Biodexa Pharmaceuticals PLC(BDRX)

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Interim results for the six months ended June 30, 2024
GlobeNewswire News Room· 2024-09-26 12:30
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].
ADR Ratio Change
GlobeNewswire News Room· 2024-09-19 20:30
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].
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
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].
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 ...
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
Biodexa Pharmaceuticals PLC After Only Two Infusions and Two Patients at Optimal Dose, Median Overall Survival Across all Patients was 16.5 Months (vs 10.0 Months in Historical Reference Cohort) (DATELINE) JULY 2 -- 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, announces data from a Phase 1 study of MTX110 in Diffuse M ...
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 ...