Continuing to build the foundations for commercial success.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its unaudited interim results for the six months ended 30 June 2023.

Operational highlights (including post-period end)

• Initial revenues following the commercial launch of our first product, Tutivia™, the Company’s post-transplant prognostic test for the assessment of risk of acute kidney rejection.
  • Full year revenues from Tutivia™ are likely to be less than expected although the Company has recently doubled the number of US transplant centers as early adopters of the test.
• The impact of lower Tutivia™ revenues is expected to be offset by higher than expected research-related revenues
  so that that cash runway expectations to mid-2024 are unchanged at this time.
• Successful clinical validation of our second product, Clarava™, the Company’s pre-transplant prognostic test, demonstrating a statistically significant result and capability to stratify patients based on their likely immune response to a transplanted kidney, informing a clear, actional response for clinicians.
  • Clarava™ is on track for initial US commercial use by the end of 2023 under prospective real-world evidence studies.
• Completed patient enrolment for the multi-centre clinical validation study of the Company’s third product, ProtegaTM, assessing long-term outcomes for kidney transplant patients.
• Received preliminary gapfill median rate of $2,650 proposed for both Clarava™ and Tutivia™ by the Centers for Medicare & Medicaid Services (“CMS”). These rates are due to be finalised later this year and represent a substantial uplift from the Company’s initial assumption for modelling purposes.
• Two key patents granted in the United States underpinning Verici Dx’s products.
• Achieved CLIA Certificate of Compliance for clinical laboratory in Nashville, TN, USA, a key requirement to obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial launch of Tutivia™ in 49 out of 50 US states to date.
• Submitted final responses to comments for our peer-reviewed publication on the Tutivia™ clinical validation. Final publication dependent on publishers.
• Initiated studies in our databank to facilitate product development and further research collaborations.
• Obtained Medicaid approvals in 15 States and a further 12 States pending.

Outstanding clinician feedback on Tutivia™
We have been delighted with the feedback on Tutivia™ following its commercial launch at the start of 2023.

“In the first few months post-transplant there are many rejection events and yet in my opinion we have not really had a biomarker that can assist at this critical time. Tutivia™ is able to give the clinician reliable test results as soon as the first week post-transplant and so is an early biomarker test which addresses this critical need.”

Dr Nicolae Leca Professor, Medical Director, Kidney and Pancreas Transplant - University of Washington

 

Financial highlights

• Adjusted EBITDA loss of $4.8m (six months to 30 June 2022: loss of $5.0m), excluding share-based payments.
• $5.3m cash balance as at 30 June 2023 (31 December 2022: $9.8m).
• Net cash outflow from operating activities in the six months to 30 June 2023 was $4.7m (six months to 30 June
  2022: $5.0m) with investing activities consuming a further $0.1m (six months to 30 June 2022: $0.7m).

The full year revenues are expected to be lower than originally projected from Tutivia™ but offset by higher than expected revenues from research collaborations. Revenues and containment of total costs mean that cash runway expectations to mid-2024 are unchanged at this time.

Sara Barrington, Chief Executive Officer of Verici Dx, said:
“I am proud of the progress we have made in the first six months of this year. The clinician response to our first product, Tutivia™, following its commercial launch at the start of the year clearly demonstrates how much they value the key benefits and recognise the strong differentiating features. We are also excited to have announced a second successful product, Clarava™, following the recently completed clinical validation study showing excellent results. This allows us to prepare for its initial launch in due course. We also completed enrolment for the validation study on our third product, ProtegaTM. Whilst this product has a much longer time frame, it completes the end-to-end testing for the portfolio as we look ahead.

“Although the timing effects on early adoption are frustrating, we have been able to make savings in other areas and are focused on research collaborations to help build a solid platform for future growth. At the same time, we are continuing to deliver on our strategy of transforming kidney transplant patient outcomes, as we move further into commercialisation.”

Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on Thursday October 5 at 4.30pm BST.

This presentation is open to all existing and potential shareholders. Questions can be submitted at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet VERICI Dx PLC via:
https://www.investormeetcompany.com/verici-dx-plc/register-investor

Investors who already follow Verici Dx on the Investor Meet Company platform will automatically be invited.

A copy of the Company’s interim results report will shortly be made available on the Company’s website.

US clinical laboratory now fully accredited in 49 states

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that further to the RNS dated 2 March 2023, the Company has received compliance authorisation for the operation of its commercial clinical laboratory testing in respect of samples from an additional four US states, including the important addition of California, with the Company laboratory now fully accredited in a total of 49 states.

Together with the CLIA certification previously obtained from the Centers for Medicare & Medicaid (“CMS”), clinicians at transplant medical centres in these additional states are now enabled to order Verici Dx’s transplant tests, expanding the Company’s commercial reach. California has consistently accounted for over 10 per cent. of the national US volume of kidney transplant procedures in each year since 1998 and has conducted the highest volume of transplants by any state each year over the same period.

Verici Dx launched its first product, Tutivia™, for the detection of acute rejection in kidney post-transplant patients, in January 2023 and recently announced the successful validation of Clarava™, a first-in-class pre-transplant prognosis test for the risk of early acute rejection in deceased donor recipients, which it expects to launch later this year. The additional state accreditations provide further validation of Verici Dx’s clinical laboratory for its tests to be used by transplant clinicians across the US.

The Company continues to work towards full accreditation in the final state of New York, which has its own
compliance requirements.

The CLIA certification and additional state approvals further exemplify Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostic services to clinicians and patients in need.

Sara Barrington, CEO of Verici Dx, said: “This is another important step in our strategy, expanding our commercial reach and making it easier for clinicians to order our tests helping to drive the adoption of both Tutivia TM and Clarava TM .”

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Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

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N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.  The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

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Clarava™, a first-in-class pre-transplant prognostic test for risk of early kidney rejection,
On track for US commercial launch by end of 2023

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces successful validation results from its prospective, blinded, international multi-centre clinical validation study for Clarava™. Clarava™, is the first pre-transplant prognostic test to enable measurement of a patient's immune response to assess the risk of early kidney graft rejection. The validation study represents a significant demonstration of Clarava™ as a predictive test capable of informing a clear, actionable response from clinicians for an estimated 65,000 eligible patients on an annual basis.

Verici Dx is on track to commence the initial US commercial launch of Clarava™ before the end of 2023. The Company has received a preliminary Medicare gapfill median rate of $2,650 for Clarava™ from the Centers for Medicare & Medicaid Services ("CMS").¹

"There is a desperate global need for an effective, personalised pre-transplant test that can identify the risk of kidney transplant rejection to inform treatment decisions. The suboptimal dosing of immunosuppressants can have detrimental consequences for patients and create additional, unnecessary healthcare costs. Clarava™ has the potential to transform kidney transplant treatment protocols and improve outcomes for patients," said Dr. Lorenzo Gallon, Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University, Chair of the Verici Dx Science Advisory Board and Non-Executive Director of the Company.

The Clarava™ study, which included a broad and diverse group of 122 patients preparing to receive a kidney transplant and a range of rejection outcomes across 13 centres, demonstrated a statistically significant result with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 to 90 days post-transplant, after receiving a kidney from a deceased donor ("DD"). Study data analysis of the clinical performance of Clarava™ demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times more likely to have a rejection than those of low risk. This represents a significant demonstration of Clarava™ as a predictive test capable of informing for a clear, actionable response from clinicians. Whilst DDs provide the majority of kidney transplants, the Company will be also exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, Clarava™ in conjunction with our post-transplant test, Tutivia™.

Clarava™ is the only pre-transplant test of its kind that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient's race, age, previous transplant history and whether they have antibodies against common donor antigens. As reported, the Clarava™ personalized risk assessment is especially important for the expanding DD transplant population.

Sara Barrington, CEO of Verici Dx, said: "This validation for Clarava is the second successful product to emerge from the Company's suite of prognostic RNA signature tests and further validates our underlying technology platform. With Tutivia™ commercially launched as a measure for post-transplant rejection risk, the addition of Clarava™ as a pre-transplant test is a significant milestone in our strategy of building a complementary suite of ground-breaking products that offer end-to-end testing for kidney transplant patients and their clinicians, to help personalise care and transform outcomes."

Verici Dx is on track to commence the initial US commercial launch of Clarava™ before the end of the year to support the utility case studies and will be offered in conjunction with its other lead product, Tutivia™, which is already available in the US. The Company intends to leverage its existing internal resources and growing network of early adopters to develop the clinical positioning and marketing collateral for both products.

^Notes

¹The proposed CMS rate is currently open for public comment before it is finalised later this year. Following finalisation, the price in the Clinical Laboratory Fee Schedule ("CLFS") is valid for a period of three years from 1 January 2024, after which it is subject to further review.

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Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.  The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

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Medicare proposed gapfill median rate of $2,650 per test

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that a gapfill median rate of $2,650 has been proposed for Tutivia™ for kidney transplant rejection by the Centers for Medicare & Medicaid Services (“CMS”).
Medicare is a national health insurance program in the US that covers 63.9 million patients. Gapfill pricing is a method used by CMS to establish payment rates for clinical laboratory tests under the Clinical Laboratory Fee Schedule (“CLFS”) when no comparable test already exists on the CLFS. The proposed rate was supported by the majority of Medicare Administrative Contractor (“MAC”) localities, including Palmetto GBA, the MAC that will process future Medicare claims submitted for tests performed in Verici’s Tennessee laboratory. This proposed rate is currently open for public comment before it is finalised later this year. Following finalisation, the price in the CLFS is valid for a period of three years from 1 January 2024, after which it is subject to further review.

Sara Barrington, Chief Executive Officer of Verici Dx, commented: “This is another important milestone in our commercial strategy, and we are pleased the majority of MAC localities have proposed pricing for our Tutivia™ tests consistent with the resources required to develop and perform these tests. I look forward to the pricing being finalised later this year and securing reimbursement coverage in due course.”

---

Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.  The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

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Successful transition from a research to commercial-stage company

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its audited final results for the year ended 31 December 2022 and provides a progress update since year end.

Strategic progress (including post-period end)

• Achieved full commercial launch of Tutivia™, the Company’s first product for the detection of acute
  kidney transplant rejection, in January 2023, leading to first revenues being recognised in FY 2023.
• Expanded its validation trial on Clarava™, the Company's pre-transplant prognostic test, for a further six
  months following positive initial data announced in September 2022. This decision was taken to
  strengthen the publication appeal of the trial and demonstrate a statistically robust and clinically
  compelling case in support of the commercial rollout and adoption of the test. The full readout from this
  trial remains on track to be announced by the end of June 2023, in line with previous guidance.
• Patient enrolment for the multi-centre clinical validation study of our third product, ProtegaTM, was
  completed in the first quarter of 2023, assessing long-term outcomes for kidney transplant patients.
• Extended cash runway until mid-2024; the Company has retained sufficient funding to achieve further
  key milestones in 2023 and the first half of 2024 which will support commercial adoption, including the
  publication of additional data and obtaining both Medicare and private payor pricing and coverage. A
  further commercial and operational update will be provided alongside the Clarava™ data readout.

Operational highlights (including post-period end)

• Announced positive results from the Tutivia™ clinical validation study in June 2022, for the detection of
  acute rejection following a kidney transplant.
• Granted CPT® Proprietary Laboratory Analyses ("PLA") codes for Clarava™ and Tutivia™ tests by the
  American Medical Association ("AMA"), providing the basis for coding and payment within the US
  healthcare market.
• In May 2023, a gapfill median rate of $2,650 was proposed for Tutivia™ for kidney transplant rejection
  by the Centers for Medicare & Medicaid Services (“CMS”) in line with the Company’s application.
• Obtained Medicaid approvals in 14 States and a further 11 States are pending.
• Two key patents granted in the United States underpinning Verici Dx’s products.\
• Achieved CLIA Certificate of Compliance for laboratory in Nashville, TN, USA, a key requirement to
  obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial
  launch of Tutivia™, in 45 US states.
• Completed analytical validation for Clarava™ and Tutivia™ in February 2022, an essential element of
  defining the performance characteristics and platform capabilities of in vitro diagnostic assays and a key
  milestone towards commercialisation.
• Announced a collaboration with Illumina, Inc., for early access to the Illumina Connected Analytics (ICA)
  platform to expedite the operational launch of data analysis processing and predictive artificial
  intelligence component of Verici’s products in due course.

Financial highlights

• Adjusted EBITDA1 loss of $10.5m (2021: loss of $7.1m).
• Cash balance at 31 December 2022 of $9.81m (2021: $10.3m).
• Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription.
• Cash runway extended to mid-2024.

Commenting on the performance and outlook, Sara Barrington, Chief Executive Officer, said:

“2022 was a transformational year for Verici Dx; we began the year as an R&D-stage company, and have now
commercially launched our first product, Tutivia™, following pleasing validation study results.
“We are well placed to deliver further progress against our strategy in 2023, building on the initial rollout of
Tutivia™ and we remain on track to announce the data read-out from the extended Clarava™ trial by the end
of June. In addition, we are taking further steps towards reimbursement that will help accelerate commercial
uptake of our lead products.”

Investor briefing

As previously announced, an investor meeting covering the FY22 financial results will be provided following
the data read-out from the extended Clarava™ trial, expected to be announced by the end of June.

 

---

Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.  The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

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First revenues from Tutivia™ following full commercial launch

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, provides an update on its operational progress made since the release of its interim results in September 2022.
Verici Dx continues to execute the commercial introduction of Tutivia™, the Company’s first product for kidney transplant rejection, with first revenues in FY 2023 and is exploring strategic options to increase sales distribution and launch its second lead product, Clarava™ by the end of the year. The Company retains sufficient funding to achieve further key milestones in 2023 and the first half of 2024, which will support commercial adoption
including the publication of additional data and obtaining both Medicare and private payor pricing and coverage.

Data continues to support product differentiation and competitive advantages Following a robust validation trial using a varied, ‘all-comers’ patient population in a clinical setting, Tutivia™, a post-transplant prognostic test for the assessment of risk of acute kidney rejection, was pilot-launched in December 2022 ahead of its full commercial launch in January 2023. The validation trial data showed a positive predictive value (PPV) of 60%, over three times that was achieved by the closest comparative product in the market when used in the same context, establishing a new industry standard. Additionally, study data analysis of the clinical performance of Tutivia™ demonstrated a differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times more likely to have a rejection than those of low risk. This represents a significant demonstration of Tutivia TM as a predictive test capable of informing a clear, actionable response from clinicians. The Directors believe that no other comparable products have been validated to this degree.

Tutivia™ also has competitive advantages, as it can be run as early as the first-week post-transplant, earlier than any other test. Tutivia™ enables clinicians to act proactively, rather than reactively, to rejection events, as well as not being confounded by other kidney health complications (such as the BK virus), which need an alternative therapy protocol. This is because Tutivia™ identifies RNA signatures that are specific to acute rejection, as opposed to other tests that detect evidence of damage that may not necessarily be caused by rejection alone.

In addition, following the positive initial data announced in September 2022 on Clarava™, the Company’s pre-transplant prognostic test, the Company chose to expand its validation trial for this lead product for a further six months. This decision was taken to strengthen the publication appeal of the trial and demonstrate a statistically robust and clinically compelling case in support of the commercial rollout and adoption of the test. The full readout from this trial is expected in Q2 2023, with the initial launch expected before the end of the year.

Strong progress on rollout strategy In line with its strategic plan, the Company is working with three leading US transplant centres in the Tutivia™ commercial launch and is supporting them with the adoption and integration of the test into the current clinical pathway, to encourage consistent and recurring utilisation. This is providing a valuable foundation for Verici Dx to make Tutivia™ as simple as possible for clinicians to use and interpret.

Following the successful progression of the Company’s laboratory registration status to Compliance Certification by the Centers for Medicare & Medicaid (‘CMS’), allowing its commercial operation for samples received from patients in 45 US states, Verici Dx is ready to build on the initial rollout activity over the course of 2023. Medicare and Medicaid account nationally for about 65% of all transplant patients and the Company is focused the initial rollout of the test where the proportion of Medicare patients is higher than the national average. To further drive adoption the Company has addressed the pricing and coverage determinations under Medicare. This is administered by the MolDx region of Palmetto given the Company’s laboratory is based in Tennesse. The Company submitted its pricing proposal in Q1 2023 and expects to get the MolDx pricing recommendation by the end of Q2 2023. The Company is currently preparing its submission for Medicare insurance reimbursement coverage, under the Local Coverage Determination (LCD) offered in Palmetto and a coverage determination is expected later this year. Registration for Medicaid has been approved in three states and submitted in a further 11 states as well as with BlueCross Blue Shield of Tennessee, the largest health benefit plan company in the state.

Prudent cash management and execution

As of 31 December 2022, the Company had a cash balance of $9.81m. The Company has taken headcount reduction and clinical trial cost containment steps in recent months and, as a result, has extended the current cash runway to last until mid-2024. The Company is focused on early revenue generation during the first half of this year and will seek to extend and broaden its revenue streams from additional centres in the second half of 2023.

The Company expects to report its preliminary results for the year ended 31 December 2022 by the end of April 2023.

Sara Barrington, CEO of Verici Dx, said:
“We have continued to make significant progress in executing our strategy, resulting in the full commercial launch of Tutivia™ in January, with Clarava’s™ initial launch expected before the end of this year.

“We achieved our internal target of attracting three key, leading US transplant sites as early adopters for
Tutivia™, a critical step that is enabling us to demonstrate the adoption and integration process for clinicians.

“Looking ahead to the rest of the year, we plan to accelerate the rollout of Tutivia™ to other major transplant sites throughout the US, and to secure pricing and health insurance coverage for this lead product. For Clarava™, we expect to report validation shortly and to initiate its initial launch before the end of the year, which will support the collation of further evidence to enable a positive coverage determination. These pivotal milestones will help refine our market positioning and further accelerate commercial uptake of both of our lead products. Verici Dx looks forward to reporting on its further progress.”

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Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, is aware of public statements and media reports relating to Silicon Valley Bank (“SVB”). The Company does not hold any cash at SVB nor does it have any banking relationship with SVB.  

---

Enquiries:

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780

Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes.  The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.  The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

The two lead products are Clarava™, a pre-transplant prognosis test for the risk of early acute rejection, and Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

Intellectual property portfolio strengthened Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has been granted two key patents in the United States that support and protect the Company’s core technologies in RNA signature biomarker tests used for assessment of the prognostic risk pre-transplant (Clarava™) and post- transplant (Tutivia™) of acute kidney transplant rejection. The patents cover broad molecular methods for predicting and diagnosing subclinical and clinical acute rejection, both pre- and post- kidney transplant by algorithmic analysis of gene sets and underpin both of Verici Dx’s lead products, Tutivia™ and Clarava™, and provide protection until 2036 and 2039 respectively. The patents underpinning Tutivia™ have also been previously granted in Europe, China and Australia. These products use a weighted pattern of RNA biomarkers (signature) to assess the risk of rejection by the kidney transplant recipient and to assess rejection earlier and more reliably than other currently available methods. Verici Dx continues to file additional patents reflecting novel refinements to its predictive RNA signatures and methodologies driven by advanced machine learning techniques. The protection of the Company’s intellectual property is fundamental to its strategy of amassing full transcriptomic data from the biological systems and interactions associated with transplant rejection and, over the longer term, informing transplant analysis in other organs and in the broader field of immune-mediated diseases. Sara Barrington, CEO of Verici Dx, said: “Clarava™ and Tutivia™ address a significant unmet need and seek to improve outcomes for kidney transplant patients, by providing early, actionable information for clinicians to inform treatment plans. These significant new patents bolster our intellectual property portfolio and protect our proprietary methods of predicting and diagnosing sub-clinical and clinical acute kidney rejection.”  

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Enquiries:

Sara Barrington, CEO Julian Baines, Chairman

www.vericidx.com Via Walbrook PR

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N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

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Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

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N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

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Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Successful CMS review and inspection solidify commercial positioning and represents a major milestone toward US Medicare reimbursement

  Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has successfully progressed its Registration status to Compliance Certification by the Centers for Medicare & Medicaid (“CMS’) for its commercial clinical operations to 45 US states. This follows the inspection by CMS of the Company’s US clinical laboratory based at the Innovation Park in Franklin, Tennessee. The Company now intends to expand commercialisation of its advanced kidney transplant service offerings including Tutivia™. This milestone of certification is also a key requirement to obtaining insurance reimbursement coverage under Medicare under the Local Coverage Determination application being submitted this year. The Company launched its first product, Tutivia™, for the detection of early acute rejection in kidney post-transplant patients, in January 2023. This CLIA certification increases the ease of ordering a Tutivia™ test from laboratories at transplant medical centres and provides further validation of Verici’s tests and services for transplant clinicians across the United States. The Company will now proceed with its plan towards full accreditation in the remaining five states, including New York, which have further compliance requirements. The CLIA certification further exemplifies Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostics services to clinicians and patients in need.   Sara Barrington, CEO of Verici Dx, said: “This milestone is an enabling step in our ability to offer our two leading diagnostic tests, Tutivia™ and Clarava™, on a national basis to patients and their clinicians. We are well positioned to achieve additional milestones and progress commercial initiatives in 2023 that will support our growth in the United States.”   Verici Dx will give further progress and strategy updates later this month.  

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Enquiries:

Sara Barrington, CEO Julian Baines, Chairman www.vericidx.com Via Walbrook PR

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N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen Tel: 020 7496 3000

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Walbrook PR Limited Paul McManus / Sam Allen Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

---

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

---

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners. The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.