Member Info for Jarv55

Wonder if the nomad rns will be next.

Good get them out.

I suppose it also depends on if they want MTD201 to be recognized as a better drug than Sandostatin Lar.

In particular, the Group's lead development product, MTD201 (Q-Octreotide), a treatment for carcinoid cancer and acromegaly, a $2 billion market, has recently completed an exploratory bioequivalence clinical trial which indicated that MTD201 compares favourably to the leading product in the market, Sandostatin® LAR® ("SLAR") from Novartis. The next stage of development for MTD201 is to potentially conduct a pivotal stage study as explained further below.

So if it is option one it will be full steam ahead multibagger incoming if it is option two or three they need to go back to the drawing board to raise more.

Previous regulatory guidance in 2017 confirmed the Company's development plans comprising an exploratory Phase I study and a confirmatory follow-on Pivotal phase to be conducted in healthy volunteers, comparing Midatech's MTD201 against Novartis' Sandostatin LAR ("SLAR") for single dose administration. The planned study design was the same for both the exploratory and pivotal phase studies save that the Pivotal phase study would require a larger number of healthy volunteer subjects. The agreed endpoints for both studies were pharmacokinetic (i.e. monitoring levels of the active drug octreotide in the blood) and pharmacodynamic responses (i.e. monitoring the effects of the active drug octreotide as assessed by levels of growth hormone as they are normalised back to baseline levels with the two treatments respectively). Data from the Phase I study suggest that MTD201 may be an equivalent alternative to SLAR based on pharmacodynamic data, or a differentiated and improved product based on pharmacokinetic data with a favourable, improved and lower variability profile of MTD201 compared to SLAR). Accordingly, in late October 2018 the Company provided a summary of the trial data to the FDA to seek confirmation on the FDA's original guidance for a single dose registration study in healthy volunteers using pharmacodynamic responses as the primary endpoint (i.e. to pursue development and commercialisation of MTD201 as an equivalent product to SLAR).

Whilst the Directors believe that the original guidance for a study in healthy volunteers will be confirmed, the nature of any regulatory perspectives and opinions cannot be guaranteed, and all options need to be contemplated. The Directors believe there are broadly three key scenarios possible including:

1) Confirmation of original study design: i.e. single dose, healthy volunteers, endpoints, number of subjects is appropriate. In this scenario and subject to a successful pivotal study and successful scale-up of manufacturing, the Directors believe it may be possible to file a new drug application ("NDA") in late 2020;

2) Requirement for multi dose study healthy volunteers: in the Directors opinion this would likely delay NDA submission for MTD201 (subject to successful pivotal study) by approximately 6 months; or

3) Requirement for a study in patients: depending on the number of patients required, this could significantly increase the costs of a trial and the time to NDA submission. In this scenario, the Company would consider the cost and time implications on the altered trial design and would consider the merits of seeking alternative sources of funding, including potentially earlier partnering to help fund and conduct the trial.

The regulatory request was submitted to the FDA in October 2018, and the board expected to receive FDA feedback in Q4 2018. The board have now been informed that FDA feedback will be received in early Q1 2019.

So they have applied for a second grant I think all the funding is in place and they are just waiting for the fdas approval hopefully it will be option 1

Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, today announces that further to the Company's announcement on 20 December 2018, the Basque regional government has approved further funding of EUR 1.5 million for the Company's manufacturing facility in Bilbao, Spain. The award, in the form of soft loan finance, follows receipt in 2018 of a related grant worth EUR 450k, and will be used as part of the commercial scale up for Midatech's MTD201 program and Q-Spheraâ„¢ technology platform.

The loan is part of the Basque government's Gauzatu Industry program, a Government funded program to support local SMEs in establishing infrastructure and capability for global industries. Separately, the Company is also applying for further funding from the Spanish Government's Reindus program, which focuses on the industrial growth of Spain. If successful, the combined funding from both programs, as well as potential EU financing, could fund the majority of the commercial scale up costs for MTD201 and the Q-Sphera technology.

Also waiting on the Fdas decision which could come any day.

Previous regulatory guidance in 2017 confirmed the Company's development plans comprising an exploratory Phase I study and a confirmatory follow-on Pivotal phase to be conducted in healthy volunteers, comparing Midatech's MTD201 against Novartis' Sandostatin LAR ("SLAR") for single dose administration. The planned study design was the same for both the exploratory and pivotal phase studies save that the Pivotal phase study would require a larger number of healthy volunteer subjects. The agreed endpoints for both studies were pharmacokinetic (i.e. monitoring levels of the active drug octreotide in the blood) and pharmacodynamic responses (i.e. monitoring the effects of the active drug octreotide as assessed by levels of growth hormone as they are normalised back to baseline levels with the two treatments respectively). Data from the Phase I study suggest that MTD201 may be an equivalent alternative to SLAR based on pharmacodynamic data, or a differentiated and improved product based on pharmacokinetic data with a favourable, improved and lower variability profile of MTD201 compared to SLAR). Accordingly, in late October 2018 the Company provided a summary of the trial data to the FDA to seek confirmation on the FDA's original guidance for a single dose registration study in healthy volunteers using pharmacodynamic responses as the primary endpoint (i.e. to pursue development and commercialisation of MTD201 as an equivalent product to SLAR).

Whilst the Directors believe that the original guidance for a study in healthy volunteers will be confirmed, the nature of any regulatory perspectives and opinions cannot be guaranteed, and all options need to be contemplated. The Directors believe there are broadly three key scenarios possible including:

1) Confirmation of original study design: i.e. single dose, healthy volunteers, endpoints, number of subjects is appropriate. In this scenario and subject to a successful pivotal study and successful scale-up of manufacturing, the Directors believe it may be possible to file a new drug application ("NDA") in late 2020;

2) Requirement for multi dose study healthy volunteers: in the Directors opinion this would likely delay NDA submission for MTD201 (subject to successful pivotal study) by approximately 6 months; or

3) Requirement for a study in patients: depending on the number of patients required, this could significantly increase the costs of a trial and the time to NDA submission. In this scenario, the Company would consider the cost and time implications on the altered trial design and would consider the merits of seeking alternative sources of funding, including potentially earlier partnering to help fund and conduct the trial.
The regulatory request was submitted to the FDA in October 2018, and the board expected to receive FDA feedback in Q4 2018. The board have now been informed that FDA feedback will be received in early Q1 20

In addition to the Proposed Subscription, the Company has been in discussions with existing institutional and additional new shareholders to carry out an equity fundraise at or around the prevailing market price per ordinary share ("Proposed Placing"). The Board believe that if possible it would be preferable to establish a clear development pathway for MTD201 (as discussed below) prior to the fundraise. On the basis of a clear development plan (see options 1 and 2 below) the Company has a number of indications of equity support. Shareholders should note that it would be the Company's intention to allow qualifying retail shareholders to participate in a fundraise alongside a Proposed Placing by way of an open offer ("Proposed Open Offer"). It is currently proposed that all participants in the Proposed Subscription, Proposed Placing and Proposed Open Offer would be granted warrants over new ordinary shares at an exercise price of 50 pence per ordinary share.

There is no certainty that the proposed license agreement or further funding will be forthcoming.

The new ordinary shares and warrants that may be offered have not been and will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The new ordinary shares and warrants will be offered only to non-U.S. persons (as such term is defined in Regulation S under the Securities Act) in transactions outside the United States in reliance on Regulation S under the Securities Act.

As announced on the 27 September 2018 and in the circular to Shareholders dated 28 September 2018, seeking approval of the Sale, the attention of Shareholders was drawn to the fact that even with the addition of the net proceeds from the Sale, the cash resources of the Company are limited and that whilst the Board would continue its efforts to secure additional non-dilutive funding, the Company was also exploring access to further equity financing in the near term, including from the UK, US or Europe, in order to support the continued development of the business and the rapid advancement of its key pipeline products MTD201 and MTX110 (for the treatment of diffuse intrinsic pontine glioma), which the Company is striving to bring to market as expeditiously as possible. The Company currently has sufficient working capital for the short term to the end of Q1 2019. For the purpose of evaluating the Company's available cash runway, the Company has assumed that no element of the potential earn-out payment associated with the Sale (up to US$6million in respect of 2018 and 2019 and which is subject to the achievement by MTP US of 2018 and 2019 net sales performance targets with respect to certain MTP US products, both individually and in the aggregate), will be paid to the Company.

A summary of current trading, including recent restructuring and cost cutting measures taken by the Group, are included in the "Current Trading" section of this announcement.

Proposed Fundraising and Proposed Licence Agreement

The Company has been in very advanced discussions with an Asian based strategic investor who has entered into a non-binding term sheet to provide £8 million in aggregate through a subscription of new ordinary shares in the Company at or around the prevailing price per ordinary share at the time of the transaction ("Proposed Subscription").

Alongside the Proposed Subscription, completion of which would be conditional on shareholder approval and a waiver of Rule 9 of the Takeover Code, it is anticipated that a company associated with the strategic investors would, upon completion of the Proposed Subscription, enter into a licence agreement in relation to the development and commercialisation of the Group's pipeline of products in Greater China and certain South East Asian countries. Following Midatech securing future US or European marketing approval for any products, the licensee, a subsidiary of a large Asian based pharmaceutical company would, pursuant to the terms of the proposed licence agreement, be responsible for the cost of development, approval and commercialisation of the Group's products in the licenced territories. It is proposed that the licence agreement would include reasonable royalty payments, sales-based milestone payments and regulatory milestone following product approval ("Proposed Licence") by FDA or EMA in the first instance, and then again upon approval by the Chinese FDA.

When the funding is announced this will do an Agl rise.

Thanks for clearing that up George ideal, it was a previous poster think that is where Babbler got the info from as well.

Yep pharmas back in the lime light check out Agl

Reading back over the thread there could be a possibility this company will just buy them out.

https://en.wikipedia.org/wiki/Novartis

Harry I would say they will be working very hard to get the price over $1 by then. Think the share price was being suppressed due to L and G selling out and the lack of clarity on the funding and licensing. Breaks will come off once that is agreed.

For Midatech to remain true to its intention, a closing bid price of at least $1 for a minimum of ten consecutive business days must be achieved by 29th April 2019. As far as I know, two shares on the Nasdaq are equivalent to one share on AIM. So, a target price of $1 on the Nasdaq means that (at the present rate of exchange) the share price must reach at least 36p on AIM by 29th April 2019. That’s way over double the present share price.

Babbler have you got a link t0 the 2 us shares for 1?

Clive he only holds 6.5% has anyone else pledged their shares to him?

Aba why is it so low crazy http://s1.q4cdn.com/460208960/files/News/2018/Zacks_SCR_Research_10032018_MTP_Bautz.pdf

https://www.proactiveinvestors.co.uk/news/details/212323/midatech-secures-15mln-loan-from-basque-government-on-friendly-terms-212323.html