Esportes - Noticiário On Line - Notícias Estadão Conteúdo Estadão Conteúdo
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Praia Clube cai diante das chinesas, e buscará o 3º lugar no Mundial feminino de vôleion December 21, 2024
VôLEI/MUNDIAL DE CLUBES FEMININO/PRAIA CLUBE/TIANJIN
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Donovan Mitchell marca 27 pontos e Cleveland Cavaliers atropela o campeão da NBA Cupon December 21, 2024
BASQUETE/NBA/CLEVELAND CAVALIERS/MILWAUKEE BUCKS
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Como advogado entusiasta das motos foi decisivo para volta da MotoGP para o Brasil em 5 mesesby Felipe Rosa Mendes on December 21, 2024
MOTOGP/GOIâNIA/WALMIR CUNHA/VELOCIDADE
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Internacional anuncia renovação de contrato com fornecedora de material esportivo até 2029on December 20, 2024
FUTEBOL/INTER/RENOVAçãO/FORNECEDORA DE MATERIAL ESPORTIVO
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Facundo Torres diz estar ansioso para jogar no futebol brasileiro: 'Palmeiras é muito grande'on December 20, 2024
FUTEBOL/PALMEIRAS/FACUNDO TORRES/REFORçO
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Guarani define Águas de Lindóia como destino para pré-temporada antes do Paulistãoon December 20, 2024
FUTEBOL/GUARANI/PRé-TEMPORADA
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Diretoria do Santos dá sequência à reformulação do elenco e rescinde contrato com Billy Arceon December 20, 2024
FUTEBOL/SANTOS FC/BILLY ARCE/RESCISãO
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São Paulo oficializa saída de Rafinha, que desperta interesse do Coritibaby Leonardo Catto on December 20, 2024
FUTEBOL/SãO PAULO/RAFINHA
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Milan supera desfalques e vence fora de casa o Verona na abertura da 17ª rodada do Italianoon December 20, 2024
FUTEBOL/CAMPEONATO ITALIANO/VERONA/MILAN
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Com início eletrizante, Bayern goleia o RB Leipzig e mantem a liderança isolada no Alemãoon December 20, 2024
FUTEBOL/CAMPEONATO ALEMãO/BAYERN DE MUNIQUE, RB LEIPZIG
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João Fonseca bate Mensik e encerra fase de grupos do Next Gen Finals com 100% de aproveitamentoon December 20, 2024
TêNIS/TORNEIO NEXT GEN FINALS/JOãO FONSECA
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Jornal inglês coloca Vinícius Júnior atrás de Rodri em eleição do melhor jogador do mundoon December 20, 2024
FUTEBOL/GUARDIAN/VINíCIUS JúNIOR/RODRI/ELEIçãO
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Simeone prevê jogo divertido no duelo com Barcelona e exalta Raphinha: 'Tem coragem e estilo'on December 20, 2024
FUTEBOL/CAMPEONATO ESPANHOL/ATLéTICO DE MADRID/SIMEONE
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Rafinha esfria renovação de contrato com o São Paulo e se aproxima de retorno ao Coritibaon December 20, 2024
FUTEBOL/RAFINHA/SãO PAULO FC/CORITIBA/RENOVAçãO
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Flick alerta Barcelona para boa fase do Atlético de Madrid e cobra o elenco: 'Queremos vencer'on December 20, 2024
FUTEBOL/CAMPEONATO ESPANHOL/BARCELONA/HANSI FLICK
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Com destaque do Corinthians, seleção brasileira sub-20 é convocada para o Sul-Americanoon December 20, 2024
FUTEBOL/SUL-AMERICANO SELEçãO BRASILEIRA SUB-20/CORINTHIANS/CONVOCAçãO/BRENO BIDON
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Fifa assina acordo com a Netflix para passar os jogos da Copa do Mundo Feminina em 2027 e 2031on December 20, 2024
FUTEBOL/FIFA/NETFLIX/COPA DO MUNDO FEMININA
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Conmebol define data e horário das estreias de Corinthians e Bahia na pré-Libertadoreson December 20, 2024
FUTEBOL/CONMEBOL/PRé-LIBERTADORES/CORINTHIANS
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Palmeiras oficializa chegada de primeiro reforço para 2025 e tenta Andreas Pereiraby Rodrigo Sampaio on December 20, 2024
FUTEBOL/PALMEIRAS/FACUNDO TORRES
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Atlético-MG anuncia que Arena MRV terá grama sintética e é mais um clube a usar piso artificialon December 20, 2024
FUTEBOL/ATLéTICO-MG/ARENA MRV/GRAMA SINTéTICA
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STJD aplica multa e suspende Carlinhos, do Flamengo, por 30 diason December 20, 2024
FUTEBOL/FLAMENGO/STJD/CARLINHOS
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Minas é eliminado e Praia Clube avança à semifinal no Mundial de Clubes femininoon December 20, 2024
VôLEI/MUNDIAL DE CLUBES FEMININO/MINAS/PRAIA CLUBE
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STJD nega recurso do Corinthians e mantém multa por cabeça de porco lançada no gramadoon December 20, 2024
FUTEBOL/CORINTHIANS/STJD/CABEçA DE PORCO/PUNIçãO/MULTA
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Paulinho é centroavante? Entenda como jogador pode se encaixar no time do Palmeirason December 20, 2024
FUTEBOL/PALMEIRAS/PAULINHO/CENTROAVANTE
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Ponte Preta não renova com casa de apostas e inicia busca por novo patrocinador masteron December 20, 2024
FUTEBOL/PONTE PRETA/PATROCINADOR/CASA DE APOSTAS
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Rival de Bortoleto acerta com RB e grid da F-1 fica completo para temporada 2025on December 20, 2024
FóRMULA 1/RB/ISACK HADJAR/GRID
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LeBron bate recorde de Abdul-Jabbar e Lakers superam Kings na NBA; Celtics perdemon December 20, 2024
BASQUETE/NBA/KINGS/LAKES/LEBRON/RECORDE
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Vasco anuncia a contratação do técnico Fábio Carille para a temporada de 2025on December 20, 2024
FUTEBOL/VASCO/FáBIO CARILLE/TéCNICO
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Chelsea bate Shamrock Rovers, mantém 100% de aproveitamento e avança em primeiro na Liga Europaon December 19, 2024
FUTEBOL/LIGA EUROPA/CHELSEA/SHAMROCK ROVERS
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Tottenham vence Manchester United com gol olímpico e vai à semifinal da Copa da Liga Inglesaon December 19, 2024
FUTEBOL/COPA DA LIGA INGLESA/TOTTENHAM/MANCHESTER UNITED
Official Newsfeed
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Tennessee basketball stars surprise Emerald Academy studentsby WBIR Staff on December 19, 2024
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A year in review: The Anderson Center for Entrepreneurship and Innovationby Katelyn Biefeldt on December 19, 2024
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GAME Change reports good progress on creating a two-state circular economy hubby Tom Ballard on December 19, 2024
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Forbes Names UT a Dream Employerby Tribune Staff on December 18, 2024
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ABR: TWRA euthanizes 13 bear cubs at rescue without including group in discussionsby Justin Wallace on December 18, 2024
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Cattle market to close year strongon December 18, 2024
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UT students uncover Civil War-era trench on campusby Ellis Rold on December 17, 2024
Digital Trends Tech Product Reviews, How To, Best Ofs, deals and Advice
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The latest Amazon Echo Show 5 is half off on Amazon today!
by Michael Bizzaco on December 18, 2024 at 9:10 pm
Take video calls, stream Netflix, indulge in your favorite tunes, and get recipe help in the kitchen with the Amazon Echo Show 5, now on sale for only $45.
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Should you invest in a smart home gym or stick with a gym membership?
by Jon Bitner on December 18, 2024 at 9:00 pm
Smart home gyms give you convenient access to workouts and stat tracking, but are they better than a gym membership? Here’s everything you need to know.
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Get up to 32% off Aqara smart locks for the holidays
by Briley Kenney on December 16, 2024 at 5:10 pm
Thanks to these holiday deals, you can get up to 32% of Aqara smart locks to liven up your home and gain entry to it easier than ever.
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YouTube gets parental code feature on TV to protect kids
by Nadeem Sarwar on December 14, 2024 at 2:45 pm
YouTube has introduced a new safety protocol that would require young users to enter a parent code if they want to watch videos outside the “kids” profile.
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These buttons and dials offer a unique way to access your smart home
by Jon Bitner on December 13, 2024 at 8:30 pm
The Flic Twist and Smart Buttons are a great addition to most smart homes, even if they lack some functionality.
Biodexa Pharmaceuticals PLC Contains the last 20 releases
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Biodexa Announces Successful Appeal of Nasdaq Delisting
on October 15, 2024 at 8:15 pm
Exhibit 99.1 October 15, 2024 Biodexa Announces Successful Appeal of Nasdaq Delisting Biodexa Pharmaceuticals PLC. (the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that a Nasdaq Hearings Panel (the “Panel”) has granted the Company’s request for an extension of time to demonstrate compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq Stock Market LLC (“Nasdaq”) set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). As a condition of the Panel’s decision, the Company is required to demonstrate compliance with the Minimum Bid Price Requirement by evidencing a closing bid price of at least $1.00 per share for a minimum of 20 consecutive trading days by October 31, 2024. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer: tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
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Interim results for the six months ended June 30, 2024
on September 26, 2024 at 12:30 pm
September 26, 2024 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Interim results for the six months ended June 30, 2024 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces its unaudited interim results for the six months ended June 30, 2024 which will also be made available on the Company’s website at www.biodexapharma.com OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended June 30, 2024: Exclusive worldwide licensing of eRapa™, a Phase 3 ready asset with a lead indication of Familial Adenomatous Polyposis (“FAP”) together with access to a $17 million grant. Six month data of eRapa in FAP showing an 83% non-progression rate and a statistically significant reduction on overall polyp burden, announced at the Digestive Disease Week scientific meeting in Washington D.C. 12 month data of eRapa in FAP showing a 75% non-progression rate and median overall decrease in polyp burden of 17%, presented at the bi-annual InSIGHT scientific meeting in Barcelona. 12 month overall survival of patient #1 in the Company’s MAGIC-G1 Phase 1 study of MTX110 in recurrent Glioblastoma (“rGBM”). 16.5 months overall survival of patients in a Phase 1 study of MTX110 in Diffuse Midline Glioma, subsequently presented at the International Symposium on Pediatric Neuro-oncology (ISPNO 2024). Allowance by the US Patent and Trademark Office of Family 13 (“Prevention of Pancreatic Cell Degeneration”), a key component of tolimidone exclusivity. Post period end: Approval by Health Canada to proceed with a Phase 2a dose confirmation study of tolimidone in Type 1 diabetes to be conducted by the University of Alberta Diabetes Institute. An update on the status of cohort A in the MAGIC-G1 study: patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively. Patients #3 and #4 remain alive with progression free survival (PFS) since the start of treatment of 6 and 9 months, respectively and OS thus far of 12 and 11 months respectively. FINANCIAL HIGHLIGHTS Receipt of $6.05 million in gross proceeds from the exercise of certain Series E and Series F warrants to purchase 4.4 million ADSs. The warrant inducement included a reduction in exercise price and issuance of replacement Series G and Series H warrants. R&D costs decreased to £2.19 million in 1H24 (1H23: £2.25 million) reflecting a reduction in spend on the MAGIC-G1 study in rGBM, termination of legacy drug delivery projects and lower personnel costs offset by the addition of MTD228 (tolimidone) and MTX230 (eRapa) preclinical and study initiation costs.ministrative costs decreased to £2.03 million (1H23: £2.29 million) as a result of a positive reversal in foreign exchange and a reduction in professional fees offset by increases in share-based payment charge and sundry other costs. Administrative costs decreased to £2.03 million (1H23: £2.29 million) as a result of a positive reversal in foreign exchange and a reduction in professional fees offset by increases in share-based payment charge and sundry other costs. Net cash used in operating activities (after changes in working capital) in 1H24 was £4.81 million (1H23: £3.88million). The Company’s cash balance at June 30, 2024 was £5.06 million. The cash balance at August 31, 2024 was £5.71 million. Post period end: Receipt of $5.0 million in gross proceeds from a Registered Direct Offering of 5.1m ADSs and 0.3m Pre-funded warrants together with a private placement of Series J and Series K warrants. Payment of the final match, enabling access to the remainder of the $17 million grant from the Cancer Prevention and Research Institute of Texas (“CPRIT”), which will be used to fund the upcoming Phase 3 registrational study of eRapa in the orphan indication of FAP. Commenting, Stephen Stamp, CEO and CFO, said “It was a busy first half for Biodexa. Licensing in eRapa, a Phase 3 ready asset with access to $17 million of non-dilutive grant funding, is an enormous step forward. The second half will be about executing on our lead programs. We already have approval from Health Canada for the IIT Phase 2a study of tolimidone in Type 1 diabetes and we are working diligently to set up a global Phase 3 registrational study of eRapa in FAP so we can begin recruiting early next year.” For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO, CFO Tel: +44 (0)29 2048 0180 www.biodexapharma.com About Biodexa Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective activator of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. CHIEF EXECUTIVE’S REVIEW Our primary focus in the first half of 2024 was on assimilating tolimidone, licensed in December 2023, into our portfolio and searching for additional clinical-stage assets to diversify and advance our pipeline which ultimately led to the licensing of eRapa in May 2024. eRapa License In line with our strategy to build a sustainable therapeutics company in rare/orphan diseases, we continue to search for opportunities to broaden and diversify our development pipeline. On April 25, 2024, we entered into a License and Collaboration Agreement (“LCA”) with Rapamycin Holdings, Inc. (d/b/a Emtora Biosciences), relating to the license of eRapa, an oral formulation of rapamycin (also known as sirolimus) for use in all diseases, states or conditions in humans. Under the LCA, we obtained an exclusive, worldwide, sublicensable right to develop, manufacture, commercialize, or otherwise exploit products containing rapamycin. Pursuant to the terms of the LCA, the Company and Emtora established a joint development committee to monitor and progress the development of eRapa. Emtora has conducted a Phase 1 study of eRapa in prostate cancer, a Phase 2 study in FAP and has an ongoing Phase 2 study in Non-muscle Invasive Bladder Cancer. Preparations are under way for a registrational Phase 3 study of eRapa in FAP. In consideration for the license, we made an upfront payment of 378,163 ADSs (equal to five percent of our then outstanding Ordinary Shares, calculated on a fully-diluted basis). In addition, we are also responsible for up to an aggregate $31.5 million in sales milestones within the first six months of commercial sale of a first-approved indication of eRapa in certain markets with decreasing milestones for subsequent approvals for additional indications. There is also a one-time $10.0 million milestone payable upon cumulative net sales of $1.0 billion. Further, we are also obligated to pay Emtora single digit tiered royalties on net sales of eRapa, in addition to honouring Emtora’s legacy royalty obligations and paying Emtora fees related to income derived from sublicensing and partnering of eRapa. In addition, a promissory note previously issued by Emtora in favour of the Company in the amount of $0.25 million was forgiven. We also made an additional $0.5 million payment which was used for a match to an advance from the CPRIT. Emtora had secured a grant of $17.0 million from CPRIT to support the Phase 3 study of eRapa in FAP. The grant requires a 1 for 2 match and Biodexa was expected to fund the match of up to $7.5 million, being 50% of the remaining CPRIT grant, which was completed in September 2024. Grant funding is available once the match payment has been certified and CPRIT has approved eligible trial expenses. In certain instances, CPRIT may advance payments before eligible trial expenses have been incurred. Upon a change of control of the Company, we will issue Emtora a warrant exercisable for 1,604,328 ADSs. The LCA also provides us with the exclusive option to acquire all of the capital stock of Emtora on commercially reasonable terms in the 90 days after acceptance of the filing of an NDA by the U.S. Food and Drug Administration (the “FDA”). R&D update Following the in-licensing of eRapa, our development pipeline has not only advanced in terms of clinical stage but expanded to six programmes overall, four of which are orphan indications: eRapa eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035. Familial Adenomatous Polyposis (“FAP”) FAP is an orphan indication characterized by a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US1 and one in 11,300 to 37,600 in Europe2. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. An open-label Phase 2 study (NCT04230499) was conducted by Emtora in seven U.S. centres of excellence in 30 adult patients. Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden, as measured by the aggregate of all polyp diameters. In May 2024, results of the Phase 2 study at six months were presented at the prestigious 2024 Digestive Disease Week annual meeting in Washington D.C. by Carol Burke, MD, the Principal Investigator. In summary, at six months, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate. In June 2024, results of the Phase 2 study at 12 months were presented at the bi-annual InSIGHT meeting in Barcelona by Dr Burke. Overall, 21 of 28 (75%) patients were deemed to be non-progressors at 12 months with a median reduction in polyp burden of 17%. In Cohort 2, the likely dosage regimen for Phase 3, eight of nine (89)% of patients were deemed non-progressors at 12 months with a median reduction in polyp burden of 29%. Over the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. The Phase 3 registrational study is planned to be a double-blind placebo-controlled design recruiting approximately 150 high risk patients diagnosed with germline or phenotypic FAP. The primary clinical endpoint is expected to be the first progression free survival event which will comprise composite endpoints including major surgery. A ‘Type C’ meeting with the FDA is planned for 4Q24 to finalise the protocol and related matters. A $17 million grant from CPRIT will support this study. Non-muscle Invasive Bladder Cancer (“NMIBC”) NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women3. Our ongoing multi-centre, double-blind, placebo-controlled Phase 2 study in NMIBC is expected to enrol up to 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported by a $3.0 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, is expected to read out in mid-2025. MTD228 – Tolimidone Tolimidone was originally discovered by Pfizer and was developed through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in a Phase II clinical trial. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate-1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Type 1 Diabetes (“T1D”) Tolimidone’s potential utility in T1D has been demonstrated by several ground-breaking preclinical studies conducted by the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Most importantly, tolimidone was able to induce proliferation in beta cells isolated from human cadavers. From a mechanism of action perspective, tolimidone has been shown to both prevent beta cell degradation and to stimulate beta cell proliferation. In a meta analysis of 1,202 articles and 193 studies, the incidence of T1D was shown to be 15 per 100,000 with a prevalence of 9.5 per 10,000 of the population4. As a first step in the continued clinical development of tolimidone, a Phase 2a Investigator Initiated Trial (IIT) at the University of Alberta Diabetes Institute is designed to establish the minimum effective dose of tolimidone in patients with T1D. The study, which was approved by Health Canada in July 2024 is expected to recruit 12 patients initially across three dose groups. The study will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events. MTX110 MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the brain tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. All three types of brain cancer being studied are orphan. Recurrent Glioblastoma (“rGBM”) Our Phase 1 MAGIC-G1 study (NCT05324501) of MTX110 in rGBM completed the dose escalation part of the study with the recruitment of the fourth patient in Cohort A. In February 2024 we announced Patient #1, who had received sub-optimal infusions of 60µM of MTX110 had survived for12 months from the start of treatment (OS=12). GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months. Post period end, we provided an update on the status of cohort A in the MAGIC-G1 study: patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively. Patients #3 and #4 remain alive with progression free survival (PFS) since the start of treatment of 6 and 9 months, respectively and OS thus far of 12 and 11 months respectively. GBM virtually always recurs with median Progression Free Survival of 1.5–6.0 months and median Overall Survival of 2.0–9.0 months5. Diffuse Midline Glioma (“DMG”) In February 2024 we announced headline data from a Phase 1 IIT study conducted by Columbia University in newly diagnosed patients with DMG. As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary objective of the study was safety and tolerability and, accordingly, the number of infusions was limited to two, each of 48 hours, 7 days apart in nine patients. One patient suffered a severe adverse event assessed by the investigators as not related to the study drug. Although not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months compared with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Study investigators subsequently presented the results of the trial at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia. Medulloblastoma An IIT Phase I study of MTX110 in medulloblastoma remains ongoing at the University of Texas. Financing As a pre-revenue biotech company, securing adequate finance to fund operations to an out-licensing and/or partnering event is a constant focus. On the back of the eRapa in-licensing and the subsequent announcement of positive 6-month and 12-month data of eRapa in FAP, we accomplished two financings; the first in May 2024 and the second post period end in July 2024. May 2024 Warrant Exercises On May 22, 2024, we raised $6.05 million of gross proceeds from the exercise of previously issued warrants following an agreement between the Company and several accredited investors to exercise existing Series E warrants and Series F warrants to purchase up to an aggregate of 4,358,322 ADSs. The warrant holders agreed to exercise the Series E and/or Series F warrants at an exercise price of $1.50 (reduced from $2.20) per ADS. In consideration for the immediate exercise of the Series E and/or Series F warrants for cash, we issued one replacement warrant for each Series E warrant exercised in the form of a Series G warrant, and one replacement warrant for each Series F warrant exercised in the form of a Series H warrant. The Series G and Series H warrants are exercisable for five years and one year, respectively, at $2.50 each. July 2024 Registered Direct Offering and Private Placement On July 22, 2024, we utilised our capacity under our Registration Statement on Form F-3 to raise $5.0 million in gross proceeds in a Registered Direct Offering with certain institutional investors for the sale of an aggregate of 5,050,808 ADSs and 278,975 pre-funded warrants at a price of $0.94 per ADS. In a concurrent Private Placement, we issued and sold to the Investors (i) Series J warrants exercisable for 5,329,783 ADSs, and (ii) Series K Warrants to purchase an aggregate of 5,329,783 ADSs. The Series J and Series K warrants are exercisable for five years and one year, respectively, at $1.00 per ADS each. 1. https://rarediseases.org/rare-diseases/familial-adenomatous-polyposis/ 2. https://www.orpha.net/en/disease/detail/733#:~:text=FAP%20has%20a%20birth%20incidence,colorectal%20cancer%20(CRC)%20cases. 3. Cassell et al., World J Oncol. 2019 Jun; 10(3): 123–131. 4. National Library of Medicine, Mobasseri et al., published online 2020 Mar 30. doi: 10.34172/hpp.2020.18 5. Birzu et al. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794906 1H24 FINANCIAL REVIEW The unaudited results for the six months ended June 30, 2024 are discussed below: Key performance indicators (KPIs): 1H 2024 1H 2023 Change R&D costs £2.19m £2.25m (3)% R&D as % of operating costs 52% 50% 5% Net cash (outflow)/inflow for the period £(0.92)m £2.39m N/M Biodexa’s KPIs focus on the key areas of operating results, R&D spend and cash management. These measures provide information on the core R&D operations. Additional financial and non-financial KPIs may be adopted in due course. Revenues Total revenue for the six months to June 30, 2024 was £Nil compared to £0.30 million in the first six months of 2023. The R&D collaboration with Janssen, which represented the entire revenue in 1H23, concluded in September 2023. Research and Development R&D costs in 1H24 reduced by £0.06 million, or 3%, to £2.19 million compared with £2.25 million in 1H23. The percentage of R&D costs as a percentage of total operating costs increased to 52% in the period from 50%. The reduction in R&D costs in 1H24 reflects a reduction in spend of £0.54 million on the MAGIC-G1 study in rGBM, the termination of legacy drug delivery projects and lower personnel costs offset by the addition of MTD228 (tolimidone) and MTX230 (eRapa) for a combined expenditure of £0.65 million in 1H24. Administrative Costs Administrative costs in 1H24 decreased by £0.26 million, or 11% to £2.03 million from £2.29 million in 1H23. The decrease in administrative costs in 1H24 is a result of a positive reversal in foreign exchange of £0.23 million and a reduction in professional fees of £0.14 million offset by increases in share-based payment charge of £0.12 million and sundry other costs. Finance Income and Expense Finance income in 1H24 and 1H23 included gains in respect of an equity settled derivative financial liability of £0.75 million (1H23: £0.39 million). The gains arose as a result of the fall in the Biodexa share price. In addition, the Company earned interest on cash deposits. Finance expense in the period related to lease liabilities and discounted interest on deferred consideration. Cash Flows Cash outflows from operating activities in 1H24 were £4.81 million compared to £3.88 million in 1H23, driven by a net loss of £3.31 million (1H23: £3.57 million) and after negative working capital of £0.87 million (1H23: positive £0.21 million) and other negative non-cash items totalling £0.63 million (1H23: negative £0.52 million). Net cash used in investing activities in 1H24 of £0.75 million in 1H24 resulted from the purchase of eRapa licence for total consideration of £3.07 million including cash consideration of £0.85 million (1H23: £Nil) offset by £0.10 million of interest received (1H23: £0.02 million). Net cash generated in financing activities in 1H24 was £4.65 million (1H23: inflow £6.25 million), which was driven by receipts from share issuances, including warrants, net of costs of £4.74 million offset by payments on lease liabilities of £0.09 million. Overall, cash decreased by £0.92 million in 1H24 compared to an increase of £2.39 million in 1H23. This resulted in a cash balance at June 30, 2024 of £5.06 million compared with £5.23 million at June 30, 2023 and £5.97 million at December 31, 2023. Going concern Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to June 30, 2024, the Group incurred a consolidated loss from operations of £3.31 million (1H23: £3.57 million) and negative cash flows from operating activities of £4.81 million (1H23: £3.88 million). As of June 30, 2024, the Group had accumulated deficit of £147.88 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Group’s consolidated interim financial information has been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at June 30, 2024, the Group had cash and cash equivalents of £5.06 million. The Directors forecast that the Group currently has enough cash to fund its planned operations into the first quarter of 2025. If the Company does not secure additional funding before the first quarter of 2025, it will no longer be a going concern and would likely be placed in Administration. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the first quarter of 2025 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. If we raise additional funds through the issuance of debt securities or additional equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares (including the ADSs) and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. On August 27, 2024, the Company received notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC advising that the Company was not in compliance with the minimum bid requirement set forth in NASDAQ’s rules for continued listing of its securities. The Company has requested a Hearing Panel which has paused any suspension or delisting action pending the hearing. If the Company’s ADSs are delisted, it could be more difficult to buy or sell the Company’s ADSs or to obtain accurate quotations, and the price of the Company’s ADSs could suffer a material decline. Delisting may impair the Company’s ability to raise capital. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies continues to be challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Group would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Group which are actionable before its cash resources run out then the Group will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. The Directors believe there are adequate options and time available to secure additional financing for the Group and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected. Stephen Stamp Chief Executive Officer and Chief Financial Officer Consolidated Statements of Comprehensive Income For the year six month period ended June 30 Note 2024 unaudited £’000 2023 unaudited £’000 Revenue – 298 Research and development costs (2,189) (2,251) Administrative costs (2,034) (2,291) Loss from operations (4,223) (4,244) Finance income 3 839 410 Finance expense 3 (49) (22) Loss before tax (3,433) (3,856) Taxation 4 125 288 Loss for the period attributable to the owners of the parent (3,308) (3,568) Total comprehensive loss attributable to the owners of the parent (3,308) (3,568) Loss per share Basic and diluted loss per ordinary share – pence 5 (0.1p) (3.6)p The accompanying notes form part of these financial statements Consolidated Statements of Financial Position Note As at June 30, 2024 unaudited £’000 As at December 31, 2023 £’000 Assets Non-current assets Property, plant and equipment 436 571 Intangible assets 6 6,008 2,941 6,444 3,512 Current assets Trade and other receivables 1,922 637 Taxation 547 422 Cash and cash equivalents 5,055 5,971 7,524 7,030 Total assets 13,968 10,542 Liabilities Non-current liabilities Deferred consideration 7 1,552 – Borrowings 208 295 1,760 295 Current liabilities Trade and other payables 1,689 1,240 Deferred consideration 7 459 – Borrowings 174 169 Derivative financial liability 8 1,159 4,160 3,481 5,569 Total liabilities 5,241 5,864 Issued capital and reserves attributable to owners of the parent Share capital 9 8,689 6,253 Share premium 91,242 86,732 Merger reserve 53,003 53,003 Warrant reserve 3,674 3,457 Accumulated deficit (147,881) (144,767) Total equity 8,727 4,678 Total equity and liabilities 13,968 10,542 The accompanying notes form part of these financial statements Consolidated Statements of Cash Flows For the six month period ended June 30 Note 2024 unaudited £’000 2023 unaudited £’000 Cash flows from operating activities Loss for the period (3,308) (3,568) Adjustments for: Depreciation of property, plant and equipment 67 72 Depreciation of right of use asset 68 70 Amortisation of intangible fixed asset 1 1 Finance income 3 (839) (410) Finance expense 3 49 22 Share-based payment expense 150 15 Taxation 4 (125) (288) Foreign exchange losses 2 – Cash flows from operating activities before changes in working capital (3,935) (4,086) (Increase)/Decrease in trade and other receivables (1,298) 103 Increase in trade and other payables 426 309 Decrease in provisions – (207) Cash used in operations (4,807) (3,881) Taxes payments – – Net cash used in operating activities (4,807) (3,881) Consolidated Statements of Cash Flows (continued) For the six month period ended June 30 Note 2024 unaudited £’000 2023 unaudited £’000 Investing activities Purchases of property, plant and equipment – (4) Proceeds from disposal of fixed assets – – Purchase intangible asset (852) – Interest received 98 24 Net cash generated from/(used in) investing activities (754) 20 Financing activities Interest paid – (7) Amounts paid on lease liabilities (93) (95) Share issues including warrants, net of costs 9 4,738 6,354 Net cash generated from/(used in) financing activities 4,645 6,252 Net increase/(decrease) in cash and cash equivalents (916) 2,391 Cash and cash equivalents at beginning of period 5,971 2,836 Cash and cash equivalents at end of period 5,055 5,227 The accompanying notes form part of these financial statements Consolidated Statements of Changes in Equity (unaudited) Note Share capital £’000 Share premium £’000 Merger reserve £’000 Warrant reserve £’000 Accumulated deficit £’000 Total equity £’000 At January 1, 2024 6,253 86,732 53,003 3,457 (144,767) 4,678 Loss for the period – – – – (3,308) (3,308) Total comprehensive loss – – – – (3,308) (3,308) Transactions with owners: Shares issued on May 22, 2024 9 1,242 3,730 – 1,690 – 6,662 Costs associated with share issue on May 22, 2024 – (369) – (125) – (494) Exercise of warrants during period 9 1,043 1,081 – (1,348) – 776 Issue of shares to purchase intangible asset 9 151 68 – – – 219 Share-based payment charge – – – – 195 195 Total contribution by and distributions to owners 2,436 4,510 – 217 195 7,357 At June 30, 2024 8,689 91,242 53,003 3,674 (147,881) 8,727 Note Share capital £’000 Share premium £’000 Merger reserve £’000 Warrant reserve £’000 Accumulated deficit £’000 Total equity £’000 At January 1, 2023 1,108 83,667 53,003 720 (135,336) 3,162 Loss for the period – – – – (3,568) (3,568) Total comprehensive loss – – – – (3,568) (3,568) Transactions with owners: Shares issued on February 15, 2023 9 1,956 3,013 – – – 4,969 Costs associated with share issue on February 15, 2023 – (903) – – – (903) Shares issued on May 26, 2023 9 2,277 – – 103 (355) 2,025 Costs associated with share issue on May 26, 2023 – – – – (527) (527) Share-based payment charge – – – – 141 141 Total contribution by and distributions to owners 4,233 2,110 – 103 (741) 5,705 At June 30, 2023 5,341 85,777 53,003 823 (139,645) 5,299 The accompanying notes form part of these financial statements Notes Forming Part of The Consolidated Unaudited Interim Financial Information For the six month period ended June 30, 2024 Basis of preparation The unaudited interim consolidated financial information for the six months ended June 30, 2024 has been prepared following the recognition and measurement principles of the International Financial Reporting Standards, International Accounting Standards and Interpretations (collectively IFRS) issued by the International Accounting Standards Board (IASB), and as adopted by the UK and in accordance with International Accounting Standard 34 Interim Financial Reporting (‘IAS 34’). The interim consolidated financial information does not include all the information and disclosures required in the annual financial information and should be read in conjunction with the audited financial statements for the year ended December 31, 2023. The accounting policies adopted are consistent with those of the previous financial year and corresponding interim reporting periods. Book values approximate to fair value at 30 June 2024, 30 June 2023 and 31 December 2023. The condensed interim financial information contained in this interim statement does not constitute statutory financial statements as defined by section 434(3) of the Companies Act 2006. The condensed interim financial information has not been audited. The comparative financial information for the six months ended June 30, 2023 and the year ended December 31, 2023 in this interim financial information does not constitute statutory financial statements for that period or year. The statutory financial statements for December 31, 2023 have been delivered to the UK Registrar of Companies. The auditor’s report on those accounts was unqualified and did not contain a statement under section 498(2) or 498(3) of the Companies Act 2006. The auditor’s report did draw attention to a material uncertainty related to going concern and the requirement, as of the date of the report, for additional funding to be raised by the Company by the fourth quarter of 2024. Biodexa Pharmaceutical’s annual reports may be downloaded from the Company’s website at https://biodexapharma.com/investors/financial-reports-and-presentations/#financial-reports or a copy may be obtained from 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ. Going Concern – material uncertainty Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to June 30, 2024, the Group incurred a consolidated loss from operations of £3.31 million (1H23: loss £3.56 million) and negative cash flows from operating activities of £4.81 million (1H23 £3.88 million). As of June 30, 2024, the Group had accumulated deficit of £147.88 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Group’s consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at June 30, 2024, the Group had cash and cash equivalents of £5.06 million. The Directors forecast that the Group currently has enough cash to fund its planned operations into the first quarter of 2025. If the Company does not secure additional funding before the first quarter of 2025, it will no longer be a going concern and would likely be placed in Administration. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the first quarter of 2025 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. If we raise additional funds through the issuance of debt securities or additional equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares (including the ADSs) and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. On August 27, 2024, the Company received notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC advising that the Company was not in compliance with the minimum bid requirement set forth in NASDAQ’s rules for continued listing of its securities. The Company has requested a Hearing Panel which has paused any suspension or delisting action pending the hearing. If the Company’s ADSs are delisted, it could be more difficult to buy or sell the Company’s ADSs or to obtain accurate quotations, and the price of the Company’s ADSs could suffer a material decline. Delisting may impair the Company’s ability to raise capital. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies continues to be challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Group would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Group which are actionable before its cash resources run out then the Group will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. The Directors believe there are adequate options and time available to secure additional financing for the Group and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected. Accounting for eRapa and CPRIT grant The LCA entered into with Emtora meets the definition of a Joint Arrangement under IFRS 11, specifically related to the FAP program. A jointly controlled escrow account was established on completion of the LCA. All FAP program transactions are processed through the escrow account, including the Company’s deposits of matching funds, as set out in the agreement, the receipt of grant funding from CPRIT and the payment of eligible R&D expenses. Although the CPRIT grant and R&D supplier contracts are with Emtora, the joint arrangement nature of the LCA results in Emtora being deemed to be acting as the Company’s agent. Accordingly, the Company recognises 100% of the grant and 100% of the R&D expenditure. The CPRIT grant recognised is on a 1 for 2 match. In accordance with the Company’s accounting policy, the grant, as it is the re-imbursement of directly related costs, is credited to R&D costs in the same period in The Statements of Comprehensive Income. The escrow account is recognised within prepayments, CPRIT grant received in advance is recognised within deferred revenue and any grant not yet received is recognised in accrued income. In 1H24 the company recognised R&D costs of £0.2 million on the FAP project, this was made up of expenditure of £0.5 million netted against CPRIT grant of £0.3 million. The balances as at June 30, 2024 were as follows in relation to the FAP project: Prepayments £1.2 million Deferred revenue £0.1 million Finance income and expense Six months ended June 30, 2024 unaudited £’000 Six months ended June 30, 2023 unaudited £’000 Finance income Interest received on bank deposits 86 24 Other interest 2 – Gain on equity settled derivative financial liability 751 386 Total finance income 839 410 The gain on the equity settled derivative financial liability in 1H24 and 1H23 arose as a result of the fall in the Biodexa share price. Six months ended June 30, 2024 unaudited £’000 Six months ended June 30, 2023 unaudited £’000 Finance expense Interest expense on lease liabilities 11 15 Interest expense on deferred consideration 38 – Other loans – 7 Total finance expense 49 22 Taxation Income tax is recognised or provided at amounts expected to be recovered or to be paid using the tax rates and tax laws that have been enacted or substantively enacted at the Group Statement of Financial Position date. Research and development tax credits are recognised on an accruals basis and are included as an income tax credit under current assets. The research and development tax credit recognised is based on management’s estimate of the expected tax claim for the period and is recorded within taxation under the Small and Medium-sized Enterprise Scheme. Six months ended June 30, 2024 unaudited £’000 Six months ended June 30, 2023 unaudited £’000 Income tax credit 125 288 Loss per share Basic loss per share amounts are calculated by dividing the net loss for the period from continuing operations, attributable to ordinary equity holders of the parent company, by the weighted average number of ordinary shares outstanding during the period. As the Group made a loss for the period the diluted loss per share is equal to the basic loss per share. Six months ended June 30, 2024 unaudited £’000 Six months ended June 30, 2023 unaudited £’000 Numerator Loss used in basic EPS and diluted EPS: (3,308) (3,568) Denominator Weighted average number of ordinary shares used in basic EPS 3,280,798,115 99,191,082 Basic and diluted loss per share: (0.1)p (3.6)p The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Pre-Funded, Abeyance Shares, Series A, Series B and Series C warrants as disclosed in note 8. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator. The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted earnings per share is presented on the same basis as basic earnings per share. Intangible Assets In-process research and development £’000 Goodwill £’000 IT/Website costs £’000 Total £’000 Cost At January 1, 2023 13,378 2,291 110 15,779 Acquisition 2,938 – – 2,938 At December 31, 2023 16,316 2,291 110 18,717 Acquisition 3,068 – – 3,068 At June 30, 2024 (unaudited) 19,384 2,291 110 21,785 In-process research and development £’000 Goodwill £’000 IT/Website Costs £’000 Total £’000 Accumulated amortisation and impairment At January 1, 2023 13,378 2,291 104 15,773 Amortisation charge for the year – – 3 3 At December 31, 2023 13,378 2,291 107 15,776 Amortisation charge for the period – – 1 1 At June 30, 2024 (unaudited) 13,378 2,291 108 15,777 Net book value At June 30, 2024 (unaudited) 6,006 – 2 6,008 At December 31,2023 2,938 – 3 2,941 The individual intangible assets which are material to the financial statements are as follows: Carrying amount Remaining amortisation period June 30, 2024 unaudited £’000 December 31, 2023 £’000 June 30, 2024 unaudited £’000 December 31, 2023 £’000 MTX228 tolimidone acquired IPRD* 2,938 2,938 n/a n/a MTX230 eRapa acquired IPRD* 3,068 – n/a n/a *asset is not yet in use and has not started amortising On April 25, 2024 the Company entered into a License and Collaboration Agreement (LCA) with Rapamycin Holdings, Inc. (d/b/a Emtora Biosciences), relating to the license of eRapa. In consideration for the License, the Company made an upfront payment of 378,163 ADSs (equal to five percent of our then outstanding Ordinary Shares, calculated on a fully-diluted basis). In addition, a promissory note previously issued by Emtora in favor of the Company in the amount of $0.25 million was forgiven and certain historical liabilities relating to their on-going FAP and NMIBC programs were settled. The Company is also obligated to make quarterly payments to Emtora of $0.25 million less 75% of any research sales by Emtora until the handover trigger event occurs. The obligation meets the definition of a financial liability in accordance with IAS32 and is measured at fair value in accordance with IFRS9. Management have estimated the expected liability to be $3.1 million and the present value as $2.5 million. $’000 £’000 378,163 ADSs issued at market value 274 219 Promissory note forgiven 250 197 Historical liabilities settled 820 655 Quarterly payment obligation 2,494 1,997 Recognised as intangible asset purchase (unaudited) 3,838 3,068 In addition, the Company is also responsible for up to $31.5 million in sales milestones within the first six months of commercial sale of a first-approved indication of eRapa in certain markets, with decreasing milestones for subsequent approvals for additional indications. There is also a one-time $10.0 million milestone payable upon cumulative net sales of $1.0 billion. Further, the Company is also obligated to pay Emtora single digit tiered royalties on net sales of eRapa, in addition to honouring Emtora’s legacy royalty obligations and paying Emtora fees related to income derived from sublicensing and partnering of eRapa. The LCA also provides the Company with the exclusive option to acquire all of the capital stock of Emtora on commercially reasonable terms in the 90 days after acceptance of the filing of an NDA by the U.S. Food and Drug Administration (the “FDA”). If the Company does not exercise the option, it would be required to make additional quarterly payments, as disclosed in note 7, until the first commercial sale of the product. Deferred Consideration As at June 30, 2024 unaudited £’000 As at December 31, 2023 £’000 Opening provision at January 1, – – On acquisition of licence 1,997 – Interest expense 38 – Foreign exchange (24) – 2,011 – Less: non-current portion (1,552) – Current portion 459 – The Company is obligated to make quarterly payments to Emtora of $0.25 million less 75% of any research sales by Emtora until the handover trigger event occurs. The obligation meets the definition of a financial liability in accordance with IAS32 and is measured at fair value in accordance with IFRS9. Management have estimated the expected liability to be $3.1 million and the present value as $2.5 million. This financial liability is measured on Level 3, the fair value is derived using a discounted cash flow approach. The discount rate applied to the obligation was 11.64% (2023: n/a). A 1% increase or decrease in the discount rate would decrease or increase the liability by approximately £0.03 million (2023: n/a) and £0.03 million (2023: n/a), respectively. An increase in the liability would result in a loss in the revaluation of financial instruments, while a decrease would result in a gain. There were no transfers between Level 1 and 2 in the period. Derivative financial liability – current As at June 30, 2024 unaudited £’000 As at December 31, 2023 £’000 At January 1 4,160 85 Warrants issued 1,368 4,562 Transfer to share premium on exercise of warrants (3,618) – Gain recognised in finance income within the consolidated statement of comprehensive income (751) (487) 1,159 4,160 Equity settled derivative financial liability is a liability that is not to be settled for cash. No warrants recognised as equity settled derivatives were exercised in 2023. The Company issues warrants exercisable into ADSs of the Company as part of registered direct offerings and private placements in the US. The number of ADSs to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the Company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account (‘FVTPL’). The financial liability is valued using the Black-Scholes model. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. A key input in the valuation of the instrument is the Company share price. Details of the warrants are as follows: May 2024 warrants In May 2024 the Company issued 2,359,012 Series G ADS Warrants and 3,695,218 Series H ADS Warrants as part of the Warrant Inducement Transaction. The exercise price per ADS is $2.50. December 2023 warrants In December 2023 the Company issued 3,000,063 Series E ADS Warrants and 3,000,063 Series F ADS Warrants as part of the Registered Offering in the US. The exercise price per ADS is $2.20. May 2023 warrants In June 2023 the Company issued 276,689 Series D ADS Warrants as part of a registered direct offering and private placement in the US after securing shareholder approval. The exercise price per ADS was $16.00. May 2020 warrants In May 2020 the Company issued 838 ADS warrants as part of a registered direct offering in the US. October 2019 warrants In October 2019 the Company issued 392 ADS warrants as part of a registered direct offering in the US. Warrant re-price On May 22, 2024 the Company entered into agreements with several accredited investors to exercise existing Series E warrants and Series F warrants, issued in December 2023, to purchase up to an aggregate of 4,358,322 ADSs. The warrant holders agreed to exercise the Series E and/or Series F warrants at an exercise price of $1.50 (reduced from $2.20) per ADS. ADS Warrants Number Original price per ADS New price per ADS Equivalent Ordinary Shares (400 Ordinary Shares per ADS) Number Series E warrants 1,572,674 $2.20 $1.50 629,069,600 Series F warrants 2,463,477 $2.20 $1.50 985,390,800 Warrants and Dara share options The Group also assumed fully vested warrants and share options on the acquisition of DARA Biosciences, Inc. (which took place in 2015). The number of ordinary shares to be issued when exercised is fixed, however the exercise prices are denominated in US Dollars. The warrants are classified equity settled derivative financial liabilities and accounted for in the same way as those detailed above. The financial liability is valued using the Black-Scholes option pricing model. The exercise price of the outstanding options is $1,903.40. The following table details the outstanding warrants and options over ADSs and ordinary shares recognised as equity settled derivative financial liabilities as at June 30, 2024, December 31, 2023 and also the movement in the year: At December 31, 2022 Lapsed Granted At December 31, 2023 Lapsed Granted Exercised At June 30, 2024 unaudited ADSs warrants May 2024 grant – – – – – 6,054,230 – 6,054,230 December 2023 grant – 6,000,126 6,000,126 – – (4,282,895) 1,717,231 May 2023 grant – 276,689 276,689 – – – 276,689 May 2020 grant 838 – – 838 – – – 838 October 19 grant 392 – – 392 – – – 392 Ordinary Shares DARA Options 138 (10) – 128 (29) – – 99 Fair value hierarchy The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique: Level 1: quoted (unadjusted) prices in active markets for identical assets and liabilities; Level 2: other techniques for which all inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly; and Level 3: techniques which use inputs that have a significant effect on the recorded fair value that are not based on observable market data. The fair value of the Group’s derivative financial liability is measured at fair value on a recurring basis. The following table gives information about how the fair value of this financial liability is determined. Financial liabilities Fair value as at June 30, 2024 Fair value as at December 31, 2023 Fair value hierarchy Valuation technique(s) and key input(s) Significant unobservable input(s) Relationship of unobservable inputs to fair value Equity settled financial derivative liability – Series H warrants £179,000 – Level 3 Black-Scholes Model Volatility rate of 100% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 0.89 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 5.09% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – Series G warrants £591,000 – Level 3 Black-Scholes Model Volatility rate of 95% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 4.33 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.33% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – Series F warrants £16,000 £2,592,000 Level 3 Black-Scholes Model Volatility rate of 120% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 0.48 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 5.33% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – Series E warrants £343,000 £1,444,000 Level 3 Black- Scholes Model Volatility rate of 100% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 4.48 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.33% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – Series D warrants £30,000 £124,000 Level 3 Black- Scholes Model Volatility rate of 105% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 4.43 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.53% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – May 2020 warrants – – Level 3 Black- Scholes Model Volatility rate of 100% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 1.38 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.90% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Equity settled financial derivative liability – October 2019 Warrants – – Level 3 2023 – Black- Scholes Model Volatility rate of 100% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 1.00 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 5.09% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value. Total £1,159,000 £4,160,000 Changing the unobservable risk-free rate input to the valuation model by 10% higher while all other variables were held constant, would not impact the carrying amount of shares (2023: nil). There were no transfers between Level 1 and 2 in the period. The financial liability measured at fair value on Level 3 fair value measurement represents consideration relating to warrants issued in May 2024, December 2023, June 2023, May 2020 and October 2019 as part of Private Placements, Registered Direct offerings and the Warrant Inducement Transaction. Share capital and reserves Authorised, allotted and fully paid – classified as equity As at June 30, 2024 unaudited Number As at June 30, 2024 unaudited £ As at December 31, 2023 Number As at December 31, 2023 £ Ordinary shares of £0.001 each 3,626,112,922 3,626,113 1,189,577,722 1,189,578 ‘A’ Deferred shares of £1 each 1,000,001 1,000,001 1,000,001 1,000,001 ‘B’ Deferred shares of £0.001 4,063,321,418 4,063,321 4,063,321,418 4,063,321 Total 8,689,435 6,252,900 During the period the Company issued the following warrants over ADSs, and these were recognised in the warrant reserve until exercise: Pre-Funded Warrants Abeyance Shares Series A Warrants Series B Warrants Series C Warrants Exercise price £0.0001 £Nil $214.40 $214.40 $16.00 As at January 1, 2023 – – – – – Issued: – Private Placement February 2023 155,461 – 32,327 48,491 – Registered Direct Offering May 2023 – – – – 415,043 Registered Offering December 2023 1,911,176 – – – – Adhera Assignment and Exchange Agreement 2,275,050 – – – – Exercised (155,461) – (32,327) (48,491) (415,043) As at December 31, 2023 4,186,226 – – – – Exercised (2,361,865) – – – – Lapsed (163) – – – – Warrant inducement May 2024 – 931,585 – – – As at June 30, 2024 (unaudited) 1,824,198 931,585 – – – The Series A, Series B and Series C warrants are exercisable on an ‘alternative cashless basis’ effectively allowing the holders to exercise for nil consideration. Ordinary and deferred shares were recorded as equity. 2024 Ordinary Shares Number ‘A’ Deferred Shares Number ‘B’ Deferred Shares Number Share Price £ Total consideration £’000 At January 1, 2024 1,189,577,722 1,000,001 4,063,321,418 February to May 2024 Exercise pre-funded warrants 944,746,000 – – 0.0040 3,732 February to May 2024 Exercise Series E & F warrants 98,697,600 – – 0.0043 – 0.0044 427 25 April 2024 Intangible asset (see note 5) 151,265,200 – – 0.0015 219 22 May 2024 Warrant inducement 1,241,826,400 – – 0.0030 3,663 At June 30, 2024 (unaudited) 277,971,722 1,000,001 4,063,321,418 2023 At January 1, 2023 5,417,137 1,000,001 – February 15, 2023 Private Placements* 98,387,275 – – 0.0505 4,967 May 26, 2023 Registered Direct Offering* 276,697,310 – – 0.0097 2,690 June 14, 2023 Share sub-division and re-designation 4,063,321,418 n/a n/a December 21, 2023 Shares issued to purchase Intangible asset (see note 5) 323,684,800 – – 0.0040 1,279 December 21, 2023 Registered Offering 485,391,200 – – 0.0040 1,918 At December 31, 2023 1,189,577,722 1,000,001 4,063,321,418 Related party transaction The Directors consider there to be no related party transactions during the periods reported other than Directors Remuneration. Contingent liabilities The Company entered into an Arrangement Agreement with Bioasis on December 13, 2022 as amended on December 18, 2022. Under the agreement the Company agreed to acquire the entire issued share capital of Bioasis for consideration of, in aggregate, approximately C$7.4 million (c£4.4 million). The agreement was subject to shareholder approval. On January 23, 2023 at the General Meeting to approve the Arrangement Agreement none of the special resolutions were passed and, accordingly, the acquisition of Bioasis did not proceed. Under the agreement the Company agreed to reimburse Bioasis US$225,000 for expenses relating to the transaction should the Company’s shareholders not approve the transaction. On March 3, 2023 the Company advised Bioasis that it would offset this liability against the $500,000 loan it advanced to them during December 2022 and January 2023. As at June 30, 2024 and December 31, 2023 the Company had a contingent liability of $225,000 in relation to this potential liability. Events after the reporting date On July 22, 2024, the Company utilised its capacity under its Registration Statement on Form F-3 to raise $5.0 million in gross proceeds in a Registered Direct Offering with certain institutional investors for the sale of an aggregate of 5,050,808 ADSs and 278,975 pre-funded warrants at a price of $0.94 per ADS. In a concurrent Private Placement, the Company issued and sold to the Investors (i) Series J warrants exercisable for 5,329,783 Depositary Shares, and (ii) Series K Warrants to purchase an aggregate of 5,329,783 Depositary Shares. The Series J and Series K warrants are exercisable for five years and one year, respectively, at $1.00 per ADS each. On August 27,2024, the Company , received a Staff Determination letter (the “Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $1.00 for 30 consecutive business days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, and as described in the Letter, unless the Company timely requested a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company requested a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. On September 19, 2024, the Company announced a ratio change on its ADSs from one (1) ADS representing four hundred (400) ordinary shares, to the new ratio of one (1) ADS representing ten thousand (10,000) ordinary shares (the “Ratio Change”). The effective date of the Ratio Change is expected to be October 4,2024. vv Attachment 24.09.26 BDRX 2024 Interim report FINAL
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Announces Closing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
on July 23, 2024 at 12:30 pm
July 23, 2024 Biodexa Pharmaceuticals PLC Announces Closing of $5.0 Million Registered Direct Offering and Concurrent Private Placement Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the closing of its previously announced registered direct offering of an aggregate of (i) 5,050,808 American Depositary Shares (the “Depositary Shares”) (each Depositary Share representing 400 of the Company’s ordinary shares, nominal value £0.001 per share) and (ii) 278,975 pre-funded warrants exercisable for Depositary Shares, at a purchase price of $0.94 per Depositary Share (or $0.9399 per pre-funded warrant). The net proceeds from the offering were approximately $4.2 million, after deducting placement agent fees and other offering expenses. The Company anticipates that the proceeds of this offering will be used to fund its development programs, including to provide the final match payment with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and initiate the Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP), for working capital and for general corporate purposes. In a concurrent private placement, the Company also issued and sold unregistered Series J warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the “Series J Warrants”) and unregistered Series K warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the “Series K Warrants”). The pre-funded warrants have an exercise price of $0.0001 per Depositary Share, are immediately exercisable and do not expire. The Series J Warrants have an exercise price of $1.00 per Depositary Share, are immediately exercisable and expire on the fifth anniversary of the issuance date. The Series K Warrants have an exercise price of $1.00 per Depositary Share, are immediately exercisable and expire on the first anniversary of the issuance date. Ladenburg Thalmann & Co. Inc. acted as sole placement agent in connection with the offering. In connection with the offering, the Company also agreed to amend the exercise price of existing Series E warrants to purchase an aggregate of 978,233 Depositary Shares, existing Series G warrants to purchase an aggregate of 2,443,995 Depositary Shares and existing Series H warrants to purchase an aggregate of 3,236,345 Depositary Shares that were previously issued in December 2023, May 2022 and May 2022, respectively, held by investors participating in the offering, such that the amended warrants now have an exercise price of $1.00 per share. The Depositary Shares (or pre-funded warrants in lieu thereof) were offered pursuant to a shelf registration statement on Form F-3 (File No. 333-267932), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on October 26, 2022. A prospectus supplement relating to the Depositary Shares and pre-funded warrants has been filed with the SEC and is available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, may be obtained, when available, from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at prospectus@ladenburg.com. The private placement of the Series J Warrants and Series K Warrants was made in a transaction not involving a public offering and the securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the ordinary shares underlying the Depositary Shares issuable upon the exercise of the Series J Warrants and Series K Warrants issued in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About the Cancer Prevention and Research Institute of Texas CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has also recruited more than 281 distinguished researchers to Texas, supported the establishment, expansion or relocation of 51 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided over 8.1 million life-saving cancer prevention and early detection services to Texans in all 254 counties. Learn more at https://cprit.texas.gov. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer: tolimidone, under development as a for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements including, but not limited to, the anticipated net proceeds, and the anticipated use of proceeds therefrom, and projected cash runway. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 20480 180www.biodexapharma.com 519412482v.2
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Announces Pricing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
on July 19, 2024 at 12:30 pm
July 19, 2024 Biodexa Pharmaceuticals PLC Announces Pricing of $5.0 Million Registered Direct Offering and Concurrent Private Placement Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced that it has entered into definitive agreements with certain institutional investors to sell an aggregate of (i) 5,050,808 American Depositary Shares (the “Depositary Shares”) (each Depositary Share representing 400 of the Company’s ordinary shares, nominal value £0.001 per share) and (ii) 278,975 pre-funded warrants exercisable for Depositary Shares, at a purchase price of $0.94 per Depositary Share (or $0.9399 per pre-funded warrant) in a registered direct offering. The gross proceeds from the offering are expected to be approximately $5.0 million, before deducting placement agent fees and other estimated offering expenses. The Company anticipates that the proceeds of this offering will be used to fund its development programs, including to provide the final match payment with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and initiate the Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP), for working capital and for general corporate purposes. In a concurrent private placement, the Company has also agreed to issue and sell unregistered Series J warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the “Series J Warrants”) and unregistered Series K warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the “Series K Warrants”). The offering is expected to close on or about July 22, 2024, subject to the satisfaction of customary closing conditions. The pre-funded warrants have an exercise price of $0.0001 per Depositary Share, will be immediately exercisable and will not expire. The Series J Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the fifth anniversary of the issuance date. The Series K Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the first anniversary of the issuance date. Ladenburg Thalmann & Co. Inc. acted as sole placement agent in connection with the offering. In connection with the offering, the Company has also agreed to amend the exercise price of existing Series E warrants to purchase an aggregate of 978,233 Depositary Shares, existing Series G warrants to purchase an aggregate of 2,443,995 Depositary Shares and existing Series H warrants to purchase an aggregate of 3,236,345 Depositary Shares that were previously issued in December 2023, May 2022 and May 2022, respectively, held by investors participating in the offering, such that, effective upon the closing of the offering, the amended warrants will have an exercise price of $1.00 per share. The Depositary Shares (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-267932), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on October 26, 2022. A prospectus supplement relating to the Depositary Shares and pre-funded warrants will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, may be obtained, when available, from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at prospectus@ladenburg.com. The private placement of the Series J Warrants and Series K Warrants are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the ordinary shares underlying the Depositary Shares issuable upon the exercise of the Series J Warrants and Series K Warrants issued in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About the Cancer Prevention and Research Institute of Texas CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has also recruited more than 281 distinguished researchers to Texas, supported the establishment, expansion or relocation of 51 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided over 8.1 million life-saving cancer prevention and early detection services to Texans in all 254 counties. Learn more at https://cprit.texas.gov. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer: tolimidone, under development as a for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements including, but not limited to, the timing, size and expectation of the closing of the private placement, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom, and projected cash runway. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 20480 180www.biodexapharma.com
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Biodexa Announces $7 Million of Gross Proceeds from Warrant Exercises
on May 22, 2024 at 12:30 pm
May 22, 2024 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”) Biodexa Announces $7 Million of Gross Proceeds from Warrant Exercises Proceeds Cover Year 1 eRapa Phase 3 Obligations, Unlocking Twice that Amount in Non-dilutive Grant Funding Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces $7 million of gross proceeds from the exercise of previously issued warrants and an agreement between the Company and several accredited investors to exercise certain existing Series E warrants (“Series E Warrants”) and Series F warrants (“Series F Warrants,” and together with the Series E Warrants, the “Existing Warrants”) to purchase up to an aggregate of 4,358,322 of the Company’s American Depositary Shares (“ADSs) (each ADS represents 400 ordinary shares, nominal value £0.001 of the Company (“Ordinary Shares”)). Stephen Stamp, CEO and CFO, commented, “These funds will more than cover our first year obligation under the eRapa Phase 3 trial in Familial Adenomatous Polyposis and, because the $17 million CPRIT grant includes a one-for-two match, will unlock twice that amount in non-dilutive funding. We were delighted with the data announced yesterday for eRapa in FAP, a rare orphan disease, which showed a statistically significant decrease in overall mean polyp burden (p=0.04) and an overall non-progression rate of 83% at six months. Our scientific collaborators look forward to presenting polyp burden data in FAP at 12 months compared with baseline at the InSIGHT scientific conference in Barcelona on June 19-22, 2024.” Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for the warrant exercise transaction. The Existing Warrants had initial exercise prices of $2.20, and were issued by the Company on December 21, 2023, with each exercise occurring at a reduced exercise price of $1.50 per ADS. The ADSs issuable upon exercise of the Existing Warrants are registered pursuant to a registration statement (File No. 333-274895), which was filed and declared effective by the Securities and Exchange Commission (the “SEC”). Certain existing warrant holders exercised warrants without a replacement warrant. The gross proceeds to the Company from the exercise of the previously issued warrants and Existing Warrants are expected to be approximately $7 million prior to deducting placement agent fees and estimated offering expenses. In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holders will receive new unregistered warrants (the “Replacement Warrants”) to purchase an aggregate of 6,537,483 ADSs (equivalent to 2,614,993,200 Ordinary Shares) in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”). The Replacement Warrants will have an exercise price of $2.50 per ADS, and terms of exercise of one year and five years from issuance for each Replacement Warrant received upon the exercise of a Series E Warrant or Series F Warrant, respectively, in connection with this transaction. The Company intends to use the net proceeds from the offering to advance its clinical stage assets and for working capital and general corporate purposes. The Replacement Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the ADSs issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs issuable upon exercise of the Replacement Warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Total Voting RightsFollowing exercise of the Existing Warrants, the Company’s issued share capital comprises 4,127,615,322 Ordinary Shares each with voting rights. The Company does not hold any shares in treasury. This figure of 4,127,615,322 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company. Each of the Company’s American Depositary Shares comprises 400 Ordinary Shares and therefore the equivalent number of ADSs in issue is 10,319,038. About the Cancer Prevention and Research Institute of TexasCPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has also recruited more than 281 distinguished researchers to Texas, supported the establishment, expansion or relocation of 51 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided over 8.1 million life-saving cancer prevention and early detection services to Texans in all 254 counties. Learn more at https://cprit.texas.gov. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 20480 180www.biodexapharma.com About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non Muscle Invasive Blader Cancer: tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective activator of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. 29 September 2023 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”) Interim results for the six months ended 30 June 2023 Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, announces its unaudited interim results for the six months ended 30 June 2023 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended 30 June 2023: Approval by the Data Safety Monitoring Board to escalate the dose of MTX110 in recurrent glioblastoma (rGBM) to 90µM, the expected optimal therapeutic dose.Closing of a private placement in the US to raise $6.0m before expenses.Following shareholder approval, and in line with its realigned strategy, the Company de-listed from AIM and its name was changed to Biodexa Pharmaceuticals PLC.Initiation of a new R&D programme, MTD217, combining MTX110 with an oxidative phosphorylation inhibitor targeted at leptomeningeal carcinomatosis.Closing of a registered direct offering and private placement in the US to raise $3.3m before expenses. Post period end: Completion of enrolment of nine patients in a Phase I study of MTX110 in diffuse midline glioma (DMG), formerly known as diffuse intrinsic pontine glioma (DIPG). FINANCIAL HIGHLIGHTS Total revenue for 1H23 was £0.30m (1H22: £0.47m). Total revenue represents income from the Company’s R&D collaboration with Janssen Pharmaceutica NV. Research and development costs in 1H23 were £2.25m (1H22: £2.41m) following a reduction in staff numbers offset by increased costs of the Company’s Phase I study of MTX110 in rGBM. Administrative expenses increased to £2.29m (1H22: £1.85m) primarily due to increased legal and professional expenses associated with financings and aborted acquisitions. Net cash used in operating activities (after changes in working capital) in 1H23 was £3.88m (1H22: £3.54m). The Company’s cash balance at 30 June 2023 was £5.23m. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 2048 0180www.biodexapharma.com Edison Group (US Investor Relations)Alyssa FactorTel: +1 (860) 573 9637Email: afactor@edisongroup.com About Biodexa Pharmaceuticals PLCBiodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain. The Company’s lead candidate, MTX110, is being studied in aggressive rare/orphan brain cancer indications including recurrent glioblastoma and diffuse midline glioma. MTX110 is a liquid formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and avoiding systemic toxicity.Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information, please visit www.biodexapharma.comForward-Looking StatementsCertain statements in this announcement are forward-looking statements or information (collectively, forward-looking statements). Biodexa hereby provides cautionary statements identifying important factors that could cause the actual results to differ materially from those projected in the forward-looking statements. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “may”, “is expected to”, “anticipates”, “estimates”, “intends”, “plans”, “projection”, “could”, “vision”, “goals”, “objective” and “outlook”) are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in the forward-looking statements.By their nature, forward-looking statements involve numerous assumptions, inherent risks and uncertainties, both general and specific, which contribute to the possibility that the predicted outcomes may not occur or may be delayed. The risks, uncertainties and other factors many of which are beyond the control of Biodexa, that could influence actual results include, but are not limited to: a limited operating history; regulatory risks; substantial capital and liquidity requirements; financing risks and dilution to shareholders; competition; reliance on management and dependence on key personnel; conflicts of interest of management; exposure to potential litigation, and other factors beyond the control of Biodexa. Forward looking statements are based on estimates and assumptions made by management in light of their experience of historical trends, current conditions and expected future developments, as well as factors that are believed to be appropriate. Such factors include, among others, Biodexa’s future product revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market Biodexa’s products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes and rapid technological change in the industry. These factors should be considered carefully and readers are cautioned to not place undue reliance on such forward-looking statements.Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, Biodexa undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statements are made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all such factors and to assess in advance the impact of each such factor on the business of the Company or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement.Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data. You should, however, review the factors and risks we describe in the reports we will file from time to time with the US Securities and Exchange Commission after the date of this announcement. As a result of these factors, we cannot assure you that the forward-looking statements in this announcement will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. CHIEF EXECUTIVE’S REVIEW Our primary focus in the first half of 2023 was on re-financing the Company before our cash runway was due to expire at the end of the first quarter of 2023 and then, having secured the immediate future, executing on our realigned strategy. Realigned strategy In the course of seeking finance for the Company in late 2022 it became clear to us that a company developing therapeutics was more investable than a drug delivery platform company. Accordingly, the Board determined that the Company should be repositioned as a therapeutics company, based around its MTX110 clinical asset, supported by its three enabling technologies, Q-Spera™, MidaSolve™ and MidaCore™. Going forward, our strategy is to move our development programmes into the clinic and add value by generating clinical data to demonstrate proof-of-concept before seeking partners. Strategic acquisitions With a single clinical asset, MTX110 being developed for three types of rare brain cancers, the Board has looked for opportunities to broaden the Company’s R&D pipeline through acquisitions of companies or licensing of assets with a focus on rare diseases and/or oncology. In December 2022, we entered into an agreement to acquire Bioasis Technologies, Inc. (Bioasis) and organised a $10.0m financing, however the transaction was voted down in General Meeting in January 2023. We continue to look for suitable assets which are either in the clinic or expected soon to enter the clinic and to which value can be added in the near term. R&D update MTX110MTX110, a novel formulation of panobinostat administered through convection enhanced delivery (CED), is in clinical development for intractable brain cancers including recurrent glioblastoma (rGBM), diffuse midline glioma (DMG) and medulloblastoma. MTX110 employs our MidaSolve technology to solubilize panobinostat, a histone deacetylase (HDAC) inhibitor, so that it can be delivered directly to a patient’s brain tumour via an onboard pump and catheter (or CED) system. Our Phase I study of MTX110 in rGBM is ongoing at two clinical centres: Duke University and Baptist MD Anderson Cancer Center. In January 2023, the Data Safety Monitoring Board approved escalation of the dose of MTX110 in rGBM to 90µM, the expected optimal therapeutic dose. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX110 following implantation of the CED system and the second cohort will also receive MTX110 but with an option, at the discretion of the treating investigator, to re-position the catheter into an area of new lesion upon tumour progression with the objective of increasing tumour coverage and improving survival. In July 2023, the second Phase I study in DMG at Columbia University completed the enrolment of nine patients. All patients (age range 4-17 years) received radiation therapy as standard of care. Each patient subsequently underwent surgery with implantation of an intratumoral catheter and a programmable subcutaneous pump and eight out of nine patients received two infusions of MTX110 via CED separated by a period of one week. No dose limiting toxicities related to the study drug have been reported. A Phase I study of MTX110 in medulloblastoma remains ongoing at the University of Texas. Q-SpheraThe Company’s drug delivery technologies have been de-prioritised. We intend to continue our existing, and seek new, collaborations for our technology but we will not be expanding our internal Q-Sphera pipeline. Q-octreotide and Q-brexpiprazole remain available for potential licensing. MTD217In March 2023 we announced the start of a new preclinical development programme, coded MTD217, which explores simultaneous inhibition of key metabolic pathways in oncology, including the so-called Warburg effect and oxidative phosphorylation (OXPHOS). We have been able to demonstrate up to a six-fold synergistic effect of administering MTX110 with an OXPHOS inhibitor in vitro in three patient-derived cancer cell lines. On the back of those data, we have established new patent positions to protect these combination formulations. Our initial target is treatment of leptomeningeal disease, a lethal complication in which metastatic cancer cells invade the cerebrospinal fluid and central nervous system. Financing February 2023 Private Placement*Following the termination of the Bioasis acquisition and related financing, we were successful in raising $6.0m before expenses in a private placement in the US in February 2023. We issued 8,125 ADSs (3,250,200 ordinary shares), 155,461 pre-funded warrants (62,184,525 ordinary shares), 32,327 Series A warrants (12,931,020 ordinary shares) and 48,491 Series B warrants (19,396,530 ordinary shares). In addition, 1,342 warrants (536,800 ordinary shares) were issued to the placement agent and 1,562 warrants exercisable for ADSs (625,000 ordinary shares) were issued to an investor in connection with a waiver of certain rights. All warrants issued were exercisable for ADSs. May 2023 Registered Direct Offering and Private Placement*We utilised our capacity under our Registration Statement on Form F-3 to raise $3.32m in a registered direct offering in the US. In connection with the registered direct offering and related private placement, we issued 276,699 ADSs (110,679,610 ordinary shares), 415,043 Series C warrants (166,017,300 ordinary shares) and 276,689 Series D warrants (110,675,600 ordinary shares). In addition, 11,067 warrants (4,426,800 ordinary shares) were issued to the placement agent. All warrants issued were exercisable for ADSs. *The above ADS numbers reflect the ADS ratio change effected on 5 July 2023. 1H23 FINANCIAL REVIEW The unaudited results for the six months ended 30 June 2023 are discussed below: Key performance indicators (KPIs): 1H 20231H 2022Change Total gross revenue(1)£0.30m£0.47m(36)%R&D costs£2.25m£2.41m(7)%R&D as % of operating costs50%57%n/aNet cash inflow/(outflow) for the period£2.39m£(3.63)mn/m (1) Total revenue represents income from R&D collaborations. Biodexa’s KPIs focus on the key areas of operating results, R&D spend and cash management. These measures provide information on the core R&D operations. Additional financial and non-financial KPIs may be adopted in due course. Revenues Total revenue for the six months to 30 June 2023 was £0.30m compared to £0.47m in the first six months of 2022, a decrease of 36%. Revenue in 1H23 and 1H22 was entirely comprised of income from R&D collaborations with Janssen. Research and Development R&D costs in 1H23 reduced by £0.16m, or 7%, to £2.25m compared with £2.41m in 1H22. The percentage of R&D costs as a percentage of operating costs reduced in the period to 50% from 57%. The reduction in R&D costs in 1H23 reflects the decision made by the Directors to reposition as a therapeutics company and to not expand our internal drug delivery platform. The resulting cost-reduction program in March 2023 saw seven staff members being made redundant at a one-time cost of £88,000. These reductions were offset in part by increased spend on the MTX110 Phase 1 clinical trial costs of £0.3m. Administrative Costs Administrative expenses in 1H23 increased by 24% to £2.29m from £1.85m in 1H22. The increase in administrative costs in 1H23 is a result of the Company expensing legal and professional fees of £0.40m in connection with the successful financing transactions and aborted acquisitions. Finance Income and Expense Finance income in 1H23 and 1H22 included gains in respect of an equity settled derivative financial liability of £0.39m (1H22: £0.40m). The gain arose as a result of the fall in the Biodexa share price. In addition, the Company earned interest on cash deposits. Finance expense in the period related to lease liabilities. Cash Flows Cash outflows from operating activities in 1H23 were £3.88m compared to £3.54m in 1H22, driven by a net loss of £3.57m (1H22: £3.06m) and after positive working capital of £0.21m (1H22: negative £0.05m) and other negative non-cash items totalling £0.52m (1H22: negative £0.43m). Net cash generated in investing activities in 1H23 of £0.02m (1H22: outflow £0.02m) includes interest received on cash deposits of £0.02m. Net cash generated in financing activities in 1H23 was £6.25m (1H22: outflow £0.08m), which was driven by receipt of funds from share issuances, including the exercise of pre-funded warrants, of £6.35m. This was offset by payments on lease liabilities of £0.10m. Overall, cash increased by £2.39m in 1H23 compared to a decrease of £3.63m in 1H22. This resulted in a cash balance at 30 June 2023 of £5.23m compared with £6.42m at 30 June 2022 and £2.84m at 31 December 2022. Post-period end On 5 July 2023, and in an effort to bring the ADS price into compliance with NASDAQ’s minimum bid price per share requirement, we effected a ratio change in the number of ordinary shares represented by our ADSs from five ordinary shares per ADS to 400 ordinary shares per ADS. Going concern Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to 30 June 2023, the Group incurred a consolidated loss from operations of £3.57m (1H22: £3.06m) and negative cash flows from operating activities of £3.88m (1H22: £3.54m). As of 30 June 2023, the Group had accumulated deficit of £138.97m. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Group’s consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at 30 June 2023, the Group had cash and cash equivalents of £5.23m. The Directors forecast that the Group currently has enough cash to fund its planned operations into the first quarter of 2024. If the Company does not secure additional funding before the first quarter of 2024, it will no longer be a going concern and would likely be placed in Administration. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the first quarter of 2024 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. If we raise additional funds through the issuance of debt securities or additional equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares (including the ADSs) and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies continues to be challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would stated at net realizable value and all liabilities would be accelerated to current liabilities. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected. Stephen StampChief Executive Officer and Chief Financial Officer Consolidated Statements of Comprehensive IncomeFor the year six month period ended 30 June Note2023unaudited£’0002022unaudited£’000Revenue 298468Other income -16Research and development costs (2,251)(2,413)Administrative costs (2,291)(1,849)Loss from operations (4,244)(3,778)Finance income2410404Finance expense2(22)(24)Loss before tax (3,856)(3,398)Taxation3288337Loss) for the period attributable to the owners of the parent (3,568)(3,061)Other comprehensive income: Items that will or may be reclassified subsequently to profit or loss: Total other comprehensive gain net of tax –Total comprehensive loss attributable to the owners of the parent (3,568)(3,061)Loss per share Basic and diluted loss per ordinary share – pence4(4)p(62)p The accompanying notes form part of these financial statements Distribution costs, sales and marketing are immaterial in 2023 and 2022 and have been included within administrative costs. Consolidated Statements of Financial Position NoteAs at 30 June 2023 unaudited£’000As at 31 December 2022£’000Assets Non-current assets Property, plant and equipment 693831Intangible assets 56 698837Current assets Trade and other receivables 9031,006Taxation 1,134846Cash and cash equivalents 5,2272,836 7,2644,688Total assets 7,9625,525Liabilities Non-current liabilities Borrowings 5380463 380463Current liabilities Trade and other payables 1,7551,447Borrowings 5164161Provisions 6-207Derivative financial liability 736485 2,2831,900Total liabilities 2,6632,363Issued capital and reserves attributable to owners of the parent Share capital 85,3411,108Share premium 84,65383,667Merger reserve 53,00353,003Warrant reserve 1,275720Accumulated deficit (138,973)(135,336)Total equity 5,2993,162Total equity and liabilities 7,9625,525 The accompanying notes form part of these financial statementsConsolidated Statements of Cash FlowsFor the six month period ended 30 June Note2023unaudited£’0002022unaudited£’000Cash flows from operating activities Loss for the period (3,568)(3,061)Adjustments for: Depreciation of property, plant and equipment 7296Depreciation of right of use asset 7086Amortisation of intangible fixed asset 1-Loss on disposal of fixed assets -2Finance income2(410)(404)Finance expense22224Share-based payment expense 15100Taxation3(288)(337)Cash flows from operating activities before changes in working capital (4,086)(3,494)Decrease/(increase) in trade and other receivables 103(224)Increase in trade and other payables 309187Decrease in provisions (207)(8)Cash used in operations (3,881)(3,539)Taxes payments –Net cash used in operating activities (3,881)(3,539) Consolidated Statements of Cash Flows (continued)For the six month period ended 30 June Note2023unaudited£’0002022unaudited£’000Investing activities Purchases of property, plant and equipment (4)(33)Proceeds from disposal of fixed assets -9Interest received 247Net cash generated from/(used in) investing activities 20(17)Financing activities Interest paid (7)(5)Amounts paid on lease liabilities (95)(73)Share issues including warrants, net of costs86,354-Net cash generated from/(used in) financing activities 6,252(78)Net increase/(decrease) in cash and cash equivalents 2,391(3,634)Cash and cash equivalents at beginning of period 2,83610,057Exchange (losses)/gains on cash and cash equivalents –Cash and cash equivalents at end of period 5,2276,423 The accompanying notes form part of these financial statements Consolidated Statements of Changes in Equity (unaudited) NoteSharecapital£’000Sharepremium£’000Merger reserve£’000Warrant reserve £’000Accumulateddeficit£’000Totalequity£’000At 1 January 2023 1,10883,66753,003720(135,336)3,162Loss for the period —-(3,568)(3,568)Total comprehensive loss —-(3,568)(3,568)Transactions with owners: Shares issued on 15 February 2023 6599-4,803-4,967Costs associated with share issue on 15 February 2023 -(29)-(874)-(903)Shares issued on 26 May 2023 2,214(1,404)-1,214-2,024Costs associated with share issue on 26 May 2023 —(317)(210)(527)Exercise of pre-funded warrants during period 1,2441,024-(2,266)-2Exercise of warrants during period 7101,296-(2,005)-1Share-based payment charge —-141141Total contribution by and distributions to owners 4,233986-555(69)5,705At 30 June 2023 5,34184,65353,0031,275(138,973)5,299 NoteSharecapital£’000Sharepremium£’000Merger reserve£’000Warrant reserve £’000Accumulateddeficit£’000Totalequity£’000At 1 January 2022 1,09883,43453,003720(127,803)10,452Loss for the period —-(3,061)(3,061)Total comprehensive loss —-(3,061)(3,061)Transactions with owners: Exercise of warrants on 22 March 2022 ——Shares issued on 3 May 2022 – —-Share-based payment charge —-100100Total contribution by and distributions to owners – –100100At 30 June 2022 1,09883,43453,003720(130,764)7,491 The accompanying notes form part of these financial statements Notes Forming Part of The Consolidated Unaudited Interim Financial InformationFor the six month period ended 30 June 2023 1. Basis of preparation The unaudited interim consolidated financial information for the six months ended 30 June 2023 has been prepared following the recognition and measurement principles of the International Financial Reporting Standards, International Accounting Standards and Interpretations (collectively IFRS) issued by the International Accounting Standards Board (IASB), and as adopted by the UK and in accordance with International Accounting Standard 34 Interim Financial Reporting (‘IAS 34’). The interim consolidated financial information does not include all the information and disclosures required in the annual financial information and should be read in conjunction with the audited financial statements for the year ended 31 December 2022. The condensed interim financial information contained in this interim statement does not constitute statutory financial statements as defined by section 434(3) of the Companies Act 2006. The condensed interim financial information has not been audited. The comparative financial information for the six months ended 30 June 2022 and the year ended 31 December 2022 in this interim financial information does not constitute statutory accounts for that year. The statutory accounts for 31 December 2022 have been delivered to the UK Registrar of Companies. The auditor’s report on those accounts was unqualified and did not contain a statement under section 498(2) or 498(3) of the Companies Act 2006. The auditor’s report did draw attention to a material uncertainty related to going concern and the requirement, as of the date of the report, for additional funding to be raised by the Company by the fourth quarter of 2023. Biodexa Pharmaceutical’s annual reports may be downloaded from the Company’s website at https://biodexapharma.com/investors/financial-reports-and-presentations/#financial-reportsor a copy may be obtained from 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ. Going Concern Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to 30 June 2023, the Group incurred a consolidated loss from operations of £3.57m (1H22: loss £3.06m) and negative cash flows from operating activities of £3.88m (1H22 £3.54m). As of 30 June 2023, the Group had accumulated deficit of £138.97m. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Group’s consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at 30 June 2023, the Group had cash and cash equivalents of £5.23m. The Directors forecast that the Group currently has enough cash to fund its planned operations into the first quarter of 2024. If the Company does not secure additional funding before the first quarter of 2024, it will no longer be a going concern and would likely be placed in Administration. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the first quarter of 2024 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. If we raise additional funds through the issuance of debt securities or additional equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares (including the ADSs) and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies is as challenging as it has been since the financial crisis of 2008-10. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would stated at net realizable value and all liabilities would be accelerated to current liabilities. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected. 2. Finance income and expense Six months ended 30 June 2023unaudited£’000Six months ended 30 June 2022unaudited£’000Finance income Interest received on bank deposits246Gain on equity settled derivative financial liability386398Total finance income410404 The gain on the equity settled derivative financial liability in 1H23 and 1H22 arose as a result of the fall in the Biodexa share price. Six months ended 30 June 2023unaudited£’000Six months ended 30 June 2022unaudited£’000Finance expense Interest expense on lease liabilities1524Other loans7-Total finance expense2224 3. Taxation Income tax is recognised or provided at amounts expected to be recovered or to be paid using the tax rates and tax laws that have been enacted or substantively enacted at the Group Statement of Financial Position date. Research and development tax credits are recognised on an accruals basis and are included as an income tax credit under current assets. The research and development tax credit recognised is based on management’s estimate of the expected tax claim for the period and is recorded within taxation under the Small and Medium-sized Enterprise Scheme. Six months ended 30 June 2023unaudited£’000Six months ended 30 June 2022unaudited£’000Income tax credit288337 4. Loss per share Basic loss per share amounts are calculated by dividing the net loss for the period from continuing operations, attributable to ordinary equity holders of the parent company, by the weighted average number of ordinary shares outstanding during the period. As the Group made a loss for the period the diluted loss per share is equal to the basic loss per share. Six months ended 30 June 2023unaudited£’000Six months ended 30 June 2022unaudited£’000Numerator Loss used in basic EPS and diluted EPS:(3,568)(3,061)Denominator Weighted average number of ordinary shares used in basic EPS99,191,0824,923,828 Basic and diluted loss per share:(4)p(62)p At a General Meeting on 24 March 2023, shareholders approved a consolidation of the Company’s Ordinary Shares on a one for 20 basis. As a result, the par value of the Ordinary Shares was changed from £0.001 per share to £0.02 per share. The denominator has been calculated to reflect the share consolidation in the current and prior period. At a General Meeting on 14 June 2023, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.02 each into to one Ordinary Share of £0.001 each and 19 ‘B’ Deferred Shares of £0.001 each. The ‘B’ Deferred Shares have limited rights and are effectively valueless. The share sub-division and redesignation did not impact the calculation of the denominator as the number of Issued Ordinary Shares did not change. On 15 February 2023 the company completed a private placement for the sale of (i)8,125 ADSs (3,250,200 Ordinary Shares), (ii) 32,327 ADSs (12,931,020 Ordinary Shares) issuable upon the exercise of Series A warrants, (iii) 48,491 ADSs (19,396,530 Ordinary Shares) issuable upon the exercise of Series B warrants, and (iv) 155,461 ADSs (62,184,525 Ordinary Shares) issuable upon the exercise of pre-funded warrants, subject to certain reset provisions set forth in the Pre-Funded Warrants, at an initial purchase price of $185.60 per ADS, for aggregate gross proceeds of approximately $6.0 million. The issuance of the Series A warrants, Series B warrants and any pre-funded warrants issuable upon a reset was subject to shareholder approval at a general meeting on 24 March 2023. In addition, in connection with the February Private Placement the Company entered into a Waiver to the Securities Purchase Agreement (‘SPA’), dated 13 December 2022 between the Company and Armistice Capital Master Fund Ltd. (‘Armistice’), as amended on 16 December 2022, providing for a permanent waiver of certain equity issuance prohibitions and participation rights under the SPA. The Company agreed to, subject to receipt of shareholder approval at the General Meeting on 24 March 2023, issue to Armistice 1,562 Series A ADS warrants exercisable for 625,000 Ordinary Shares (‘Investor warrants’). The Series A and Series B warrants are exercisable on an ‘alternative cashless basis’ effectively allowing the holders to exercise for nil consideration. All resolutions were passed at the General Meeting on 24 March 2023.On 26 May 2023 the company completed a Registered Direct Offering for the sale of (i) 276,699 ADSs (110,679,610 Ordinary Shares), (ii) 415,043 ADSs (166,017,300 Ordinary Shares) issuable upon the exercise of Series C warrants, and (iii) 276,689 ADSs (110,675,600 Ordinary Shares) issuable upon the exercise of Series C warrants, at an initial price per ADS of $12.00, for aggregate gross proceeds of $3.32 million. The issuance of the Series C warrants and Series D warrants issuable was subject to shareholder approval at a general meeting on 14 June 2023. The Series C warrants are exercisable on an ‘alternative cashless basis’ effectively allowing the holders to exercise for nil consideration. All resolutions were passed at the General Meeting on 14 June 2023. The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Series A, Series B, Series C, Pre-funded and Investor warrants. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator. The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted earnings per share is presented on the same basis as basic earning per share. *The above ADS numbers reflect the ADS ratio change effected on 5 July 2023. 5. Borrowings As at 30 June 2023 unaudited£’000As at 31 December 2022£’000Current Lease liabilities164161Total164161Non-current Lease liabilities380463Total380463 Book values approximate to fair value at 30 June 2023 and 31 December 2022. Obligations under finance leases are secured by a fixed charge over the fixed assets to which they relate. During the period the finance lease was satisfied. 6. Provision As at 30 June 2023 unaudited£’000As at 31 December 2022£’000Opening provision at 1 January20750Utilisation of provision(207)(43)Provision recognised during the period-200 -207 On 19 December 2022 the Company entered into a Promissory Note and Security Agreement with Bioasis to assist in the short term with Bioasis’ working capital requirements. Under the agreement the Company agreed to advance Bioasis up to US$750,000 in 3 tranches payable on 19 December 2022, 3 January 2023 and 6 February 2023. The Company advanced US$250,000 to Bioasis in the year to 31 December 2022. A further advance of US$250,000 was made to Bioasis on 3 January 2023. Management considers recovery of the debt to be uncertain and in 2022 recognised an impairment provision of £207,000 against the advance made in December 2022 and a provision of £207,000 against future credit losses resulting from the Promissory Note. On 3 February 2023 Bioasis announced they were ‘urgently exploring and evaluating all financing and strategic alternatives that may be available to address its liquidity requirements’ which triggered an event of default. As a result of this the 3rd payment under the agreement was not made. On 5 March 2023 Bioasis were served with a notice of an event of default. On 20 June 2023 Bioasis announced the suspension of operations. In 2023 the provision was utilised against the advance made to Bioasis in January 2023. 7. Derivative financial liability – current As at 30 June 2023 unaudited£’000As at 31 December 2022£’000At 1 January85553Warrants issued665-Gain recognised in finance income within the consolidated statement of comprehensive income(386)(468) 36485 Equity settled derivative financial liability is a liability that is not to be settled for cash. During the period the following warrants were exercised: No warrants recognised as equity settled derivatives were exercised in 2023 or 2022. The Company issues warrants in the ADSs of the Company as part of registered direct offerings and private placements in the US. The number of ADSs to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the Company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account (‘FVTPL’). The financial liability is valued using the Black-Scholes model in 2023, in previous periods the Monte Carlo model was used. The change in methodology is as result of the Company de-listing from AIM in 2023 and no longer needing to consider foreign exchange movements in fair value calculation. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. A key input in the valuation of the instrument is the Company share price. Details of the warrants are as follows: The below ADS numbers reflect the ADS ratio change effected on 5 July 2023. May 2023 warrants In June 2023 the Company issued 276,689 Series D ADS warrants as part of a registered direct offering and private placement that occurred in May 2023 in the US after securing shareholder approval. The exercise price per ADS was $16.00. May 2020 warrants In May 2020 the Company issued 838 ADS warrants as part of a registered direct offering in the US. October 2019 warrants In October 2019 the Company issued 392 ADS warrants as part of a registered direct offering in the US. May 2020 and October 2019 warrant re-price On 13 December 2022 the Company entered into a Securities Purchase Agreement with Armistice Capital Master Fund Ltd (‘Armistice’) to re-price previously issued ADS warrants issued to Armistice to $320 per ADS. The impact of the re-pricing is shown in the table below: The warrant exercise price per ADS for the remaining warrants remains unchanged as follows: October 2019 warrants at $10,000 per ADS; May 2020 warrants at $3,280 and $3,300 per ADS. ADS Warrants Number*Original price per ADS*New price per ADSEquivalent Ordinary Shares (400 ordinary shares per ADS)NumberOctober 2019 warrants375$10,000$320150,000May 2020 warrants406$3,280$320162,400 *Number and original price of warrants have been adjusted to reflect the share consolidation and ratio change of ADS’s to ordinary shares that occurred on 2 March 2020 and 24 March 2023 and the ratio change of ADS’s to ordinary shares on 26 September 2022 and 5 July 2023. DARA warrants and share options The Group also assumed fully vested warrants and share options on the acquisition of DARA Biosciences, Inc. (which took place in 2015). The number of ordinary shares to be issued when exercised is fixed, however the exercise prices are denominated in US Dollars. The warrants are classified equity settled derivative financial liabilities and accounted for in the same way as those detailed above. The financial liability is valued using the Black-Scholes option pricing model. The exercise price of the outstanding options is $1,903.40. The following table details the outstanding warrants and options recognised as equity settled derivative financial liabilities as at 30 June 2023, 31 December 2022 and also the movement in the period: At 1 January 2022LapsedAt 31 December 2022GrantedLapsedExercisedAt 30 June 2023ADSs May 2023 grant ‘D’ warrants–––276,689––276,689May 2020 grant838–838–––838October 2019 grant392–392–––392 Ordinary Shares DARA Warrants204(204)–––––DARA Options138–138 (4)–134 Fair value hierarchy The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique: Level 1: quoted (unadjusted) prices in active markets for identical assets and liabilities; Level 2: other techniques for which all inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly; and Level 3: techniques which use inputs that have a significant effect on the recorded fair value that are not based on observable market data. The fair value of the Group’s derivative financial liability is measured at fair value on a recurring basis. The following table gives information about how the fair value of this financial liability is determined. Financial liabilitiesFair value as at 30 June2023Fair value as at 31 December2022Fair value hierarchyValuation technique(s)and key input(s)Significant unobservable input(s) Relationship of unobservable inputs to fair valueEquity settled financial derivative liability – June 2023£364,000-Level 32023 – Black-Scholes ModelVolatility rate of 90% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life of 4.98 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.13% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value.Equity settled financial derivative liability – May 2020 Warrants–£48,000Level 32023 – Black- Scholes Model 2022 – Monte Carlo simulation modelVolatility rate of 90% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 2.38 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.68% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value.Equity settled financial derivative liability – October 2019 Warrants–£37,000Level 32023 – Black- Scholes Model 2022 – Monte Carlo simulation modelVolatility rate of 90% determined using historical volatility of comparable companies. The higher the volatility the higher the fair value. Expected life between a range of 0.1 and 2.00 years determined using the remaining life of the share options. The shorter the expected life the lower the fair value. Risk-free rate of 4.87% determined using the expected life assumptions. The higher the risk-free rate the higher the fair value.Total£364,000£85,000 Changing the unobservable risk-free rate input to the valuation model by 10% higher while all other variables were held constant, would not impact the carrying amount of shares (2022: nil). There were no transfers between Level 1 and 2 in the period. The financial liability measured at fair value on Level 3 fair value measurement represents consideration relating to warrants issued in June 2023, May 2020 and October 2019 as part of Private Placements and Registered Direct offerings. 8. Share capital and reserves Authorised, allotted and fully paid – classified as equityAs at 30 June 2023 unauditedNumberAs at 30 June 2023 unaudited£As at 31 December 2022NumberAs at 31 December 2022£Ordinary shares of £0.001 each277,971,722277,9725,417,137108,343‘A’ Deferred shares of £1 each1,000,0011,000,0011,000,0011,000,001‘B’ Deferred shares of £0.0014,063,321,4184,063,321––Total 5,341,294 1,108,344 At a General Meeting on 24 March 2023, shareholders approved a consolidation of the Company’s Ordinary Shares on a one for 20 basis. As a result, the par value of the Ordinary Shares was changed from £0.001 per share to £0.02 per share. The above table reflects the share consolidation in the comparative figures. At a General Meeting on 14 June 2023, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.02 each into to one Ordinary Share of £0.001 each and 19 ‘B’ Deferred Shares of £0.001 each. The ‘B’ Deferred Shares have limited rights and are effectively valueless. The previously issued Deferred Shares were redesignated ‘A’ Deferred Shares. On 26 May 2023 the Company entered into private placement as set out in note 4. As no share premium was recognised in relation to this transaction the transaction costs allocated to the initial issue of shares have been charged to retained earnings. During the period the Company entered into two private placements as set out in note 4. The pre-funded, Series A, Series B, Series C and Investor warrants have been accounted for as equity warrants and the fair value on recognition allocated to the warrant reserve, net of transaction costs. On exercise of the warrants the fair value has been transferred to share capital and share premium. Ordinary and deferred shares were recorded as equity. Rights attaching to the shares of Biodexa Pharmaceuticals PLC Shares classified as equity The holders of ordinary shares in the capital of the Company have the following rights: (a) to receive notice of, to attend and to vote at all general meetings of the Company, in which case shareholders shall have one vote for each share of which he is the holder; and, (b) to receive such dividend as is declared by the Board on each share held. The holders of deferred shares in the capital of the Company: (a) shall not be entitled to receive notice of or to attend or speak at any general meeting of the Company or to vote on any resolution to be proposed at any general meeting of the Company; and (b) shall not be entitled to receive any dividend or other distribution of out of the profits of the Company. In the event of a distribution of assets, the deferred shareholders shall receive the nominal amount paid up on such share after the holder of each ordinary share shall have received (in cash or specie) the amount paid up or credited as paid up on such ordinary share together with an additional payment of £100 per share. The Company has the authority to purchase the deferred shares and may require the holder of the deferred shares to sell them for a price not exceeding 1p for all the deferred shares. 2023 Ordinary SharesNumber‘A’ Deferred SharesNumber‘B’ Deferred Shares NumberShare Price£Total consideration£’000At 1 January 20235,417,1371,000,001- 15 February 2023Private Placements3,250,200–0.050516426 May 2023Registered Direct Offering110,679,610–0.00971,076April – June 2023Exercise February 2023 pre-funded warrants62,184,525–0.05053,139March 2023Exercise Series ‘A’ warrants12,931,020–0.0505653March 2023Exercise Series ‘B’ warrants19,396,530–0.050597915 June 2023Exercise Investor warrants625,000–0.05053214 June 2023Share sub-division and re-designation–4,063,321,418n/an/a30 June 2023Exercise ‘C’ warrants63,487,700–0.0097617At 30 June 2023 (unaudited)277,971,7221,000,0014,063,321,418 2022 At 1 January 2022 4,923,4201,000,001- 22 March 2022Exercise of warrants1–200.000-3 May 2022Share issue to SIPP trustee*1,250–0.001-19 December 2022Registered Direct Offering492,466–0.6660321At 31 December 20225,417,1371,000,001- *Share issued to Biodexa Pharmaceuticals PLC employee benefit trust 9. Related party transaction The Directors consider there to be no related party transactions during the periods reported other than Directors Remuneration. 10. Contingent liabilities The Company entered into an Arrangement Agreement with Bioasis on 13 December 2022 as amended on 18 December 2022. Under the agreement the Company agreed to acquire the entire issued share capital of Bioasis for consideration of, in aggregate, approximately C$7.4 million (c£4.4 million). The agreement was subject to shareholder approval. Under the agreement the Company agreed to reimburse Bioasis US$225,000 expenses relating to the transaction should the Company’s shareholders not approve the transaction. As at 31 December 2022 and 30 June 2023 the Company had a contingent liability of $225,000 in relation to this potential liability. On 23 January 2023 at the General Meeting to approve the Arrangement Agreement none of the special resolutions were passed and, accordingly, the acquisition of Bioasis did not proceed. On 23 January Bioasis terminated the Arrangement Agreement and requested reimbursement of US$225,000 expenses relating to the transaction, to date these expenses have not been paid. 11. Events after the reporting date On 5 July 2023, and in an effort to bring the ADS price into compliance with NASDAQ’s minimum bid price per share requirement, we effected a ratio change in the number of Ordinary Shares represented by our ADSs from five Ordinary Shares per ADS to 400 Ordinary Shares per ADS.