TIDMSYNC
RNS Number : 3606E
Syncona Limited
10 March 2022
Syncona Limited
Autolus Reports Fourth Quarter and Full Year 2021 Financial
Results and Operational Progress
10 March 2022
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes that its portfolio company, Autolus Therapeutics Plc (NASDAQ:
AUTL) (Autolus), announced its operational and financial results
for the fourth quarter and full year ended December 31, 2021.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and the full text of the
announcement from Autolus is contained below. Autolus management
will host a conference call today, at 8:30 am ET/ 1:30 pm GMT, to
discuss the company's financial results and provide a general
business update. To listen to the webcast and view the accompanying
slide presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
.
[S]
Enquiries
Syncona Ltd
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life.
We do this by founding and building a portfolio of global leaders
in life science to deliver transformational treatments to patients
in areas of high unmet need.
Our strategy is to found, build and fund companies around
exceptional science to create a diversified portfolio of 15-20
globally leading healthcare businesses for the benefit of all our
stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and
management teams. Our balance sheet underpins our strategy enabling
us to take a long-term view as we look to improve the lives of
patients with no or poor treatment options, build sustainable life
science companies and deliver strong risk-adjusted returns to
shareholders.
Autolus Therapeutics Reports Fourth Quarter and Full Year 2021
Financial Results and Operational Progress
- Conference call to be held on March 10, 2022 at 8:30 am
ET/1:30 pm GMT -
LONDON , March 10, 2022 - Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announced its
operational and financial results for the fourth quarter and full
year ended December 31, 2021.
"We rounded off the 2021 financial year announcing a
collaboration with Blackstone Life Sciences, adding $150M in
capital with an additional $100M in potential milestone payments
triggered by future development progress of obe-cel, as well as
positive clinical data from our pipeline, notably data from the
Phase 1b portion of the FELIX study of obe-cel in adult ALL
patients. Recruitment is ongoing in the Phase 2 portion of this
pivotal study and we look forward to announcing initial Phase 2
data this year, as well as starting preparations for submitting a
BLA in 2023, " said Dr. Christian Itin, Chief Executive Officer of
Autolus. " We are excited about Autolus' outlook and look forward
to updating you on progress with obe-cel, as well as AUTO4 and
AUTO1/22 over the coming months."
Key Clinical and Pipeline Updates during 2021:
-- Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL
o FELIX Study - Autolus continues to enroll patients in the
Phase 2 portion of the FELIX study. As presented at ASH in December
2021, the data from the Phase 1b portion of the FELIX study show a
favorable safety and efficacy profile consistent with our
experience in the ALLCAR19 study in adult r/r B-ALL and the CARPALL
study in pediatric r/r ALL patients treated with obe-cel . No
patient experienced high grade (>= Grade 3) cytokine release
syndrome (CRS) and neurotoxicity (ICANS) of any grade was limited
to 13% of patients and only 6% experienced a Grade 3 event.
o ALLCAR19 Study - Data were published in the Journal of
Clinical Oncology (JCO)(1) in September 2021 from the ALLCAR19
trial in r/r adult ALL patients. Obe-cel demonstrated a manageable
adverse events profile, with no patients experiencing high grade
CRS, despite the majority of patients enrolled in the study having
a high disease burden prior to lymphodepletio n. As presented at
ASH in December 2021, duration of response remains highly
encouraging with morphological EFS for obe-cel of 46% at 24 months
with a median follow-up of 29.3 months and patients approaching up
to 42 months of durability, as of the cut-off date of October 15,
2021.
-- Obe-cel in r/r B-NHL - ALLCAR19 extension
o The latest data of obe-cel in relapsed/refractory B-Cell
Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia
(CLL) were presented by Autolus at ASH in December 2021. As of the
data cut-off date of October 15, 2021, 15 patients with r/r B-NHL
and 1 patient with B-CLL had received obe-cel, with 14 patients
evaluable for response. 14 of 14 patients responded to obe-cel, of
which 13 of 14 patients achieved complete metabolic response per
Lugano 2014, with 1 B-CLL patient achieving a partial response. 15
of 16 patients had no disease progression at last follow-up, with 1
of 16 patients having died in CR from COVID-19. Furthermore, long
term persistence was demonstrated by quantitative PCR. Across all
evaluable patients, obe-cel demonstrated a favorable safety profile
with no ICANS or severe Grade >= 3 CRS events.
-- Autolus received preferred regulatory access for obe-cel from
UK Medicines and Healthcare products Regulatory Agency (MHRA) and
European Medicines Agency (EMA):
o Autolus received an innovative licensing and access pathway
(ILAP) designation from the MHRA for obe-cel, which is being
investigated in the ongoing FELIX trial in ALL.
o Autolus also received PRIority MEdicines (PRIME) designation
from the EMA.
-- AUTO1/22 in pediatric ALL
o Pre-clinical data presented at ASH in December 2021
demonstrated a high level of in vitro and in vivo activity of
AUTO1/22 against leukemia cells. AUTO1/22 was shown to control
leukemia in a mouse model of CD19 negative escape. AUTO1/22 is
currently being tested in a study of r/r pediatric B-ALL. As of the
cut-off date of October 21, 2021, 6 patients had received AUTO1/22.
All patients showed engraftment of single and double CAR positive
populations, pointing to early CAR T cell persistence.
-- AUTO4 in Peripheral T Cell Lymphoma
o Autolus received ILAP designation from the MHRA. The AUTO4
Phase 1 clinical trial is progressing through dose escalation.
Key Operational Updates during 2021
-- In November 2021, Autolus announced that it had entered into
a strategic collaboration and financing agreement under which
Blackstone Life Sciences will provide up to $250 million in equity
and milestones to support obe-cel, as well as next generation
product therapies of obe-cel in B-cell malignancies.
-- In Nove mber 2021, Dr. William D. Young, a Senior Advisor to
Blackstone Life Sciences, was appointed as a Non-Executive Director
to the Autolus Board of Directors.
-- In September 2021, Autolus gave an update on its
manufacturing strategy, announcing that planning approval had been
granted to build the Company's new 70,000 square foot manufacturing
facility in Stevenage, UK. This commercial facility is designed for
a capacity of 2,000 batches a year, with an opportunity to
expand.
-- Also in September 2021, Autolus announced the appointment of
John H. Johnson as Non-Executive Chairman of the Board of
Directors.
-- In July 2021, Autolus announced its entry into an agreement
with Moderna, Inc., granting Moderna an exclusive license to
develop and commercialize mRNA-based therapeutics incorporating
Autolus' proprietary binders for up to four immuno-oncology
targets.
-- Updates to Autolus' executive team over the course of the year:
o In July 2021, Autolus announced the appointment of Edgar
Braendle M.D., Ph.D., as Chief Development Officer.
o In October 2021, Alexander Swan was promoted to Senior Vice
President, Human Resources and Dr. Chris Williams was promoted to
Senior Vice President, Corporate Development.
Post Period Updates:
-- In January 2022 Autolus announced the retirement of Andrew J.
Oakley as its Chief Financial Officer, effective March 31, 2022.
Dr. Lucinda Crabtree, Senior Vice President of Business Strategy
& Planning at Autolus, will succeed Mr. Oakley as Autolus'
Chief Financial Officer. Brent Rice was also promoted to Senior
Vice President, Chief Commercial Officer.
Key Anticipated Clinical Milestones:
-- Updates on the FELIX trial, where Autolus is evaluating
obe-cel in r/r adult ALL patients. The trial is currently enrolling
patients into the Phase 2 portion. The Company expects to report
initial clinical data from the Phase 2 study in H2 2022 and full
data in H1 2023.
-- Updates from the ALLCAR19 extension trial in patients with
r/r B-NHL and CLL and longer-term follow-up of the fully enrolled
r/r adult ALL cohort expected in H1 2022.
-- Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in H1 2022.
-- Initial clinical data from the AUTO1/22 CARPALL extension
trial in pediatric ALL expected to be reported in H1 2022 and with
longer follow up in H2 2022.
-- Initial clinical data from AUTO4 LibraT1 Phase 1 trial in
TRBC1+ Peripheral TCL expected to be reported in H1 2022.
-- AUTO8 in Multiple Myeloma Phase 1 trial expected to be initiated in H1 2022.
-- AUTO6NG - Neuroblastoma Phase 1 trial expected to start mid 2022.
(1) Roddie et al. "Durable responses and low toxicity after fast
off-rate CD19 CAR-T therapy in adults with relapsed/ refractory
B-ALL." DOI: 10.1200/JCO.21.00917 Journal of Clinical Oncology -
published online before print August 31, 2021
Financial Results for the Quarter and Year Ended December 31,
2021
Cash at December 31, 2021, totaled $310.3 million, as compared
to $153.3 million at December 31, 2020. Net total operating
expenses for the twelve months ended December 31, 2021 were $165.0
million, net of grant income and license revenue of $2.3 million,
as compared to net operating expenses of $168.1 million, net of
grant income and license revenue of $1.7 million, for the same
period in 2020.
Research and development expenses remained relatively flat at
$134.8 million for the year ended December 31, 2021 when compared
to $134.9 million for the year ended December 31, 2020. Cash costs,
which exclude depreciation and amortization as well as share-based
compensation, increased to $121.4 million from $116.9 million. The
increase in research and development cash costs of $4.5 million
consisted primarily of (i) an increase in compensation and
employment related costs of $3.8 million due to a combination of an
increase in employee headcount, to support the advancement of our
product candidates in clinical development, and to severance
payments related to the reduction in workforce that was initiated
during the first quarter of 2021, (ii) an increase of $2.5 million
in facilities costs related to the continued scaling of
manufacturing operations, (iii) an increase of $2.4 million in
purchased consumables used in the manufacturing of obe-cel in the
FELIX study, (iv) an increase of $0.9 million in IT infrastructure
and support for information systems related to the conduct of
clinical trials and manufacturing operations, and (v) an increase
of $0.1 million related to cell logistics, which is offset by a
reduction in clinical trial costs of $5.2 million.
Non-cash costs decreased to $13.4 million for the year ended
December 31, 2021 from $18.1 million for the year ended December
31, 2020. The $4.7 million decrease of non-cash costs is related to
a decrease of $7.7 million share-based compensation expense as a
result of a lower fair value of options recognized during the
period and due to the reduction in workforce that was initiated
during the first quarter of 2021, offset by a $3.0 million increase
in depreciation expense.
General and administrative expenses decreased to $31.9 million
for the year ended December 31, 2021 from $35.0 million for the
year ended December 31, 2020. Cash costs, which exclude
depreciation as well as share-based compensation decreased to $26.7
million from $27.4 million. There were decreases of $0.7 million of
costs related to (i) $0.8 million of expenses relating to the
Company's commercial preparation costs, (ii) $0.6 million of
employee compensation expense due to the reduction in workforce
during the first quarter of 2021 and lower retention costs, (iii)
$0.5 million of facilities costs, and (iv) $0.1 million in general
administration expenses, offset by increases in director and
officer insurance and IT infrastructure and support for information
systems of $1.0 million and $0.3 million, respectively.
Non-cash costs decreased to $5.2 million for the year ended
December 31, 2021 from $7.6 million for the year ended December 31,
2020. The $2.4 million decrease of non-cash costs is mainly
attributed to lower share-based compensation expenses as a result
of the lower fair value of options recognized during the period and
due to the reduction in workforce that was initiated during the
first quarter of 2021.
Interest income decreased to $0.3 million for the year ended
December 31, 2021 from $0.5 million for the year ended December 31,
2020. This decrease is due to the lower cash balances held during
the year combined with lower interest rates for cash held on
deposit.
Interest expense increased to $1.1 million for the year ended
December 31, 2021 and relates to the liability relating to the sale
of future revenue which arose upon entering into the Collaboration
and Financing Agreement with Blackstone.
Income tax benefit decreased to $23.9 million for the year ended
December 31, 2021 from $24.2 million for the year ended December
31, 2020 due to small decrease in the research and development
expenditures which were qualifying for tax credits for the year. As
research and development credits fell at a faster rate than the
Company's net loss before income tax, this led to a lower effective
tax rate. Research and development credits are obtained at a
maximum rate of 33.35% of the Company's qualifying research and
development expenses, and the decrease in the net credit was
primarily attributable to a decrease in its eligible research and
development expenses.
Net loss attributable to ordinary shareholders was $142.1
million for the twelve months ended December 31, 2021, compared to
$142.1 million for the same period in 2020. The basic and diluted
net loss per ordinary share for the twelve months ended December
31, 2021, totaled $(1.97) compared to a basic and diluted net loss
per ordinary share of $(2.76) for the twelve months ended December
31, 2020.
Autolus estimates that its current cash on hand and anticipated
milestone payments from Blackstone, extends the Company's runway
into 2024.
Financial Results for the Year Ended December 31, 2021
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2021 2020
---------- ----------
Assets
Current assets:
Cash $310,338 $153,299
Restricted cash 338 786
Prepaid expenses and other current assets 36,276 42,899
---------- ----------
Total current assets 346,952 196,984
Non-current assets:
Property and equipment, net 33,541 38,046
Prepaid expenses and other non-current assets 2,362 3,033
Operating lease right-of-use assets, net 18,775 51,637
Long-term deposits 2,039 2,625
Deferred tax asset 1,826 1,754
Intangible assets, net 65 158
---------- ----------
Total assets $405,560 $294,237
========== ==========
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 431 2,263
Accrued expenses and other liabilities 23,667 27,781
Operating lease liabilities, current 4,453 3,590
---------- ----------
Total current liabilities 28,551 33,634
Non-current liabilities:
Operating lease liabilities, non-current 16,545 50,571
Liability related to sale of future revenue, 47,016 -
net
Other long term payables 128 -
---------- ----------
Total liabilities 92,240 84,205
Commitments and contingencies (Note 15)
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized at December 31, 2021 and
2020, 90,907,830 and 52,346,231 shares issued
and outstanding at December 31, 2021 and 2020 4 3
Deferred shares, GBP0.00001 par value; 34,425
shares authorized, issued and outstanding at
December 31, 2021 and 2020 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at
December 31, 2021 and 2020 118 118
Deferred C shares, GBP0.000008 par value; 1
share authorized, issued and outstanding at
December 31, 2021 and 2020 - -
Additional paid-in capital 843,108 595,016
Accumulated other comprehensive loss (8,570) (5,861)
Accumulated deficit (521,340) (379,244)
---------- ----------
Total stockholders' equity 313,320 210,032
---------- ----------
Total liabilities and stockholders' equity $405,560 $294,237
========== ==========
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
December 31,
2021 2020 2019
----------- ----------- -----------
Grant income $823 $1,473 $2,908
License revenue 1,507 242 -
Operating expenses:
Research and development (134,789) (134,888) (105,418)
General and administrative (31,865) (34,972) (39,452)
Loss on impairment of leasehold improvements - - (4,102)
Loss on disposal of leasehold improvements (676) - -
----------- ----------- -----------
Total operating expenses, net (165,000) (168,145) (146,064)
Other (expense) income:
Interest income 262 536 2,542
Other (expense) income (145) 1,352 4,514
Interest expense (1,105) - -
----------- ----------- -----------
Total other (expense) income, net (988) 1,888 7,056
----------- ----------- -----------
Net loss before income tax (165,988) (166,257) (139,008)
Income tax benefit 23,892 24,163 15,159
----------- ----------- -----------
Net loss attributable to ordinary
shareholders (142,096) (142,094) (123,849)
Other comprehensive (loss) income:
Foreign currency exchange translation
adjustment (2,709) 2,830 6,797
----------- ----------- -----------
Total comprehensive loss (144,805) (139,264) (117,052)
=========== =========== ===========
Basic and diluted net loss per ordinary
share $(1.97) $(2.76) $(2.88)
Weighted-average basic and diluted
ordinary shares 72,034,803 51,558,075 43,065,542
Conference Call
Management will host a conference call and webcast today at 8:30
am ET/1:30 pm GMT to discuss the Company's financial results and
provide a general business update. To listen to the webcast and
view the accompanying slide presentation, please go to the events
section of Autolus' website.
The call may also be accessed by dialing (866) 679-5407 for U.S.
and Canada callers or (409) 217-8320 for international callers.
Please reference conference ID: 2794888. After the conference call,
a replay will be available for one week. To access the replay,
please dial (855) 859-2056 for U.S. and Canada callers or (404)
537-3406 for international callers. Please reference conference ID:
2794888.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing
next-generation, programmed T cell therapies for the treatment of
cancer. Using a broad suite of proprietary and modular T cell
programming technologies, the Company is engineering precisely
targeted, controlled and highly active T cell therapies that are
designed to better recognize cancer cells, break down their defense
mechanisms and eliminate these cells. Autolus has a pipeline of
product candidates in development for the treatment of
hematological malignancies and solid tumors. For more information,
please visit www.autolus.com.
About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to
overcome the limitations in clinical activity and safety compared
to current CD19 CAR T cell therapies. Designed to have a fast
target binding off-rate to minimize excessive activation of the
programmed T cells, obe-cel may reduce toxicity and be less prone
to T cell exhaustion, which could enhance persistence and improve
the ability of the programmed T cells to engage in serial killing
of target cancer cells. In collaboration with Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase 1
clinical trials for B-NHL. Autolus has progressed obe-cel to the
FELIX trial, a potential pivotal trial for adult ALL.
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling adult
patients with relapsed / refractory B-precursor ALL. The trial had
a Phase 1b component prior to proceeding to the single arm, Phase 2
clinical trial. The primary endpoint is overall response rate, and
the secondary endpoints include duration of response, MRD negative
CR rate and safety. The trial is designed to enroll approximately
100 patients across 30 of the leading academic and non-academic
centers in the United States, United Kingdom and Europe.
[NCT04404660]
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell based therapy
candidate based on obe-cel. It is designed to combine the enhanced
safety, robust expansion & persistence seen with the fast off
rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to
reduce antigen negative relapses. This product candidate is
currently in a Phase 1 clinical trial for patients with r/r
pediatric ALL. [ NCT02443831 ]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO4 is
specifically designed to target TRBC1 derived cancers, which
account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in
pre-clinical development.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO5 is
specifically designed to target TRBC2 derived cancers, which
account for approximately 60% of T cell lymphomas, and is a
complement to the AUTO4 T cell product candidate currently in
clinical development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate
in pre-clinical development. AUTO6NG builds on preliminary proof of
concept data from AUTO6, a CAR targeting GD2-expression cancer cell
currently in clinical development for the treatment of
neuroblastoma. AUTO6NG incorporates additional cell programming
modules to overcome immune suppressive defense mechanisms in the
tumor microenvironment, in addition to endowing the CAR T cells
with extended persistence capacity. AUTO6NG is currently in
pre-clinical development for the potential treatment of both
neuroblastoma and other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple
myeloma which comprises two independent CARs for the multiple
myeloma targets, BCMA and CD19. We have developed an optimized BCMA
CAR which is designed for improved killing of target cell that
express BCMA at low levels. This has been combined with fast off
rate CD19 CAR from obe-cel. We believe that the design of AUTO8 has
the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in
development.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts, and in
some cases can be identified by terms such as "may," "will,"
"could," "expects," "plans, " "anticipates," and "believes." These
statements include, but are not limited to, statements regarding
Autolus' development of the obe-cel program; the future clinical
development, efficacy, safety and therapeutic potential of its
product candidates, including progress, expectations as to the
reporting of data, conduct and timing and potential future clinical
activity and milestones; expectations regarding the initiation,
design and reporting of data from clinical trials; expectations
regarding regulatory approval process for any product candidates;
the collaboration between Autolus and Blackstone; the discovery,
development and potential commercialization of potential product
candidates including obe-cel using Autolus' technology and under
the collaboration agreement; the therapeutic potential for Autolus
in next generation product developments of obe-cel in B-cell
malignancies; the potential and timing to receive milestone
payments and pay royalties under the strategic collaboration; and
the Company's anticipated cash runway. Any forward-looking
statements are based on management's current views and assumptions
and involve risks and uncertainties that could cause actual
results, performance, or events to differ materially from those
expressed or implied in such statements. These risks and
uncertainties include, but are not limited to, the risks that
Autolus' preclinical or clinical programs do not advance or result
in approved products on a timely or cost effective basis or at all;
the results of early clinical trials are not always being
predictive of future results; the cost, timing and results of
clinical trials; that many product candidates do not become
approved drugs on a timely or cost effective basis or at all; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; and the impact of the ongoing COVID-19 pandemic
on Autolus' business. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause Autolus' actual results to differ from those contained in the
forward-looking statements, see the section titled "Risk Factors"
in Autolus' Annual Report on Form 20-F filed with the Securities
and Exchange Commission on March 4, 2021, as well as discussions of
potential risks, uncertainties, and other important factors in
Autolus' subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Autolus undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by
law.
Contact:
Olivia Manser
o.manser@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
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