share listing expense |
|
|
|
|
|
|
(152,787) |
|
|
|
- |
|
|
|
(152,787) |
|
|
- |
|
|
|
Financial result |
|
|
|
|
|
|
(158,316) |
|
|
|
2,783 |
|
|
|
(157,343) |
|
|
(3,181) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
|
|
|
|
(177,113) |
|
|
|
(4,973) |
|
|
|
(207,028) |
|
|
(17,550) |
|
|
|
Taxes on income |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
- |
- |
|
|
Net loss |
|
|
|
|
|
|
(177,113) |
|
|
|
(4,973) |
|
|
|
(207,028) |
|
|
(17,550) |
|
|
|
Attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent |
|
|
|
|
|
|
(177,113) |
|
|
|
(4,711) |
|
|
|
(206,471) |
|
|
(16,859) |
|
|
|
Non-controlling interest |
|
|
|
|
|
|
- |
|
|
|
(262) |
|
|
|
(557) |
|
|
(691) |
|
|
|
Net loss |
|
|
|
|
|
|
(177,113) |
|
|
|
(4,973) |
|
|
|
(207,028) |
|
|
(17,550) |
|
|
|
Net loss per share—basic and diluted |
|
|
|
|
|
|
(2.82) |
|
|
|
(0.14) |
|
|
|
(4.80) |
|
|
(0.51) |
|
|
|
Weighted average shares outstanding—basic and diluted |
|
|
|
|
|
|
62,908,617 |
|
|
|
33,093,838 |
|
|
|
43,032,098 |
|
|
33,093,838 |
|
|
|
Immatics N.V. and subsidiariesUnaudited
Condensed Consolidated Statement of Comprehensive Loss of Immatics
N.V.
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
(Euros in thousands) |
|
(Euros in thousands) |
Net Loss |
|
|
(177,113) |
|
(4,973) |
|
(207,028) |
|
(17,550) |
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
Items
that may be reclassified subsequently to profit or loss, net of
tax |
|
|
- |
|
- |
|
- |
|
- |
Currency translation differences from foreign operations |
|
|
(3,487) |
|
(727) |
|
(3,387) |
|
(735) |
Total comprehensive loss for the period |
|
|
(180,600) |
|
(5,700) |
|
(210,415) |
|
(18,285) |
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
|
|
|
|
Equity holders of the parent |
|
|
(180,600) |
|
(5,438) |
|
(209,858) |
|
(17,594) |
Non-controlling interest |
|
|
- |
|
(262) |
|
(557) |
|
(691) |
Total comprehensive loss for the period |
|
|
(180,600) |
|
(5,700) |
|
(210,415) |
|
(18,285) |
Immatics N.V. and subsidiariesUnaudited
Condensed Consolidated Statement of Cash Flows of Immatics
N.V.
|
Nine months ended September 30, |
|
2020 |
|
2019 |
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
|
Loss before taxation |
(207,028) |
|
(17,550) |
Adjustments for: |
|
|
|
Interest
income |
(1,072) |
|
(439) |
Depreciation and amortization |
3,466 |
|
2,795 |
Interest
expense |
188 |
|
138 |
Share
listing expense |
152,787 |
|
- |
Equity
settled share-based payment |
15,031 |
|
116 |
MD
Anderson compensation expense |
45 |
|
503 |
(Decrease) Increase in other liabilities resulting from share
appreciation rights |
(1,893) |
|
151 |
Payment
related to share-based compensation awards previously classified as
equity-settled |
(4,322) |
|
- |
Changes in working capital |
|
|
|
Decrease
(increase) in accounts receivable |
328 |
|
(720) |
(Increase) decrease in other assets |
(2,211) |
|
432 |
(Increase) decrease in accounts payable and other current
liabilities |
(16,026) |
|
56,739 |
Interest
received |
1,030 |
|
341 |
Interest paid |
(188) |
|
(138) |
Net cash provided by/(used in) operating
activities |
(59,865) |
|
42,368 |
Cash flows from investing activities |
|
|
|
Payments
for property, plant and equipment |
(5,864) |
|
(1,403) |
Cash
paid for investments classified in Other financial assets |
(58,482) |
|
(4,450) |
Cash
received from maturity of investments classified in Other financial
assets |
48,881 |
|
17,551 |
Payments
for intangible assets |
(86) |
|
(60) |
Proceeds from disposal of property, plant and equipment |
- |
|
97 |
Net cash provided by/(used in) investing
activities |
(15,551) |
|
11,735 |
Cash flows from financing activities |
|
|
|
Proceeds
from issuance of shares to equity holders of the parent |
209,369 |
|
- |
Payments for leases |
(1,633) |
|
(1,395) |
Net cash provided by/(used in) financing
activities |
207,736 |
|
(1,395) |
Net increase in cash and cash equivalents |
132,320 |
|
52,708 |
Cash and cash equivalents at beginning of
period |
103,353 |
|
39,367 |
Effects of exchange rate changes on cash and cash equivalents |
(1,997) |
|
16 |
Cash and cash equivalents at end of period |
233,676 |
|
92,091 |
Immatics N.V. and subsidiariesUnaudited
Condensed Consolidated Statement of Changes in Shareholders’ equity
(deficit) of Immatics N.V.
(Euros in thousands) |
|
Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total equity attributable to shareholders of the
parent |
Non-controlling interest |
Total share-holders' equity (deficit) |
Balance as of January 1, 2019 |
|
1,164 |
190,793 |
(201,623) |
(741) |
(10,407) |
1,236 |
(9,171) |
Other
comprehensive loss |
|
- |
- |
- |
(735) |
(735) |
- |
(735) |
Net loss |
|
- |
- |
(16,858) |
- |
(16,858) |
(691) |
(17,549) |
Comprehensive loss for the year |
|
- |
- |
(16,858) |
(735) |
(17,593) |
(691) |
(18,284) |
Equity-settled tandem awards |
|
- |
116 |
- |
- |
116 |
- |
116 |
MD Anderson milestone compensation expense |
|
- |
- |
- |
- |
- |
503 |
503 |
Balance as of September 30, 2019 |
|
1,164 |
190,909 |
(218,481) |
(1,476) |
(27,884) |
1,048 |
(26,836) |
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2020 |
|
1,164 |
190,945 |
(233,194) |
(770) |
(41,855) |
1,020 |
(40,835) |
Other
comprehensive loss |
|
- |
- |
- |
(3,387) |
(3,387) |
- |
(3,387) |
Net
loss |
|
- |
- |
(206,471) |
- |
(206,471) |
(557) |
(207,028) |
Comprehensive loss for the year |
|
- |
- |
(206,471) |
(3,387) |
(209,858) |
(557) |
(210,415) |
Reorganization |
|
(833) |
833 |
- |
- |
- |
- |
- |
Issue of share capital |
|
|
|
|
|
|
|
|
MD Anderson
Share Exchange |
|
7 |
501 |
- |
- |
508 |
(508) |
- |
PIPE
Financing, net of transaction costs |
|
104 |
89,749 |
- |
- |
89,853 |
- |
89,853 |
ARYA
Merger, net of transaction costs |
|
180 |
272,122 |
- |
- |
272,302 |
- |
272,302 |
SAR conversion |
|
7 |
(7) |
- |
- |
- |
- |
- |
Total issuance of share capital |
|
298 |
362,365 |
- |
- |
362,663 |
(508) |
362,155 |
Equity-settled share-based compensation |
|
- |
15,031 |
- |
- |
15,031 |
- |
15,031 |
Payment
related to share-based compensation awards previously classified as
equity-settled |
|
- |
(4,322) |
- |
- |
(4,322) |
- |
(4,322) |
MD Anderson milestone compensation expense |
|
- |
- |
- |
- |
- |
45 |
45 |
Balance as of September 30, 2020 |
|
629 |
564,852 |
(439,665) |
(4,157) |
121,659 |
- |
121,659 |
Immatics NV (NASDAQ:IMTX)
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