BVX Bivictrix Therapeutics Plc

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BIVICTRIX THERAPEUTICS PLC

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

Interim Results for the Six Months Ended 30 June 2024

Alderley Park, 1 August 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 reducing treatment-related toxicities, today announces its unaudited interim results for the six months ended 30 June 2024.

Highlights, including post period:

·    Safety data supports progression of BVX001 into the clinic. Data compares favourably to approved ADCs with same linker and cytotoxic payload and informs clinical dose selection ahead of final IND-enabling studies

·    BVX001 granted Orphan Drug Designation by the FDA for the treatment of AML, providing commercial and regulatory benefits

·    Positive INTERACT meeting with the FDA for BVX001, providing efficient route forward for IND submission

·    Innovate UK grant provides non-dilutive capital to accelerate BVX002, our second drug candidate which targets solid tumours

·    Continued progression and expansion of target discovery platform with Bi-Cygni® target pairs discovered in over ten different cancer types, including lung, breast and bladder cancer

·    Cash and cash equivalents of £1.7 million as at 30 June 2024 (£1.9 million at 30 June 2023)

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, commented: "In the first half of the year, BiVictriX has continued to execute on its strategy of discovering and developing novel,  potentially best-in-class bispecific ADCs targeting multiple cancer types. Our lead product, BVX001, has now shown positive preclinical safety and efficacy data in multiple in vivo models, highlighting its potential for improved efficacy and superior cancer selectivity compared with existing AML agents. I am pleased with our initial interaction with the FDA, as we look to progress BVX001 into the clinic. Furthermore, we have made significant progress in the solid tumour space through the identification of a lead for our solid tumour programme, BVX002, together with the expansion of our target discovery library to include some of the largest commercial cancer types, including lung and breast cancers."

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About BiVictriX Therapeutics plc

BiVictriX (AIM: BVX) is an emerging biotechnology company leveraging clinical experience and its proprietary discovery engine to advance a new class of highly cancer-selective, next-generation precision cancer therapies in one of the fastest-growing markets in oncology. BiVictriX's first-in-class Bi-Cygni® Antibody Drug Conjugates ("ADCs") combine superior efficacy with substantially improved cancer-selectivity and safety to provide opportunities for prolonged dosing and greater efficacy in the clinic. The Company is advancing its pipeline to deliver the future of cancer care across a broad range of haematological and solid cancer indications in areas of high unmet medical need.

Find out more at www.bivictrix.com and connect with us on LinkedIn and Twitter @BiVictriX.

Chairman's Statement

I am pleased to report on our encouraging progress in the first half of 2024, as we continue our path to becoming a clinical stage biotech company with a novel and differentiated therapeutic pipeline of bispecific Antibody Drug Conjugates ("ADCs") with enhanced selectivity for tumour over normal cells.

The BiVictriX team continues to expand our potential with a growing portfolio of proprietary bispecific ADCs targeting both solid and liquid tumours.  Our unique approach with our proprietary Bi-Cygni® platform enables us to target novel cancer-specific twin antigen fingerprints, with bespoke tuneable, ADC therapeutics.

Our lead programme and primary focus, BVX001, targets Acute Myeloid Leukaemia ("AML"), the most aggressive form of adult leukaemia, a disease with dismal clinical outcomes and poor survival rates.

During the period, we reported further positive preclinical safety and efficacy results in established in vivo models and using AML cells directly from patients. Our data package strongly supports the progression of BVX001 into the clinic, and we believe we have an emerging profile that could be best-in-class targeting neoplastic cells whilst sparing normal myeloid cells, including disease-fighting neutrophils. This has been further supported by initial positive interactions with the FDA and with the recent grant of Orphan Drug Designation for BVX001.

Consistent with our identification of BVX002 for the treatment of ovarian cancer, our wider platform has the ability to address over ten different cancer types.  We have recently expanded our proprietary twin-antigen target library to include novel, cancer-specific target pairs across a number of commercially meaningful indications, including lung, breast and bladder cancer, areas of significant and growing commercial interest.

During the reporting period and aligned with our focus, we have prioritised our Research & Development ("R&D") capabilities, with the Company investing £1.2 million in the first half of the year.

Outlook

Looking ahead, with the strong fundamentals BiVictriX has built, we plan to expand our Intellectual Property portfolio and target discovery activities to build a robust library of commercially attractive novel therapeutic leads, while continuing to progress BVX001 and BVX002 towards the clinic.

The Directors believe BiVictriX has one of the leading platforms in the bispecific ADC space and needs to be able to maintain competitiveness in a rapidly expanding landscape by moving BVX001 as expeditiously as possible into the clinic and demonstrating anti-leukemic activity and tolerability, as well as to progress our other programmes at a competitive rate.

With recent precedents in AML for granting accelerated / conditional approval, we believe there is a substantial opportunity to generate additional shareholder value. As such, the Directors will continue to assess the various commercial and strategic business development opportunities available to them with regards to both the future funding and growth of the Company.

Conclusions

In summary, we have made encouraging progress with our R&D pipeline. These accomplishments, coupled with the promising in vivo safety and efficacy data on BVX001 and the development of our lead drug candidate in our solid tumour programme, BVX002, have established a solid foundation for BiVictriX, setting us up to take advantage of future opportunities.

I would like to extend my gratitude to Tiffany Thorn, our CEO, for her leadership and to the entire team for their diligent work over the past six months, which has been instrumental in establishing BiVictriX as a prominent biotech company. In addition, I'd like to thank the BiVictriX Board for their diligence in helping the Company advance. I also express my appreciation to our shareholders for their continued support, and I eagerly look forward to updating the shareholders on our progress in the year ahead.

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

Chairman of BiVictriX Therapeutics plc

Chief Executive Officer's Report

The year to date has been a period of significant progress towards advancing our lead assets towards the clinic and establishing BiVictriX as a global leader in the bispecific ADC space. We have once again met our challenging R&D milestones and delivered highly compelling data across our lead AML and solid tumour assets whilst prudently managing our capital. We have placed an increased and significant emphasis on our corporate activities during the period, to take advantage of the continuing global commercial interest in novel ADC approaches by large pharma and other biotech companies, as our technology gains greater visibility and appreciation.

Our R&D activities have centred upon the progression of BVX001 towards clinical readiness, accelerating our path to the clinic for BVX002, and scaling our drug discovery platform to address a wider range of solid tumours. We continue to strengthen and maintain our Intellectual Property portfolio and are very encouraged by our initial positive interactions with the FDA and leading Key Opinion Leaders ("KOLs") in the AML space, highlighting a clear path forward for BVX001. I continue to work closely with our executive team, internal R&D teams and Board to achieve key value-enhancing milestones for our business, with a key focus on value creation for our shareholders.

Meaningful scientific progress

Over the past six months, we have continued to execute on our development plan for our lead therapeutic asset, BVX001. We have met several key preclinical milestones which are essential for progressing this molecule towards the clinic.

Since nominating our clinical candidate in June 2023, based on a positive in vivo efficacy profile in murine models of disease, we have been able to further demonstrate the potential efficacy of this therapeutic across a panel of primary samples from patients with AML. The preclinical profile thus far observed with BVX001 is consistent with the potential to result in deeper and more durable regressions with markedly reduced activity against normal infection-fighting white blood cells, thereby offering the possibility of reducing potentially fatal toxicity for patients with AML and related diseases.

Further to this, in June of this year, we reported data for BVX001 showing an in vivo safety profile in an established rodent model of toxicity supporting progression to final IND-enabling studies and towards clinical studies. This repeat dose finding preclinical study assessed the tolerability, toxicity and toxicokinetics of BVX001 at 10, 30 and 55mg/kg given intravenously, and studied the effects on standard behavioural and clinical endpoints (including haematology and serum chemistry) and macro/microscopic changes in a number of organs and tissues. BVX001 was tolerated across the dose-range with adverse clinical and anatomic pathology changes primarily observed only at the high dose level, far in excess of doses required for anti-leukaemic activity as discussed below. Ocular toxicity was not observed at mid to low doses, and affects at higher doses were graded as minimal with no severe pathological changes seen at all doses tested.

Importantly, if converted to human equivalent doses, the doses tested here were up to 11-times higher than equivalent doses used in a mouse xenograft study that showed significant tumour regressions (up to 97% versus control) in a hard-to-treat AML tumour model, as we reported in 2023. These data provide us with further confidence in the tolerability of this drug candidate at doses that confer marked anti-leukemic activity in the preclinical models. Together, they highlight the clear benefits of the Bi-Cygni® platform versus the de facto (single antigen) ADC approach, where the safety window for killing tumour versus normal cells reported is typically minimal.

We are greatly encouraged by these data as they round out our comprehensive preclinical package. These data will be submitted for formal presentation at forthcoming medical meetings, as part of our strategy to showcase our data to a wider audience.

In total, our preclinical studies demonstrate the significant potential of BVX001 as an effective treatment for AML with a potentially higher therapeutic window as compared to existing therapeutic options and support our plans to progress BVX001 into the clinic. In addition, progress with our lead bispecific ADC validates the wider Bi-Cygni® platform approach to offer the ability for improved cancer cell-specific targeting leading to the potential for reduced serious side effects across a broad range of cancer indications.

Expanding and accelerating our BiVictriX Solid Tumour pipeline

Solid tumours represent the largest commercial opportunity for ADC therapeutics, which aligns to BiVictriX's increased activities in this space during 2023 to 2024. Our lead solid tumour asset, BVX002, is progressing well, and we were delighted to receive an Innovate Grant from the UK Government in recognition of the drug's potential in the ovarian cancer setting. This grant of c. £0.4 million enables us to perform key preclinical work as we progress our plans towards filing an IND for BVX002.

Additionally, we have expanded our Bi-Cygni® target pair library with the identification of novel and proprietary, cancer-specific antigen pairs across ten different cancer types, including breast and lung cancers which represent some of the largest commercial opportunities. Our plans are to develop our solid tumour pipeline to provide the Company with future partnership opportunities.

Positive initial FDA interactions

During the first half of 2024, we concluded our first successful interactions with the FDA, the key regulatory body in the United States, where we recently received confirmation of grant of Orphan Drug Designation status for BVX001, providing significant potential patent exclusivity and regulatory benefits to BiVictriX as we progress the candidate towards clinical studies. Further to this, we have also received positive feedback from the FDA via the INTERACT meeting, providing initial support for our plans for an efficient path to IND for BVX001. We now head towards our IND filing for BVX001 with increasing confidence.

Business development

We have continued to build key external relationships over the period, with an aim of establishing and maintaining a network of connections with academia, KOLs, other clinicians, regulators and industry partners. There has been much activity across all these fronts in 2024 to date, as we benefit from the increasing acceptance of ADCs as a key component of cancer therapy in the future. Ongoing and further work with these key partners will provide multiple opportunities for future manufacturing, clinical and commercialisation alliances to optimise the value potential of our entire business.

We have attended major international scientific and investor conferences to continue building on this network and to highlight our next-generation precision ADC approach. Notably, we attended the European Hematology Association (EHA) meeting in May 2024, securing meetings with many global leaders in the AML space. These relationships are key to optimise our clinical trial design and ensure we are working with leading physicians to bring our product to patients. 

Financial performance

The Groups's loss after tax for the period was £1.3 million (H1 2023: £1.2 million), reflecting investment in R&D of £1.2 million (H1 2023: £1.1 million) and administrative expenses of £0.4 million (H1 2023: £0.3 million).

The Group closed the period with a cash balance of £1.7 million at 30 June 2024 (30 June 2023: £1.9 million). Excluding the manufacturing and clinical trial costs for BVX001, the Company currently has sufficient capital to funds its working capital requirements into Q2 2025.

Summary and outlook

BiVictriX is at a key juncture having achieved much success from our novel technology with prudent capital utilisation. We are proud of our progress in bringing our lead asset all the way from concept to "IND ready", at a fraction of the cost of our peers, prioritising R&D expenditure towards key data that will drive value in BiVictriX. As we move towards obtaining clinical data across our portfolio, we believe we are well placed to scale our activities to broaden our pipeline further. The increasing breadth of BiVictriX and the ongoing interest in ADCs as a therapeutic class provides a significant tailwind for our business.

I am encouraged by the continued progress made in the period, showcasing the advantages of our novel therapeutic approach and believe that the progression of our lead asset to reach early clinical efficacy data will help to ensure the Company is well placed to feature on the global ADC stage, as a future driver of this technology. Over the next period and beyond, I remain fully committed to our key business goals, including identifying opportunities to accelerate the Company's growth through partnerships and alliances, and I look forward to achieving the next key value-enhancing milestones, with a primary focus on the acceleration of BVX001 into clinical trials in AML and related conditions, as well as expansion into the solid tumour space initially with BVX002.

I would like to thank the entire BiVictriX team and Board for their hard work in 2024 to date and express my gratitude to all of our existing shareholders for their continued support, belief and confidence in BiVictriX's future as a global leader delivering next generation, highly targeted cancer therapeutics.

Tiffany Thorn,

Chief Executive Officer and Founder of BiVictriX Therapeutics plc

BiVictriX Therapeutics plc

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024

Statement of Comprehensive Income

BiVictriX Therapeutics plc

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024

Statement of Financial Position

BiVictriX Therapeutics plc

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024

Consolidated Statement of Changes in Equity

BiVictriX Therapeutics plc

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024

Statement of Cash Flows

BiVictriX Therapeutics plc

Notes to the financial information

1. Company Information

BiVictriX Therapeutics plc (BiVictriX' or 'the Company') is a public limited company incorporated in England and Wales.  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

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.

These interim financial statements do not include all the information required for a complete set of financial statements prepared in accordance with IFRS Standards. However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group's financial position and performance since the last annual consolidated financial statements.

The financial information provided for the six-month period ended 30 June 2024 is unaudited, however, the same accounting policies, presentation and methods of computation have been followed in these interim financial statements as those which were applied in the preparation of the Group's annual consolidated financial statements for the year ended 31 December 2023.

These unaudited interim financial statements were authorised for issue by the Company's Board of Directors on 31 July 2024.

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.

The nature of the Group's operations mean that recorded financial performance is not seasonal or cyclical in nature.

Going concern

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 approval of these financial statements includes levers and controls which could be applied, if necessary.

The Board has considered ongoing international conflicts and the impact that they may have on worldwide supplies; together with foreign exchange risk and the reducing inflationary outlook. These risks are closely monitored as part of controlled, defined expenditure to meet business objectives.

Operational cashflows focus on 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, they continue to adopt the going concern basis in preparing these unaudited financial statements.

At 30 June 2024, the Group had cash and cash equivalents of £1.7 million (30 June 2023: £1.9 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 reported performance, position of disclosure of the Group.

Government grants

UK government grants are for named projects and provide reimbursement of specific costs incurred on these projects. The grants are paid after each reporting period when the claim is submitted. The administering body has the right to request information on any items included in each grant claim and to request an Independent Auditor's report.

There are no clawback provisions relating to the grants as they are not paid until after the relevant expenditure has been incurred and agreed, and this is the only condition.

Revenue-based grants have been credited to the statement of comprehensive income in the period to which they relate and reported as other income.

Research and development expenditure

Expenditure on pure and applied research are charged to the profit and loss account in the year in which it is incurred. Development costs are charged to the profit and loss account unless it can be demonstrated that the costs represent an intangible asset which meets all the criteria for capitalisation set out in para 57 of IAS38. As BiVictriX's lead programme is in the early stages of clinical development, all costs are expensed to the income statement.

Share-based compensation

The Group has issued share options to certain employees and Directors. Warrants have been issued to certain external third parties. Such 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.

At 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.

Share based payment charges

In the period, share options were issued to certain employees and a Black-Scholes model was used to calculate the share-based payment charge.

The calculation involves estimates and judgements to establish the appropriate inputs to be entered into the model, including interest rate, dividend rate, exercise restrictions and behavioural considerations.

The total charge in the period was £65,392 (H1 2023: £46,239).

3. Other Income

Other operating income of £66,107 (H1 2023: Nil) was derived from the first quarter of a £0.4 million Innovate UK grant, which was awarded on 4 June 2024.

4. Loss per Share

Basic loss 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.

For diluted loss per share, the loss for the period attributable to equity holders and the weighted average number of ordinary shares outstanding during the period is adjusted to assume conversion of all dilutive potential ordinary shares.

At 30 June 2024, the Group had 10,533,616 (30 June 2023: 8,804,184) share options, warrants and subscriptions outstanding.

The calculation of the Group's basic and diluted loss per share is based on the following data:

The loss and the weighted average number of ordinary shares for the period ended 30 June 2024 and 30 June 2023 used 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.

5. Share option grants

The Group operates an Enterprise Incentive (EMI) share option plan and an Employee Related Share (ERS) scheme for employees, together with a non-employee share option plan. Options are granted for nil consideration and are exercisable at a price which is determined on the date of the grant.

Directors and employees hold options to subscribe for shares in BiVictrix Therapeutics plc in accordance with the rules of the Group share option plans. The maximum number of Ordinary shares which may be issued under the Group's share option plans is 12,245,050. At 30 June 2024, this share option pool represented 14.8 per cent of the issued share capital in BiVictrix Therapeutics plc.

In addition to the Company share option pool of 12,245,050 share options, Tiffany Thorn holds 2,023,500 share options arising from pre-existing share options which were exchanged at Admission in August 2021, for new options over ordinary shares in BiVictriX Therapeutics plc.

At 30 June 2024, the Company had 9,283,334 share options under grant. 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:

Of the 9,283,334 options in issue at 30 June 2024, 8,483,334 were issued to employees including 4,036,334 options granted under the EMI scheme and 4,447,000 granted under the ERS. Option grants under the non-employee share option plan were 800,000.

The total charge in the period relating to share based compensation was £65,392 (H1 2023: £46,239).

6. Post balance sheet events

 There were no post balance sheet events to report.

7. Copies of the interim report

Copies of the interim report are available on the Company's website at www.bivictrix.com