Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its inaugural audited results for the period ended 31 December 2020.
Strategic and Operational highlights
- Verici Dx was successfully admitted to AIM in November raising gross proceeds of c.$18.8m (£14.5m)
- The fundraising was significantly oversubscribed by institutional and other investors, and the current share price has notably outperformed the market since IPO
- The net proceeds are being used primarily to fund the clinical utility and validation studies for lead products Clarava™ and Tuteva™, as well as other bioinformatics and health economic studies
- Appointed Angela Rose as Senior Director of Clinical Trial Operations in December 2020 to oversee the clinical trials to their conclusion
Financial highlights
- Adjusted EBITDA loss of $1.24m1
- Cash balance at 31 December 2020 of $17.8m
Post-period end
- Expanded scope of licence agreement with Mount Sinai, in January 2021, to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft
- Accelerated CLIA1 approval strategy to enable faster commercial launch of leading products
- In February 2021, appointed David Schultenover as Vice President of Quality and Regulatory to project manage the accelerated CLIA approval strategy
Commenting on the outlook, Julian Baines, Non-executive Chairman, said: “We have been very pleased with the progress of the Company in such a short time and our primary focus remains on the successful prosecution of our clinical trials, as the first key step in commercialising our innovative transplant products.
“We are already making good progress, initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.
“On behalf of the Board, I would like to thank our employees, stakeholders and shareholders for their support and we look forward to providing further updates on progress throughout the current year.”
Notes:
- Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items and foreign exchange loss
- The CLIA (Clinical Laboratory Improvement Amendments) regime is used by the Center for Medicare and Medicaid Services (CMS) to regulate laboratory testing in the US, and requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing
Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results via the Investor Meet Company platform on Wednesday 14 April 2021 at 5.00 p.m. (BST).
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9.00 a.m. the day before the meeting or 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 plc on the Investor Meet Company platform will automatically be invited.
Enquiries:
About Verici Dx plc
Verici Dx is an immuno-diagnostics company developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
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.
Chairman’s statement
I am delighted to report on the first annual results for Verici Dx plc since admission to AIM in November 2020 and this report covers the period from the Company’s incorporation on 22 April 2020 to 31 December 2020.
A full description of our strategy and business model is provided in the Strategic Report below, however in summary Verici Dx is an immuno-diagnostics development company, initially focussed on the kidney transplantation market, incorporating the FractalDx technology and associated assets previously owned by Renalytix AI plc and licensed from the Icahn School of Medicine at Mount Sinai, New York.
We have two leading products which aim to understand how a patient will and is responding to kidney transplantation and these have started clinical validation trials:
- Clarava™, which is a pre-transplant prognosis for the risk of early acute rejection; and
- Tuteva™, a post-transplant diagnostic focused upon acute cellular rejection, including sub-clinical rejection not being diagnosed through the current standard of care of rising serum creatinine levels.
Our kidney transplant assays use advanced next-generation sequencing that we believe can define a personalised risk profile for each patient over the course of their transplant journey and can detect injury in advance of currently available clinical tests, with a view to minimising risk of transplant rejection.
The initial focus of Verici Dx on the kidney transplantation market reflects the urgent clinical need in this area. According to the World Health Organisation (WHO), there are reports to suggest that between five and ten million people die annually from kidney disease (compared to 1.8m who die from the most prominent cancer, lung cancer) and about 300,000 people around the world are currently on a waiting list waiting for a kidney transplant and is expected to rise due to an increase in kidney disease. We believe we have unique kidney transplant diagnostic technology that enables accurate, data-driven support for clinical decisions, such as the most appropriate immunosuppressive therapy for that patient. This has not only near-term scope to reduce the unnecessary and serious consequences from over- or under-dosing for immunosuppression, but also to improve the longevity of transplanted kidneys and, by reducing the risk and rate of transplant failure, much broader potential to deliver huge health economic benefits by improving transplant outcomes.
In early November last year, Verici Dx was successfully admitted to trading on AIM, raising gross proceeds of c.$18.8m (£14.5m). The fundraising was significantly oversubscribed by institutional and other investors, and the share price has appreciably outperformed the market in the period since then. The net proceeds are being used primarily to fund the clinical utility and validation studies for Clarava™ and Tuteva™, as well as other bioinformatics and health economic studies.
We are already making good progress initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.
I am also very pleased that we have been able to announce further key milestones in the development of our strategy during the reporting period and post-period end:
- In December 2020, we announced the appointment of Angela Rose as Senior Director of Clinical Trial Operations. Angela has over 15 years’ experience in clinical trial project management and she will be instrumental in overseeing the clinical trials to their conclusion.
- In January 2021, we announced the expansion of the scope of our licence agreement with Mount Sinai to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft. Assuming successful development, the addition of a product that can predict the risk of long-term graft failure will establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.
Three leading US centres first to collaborate with Verici in clinical validation trial for lead products
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has partnered with Lorenzo Gallon, MD, at Northwestern University Feinberg School of Medicine; Milagros Samaniego, MD, at Henry Ford Health System and Daniel G. Maluf, MD, at the University of Maryland, Baltimore to collaborate on Verici Dx’s clinical trial surrounding its two lead products, ClaravaTM and TutevaTM, and longer term, the validation of the fibrosis test.
The study uses next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx immune-phenotype signature tests.
Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation), Dr. Gallon is an alumnus of the University of Padua Medical School, Italy and is the Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University.
Dr. Samaniego is the Medical Director of Kidney and Kidney Pancreas Transplantation and Director of Research and Outreach Kidney Transplant Program the Henry Ford Transplant Institute with over 21 years of experience. She completed her residency at Baylor College of Medicine and her fellowship at Johns Hopkins Hospital. She is an American Society of Nephrology and American College of Physicians fellow, and her research has been focused on antibody-mediated rejection and studying new immunosuppression approaches to optimize the success of kidney transplants.
Dr. Maluf, Director of the Program in Transplantation at the University of Maryland School of Medicine, performs renal transplantation at the University of Maryland Medical Centre. He has clinical and scientific expertise in kidney and liver transplantation, including living donor liver transplantation. Dr. Maluf is nationally and internationally recognized for his work with the American Transplant Society and the International Liver Transplant Society.
Sara Barrington, CEO of Verici Dx, said:
“We are delighted at the level of global interest in our validation trial and highly appreciative that these centres were able to lead our first clinical trials in the United States. Lorenzo, Milagros and Daniel have excellent, demonstrable track records in the medical industry, and have collectively helped pioneer organ transplant research in the modern era. We are excited to be onboarding more US sites shortly and are currently progressing with a number of EU sites to ensure that the two leading products are fully tested for validation by the end of the year.”
Enquiries:
Worldwide exclusive licence to liquid biopsy IP for predicting risk of fibrosis and chronic damage rejection
Strengthens patent portfolio covering the entire kidney transplant diagnostic pathway
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has expanded the scope of its licence agreement with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.
Interstitial fibrosis and tubular atrophy (IF/TA) is a significant complication in 50-65% of transplants at 12-24 months1 and a major cause of graft rejection in the first year after transplantation2.
The development of a product that can predict risk of fibrosis and rejection using the Company’s core technological approach would extend Verici Dx’s portfolio across the full course of a patient’s transplant journey and complement the Company’s two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. A further product using this technological approach and focused on risk of fibrosis would support the diagnosis of risk of longer-term graft failure as well.
The development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis fits well with Verici Dx’s current laboratory capabilities, instrumentation and expertise. Liquid biopsy also allows for easier deployment in clinical care given the limited population of transplant centres that undertake tissue allograft surveillance biopsies and the lower risk and costs associated with blood-based biopsies.
The Company’s multi-centre observational clinical study to validate the clinical performance of Clarava™ and Tuteva™ will also include patients being assessed for fibrosis for an extended study period beyond the initial end points for the first two products in order to collect data in support of validation for this newly licensed test to predict risk of fibrosis.
Commenting Sara Barrington, CEO of Verici Dx, said:
“The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant. There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage.”
Notes
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4065724/#B41
- Nankivell et al. The Natural History of Chronic Allograft Nephropathy, NEJM 2003
Enquiries:
23 December 2020
Verici Dx plc
(“Verici Dx” or the “Company”)
Appointment of Senior Director of Clinical Trial Operations
Preparatory phase for validation trials complete
Site initiation of transplant centres on track for January 2021
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has appointed Angela Rose as Senior Director, Clinical Trial Operations with immediate effect.
Angela, a senior clinical trial project management professional with over 15 years of experience in managing medical device, diagnostics, biologic and drug global clinical trial operations for regulatory approval, will be responsible for overseeing Verici Dx’s planned multi-centre observational clinical validation studies for its two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. These tests have the potential to define a personalised risk profile of kidney transplant patients over the course of their transplant journey and may also detect injury in advance of currently available clinical tests.
The preparatory phase for these validation studies has now been completed following the Company’s successful IPO fundraise in November 2020, and Angela will be instrumental in overseeing the clinical trial operations to the conclusion of the studies.
Angela joins Verici Dx from regenerative medicine biotech company Humacyte Inc., where she was responsible for global operational oversight and delivery of their clinical development projects and clinical trials. Angela’s extensive experience in clinical project management includes prior roles at biotech pharma company BioCryst Pharmaceuticals Inc., global contract research organisation Quintiles, biopharmaceutical firm Gilead Sciences, Inc., and infectious disease diagnostics company bioMérieux, Inc. Angela’s educational training at Duke University specialised in clinical laboratory science and, together with her industry experience in trials, positions her to engage in validation of diagnostic testing with deep understanding of the field in a commercial context.
Commenting on Angela’s appointment Sara Barrington, CEO of Verici Dx, said:
“We are delighted to have someone with Angela’s experience in clinical trial project management on board to oversee our clinical validation studies focused on Clarava™ and Tuteva™. We are on track to commence enrolment in transplant centres in the new year for trials to be conducted in 2021. Successful conclusion will validate our key products at the forefront of kidney transplant diagnostics.”
About the validation trials
The multi-centre observational clinical study will seek to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for the Company’s in vitro diagnostic assays. The study will allow clinico-pathologic data to be collected and studied while validating based on biopsy findings in central pathology and clinical outcomes. The study is expected to enrol approximately 200 subjects for the Clarava™ and Tuteva™ validation. Verici Dx expects enrolment in these validation trials to complete by the end of 2021.
Enquiries:
Verici Dx
www.vericidx.com
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
N+1 Singer (Nominated Adviser & Broker)
Tel: 020 7496 3000
Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen (Corporate Broking)
Walbrook PR Limited
Tel: 020 7933 8780 or vericidx@walbrookpr.com
Paul McManus / Sam Allen
Mob: 07980 541 893 / 07748 651 727
About Verici Dx plc www.vericidx.com Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects. 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.
NOTIFICATION OF MAJOR HOLDINGS(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i |
||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: | VERICI DX | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | ||||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | YES | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify)iii: | ||||||
| 3. Details of person subject to the notification obligationiv | ||||||
| Name | Harwood Capital Management (Gibraltar) Limited (as investment adviser/manager) to 1.Oryx International Growth Fund Limited
and Harwood Capital LLP (as investment adviser/manager) to 2. North Atlantic Smaller Companies Investment Trust PLC and 3 Harwood Capital LLP
|
|||||
| City and country of registered office (if applicable) | 1. Guernsey
2 & 3 London, United Kingdom |
|||||
| 4. Full name of shareholder(s) (if different from 3.)v | ||||||
| Name |
|
|||||
| City and country of registered office (if applicable) | As above | |||||
| 5. Date on which the threshold was crossed or reachedvi: | 5 November 2020 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 9 November 2020 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
| Resulting situation on the date on which threshold was crossed or reached | 1. 3.88%
2. 11.64% 3. 5.47% |
1. 3.88%
2. 11.66% 3. 5.47% |
141,747,816 | |||
| Position of previous notification (if applicable) | 1. 3.88%
2. 11.64% 3. 5.83% |
1. 3.88%
2. 11.66% 3. 5.83%
|
||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
| Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
||||||
| GB00BM3HZD43
1. 2. 3.
|
5,500,000
16,500,000 7,758,572 |
3.88%
11.64% 5.47% |
|||||||
| SUBTOTAL 8. A | 29,758,572 | 20.99% | |||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is
exercised/converted. |
% of voting rights | |||||
| SUBTOTAL 8. B 1 | |||||||||
| B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Period xi |
Physical or cash
settlementxii |
Number of voting rights | % of voting rights | ||||
| SUBTOTAL 8.B.2 | |||||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
x | |||
| Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| Christopher Harwood Bernard Mills | 3.88 | 0 | 3.88 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| Oryx International Growth Fund Ltd | ||||
| Christopher Harwood Bernard Mills | 11.64 | 0 | 11.64 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| North Atlantic Smaller Companies Investment | ||||
| Christopher Harwood Bernard Mills | 5.47 | 0 | 5.47 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional informationxvi | ||||
| Place of completion | London |
| Date of completion | 9 November 2020 |
Enquiries:
NOTIFICATION OF MAJOR HOLDINGS(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i |
||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: | VERICI DX | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | ||||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | YES | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify)iii: | ||||||
| 3. Details of person subject to the notification obligationiv | ||||||
| Name | Harwood Capital Management (Gibraltar) Limited (as investment adviser/manager) to 1.Oryx International Growth Fund Limited
and Harwood Capital LLP (as investment adviser/manager) to 2. North Atlantic Smaller Companies Investment Trust PLC and 3 Harwood Capital LLP |
|||||
| City and country of registered office (if applicable) |
|
|||||
| 4. Full name of shareholder(s) (if different from 3.)v | ||||||
| Name |
|
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| City and country of registered office (if applicable) | As above | |||||
| 5. Date on which the threshold was crossed or reachedvi: | 3 November 2020 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 9 November 2020 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
| Resulting situation on the date on which threshold was crossed or reached | 1. 3.88%
2. 11.64% 3. 5.83% |
1. 3.88%
2. 11.66% 3. 5.83% |
141,747,816 | |||
| Position of previous notification (if applicable) |
|
|
||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
| Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
||||||
| GB00BM3HZD43
1. 2. 3.
|
5,500,000
16,500,000 8,258,572 |
3.88%
11.64% 5.83% |
|||||||
| SUBTOTAL 8. A | 30,258,572 | 21.35% | |||||||
|
|
|||||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is
exercised/converted. |
% of voting rights | |||||
| SUBTOTAL 8. B 1 | |||||||||
| B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Period xi |
Physical or cash
settlementxii |
Number of voting rights | % of voting rights | ||||
| SUBTOTAL 8.B.2 | |||||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) |
||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
x | |||
| Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| Christopher Harwood Bernard Mills | 3.88 | 0 | 3.88 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| Oryx International Growth Fund Ltd | ||||
| Christopher Harwood Bernard Mills | 11.64 | 0 | 11.64 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| North Atlantic Smaller Companies Investment | ||||
| Christopher Harwood Bernard Mills | 5.83 | 0 | 5.83 | |
| Harwood Capital Management Ltd | ||||
| Harwood Capital LLP | ||||
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional informationxvi | ||||
| Place of completion | London |
| Date of completion | 9 November 2020 |
NOTIFICATION OF MAJOR HOLDINGS(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i |
||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: |
Verici DX Plc |
|||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) |
||||||
| Non-UK issuer | ||||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) |
||||||
| An acquisition or disposal of voting rights |
X |
|||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights |
X |
|||||
| Other (please specify)iii: | ||||||
| 3. Details of person subject to the notification obligationiv | ||||||
| Name |
Unicorn Asset Management Limited |
|||||
| City and country of registered office (if applicable) |
London, United Kingdom |
|||||
| 4. Full name of shareholder(s) (if different from 3.)v |
||||||
| Name |
Unicorn AIM VCT plc |
|||||
| City and country of registered office (if applicable) |
Newton Abbot, United Kingdom |
|||||
| 5. Date on which the threshold was crossed or reachedvi: |
03 November 2020 |
|||||
| 6. Date on which issuer notified (DD/MM/YYYY): |
05 November 2020 |
|||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
| Resulting situation on the date on which threshold was crossed or reached | 3.17% | 3.17% | 141,747,816 | |||
| Position of previous notification (if
applicable) |
N/A | N/A | ||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
| Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
||||||
| Ordinary shares GB00BM8HZD43 |
4,500,000 | 3.17% | |||||||
| SUBTOTAL 8. A | 4,500,000 | 3.17% | |||||||
|
|
|||||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. | % of voting rights | |||||
| SUBTOTAL 8. B 1 | |||||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Period xi |
Physical or cash
settlementxii |
Number of voting rights | % of voting rights | ||||
| SUBTOTAL 8.B.2 | |||||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) |
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| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | X | |||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
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| Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | See Section 4 | |||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional informationxvi | ||||
| Figures are based on total voting rights of 141,747,816 | ||||
| Place of completion | Unicorn Asset Management Limited, Preachers Court, Charterhouse, Charterhouse Square, London, EC1M 6AU |
| Date of completion | 05th November 2020 |
Enquiries:
Capitalised terms used in this announcement shall, unless the context provides otherwise, have the same meaning as defined in the Admission Document.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that admission to trading on AIM (“Admission”) will take place and dealings will commence at 8.00 a.m. today under the ticker VRCI and ISIN GB00BM8HZD43.
Key Highlights:
- Successful Fundraising for gross proceeds of £14.5 million
- The Fundraising was significantly oversubscribed across all components, including the Placing (approximately £12.06 million), the Subscription (approximately £2.06 million) and the Restricted Offer (approximately £0.38 million)
- Market capitalisation of approximately £28.35 million on Admission
- Enlarged Share Capital on Admission of 141,747,816 Ordinary Shares
- The 72,500,000 New Ordinary Shares represent 51.2 per cent. of the Enlarged Share Capital
- N+1 Singer acted as Sole Bookrunner in relation to the Placing and is acting as the Company’s Nominated Adviser and Broker from Admission
About Verici Dx
The Company is an immuno-diagnostics development company, initially focussed on the kidney transplantation market. The Company’s kidney transplant assays will use advanced next-generation sequencing that may define a personalised risk profile of each patient over the course of their transplant journey, and may also detect injury in advance of currently available clinical tests.
The Company develops tests to understand how a patient is likely to, and may be, responding to kidney transplant. There are two leading products for clinical validation and commercialisation:
- Clarava™, which is a pre-transplant prognosis for the risk of early acute rejection; and
- Tuteva™, a post-transplant diagnostic focused upon acute cellular rejection, including sub-clinical rejection not being diagnosed through the current standard of care of rising serum creatinine levels.
In terms of validation trials, the Company is preparing to initiate a comprehensive multi-centre observational clinical study, commencing shortly after receipt of the net proceeds from the Fundraising. The primary study objective is to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for both Clarava™ and Tuteva™.
In terms of commercialisation, the Company intends to continue building its collaborative, multi-centre working group to further develop, validate and commercialise its products and technology platform.
In terms of reimbursement, the Company intends to seek coverage and reimbursement for Clarava™ and Tuteva™ products with Medicare Administrative Contractors of the Centers for Medicare & Medicaid Services (“CMS”) and major third-party private payors in the US.
Prior to full commercial scaling, the Company expects to focus its first revenues from a small number of early adopting sites. This is expected to be within 24 months of the Admission, subject to successful validation trials and approvals under CLIA certification.
Kidney Transplant Need
Globally, there are approximately 95,000 transplants performed each year of which about 24,000 are performed in the US and some 25,000 in Europe. The comparatively low number in comparison to the waiting list in the US was recognised as an issue for patients waiting for a transplant for on average 3 to 5 years, even longer in some geographical locations.
It also formed part of the policy in the US Executive Order, Advancing American Kidney Health, where the agency was required to improve efficiencies in the transplant network and expand support for living donors, with the goal of doubling the number of available transplants by 2030.
It is estimated that about 37 to 50 per cent. of all grafts will experience a clinical (10 to 15 per cent.) or subclinical (27 to 40 per cent.) rejection condition in the first year following transplant and clinicians use immunosuppression therapy to try to manage the rejection risk. Despite that, the failure rate in the US has remained largely unchanged and is 16 per cent. (live donor) to 28 per cent. (cadaver) at 5 years. In the EU this is 13 to 21 per cent. respectively.
Use of Proceeds
The net proceeds of the Fundraising of approximately £13.5 million will be used by the Company as follows:
- to undertake clinical utility and validation studies for the Clarava™ and Tuteva™ products, which are expected to begin in late 2020;
- on bioinformatics and health economic studies;
- on staff and related benefits;
- for general corporate overheads, including marketing and business development and for general working capital purposes; and
- on licence and royalties and capital expenditure (including to build additional testing capacity) and resourcing potential strategic partnerships.
The balance, being approximately £4.2 million, will be available as a contingency against delays in revenue or increased costs and providing additional working capital beyond the 21 month period following Admission.
Sara Barrington, CEO of Verici Dx, said:
“We are very grateful for the strong support shown by institutional and other investors to the Verici Dx IPO. Obtaining funding in a public market is a strong signal of quality to prospective partners and customers, raises the profile of the business and its innovative products considerably, and gives us a supportive platform as we advance our strategy. We look forward to providing further updates on the execution of our validation and commercialisation plans as we deploy the capital raised towards addressing a significant unmet clinical need.”
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
About Verici Dx plc www.vericidx.com
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
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.
IMPORTANT INFORMATION
This announcement does not constitute, or form part of, any offer or invitation to sell, allot or issue, or any solicitation of any offer to purchase or subscribe for, any securities in the Company in any jurisdiction nor shall it, or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with or act as an inducement to enter into, any contract or commitment therefor.
Recipients of this announcement who are considering subscribing for or acquiring New Ordinary Shares are reminded that any such acquisition or subscription must be made only on the basis of the information contained in the final Admission Document. To the fullest extent permitted by applicable law or regulation, no undertaking, representation or warranty, express or implied, is given by or on behalf of the Company, Nplus1 Singer Advisory LLP (“N+1 Singer”) or their respective parent or subsidiary undertakings or the subsidiary undertakings of any such parent undertakings or any of their respective directors, officers, partners, employees, agents, affiliates, representatives or advisers or any other person as to the accuracy, sufficiency, completeness or fairness of the information, opinions or beliefs contained in this announcement and, save in the case of fraud, no responsibility or liability is accepted by any of them for any errors, omissions or inaccuracies in such information or opinions or for any loss, cost or damage suffered or incurred, howsoever arising, from any use, as a result of the reliance on, or otherwise in connection with this announcement. N+1 Singer does not accept any liability, whatsoever, for the accuracy of any information or opinions contained in this announcement or for the omission of any information from this announcement for which the Company and the directors are solely responsible.
N+1 Singer, which is authorised and regulated by the Financial Conduct Authority, is acting only for the Company in connection with the proposed Placing and Admission and is not acting for or advising any other person, or treating any other person as its client, in relation thereto and will not be responsible for providing the regulatory protection afforded to clients of N+1 Singer or advice to any other person in relation to the matters contained herein. Such persons should seek their own independent legal, investment and tax advice as they see fit. N+1 Singer‘s responsibilities as the Company’s nominated adviser under the AIM Rules for Nominated Advisers and AIM Rules for Companies will be owed solely to the London Stock Exchange and not to the Company, to any of its directors or to any other person in respect of a decision to subscribe for or otherwise acquire Ordinary Shares in reliance on the Admission Document. N+1 Singer has not authorised or approved the contents of, or any part of, this announcement and no representation or warranty, express or implied, is made by N+1 Singer or its affiliates as to any of its contents.
This announcement is only addressed to, and directed at, persons in member states of the European Economic Area who are qualified investors within the meaning of Article 2(e) of the Prospectus Regulation (EU) 2017/1129 (“Qualified Investors”). In addition, in the United Kingdom, this announcement is addressed to and directed only at Qualified Investors who are (i) persons having professional experience in matters relating to investments, i.e., investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “FPO”); (ii) high net-worth companies, unincorporated associations and other bodies within the meaning of Article 49 of the FPO; and (iii) persons to whom it is otherwise lawful to communicate it to. It is not intended that this announcement be distributed or passed on, directly or indirectly, to any other class of person and in any event, and under no circumstances should persons of any other description rely on or act upon the contents of this announcement.
Neither this announcement nor any copy of it may be (i) taken or transmitted into, distributed, published, reproduced or otherwise made available, directly or indirectly, in the United States (within the meaning of Regulation S under the US Securities Act of 1933, as amended (the “US Securities Act”)), (ii) taken or transmitted into, distributed, published, reproduced or otherwise made available or disclosed in Australia, Canada, New Zealand or the Republic of South Africa or to any resident thereof, except in compliance with applicable securities laws, or (iii) taken or transmitted into or distributed in Japan or to any resident thereof for the purpose of solicitation or subscription or offer for sale of any securities or in the context where the distribution thereof may be construed as such a solicitation or offer. Any failure to comply with these restrictions may constitute a violation of the securities laws or the other laws of any such jurisdiction. The distribution of this announcement in other jurisdictions may be restricted by law and the persons into whose possession this announcement comes should inform themselves about, and observe, any such restrictions.
The New Ordinary Shares have not been and will not be registered under the US Securities Act, and may not be offered or sold in the United States, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act. No public offering of securities is being made in the United States. Neither the US Securities and Exchange Commission nor any state securities commission or other regulatory authority in the United States has approved or disapproved of the New Ordinary Shares or passed upon or endorsed the merits of the offering of the New Ordinary Shares or the adequacy or accuracy of this announcement. Any representation to the contrary is a criminal offence in the United States.
No securities commission or similar authority in Canada has in any way passed on the merits of the securities offered hereunder and any representation to the contrary is an offence. No document in relation to the proposed placing of the New Ordinary Shares has been, or will be, lodged with, or registered by, the Australian Securities and Investments Commission, and no registration statement has been, or will be, filed with the Japanese Ministry of Finance. Accordingly, subject to certain exceptions, the New Ordinary Shares may not be, directly or indirectly, offered, sold, taken up, delivered or transferred in or into or from any jurisdiction in which the same would be unlawful or offered or sold to a person within such a jurisdiction.
This announcement contains certain statements that are, or may be, forward looking statements with respect to the financial condition, results of operations, business achievements and/or investment strategy of the Company. Such forward looking statements are based on the Board’s expectations of external conditions and events, current business strategy, plans and the other objectives of management for future operations, and estimates and projections of the Company’s financial performance. Though the Board believes these expectations to be reasonable at the date of this announcement, they may prove to be erroneous. Forward looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, achievements or performance of the Group, or the industry in which the Group operates, to be materially different from any future results, achievements or performance expressed or implied by such forward looking statements.
Certain figures in this announcement, including financial information, have been subject to rounding adjustments. Accordingly, in certain instances, the sum or percentage change of the numbers contained in this announcement may not conform exactly to the total figure given.
Information to Distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the New Ordinary Shares have been subject to a product approval process, which has determined that the New Ordinary Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Ordinary Shares may decline and investors could lose all or part of their investment; the New Ordinary Shares offer no guaranteed income and no capital protection; and an investment in the New Ordinary Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offer. Furthermore, it is noted that, notwithstanding the Target Market Assessment, N+1 Singer will only procure investors who meet the criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Ordinary Shares.
Each distributor is responsible for undertaking its own target market assessment in respect of the Ordinary Shares and determining appropriate distribution channels.