Exscientia plc (Nasdaq: EXAI):
Recent advancements in the Company’s pipeline, collaborations
and operations, as well as financial results for the third quarter
of 2023, are summarised below. Exscientia will host a conference
call Thursday, November 9 at 1:30 p.m. GMT / 8:30 a.m. EST.
“At Exscientia, we are laser-focused on building an engine that
designs and develops high impact medicines that have the potential
to transform patients’ lives,” said Professor Andrew Hopkins FRS
FMedSci, founder and Chief Executive Officer of Exscientia. “We are
continuing to build out a highly-differentiated internal oncology
pipeline, particularly with clinical and IND-enabling stage
programmes targeting CDK7 and LSD1. In addition, our partnerships
are steadily progressing, including our recently announced first
milestone with Sanofi and a new collaboration with Merck KGaA,
Darmstadt, Germany. These advancements, paired with our commitment
to technological capabilities, such as automation and ex vivo
patient tissue analysis, solidify Exscientia’s leadership in
AI-enabled drug design and development.”
Recent Highlights
Internal pipeline
- ELUCIDATE, the adaptive Phase 1/2 trial studying GTAEXS617
(‘617), Exscientia and partner GT Apeiron’s potential best-in-class
CDK7 inhibitor, continues to enrol patients with advanced solid
tumours including head and neck cancer, pancreatic cancer,
non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer,
colorectal cancer and ovarian cancer
- The Company announced in October 2023 that it is prioritising
the advancement of its LSD1 inhibitor, EXS74539 (‘539), towards the
clinic, with IND submission expected in 1Q 2024 and commencement of
a first-in-human healthy volunteer trial anticipated in 1H 2024 in
the United States
-
Exscientia presented new preclinical data at the European
Society for Medical Oncology (ESMO) Congress 2023, demonstrating
that ‘539 induces differentiation of primary human acute myeloid
leukaemia (AML) samples ex vivo, highlighting potential activity of
‘539 in AML
-
The Company also presented data supporting ‘539’s combinatorial
potential with standard of care AML treatments
- EXS73565 (‘565), the Company’s MALT1 inhibitor, continues to
progress through IND/CTA-enabling studies and the Company expects
to provide further updates in 1H 2024
Partnered programmes
- In September 2023, Exscientia announced a new collaboration
with Merck KGaA, Darmstadt, Germany focused on the discovery of
novel small molecule drug candidates across oncology and immunology
using Exscientia’s AI-driven precision drug design and discovery
capabilities
-
Three potential first-in-class or best-in-class targets have
been identified as the initial focus of the partnership
-
Exscientia will receive $20 million upfront and is eligible for
discovery, development, regulatory and sales-based milestone
payments
- In September 2023, Exscientia achieved the first milestone in
its collaboration with Sanofi
-
$4 million milestone payment represents first of up to $343
million in milestone payments per programme
-
First target identified in immunology & inflammation
(I&I) is one of up to 15 oncology and immunology targets
- EXS4318 (‘4318), a PKC-theta inhibitor designed by Exscientia
and in-licensed by Bristol-Myers Squibb, is continuing in a Phase 1
study
-
Two programmes designed by Exscientia for Sumitomo Pharma,
DSP-0038 (5-HT1A agonist/5-HT2A antagonist) and DSP-2342 (dual
5-HT2A/5-HT7 antagonist), are also continuing in Phase 1
studies
-
As part of the company’s pipeline prioritisation, Exscientia
refined its internal and partnered discovery pipelines to focus
investment on programmes that Exscientia and its partners believe
are differentiated and that have the highest potential impact
-
In October 2023, the Company announced that it had discontinued
internal development of its A2A receptor antagonist, EXS21546, and
is winding down the Phase 1/2 clinical trial of ‘546 for the
treatment of relapsed/refractory renal cell carcinoma and NSCLC
- The Company ended its collaboration with EQRx following EQRx’s
announced acquisition by Revolution Medicines. Exscientia retained
the exclusive rights to the intellectual property from all
collaboration projects
-
The Company and Bristol Myers Squibb (BMS) mutually determined
not to proceed with development of certain projects and prioritise
others within the BMS collaboration
-
Work is progressing on multiple projects with Sanofi, BMS and
Merck KGaA, Darmstadt, Germany
Technology updates
- In September 2023, Exscientia presented data on its automated
kinase design method, which is able to deliver potent kinase hits
on certain targets from AlphaFold structures. Learnings from prior
successful projects were encoded and automated to develop this
tool. The Company expects to apply it at scale across future
projects
- Exscientia’s automation facility recently opened and the
Company has begun moving select biological assays and chemical
synthesis to the facility. Productivity in the automated laboratory
will ramp up through 2024, with meaningful impact on data and
efficiency expected in 2025
Precision medicine
- EXCYTE-1, the first multi-centre trial evaluating the potential
of Exscientia’s functional precision medicine platform in a solid
tumour indication continues to progress in ovarian cancer
- Exscientia’s collaboration with Charité – Universitätsmedizin
Berlin in haematological cancers is ongoing, which is utilising
cloud-based AI to analyse samples imaged onsite at Charité
Investor Call and Webcast Information
Exscientia will host a conference call on Thursday, November 9
at 1:30 p.m. GMT / 8:30 a.m. EST.
A webcast of the live call can be accessed by visiting the
“Investors and Media” section of the Company’s website at
investors.exscientia.ai. Alternatively, the live conference call
can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433
3846 (U.K.), +1 (646) 960 0857 (International) and entering the
conference ID: 8333895. A replay will be available for 90 days
under “Events and Presentations” in the “Investors and Media”
section of the Exscientia website.
Third Quarter and First Nine Months 2023 Financial
Results
For the convenience of the reader, the company has translated
pound sterling amounts to U.S. dollars at the rate of £1.000 to
$1.2214, which was the noon buying rate of the Federal Reserve Bank
of New York on September 29, 2023.
Revenue: Revenue for the three and nine months ended
September 30, 2023 was $10.8 million and $21.6 million
respectively, compared to $7.7 million and $24.9 million for the
three and nine months ended September 30, 2022. The increase in
revenue quarter over quarter was primarily due to $8.38 million in
revenue recognised from the projects that Exscientia and BMS
mutually determined not to proceed with further development of
under the BMS collaboration.
Research and development expenses: R&D expenses for
the three and nine months ended September 30, 2023 were $39.8
million and $120.9 million respectively, as compared to $44.9
million and $113.9 million for the same period ended September 30,
2022. The current quarter over quarter decrease in research and
development expenses was due to pipeline prioritisation activities
and cost savings from operational efficiencies, including achieving
faster cycle times and lower outsourcing costs.
General and administrative expenses: G&A expenses for
the three and nine months ended September 30, 2023, were $13.6
million and $41.1 million respectively, or 22% of total operating
expenses. For the three and nine months ended September 30, 2023,
G&A expenses increased by $1.0 million and $4.2 million
compared to the three and nine months ended September 30, 2022,
primarily associated with the growth of the business being offset
by automation and cost efficiency measures.
Cash inflows: For the first nine months of 2023,
Exscientia received $3.5 million in cash inflows from its
collaborations as compared to $117.3 million during the first nine
months of 2022, when the upfront payment for the Sanofi
collaboration was received.
Net operating cash flow and cash balance: For the first
nine months ended September 30, 2023, net operating cash outflows
were $145.1 million, in comparison to net operating cash outflows
of $16.5 million for the nine months ended September 30, 2022.
Cash, cash equivalents and short term bank deposits as of September
30, 2023 were $447.8 million, as compared to $617.8 million as of
December 31, 2022 using the September 30, 2023 constant currency
rate. With its pipeline prioritisation strategy, the Company
expects to maintain a cash runway well into 2026.
- Includes constant currency mark-to-market foreign exchange
impact of 1% based on a slight strengthening of pounds sterling for
the nine months through September 30, 2023
- During the third quarter of 2023, Exscientia recognised net
foreign exchange gain of $4.0 million
- The Company holds its deposits in both GBP and USD, intended to
match expected operational cash needs in order to limit the impact
of exchange rate fluctuations
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT
CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
$1.2214)
Three months ended September
30,
Nine months ended September
30,
2023
2022
2023
2022
Revenue
10.8
7.7
21.6
24.9
Cost of sales
(8.2)
(11.2)
(26.2)
(29.0)
Research and development expenses
(39.8)
(44.9)
(120.9)
(113.9)
General and administrative expenses
(13.6)
(12.6)
(41.1)
(36.9)
Operating expenses
(61.6)
(68.7)
(188.2)
(179.8)
Foreign exchange gains/(losses)
4.0
9.0
2.0
35.0
Other income
1.4
1.5
6.8
5.1
Operating loss
(45.4)
(50.5)
(157.8)
(114.8)
Finance income/(expense)
5.1
2.5
13.9
3.0
Share of loss on joint ventures
(0.7)
(0.1)
(1.4)
(0.8)
Loss before taxation
(41.0)
(48.1)
(145.3)
(112.6)
Income tax benefit
2.9
4.8
17.4
15.4
Loss for the period
(38.1)
(43.3)
(127.9)
(97.2)
Net loss per share
(0.31)
(0.35)
(1.03)
(0.79)
Weighted average shares outstanding
(basic and diluted)
124,511,492
122,674,016
123,844,172
121,851,437
SELECTED CONSOLIDATED STATEMENT OF CASH FLOWS. CONSTANT
CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
$1.2214)
September 30, 2023
December 31, 2022
Cash, cash equivalents & short-term
bank deposits
447.8
617.8
Total assets
671.9
793.5
Total equity
480.0
584.9
Total liabilities
191.9
208.6
Total equity and liabilities
671.9
793.5
SELECTED CONSOLIDATED STATEMENT OF CASH FLOWS. CONSTANT
CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
$1.2214)
Nine months ended September
30,
2023
2022
Net cash outflows from operating
activities
(145.1)
(16.5)
Net cash flows used in investing
activities
(211.4)
(142.7)
Net cash used in financing activities
(3.1)
(4.2)
Net decrease in cash and cash
equivalents
(359.7)
(163.4)
Exchange (loss)/gain on cash and cash
equivalents
(1.0)
39.1
Net decrease in cash, cash equivalents
and short-term bank deposits*
(170.0)
(1.3)
* Includes both increases in short term
bank deposits and foreign exchange gains on cash and cash
equivalents
About Exscientia
Exscientia is an AI-driven precision medicine company committed
to discovering, designing and developing the best possible drugs in
the fastest and most effective manner. Exscientia developed the
first-ever functional precision oncology platform to successfully
guide treatment selection and improve patient outcomes in a
prospective interventional clinical study, as well as to progress
AI-designed small molecules into the clinical setting. Our internal
pipeline is focused on leveraging our precision medicine platform
in oncology, while our partnered pipeline broadens our approach to
other therapeutic areas. By pioneering a new approach to medicine
creation, we believe the best ideas of science can rapidly become
the best medicines for patients.
Visit us at www.exscientia.ai or follow us on X/Twitter
@exscientiaAI.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. Words such as
“anticipates,” "believes," “expects,” "intends," "projects," and
"future" or similar expressions are intended to identify
forward-looking statements. These forward-looking statements,
include statements with regard to Exscientia’s expectations
regarding its the initiation, timing and progress of, and data
collected during and reported from, the Company’s clinical trials,
as well as expectations with respect to the outcome or benefit of
such trials, expectations regarding the performance of Exscientia’s
technology platform, including its automated kinase design method,
and the Company’s expectation that its existing cash and cash
equivalents will be sufficient to fund its operations into 2026.
Such statements are subject to a number of risks, uncertainties and
assumptions, including those related to: the initiation, scope and
progress of Exscientia’s and its partners’ planned and ongoing
preclinical studies and clinical trials and ramifications for the
cost thereof; clinical, scientific, regulatory and technical
developments; the process of discovering, developing and
commercialising product candidates that are safe and effective for
use as human therapeutics; and the endeavour of building a business
around such product candidates. In light of these risks and
uncertainties, and other risks and uncertainties that are described
in the Risk Factors section and other sections of Exscientia’s
Annual Report on Form 20-F, filed with the Securities and Exchange
Commission (SEC) on March 23, 2022 (File No. 001-40850), and other
filings that Exscientia makes with the SEC from time to time (which
are available at https://www.sec.gov/), the events and
circumstances discussed in such forward-looking statements may not
occur, and Exscientia’s actual results could differ materially and
adversely from those anticipated or implied thereby. Although
Exscientia’s forward-looking statements reflect the good faith
judgement of its management, these statements are based only on
facts and factors currently known by the Company. As a result, you
are cautioned not to rely on these forward-looking statements.
Exscientia undertakes no obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231109551909/en/
Investor Relations: Sara Sherman
investors@exscientia.ai
Media: Oliver Stohlmann media@exscientia.ai
Exscientia (NASDAQ:EXAI)
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