Biodexa Pharmaceuticals — In a period of transition

Biodexa Pharmaceuticals (NASDAQ: BDRX)

Last close As at 01/11/2024

0.99

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Research: Healthcare

Biodexa Pharmaceuticals — In a period of transition

FY23 was a transitional year for Biodexa, following the restructuring announced in March 2023 into a therapeutic company from a drug delivery specialist, and the implementation of cost-saving initiatives in light of the macroeconomic environment. The pipeline expansion primarily de-risks the business, partially fulfilled with the acquisition of lyn kinase activator tolimidone, for type 1 diabetes (T1D), in late 2023. Management estimates gross cash of £5.97m at end-FY23 to provide a runway into Q424, past the planned Phase IIa trial initiation for tolimidone. The next catalyst will likely be the initial efficacy data readouts from the Phase I MAGIC-G1 in recurrent glioblastoma (rGBM) in Q224, which, if positive, could provide improved and possibly non-dilutive financing opportunities.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Biodexa Pharmaceuticals

In a period of transition

Pharma and biotech

Spotlight - Update

26 April 2024

Price

$0.77

Market cap

$4m

Share price graph

Share details

Code

BDRX

Listing

Nasdaq

ADS in issue at April 2023

4.8m

Net cash (end December-2023) excluding lease liabilities

£5.5m

Business description

Biodexa Pharmaceuticals is a UK-based clinical-stage biopharmaceutical company developing treatments for diseases with unmet medical needs. The lead asset is tolimidone and is being developed as a potentially disease-modifying treatment for type I diabetes (Phase IIa trial to start in Q224). MTX110 is the legacy asset and is in Phase I clinical studies in aggressive rare/orphan brain cancer indications. The pre-clinical pipeline includes MTD217, targeting leptomeningeal disease, a secondary metastatic cancer of the central nervous system.

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

FY23 was a transitional year for Biodexa, following the restructuring announced in March 2023 into a therapeutic company from a drug delivery specialist, and the implementation of cost-saving initiatives in light of the macroeconomic environment. The pipeline expansion primarily de-risks the business, partially fulfilled with the acquisition of lyn kinase activator tolimidone, for type 1 diabetes (T1D), in late 2023. Management estimates gross cash of £5.97m at end-FY23 to provide a runway into Q424, past the planned Phase IIa trial initiation for tolimidone. The next catalyst will likely be the initial efficacy data readouts from the Phase I MAGIC-G1 in recurrent glioblastoma (rGBM) in Q224, which, if positive, could provide improved and possibly non-dilutive financing opportunities.

Historical financials

Year
end

Revenue
(£m)

PBT*
(£m)

EPADS*
(£)

DPADS
(£)

P/E
(x)

Yield
(%)

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

12/23

0.38

(7.5)

(800)

0.0

N/A

N/A

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

Clinical pipeline to be fronted by tolimidone

Following its acquisition in December 2023, tolimidone will lead Biodexa’s clinical efforts in 2024, with the expected initiation of a Phase IIa dose confirmation study in Q224. As a lyn kinase activator, tolimidone’s competitive edge stems from its dual activity: modulating insulin sensitivity and regulating blood glucose, but more importantly, promoting beta cell survival, an indicator of disease-modification. The latter, if proved in the clinic, may provide significant differentiation, in our opinion. We acknowledge that the recent in vitro experiment proved inconclusive on the drug’s beta-cell proliferation abilities, but note that the company plans to review the findings in an in vivo study, with clinical plans remaining on track for now.

Several upcoming catalysts for MTX-110

MTX-110, Biodexa’s legacy program (solubilized panobinostat) is being evaluated in multiple aggressive brain cancers (such as rGBM, diffuse midline gliomas (DMG) and medulloblastoma) and we expect 2024 to be a crucial year for clinical progress. Central to the drug’s potential will be the initial progression-free-survival (PFS) data (cohort-A) from the Phase I MAGIC-G1 study in rGBM, expected in Q224. If positive, we expect it to provide impetus for potential partnering discussions. This should be complemented by the recently reported positive topline data from the second Phase I study in DMG (median overall survival (OS) of 16.5 months), which supports the company’s plans for IND submission in 2024 to initiate a Phase II trial.

Funded into Q424 following capital raises

Biodexa undertook three rounds of capital raising in FY23, netting the company US$15.3m in gross proceeds and supporting its acquisition of tolimidone. Management expects the end-FY23 gross cash balance (£5.97m) to support operations into Q424 and plans to raise additional funds prior to that.

FY23 results: Reflecting the refreshed strategy

Biodexa’s FY23 results reflected the company’s efforts towards repositioning itself as a therapeutics business, away from its traditional focus on drug delivery. As it is in the clinical stages of development, revenue continued to be limited to collaboration income, and was reported at £0.38m, down 46% y-o-y from £0.70m in FY22. This was completely attributable to Biodexa’s R&D collaboration with Janssen, under which the company was assigned to work on maximizing drug loading, and optimizing in vitro release duration, of Janssen’s experimental large molecules using Biodexa’s Q-Sphera technology platform. Management has indicated that this agreement has now ceased, and we do not expect the company to recognize any further income on this front.

The effect of the restructuring and cost control initiatives (announced in March 2023) were also reflected in the lower operating expenses. The FY23 R&D expenses were 20% lower than the previous year (£4.07m, vs £5.11m in FY22) as the company pulled back on its expansion initiatives on the internal drug delivery platforms (Q-Sphera, MidaSolve and MidaCore), resulting in a £0.87m reduction in pre-clinical expenses. This was aided further by a £0.39m reduction in R&D specific personnel expenses, due to a lower headcount. This decline was partially offset by a £0.41m increase in expenses relating to the MTX-110 clinical program (the Phase I Magic-G1 study in rGBM and the second Phase I study in DMG). Overall, R&D as a percentage of operating expenses declined to 48% (vs 58% in FY22). Looking ahead, we expect core R&D expenses to increase in FY24 with the planned initiation of the tolimidone Phase II trial, continued development work on advancing MTX-110 to proof-of-concept (including a potential IND filing in DMG) and ongoing pre-clinical efforts (including MTD217).

Administrative expenses were broadly flat at £4.34m (vs £4.54m in FY22) and included £2.06m in personnel expenses (down 19% from £2.52m in FY22, following workforce reduction) and £1.31m in legal and professional fees related to the acquisition of global rights to tolimidone, fund-raising efforts and shelved acquisitions (ie Bioasis). The comparable figure in FY22 was £1.36m, related to the terminated acquisition of Bioasis in December 2022 and a £0.4m provision against payment made and loan commitments to Bioasis. We note that Biodexa had extended a £0.08m loan to Adhera Therapeutics (the previous license holder of tolimidone), which was written-off following the deal completion in December 2023. Overall, the operating loss for the year declined by 10% y-o-y to £8.01m (vs £8.93m in FY22). The net loss was reported at £7.08m (vs £7.66m in FY22).

Operating cash burn for FY23 broadly mirrored the FY22 trend (net outflow of £6.82m vs £7.05m in FY22). The company finished FY23 with a gross cash balance of £5.97m, which was supported by US$15.3m raised across three rounds of funding: US$6m through a private placement (February 2023), US$3.3m through a registered direct offering (May 2023) and a US$6m registered offering in connection with the acquisition of tolimidone (refer to our previous note for more details). Based on the company’s internal forecasts, management expects the available cash balance to provide an operational runway into Q424 (provided clinical activities advance as planned). Management has communicated that this would be sufficient for the company to deliver two sets of pre-clinical data (which we assume to be pre-clinical data for MTD217 and in vivo data for tolimidone) and three sets of clinical data (which we believe will include PFS data from the rGBM study – cohort A, expected in Q224). Management anticipates the need to raise further external funding prior to Q424 to advance its development programs.


Transition continues into FY24

2023 was a tumultuous year for Biodexa, with operational constraints exacerbated by capital market tightness and overall biotech sector softness. In March 2023, the company decided to pivot its strategic positioning from being a pure-play drug-delivery company, to one focused on the development of therapeutics for diseases areas with significant unmet need. A key part of this strategy was bolstering the company’s pipeline in an effort to produce incremental upside opportunities and diversify risk. The acquisitions of the pre-clinical asset MTD217 (in March 2023) and tolimidone (in December 2023) formed part of this strategy, and the company will continue to seek further deals opportunistically. Exhibit 1 presents Biodexa’s current R&D pipeline.

Exhibit 1: Biodexa’s therapeutic pipeline

Source: Biodexa Pharmaceuticals 6-K, April 2024

Tolimidone: Plans undeterred despite recent in vitro data

Tolimidone is a small molecule selective activator of lyn kinase, a protein that modulates insulin sensitivity and regulates blood glucose in fat cells by potentiating insulin receptor activation and the insulin receptor substrate-phosphatidylinositol-3 (IRS-PI3K) signaling pathway. While this property has been widely tested and demonstrated in both pre-clinical and clinical studies (for type 2 diabetes), market interest has been piqued by the drug’s potential disease-modifying properties (ie promotion of beta cell survival and proliferation in pancreatic islets). Early pre-clinical studies (both in vitro and in vivo) in T1D, conducted by University of Alberta Professor Dr Jean Buteau, had shown that tolimidone intervention not only prevents beta cell degradation, but also induces proliferation in beta cells isolated from human cadavers, signaling possible regenerative properties; we believe this was a key motivator for Biodexa’s acquisition of the drug.

Curative or disease-modifying treatments are widely believed to be the holy grail of therapeutic intervention, although such successes have been few and far between. While there are currently no curative treatment options for T1D, immunotherapies, cell therapies and gene therapies are being developed as potential treatment approaches, aiming to either prevent or reverse the underlying autoimmune process, as well as restore beta cell function. We also highlight that an area receiving increasing attention is that of preventative treatments, aimed at early-stage T1D patients who still have functioning insulin-producing beta cells. The first treatment to be approved in this category was the CD3-directed monoclonal antibody Tzield (teplizumab-mzwv; developed by Provention Bio and acquired by Sanofi for $2.9bn in 2023), and we believe that, contingent on clinical progression, tolimidone could be positioned similarly to Tzield, targeting newly diagnosed T1D patients.

Although previous pre-clinical studies have hinted at the disease-modifying potential of tolimidone, we note that data from an in vitro experiment conducted on behalf of the company by a contract research organization (announced in February 2024) was inconclusive on these claims and did not correlate with previously noted results. While we acknowledge that this was unexpected and somewhat of a setback for the program, Biodexa remains confident and is planning a follow-up in vitro study to re-evaluate the results. Management also plans to go ahead with the initiation of the Phase IIa open-label dose-confirmation study, which will recruit 15 patients with T1D over three months (expected to commence in Q224). The study endpoints will be change in C-peptide levels (a marker for insulin), HbA1c (indicator of blood glucose levels) and number of severe hyperglycaemic events. If the results are positive, this will be followed by a Phase IIb double-blinded, placebo-controlled study in 40–45 patients using similar study objectives. Provided Biodexa stays on track for a Q224 clinical study initiation, we expect the company to be funded to data readouts in Q324.

MTX110: Making clinical headway

MTX110 (a solubilized formulation of panobinostat, traditionally used in the treatment of relapsed/refractory multiple myeloma) is Biodexa’s legacy asset, and is being developed using its drug delivery platform MidaSolve. The drug is currently in clinical trials for three aggressive and rare brain cancers: rGBM, DMG and medulloblastoma (all ongoing studies are investigator-sponsored).

The company recently reported positive topline data from a second Phase I clinical trial in DMG, conducted by Columbia University. The study included nine patients across three dose cohorts (30uM, 60uM and 90uM), with the drug administered through an implanted convection enhanced delivery (CED) catheter. The median OS of patients in the study was 16.5 months, compared to 10.0 months in a comparable cohort (historical study; n=316) with standard of care (SoC). These results further consolidate the favorable data from the first Phase I study (data reported in October 2020) conducted by the University of California, San Francisco (UCSF), which reported a median survival of 26 months for the seven patients treated (this trial used a different CED system). We caution that while these results are encouraging, these studies were not powered for efficacy and the results would need to be reproduced in larger clinical trials to establish clear benefits. Nevertheless, this data is encouraging enough for Biodexa to warrant continued development, and the company plans to file the IND with the FDA in Q324 to conduct a Phase II study.

DMG is an extremely rare and very aggressive form of pediatric brain cancer, with around 1,000 cases worldwide per year and a median survival rate of less than 10 months. Due to the location of the tumor, surgery is not possible, and the SoC remains radiotherapy.

The rGBM Phase I study (MAGIC-G1) commenced patient enrollment in November 2022, across two cohorts (A and B) with a minimum of four patients each, with cohort A receiving MTX110 as monotherapy, and cohort B receiving MTX110 in combination with lomustine (a cytotoxic chemotherapy drug approved for patients with rGBM). Recruitment for cohort A was completed in October 2023, and PFS data from this cohort is expected in Q224, marking a major inflection point for the company, in our view. Patient enrolment in cohort B is expected to commence this year. Like DMG, this study also utilizes a CED system to deliver therapeutic doses of the drug directly to the tumor site. We highlight that, unlike in other cancer indications, chemotherapy drugs have not been as successful in brain cancers due to their inability to cross the blood-brain barrier. By using a CED system, Biodexa aims to circumvent this issue, and maximize treatment efficacy.

GBM is the most common and most aggressive form of brain cancer in adults (incidence of 3.21 per 100,000 population), and continues to have a poor prognosis, with a survival rate of three to nine months following recurrence. Current SoC includes surgical resection, followed by radiotherapy and chemotherapy (temozolomide; TMZ). The GBM treatment market was valued at $2.71bn in 2023, and is projected to grow to $5.65bn by 2032 (a compound annual growth rate of 8.5%).

Biodexa is also evaluating MTX-110’s efficacy in medulloblastoma in a pilot Phase I exploratory study led by the University of Texas. Unlike the other two indications, in this study the drug will be directly administered into the fourth ventricle, allowing it to circulate throughout the central spinal fluid (CSF). Unlike other brain cancers, medulloblastoma (which starts in the cerebellum) tends to metastasize to different locations in the brain and spinal cord, spreading through the CSF. This condition is rare, with 435 patients diagnosed each year in the US, although the five-year survival rate is fairly high at around 80%. Children comprise c 70% of all medulloblastoma cases.

MTD217: Focusing on the groundwork

MTD217 (MTX110 in combination with an OXPHOS inhibitor) is Biodexa’s pre-clinical program, targeting leptomeningeal disease (LMD), a secondary metastatic cancer where the cancer cells invade the CSF and central nervous system; the condition has a 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. MTD217 is a water-soluble drug formulation that can be delivered directly to the tumor microenvironment (maximizing efficacy and limiting off-target toxicities) and 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. Management plans to generate pre-clinical data (in vitro and in vivo) for the drug in 2024 to support an IND application.

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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.

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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

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