- IMA203 TCR-T candidate targeting PRAME
demonstrated a
50% objective
response rate across
different solid tumor types in an interim
update of Phase 1a
dose escalation
- Multiple
IMA203 Phase
1b expansion
cohorts being
initiated in Q2
2022 including
monotherapy at target dose
level, checkpoint combination
therapy, and
2nd-generation
approach
IMA203CD8
- Immatics entered
a global licensing agreement with Bristol
Myers Squibb to collaborate on clinical development of
TCR Bispecific
(TCER®)
IMA401 targeting
MAGEA4/A8; agreement
includes $150million upfront
payment, up to $770 million
in milestone payments,
tiered double-digit royalties and
a co-promotion
option in the
U.S.
- TCER®
IMA401
IND1 approved by
regulatory authorities in February 2022;
initiation of patient
treatment in the first half
of 2022
- TCER® IMA402 targeting PRAME
demonstrated preclinical proof-of-concept
and initial steps towards
GMP manufacturing have
been initiated
- Nancy Valente appointed to
Immatics’ Board of
Directors
- Cash and cash equivalents as well as
Other financial
assets amount to
$164
million2
(€145
million) as of December 31,
2021.
Addition
of upfront payment from
the recent collaboration
agreement with Bristol
Myers
Squibb received in
February 2022 ensures
cash runway into
2024
Tuebingen,
Germany and Houston, TX,
March
23,
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 provided an update on its
corporate progress and reported financial results for the quarter
and full year ended December 31, 2021.
Harpreet Singh, Ph.D., CEO and Co-Founder of
Immatics commented, “Over the course of 2021, Immatics has
continued to deliver important milestones across both our clinical
and preclinical portfolio. Our Phase 1a data presentation at SITC
demonstrated high initial objective response rates in solid cancer
patients treated with our ACTengine® IMA203 TCR-T candidate, and we
have achieved preclinical proof-of-concept for our TCR Bispecific
candidate, TCER® IMA402 – both targeting PRAME, a target frequently
expressed on multiple solid cancers. We have also expanded our
collaboration with Bristol Myers Squibb to jointly develop our
TCER® IMA401 targeting MAGEA4 and MAGEA8 and we plan to initiate
the first-in-man clinical trial of IMA401 in the first half of
2022. Together with the company’s strong cash position and further
potential opportunities to create valuable partnerships based on
our differentiated TCR-based platforms, we are very well positioned
to deliver on all relevant upcoming value inflections points across
our cell therapy and bispecifics portfolio.”
Fourth Quarter
2021 and Subsequent Company
Progress
Adoptive Cell Therapy
Programs
-
ACTengine®
IMA203 (PRAME) -
Immatics provided an interim update on its most advanced Phase 1a
TCR-T trial with IMA203 targeting PRAME in a late-breaking oral
presentation by Dr. Martin Wermke, coordinating investigator of the
trial, at the 36th Annual Meeting of the Society for Immunotherapy
of Cancer (SITC) in November 2021. Objective responses (confirmed
and unconfirmed partial responses, RECIST 1.1) were observed in 8
out of 16 patients (50%), and 8 out of 13 patients (62%) who were
treated at intermediate dose levels 2 and 3 in the dose escalation
part of the trial. Objective responses were associated with tumor
infiltration and peak T cell persistence in the blood.
Treatment-emergent events were transient and manageable; no grade 3
or higher cytokine release syndrome or neurological toxicities were
observed.
- Patient treatment in the Phase 1a
study with IMA203 has been completed. Dose level 4 (up to 1.2
billion transduced T cells per m2) has been determined as the
provisional Recommended Phase 2 Dose (RP2D). The next data read-out
for IMA203 monotherapy is planned for 2H 2022.
- Based on these interim results, Immatics is expanding the
IMA203 study to three Phase 1b dose expansion cohorts, each
designed to evaluate the observed objective response rate,
demonstrate durability of response and provide the basis for
entering registration trials. Cohorts include IMA203 as monotherapy
in focus indications, IMA203 in combination with an immune
checkpoint inhibitor and IMA203CD8, a 2nd generation monotherapy
where IMA203 is co-transduced with a CD8 co-receptor, thereby
inducing anti-tumor activity of both CD4 and CD8 T cells. These
three Phase 1b IMA203 expansion cohorts are being initiated in Q2
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 (MAGEA4/8)
and IMA202 (MAGEA1) – In November
2021, Immatics presented interim data on 12 heavily pre-treated
patients that were treated with product candidates IMA201 and
IMA202. 8 out of 12 patients (67%) showed disease control, and
tumor shrinkage was observed in 6 patients (50%). All adverse
events for IMA201 and IMA202 were transient and manageable with no
dose-limiting toxicities observed. For IMA202, patient recruitment
in the dose escalation part of the Phase 1 trial has been
completed. For IMA201, dose escalation is ongoing.
- ACTengine® IMA204 (COL6A3
exon 6) – IMA204 is a first-in-class TCR-T directed
against COL6A3 exon 6, a novel tumor stroma target highly expressed
in several solid cancers. IMA204 utilizes a next-generation
CD8-independent TCR with full functionality in both CD4 and CD8 T
cells. IND-enabling studies are nearing completion. Submission of
the IND application for IMA204 is expected by the end of 2022.
TCR Bispecifics
Programs
- TCER®
IMA401 (MAGEA4/8) – Immatics
entered a global exclusive licensing deal with Bristol Myers Squibb
for its most advanced TCER® product candidate, IMA401. The
agreement included an upfront payment of $150 million as well as up
to $770 million in additional milestone payments plus tiered
double-digit royalties on net product sales, and includes the
retention of the option to co-fund U.S. development in return for
further enhanced U.S. royalties. Both companies will collaborate to
advance the program through clinical development with Immatics
retaining a co-promotion option in the U.S. In preclinical
proof-of-concept studies, IMA401 demonstrated anti-tumor activity
with complete remissions in different in vivo tumor models
including patient-derived xenograft models. A clinical trial
application (CTA, the equivalent of an IND in Europe) for the
IMA401 program was filed in November 2021 with the
Paul-Ehrlich-Institute, the relevant German regulatory authority
and approved in February 2022. Start of the Phase 1 clinical trial
is planned for the first half of 2022.
- TCER®
IMA402 (PRAME) – Immatics
presented data from its second TCER® program IMA402 at the 17th
Annual PEGS Boston Protein Engineering and Cell Therapy Summit in
May 2021 demonstrating preclinical proof-of-concept for the
program. IMA402 showed in vitro anti-tumor activity and consistent
tumor regression including complete responses in an in vivo tumor
model. Continuation of GMP process development and IND-enabling
activities for IMA402 is anticipated in 2022. Manufacturing of the
clinical batch is targeted for the second half of 2022 and
initiation of the Phase 1 trial is planned in 2023.
Corporate
Developments
Board of Directors
Update
- In March 2022, Nancy Valente, M.D., was appointed to the
Immatics’ Board of Directors and will be nominated for election at
the Company’s Annual General Meeting in June 2022. Nancy Valente
brings to Immatics 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 including
Gazyva®, Polivy®, Hemlibra® and Venclexta®, a first-to-market BCL-2
inhibitor. Additional information about Nancy Valente and the other
members of Immatics’ Board of Directors can be found on the
Immatics website.
- In July 2021, Immatics adopted a one-tier structure for its
Board of Directors. As part of this process, the company’s CEO
Harpreet Singh, Ph.D., joined the Board.
- In June 2021, Friedrich von Bohlen und Halbach, Ph.D., Managing
Director of dievini Hopp BioTech Holding GmbH & Co. KG was
elected to Immatics’ Board of Directors. Dr. von Bohlen und Halbach
replaced Christof Hettich, L.L.D., who stepped down from the Board
of Directors after 15 years of valuable service to the
company.
Full Year
2021 Financial
Results
Cash Position: Cash and cash equivalents as well
as other financial assets total €145.1 million ($164.3 million2) as
of December 31, 2021 compared to €232.0 million ($262.7 million2)
as of December 31, 2020. The decrease is mainly the result of
financing of our ongoing research and development activities. This
does not include $150 million cash received in February 2022 from
the collaboration agreement signed with Bristol Myers Squibb in
December 2021. Adding this upfront payment, the Company projects a
cash runway into 2024.
Revenue: Total revenue, consisting of revenue
from collaboration agreements, was €34.8 million ($39.4 million2)
for the year ended December 31, 2021, compared to €31.3 million
($35.4 million2) for the year ended December 31, 2020.
Research and Development Expenses: R&D
expenses were €87.6 million ($99.2 million2) for the year ended
December 31, 2021, compared to €67.1 million ($76.0 million2) for
the year ended December 31, 2020. The increase mainly resulted from
higher costs associated with the advancement of the clinical and
pre-IND pipeline of candidates.
General and Administrative Expenses: G&A
expenses were €33.8 million ($38.3 million2) for the year ended
December 31, 2021, compared to €34.2 million ($38.7 million2) for
the year ended December 31, 2020.
Net Loss: Net loss was €93.3 million ($105.7
million2) for the year ended December 31, 2021, compared to €211.8
million ($239.9 million2) for the year ended December 31, 2020. The
decrease mainly resulted from a one-time, non-cash expense in
connection with the ARYA merger in 2020 of €152.8 million ($173.0
million2).
Full financial statements can be found in the
Annual Report on Form 20-F filed with the Securities and Exchange
Commission (SEC) and published on the SEC website under
www.sec.gov.
2 All amounts translated using the exchange rate
published by the European Central Bank in effect as of December 31,
2021 (1 EUR = 1.1326 USD).
Upcoming Investor Conferences
- Bank of America Healthcare
Conference (in person) Las Vegas, NV – May 10-12, 2022
- Jefferies LLC Healthcare Conference
(in-person) New York, NY – June 8-10, 2022
- Goldman Sachs Global Healthcare
Conference, Rancho Palos Verdes, CA – June 14-16, 2022
- Jefferies LLC 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.
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,
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 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:
Media and Investor Relations Contact |
|
Jacob Verghese or Stephanie May |
|
Trophic Communications |
|
Phone: +49 89 2388 7731 |
|
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 |
1 Genehmigung des Studienzulassungsantrages (clinical trial
application, CTA)
2 Alle Beträge wurden mit dem von der Europäischen Zentralbank
veröffentlichten Wechselkurs zum 31. Dezember 2021 umgerechnet (1
EUR = 1,1326 US-Dollar).
Immatics N.V. and subsidiariesCondensed
Consolidated Statement of Financial Position of Immatics
N.V.
|
As of |
|
December 31, 2021 |
December 31, 2020 |
|
(Euros in thousands) |
Assets |
|
|
Current assets |
|
|
Cash and cash
equivalents |
132,994 |
207,530 |
Other financial
assets |
12,123 |
24,448 |
Accounts
receivable |
682 |
1,250 |
Other current
assets |
6,408 |
5,763 |
|
|
|
Total current
assets |
152,207 |
238,991 |
Non-current assets |
|
|
Property, plant and
equipment |
10,506 |
7,868 |
Intangible
assets |
1,315 |
914 |
Right-of-use assets
|
9,982 |
6,149 |
Other non-current
assets |
636 |
724 |
|
|
|
Total non-current
assets |
22,439 |
15,655 |
|
|
|
Total
assets |
174,646 |
254,646 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Provisions |
51 |
51 |
Accounts
payable |
11,624 |
10,052 |
Deferred
revenue |
50,402 |
46,600 |
Other financial
liabilities |
27,859 |
16,869 |
Lease
liabilities |
2,711 |
1,881 |
Other current
liabilities |
2,501 |
2,025 |
|
|
|
Total current
liabilities |
95,148 |
77,478 |
Non-current liabilities |
|
|
Deferred
revenue |
48,225 |
85,475 |
Lease
liabilities |
7,142 |
4,306 |
Other non-current
liabilities |
68 |
— |
Total non-current
liabilities |
55,435 |
89,781 |
Shareholders’ equity |
|
|
Share capital |
629 |
629 |
Share premium |
565,192 |
538,695 |
Accumulated
deficit |
(537,813) |
(444,478) |
Other reserves |
(3,945) |
(7,459) |
|
|
|
Total shareholders’
equity |
24,063 |
87,387 |
|
|
|
Total liabilities and shareholders’
equity |
174,646 |
254,646 |
|
|
|
Immatics N.V. and subsidiariesCondensed
Consolidated Statement of Loss of Immatics N.V.
|
Year ended December 31, |
|
2021 |
2020 |
2019 |
|
(Euros in thousands, except share and
pershare data) |
Revenue from collaboration
agreements |
34,763 |
31,253 |
18,449 |
Research and development
expenses |
(87,574) |
(67,085) |
(40,091) |
General and administrative
expenses |
(33,808) |
(34,186) |
(11,756) |
Other income |
332 |
303 |
385 |
|
|
|
|
Operating
result |
(86,294) |
(69,715) |
(33,013) |
Financial
income |
5,675 |
2,949 |
790 |
Financial
expenses |
(1,726) |
(10,063) |
(264) |
Change in fair value of warrant
liabilities |
(10,990) |
17,775 |
— |
Share listing
expense |
- |
(152,787) |
— |
|
|
|
|
Financial
result |
(7,041) |
(142,126) |
526 |
|
|
|
|
Loss before
taxes |
(93,335) |
(211,841) |
(32,487) |
Taxes on
income |
— |
— |
— |
|
|
|
|
Net
loss |
(93,335) |
(211,841) |
(32,487) |
Attributable
to: |
|
|
|
Equity holders of
the parent |
(93,335) |
(211,284) |
(31,571) |
Non-controlling
interest |
- |
(557) |
(916) |
|
|
|
|
Net
loss |
(93,335) |
(211,841) |
(32,487) |
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
(1.48) |
(4.40) |
(0.95) |
Weighted average shares outstanding - basic and
diluted |
62,912,921 |
48,001,228 |
33,093,838 |
Immatics N.V. and subsidiariesCondensed
Consolidated Statement of Comprehensive Loss of Immatics
N.V.
|
Year ended December 31, |
|
2021 |
2020 |
2019 |
|
(Euros in thousands) |
Net
Loss |
(93,335) |
(211,841) |
(32,487) |
Other comprehensive loss |
|
|
|
Items that may be reclassified subsequently to profit or loss, net
of tax |
— |
— |
— |
Currency translation differences from foreign
operations |
3,514 |
(6,689) |
(29) |
|
|
|
|
Total comprehensive loss for the
period |
(89,821) |
(218,530) |
(32,516) |
Attributable
to: |
|
|
|
Equity holders of
the parent |
(89,821) |
(217,973) |
(31,600) |
Non-controlling
interest |
— |
(557) |
(916) |
|
|
|
|
Total comprehensive loss for the
period |
(89,821) |
(218,530) |
(32,516) |
|
|
|
|
Immatics N.V. and subsidiariesCondensed
Consolidated Statement of Cash Flows of Immatics N.V.
|
Year ended December 31, |
|
2021 |
2020 |
2019 |
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
|
Loss before
taxation |
(93,335) |
(211,841) |
(32,487) |
Adjustments for: |
|
|
|
Interest
income |
(133) |
(850) |
(790) |
Depreciation and
amortization |
5,260 |
4,424 |
3,858 |
Interest
expense |
566 |
289 |
170 |
Share listing
expense |
— |
152,787 |
— |
Equity settled share-based
payment |
26,403 |
22,908 |
152 |
MD Anderson compensation
expense |
— |
45 |
700 |
(Decrease) Increase in other liabilities resulting from share
appreciation
rights |
— |
(2,036) |
1,864 |
Payment related to share-based compensation awards previously
classified as
equity-settled |
— |
(4,322) |
— |
Net foreign exchange
differences |
554 |
(4,477) |
3 |
Change in fair value of warrant
liabilities |
10,990 |
(17,775) |
— |
Changes in working capital |
|
|
|
Decrease (increase) in accounts
receivable |
569 |
(294) |
(563) |
(Increase) in
other assets |
(483) |
(1,600) |
(1,497) |
(Decrease) increase in accounts payable and other current
liabilities |
(31,784) |
(23,387) |
98,937 |
Interest
received |
175 |
808 |
790 |
Interest paid |
(566) |
(289) |
(170) |
|
|
|
|
Net cash used in operating
activities |
(81,784) |
(85,610) |
70,967 |
|
|
|
|
Cash flows from investing activities |
|
|
|
Payments for property, plant and
equipment |
(5,106) |
(7,420) |
(2,143) |
Cash paid for investments in Other financial
assets |
(11,298) |
(58,087) |
(77,810) |
Cash received from maturity of investments classified in Other
financial
assets |
24,448 |
49,662 |
74,888 |
Payments for intangible
assets |
(551) |
(104) |
(91) |
Proceeds from disposal of property, plant and
equipment |
— |
— |
97 |
|
|
|
|
Net cash (used in)/provided by investing
activities |
7,493 |
(15,949) |
(5,059) |
|
|
|
|
Cash flows from financing activities |
|
|
|
Proceeds from issuance of shares to equity holders of the
parent |
94 |
217,918 |
— |
Transaction cost deducted from
equity |
— |
(7,939) |
— |
Payments for
leases |
(2,707) |
(2,096) |
(1,862) |
|
|
|
|
Net cash used in financing
activities |
(2,613) |
207,883 |
(1,862) |
|
|
|
|
Net increase in cash and cash
equivalents |
(76,904) |
106,324 |
64,046 |
|
|
|
|
Cash and cash equivalents at beginning of
period |
207,530 |
103,353 |
39,367 |
|
|
|
|
Effects of exchange rate changes on cash and cash
equivalents |
2,368 |
(2,147) |
(60) |
|
|
|
|
Cash and cash equivalents at end of
period |
132,994 |
207,530 |
103,353 |
|
|
|
|
Immatics N.V. and subsidiariesCondensed
Consolidated Statement of Changes in Shareholders’ equity (deficit)
of Immatics N.V.
(Euros
in thousands) |
Sharecapital |
Sharepremium |
Accumulateddeficit |
Otherreserves |
Total equity
(deficit)cccattributabletoshareholdersof
the parent |
Non-controllinginterest |
Totalshare-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 |
— |
— |
— |
(29) |
(29) |
— |
(29) |
Net loss |
— |
— |
(31,571) |
— |
(31,571) |
(916) |
(32,487) |
Comprehensive loss for the year |
— |
— |
(31,571) |
(29) |
(31,600) |
(916) |
(32,516) |
Equity-settled tandem awards |
— |
152 |
— |
— |
152 |
— |
152 |
MD Anderson compensation expense |
— |
— |
— |
— |
— |
700 |
700 |
|
|
|
|
|
|
|
|
Balance as of December 31, 2019 |
1,164 |
190,945 |
(233,194) |
(770) |
(41,855) |
1,020 |
(40,835) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2020 |
1,164 |
190,945 |
(233,194) |
(770) |
(41,855) |
1,020 |
(40,835) |
Other comprehensive loss |
— |
— |
— |
(6,689) |
(6,689) |
— |
(6,689) |
Net loss |
— |
— |
(211,284) |
— |
(211,284) |
(557) |
(211,841) |
Comprehensive loss for the year |
— |
— |
(211,284) |
(6,689) |
(217,973) |
(557) |
(218,530) |
Reorganization |
(833) |
833 |
— |
— |
— |
— |
— |
Issue of share capital |
|
|
|
|
|
|
|
MD Anderson Share Exchange |
7 |
501 |
— |
— |
508 |
(508) |
— |
PIPE Financing, net of transaction costs |
104 |
89,973 |
— |
— |
90,077 |
— |
90,077 |
ARYA Merger, net of transaction costs |
180 |
237,864 |
— |
— |
238,044 |
— |
238,044 |
SAR conversion |
7 |
(7) |
— |
— |
— |
— |
— |
|
|
|
|
|
|
|
|
Total issuance of share capital |
298 |
328,331 |
— |
— |
328,629 |
(508) |
328,121 |
Equity-settled share-based compensation |
— |
22,908 |
— |
— |
22,908 |
— |
22,908 |
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 December 31, 2020 |
629 |
538,695 |
(444,478) |
(7,459) |
87,387 |
— |
87,387 |
|
|
|
|
|
|
|
|
Balance as of January 1, 2021 |
629 |
538,695 |
(444,478) |
(7,459) |
87,387 |
— |
87,387 |
Other comprehensive income |
— |
— |
— |
3,514 |
3,514 |
— |
3,514 |
Net loss |
— |
— |
(93,335) |
— |
(93,335) |
— |
(93,335) |
Comprehensive income/(loss) for the year |
— |
— |
(93,335) |
3,514 |
(89,821) |
— |
(89,821) |
Equity-settled share-based compensation |
— |
26,403 |
— |
— |
26,403 |
— |
26,403 |
Share options exercised |
— |
94 |
— |
— |
94 |
— |
94 |
|
|
|
|
|
|
|
|
Balance as of December 31, 2021 |
629 |
565,192 |
(537,813) |
(3,945) |
24,063 |
— |
24,063 |
|
|
|
|
|
|
|
|
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