BiVictriX Full Year Results

RNS Number : 6992U

BiVictriX Therapeutics PLC

30 March 2023

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED.  ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or "the Company" or "the Group")

Full year results for the twelve months ended 31 December 2022

· Good progress towards identifying a clinical candidate

· Broadening and strengthening the Company's pipeline portfolio

· Expansion of scientific capabilities and premises

Alderley Park, 30 March 2023 - BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a novel approach to develop next-generation cancer therapies with improved tolerability and anti-cancer activity, today announces its audited full year results for the twelve months ended 31 December 2022.

The Annual Report is available to review on the Company's website and hard copies will be posted to shareholders shortly.

Corporate Highlights including post period end events

•	Identified a development lead for the BVX001 programme which will be progressed to in vivo studies
•	Expanded the therapeutic pipeline with two additional programmes, BVX002 and BVX003, both entering the early stages of drug development
•	Developed a unique, state-of-the-art, Bi-Cygni® discovery engine that will feed the Company's growing proprietary Bi-Cygni® library, IP portfolio and expanding therapeutic pipeline
•	Expanded the newly established internal R&D premises at Alderley Park, UK, to incorporate a dedicated protein expression division and biomarker discovery unit
•	Post period, the Company announced the appointment of Dr. Michael Kauffman as Non-Executive Chairman
•	Post period, the Company reported positive preclinical data with the BVX001 programme, demonstrating a highly favourable safety profile compared to MylotargTM in an in vivo model assessing the risk for bone marrow toxicity and neutropenia

Financial highlights

•	Increased investment in R&D of £2.1 million (2021: £0.7 million)
•	Loss after tax of £2.5 million (2021: £2.3 million)
•	Closing cash balance of £3.3 million at 31 December 2022 (2021: £6.1 million)

Tiffany Thorn, Chief Executive Officer of BiVictriX, commented: "We have made signficant progress over the past year with our lead programme, BVX001, advancing this candidate towards the clinic. In addition to identifying a development lead for BVX001, at the beginning of this year we reported a highly favourable safety profile in a preclinical study comparing two doses of BVX001 to the only currently approved ADC indicated for AML. Beyond BVX001, we've diversified our pipeline with the addition of two additional programmes, BVX002 and BVX003, to our portfolio. Further, we've established of our new wholly-owned Bi-Cygni® discovery engine, laying the groundwork for future expansion and value creation in the years ahead."

For more information, please contact: BiVictriX Therapeutics plc Tiffany Thorn, Chief Executive Officer Email: [e-mail] SP Angel Corporate Finance LLP (NOMAD and Broker) Tel: [phone] David Hignell, Kasia Brzozowska (Corporate Finance) Vadim Alexandre, Rob Rees (Sales and Broking) Panmure Gordon (UK) Limited (Joint Broker) Tel: [phone] Rupert Dearden/Freddy Crossley/Emma Earl Consilium Strategic Communications Mary-Jane Elliott, Namrata Taak, Genevieve Wilson, Emmalee Hoppe Tel: [phone] Email: [e-mail]

About BiVictriX Therapeutics plc

BiVictriX is a UK-based drug discovery and development company which is focused on leveraging clinical experience to develop a new class of highly selective, next generation cancer therapeutics which exhibit superior potency, whilst significantly reducing treatment-related toxicities.

The Company utilises a first-in-class approach to generate a proprietary pipeline of Bi-Cygni® Antibody Drug Conjugate therapeutics which are designed to selectively target cancer-specific antigen pairs, or "Bi-Cygni® fingerprints", on tumour cells, which are largely absent from healthy cells.

BiVictriX has established a growing proprietary library of cancer-specific Bi-Cygni® fingerprints, which enable the Company to target a diverse array of different cancer types. The Company utilises these novel Bi-Cygni® fingerprints, together with the Company's novel Antibody Drug Conjugate therapeutic design, to develop more effective and safer therapeutics to target cancers that are expected to constitute orphan indications and areas of high unmet medical need.

Find out more about BiVictriX online at  www.bivictrix.com

Chairman's Statement

For the year ended 31 December 2022

I am delighted to report on the Company's most recent and notable developments and am confident that we will continue to see significant progress with our pipeline over the coming year as we advance towards the clinic.

Since joining BiVictriX in 2021, my role has focused on supporting our CEO, Tiffany Thorn, and the Company in establishing a strong foundation from which it can develop and mature into a meaningful biotech company. It is my belief that, over the past 12 months, we have achieved this across all aspects of the business, in line with the Company's goals laid out at the time of the last statement.

We have produced promising in vitro safety and efficacy data, resulting in the identification of a development lead for the BVX001 programme and marking a significant step forward towards progressing this programme to the clinic.

We have successfully built upon our existing internal R&D capabilities, incorporating a fully functional protein expression laboratory to satisfy our tumour-selective bispecific antibody (Bi-Cygni®) requirements across both the lead programme and broader pipeline.

In addition, in pursuit of our aim to decrease the development time from discovery to lead selection, we established our own unique Bi-Cygni® discovery engine which enables the expansion of our library of proprietary cancer-selective fingerprints, using patient-derived next-generation sequencing data.

During the period, the Company expanded its development pipeline to include two new programmes, BVX002 & BVX003, which have entered discovery. These programmes target a spectrum of solid tumour and haematological cancer indications, demonstrating the broad utility of the Bi-Cygni® concept as a first-in-class approach to better cancer treatment. Selection of development leads for the two new programmes, together with further patent filings, is anticipated during the next year.

We have continued to maintain tight control of our finances and have been both robust and prudent with the use of shareholders' funds. In terms of governance and oversight during the year, we strengthened the Board with the appointment of Dr Michael Kauffman, who broadens the Board's capabilities and experience by providing his expertise in preclinical research, clinical development, and regulatory strategy. Recently, we announced that I am handing over the Chairman role to Michael. I look forward to remaining with the Company as a member of the Board and continuing as a supportive shareholder.  It has been a privilege to serve BiVictriX as Chairman since 2021, through the Company's initial public offering in August 2021 and the significant progress made since.

In summary, the journey of any biotech company is often non-linear, but we have nevertheless continued to make great progress in the past year, which has proven very challenging for many small biotech companies. We have built an effective, fit-for-purpose R&D team with expanded capabilities, and broadened our know-how in the business. A development lead for the BVX001 programme was selected in December 2022, and we have expanded our discovery capabilities along with our development pipeline, which we believe over time will address substantial numbers of patients with cancers and thus represent very substantial commercial markets. The fundamentals of this business remain strong and I am confident we will make substantial progress in the coming year.

I would like to thank all my fellow Directors and our terrific team in Alderley Park, UK, led by our exceptional CEO, Tiffany Thorn, for all their efforts over the past year. And, as always, we remain grateful for the ongoing support of our shareholders, whose faith in the company makes possible everything we do.

Iain Ross

Former Non-Executive Chairman - (August 2021 - January 2023)

29 March 2023

 

Chief Executive Officer's Review

For the year ended 31 December 2022

It is with great pleasure that I am delivering the Company's second Annual Report as CEO of BiVictriX Therapeutics plc, following our IPO in 2021. I am delighted to share the meaningful recent progress that we have made in advancing our state-of-the-art approach to developing more effective and safer anti-cancer therapeutics. The original idea I had while serving as a Clinical Immunologist in the NHS is moving ever closer to delivering value in a patient setting and offering a potentially "game-changing" approach to cancer treatment. This would not be possible without the continued and valued support of our dedicated staff and shareholders, to whom I am extremely grateful for their enthusiasm and belief in BiVictriX.

The business

BiVictriX is a UK-based drug discovery and development company with a vision to revolutionise cancer therapy for some of the most difficult to treat cancers. The Company is focused on applying our innovative, proprietary Bi-Cygni® approach to develop a new class of highly selective, next-generation cancer therapeutics which exhibit superior potency, whilst substantially reducing treatment-related toxicities by greatly improving the specificity of these molecules for targeting the cancer. Our lead programme, BVX001, is focused on Acute Myeloid leukaemia ("AML"), one of the most aggressive forms of blood cancer which, to this day, carries an incredibly poor prognosis, leading to death in 60%-90% of adult cases depending on the patient's age.

Bi-Cygni®: A game-changing approach to treat cancer

Bi-Cygni® is a unique, proprietary platform which combines the discovery of novel, cancer-selective twin-antigen pairs or "fingerprints" (typically two different proteins), with our expert bispecific antibody engineering insights; to create a new class of highly selective, next-generation anti-cancer therapeutics. Together with our proprietary library of these newly identified cancer-specific fingerprints, which are found to be aberrantly present on tumour cells, but largely absent from normal, healthy cells; we develop first-in-class obligate bispecific therapeutics (Bi-Cygni® therapeutics) that are exquisitely cancer-selective.

Because our first-in-class Bi-Cygni® therapeutics have high selectivity for cancer cells with reduced toxicity on normal cells, we have the potential to generate a pipeline of anti-cancer drugs across both solid and haematologic cancers with the widest therapeutic windows. Consequently, these drugs have the potential to reduce the development of treatment-limiting (and sometimes life-threatening) toxicities and enable clinicians to give patients higher, more effective doses of therapy over prolonged periods in order to improve both depth and duration of anti-tumour responses with reduced likelihood of causing harm.

Since establishing operations in 2017, the Company has maintained its vision to combine our unique innovations in therapeutic design with established, clinically validated, therapeutic modes of action. Applying advances in our understanding of precision targeting through the Bi-Cygni® platform to the established, highly potent Antibody Drug Conjugate "ADC" concept enables us to generate a broad pipeline of next generation ADC therapeutics which could deliver increased tumour cell kill while reducing effects on normal cells. Thus, my fellow directors and I believe that in the clinic, these therapeutics will have the potential to deliver very high response rates and longer-term tolerability over and above the standard ADC design, while effectively reducing early developmental risk and time-to-market. This will enable, for the first time, the broader utilisation of this therapeutic class across a wider range of difficult-to-treat solid tumour and haematologic cancers.

Key achievements in 2022

Following our IPO on to the AIM market of the London Stock Exchange in 2021, which was recognised as Investment Deal of the Year at Bionow's 20^th annual awards, I am pleased to report the Company has continued to make value-creating progress in line with our strategy in what has been a significant year for the ADC space. We continue to utilise the net proceeds of our £7.5 million fundraise at the time of IPO with care and precision, ensuring absolute priority is given to the progression of our R&D programmes and to meeting the corporate goals. We have made good progress in the period in meeting these goals, which include:

•	building a fit-for-purpose internal R&D team to ensure value-creation and know-how is retained in the business;
•	identifying a development lead for the BVX001 programme to accelerate progression towards the clinic; and
•	expansion of our early-stage pipeline and growth of our IP portfolio, with the development of a novel "Bi-Cygni® discovery engine" - utilising state-of-the-art, patient-derived, next-generation sequencing data, with the addition of two further candidates to our pipeline.

A more detailed description of our progress and key drivers follows below.

Board of Directors

On 6 January 2023, post period end, we announced that Dr. Michael Kauffman, M.D., Ph.D. has been appointed as Non-Executive Chairman of BiVictriX. Dr. Kauffman took over the role from Iain Ross, who will continue as a Non-Executive Director at BiVictriX and stepped down from the role of Chairman due to his additional responsibilities at ReNeuron Group plc.

Dr Kauffman takes over the reins as Non-Executive Chairman at a crucial time for the Company, as we plan to progress our BVX001 development lead into the clinic. Since his appointment to the Board of Directors in January 2022, Dr Kauffman has seen the business progress the lead drug candidate from an early-stage asset towards a clinical candidate. Having been instrumental in the approval of several oncology therapeutics over twenty five years of working across preclinical research, clinical development, regulatory strategy and commercialisation, he is very well placed to draw from his experience as a highly seasoned cancer drug developer to support the business as we progress the asset towards clinical development and commercialisation.

As Non-Executive Chairman, Dr Kauffman will utilise his previous experience as Co-Founder and Chief Executive Officer of oncology company Karyopharm Therapeutics Inc., which he guided from a discovery stage biotechnology company to a commercial stage organisation, achieving global approvals of XPOVIO®. He also led the Kyprolis® development programme at Proteolix and then Onyx Pharmaceuticals, the Velcade® development programme at Millennium Pharmaceuticals, and has held a number of senior positions at Millennium Predictive Medicine and Biogen, and other companies.

I would like to personally thank Iain Ross for his commitment and support of the business, his mentorship and his valued guidance in helping to take the Company from a private entity to a publicly listed business during our IPO in August 2021. I look forward to continuing to work closely with Iain and Michael, together with our wider group of seasoned Non-Executive Directors, as we look to navigate the Company towards commercial success.

Internal R&D capabilities

In 2022, we expanded our newly established internal R&D premises to incorporate a dedicated protein expression division. This additional capability will be key in reducing timelines from discovery to the identification of development leads, across the pipeline. In addition, the new division will expand and diversify internal know-how surrounding the development of novel bispecific antibody formats, a key aspect of our approach. Ultimately, this will reduce the time-to-market and increase patent life for each asset, as well as drive further value in the platform offering of the business.

To support our expanded internal capabilities and our growing pipeline, during the period we continued to build our dedicated team of experienced scientific staff. This included the recruitment of four exceptional scientists to provide support across each of the three internal R&D divisions at BiVictriX: namely protein expression, bioconjugation and biology/biomarker discovery. 

Scientific progress

We have continued to make good progress during the period through the optimisation of BVX001, our lead therapeutic development programme. In December 2022, we announced that we have successfully identified a development lead for this programme, which is a substantial step forward in identifying a final clinical candidate - a milestone which we anticipate meeting later this year.

As the first asset utilising our proprietary Bi-Cygni® approach, navigating the clinical development landscape for a completely novel drug candidate was always going to require careful preparation and planning. I am pleased to report that the Company has made great progress in identifying a suitable and timely development path, in conjunction with support and guidance from our regulatory advisors, which we believe will ensure a streamlined path to the clinic for this asset. This will effectively set the precedent and will aim to reduce time-to-market for all future pipeline assets aligned to this approach.

The development lead identified for the BVX001 programme was selected based on a highly encouraging and comprehensive in vitro data package. The data package report included positive readouts on cancer cell potency across different target-expressing cell lines, improved cancer selectivity and safety studies using human-derived healthy cells, as well as a suitable developability, stability and manufacturing profile reported. As such assays, many of which are proprietary, have been developed, established, and validated in house at BiVictriX, they will also serve the entire pipeline of the Company.  In particular, we believe that these now established assays will help to drive shorter timelines from discovery activities to selection of future asset leads.

The development lead will now be further assessed in in vivo models of efficacy to assess the optimised dosing regimen, data which is anticipated later this year and will represent an exciting milestone for the business. The results will support manufacturing preparation of material for human trials and guide dosing in first-in-human studies to follow.

During the period, we have also made good progress with our proposed strategy to expand the therapeutic pipeline and identify new ways in which we could rapidly expand our proprietary Bi-Cygni® fingerprint library.

I am pleased to report that, through utilising patient-derived, next-generation sequencing data and state-of-the-art bioinformatics approaches, we have established a wholly-owned Bi-Cygni® discovery engine. The Bi-Cygni® discovery engine enables the efficient discovery of a wide range of novel, cancer-selective Bi-Cygni® fingerprints to feed our growing proprietary library, IP portfolio and expanding therapeutic pipeline. The discovery engine will serve an important, valued asset for the business and will enable BiVictriX to progress the Bi-Cygni® platform further into areas of significant unmet medical need and high commercial interest. Importantly, the Bi-Cygni® discovery engine will enable the business to expand the utility of the Bi-Cygni® concept across a wide range of solid tumour and haematological cancer indications, while also enabling the Company to enter new, well-sought-after markets, such as immuno-oncology. I believe this to be a crucial step forward for the business as we look to increase our value proposition aligned to our proprietary Bi-Cygni® concept and as we look towards securing commercial partnerships with third parties. 

Post period end, we reported positive preclinical safety data with BVX001 when compared to Mylotarg^TM - the only currently approved ADC indicated for AML. In January 2023, we reported that in an in vivo model evaluating the risk for bone marrow toxicity and neutropenia - a potentially life-threatening toxicity linked to currently approved therapies in AML - BVX001 showed no adverse effect to these healthy cells. The model was run head-to-head with Mylotarg^TM with BVX001 demonstrating a highly favourable safety profile when compared to this commercial comparator. These results build upon the previously documented excellent in vivo efficacy data and ex vivo safety data reported for this programme

Commercial strategy

It is my belief, and that of the Board, that the Bi-Cygni® platform can be applied to build a diverse pipeline of first-in-class therapeutics to treat a wide range of solid tumour and haematological cancer indications, offering a competitive therapeutic advantage to the existing milieu of drugs currently in development and addressing key unmet needs in the market. BiVictriX's ambition is to validate the Bi-Cygni® approach within a panel of difficult-to-treat cancer indications, beginning with BVX001 in AML, to demonstrate the wide applicability of the concept, propelling the Group forward as a global leader in the field.

To realise maximum value, we are committed to ensuring the focused, expedient development of our therapeutic pipeline towards reaching key value inflection points, subsequently validating the wide utility of our proprietary Bi-Cygni® approach to treat multiple cancer types. Alongside this, we aim to further strengthen and grow our broad patent portfolio through the newly established Bi-Cygni discovery engine, safeguarding both current and future cancer-specific fingerprints for the Group, or our chosen partners. In addition, a number of our now established in-house assays represent trade secrets and provide further barriers to entry for potential competitors.

We are strongly focused on utilising our capital efficiently to secure value-enhancing milestones across our therapeutic products and wider platform, which will enable us to target commercial partnerships, including licensing agreements.

BVX001, as our lead asset, will be important in providing validation to the market for the wider Bi-Cygni platform. I believe there are three key milestones within the development pathway for our lead, namely nominating a clinical candidate, achieving IND approval and establishing early clinical proof of concept through an initial Phase I/II clinical trial. The first value-enhancement for BVX001 is on track to be achieved during 2023. The Board believes that nomination of a clinical candidate will have the potential to attract third party interest, including from pharma and mid-sized biotech companies operating within the sector, who may be interested in partnerships and/or licensing opportunities, providing long-term revenue streams to BiVictriX.

As we near completion of this major corporate milestone, we will continue to increase visibility of the Company at major sector conferences, building upon our well-received presentations and active involvement at the Immuno-Oncology Summit Europe and PEGS Europe during the period, together with our upcoming presentation at PEGS Boston in 2023. We were delighted to be included, nominated, and recognised for a variety of awards in 2022, notably EY's Entrepreneur of the Year and the European Mediscience Awards, in the 'Emerging Star' category. To enable the Company to actively seek out and explore potential opportunities in the near term, we will also bring onboard additional resource.

While we have had some early interest in our platform, our aim is to strike a balance between demonstrating commercial value of both our platform and our specific programmes, with an appropriate deal structure for the Company and our stakeholders. We, as a Company and Board, believe that our position to negotiate an appropriate deal structure for the lead asset will be strengthened by the continued development of the wider pipeline alongside the further development of BVX001. Therefore, in order to expedite the development of the lead asset and to ensure the Company is in a strong position to find the most appropriate partnership structure, we will also seek early-stage partnerships within specified territories which may provide additional financial support to move the asset forward within the shortest timeframe.

Immediate goals

Through our expanding pipeline, broad patent portfolio and internal know-how, the Company is well positioned to target multiple early-stage, preclinical partnership opportunities on the wider pipeline.  

To succeed at achieving these goals we are focused on delivering upon the following key milestones:

·     Nomination of a clinical candidate for the BVX001 programme based on in vivo efficacy data, anticipated during 2023;

·     Identification of development leads for BVX002 and BVX003 within the next 12 months;

·     Consolidation of the intellectual property landscape surrounding further potential cancer-specific Bi-Cygni® fingerprints, supported by the newly established discovery engine;

·     Bringing onboard dedicated business development resource to actively seek out appropriate partnership opportunities for the BVX001 and/or other programmes; and

· Securing key discovery-stage collaborations with industry and academia to expand the Bi-Cygni® platform across other therapeutic platforms/other therapeutic indications.

Financials

Management controls operate across the business to ensure that our financial resources are prioritised towards the further development of the Company's therapeutic programmes and platform to reach the key value points outlined above.

This focus was reflected in the R&D expenditure which increased to £2.1 million (2021: £0.7 million) in the year and a loss after tax of £2.5 million (2021: £2.3 million).

We added to our internal laboratory capabilities by investing a further £241k (2021: £64k) in laboratory equipment.

The Group ended the year with a cash balance of £3.3 million (2021: £6.1 million)

Summary and outlook

I am very encouraged by the progress we have made during the period, including the progression of our lead therapeutic programme and the further strengthening of our IP portfolio; together with the positive strides we have made in future-proofing the business through the establishment of the Bi-Cygni® discovery engine, expansion of the pipeline and broadening of our internal capabilities and know-how. As we draw closer to reaching key value inflection points during 2023, our focus will be on increasing the visibility of the Company and showcasing our clear value proposition to potential third-party collaborators. 

I remain fully committed to our business goals, our continued delivery against objectives and to prioritising the use of proceeds to create further significant value in the Company and to provide multiple potential opportunities for financial return to our valued shareholders.

Finally , and on a personal note, I would like to thank our exceptional scientific team for their enthusiasm, commitment and hard work over the past twelve months, for which our progress to date would not have been possible, the Board for their guidance throughout the period and of course, our shareholders for their much valued continued support and investment in our business.

Tiffany Thorn

Chief Executive Officer

29 March 2023

 

C o n s olidated Statement of Comprehensive Income

For the year ended 31 December 2022

	Notes	Year Ended 31 Dec 2022	Year Ended 31 Dec 2021
		£'000	£'000
Operating expenses
Research and Development	3	(2,110)	(711)
General and Administration	3	(738)	(567)
Share based compensation	14	(127)	(224)
Total operating expenses before non-recurring costs		(2,975)	(1,502)
Non-recurring costs	3	-	(389)
Operating loss		(2,975)	(1,891)
Finance income/(cost)		4	(641)
Loss on ordinary activities before taxation		(2,971)	(2,532)
Taxation	6	474	192
Loss and total comprehensive expenses attributable to equity holders of the parent for the year		(2,497)	(2,340)
Loss per share attributable to equity holders of the parent (pence)	7
Basic loss per share (pence)		(3.78)	(6.02)
Diluted loss per share (pence)		(3.78)	(6.02)

C o n s olidated and Company Statements of Financial Position

a s at 31 December2022

		Group		Company
	Notes	As at 31 Dec 2022 £'000	As at 31 Dec 2021 £'000	As at 31 Dec 2022 £'000	As at 31 Dec 2021 £'000
A ssets
N o n-current assets
P r o p e r t y , plant and equipment	8	571	339	-	-
I nvestment in subsidiary undertakings	9	-	-	214	214
Amounts receivable from subsidiaries		-	-	5,173	2,906
T ot a l non-current assets		571	339	5,387	3,120
C u rren t assets
T rad e and o the r receivables	10	224	287	74	11
C u r r e n t tax receivable		454	192	-	-
Cash and cash equivalents	11	3,287	6,063	3,002	5,500
Total current assets		3,965	6,542	3,076	5,511
Total assets		4,536	6,881	8,463	8,631
Liabilities and equity
Current liabilities
Trade and other payables	12	284	308	43	2
Lease liabilities	15	107	71	-	-
Total current liabilities		391	379	43	2
Non-current Liabilities		188	175	-	-
Total Liabilities		579	554	43	2
Equity
Ordinary shares	13	661	661	661	661
Share premium	13	12,052	12,052	8,002	8,002
Share based compensation	13	351	224	351	224
Warrant reserve	13	73	73	73	73
Merger reserve	13	(2,834)	(2,834)	-	-
Retained losses	13	(6,346)	(3,849)	(667)	(331)
Total equity attributable to equity holders of the parent		3,957	6,327	8,420	8,629
Total liabilities and equity		4,536	6,881	8,463	8,631

N o Statement of Comprehensive Income is presented in these financial statements for the parent company as provided by Section 408 of the Companies Act 2006. The loss for the financial year dealt with in the financial statements of the parent company was £345k (2021: £331k).

T h e financial s t a t eme n t s were approved by the Board of Directors and authorised for issue on 29 March2023and were signed on its behalf by:

Michael Kauffman  Tiffany Thorn

Chairman                                                                                                                  Chi e f Executive O f ficer

29 March 2023

BiVictriX Therapeutics p l c

Reg i s t e r e d number: 13470690

Consolidated S tatement of Changes in Equity

f o r the year ended 31 December 2022

	Ordinary shares	Share Premium	Merger reserve	Share based compensation	Warrant reserve	Fair Value Reserve	Retained deficit	Total
	£'000	£'000	£'000	£'000	£'000	£'000	£'000	£'000
Balance at 31 December 2020	1	1,428	-	10	-	147	(1,519)	67
Total comprehensive expense for the period	-	-	-	-	-	-	(2,340)	(2,340)
Transactions with owners
Acquisition of BiVictriX Limited	212	2,622	(2,834)	-	-	-	-	-
Share issue - convertible loan notes	73	1,387	-	-	-	(147)	-	1,313
Share issue - cash	375	7,125	-	-	-	-	-	7,500
Expense of share issue	-	(437)	-	-	-	-	-	(437)
Share based compensation - share options	-	-	-	224	-	-	-	224
Issue of warrants	-	(73)	-	-	73	-	-	-
Share based compensation -lapsed options	-	-	-	(10)	-	-	10	-
Total transactions with owners	660	10,624	(2,834)	214	73	(147)	10	8,600
Balance at 31 December 2021	661	12,052	(2,834)	224	73	-	(3,849)	6,327
Total comprehensive expense for the period							(2,497)	(2,497)
Transactions with owners
Share based compensation - share options				127				127
Total transactions with owners	-	-	-	127	-	-	-	127
Balance at 31 December 2022	661	12,052	(2,834)	351	73	-	(6,346)	3,957

C o mpa n y Statement of Changes in Equity

f o r the year ended 31 December 2022

	A t tribu table to equity holders of the parent
		Ordinary shares	Sharepremium	Share based compensation	Warrant reserve	Fair Value Reserve	R e tained deficit	T o tal
		£ ' 000	£ ' 000	£ ' 000	£ ' 000	' 000	£ ' 000	£ ' 000
Bala n ce a t 31 December 2020		-	-	-	-	-	-	-
T o t a l c omp r ehens i v e expense for the period		-	-	-	-	-	(331)	(331)
	T ra ns a c tio n s wit h owners
Share issue - acquisition of BiVictriX Limited		213	-	-	-	-	-	213
Share issue - convertible loan notes		73	1,387	-	-	-	-	1,460
Sh a r e i s s u e - cash		375	7,125	-	-	-	-	7,500
Expense of share issue		-	(437)	-	-	-	-	(437)
Sh a r e based c om p en s ati o n - share options		-	-	224	-	-	-	224
Share based compensation - warrant reserve		-	(73)	-	73	-	-	-
T ot a l transactions with owners		661	8,002	224	73	-	-	8,960
Bala n ce a t 31 December 2021		661	8,002	224	73		(331)	8,629
T o t a l c omp r ehens i v e expense for the period							(336)	(336)
	T ra ns a c tio n s wit h owners
Sh a r e based c om p en s ati o n - share options				127				127
T ot a l transactions with owners				127				127
Bala n ce a t 31 December 2022		661	8,002	351	73		(667)	8,420

Consolidated a n d Company Statements of Cash Flows

f o r the year ended 31 December2022

	Group		C om pany
	Y ear ended 31 Dec 2022 £'000	Y ear ended 31 Dec 2021 £'000	Y ear ended 31 Dec 2022 £'000	Y ear ended 31 Dec 2021 £'000
Cas h flows from operating activities
L o s s before taxation	(2,971)	(2,532)	(336)	( 331)
D ep r eci ati o n and amortisation	151	46	-	-
Sh a r e based co m p en s a t i o n	127	224	127	224
Finance costs	(4)	641	-	-
	(2,697)	(1,621)	(209)	( 107 )
Chang es i n working capital
( I nc r e as e ) / dec r e as e i n trade and other receivables	63	(227)	(63)	(11)
I nc r e as e / ( dec r e as e ) i n trade and other payables	25	(21)	41	1
Cash used in operations	88	(248)	(22)	(10)
Taxation received	212	84	-	-
Net cas h used i n operating activities	(2,397)	(1,785)	(231)	(117)
Cash flows (used in)/generated from investing activities
Acquisition of tangible fixed assets	(389)	(46)	-	-
Disposal of tangible fixed assets	10	-	-	-
Loans to subsidiary	-	-	(2,267)	(1,446)
Net cash (used in)/generated from investing activities	(379)	(46)	(2,267)	(1,446)
Cas h flows from financing activities
Proceeds from issue of shares	-	7,500	-	7,500
Is s u e costs	-	(437)	-	(437)
Repayment of lease liabilities	-	(31)	-	-
N et cash generated from financing activities	-	7,032	-	7,063
M o v e m en ts in cash and cash equivalents in the period	(2,776)	5,201	(2,498)	5,500
Cash and cash eq u i vale n t s at start of period	6,063	862	5,500	-
Cas h a n d cash equivalents at end of period	3,287	6,063	3,002	5,500

No t e s to the Financial Statements

1 . General Information

BiVictriX Therapeutics plc ('the Company') is a public limited company incorporated in England and Wales and was admitted to trading on the AIM market of the London Stock Exchange under the symbol "BVX" on 11 August 2021. The address of its registered office is Mereside, Alderley Park, Alderley Edge, Macclesfield, England, SK10 4TG and the registered company number is 13470690. The principal activity of the Company is research and experimental development of pharmaceutical products.

2. Significant Accounting Policies and Basis of Preparation

B a si s o f preparation

The consolidated financial statements have been prepared in accordance with United Kingdom International Financial Reporting Standards ('IFRS') as adopted by the UK, IFRIC interpretations and the Companies Act 2006 applicable to companies operating under IFRS. The Company's financial statements have been prepared in accordance with Financial Reporting Standard 102 (United Kingdom Generally Accepted Accounting Practice).

The financial statements are presented in Sterling (£) and rounded to the nearest £000. This is the predominant functional currency of the Group and is the currency of the primary economic environment in which it operates. Foreign transactions are accounted in accordance with the policies set out below.

B a si s o f consolidation

The financial statements incorporate the financial statements of the Company and entities controlled by the Company. Control is achieved when the Company has the power over the investee; is exposed, or has rights, to variable return from its involvement with the investee; and, has the ability to use its power to affect its returns. The Company reassesses whether it controls an investee if facts and circumstances indicate that there are changes to one or more of the three elements of control listed above.

Consolidation of a subsidiary begins when the Company obtains control over the subsidiary and ceases when the Company loses control of the subsidiary. Specifically, the results of subsidiaries acquired or disposed of during the period are included in the Consolidated Statement of Comprehensive Income from the date the Company gains control until the date when the Company ceases to control the subsidiary.

Where necessary, adjustments are made to the financial statements of subsidiaries to bring the accounting policies used into line with the Group's accounting policies.

All intra-Group assets and liabilities, equity, income, expenses and cash flows relating to transactions between the members of the Group are eliminated on consolidation.

G oi n g concern

In considering the Group's financial commitments and forecasts, the Board has followed the guidelines published by the Financial Reporting Council entitled ''Guidance on Risk Management and Internal Control and Related Financial and Business Reporting''.

In the normal course of business, the Directors regularly review rolling cash flow forecasts. The review of financial forecasts and cash flows looking at least 12 months from the approval of these financial statement includes levers and controls which could be applied, if necessary.

The Board has considered the impact of rising inflation and foreign exchange risk. In addition, consideration has been given to the conflict in Ukraine and the impact that may have on worldwide supplies. These risks are closely monitored as part of controlled, defined expenditure to meet business objectives.

Operational cashflows include planned research and development activities to advance the Group's lead and pipeline programmes. The timing and quantum of this expenditure is under the control and direction of management with oversight provided by the Board.

After considering cash flow forecasts and associated risks, the Directors have a reasonable expectation that the Group has adequate resources to continue in operational existence for the foreseeable future.  Accordingly, the Company continues to adopt the going concern basis in preparing these financial statements.

At 31 December 2022, the Group had cash and cash equivalents, including short-term investments and cash on deposit, of £3.3 million.

Standards, interpretations and amendments to published standards not yet effective

The Directors have considered those standards and interpretations, which have not been applied in these financial statements but which are relevant to the group's operations, that are in issue but not yet effective and do not consider that they will have a material effect on the future results of the Group

Currencies

Functional and presentational currency

F o r e ig n c u r r en c y transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions or at an average rate for a period if the rates do not fluctuate significantly. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the Consolidated Statement of Comprehensive Income. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated. The presentational currency is also the functional currency.

Property , plant and equipment

Property, plant and equipment are stated at cost less accumulated depreciation and any impairment losses. Cost includes the original purchase price of the asset and the costs attributable to bringing the asset to its working condition for its intended use.

Office equipment - 25% straight line

Plant and equipment - 16% straight line

Furniture, fixtures and fittings - 25% straight line

The gain or loss arising on the disposal of an asset is determined as the difference between the sales proceeds and the carrying amount of the asset and is recognised in the Consolidated Statement of Comprehensive Income.

At each reporting date, the Group reviews the carrying amounts of its property, plant and equipment assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset i s estimated in order to determine the extent of the impairment loss (if any).

Leases

The Group assesses at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

The Group applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The Group recognises lease liabilities, representing obligations to make lease payments and right-of-use assets representing the right to use the underlying assets.

Right-of-use assets

The Group recognises right-of-use assets at the commencement date of the leases (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognised, initial direct costs incurred, and lease payments made at or before the commencement date less and lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the remainder of the lease term.

Lease liabilities

At the commencement date of the lease, the Group recognises lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Group and payments of penalties for terminating the lease, if the lease term reflects the Group exercising the option to terminate. The Group's lease liabilities are included in interest-bearing loans and borrowings.

Short-term leases and leases of low-value assets

The Group applies the short-term lease recognition exemption to its short-term leases of machinery and equipment (i.e., those leases that have a lease term of 12 months or less from the commencement date and do not contain a purchase option). It also applies the lease of low-value assets recognition exemption to leases of office equipment that are considered to be low value. Lease payments on short-term leases and leases of low-value assets are recognised as an expense on a straight-line bases over the lease term.

Extension and termination options

The Group determines the lease term as the non-cancellable term of the lease, together with any periods covered by an option to extend the lease if it is reasonably certain to be exercised, or any periods covered by an option to terminate the lease, if it is reasonably certain not to be exercised.

The Group applies IAS 36 to determine whether a right-of-use asset is impaired and accounts for any identified impairment loss.

R es ea r ch and development

Expenditure on pure and applied research are charged to the profit and loss account in the year in which they are incurred. Development costs are charged to profit and loss account unless it can be demonstrated that the costs represent an intangible asset which meets all of the criteria for capitalisation set out in para 57 of IAS38.

In c om e tax

The tax expense or credit represents the sum of the tax currently payable or recoverable and the movement in deferred tax assets and liabilities.

(a) Current income tax

Current tax, including R&D tax credits which have the characteristics of income tax, is based on taxable income for the period and any adjustment to tax from previous periods. Taxable income differs from net income in the Consolidated Statement of Comprehensive Income because it excludes items of income or expense that are taxable or deductible in other periods or that are never taxable or deductible. The calculation u s e s the latest tax rates for the period that have been enacted or substantively enacted by the dates of the Consolidated Statement of Financial Position.

(b ) Deferred tax

Deferred tax is calculated at the latest tax rates that have been substantially enacted by the reporting date that are expected to apply when settled. It is charged or credited in the Consolidated Statement of Comprehensive Income, except when it relates to items credited or charged directly to equity, in which case it is also dealt with in equity.

Deferred tax is the tax expected to be payable or recoverable on differences between the carrying amounts of assets and liabilities in the financial statements and the corresponding tax bases used in the computation of taxable income, and is accounted for using the liability method.

Deferred tax liabilities are generally recognised for all taxable temporary differences and deferred tax assets are recognised to the extent that it is probable that taxable income will be available against which the asset can be utilised. Such assets are reduced to the extent that it is no longer probable that the asset can be utilised.

Deferred tax assets and liabilities are offset when there is a legal right to offset current tax assets and liabilities, and when the deferred tax assets and liabilities relate to taxes levied by the same taxation authority on either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.

Deferred tax assets are not recognised due to uncertainty concerning crystallisation .

Payroll e xpe n s e an d related contributions

W a g es , salaries, payroll tax, paid annual leave and sick leave, bonuses, and non-monetary benefits are accrued in the period in whichthe associated services are rendered.

Pension c o sts

T h e Group makes c o n t ribu t io n s to the private pension schemes of Directors and employees.  Contributions are recognised in the periods to which they relate.

Sh ar e - based c om pe n sa ti o n

T h e Group i s s ue s share based payments to certain employees and Directors and warrants have been issued to certain suppliers. Equity- settled share-based payments are measured at fair value at the date of grant and expensed on a straight-line basis over the vesting period, along with a corresponding increase in equity.

A t each reporting date, the Group revises its estimate of the number of equity instruments expected to vest as a result of the effect of non-market based vesting conditions. The impact of any revision is recognised in the Consolidated Statement of Comprehensive Income, with a corresponding adjustment to equity reserves.

T h e fai r value of share options and warrants are determined using a Black-Scholes model, taking into consideration the best estimate of the expectedlife of the option or warrant and the estimated number of shares that will eventually vest.

Operating segments

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker is responsible for allocating resources and assessing performance of operating segments.

The Directors consider that there are no identifiable business segments that are subject to risks and returns different to the core business. The information reported to the Directors, for the purposes of resource allocation and assessment of performance is based wholly on the overall activities of the Group. The Group has therefore determined that it has only one reportable segment under IFRS 8.

The results and assets for this segment can be determined by reference to the Consolidated Statement of Comprehensive Income and Consolidated Statement of Financial Position.

I n v e stment in subsidiaries

I n v estme n t in subsidiaries are shown in the Company balance sheet at cost and are reviewed annually for impairment.

Fi n an cial instruments

F i n a nci a l as s e t s and financial liabilities are recognised in the Group's Consolidated Statement of Financial Position when the Group becomes party to the contractualprovisions of the instrument. Financial assets are derecognised when the contractual rights to the cash flows from the financial asset expire or when the contractual rights to those assets are transferred. Financial liabilities are derecognised when the obligation specified in the contract is discharged, cancelled or expired.

T rad e and other receivables

Trade and other receivables that do not contain a significant financing component are initially recognised at fair value and subsequently held at amortised cost less provision for impairment. Provisions for impairment are based on an expected credit loss model as required by IFRS 9.

Cas h , cash eq u i v al e n ts and short-term investments

Cash and cash e q u iv a le n t s consist of cash on hand, demand deposits, and other short-term highly liquid investments that are readilyconvertible to a known amount of cash and are subject to an insignificant risk of changes in value.

T rad e and other payables

T ra d e and o th e r payables are not interest-bearing and are stated at nominal value.

Classification a s d eb t or equity

D e b t and equity instruments issued by the Group are classified as either financial liabilities or as equity in accordance with the substance of the contractualarrangements and the definitions of a financial liability and an equity instrument.

E q u i t y instruments

A n equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all its liabilities. Equity instrumentsissued by the Group are recognised as the proceeds received, net of direct issue costs.

Cap it a l risk management

T h e Group has b ee n funded by equity. The components of shareholders' equity are:

(a ) T h e share capital and share p r e mi u m account arising on the issue of shares.

( b ) Merger r e s e r ve , which was created as a result of the acquisition by the Company of the entire issued share capital of BiVictriXLimited on 9 August 2021.

( c ) The share based c om p e n s at io n reserve results from the Group's grant of equity-settled share options to selected employees and Directors.

( d ) The retained d e ficit reflecting comprehensive loss to date.

T h e G r o u p ' s objective when managing capital is to maintain adequate financial flexibility to preserve its ability to meet financial obligations, both current and long term. The capital structure of the Group is managed and adjusted to reflect changesin economic conditions. The Group funds its expenditures on commitments from existing cash and cash equivalent balances, primarily received from issuances of shareholders' equity. There are no externally imposed capital requirements. Financing decisions are made based on forecasts of the expected timing and level of capital and operating expenditure required to meet the Group's commitments and development plans.

F ai r v al u e estimation

T h e carrying value les s impairment provision of trade receivables and payables are assumed to approximate their fair values because of the short term nature of such assets and the effect of discounting liabilities is negligible.

S i g n i ficant management judgement in applying accounting policies and estimation uncertainty

When preparingthe financial statements, the Directors make estimates and assumptions about the recognition and measurement of assets, liabilities, income and expenses.

Estimation u n c e r t ain t y

Re c e iva b le s f r o m the subsidiary, being amounts due from BiVictriX Limitedadvanced to support the Group's research expenditure, will be recoverable from future commercial revenues or capital receipts in the subsidiary, which are not certain to arise.

Taxation

I n recognising income tax assets and liabilities, management makes estimates of the likely outcome of decisions by tax authorities on transactions and events whose treatment for tax purposes is uncertain. In particular, amounts claimed for R&D tax credits may not be receivable. Where the final outcome of such matters is different, or expected to be different, from previous assessments made by management, a change to the carrying value of income tax assets and liabilities will be recorded in the period in which such a determination is made. The carrying values of current tax are disclosed separately in the statement of financial position

Sh ar e based payment charge

A Black-Scholes model was used to calculate the appropriate charge for share based payments.The model involves using a number of estimates and judgements to establish the appropriate inputs includingan appropriateinterest rate and dividend rate, exercise restrictions and behavioural considerations. A significant element of judgement is therefore involved in the calculation of the charge. The total charge in the year to 31 December2022was £127k (year to 31 December2021: £224k).

3 . Operating Loss

A n analysis of the Group's operating loss has been arrived at after charging:

	Y ear ended 3 1 Dec 2022	Y ear ended 3 1 Dec 2021
	£ ' 000	£ ' 000
Res e a r c h and d ev e lop me n t:
Other research and development	1,237	306
S t a ff costs - Note 5	722	349
D ep r eci ati o n of property, plant and equipment	151	46
O p e r ati n g lease cost - land and buildings	-	10
General and Administrative:
S t a ff costs - Note 5	314	329
A d mi n ist r at ion e xp ense s	424	238
Share based compensation	127	224
Non-recurring costs	-	389
T ot a l operating expenses	2,975	1,891

T h e Group has o n e reportable segment, namely the development of pharmaceutical products all within the United Kingdom.

Non-recurring costs represent the costs of the Company's admission to AIM in the period ended 31 December 2021 which were recognised as an expense.

4 . Auditor's Remuneration

T h e analysis o f the auditor's remuneration is as follows:

	Year ended 31 Dec 2022	Y ear ended 3 1 Dec 2021
	£'000	£ ' 000
Fe e s payable t o the Group's auditors for the audit of:
th e consolidated and Company annual accounts	38	33
the subsidiary's annual accounts		-
T ot a l audit fees	38	33
Aud i t related services	4	4
T ot a l audit related fees	42	37
Other services	-	-
Total non-audit fees	4	4

5 . Employees and Directors

T h e average mo n th l y number of persons (including Executive Directors) employed by the Group was:

	Group		Company
	Year ended 31 Dec 2022 Number	Year ended 31 Dec 2021 Number	Year ended 31 Dec 2022 Number	Year ended 31 Dec 2021 Number
D i r e c t or s	6	5	6	5
Scientists and administration staff	10	5	-	-
A v e r a g e total persons employed	16	10	6	5

At 3 1 December2022the Group had 17employees (31 December2021: 7).

Staff costs i n respect of these employees were:

	Group
	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
S a l a r ie s and o the r short-term employee benefits	899	395
E mpl o y e r ' s National Insurance	102	44
Pens i on con t ribu t i o n s	35	16
O p ti o n s vesting under share option schemes	127	224
T ot a l remuneration including vesting of share options	1,163	679

T h e Group m a k e s contributions to apension schemeon behalf oftheDirectorand employees.

T h e t o t a l remunerationof the highest paid Director excluding share based payments wa s £212,950(31 December2021: £181,290).

T h e D i r e c t ors h av e th e authority and responsibility for planning, directing and controlling, directly or indirectly, the activities of the Group and they therefore comprise key management personnel as defined by IAS 24.

Ag g r e g a t e emoluments of theDirectorsof BiVictrixTherapeuticsPlc:

	Group
	Y ear ended 3 1 Dec 2022	Y ear ended 3 1 Dec 2021
	£ ' 000	£ ' 000
A g g r e g a t e emoluments of Directors:
S a l a r ie s and o the r short-term employee benefits	375	205
E mpl o y e r ' s National Insurance	38	28
Pensi o n con t ribu t i o n s	8	7
O p ti o n s vesting under share option schemes	106	224
T ot a l remuneration including vesting of share options	527	464

6 . Taxation

	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
C u rren t tax
Current period - UK corporation tax	-	-
R&D tax credit	454	192
A d j ustme n t s in respect of prior periods	20	-
N et tax credit	474	192

T h e ta x creditfor each period can be reconciled to the loss per Consolidated Statement of Comprehensive Income as follows:

	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
L o s s on ordinary activities before taxation	(2,971)	(2,532 )
L o s s before tax at the effective rate of corporation tax in the United Kingdom of 19% (202119%)	(566)	(481 )
Effects of:
Fixed asset differences	(15)	-
Expenses not deductible for tax purposes	59	-
Additional deduction for R&D expenditure	(336)	-
Surrender of tax losses for R&D tax credit refund	596	-
Movement in deferred tax not recognised	262	481
R & D tax credit	474	192
T ax credit for the year	474	192

T h e Group ha s a d e f e r r e d tax liability being accelerated capital allowances, for which the tax, measured at a standard rate of 19%in all periods is 31 December2022 £262 (2021: £18,000). This has not been recognised as it is covered by accumulated tax losses in all periods.

T h e G r ou p has a d e f e r r e d tax asset for share-based payments, for which the tax, measured at a standard rate of 19%in all periods is 31 December2022£66,000(2021: £45,000). No deferred tax assets have been recognised due to the uncertainty of the availability of future profits.

At 31 December 2022 the Group had UK carried forward tax losses of approximately £3,668,000 (2021: £3,703,000) for which no deferred tax asset has been recognised.

7 . Loss per Share

B a s i c los s per share is calculated by dividing the loss for the period attributable to equity holders by the weighted average number of ordinary shares outstanding during the year.

F o r d il u t e d loss per share, the loss for the year attributable to equity holders and the weighted average number of ordinary shares outstanding during the year is adjusted to assume conversion of all dilutive potential ordinary shares.

A s at 31 December2022, the Group had 8,734,184(2021: 8,614,184) share options, warrants and subscriptions outstanding which are potentially dilutive.

T h e calculation o f the Group's basic and diluted loss per share is based on the following data:

	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
Loss for the year attributable to equity holders for basic loss and adjusted for the effects of dilution	(2,497)	(2,340)

	Y ear ended 3 1 Dec 2022	Y ear ended 3 1 Dec 2021
W e ig h t ed average number of ordinary shares for basic loss per share	66,115,171	38,865,782
E ffects of dilution:	-	-
Share options
W e ig h t ed average number of ordinary shares adjusted for the effects of dilution	66,115,171	38,865,782

	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
L o s s per share - basic and diluted	(3.78)	(6.02 )

T h e los s and the weighted average number of ordinary shares for the years ended 31 December2022and 2021used for calculating the diluted loss per share are identical to those for the basic loss per share. This is because the outstanding share options would have the effect of reducing the loss per ordinary share and would therefore not be dilutive under the terms of International Accounting Standard ('IAS') No 33.

8 . Property, Plantand Equipment

	Office equipment, fixtures and fittings	Building improvements	Plant and machinery	Motor Vehicles	Right of Use Asset	Total
	£'000s	£'000s	£'000s	£'000s	£'000s	£'000s
Cost
At 31 December 2021	12	3	97	-	275	387
Additions	5	2	229	4	148	388
Disposals	-	-	(7)	-	-	(7)
At 31 December 2022	17	5	319	4	423	768
Accumulated Depreciation
At 31 December 2021	2	1	16	-	29	48
Provided during the year	4	1	43	-	102	150
Disposals	-	-	(1)	-	-	(1)
At 31 December 2022	6	2	58	-	131	197
Net Book Value
At 31 December 2021	10	2	81	-	246	339
At 31 December 2022	11	3	261	4	292	571

D ep r eci at io n is charged to operating expenses.

	Office equipment, fixtures and fittings	Building improvements	Plant and machinery	Right of Use Asset	Total
	£'000s	£'000s	£'000s	£'000s	£'000s
Cost
At 31 December 2019	2	-	-	-	2
Additions	1	2	61	-	64
Disposals
At 31 December 2020	3	2	61		66
Additions	9	1	36	275	321
Disposals
At 31 December 2021	12	3	97	275	387
Accumulated Depreciation
At 31 December 2019	1	-	-	-	1
Provided during the year	-	-	1	-	1
At 31 December 2020	1	-	1	-	2
Provided during the year	1	1	15	29	46
At 31 December 2021	2	1	16	29	48
Net Book Value
At 31 December 2020	1	2	60	-	63
At 31 December 2021	10	2	81	246	339

9 . Investment in Subsidiary Undertakings

T h e c o n so l i d a t e d financial statements of the Group at 31 December2022include:

N am e of subsidiary	Clas s o f share	Place o f incorporation	Principle a ctivities	Proportion of ownership interest	Proportion of voting rights held
BiVictriX L i m i t e d	Ordina r y	Unite d Kingdom	R esear c h and dev elopment	1 0 0 %	1 0 0 %

	Group		C om pany
	2022 £ ' 000	2021 £ ' 000	2022 £ ' 000	2021 £ ' 000
Cost at 1 January	-	-	214	-
Acquisitions during the year	-	-	-	214
C o s t a t 31 December	-	-	214	214
C a r r y in g V a l u e as at 31 December	-	-	214	214
	Group		C om pany
B r e a k d o w n of carrying value of investment:	2022 £ ' 000	2021 £ ' 000	2022 £ ' 000	2021 £ ' 000
BiVictriX L imi t e d	-	-	214	214

I n v estme n t s are tested for impairment at the balance sheet date. The recoverable amount of the investment in BiVictriXLimited at 31 December2022was assessed on the basis of value in use. As this exceeded carrying value no impairment loss was recognised.

T h e k e y assumptions used for the value in usecalculation in 2022were as follows:

	%
D is count r a t e	13.8

T h e D i r e c t or s have made significant estimates on the future revenues based around a typical partnering with a large FMCG or Pharma partner. Assumptions have been made based upon on the size of the potential market, a patent will be achieved from which royalties will flow and  the expected royalty % across the lifetime of the patent.

T h e D i r e c t or s have performed a sensitivity analysis to assess the impact of downside risk of the key assumptions underpinning the projected results of the Group. The projection used is sensitive to the projected royalty assumptions that have been applied.

1 0 . Trade and Other Receivables

	G r ou p		C om pany
	As at 3 1 Dec 2022 £ ' 000	As at 3 1 Dec 2021 £ ' 000	As at 3 1 Dec 2022 £ ' 000	As at 3 1 Dec 2021 £ ' 000
A m ou n ts receivable within one year
O the r taxation and social security	111	68	32	6
P r e p a y me n t s	113	219	42	5
T r ad e and other receivables	224	287	74	11

T h e D i r e c t or s believe that the carrying value of trade and other receivables represents their fair value. In determining the recoverability of trade receivables, the Group considers any change in the credit quality of the receivable from the date credit was granted up to the reporting date. In addition, an expected credit losses model is used which broadens the information that an entity is required to consider when determining its expectations of impairment. Under this model, expectations from future events are taken into account which could result in the earlier recognition of impairments. Details on the Group's credit risk management policies are shown in Note 16. The Group does not hold any collateral as security for its trade and other receivables.

Amounts due to the Company from subsidiary undertakings are not considered to be receivable within one year - see note 17

1 1. Cash, Cash Equivalents and Short-Term Investments

	G r ou p		C om pany
	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear en ded 3 1 Dec 2021 £ ' 000	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear en ded 3 1 Dec 2021 £ ' 000
Cas h a t bank and in hand	3,287	6,063	3,002	5,500

1 2 . Trade and Other Payables

	G r ou p		C om pany
	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000	Y ear ended 3 1 Dec 2022 £ ' 000	Y ear ended 3 1 Dec 2021 £ ' 000
A m ou n ts falling due within one year
T rad e p a y ab le s	112	69	-	2
O the r taxation and social security	40	65	-	-
Accr u e d expenses	132	174	43	-
T r ad e and other payables	284	308	43	2

T ra d e and o th e r payables principally consist of amounts outstanding for trade purchases and ongoing costs. They are non-interest bearing and are normally settled on 30 to 45 day terms. The Directors consider that the carrying value of trade and other payables approximates to their fair value. All trade and other payables are denominated in Sterling. The Group has financial risk management policies in place to ensure that all payables are paid within the credit timeframe and no interest has been charged by any suppliers as a result of late payment of invoices during the period.

T h e fai r value of trade and other payables approximates to their current book values.

1 3 . Issued Capital and Reserves

O r di n a r y shares

	Company
Ordinary shares of 1p each:	Number	Share Capital	Share Premium	Total
		£'000	£'000	£'000
At 31 December 2021	66,115,171	661	12,052	12,713
At 31 December 2022	66,115,171	661	12,052	12,713

O th e r reserves

T h e share p r e mi u m reserve r ep r e s e n t s the difference between the net proceeds of equity issues and the nominal share capital of the shares issued.

T h e merger r e s e r v e a t 31 December 2022 a r o s e f r o m the acquisition of BiVictriX Limitedon 9 August 2021, which is accounted for using the merger method of accounting.

T h e share-based c om p e n s at io n reserve reflects the cumulative expense for outstanding share based instruments .

Re s e r v e s c las s i fied as retained deficit represent accumulated losses. None of the reserves are distributable.

1 4 . Share-based Payments

Certain Directors and employees of the Group are granted options to subscribe for shares in the Group in accordance with the rules of the Company's share option schemes. The number of shares subject to options, the periods in which they were granted and the period in which they may be exercised are given below.

The Group operates one share option scheme, in addition share options have been granted under standalone unapproved share option agreements. Options are currently granted for £nil consideration and are exercisable at a price determined on the date of the grant.

At 31 December 2022 the Company had 8,744,184 (2021: 8,614,184) unissued ordinary shares of 1p under the Company's share option schemes, details of which are as follows:

M ov eme n t s on share options during the year were as follows:

E x e r cis e price	A t 1 Jan 2022	Granted	L aps ed/ Cancelled	At 3 1 Dec 2022	Date from which exercisable	E xpiry date
0.250		30,000	-	30,000	3 May 2025	2 May 2032
0.205		40,000	-	40,000	14 Sep 2025	13 Sep 2032
0.170		30,000	-	30,000	22 Dec 2025	21 Dec 2032
0.170		20,000	-	20,000	22 Dec 2025	21 Dec 2032

A s at 31 December 2022, the share option scheme movements wasas follows:

	As a t 31 Dec 2022		As a t 31 Dec 2021
	N u m ber	W e ighted average exercise price Pence	N u m ber	W e ighted average exercise price Pence
O ut s t a nd i n g at start of the year	8,614,184	20.16	-	-
Granted	120,000	20.17	8,614,184	20.16
L a ps e d / c a nc ell e d			-	-
Ou tstanding at end of year	8,734,184	20.16	8,614,184	20.16
E x er cisable a t end of year	4,900,677	19.54	3,656,170	19.17

T he fair values of share options granted during the period were calculated using the Black Scholes option pricing model. The inputs into the model for awards granted were as follows:

Options issued	30,000	40,000	30,000	20,000
Grant date	3 May 2022	14 Sep 2022	22 Dec 2022	22 Dec 2022
Expiry date	2 May 2032	13 Sep 2032	21 Dec 2032	21 Dec 2032
Vesting period	Over 3 years from grant	Over 3 years from grant	Over 3 years from grant	Over 3 years from grant
Share price (pence)	25.0p	20.5p	17.0p	17.0p
Exercise price (pence)	25.0p	20.5p	17.0p	17.0p
Expected volatility	52.5%	52.5%	52.5%	52.5%
Risk free rate	0.75%	1.75%	3.5%	3.5%

The expected volatility of 52.5% has been estimated based on comparable companies listed on AIM. 

15 . Lease liabilities

Amounts recognised in the statement of financial position

Right-of-use assets

Details of the Right-of-use assets held at 31 December 2022 can be found in note 8.

Lease liabilities

	As at 31 December 2022	As at 31 December 2021
	£'000	£'000
Current	107	71
Non-current	188	175
	295	246
Future minimum lease payments are as follows:
Not later than one year	107	71
Later than one year and not later than 5 years	188	175
Total gross payments	295	246
Impact of finance expenses	-	-
Carrying amount of liability	295	246

Lease liabilities have been recognised on the incremental borrowing rate for Land and Buildings and Office Equipment.

Amounts recognised in the statement of comprehensive income

	As at 31 December 2022	As at 31 December 2021
	£'000	£'000
Depreciation charge	(103)	(29)
Interest of lease liabilities	(12)	(2)
Rental payments with lease term less than 12 months		-
	(115)	(31)

Amounts recognised in the statement of cash flows

	As at 31 December 2022	As at 31 December 2021
	£'000	£'000
Principal elements of lease payments	(75)	(1)
Interest of lease liabilities	-	-
Rental payments with lease term less than 12 months	-	(1)
	(75)	(2)

1 6 . Financial Risk Management

The main risks arising from the Group's financial instruments are cash flow and liquidity and credit risk. The Group's financial instruments comprise cash and various items such as trade payables, which arise directly from its operations.

Cas h flow and liquidity risk

Management monitors the level of cash on a regular basis to ensure that the Group has sufficient funds to meet its commitments where due. The table below analyses the Group and Company's financial assets and liabilities by category:

	G r ou p				C om pany
	Y ear ended 31 Dec 2022 Financial assets at amortised cost £ ' 000		Y ear en ded 31 Dec 2021Financial assets at amortised cost £ ' 000		Y ear ended 31 Dec 2022 Financial assets at amortised cost £ ' 000		Y ear en ded 31 Dec 2021Financial assets at amortised cost £ ' 000
A ssets as pe r statement of financial position
O the r receivables	111		68		5,205		2,911
Cash and cash eq u i vale n t s	3,287		6,063		3,002		5,500
	3,398		6,131		8,207		8,411
	G r ou p				C om pany
	Y ear ended 31 Dec 2022 Financial assets at amortised cost £ ' 000		Y ear en ded 31 Dec 2021Financial assets at amortised Cost £ ' 000		Y ear ended 31 Dec 2022 Financial assets at amortised cost £ ' 000		Y ear en ded 31 Dec 2021Financial assets at amortised cost £ ' 000
T rad e p a y ab le s	112		69		-		1
O the r creditors and accruals	172	239			43	-
	284	308			43	1

All liabilities are due within 30 days except for lease liabilities which are dealt with in note 15.

Cr edit risk

The G r ou p gi v e s careful consideration to which organisations it uses for banking in order to minimise credit risk. The Group holds cash with two large banks in the UK. The amounts of cash held at the reporting date can be seen in the financial assets table above. All of the cash and equivalents were denominated in UK Sterling. The Group's policyis to minimisethe risks associated with cash and cash equivalents by placing these deposits with institutions with a recognised high credit rating.

T h e carrying amo u n t of financial assets recorded in the Consolidated Statement of Financial Position, net of any allowances for losses, represents the Group's maximum exposure to credit risk without taking account of the value of any collateral obtained.

N o allowance has been made for impairment losses. In the Directors' opinion, there has been no impairment of financial assets during the period.

A n allowance for impairment is made where there is an identified creditloss which, based on previous experience, is evidence of a reduction in the recoverability of the cash flows. The Directors consider the above measures to be sufficient to control the credit risk exposure. No collateral is held by the Group as security in relation to its financial assets.

Fo r e ig n currency r is k

T h e G r ou p ' s exposure to the risk of changes in foreign exchange rates relates solely to the Group's use of suppliersoperating overseas, primarily denominated in Euros and US Dollars. The Group's use of foreign suppliers is minimal and as such exposure to foreign currency changes is not material.

T h e carrying amo u n t s of the Group's foreign currency denominated monetary assets and monetary liabilities at the year end were £16,000(2021: 1,000).

A t present the Group does not make use of financial instruments to minimise any foreign exchange gains or losses so any fluctuations in foreign exchangemovements may have a material adverse impact on the results from operating activities.

F ai r v al u e of financial assets and liabilities

T h e r e i s no material difference between the fair value and the carrying values of the financial instruments because of the short maturity period of these financial instruments and their intrinsic size and risk.

Cap it a l risk management

T h e Group c o ns i d er s capital to be shareholders' equity as shown in the consolidated statement of financial position, as the Group is primarily funded by equity finance. The Group is not yet in a position to pay a dividend.

T h e o b j e c t i v e s when managing capital are to safeguard the Group's ability to continue as a going concern in order to provide returns for shareholders and for other stakeholders. In order to maintain or adjust the capital structure the Group may return capital to shareholders and issue new shares.

1 7 . Related Party Transactions

T r an s a c t io n s b e tween the Company and its subsidiaries, which are related parties, have been eliminated on consolidation and are not disclosed in this note.

Ke y m a na g eme n t compensation is disclosed in Note 5 of the consolidated financial statements. Directors' emoluments are disclosed in the RemunerationCommittee Report.

18. Transactions with shareholders

The following transactions with shareholders and companies controlled by directors or former directors of Bivictrix were recorded, excluding VAT, during the year:

		Year to 31 December 2022	Year to 31 December 2021
		£'000	£'000
Acceleris (David Youngman/Norman Molyneux) Non-Executive Director fees, funding support fees and expenses		-	129
Gladstone Consultancy Partnership (Iain Ross) Consultancy fees		-	39

C ompa n y

T h e Company i s responsible for financing and setting Group strategy. The Company's subsidiary carried out the Group's research anddevelopment strategy including the management ofthe Group's intellectual property. The Company provides funding to its subsidiary in the form of a loan. This loan is classified as non-current to reflect the likely repayment schedule of the loan. Interest is accrued at a rate of 4.5% per annum which is considered to be a market rate. Balance outstanding, including accrued interest, at the 31 December 2022 was £5,173,000 (31 December 2021: 2,906,000)

19 . Contingent L iabil i ti e s

T h e Group has n o contingent liabilities at 31 December2022(2021: nil).

20. Convertible loan notes

In 2020 BiVictriX Limited entered into a Convertible Loan Agreement ('CLA') with the Future Fund, Development Bank of Wales and Alderley Park Ventures.  The CLA had 36 months term with interest payable of  8% p.a  Loan note holders had the right to receive repayment in full and a 100% redemption premium or convert to equity at 20% to the prevailing share price or the previous round price, whichever was the lower..

On 10 August 2021, the loan note holders elected to convert the CLA and accrued interest. All loan notes were converted to ordinary shares at a price of 11.7 pence per share. The discount against the Admission price of 20.0 pence per share has been recognised in the statement of comprehensive income.

21. Events after the Reporting Date

In January 2023, Dr. Michael Kauffman was appointed as Non-Executive Chairman.

In January 2023, positive preclinical data was reported with the BVX001 programme, demonstrating a highly favourable safety profile compared to Mylotarg^TM in an in vivo model assessing the risk for bone marrow toxicity and neutropenia.

22 . Ultimate Controlling Party

There is no ultimate controlling party of the Group.

 

END

 

 

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