Core Insights - Biodexa Pharmaceuticals has received allowance for a U.S. patent covering its oral rapamycin nanoparticle preparations, known as eRapa, which is set to issue on March 4, 2025, and is expected to expire in March 2034 [1][2] - The company plans to initiate a Phase 3 registrational study of eRapa in Familial Adenomatous Polyposis (FAP) in the next quarter, with substantial funding from a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) [1][2] - eRapa is designed to improve the bioavailability and reduce toxicity associated with existing forms of rapamycin, leveraging nanotechnology and pH-sensitive polymers [2][5] Company Overview - Biodexa Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other programs targeting type 1 diabetes and aggressive rare brain cancers [4][8] - The company has a proprietary oral tablet formulation of rapamycin, which acts as an mTOR inhibitor, targeting pathways involved in cellular metabolism and tumorigenesis [2][5] Funding and Support - CPRIT has awarded a total of $2.9 billion in grants to Texas research institutions, supporting cancer research and prevention initiatives, which includes funding for Biodexa's Phase 3 study [3] - The funding from CPRIT is matched by Biodexa's contributions of $8.5 million, demonstrating a strong commitment to advancing cancer treatment research [2]

Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs [6] - The company is listed on NASDAQ under the ticker BDRX [6] Upcoming Conference - Biodexa has been invited to present at the Emerging Growth Conference on February 19, 2025, at 09:40 AM Eastern time for a duration of 30 minutes [1][3] - The presentation will be led by CEO/CFO Stephen Stamp, who will also engage with the audience for questions [2] Product Pipeline - The company's lead development programs include: - eRapa, an oral tablet formulation of rapamycin for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer [6][7] - Tolimidone, a selective inhibitor of Lyn kinase for type 1 diabetes treatment [6][8] - MTX110, a formulation of the HDAC inhibitor panobinostat for aggressive rare/orphan brain cancer [6][9] Drug Delivery Technologies - Biodexa utilizes three proprietary drug delivery technologies aimed at enhancing the bio-delivery and bio-distribution of its medicines [10]

Core Insights - Biodexa Pharmaceuticals has received Fast Track designation from the US FDA for eRapa, a treatment for familial adenomatous polyposis (FAP), highlighting the urgent need for alternatives to surgical intervention [1][2] Group 1: eRapa and Its Development - eRapa is a proprietary encapsulated form of rapamycin, designed to address the unmet medical need for FAP, a condition that can lead to colorectal cancer if untreated [1][2] - The Phase 2 study of eRapa demonstrated a median 17% reduction in total polyp burden at 12 months compared to baseline, with a 75% non-progression rate overall [2] - In cohort 2 of the study, patients experienced an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months, with a preferred dosing regimen of daily every other week for the upcoming Phase 3 study [2] Group 2: Familial Adenomatous Polyposis (FAP) - FAP is characterized by a proliferation of polyps in the colon and/or rectum, typically beginning in the mid-teens, with no approved therapeutic options currently available [3] - The prevalence of FAP is reported to be one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe, indicating a significant hereditary component [3] Group 3: Mechanism and Technology - eRapa functions as an mTOR inhibitor, which plays a crucial role in cellular metabolism, growth, and proliferation, and is over-expressed in FAP polyps [4][8] - The formulation of eRapa utilizes nanotechnology and pH-sensitive polymers to improve bioavailability and reduce toxicity associated with existing rapamycin forms [4] Group 4: Company Overview - Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other programs targeting type 1 diabetes and rare brain cancers [7]

Management Team Strengthening - Biodexa Pharmaceuticals PLC appointed Dr Gary A Shangold as Chief Medical Officer effective immediately [2] - Dr Shangold brings extensive experience across all phases of drug development in multiple therapeutic areas [4] - He previously served as Chief Medical Officer at Enteris BioPharma and Xanodyne Pharmaceuticals, and as CEO of NovaDel Pharma [4] - Dr Shangold holds an MD from Columbia University and completed residency and fellowship programs in Obstetrics & Gynecology and Reproductive Endocrinology [5] - He has approximately 10 years of experience in clinical and regulatory affairs at Johnson & Johnson's R W Johnson Pharmaceutical Research Institute [5] Company Overview - Biodexa is a clinical-stage biopharmaceutical company developing innovative products for diseases with unmet medical needs [8] - The company's lead development programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancers [8] - Biodexa utilizes three proprietary drug delivery technologies to improve bio-delivery and bio-distribution of medicines [12] - The company is headquartered in Cardiff, UK with an R&D facility [12] Product Pipeline - eRapa is an oral tablet formulation of rapamycin, an mTOR inhibitor that regulates cellular metabolism, growth, and proliferation [9] - Tolimidone is an oral Lyn kinase inhibitor that demonstrates glycemic control via insulin sensitization in animal models of diabetes [10] - MTX110 is a solubilized formulation of panobinostat, delivered via convection-enhanced delivery directly to tumor sites, bypassing the blood-brain barrier [11][12] Leadership Commentary - CEO Stephen Stamp emphasized the importance of Dr Shangold's expertise as Biodexa advances to later clinical stages, including a global Phase 3 registrational study in FAP [3] - Dr Shangold's previous experience includes securing two NDAs at Xanodyne Pharmaceuticals [3]

Core Viewpoint - Biodexa Pharmaceuticals Plc is under investigation for potential claims related to its securities following the release of concerning clinical trial data for its drug MX110, which has led to a significant drop in its stock price [1][2]. Investigation Details - On October 4, 2024, Biodexa reported updated data from a Phase 1 study of MX110 for recurrent glioblastoma, revealing that out of four patients in Cohort A, two have died, with overall survival times of 12 and 13 months for the remaining patients [2]. - Following this announcement, Biodexa's stock price decreased by $0.45, or 7.5%, closing at $5.55 per share on the same day [2]. Next Steps - Investors who have information related to the investigation or who purchased Biodexa securities are encouraged to assist by visiting the law firm's website [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if they are successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a recognized firm specializing in representing investors in securities fraud class actions and has successfully recovered hundreds of millions of dollars for investors [5].

Core Insights - Biodexa Pharmaceuticals PLC reported its interim results for the six months ended June 30, 2024, highlighting significant advancements in its clinical pipeline and financial activities [1]. Operational Highlights - The company secured exclusive worldwide licensing of eRapa™, a Phase 3 ready asset targeting Familial Adenomatous Polyposis (FAP), along with access to a $17 million grant [2]. - Six-month data for eRapa in FAP indicated an 83% non-progression rate and a statistically significant reduction in overall polyp burden [2]. - Twelve-month data for eRapa showed a 75% non-progression rate and a median overall decrease in polyp burden of 17% [3]. - The US Patent and Trademark Office allowed a patent related to tolimidone, enhancing its exclusivity [4]. - Health Canada approved a Phase 2a dose confirmation study of tolimidone in Type 1 diabetes, to be conducted by the University of Alberta Diabetes Institute [4]. Financial Highlights - The company received $6.05 million from the exercise of Series E and Series F warrants, resulting in the issuance of 4.4 million American Depositary Shares (ADSs) [6]. - Research and Development (R&D) costs decreased to £2.19 million in 1H24 from £2.25 million in 1H23, reflecting reduced spending on the MAGIC-G1 study and lower personnel costs [7]. - Administrative costs also decreased to £2.03 million in 1H24 from £2.29 million in 1H23, attributed to favorable foreign exchange reversals and reduced professional fees [8]. - The company reported a net cash outflow from operating activities of £4.81 million in 1H24, compared to £3.88 million in 1H23, with a cash balance of £5.06 million as of June 30, 2024 [8][48]. R&D Update - Following the licensing of eRapa, Biodexa's development pipeline expanded to six programs, four of which are focused on orphan indications [23]. - eRapa is designed to improve the bioavailability and reduce toxicity associated with existing forms of rapamycin, with patent protection extending through 2035 [23]. - The Phase 3 registrational study for eRapa in FAP is planned to recruit approximately 150 high-risk patients, with a primary endpoint of progression-free survival [28]. Financing Activities - The company raised $5.0 million through a Registered Direct Offering and a concurrent private placement of warrants post-period end [9]. - The completion of a matching payment enabled access to the remaining $17 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) for the upcoming Phase 3 study of eRapa [9].

Core Viewpoint - Biodexa Pharmaceuticals PLC is implementing a change in the ratio of its American Depositary Receipts (ADRs) to comply with Nasdaq's minimum bid price requirement, transitioning from one ADR representing 400 ordinary shares to one ADR representing 10,000 ordinary shares, effective October 4, 2024 [1][3]. Group 1 - The new ratio will require ADR holders to surrender their existing ADRs for cancellation and exchange, receiving one new ADR for every twenty-five old ADRs, with no fractional ADRs allocated [2][3]. - The change is effectively a one-for-twenty-five reverse ADR split, while the ordinary shares of Biodexa will remain unaffected by this adjustment [3]. - The primary goal of the ratio change is to bring the ADR price into compliance with Nasdaq's $1.00 minimum bid price per share requirement, although the company cannot guarantee the effectiveness of this measure [3].

Core Viewpoint - Biodexa Pharmaceuticals PLC has successfully closed a registered direct offering and a concurrent private placement, raising approximately $5.0 million to fund its development programs and working capital needs [2][14]. Group 1: Offering Details - The registered direct offering included 5,050,808 American Depositary Shares (ADS) at a purchase price of $0.94 per ADS, along with 278,975 pre-funded warrants [2]. - In a concurrent private placement, the company issued Series J and Series K warrants, each allowing the purchase of up to 5,329,783 ADS [3]. - The net proceeds from the offering were approximately $4.2 million after deducting fees and expenses [14]. Group 2: Use of Proceeds - The proceeds will be used to fund development programs, including a final match payment for a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and to initiate a Phase 3 clinical trial of eRapa for Familial Adenomatous Polyposis (FAP) [14]. Group 3: Warrant Details - The pre-funded warrants have an exercise price of $0.0001 per ADS and do not expire, while Series J and Series K warrants have an exercise price of $1.00 per ADS, with different expiration terms [15]. - The company also amended the exercise price of existing Series E, G, and H warrants to $1.00 per share [16]. Group 4: Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, including eRapa for Familial Adenomatous Polyposis and MTX110 for aggressive brain cancer [20][22]. - The company utilizes proprietary drug delivery technologies to enhance the bio-delivery and bio-distribution of its medicines [22].

Core Viewpoint - Biodexa Pharmaceuticals PLC has successfully closed a $5.0 million registered direct offering and a concurrent private placement to fund its development programs and working capital needs [1][2]. Group 1: Offering Details - The registered direct offering included 5,050,808 American Depositary Shares (ADS) and 278,975 pre-funded warrants, priced at $0.94 per ADS [1]. - The net proceeds from the offering were approximately $4.2 million after deducting fees and expenses [2]. - The concurrent private placement involved the issuance of unregistered Series J and Series K warrants, each allowing the purchase of up to 5,329,783 ADS [3]. Group 2: Use of Proceeds - The proceeds from the offering will be used to fund development programs, including a final match payment for a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and to initiate a Phase 3 clinical trial of eRapa for Familial Adenomatous Polyposis (FAP) [2]. Group 3: Warrant Details - The pre-funded warrants have an exercise price of $0.0001 per ADS and do not expire [4]. - Series J and Series K warrants have an exercise price of $1.00 per ADS, with Series J expiring on the fifth anniversary and Series K on the first anniversary of issuance [4]. Group 4: Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, including eRapa for FAP and tolimidone for type 1 diabetes [11][12][13]. - The company is headquartered in Cardiff, UK, and utilizes proprietary drug delivery technologies to enhance the bio-delivery of its medicines [15].

Core Viewpoint - Biodexa Pharmaceuticals PLC has announced a registered direct offering to sell 5,050,808 American Depositary Shares and 278,975 pre-funded warrants at a price of $0.94 per Depositary Share, aiming to raise approximately $5.0 million for development programs and working capital [1][10]. Group 1: Offering Details - The offering includes 5,050,808 American Depositary Shares, each representing 400 ordinary shares, and 278,975 pre-funded warrants [1]. - The pre-funded warrants have an exercise price of $0.0001 per Depositary Share and will be immediately exercisable without expiration [7]. - The Series J and Series K Warrants will have an exercise price of $1.00 per Depositary Share, will be immediately exercisable, and will expire on the fifth and first anniversary of issuance, respectively [7][18]. Group 2: Use of Proceeds - The gross proceeds from the offering are expected to be approximately $5.0 million, which will be used to fund development programs, including a $17 million grant match from the Cancer Prevention Research Institute of Texas (CPRIT) and to initiate a Phase 3 clinical trial of eRapa for Familial Adenomatous Polyposis [10][20]. Group 3: Company Background - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, with lead programs including eRapa, tolimidone, and MTX110 [20]. - The company is supported by proprietary drug delivery technologies aimed at improving the bio-delivery and bio-distribution of medicines [13].