BVX Bivictrix Therapeutics Plc

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BIVICTRIX THERAPEUTICS PLC

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

Final results for the year ended 31 December 2023

·   Significant scientific and corporate progress towards first clinical study for BVX001 in Acute Myeloid Leukaemia ("AML")

·    Expansion of the Bi-Cygni® discovery across ten solid and haematological tumour types and strengthening of our IP portfolio

·   BVX001 - Positive INTERACT meeting with the FDA with strong regulatory alignment of our ongoing IND-enabling plans; US Orphan Drug Designation granted by the FDA for BVX001, post period end

·    Targeting two ready-for-clinic Bi-Cygni® antibody drug conjugates ("ADCs") in 2026

Alderley Park, 31 May 2024 - BiVictriX Therapeutics plc (AIM: BVX), a drug discovery and development company applying an innovative, proprietary approach to develop a new class of highly selective, next generation cancer therapeutics, bispecific antibody drug conjugates (Bi-Cygni® ADCs), which exhibit superior potency, whilst eliminating treatment-related toxicities, today announces its audited results for the twelve months ended 31 December 2023. The Annual Report and Accounts for the year ended 31 December 2023, will be posted to shareholders in due course together with the notice of the 2024 Annual General Meeting.

Corporate Highlights including post period end events

·    Compelling data  generated to demonstrate the potential and differentiation of the drug in the treatment of AML, including improved characterisation of BVX001's target patient population, clinical position and commercial opportunity

·    Interim data from an established preclinical model delivered promising safety data for BVX001, highlighting our potential starting dose selection for first-in-human studies and the product's wide therapeutic window

·    Successful fund raise of £2.1 million gross proceeds with support from existing and new investors, completed on 8th August 2023 at a subscription price of 13p/share

·    Selection of a preclinical lead for BVX002, our lead solid tumour targeting product with a lead target indication of ovarian cancer identified based on strong data

·    Strengthening of our external scientific and clinical advisory network to include Dr Eric Rowinsky and Dr Tami Rashal, experts in the solid tumour and haematological fields, respectively

·    Two leadership appointments including Dr Michael Kauffman as Non-Executive Chairman and Dr Adrian Howd as Chief Financial Officer (CFO) and Chief Business Officer (CBO)

Financial highlights

·    Investment in R&D of £2.0 million (2022: £2.1 million)

·    Loss after tax of £2.5 million (2022: £2.5 million)

·    Cash and cash equivalents of  £3.3 million at 31 December 2023 (2022: £3.3 million)

Tiffany Thorn, Chief Executive Officer of BiVictriX, commented: "2023 has been a remarkable year for BiVictriX. We have made considerable progress with BVX001, the Company's lead bispecific ADC, towards getting this asset ready for the clinic, identifying our route to market and attracting the support of globally recognised KOLs in the AML space. Post period end, we have continued to make significant progress across our wider portfolio, and we are on track to nominate a clinical candidate for our solid tumour programme, BVX002, and further expand our IP portfolio, increasing the value proposition for our shareholders. I would like to thank our dedicated scientific team and our valued shareholders for their continued support as we look to forward to realising the value across our next-generation therapeutic programmes."

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 2023

It is a pleasure to report on the Company's developments and progress in 2023, which was my first year as the Company's Chairman. Our science continues to deliver differentiated data and I look forward to meeting our objectives of becoming a clinical ADC company.

My first year as Chairman of BiVictriX has seen considerable progress on multiple fronts and I have enjoyed working with our CEO, Tiffany Thorn, the Senior Management Team and the Board to ensure we are well placed to make the best of what we have and achieve our goal of developing novel, differentiated bispecific ADCs.

During 2023, we generated promising preclinical safety and efficacy data for our lead product, BVX001. The data supports our view of a differentiated clinical profile which may offer distinct advantages for the treatment of AML, a disease with significant unmet medical need.

I have been working closely with the team to sharpen our clinical trial plan for BVX001, complete a robust preclinical data package and ensure we maximise our first-in-human study and position the product accordingly. 

To that end, we were delighted to be granted an INTERACT meeting with the FDA after period end, and our initial regulatory interactions have been highly constructive and aligned with our strategic thinking.

In December 2023 we held an inaugural key opinion leader meeting with a number of world-renowned AML experts to appraise BVX001, which I chaired. We gained positive endorsement for our approach and data from which we will leverage, particularly as we move to the next phase of clinical trial planning and principal investigator contact.

Our technology platform continues to offer significant opportunities in the larger solid tumour space, and we accelerated our efforts in relation to BVX002 during 2023, with an initial therapeutic focus in the ovarian cancer setting. New target pairs are rapidly emerging from our R&D activities, and we look to broaden the applicability of our technology and further developing our pipeline of novel therapies during 2024.

We have achieved a lot whilst prudently managing our cost base in 2023, and I have worked with the team to ensure we focus on the generation of the optimal data sets to properly evaluate our assets and their path to the clinic.

The opportunity from our science is significant, and I am proud of the differentiation and progress we have made in 2023 and the trajectory of our business in this highly valuable therapeutic segment.

I would like to take this opportunity to thank my fellow Directors for their strategic input, governance and oversight during the year. The whole team at Alderley Park led by our CEO, Tiffany Thorn, have made much progress through their hard work and I thank them all.

Lastly, I wish to thank all of our shareholders for their loyal support of our vision and for enabling us to continue striving to develop new, game changing cancer therapeutics.

Michael Kauffman, M.D., Ph.D.

Non-Executive Chairman of BiVictriX Therapeutics PLC

31 May 2024

Chief Executive Officer's Review

For the year ended 31 December 2023

It is my privilege to present the Company's third Annual Report as CEO of BiVictriX Therapeutics plc. I am delighted to report the achievements we have made to advance our novel approach to develop more effective and safer anti-cancer therapeutics - targeting the cancer, not the patient. This would not be possible without the valued support of our talented staff and our shareholders, to whom I am thankful for their confidence and trust in BiVictriX.

The business

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 ("ADC") 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 operates in the ADC space, which showed a very significant year of corporate activity in 2023, and I am pleased to report the Company has continued to make strong progress in line with our strategy.

There are over 180 ADCs in clinical development, but only 3 of these are bispecific ADCs that target twin antigens in a similar manner to BiVictriX. Global revenues of the 16 approved ADC therapies reached $9.7 billion[1] in 2023 and are forecasted to grow to $19.8bn by 20281. BiVictriX has established a growing proprietary library of cancer-specific Bi-Cygni® fingerprints, enabling the Company to target a diverse array of different cancer types.

Our lead programme, BVX001, is focused on Acute Myeloid Leukaemia ("AML"), one of the most aggressive forms of blood cancer with one of the poorest overall survival rates across all cancers. All currently approved AML therapies are associated with severely toxic side effects, including potentially fatal infections and sepsis, limiting their use to younger, fitter patients.

Bi-Cygni®: A first-in-class 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 bispecific antibody engineering insights; to create a new class of highly selective, next-generation anti-cancer therapeutics. Together with our proprietary library of these novel 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 bispecific therapeutics (Bi-Cygni® therapeutics) that are highly cancer-selective.

As our 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 very wide 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, to improve both depth and duration of anti-tumour responses with reduced likelihood of causing harm.

The Company has maintained its vision to combine innovation 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 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 2023

Having continued to prioritise R&D progress, particularly BVX001 and successfully completed a £2.1 million (gross) fundraise in August 2023, we have made good progress in the period, which additionally included:

·    Strengthened the BVX001 preclinical data package for AML with positive data from a toxicity evaluation study and from two in vivo efficacy studies in murine models

·    Patents granted in the United States and Japan providing very broad protection for BVX001 with patent protection being prosecuted in a further six jurisdictions

·    Two leadership appointments including Dr Michael Kauffman as Non-Executive Chairman and Dr Adrian Howd as Chief Financial Officer (CFO) and Chief Business Officer (CBO)

·    Hosted inaugural roundtable discussion with globally renowned clinical experts in the ADC space to assist in shaping a route for BVX001 to patients

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

Board and Leadership Team

On 6 January 2023, we announced that Dr Michael Kauffman, M.D., Ph.D. was appointed as Non-Executive Chairman of BiVictriX. Dr Kauffman took over the role from Iain Ross, who continued as a Non-Executive Director at BiVictriX until 5 December 2023.

Dr Kauffman has taken over as Non-Executive Chairman at a crucial time for the Company, as we progress BVX001 towards first in human studies. Since his appointment to the Board of Directors in January 2022, Dr Kauffman has seen us rapidly progress BVX001 from an early-stage asset towards a clinical candidate.

Having been instrumental in the approval of several oncology therapeutics, including XPOVIO®, Kyprolis® and Velcade®, and bringing over twenty-five years of working across preclinical research, clinical development, regulatory strategy and commercialisation, Dr Kauffman is very well placed to draw from his experience as a seasoned cancer drug developer to support the business at this juncture.

I would like to personally thank Iain Ross for his commitment and support of the business. His mentorship, and his valued guidance were instrumental to taking the Company from a private entity to a publicly listed business and beyond, and I would like to wish him all the very best for the future.

On 3 October 2023, we appointed Adrian Howd as CFO and CBO. Adrian joined BiVictriX with over 20 years of strategic, financial and commercial experience in the biopharmaceutical industry, having held various financial roles, private and public executive management positions and board roles across the sector, including Chief Investment Officer and Chief Executive Officer at investment firm, Malin plc.

During his career, he has led multiple asset and corporate business development transactions, as well as numerous equity capital market fundraises totalling over €430 million in the UK and overseas, gained during his previous senior roles at Malin, Berenberg, ABN Amro, and Nomura.  

Notably, Adrian led early investments in, and served on the Boards of Immunocore (a UK based company with an FDA approved bispecific cancer therapy, KIMMTRAK) and Kymab, two highly successful UK platform-based therapeutic companies, which both achieved multi $bn exits on NASDAQ and through M&A respectively.

These additions strengthen the BiVictriX team for the next phase of growth.

Internal R&D capabilities

In 2023, we dedicated significant operational and financial resources to R&D, having invested £2.0 million. This investment has enabled us to advance our lead asset BVX001 to IND-enabling studies and accelerate solid tumour focus with BVX002, advancing the Group's lead and pipeline programmes. 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.

Scientific progress

Over the last year, we have continued to execute our development plan for our lead asset, BVX001, marked by the achievement of several key preclinical milestones essential for progressing this molecule towards the clinic.

Following the identification of a development lead for BVX001 in December 2022, the Company announced in January 2023 additional data to strengthen the preclinical data package for this asset in AML. This included positive in vivo results from a toxicity evaluation study for BVX001, conducted head-to-head with the approved clinical comparator gemtuzumab ozogamicin ("GO").

GO, marketed as Mylotarg™, is currently the only approved ADC for the treatment of AML. These data showed a highly favourable safety profile and reduced off-target effects across two doses of BVX001 versus the reported maximum tolerated dose of Mylotarg™ in a well validated toxicity model.

These results were bolstered by two further in vivo efficacy studies in murine models of AML. In June 2023, we announced the nomination of a clinical candidate for our lead BVX001 programme following results of a four-week study. In this study, the nominated clinical candidate demonstrated highly statistically significant tumour regressions of up to 93% at day 28 (p-value <0.001) when compared to the untreated negative control group, with seven of the nine animals treated reported as either completely tumour free or with non-measurable tumours, at the end of dosing. Importantly, no adverse effects, including weight loss, were reported with BVX001 in these studies even, at the higher doses tested. 

Following the 28-day dosing period and efficacy assessment, the duration of survival post treatment was determined. In October 2023, we announced that BVX001 increased survival rates in this difficult-to-treat pre-clinical model of AML by 126% when compared to untreated control. The data here demonstrating that BVX001 provides clear survival benefits, even in this challenging AML setting.

This strong data was supported by a second study, in which the AML tumours were established at a much larger size relative to the first study (~650mm3 vs ~200mm3), prior to the initiation of BVX001 dosing. Of note, many anti-cancer agents perform less favourably in larger tumours due to reduced drug penetration, making any anti-tumour response more significant. In July 2023, we announced full results indicating that BVX001 retains its potent anti-tumour activity even in this more difficult setting, demonstrating highly statistically significant tumour regressions of 97% at day 28 (p-value <0.001), with five of the six animals treated reported as either completely tumour free or with non-measurable tumours at the end of dosing; all placebo treated animals had growing tumours.  Again, there were no observed adverse effects with BVX001. Further preclinical studies will be progressed to support regulatory approvals to initiate human trials.

Together, these studies offer a strong preclinical data package, demonstrating the significant potential of BVX001 as an effective treatment for AML offering a much wider therapeutic window, supporting our plans to progress BVX001 into the clinic. Further, it provides validation of our wider Bi-Cygni® platform to improve cancer-specific targeting, reducing potentially harmful or fatal side effects across a broad range of cancer indications.

We have continued to broaden our patent portfolio with the addition of new filings to provide further robust protection for BVX001 and the wider platform, including BVX002 and our proprietary bispecific antibody format. We also received notice that our patent from the initial broad patent family, which provides wide protection for BVX001 at the antigen fingerprint level, has been granted in the United States and Japan.

The claims granted provide broad protection to prevent any third party from developing an antibody-based therapeutic which is linked to a cytotoxic payload and requires binding to CD33 and CD7, for use across any CD7+CD33+ haematological cancer type.  Along these lines, in addition to AML, both CD33 and CD7 are expressed in a subset of patients with Myelodysplastic Syndromes and T-Cell Acute Lymphoblastic Leukaemia, as well as patients with other cancer types.

In addition to the aforementioned, the Company is pursuing prosecution for this patent family in a further six global jurisdictions. This will ultimately provide worldwide protection for the therapeutic asset, at the broadest level, across all relevant markets, with further patent grants anticipated within the coming months.

Good progress has also been made across our two discovery-stage, solid tumour programmes, BVX002 and BVX003. The Company is on track to nominate a clinical candidate for BVX002, the Company's second proprietary programme targeting high unmet in Ovarian Cancer, in the second half of this year, following the successful identification of a development lead earlier in the year. Mounting early-stage third-party interest in this asset is currently being explored by the Company.

Further to this, we have successfully taken our third programme, BVX003, which can target a range of solid tumour types, from initial pipeline discovery through to the identification of a therapeutic development lead. This programme is now available for partnership; enabling the core R&D team at BiVictriX to focus internally on progressing BVX001 and BVX002 towards the clinic.

Commercial strategy

The Board and our team believe the Bi-Cygni® platform can create a portfolio of first-in-class therapeutics for various solid and blood cancer types, providing a competitive edge over the current drugs under development and meeting critical market needs.

BiVictriX's goal is to prove the Bi-Cygni® method in a range of hard-to-treat cancer types, starting with BVX001 in AML, to show the broad potential of the concept, driving the Group as a world leader in the field.

We are dedicated to achieving maximum value by developing our therapeutic pipeline in a focused and effective manner, reaching key milestones that validate the wide applicability of our exclusive Bi-Cygni® method for treating various cancer types. We aim to do this while also ensuring we utilise our capital in the most efficient manner to reach the value-enhancing milestones that matter to our shareholders. For this reason, we have decided to dedicate our internal R&D focus on our two leading assets, BVX001 and BVX002, which together showcase the Company's technology platform across both solid and liquid tumour types, and which are already gaining traction with potential partners. The Company is looking to explore all options regarding early-stage collaborations which may support the progression of the pipeline towards key value-inflection points. 

We believe that BVX001, as our most advanced asset, is critical in providing validation to the market for the wider Bi-Cygni® platform as a disruptive new approach in the oncology therapeutic sector. Based upon the promising data generated to date, our aim is to progress this asset to achieve full IND approval and establish early clinical proof of concept through an initial Phase I/II clinical trial, with the focus on attracting third party interest at key junctures within this development pathway, who may be interested in partnerships and/or licensing opportunities, providing long-term revenue streams to BiVictriX. To support this, our next immediate goal is to finalise our initial preclinical data package with a key readout on the safety of the therapeutic in a well-established model of toxicity, with final data expected by end H1 2024.

As we near completion of this major corporate milestone, we will continue to drive interest in the Company at relevant sector conferences, building upon our well-received presentations and active involvement at the Immuno-Oncology Summit Europe and PEGS Europe during the period.

I was also delighted by BiVictriX being included in the 2023 roundup of BusinessCloud's MedTech 50, an annual ranking of the most innovative medical technology creators in the UK. We have also increased our engagement with key consultants in the field to support our business development focus and to optimise our potential opportunities.

We have received interest in our platform, and our goal is to balance the commercial value of both our platform and our specific programmes, with suitable deal structures for the Company and our stakeholders.

Immediate goals

Through our expanding pipeline, broad patent portfolio and internal know-how, the Company is well positioned to progress our pipeline and build collaborative alliances.

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

·    Generation of further preclinical data for BVX001 to complete the safety and efficacy data package

·    Further engagement with the FDA and MHRA to finalise the regulatory pathway to the clinic

·    Finalise the manufacturing strategy for BVX001

·    Nomination of a clinical candidate for the BVX002 programme, targeting ovarian cancer, our first solid tumour programme

·    Securing discovery and clinical development stage collaborations with industry partners to support and accelerate the progression of our lead assets to clinical proof of concept, regulatory approvals and commercialisation

Financials

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

This focus was reflected in the R&D expenditure for the year of £2.0 million, broadly consistent with that reported in the prior year (2022: £2.1 million); together with a loss after tax of £2.5 million (2022: £2.5 million).

The Group ended the year with a cash balance of £3.3 million (2022: £3.3 million) following the successful fundraising in August 2023, raising £2.1 million (gross).

Summary and outlook 

I am extremely encouraged by the progress we have made during and after the period, including the striking progression of our lead therapeutic programme towards the clinic, together with the development of our solid tumour assets and further strengthening of our broad IP portfolio.

As we draw closer to reaching key inflection points during 2024, our focus will be on increasing the visibility of the Company and demonstrating the clear value proposition to third parties. 

I remain fully committed to our business goals, our continued delivery against objectives and to prioritising our capital allocation to create further significant value and multiple potential opportunities for financial return to our valued shareholders.

Finally, and on a personal note, I would like to thank our exceptional scientific and corporate team for their enthusiasm, commitment, and hard work over the past twelve months, without 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 continued support and investment in our business.

Tiffany Thorn

Chief Executive Officer

31 May 2024