Biodexa Pharmaceuticals — Foray into T1D expands business scope

Biodexa Pharmaceuticals (NASDAQ: BDRX)

Last close As at 26/02/2024

USD1.49

−0.05 (−3.25%)

Market capitalisation

USD5m

More on this equity

Research: Healthcare

Biodexa Pharmaceuticals — Foray into T1D expands business scope

Biodexa has completed the acquisition of global rights to tolimidone from Adhera Therapeutics after a successful $6m (gross proceeds) equity raise, conditional on at least $4m being subscribed for by Adhera secured noteholders. Tolimidone is a clinical-stage lyn kinase activator, which management plans to develop as a potentially disease-modifying treatment for type I diabetes (T1D), bolstering Biodexa’s clinical pipeline and expanding its therapeutic focus beyond oncology. The deal closure follows Biodexa’s completion of a $6m (gross proceeds) equity raise by issuing c 3m stock units at c $2/unit (including ADS/pre-funded warrants along with two attached warrants). The fund-raise is anticipated to support a planned Phase IIa trial in Q224, followed by a Phase IIb trial in Q424.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Midatech Pharma_resized

Healthcare

Biodexa Pharmaceuticals

Foray into T1D expands business scope

Pharma and biotech

Spotlight - Update

31 January 2024

Price

$1.67

Market cap

$4m

Share price graph

Share details

Code

BDRX

Listing

Nasdaq

ADS in issue at December 2023

2.6m

Net cash (end June-2023) excluding lease liabilities

£5.2m

Business description

Biodexa Pharmaceuticals is a UK-based clinical-stage biopharmaceutical company developing candidates for the treatment of diseases with unmet medical needs. The lead asset is the recently acquired tolimidone, being developed as a potentially disease-modifying treatment for type I diabetes (Phase I trial to start in Q124). The other clinical candidate is legacy asset MTX110, currently in Phase I clinical studies in aggressive rare/orphan brain cancer indications. The preclinical pipeline includes MTD217, targeting leptomeningeal disease, a secondary metastatic cancer of the central nervous system with a poor prognosis.

Bull

First-in-class potential with tolimidone in T1D and MTX110 in aggressive brain cancers

Therapeutics portfolio supported by three enabling platforms.

Multiple clinical milestones in 2024.

Bear

Both clinical assets target difficult-to-treat indications.

Challenges in finding partners/out-licensing opportunities.

Incremental fund-raising may lead to shareholder dilution.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Biodexa Pharmaceuticals is a research client of Edison Investment Research Limited

Biodexa has completed the acquisition of global rights to tolimidone from Adhera Therapeutics after a successful $6m (gross proceeds) equity raise, conditional on at least $4m being subscribed for by Adhera secured noteholders. Tolimidone is a clinical-stage lyn kinase activator, which management plans to develop as a potentially disease-modifying treatment for type I diabetes (T1D), bolstering Biodexa’s clinical pipeline and expanding its therapeutic focus beyond oncology. The deal closure follows Biodexa’s completion of a $6m (gross proceeds) equity raise by issuing c 3m stock units at c $2/unit (including ADS/pre-funded warrants along with two attached warrants). The fund-raise is anticipated to support a planned Phase IIa trial in Q224, followed by a Phase IIb trial in Q424.

Historical financials

Year
end

Revenue
(£m)

PBT*
(£m)

EPADS*
(£)

DPADS
(£)

P/E
(x)

Yield
(%)

12/19

0.67

(10.9)

N/A

0.0

N/A

N/A

12/20

0.34

(11.1)

(4,144)

0.0

N/A

N/A

12/21

0.58

(6.1)

(544)

0.0

N/A

N/A

12/22

0.70

(8.5)

(620)

0.0

N/A

N/A

Source: Biodexa company filings. Note: PBT and EPADS are normalized. *One ADS is equal to 400 ordinary shares.

Tolimidone: Potentially disease-modifying treatment

Research on disease-modifying treatments for T1D has focused on allogenic beta cell replacement therapies, which are challenged by sourcing difficulties and the need for immunosuppression, restricting applicability. Tolimidone, a lyn kinase activator, aims to leverage the dual activity of the enzyme (modulating insulin sensitivity and regulating blood glucose in fat cells, and promoting beta cell survival and possibly proliferation in pancreatic cells) to present a more convenient (oral) and effective therapeutic approach for newly diagnosed patients. Supported by existing animal and clinical data, Biodexa plans to initiate a Phase IIa dose-finding study in Q224, followed by a randomized Phase IIb trial by end-FY24.

Fund-raise dilutive but offers increased headroom

We expect the recent $6m (c £4.7m) raise to offer increased headroom to undertake clinical trials for lead asset tolimidone and support clinical activity for MTX110. We note that the fund-raise (of which at least $4m has been subscribed for by Adhera noteholders) and subsequent stock consideration for the acquisition of tolimidone worldwide rights (detailed below), while dilutive to existing shareholders (over 85% based on our calculation of pro-forma ADS outstanding post-closure), allow the company to continue operations, expand its portfolio and action its new business strategy.

Near-term catalysts on the horizon for MTX110

2024 is likely to be a catalyst-rich year for Biodexa, with the progression-free survival data from the MAGIC-G1 study for MTX110 in recurrent glioblastoma expected in Q224 and submission of the IND in diffuse midline gliomas planned for Q324, each of which could be a potential inflection point for the company.

Tolimidone acquisition completed…

In December 2023, Biodexa completed the acquisition of the worldwide licensing rights to tolimidone from Adhera Therapeutics. Tolimidone was originally discovered by Pfizer and was taken through Phase II trials for gastric ulcers by the company before it discontinued development due to lack of efficacy. The rights were subsequently acquired by Melior Pharmaceuticals, which decided to develop tolimidone in type II diabetes (T2D) (Phase II) and non-alcoholic steatohepatitis (Phase I). In 2021, Adhera in-licensed the development and commercialization rights to tolimidone from Melior (with the aim to evaluate it in T1D) covering all territories except for China, South Korea and several smaller Asian territories. Rights to these geographies had been licensed to Bukwang Pharmaceuticals.

As per previously agreed terms, following the closure of the acquisition, Biodexa paid out a cash consideration of $640k to Adhera (in addition to the $60k paid out in the initial agreement) and another $5m in stock consideration to certain secured noteholders in Adhera – by issuing an aggregate of 224,947 American depository shares (ADS) and another 2,275,050 pre-funded warrants. In addition to this, the secured noteholders are entitled to another $4m in stock consideration, contingent on certain milestones being met ($1m on positive Phase II studies and $3m on first commercial sales). We note that Biodexa was also obligated to issue 9.9% of its fully diluted share capital (in ADS) upfront to Melior and partner Bukwang (50% each) for the new tolimidone license, under which the company has issued 354,428 ADS to Melior with an equal number expected to be issued to Bukwang, subject to satisfaction of certain obligations under the license agreement.

…with the backing of the $6m equity raise

The deal closure followed the successful completion of a $6m/c £4.7m (gross proceeds) equity raise by Biodexa. Based on the deal consideration paid for tolimidone, we believe that at least $4m of the total $6m equity issue has been subscribed for by the Adhera secured noteholders. As part of the fund-raise, Biodexa has issued two classes of stock units:

Class A – 697,614 units with an offer price of $2/unit. Each Class A unit includes one ADS (equivalent to 400 ordinary shares in the company) and one Series E and Series F warrant. Both warrants have an exercise price of $2.2/warrant unit and come with an expiry period of five years and one year from the date of issue respectively.

Class B – 1,911,176 units with an offer price of $1.9999/unit. Each Class B unit includes one pre-funded warrant (exercise price of $0.0001) together with one Series E and Series F warrant each.

In addition, the company issued another 391,273 Class A units following the exercise of the overallotment option by the underwriters.

We note that the exercise of pre-funded warrants will be conditional on the shareholders owning not more than a 4.99% or 9.99% stake in the company post exercise at any one time. The exercise of the Series E and F warrants is also subject to the same shareholding conditions. Assuming full exercise of the pre-funded warrants, and taking into account the additional ADS issued as part of the stock consideration for the tolimidone acquisition, including the units to be issued to Bukwang (as detailed in the previous section), we estimate the pro-forma number of ADS outstanding to be 7,160,170 versus the pre-deal shares outstanding of 951k, suggesting a potential dilution of over 85% for current shareholders, before any further fund-raising. Exhibit 1 presents a summary of our calculations. Note that this calculation does not consider the conversion of the Series E or Series F warrants, which are out-of-the-money at the time of writing.

Exhibit 1: Biodexa pro-forma shares outstanding following fund-raise and tolimidone deal

ADS outstanding

% holding

Corresponding amounts ($m)

Issued – pre-equity raise and Adhera deal

951,254

13.29%

Related to equity financing

Class A issued (including underwriter options)

1,088,887

15.21%

2.18

Class B issued (assuming full conversion)

1,911,176

26.69%

3.82

Total (equity-financing)

3,000,063

6.00

Related to tolimidone deal with Adhera/Melior/Bukwang

ADS to Adhera secured noteholders

224,947

3.14%

0.45

Pre-funded warrants to Adhera secured noteholders

2,275,050

31.77%

4.55

ADS to Melior

354,428

4.95%

0.71

ADS expected to be issued to Bukwang

354,428

4.95%

0.71

Total (tolimidone deal)

3,208,853

6.42

Total no. of pro-forma ADS outstanding

7,160,170

Source: Biodexa filings, Edison Investment Research

Tolimidone: Leveraging lyn’s role in insulin regulation

Tolimidone is a selective activator of lyn kinase, an enzyme that modulates insulin sensitivity and regulates blood glucose by potentiating insulin receptor activation and the insulin receptor substrate-phosphatidylinositol-3 (IRS-PI3K) signaling pathway. The enzyme has two important functions – in fat cells it increases the utilization of insulin, resulting in decreased blood sugar levels without affecting insulin production and, more importantly, in pancreatic islets, activation of lyn kinase has been found to promote beta cell survival and proliferation in preclinical models. Tolimidone has been evaluated in over 700 patients across studies undertaken by Pfizer and Melior/Bukwang (Phase I and two Phase II studies in T2D), displaying a good safety and tolerability profile. If proven effective in larger clinical trials, a key advantage of this treatment would be the non-requirement of immunosuppressive agents, a major limitation of current disease-modifying treatments under development (discussed in more detail later in the note).

Tolimidone’s early potential in T1D has been demonstrated in preclinical in vitro studies (ie outside of a biological context) and in vivo studies (ie within a biological context) conducted by Professor Jean Buteau at the University of Alberta and the Alberta Diabetes Institute, which identified lyn kinase as a key factor for beta cell survival and proliferation. Interestingly, tolimidone was shown to not only prevent beta cell degradation but was also able to induce proliferation in beta cells isolated from human cadavers, signaling possible regenerative properties. In a mouse model, tolimidone was shown to increase beta cell mass by promoting their survival, as shown in Exhibit 2. The beta cell function preservation has been attributed to either the direct protective activity of tolimidone on the cells or reduction of glucotoxicity.

Exhibit 2: Tolimidone effects in T1D mouse model

Source: Biodexa corporate presentation, December 2023

The preclinical data also demonstrated improved glucose control and islet health markers, even after treatment completion (Exhibit 3).

Exhibit 3: Improved glucose control and health markers following treatment with tolimidone

Source: Biodexa corporate presentation, December 2023

Clinical development in T1D expected to commence in Q224

Biodexa now plans to explore the drug’s beta cell preserving/regenerative properties in clinical trials in collaboration with the University of Alberta. As per the latest available information, the company has appointed a clinical research organization to conduct experiments and expects to announce data from an in vitro study of beta-cell survival and proliferation in a validated model in Q124. A Phase IIa efficacy dose-confirmation study is expected to commence in Q224, aiming to establish the recommended dose in T1D patients. The trial will be open label and will enroll 12–15 patients across three dose cohorts to select the optimal Phase IIb and III dose(s). The study will also include measurement of c-peptide (a marker of insulin), HbA1c (a measure of plasma glucose levels) and number of hyperglycemic events. The company plans to announce preliminary data before the end of 2024. This will be followed by a double-blinded, placebo-controlled Phase IIb trial, expected to commence in Q424. This subsequent study will aim to enroll c 35 adult patients with T1D, diagnosed for between one and five years at the time of randomization. The study cohort will be selected for patients with adequate c-peptide levels at baseline, meaning that the selected cohort will continue to have some insulin-producing beta cells in the pancreas. The treatment duration will be six months, with a primary endpoint of changes in area under the curve of c-peptide after a two-hour mixed meal tolerance test over the course of the treatment. We see the potential for material commercial opportunity for tolimidone, provided the drug can demonstrate its insulin producing-cell preservation, and/or regeneration, properties in larger, randomized clinical trials.

Broader pipeline with tolimidone’s acquisition

Following Biodexa’s strategic decision in March 2023 to restructure its business operations and reposition itself as a therapeutic company (from its traditional focus on drug delivery), the company has been focusing on expanding its preclinical and clinical pipeline. In addition to its legacy MTX110 program, Biodexa announced a new preclinical asset, MTD217, in March 2023, targeting leptomeningeal disease (LMD), a secondary metastatic cancer of the central nervous system (CNS) with poor prognosis (average survival of three to six months).

We believe that the acquisition of tolimidone bolsters the company’s therapeutic pipeline and (although outside of Biodexa’s focus on oncology, CNS and rare disease spaces) it does diversify the company’s pipeline in an area with sizeable commercial opportunity, and one that remains underserved despite ongoing clinical development efforts. Following the completion of this acquisition, Biodexa now has three ongoing and planned clinical programs, including two Phase I trials for lead asset MTX110, in recurrent glioblastoma (rGBM) and diffuse midline gliomas (DMG). Progression-free survival data from the Phase I MAGIC-G1 study in rGBM are expected in Q224 and the investigational new drug (IND) submission in DMG is planned for Q324. Exhibit 4 presents a snapshot of the company’s therapeutic pipeline, including the initial focus areas.

Exhibit 4: Biodexa’s therapeutic pipeline

Source: Biodexa corporate presentation, January 2024

MTX110: Approaching key milestones

MTX110 is in Phase I development for three rare brain cancers – rGBM, DMG and medulloblastoma – and we see the biggest opportunity in rGBM given its sizeable market potential and unmet need. GBM is the most common (accounting for 48% of all primary malignant brain tumours) and aggressive primary intracranial tumor, with poor prognosis – despite treatment, the median survival is less than 15 months. The GBM treatment market was valued at $2.71bn in 2023 and is projected to grow to $5.65bn by 2032, at a compound annual growth rate of 8.5%.

Patient recruitment to the Phase I study in rGBM (MAGIC-G1 study) began in November 2022. The study is an open-label, dose-escalation study, recruiting patients across two cohorts (A and B) with a minimum of four patients each, with one cohort receiving MTX110 as monotherapy and the other receiving MTX110 in combination with lomustine (a cytotoxic chemotherapy drug approved for patients with rGBM). The primary objectives are to assess the feasibility and safety of intermittent infusions of MTX110 delivered through an implantable convection-enhanced delivery system, although the study will likely also track preliminary efficacy signals. In October 2023, the company completed recruitment in Cohort A. The administered dose on the study was increased from 60uM to 90uM (expected to be the target therapeutic dose for MTX110) in January 2023 after the company received the recommendation for dose escalation from the Data Safety Monitoring Board following completion of one month of treatment for the first patient on the lower dose, which was well tolerated. We believe that recruitment for Cohort B was initiated in Q423, with progression-free survival data from Cohort A expected to be reported in mid-2024, a material catalyst for investor attention. In addition to rGBM, the company plans to file an IND application in DMG in Q324.

MTD217: Heading to the clinic

In March 2023, Biodexa announced a new preclinical program, MTD217 targeting LMD, a secondary metastatic cancer of the CNS with poor prognosis (average survival of three to six months). According to available reports, around 5% of all cancer patients develop LMD, highlighting the sizeable patient population and commensurate market opportunity. MTD217 is being designed to simultaneously target key metabolic pathways – glycolysis/Warburg effect and the oxidative phosphorylation (OXPHOS) pathway, used by cancer cells to generate energy for growth and proliferation. According to the company, under induced stress, cancer cells switch from glycolysis to the OXPHOS pathway for energy, so the inhibition of both should support broader utility and efficacy. While small-molecule drugs can be used to downregulate these pathways, usage has been restricted by off-target toxicity from systemic administration of these drugs. By solubilizing these drugs using the MidaSolve technology and directly delivering the therapeutics to the site of the cancer cells (simultaneously or sequentially), Biodexa is proposing a more effective (higher dose concentrations) and safer (limiting off-target toxicity) alternative to available treatments, for both primary and metastatic cancers. Management plans to announce in vivo data from a preclinical study in Q124, followed by submission of an IND application in Q424.

T1D: Seeking a permanent fix

Unlike T2D, which is a lifestyle disease, T1D is an autoimmune condition where the immune system attacks pancreatic beta cells, destroying their ability to produce insulin (which regulates blood sugar levels) (see Exhibit 5). This requires the afflicted population to take daily insulin injections. While T1D can develop at any age, it is typically first diagnosed in children and young patients, and accounts for 510% of all diabetes cases. T1D can be differentiated from T2D by testing for biomarkers, such as the presence of autoantibodies and/or depleted levels of cpeptide, a measure of insulin production by beta cells (c-peptide levels less than 0.2nM are indicative of T1D).

The prevalence of T1D is believed to grow at an annual rate of 0.34%, and it is estimated that the condition afflicts c 8.4 million people worldwide (13.5–17.4 million cases expected by 2040). The T1D market was valued at $7.59bn in 2022 and is expected to grow to $13.6bn by 2030 (a compound annual growth rate of 7.6%), indicating significant commercial opportunity for novel treatments, as well as potentially curative therapies.

Exhibit 5: Key differences between type I and type II diabetes

Source: Biodexa corporate presentation, December 2023; Edison Investment Research

Exhibit 5: Key differences between type I and type II diabetes

Source: Biodexa corporate presentation, December 2023; Edison Investment Research

Current development landscape led by cell therapies…

While there is currently no curative treatment for T1D, immunotherapy, cell therapy and gene therapy are some of the treatment approaches in development for T1D in a bid to either prevent or reverse the underlying autoimmune process, as well as restore beta cell function. Recent development work has focused on cell replacement therapies – either donor-sourced pancreatic beta cells or stem cell-derived insulin-producing beta-like cells – as a longer-lasting and permanent treatment alternative to daily insulin injections. In June 2023, the FDA approved the first cell therapy for T1D, CellTrans Lantidra (donislecel) for the treatment of adults with T1D with poorly managed blood glucose levels (repeated episodes of severe hypoglycemia or low blood sugar) despite intensive diabetes management. The treatment uses allogeneic islet beta cells, extracted from donor pancreatic cells, which are then administered as an infusion into the hepatic (liver) portal vein. The rationale is that in some patients these infused cells can produce enough insulin for the patient to negate the need to take supplementary insulin to control blood sugar levels. While theoretically sound, the utility of this treatment is hindered by difficulties in sourcing sufficient donor-derived beta cells. Another restrictive component of this treatment is the requirement for lifelong immunosuppression to maintain islet cell viability, which comes with its own side effects. Due to these reasons, the treatment may struggle to find broad applicability with usage restricted to only a small population of poorly controlled T1D cases.

To overcome the challenges related to sourcing islet beta cells from donors, other treatments in clinical development are focusing on using stem cell-derived insulin-producing islet cells or beta-like cells as an alternative. The most advanced program in this category is Vertex Pharmaceuticals’ VX-880, currently being tested in a Phase I/II study, although we note that this treatment also requires systemic immunosuppression. Vertex is also developing a second drug, VX-264, for the same condition, wherein it plans to encapsulate the stem cell-derived islet cells in a protective device to be surgically implanted in the body. The aim is for the device to protect the cells from being attacked by the body’s immune system, thereby removing the need for immunosuppression. A Phase I/II clinical trial for VX-264 was initiated in May 2023 with an expected completion date of May 2026. We note that Vertex has recently halted the clinical trial for VX-880 after two unrelated patient deaths. The trial has been paused pending a review of data by an independent data monitoring committee and global regulators. The trial was previously placed on hold by the FDA in November 2022 due to concerns around dose escalation, but the hold was lifted after a few months. Exhibit 6 presents the most advanced cell therapies in development for the treatment of T1D.

Exhibit 6: Selected development-stage pipeline for the treatment of T1D (cell therapies)

Company

Partner

Product name

Description

Clinical stage

Notes

Vertex Pharmaceuticals

N/A

VX-880

Stem cell-derived islet cell infusion, requires systemic immunosuppression

Phase I/II

Phase I/II study commenced in March 2021 and aims to recruit 17 patients with T1D with impaired hypoglycemia awareness and severe hypoglycemia. In October 2023, the company presented promising early efficacy data from the study, noting that the first three patients on the treatment all achieved insulin independence, persisting through 12 months of follow up. Further patient recruitment was halted in January 2024, following two unrelated patient deaths.

Vertex Pharmaceuticals

N/A

VX-264

Stem cell-derived islet cell-device combo, does not require systemic immunosuppression

Phase I/II

Phase I/II trial initiated in May 2023 aiming to recruit 17 patients. Study expected to complete in May 2026.

Sernova

N/A

N/A

Cell Pouch with human donor islets; islet cell-device combo, requires systemic immunosuppression

Phase I/II

Phase I/II initiated in February 2019 (n=13) with expected completion date of September 2025. In June 2023, the company presented encouraging interim data from the first five-patient cohort, who managed to achieve insulin-independence for ongoing periods of six to 38 months. Modest islet top-up was required.

CRISPR Therapeutics

ViaCyte/

Vertex

VCTX211/
CTX211

Gene-edited allogenic, immune-evasive stem cell therapy

Phase I/II

Phase I/II trial initiated in January 2023. In January 2024, Vertex decided to opt out of the collaboration. CRISPR will now undertake development work on the asset independently.

Sernova

Evotec

N/A

Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet-like clusters

Preclinical

In May 2022, Sernova and Evotec entered a global strategic partnership to develop an implantable off-the-shelf iPSC-based islet replacement therapy. In April 2023, the company presented favorable preclinical data. IND filing and Phase I/II clinical trials expected in 2024.

Sigilon/Eli Lilly

N/A

SIG-002

Encapsulated islet cell therapeutic

Preclinical

Sigilon acquired by Eli Lilly in June 2023 for $35m in upfront payment (up to $310m in total, including potential milestone payments). IND-enabling studies for SIG-002 commenced in H223, with a clinical trial application anticipated to be filed in 2024.

Source: EvaluatePharma, Edison Investment Research

…with increasing attention to preventative treatments

Another area with increasing therapeutic focus is more ‘preventative’ treatments for patients with early-stage T1D who still have functioning beta cells producing insulin. The first treatment to be approved in this category is Sanofi/MacroGenics’ CD3-directed monoclonal antibody (approved in November 2022), Tzield (teplizumab-mzwv; developed by Provention Bio and acquired by Sanofi for $2.9Bn in March 2023), which was the first immunotherapy-based treatment to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. We note that the eligible patient population for this treatment will be limited given that most cases are not diagnosed until stage 3, when clinical symptoms begin to show. Another advanced clinical-stage immunotherapy under development is Diamyd, an antigen-specific immunotherapy for the preservation of endogenous insulin production in recent-onset patients who carry the genetic HLA DR3-DQ2 haplotype (c 34% of all screened patients). A Phase III confirmatory trial, DIAGNODE-3, is ongoing (expected to recruit 330 participants) with an expected completion date in December 2025. Another clinical-stage asset targeting early-onset disease is Precigen ActoBio’s AG019, currently in Phase II trials. The drug works by inducing specific regulatory T-cells (Tregs) that reduce or eliminate the destruction of beta cells, thereby stabilizing or improving insulin production.

Financials

Biodexa reported its H123 interim results in September 2023, reporting revenues of £0.3m during the half-year (£0.47m in H122). As with recent periods, the revenues were fully attributed to the company’s R&D collaboration with Janssen. R&D expenses declined c 7% y-o-y to £2.25m (R&D as a percentage of opex declined to 50% from 57% in H122). The decline in R&D was driven by the company’s decision to halt R&D-related activities on its drug delivery platforms as part of its repositioning as a therapeutics company. One-time redundancy-related expenses of £88k were recognised in R&D related expenses during the period. Administrative expenses grew c 34% y-o-y to £2.29m, with the increase primarily attributable to £0.4m in legal and professional fees related to financing transactions and shelved acquisitions during the period. Net cash outflow from operating activities was £3.88m versus £3.54m in H122, mainly attributed to a higher net loss figure (£3.57m vs £3.06m in H122) partially offset by a positive working capital figure of £0.21m (outflow of £0.05m in H122). Biodexa ended H123 with a net cash balance of £5.2m and we expect the additional $6m (£4.7m) in gross proceeds from the latest equity raise to provide improved operational headroom to support the company’s pipeline development plans.

General disclaimer and copyright

This report has been commissioned by Biodexa Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Biodexa Pharmaceuticals. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2024 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Biodexa Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Biodexa Pharmaceuticals. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2024 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

More on Biodexa Pharmaceuticals

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Industrials

Smiths News — On track to meet guidance

Smiths News’ trading update highlights the resilience of its business model in a tough macroeconomic environment, with FY24 results expected to be in line with consensus. As a reminder, our 2024e PBT forecast stands flat at £33.4m despite an anticipated 6% y-o-y decline in revenue to £1.0bn, attributable to management’s tight control of the business and the ongoing annual efficiencies being delivered. Smiths has renewed several long-term publisher contracts in the past year, which could imply visibility over c 74% of annual revenues to 2029, with potential for expansion. This should further bolster the company’s cash-generative business model and underpin the sustainability of the business in the long term.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free