Tillkännagivande • Aug 12
BiVictriX Therapeutics plc Proposes Voluntary Cancellation of Admission of Ordinary Shares to Trading on AIM BiVictriX Therapeutics plc announced the proposed cancellation of the admission of its ordinary shares of £0.01 each ("Ordinary Shares") from trading on AIM (the "Cancellation") and the re-registration of the Company as a private limited company (the "Re-registration"). A circular ("Circular") will be sent to Shareholders, setting out the background to and reasons for the Cancellation and the Re-registration. The Company is seeking Shareholder approval for the Cancellation and Re-registration at a general meeting, which has been convened for 11:30 a.m. on 29 August 2024 at the Company's registered office, Mereside Alderley Park, Alderley Edge, Manchester SK10 4TG ("General Meeting"), notice of which is included in the Circular. The Company is also seeking Shareholder approval at the General Meeting for the adoption of new articles of association (the "New Articles") to be effective on the Re-registration. If the Cancellation Resolution is passed at the General Meeting, it is anticipated that the Cancellation will become effective at 7:00 a.m. on 11 September 2024. The Cancellation Resolution is conditional, pursuant to Rule 41 of the AIM Rules, upon the approval of Shareholders holding not less than 75 per cent. of the votes cast by Shareholders (whether present in person or by proxy) at the General Meeting. The Company has received irrevocable undertakings from DBW Investments, Robert Keith, Alderley Park Ventures Limited, BioCity Investments Limited, Alden AS and those Directors who are also Shareholders,as set out below, representing in aggregate approximately 42.5 per cent. of the Company's issued share capital, to vote in favour of the Resolutions set out in the Circular. New Risk • Aug 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -UK£2.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£2.1m free cash flow). Earnings have declined by 29% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (UK£10.7m market cap, or US$13.7m). Tillkännagivande • Jun 27
BiVictriX Therapeutics Plc, Annual General Meeting, Jul 24, 2024 BiVictriX Therapeutics Plc, Annual General Meeting, Jul 24, 2024. Location: the office of bivictrix therapeutics plc, mereside alderley park, alderley edge, macclesfield, england, sk10 4tg, United Kingdom Tillkännagivande • Jun 09
BiVictriX Therapeutics plc Receives Grants to Accelerate Solid Tumour Targeting ADC Pipeline from Innovate UK BiVictriX Therapeutics Plc announced it has been awarded a grant for £0.37 million from Innovate UK. The grant will facilitate accelerating the preclinical development of BiVictriX's second pipeline product, BVX002, a novel bispecific ADC targeting the treatment of ovarian cancer. In line with the Company's strategy to seek non-dilutive capital to progress R&D, the Innovate UK grant will enable BiVictriX to accelerate its efforts tofurther advance BVX002, including preclinical studies and preparation for the selection of a clinical lead candidate. The funds will be used on R&D activities to enhance the value of BVX002 and BiVictriX's expertise in the solid tumour setting. The Innovate UK research and development project (funded for 18 months) will consist of two primary elements: selection of the optimal linker/payload and therapeutic format combination, followed by assessment of in vivo efficacy, selectivity and safety to move the best bispecific ADC molecules towards nomination of a clinical lead candidate for BVX002. New Risk • Jun 07
New major risk - Revenue and earnings growth Earnings have declined by 40% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 40% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (UK£9.90m market cap, or US$12.7m). New Risk • Apr 07
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (UK£9.28m market cap, or US$11.7m). Tillkännagivande • Dec 05
Bivictrix Therapeutics plc Announces Resignation of Iain Ross from the Board BiVictriX Therapeutics plc announced that Non-Executive Director, Iain Ross, is stepping down from the board with immediate effect to pursue other interests. A Nomination Committee, consisting of Non-Executive Directors and chaired by Dr. Michael Kauffman, will initiate a search for Iain's replacement with appropriate skills to help move the Company forward, in anticipation of its first clinical trials in patients with Acute Myeloid Leukaemia. New Risk • Aug 13
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£2.8m free cash flow). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (UK£10.7m market cap, or US$13.6m). Breakeven Date Change • Mar 31
Forecast to breakeven in 2025 The analyst covering BiVictriX Therapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of UK£2.91m in 2025. Average annual earnings growth of 53% is required to achieve expected profit on schedule. Tillkännagivande • Jan 31
BiVictriX Therapeutics Plc Announces Positive Data from Preclinical Study of BVX001 BiVictriX Therapeutics plc announced positive in vivo data from a toxicity evaluation study with BVX001, BiVictriX's lead programme, compared to gemtuzumab ozogamicin (GO). GO, marketed as Mylotarg™, is the only approved antibody drug conjugate (ADC) indicated for the treatment of acute myeloid leukaemia (AML).One of the significant toxicities of GO is the reduction in normal neutrophil counts in patients with AML. Neutrophils are a form of immune cell and a reduction in the number of these cells heightens the risk of developing potential fatal severe infections and sepsis, a major concern in patients with AML. BVX001 was reported to be well-tolerated and showed a highly favorable safety profile across two doses of BVX001 (0.3 mg/kg and 3 mg/kg), compared with the reported maximum tolerated dose of GO1 (0.3 mg/kg) in a CD34-boosted humanised murine model. The results showed that: The proportion of healthy human CD33+ myeloid cells in the bone marrow was significantly lower with GO compared to BVX001 at both an equivalent dose to GO (0.3mg/kg) and a 10-fold higher dose (3mg/kg), at seven- and fourteen-days post-injection. The total number of healthy neutrophils and total healthy leukocytes, types of specialised immune cells, were significantly lower with GO compared to the equivalent dose of BVX001, at fourteen days post-injection. The total number of healthy human CD33+ cells was significantly lower with GO compared to the vehicle control seven days post-injection. These results model commonly reported toxicities of GO in clinical practice. Other observed effects with GO included a non-statistical lower level of healthy early bone marrow progenitor cells at day fourteen post injection, compared to both doses of BVX001. A non-statistical higher proportion of CD7+ cells among CD3+ T cells in blood at day three post injection was reported with GO, compared to BVX001 and the control vehicle. This announcement follows the identification of a development lead for BiVictriX's BVX001 programme asannounced on 7 December 2022, together with the Company's previously shared in vivo efficacy data for this programme. The Company is now focused on delivering additional in vivo efficacy data to further strengthen the preclinical data package for BVX001, as the Company looks to progress this molecule towards the clinic. The results from this in vivo toxicity evaluation study will be submitted for publication and will be presented at an upcoming scientific conference. Tillkännagivande • Jan 06
BiVictriX Therapeutics Plc Announces Board Changes BiVictriX Therapeutics Plc announces that Dr. Michael Kauffman, M.D., Ph.D. has been appointed as Non-Executive Chairman. Dr. Kauffman takes over from Iain Ross, who will continue as a Non-Executive Director on the BiVictriX Board, but steps down as Chairman due to other work commitments. Prior to becoming Non-Executive Chairman, Dr. Kauffman was appointed as Non-Executive Director of BiVictriXin January 2022. He is a highly experienced cancer drug developer, having been instrumental in the approval of several oncology therapeutics over twenty years of working across preclinical research, clinical development, regulatory strategy and commercialisation. As Non-Executive Chairman, he will draw upon 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, with 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. Dr. Kauffman currently holds other Non-Executive Board positions atVerastem Oncology, Adicet Bio and Kezar Life Sciences. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The analyst covering BiVictriX Therapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of UK£2.91m in 2025. Average annual earnings growth of 41% is required to achieve expected profit on schedule. Tillkännagivande • Dec 07
BiVictriX Therapeutics Plc Identifies Development Lead for BVX001 Programme BiVictriX Therapeutics Plc announced that it has identified a development lead for its BVX001 programme. The Lead was developed using BiVictriX's proprietary Bi-Cygni® approach, which aims to generate the next-generation of Antibody Drug Conjugates ("ADCs") with superior cancer selectivity. The Lead was selected based on promising in vitro potency and cancer cell selectivity data, together with encouraging data reported from a panel of ex-vivo safety assays using healthy human cells. The Lead, together with backup candidates, will now betaken forward into a panel of in vivo models. These will include models of Acute Myeloid Leukaemia to investigate the optimum dose of the molecule. In addition, the Lead will be assessed in safety models providing indicative safety data for the programme. Results from these experiments, in addition to the data already obtained, will support manufacturing preparations and guide future clinical trials. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. CEO & Executive Director Tiffany Thorn is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Jul 08
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. CEO & Executive Director Tiffany Thorn is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Feb 24
Bivictrix Therapeutics plc Announces Expansion of Its Therapeutic Pipeline with Two Additional Drug Discovery Programmes BiVictriX Therapeutics Plc announced the expansion of the Company's therapeutic pipeline with two additional programmes, BVX002 and BVX003, both entering the early stages of drug development. BVX002 and BVX003 target novel cancer-specific twin antigen fingerprints, incorporating the Company's proprietary Bi-Cygni® technology, alongside the established and validated Antibody Drug Conjugate (ADC) mechanism-of-action, to form the next-generation of Bi-Cygni® ADCs with superior cancer selectivity. These programmes enable the targeting of several haematological and solid tumour cancer indications and will be developed alongside BiVictriX's lead asset, BVX001, which has a lead indication in Acute Myeloid Leukaemia (AML). This pipeline expansion demonstrates the broad utility of the Bi-Cygni® approach across a wide range of solid tumour and haematological cancer types which constitute areas of significant unmet medical need, and further highlights the potential expansion of the platform in novel areas of immuno-oncology. The pipeline expansion follows the Company's recent filing of four new patent applications to further strengthen its growing intellectual property portfolio in the UK and internationally. The patents, which will form part of a new patent family for BiVictriX, relate to several novel cancer-specific antigen pairs or "fingerprints" across a range of oncology indications, which have been identified by the Company. Tillkännagivande • Feb 22
BiVictriX Therapeutics Plc Strengthens Its Patent Portfolio BiVictriX Therapeutics Plc announces that it has filed four new patent applications in the UK related to several novel cancer-specific antigen pairs or "fingerprints" across a range of oncology indications. The new patent applications focus on three novel cancer-specific antigen fingerprints that have been identified by the Company and can be used to support the development of a pipeline of highly selective, cancer therapeutics utilising the Company's proprietary Bi-Cygni® approach. This will further strengthen BiVictriX's growing intellectual property portfolio and provide opportunities to widen the application of the Company's Bi-Cygni® technology across several solid tumour and haematological cancers, demonstrating the broad utility of the approach. These filings are the next step in the Company's strategy to broaden its patent portfolio both in the UK and internationally. Tillkännagivande • Aug 12
BiVictriX Therapeutics plc has completed an IPO in the amount of £7.5 million. BiVictriX Therapeutics plc has completed an IPO in the amount of £7.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 37,500,000
Price\Range: £0.2
Transaction Features: Direct Listing; Regulation S; Sponsor Backed Offering Board Change • Aug 12
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. was the last director to join the board, commencing their role in . The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.