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Biodexa Pharmaceuticals PLC(BDRX) - Prospectus
2024-08-12 20:36
Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST 12, 2024 THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) Caspia ...
Announces Closing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
GlobeNewswire News Room· 2024-07-23 12:30
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].
Announces Closing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
Newsfilter· 2024-07-23 12:30
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].
Announces Pricing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
Newsfilter· 2024-07-19 12:30
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. July ...
Announces Pricing of $5.0 Million Registered Direct Offering and Concurrent Private Placement
GlobeNewswire News Room· 2024-07-19 12:30
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].
Biodexa Announces Phase 2a Study of Tolimidone in Type 1 Diabetes Approved by Health Canada
Newsfilter· 2024-07-16 12:30
July 16, 2024 Biodexa Pharmaceuticals PLC ("Biodexa" or "the Company"), (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes ("T1D"). Commenting, Stephen Stamp, CEO and CFO of Biodexa said: "We are excited to initiate our clinical program in Type 1 diabetes with the University of Alberta and build on the extensive tolim ...
Why Is Biodexa Pharmaceuticals (BDRX) Up 56% Today?
Investor Place· 2024-07-11 16:10
Biodexa Pharmaceuticals (NASDAQ:BDRX) stock is rocketing higher on Thursday after announcing additional positive results from a Phase 2 clinical trial. According to the company, results from its study of eRapa are going well. This is its treatment candidate for Familial Adenomatous Polyposis (FAP). That's a mostly inherited condition that increases the risk of developing colorectal cancer. Results from 12 months of study show a median 17% decrease in overall polyp burden. It also showed an overall non-progr ...
Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024
Newsfilter· 2024-07-02 12:30
Core Insights - Biodexa Pharmaceuticals PLC presented positive Phase 1 clinical data for MTX110 in treating Diffuse Midline Glioma (DMG), showing a median overall survival of 16.5 months compared to 10.0 months in historical cohorts [1][2][8] Study Design and Results - The Phase 1 study was an open-label, investigator-initiated trial conducted by Columbia University, involving nine patients newly diagnosed with DMG [3][8] - Patients received two infusions of MTX110 via convection enhanced delivery (CED), with a median progression-free survival of 10 months and overall survival ranging from 12 to 35 months [2][7] - The primary endpoint was to determine the dosage regimen for a proposed Phase II study, with preliminary data suggesting a dose between 60μM and 90μM for future trials [9] Safety and Tolerability - The treatment was well tolerated, with one Grade 4 adverse event deemed unrelated to the drug, while most other adverse events were classified as Grade 2 to 3 [7][8] - The study was not powered to demonstrate statistical significance for efficacy, but the results indicate a favorable outcome compared to historical data [2][10] Product Information - MTX110 is a solubilized formulation of the histone deacetylase (HDAC) inhibitor panobinostat, designed to bypass the blood-brain barrier and minimize systemic toxicity [13][20] - The company is also developing other products, including eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, and tolimidone for type 1 diabetes [11][12]
Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP)
Newsfilter· 2024-06-24 12:30
June 24, 2024 Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP) Median Decrease in Overall Polyp Burden at 12 Months of 17% Cohort 2 Non-progression Rate at 12 months of 81% and Median Decrease in Poly Burden of 29% Informs Phase 3 Dosage Regimen (DATELINE) JUNE 24 -- Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company") (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative ...
Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP)
GlobeNewswire News Room· 2024-06-24 12:30
Core Insights - Biodexa Pharmaceuticals PLC announced promising results from a Phase 2 clinical trial of eRapa™ for Familial Adenomatous Polyposis (FAP), showing a 75% non-progression rate at 12 months and a median reduction in polyp burden of 17% [1][4][5] Group 1: Clinical Trial Results - The Phase 2 study reported that 21 out of 28 patients (75%) were non-progressors at 12 months, with a median reduction in polyp burden of 17% [4][5] - In Cohort 2, 89% of patients were non-progressors with a median reduction in polyp burden of 29% [5][12] - The study was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) [2] Group 2: Future Studies and Funding - A Phase 3 registrational study is planned, which will be a double-blind placebo-controlled trial involving approximately 140 high-risk patients [6] - The Phase 3 study is supported by a $17 million grant from CPRIT [2][6] - The primary endpoint for the Phase 3 study will focus on the first progression-free survival event, including major surgery and diagnosis of high-grade dysplasia or cancer [6] Group 3: Drug Information - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [7][19] - eRapa has received Orphan Designation in the US, with plans to seek similar designation in Europe [15] Group 4: Company Overview - Biodexa Pharmaceuticals PLC is a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other products for different indications [23][25]