reports
- Sean Conroy
Pharnext - Termination of coverage
Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web...
- Sean Conroy
Pharnext - Potential licensing deals could add confidence
Pharnext announced that it is in the final stages of signing a licensing agreement for its lead asset PXT3003. Management indicated that the non-binding bids for the asset are c €400m, with roughly 10% of potential total deal value to be received upfront. It expects to receive the first binding offers on 29 September and plans to conclude the transaction by the end of October. As a reminder, PXT3003 targets a rare genetic peripheral nerve disorder and is in the Phase III PREMIER trial with preli...
- Sean Conroy
Pharnext - Improving FY23 financial footing
Pharnext’s FY22 results covered an eventful period marked by efforts to bolster its financial position to see it through to top-line readouts of its potentially first-in-class Phase III asset, PXT3003. FY22 also saw Pharnext strengthen its ties with Neovacs (following a strategic €20.7m debt funding agreement in September 2022 and a €24m debt commitment in January 2023), culminating in a revised legal framework with Neovacs’s CEO Hugo Brugière at the helm. The FY22 operating costs were higher th...
- Sean Conroy
Pharnext - Revised legal structure to offer operational stability
In a bid to increase operational oversight and financial stability, Pharnext has changed its legal framework, from a public limited company to a limited partnership with shares, following shareholder approval. Pharnext Développement, a joint-stock company controlled by Neovacs (with Hugo Brugière as chairman), will be the sole general partner with existing shareholders as limited partners. This follows the January 2022 commitment by Neovacs to provide liquidity support to Pharnext (up to €24m to...
- Sean Conroy
Pharnext - Neovacs trust to manage Pharnext deal
As a follow-up to the c €20.7m Neovacs strategic investment in Pharnext, the French biotech has set up a management trust with Equitis Gestion, as trustee, to manage obligations, rights and activities with respect to the convertible debt. In this capacity, Equitis Gestion will be responsible for managing all securities issued by Pharnext (including warrants to purchase the bonds plus associated warrants to subscribe to common equity) as well as related obligation and exercise rights. As a remind...
- Sean Conroy
Pharnext - Funding headroom to support PXT3003 progress
We revisit our estimates for Pharnext following a busy period marked by completion of patient enrolment in the pivotal PREMIER Phase III trial, initiation of the long-term extension study (PREMIER-OLE) and, more importantly, signing a €21m strategic financing deal with Neovacs. This cash infusion, combined with another €26m from available OCEANE-BSA tranches, alleviates the funding overhang and extends the runway into Q124, past the crucial final data readout from the PREMIER trial in Q423. We m...
- Sean Conroy
Pharnext - €20.7m funding agreement with Neovacs inked
Pharnext has announced that it has finalised its strategic funding agreement with Neovacs for total net proceeds of €20.7m. The funds will be raised by issuing bonds across 11 monthly tranches and associated warrants (equal to 50% of Pharnext’s total outstanding shares). The warrants become applicable for exercise on 1 January 2024, allowing Neovacs to hold one-third of Pharnext’s diluted share capital once fully converted. Proceeds from the first bond tranche (€10.7m) have been used to repay th...
- Sean Conroy
Pharnext - First patient enrolled in PREMIER extension study
Pharnext has announced enrolment of the first patient in the PREMIER open-label extension study (PREMIER-OLE) in the United States. All patients who complete the 15-month pivotal Phase III PREMIER trial, evaluating PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A), will be eligible to join the PREMIER-OLE study and will receive the high dose of PXT3003 until the treatment is commercially available. The first patient enrolled in the PREMIER-OLE study completed the PREMIER trial...
- Sean Conroy
Pharnext - Neovacs €2.5m loan part of a potential larger deal
Pharnext announced that it has signed a €2.5m short-term bridge loan agreement with the French biotechnology company Neovacs (ALNEV). The loan has a six-month maturity and will carry an interest rate of 1% per month. The current loan is part of ongoing discussions between Pharnext and Neovacs to potentially enter into a broader financing agreement. As a reminder, in June 2022, Pharnext had raised another €12.0m in short-term, fixed-rate financing from Global Tech Opportunities 13, a member of th...
- Sean Conroy
Pharnext - Approaching clinical validation
We revisit our assessment for Pharnext after an eventful few weeks that saw the company announce encouraging new data (five years of trial time) from its PLEO-CMT-FU open-label extension study, complete patient enrolment in its pivotal Phase III PREMIER trial and make progress in raising new, non-dilutive financing. We maintain our outlook for the PREMIER study (likely to conclude in Q423), bolstered by the positive data from the extension study (sustained benefit to patients after five years of...
- Sean Conroy
Pharnext - €12m loan to ease funding overhang
Pharnext announced that it has raised €12m in short-term, fixed-rate financing from Global Tech Opportunities 13, a member of the Alpha Blue Ocean group and the company’s convertible debt (OCEANE-BSA) holder. This refinancing will be used to pay off the outstanding €8m in venture debt obligations to IPF Partners (raised in 2018), releasing Pharnext from the restrictive covenants requiring it to maintain a €8m cash balance. Additionally, the funds will serve as an alternative source of financing ...
- Sean Conroy
Pharnext - PREMIER trial completes patient recruitment
Pharnext has announced it has completed patient enrolment in the pivotal Phase III PREMIER trial evaluating PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A) meeting its previously announced timeline of Q222. This follows the recently presented positive data from the long-term open-label PLEO-CMT-FU study, which continued to show a sustained benefit for patients after five years of treatment and which has a strong read-across for the PREMIER trial, in our view. Recruitment com...
New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit...
New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time New data from the ongoing Open-Label Phase III Extension Study of PXT3003, the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time126 patients with mild-to-moderate Charcot-Marie-Tooth Disease Type 1A are still on treatment with PXT3003 High Dose in the PLEO-CMT-FU trial PARIS, France, May 16th, 20...
New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit...
New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time New data from the ongoing Open-Label Phase III Extension Study of PXT3003, the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial ti...
- Sean Conroy
Pharnext - Convertible debt terms revised
Due at least in part to significant recent share price depreciation, Pharnext has announced a revision in the terms of its June 2021 convertible debt financing (OCEANE-BSA). Effective February 2022, the number of tranches will be reduced to 12 from 35, with the last five tranches to be issued between January and May 2022 for total proceeds of €15m. As of 28 December, the first six tranches have been drawn down for gross proceeds of €20.5m. This development has the potential, in time, to reassure...
- Sean Conroy
Pharnext - Convertible debt terms revised
Due at least in part to significant recent share price depreciation, Pharnext has announced a revision in the terms of its June 2021 convertible debt financing (OCEANE-BSA). Effective February 2022, the number of tranches will be reduced to 12 from 35, with the last five tranches to be issued between January and May 2022 for total proceeds of €15m. As of 28 December, the first six tranches have been drawn down for gross proceeds of €20.5m. This development has the potential, in time, to reassure...
- Sean Conroy
Pharnext - Clinically healthy
The past weeks have been eventful for Pharnext, with the company releasing its H121 results, announcing multiple C-Suite appointments, and conducting its R&D day. On the business front, the financing situation appears manageable following the June 2021 convertible debt financing, and the pivotal Phase III PREMIER trial remains on track to conclude enrolment in Q222. However, the continued stock price softness (triggered by the financing) remains an overhang. We believe there is the possibility f...
- Sean Conroy
Pharnext - Clinically healthy
The past weeks have been eventful for Pharnext, with the company releasing its H121 results, announcing multiple C-Suite appointments, and conducting its R&D day. On the business front, the financing situation appears manageable following the June 2021 convertible debt financing, and the pivotal Phase III PREMIER trial remains on track to conclude enrolment in Q222. However, the continued stock price softness (triggered by the financing) remains an overhang. We believe there is the possibility f...
- Sean Conroy
Pharnext - Back in the saddle again
In many respects, 2020 was a year of rebuilding for Pharnext following the disruption in its previous Phase III clinical study of PXT3003 for the treatment of Charcot-Marie-Tooth disease, type 1A (CMT1A). While showing positive results, the study’s high dose arm was prematurely discontinued due to a manufacturing issue. In 2020, Pharnext completed gathering data from the study and met with the FDA and other authorities in preparation for the re-initiation of its pivotal Phase III clinical progra...
Interim Analysis from the Ongoing Open-Label Phase III Extension Study...
Interim Analysis from the Ongoing Open-Label Phase III Extension Study Shows Sustained Benefits of PXT3003 for Patients with Charcot-Marie-Tooth Disease Type 1A (‘CMT1A’) Interim Analysis from the Ongoing Open-Label Phase III Extension Study Shows Sustained Benefits of PXT3003 for Patients with Charcot-Marie-Tooth Disease Type 1A (‘CMT1A’) New results suggest good safety profile and sustained efficacy of PXT3003 as measured with the Overall Neuropathy Limitation Scale (‘ONLS’), after 4.5 years of total trial time. A live conference call and webcast will be held tomorrow, Thursday April 29...
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