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Pixium Vision announced that safeguard proceedings have been opened by the Commercial Court of Paris. Despite the company’s best efforts in seeking financing options to extend its funding runway, it has determined that it may not be able to satisfy its financial obligations after the end of November 2023 without the protection of such proceedings. Given its liquidity risk and the absence of new financing to date, Pixium requested that the Commercial Court of Paris open safeguard proceedings. As the Court has now appointed other parties (SCP Abitbol & Rousselet and Selarl FHB) as co-administrators with supervisory responsibility for Pixium, we estimate the likelihood of any material residual value remaining attributable to the common equity holders of Pixium Vision following the court proceedings as highly speculative. As such, we are withdrawing our estimates and forecasts.
Pixium Vision
Pixium Vision recently announced that it has received a €3m bridge financing loan from shareholders Sofinnova (€1m) and Bpifrance (€2m), which extend its cash runway through to the end of November. The loan will bear interest at 12% pa and mature on 31 July 2023. The loan is a positive step and signal of confidence from these two institutional investors as Pixium works towards securing broader additional financing to bring it past the conclusion of the PRIMAvera European pivotal study, for which results are still anticipated in or around year-end 2023. We maintain our pipeline rNPV valuation of €140.1m but our equity valuation per pre-consolidation basic share is €0.90 (vs €0.92 previously) after adjusting for estimated H123 net debt.
Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pixium has since taken further steps to curb its cash burn rate, and it now expects its funds on hand (€4.7m gross cash as of 31 March) to last until approximately the end of July, versus its prior guidance of June 2023. It is working actively to raise additional funds and has hired two investment banks to reach potential investors worldwide. We have rolled forward our estimates and given that we expect the company’s focus in 2023 and 2024 will be on preparing the Prima System for EU market approval and launch (which we continue to model in H125), we have pushed back our US commercialisation forecast by one year, to H227. We now obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously).
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation (BDD) to Pixium’s wireless Prima bionic vision system (BVS), which is currently being assessed in the European PRIMAvera pivotal study in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). This achievement suggests that the FDA recognises GA-AMD is an irreversibly debilitating human disease and that Prima BVS has the potential to provide an effective treatment in this area of unmet need. Pixium remains on track to report top-line data from PRIMAvera in or around year-end 2023. If positive, a CE Mark regulatory marketing submission can be filed in 2024, which we estimate could lead to commercialisation of the Prima system in H125.
Pixium has terminated its convertible note financing arrangement with the European Select Growth Opportunities Fund (ESGO) without any penalties. The termination is not surprising, given the arrangement required a minimum share price of €0.25 for Pixium to be permitted to issue any additional convertible notes beyond the initial 550 (representing €5.5m; each note had a nominal value of €10,000) that formed part of the first (and only) tranche issued. Pixium’s share price had remained below this minimum price threshold since August 2022 and the company acknowledged in October 2022 that it was not able to draw further tranches. Pixium reiterates that it is funded until the end of Q223 and is exploring various mechanisms to secure its cash flow necessary to pursue its strategic and development objectives.
Pixium has announced the publication of data in three peer reviewed journals highlighting that its second-generation (2G) Prima sub-retinal implant chip has the potential to restore vision at an up to five times higher spatial resolution than the current-generation (1G) implant chip. While the 1G implant is being advanced for patients with severe vision loss due to dry age-related macular degeneration (dry AMD), we believe the 2G Prima, if successful, can significantly expand the addressable target market to patients with less severe forms of the disease. Pixium is developing the 2G Prima in collaboration with Stanford University and it holds a worldwide exclusive licence to the technology. The company plans to start clinical trials with the 2G Prima implant chip within the next two years.
Meeting its prior guidance, Pixium Vision has now completed all of the implantations required as part of the PRIMAvera pivotal trial assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). In total, 38 patients have been implanted with the Prima sub-retinal photovoltaic device and Pixium expects to report primary endpoint data around the end of 2023, filing for European approval in H124. We continue to model for EU market approval in H125.
Coverage dropped From 11th October, we will no longer include in our research universe companies below 4D PHARMA CORPORATE | 360p HUMANIGEN U.R | U.R THERANEXUS CORPORATE | EUR20 BONE THERAPEUTICS CORPORATE | EUR2.5 PIXIUM VISION CORPORATE | EUR3.4
PIX BIOS BOTHE ALTHX HGEN HGENQ DDDD PXMVF
Meeting its prior guidance, Pixium Vision announced that it has now reached its enrolment target of 38 patients for the PRIMAvera pivotal trial assessing the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company has also established a waiting list for additional patients in the event that any of the currently enrolled 38 patients become ineligible for implantation or drop out of the study. Pixium expects to complete all implantation procedures of the Prima sub-retinal photovoltaic device by year-end FY22, and to report primary endpoint data at around year-end 2023.
Pixium Vision announced the successful first implantation of a patient in Italy as part of the PRIMAvera pivotal trial assessing the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The expansion of PRIMAvera to Italy follows implantations occurring at sites in France, Germany, the UK and the Netherlands. The company reiterated its guidance that it expects to complete PRIMAvera study patient enrolment by year-end FY22, and to report primary endpoint data at around year-end 2023. The PRIMAvera study is the final clinical trial needed before European market authorisation can be sought, and we continue to estimate that Pixium could receive potential European market approval and launch the product in H125.
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