お知らせ • Feb 04
Midatech Pharma Announces Receipt of NASDAQ Notice Midatech Pharma plc announced that it received written notification from The NASDAQ Stock Market LLC, dated 31 January 2023, stating that the Company is not in compliance with the minimum bid price requirement set forth in NASDAQ's rules for continued listing on The NASDAQ Capital Market. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's American Depositary Shares (the "Depositary Shares"), each representing 25 ordinary shares of the Company, for the 30 consecutive business days beginning14 December2022, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing of the Depositary Shares, and they will continue to trade on The NASDAQ Capital Market under the symbol "MTP." In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until 31 July 2023 (the "Compliance Period"), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Depositary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the Compliance Period. If the Depositary Shares do not regain compliance with the minimum bid price requirement during the Compliance Period, the Company may be eligible for an additional grace period of 180 calendar days provided that the Company satisfies NASDAQ's initial listing standards for listing on The NASDAQ Capital Market, other than the minimum bid price requirement, and provides written notice to NASDAQ of its intention to cure the delinquency during the second grace period. If the Company does not regain compliance during the initial grace period and is not eligible for an additional grace period, NASDAQ will provide written notice that the Depositary Shares are subject to delisting from The NASDAQ Capital Market. In that event, the Company may appeal such determination to a hearing panel. The Company intends to monitor the bid price of its Depositary Shares during the Compliance Period and will consider taking such actions as may be necessary and appropriate to achieve compliance with continued listing requirements prior to the expiration of all available grace periods. The Company's business operations are not affected by the receipt of the Notification Letter. The Company's ordinary shares are admitted to trading on the AIM Market of the London Stock Exchange, and the Notification Letter does not affect the Company's compliance status with the AIM Rules for Companies. お知らせ • Jan 12
Midatech Pharma PLC Announces Planned Dose Escalation in MTX-110 Phase 1 Study Midatech Pharma PLC announced that following completion of one month of treatment with MTX-110 in the first patient, its Phase I study of MTX-110 in recurrent glioblastoma (rGB) (NCT 05324501) will continue with a planned dose escalation following a positive recommendation from the study's Data Safety Monitoring Board (DSMB). The Phase I study, the MAGIC-G1 study, is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX-110 only and the second cohort will receive MTX-110 in combination with lomustine. The first patient in the study was dosed at 60uM of MTX-110 via direct-to-tumour delivery and has received four 48-hour infusions over a period of four weeks. No treatment-associated adverse events were noted in the patient during this period. Following successful completion of the first month of treatment, the DSMB reviewed the available data on 11 January 2023 and recommended dose escalation in the study to 90uM. This dose is expected to be the optimal one of MTX-110 and is the one currently being used in the ongoing Phase I study of patients with diffuse intrinsic pontine glioma (DIPG) at the Columbia University, USA. Patient 1 continues treatment as per the study protocol and patient 2 is expected to start treatment by the end of January 2023 and will receive the 90uM dose. GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months. Currently, no standard of care is established for rGB. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favorable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559). Reported Earnings • Sep 15
First half 2022 earnings released: UK£0.031 loss per share (vs UK£0.05 loss in 1H 2021) First half 2022 results: UK£0.031 loss per share (improved from UK£0.05 loss in 1H 2021). Net loss: UK£3.06m (loss narrowed 2.9% from 1H 2021). Over the last 3 years on average, earnings per share has increased by 84% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Reported Earnings • Apr 29
Full year 2021 earnings released: UK£0.07 loss per share (vs UK£0.52 loss in FY 2020) Full year 2021 results: UK£0.07 loss per share (up from UK£0.52 loss in FY 2020). Net loss: UK£5.46m (loss narrowed 75% from FY 2020). Over the last 3 years on average, earnings per share has increased by 90% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. Reported Earnings • Sep 20
First half 2021 earnings released: UK£0.05 loss per share (vs UK£0.64 loss in 1H 2020) First half 2021 results: Net loss: UK£3.15m (loss narrowed 82% from 1H 2020). Is New 90 Day High Low • Feb 05
New 90-day high: €0.45 The company is up 69% from its price of €0.26 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 9.0% over the same period.