PARIS, France, October 30, 2023 at 8:30 a.m. (CET) – Pharnext SCA (FR001400JXB0 – ALPHA)
(the “Company”), an advanced clinical stage biopharmaceutical company developing new therapies for neurodegenerative diseases without a satisfactory therapeutic solution, today announces that it has received a non-binding offer with economic conditions very clearly superior to the two binding offers already announced, with a view to signing an agreement to valorize PXT3003
[1]
its most advanced drug candidate currently in pivotal Phase III clinical study (PREMIER trial) in Charcot-Marie-Tooth disease type 1A (CMT1A), a rare debilitating peripheral neuropathy.
This latest offer, from a laboratory ranked among the world’s top 10, concerns an exclusive license agreement with a minimum overall valuation (excluding royalties indexed to sales of the future drug) estimated at €510 million, compared to more than €250 million for previous offers.
In addition, this new offer provides for a first payment of €10 million upon signing an exclusivity agreement and a second payment of €70 million in the event of the conclusion of a licensing agreement subsequent to the publication of the first results of the pivotal Phase III clinical study (PREMIER trial) expected before the end of the year.
As a reminder, this future agreement would complement the licensing agreement already concluded in 2017 granting GeneNet (a research and development joint venture controlled by Tasly Pharmaceutical and in which Pharnext holds 30%) the marketing rights for PXT3003 in the CMT1A on Chinese territory (mainland China, Hong Kong, Taiwan and Macau) and having already generated €30 million of investment from Tasly in Pharnext.
In this context, Pharnext has decided to study this offer and to give the new candidate, taking into account its scale and the undeniable recognition of the value of the drug candidate PXT3003, the time necessary to formulate a binding offer in a reasonable period of time. Pharnext will communicate on the progress of this final phase as soon as possible.
As a reminder, the signing of an agreement could make it possible to cover Pharnext’s financing needs and thus put an end to the financing line by issuing OCEANE-BSA subscribed by Global Tech Opportunities 13.
In order to give the company the financial comfort necessary to negotiate such an agreement, Pharnext’s two financial partners, Néovacs and Global Tech Opportunities 13, have each agreed to postpone the deadline of their respective financing agreements until December 2024. . The other terms of the financing agreements remain unchanged and Pharnext will not suffer any financial penalties linked to the postponement of the deadlines of the financing contracts.
Hugo Brugière, Pharnext management representative, declares: “
It’s a real twist of theater that has just happened and one that we didn’t dare dream of. Not only does the new offer received come from a laboratory with a world-renowned reputation in neurology and immunology, but it is also doubly more advantageous. In the short term, with potential payments from 2023 of €80 million. In the medium term, with an overall valuation of more than €500 million compared to, dare I hardly say, more than €250 million for previous offers.
It is therefore with serenity, and thanks to the unwavering support of Néovacs and GTO13, that we are approaching this final straight line of discussions in order to finalize an agreement and focus on our mission: to bring a medical solution to the market as quickly as possible. to the millions of suffering patients and families. »
About Charcot-Marie-Tooth disease type 1A (CMT1A)
Charcot-Marie-Tooth (CMT) diseases bring together a heterogeneous group of peripheral, hereditary, severe, disabling, progressive and chronic neuropathies. CMT1A, the most common subtype of CMT, is an orphan disease with a prevalence of 1/5000 affecting approximately 150,000 people in Europe and the United States, and approximately 1,500,000 people worldwide. The genetic mutation causing CMT1A is a duplication of the PMP22 gene encoding a peripheral myelin protein. Duplication of this gene induces overexpression of the PMP22 protein and the inability of Schwann cells to produce normal myelin (neuron sheath). The myelin sheath thus degraded (structure and functionality) disrupts the conduction of nerve impulses at the level of peripheral nerves and causes the degradation of axons. Because of this degradation of peripheral nerves, patients suffer from progressive muscle atrophy in the legs and arms leading to problems with walking, running and balance, as well as problems with the functionality of the hands. They may also suffer from mild to moderate sensory disturbances. The first symptoms generally appear in adolescence and gradually evolve throughout the patient’s life. In the most severe cases, CMT1A patients become dependent on a wheelchair (at least 5% of cases). To date, no curative or symptomatic drug has received marketing authorization for CMT1A. Management of the disease is limited to supportive care such as orthotics, splints, physiotherapy, occupational therapy or even surgery.
More information at https://pharnext.com/fr/disease/charcot-marie-tooth.
Warning :
The company Pharnext has set up financing in the form of OCEANE-BSA with the company Global Tech Opportunities 13, which, after having received the shares resulting from the conversion or exercise of these instruments, is not intended to remain a shareholder of the company.
The shares resulting from the conversion or exercise of the above-mentioned securities will, in general, be sold in the market very quickly, which may create strong downward pressure on the share price.
Shareholders may suffer a loss of their invested capital due to a significant decrease in the value of the company’s stock, as well as significant dilution due to the large number of securities issued to the Global Tech Opportunities Company. 13.
Investors are advised to be very vigilant before making the decision to invest in the securities of the company admitted to trading which carries out such dilutive financing transactions, particularly when they are carried out successively. The company recalls that this dilutive financing operation is not the first that it has implemented.
Investors are particularly invited to take note of the risks relating to these operations, mentioned in the press release below.
About Pharnext
Pharnext is a late-stage clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases currently without satisfactory therapeutic solutions. Pharnext has a new drug candidate, PXT3003, in development for Charcot-Marie-Tooth disease type 1A (CMT1A), a rare and debilitating hereditary peripheral neuropathy. PXT3003 benefits from orphan drug status in Europe and the United States. In 2018, PXT3003 completed a Phase III clinical study, the PLEO-CMT trial, with encouraging preliminary results. This trial was followed by an open-label extension study, the PLEO-CMT-FU trial, in which 120 patients are still continuing treatment with PXT3003. The long-term results suggest a benefit maintained in terms of tolerance and effectiveness, after a total clinical study duration of 6 years. A pivotal international Phase III clinical study, the PREMIER trial, including 387 patients with CMT1A was completed in August 2023. The first results of the PREMIER trial are expected in the fourth quarter of 2023. PXT3003 was discovered with the Pleotherapy™ R&D approach. Pharnext draws investors’ attention to the risk factors, particularly financial, detailed in its financial reports. More information on www.pharnext.com.
Pharnext is listed on the Euronext Growth market in Paris (ISIN code: FR001400JXB0).
Contacts
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Financial Press Relations NEWS finance & communication Anne-Charlotte Dudicourt [email protected] +33 (0)1 53 67 36 32 |
Investor Relations NEWS finance & communication Jérôme Fabreguettes Leib [email protected] +33 (0)1 53 67 36 78 |
[1]
The marketing of PXT3003 is subject to a positive pivotal Phase III clinical study (PREMIER trial) and approval from regulatory agencies.
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