Exscientia Business Update for First Quarter 2024
Positive early Phase 1 results for BMS-partnered programme ‘4318 (PKC-theta inhibitor)
GTAEXS617 (CDK7 inhibitor) initial Phase I data expected in 2H24
LSD1 and MALT1 inhibitor programmes expected to advance into clinic in 2H24 and early 2025 , respectively
AI-design integration enhanced with full experiment automation driving towards maximum speed, quality and autonomous drug design
Leveraging technology advancements and streamlining operations to realise annualised savings of
“With the ramp up of activities at our automation lab, we are beginning to see the transformative power of fully integrating AI drug design with the sheer capacity of comprehensive robotic automation across the entire experimentation cycle,” said Dr.
Key Business Updates
Pipeline
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Patient enrolment for the dose escalation phase of the Company’s adaptive Phase 1/2 ELUCIDATE trial evaluating ‘617, a potential best-in-class CDK7 inhibitor for the treatment of advanced solid tumours, is ongoing.
Exscientia anticipates moving into a combination phase of the trial in the second half of 2024- The Company expects to announce topline pharmacokinetics and safety data from the dose escalation phase of the trial in the second half of 2024
- EXS74539 (‘539), Exscientia’s highly differentiated LSD1 inhibitor, is advancing through IND/CTA-enabling studies. The Company anticipates submitting an IND or CTA in the third quarter of 2024, with the goal to initiate a Phase 1/2 clinical trial in AML patients by the end of 2024
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Based on patient unmet need, supporting preclinical data and the unique precision designed properties of Exscientia’s MALT1 inhibitor, EXS73565 (‘565), the Company is preparing to submit an IND or CTA in the second half of 2024 to study ‘565 in a Phase 1/2 clinical trial in B-cell malignancies, including CLL, which
Exscientia expects to launch in early 2025- This clinical development programme aims to support the assessment of ‘565 in combination with current standard of care options
Collaborations & Partnerships
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EXS4318 (‘4318), a potential first-in-class PKC-theta inhibitor designed by
Exscientia and in-licensed byBristol Myers Squibb , has shown positive early results in its Phase 1 study and has the potential to be a first-in-class immunology drugExscientia designed the first potent and selective PKC-theta inhibitor after over ten biopharma companies halted programmes for drug candidates designed using traditional drug discovery techniquesExscientia retains rights to receive milestone payments and potential royalties for ‘4318
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The Sanofi partnership continues to make strong progress across multiple programmes, primarily focused on inflammation & immunology targets
Exscientia received a$4.0 million payment in the first quarter of 2024 related to the additional programme that entered the portfolio inDecember 2023
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Exscientia’s collaboration with Merck KGaA, Darmstadt,
Germany continues to advance with multiple programmes now in early discovery
Advancing autonomous drug design and experimentation
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The first three drug discovery programmes have been initiated in the Company’s novel, industry leading discovery automation laboratory
- The facility is expected to be fully operational by year end - additional drug discovery programmes are expected to commence on the platform in the coming months
- The automation lab tightly integrates artificial intelligence with robotic experimentation creating fully automated, generative design-make-test-learn (DMTL) loops
- This has the potential to dramatically reduce the time and cost of discovery cycles and lower the need for contract research organisations as well as redefining how AI-based design can be autonomously integrated with laboratory experimentation
Benefits from integration of technology and streamlining activities continues to improve operational efficiencies
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While continuing to focus on its strategic priorities,
Exscientia will initiate efficiency measures through the rest of the year designed to streamline the Company’s operations, which it expects to result in annualised savings of$40 million or more beginning in 2025- A number of Exscientia’s multi-year investments, including projects related to its proprietary technology platform, are coming to conclusion and expected to result in efficiency gains
- The changes also leverage the expected efficiency gains from the Company’s automation laboratory and will not impact the internal pipeline, partnership or drug design activities
- As part of these cost efficiency measures, a 20-25% headcount reduction is expected to be completed by the end of 2024, targeting some areas of target identification, precision medicine, experimentation, engineering and infrastructure
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The initiative is expected to result in severance and termination-related costs that will be between approximately
$7.4 million and$9.6 million .Exscientia expects to record these charges in the second quarter of 2024 and pay these costs throughout the remainder of the calendar year - Excluding any potential cash inflows from new business development or financing, these changes are expected to extend the Company’s cash runway well into 2027
Investor Call and Webcast Information
First Quarter 2024 Financial Results
For the convenience of the reader, the Company has translated pound sterling amounts to
Revenue: Revenue for the first quarter of 2024 was
Research and development expenses (R&D): R&D expenses for the three months ended
General and administrative expenses (G&A): G&A expenses for the three months ended
Cash inflows: For the three months ended
Net operating cash flow and cash balance: For the three months ended
Based on its current operating plans, including the addition of the Sanofi programme and after accounting for the headcount reduction and other anticipated cost efficiencies, the Company believes that its existing cash, cash equivalents and short-term bank deposits and anticipated milestones will be sufficient to fund its operations and capital expenditure requirements well into 2027. This estimate excludes any potential cash inflows from new business development or financing activities.
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
|
Three months ended |
|||
|
2024 |
2023 |
||
Revenue |
6.7 |
7.3 |
||
Cost of sales |
(9.4) |
(10.7) |
||
Research and development expenses |
(29.8) |
(42.2) |
||
General and administrative expenses |
(4.3) |
(13.8) |
||
Operating expenses |
(43.5) |
(66.7) |
||
Foreign exchange gains/(losses) |
1.1 |
(1.5) |
||
Other income |
1.6 |
3.3 |
||
Operating loss |
(34.1) |
(57.6) |
||
Net finance income |
4.6 |
4.2 |
||
Share of loss on joint ventures |
(0.7) |
(0.6) |
||
Loss before taxation |
(30.2) |
(54.0) |
||
Income tax benefit |
3.7 |
6.5 |
||
Loss for the period |
(26.5) |
(47.5) |
||
Net loss per share |
(0.21) |
(0.39) |
||
Weighted average shares outstanding (basic and diluted) |
125,975,607 |
123,257,529 |
SELECTED CONSOLIDATED BALANCE SHEET, CONSTANT CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
|
|
|
||
Cash, cash equivalents and short term deposits |
416.9 |
458.8 |
||
Total assets |
598.4 |
645.4 |
||
Total equity |
417.7 |
449.5 |
||
Total liabilities |
180.7 |
195.9 |
||
Total equity and liabilities |
598.4 |
645.4 |
SELECTED CONSOLIDATED STATEMENT OF CASH FLOWS, CONSTANT CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to
|
|
|
||
Net cash outflows from operating activities |
(39.0) |
(54.8) |
||
Net cash flows used in investing activities |
(63.0) |
(206.5) |
||
Net cash used in financing activities |
(1.1) |
(0.9) |
||
Net decrease in cash and cash equivalents |
(103.1) |
(262.2) |
||
Exchange gain/(loss) on cash and cash equivalents |
0.6 |
(2.1) |
||
Net decrease in cash, cash equivalents and short-term bank deposits* |
(41.9) |
(73.9) |
* Includes both increases in short term bank deposits and foreign exchange gains/(losses) on cash and cash equivalents
About
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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,” and “projects” or similar expressions are intended to identify forward-looking statements. These forward-looking statements, include statements with regard to Exscientia’s expectations regarding: the initiation, timing and progress of, and data collected during and reported from, the Company’s and its partners’ clinical trials, as well as expectations with respect to the outcome or benefit of such trials; the progress of Exscientia’s collaborations and partnered programmes; the commencement of additional discovery programmes using Exscientia’s platform and automation facility; the timing and outcome of and any anticipated savings from Exscientia’s planned headcount reduction and other cost efficiency measures; and the Company’s expectation that its existing cash, cash equivalents and short-term bank deposits will be sufficient to fund its operations well into 2027. 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 development and deployment of new technology and facilities; the timing and effects of the planned headcount reduction and other cost efficiency measures; and 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
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