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Theranexus
Earnings Release • Apr 29, 2024
1703_iss_2024-04-29_1015bd2d-de97-4a93-82f8-f2faa69ce010.pdf
Earnings Release
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THERANEXUS PUBLISHES ITS 2023 FULL-YEAR RESULTS AND PRESENTS ITS PROGRESS REPORT
Lyon, France – 29 April 2024 – 6pm CET – Theranexus, a biopharmaceu2cal company innova2ng in the treatment of rare neurological diseases, today publishes its results for the year ending 31 December 2023 and its cash posi2on as of 31 March 2024, and presents its progress report.
"During 2023, we concentrated our efforts on conduc5ng the Phase I/II clinical trial of our Ba=en-1 drug candidate, receiving posi5ve opinions from the Food and Drug Administra5on (FDA) and the European Medicines Agency (EMA) on the design of our Phase III trial for Ba=en disease. The posi5ve 18-month efficacy and safety results announced recently illustrate the strong therapeu5c poten5al of Ba=en 1. We are currently exploring various funding op5ons to begin the trial that should enable us to gain approval for Ba=en-1. At the same 5me, we are con5nuing our research with the AlstroSight project team and Inserm Transfert to iden5fy and characterize novel, innova5ve therapeu5c targets for rare neurological diseases. In the same vein, in collabora5on with Diverchim and Inserm's ARNA laboratory, we are sponsoring the PickASO project which aims to develop an innova5ve drug candidate, the first an5sense oligonucleo5de targe5ng the TFEB protein regula5ng autophagy. Our ambi5on is to broaden and enhance our porZolio of products in the field of rare neurological diseases with significant unmet medical needs", explained Theranexus Chairman and CEO, Mathieu Charvériat.
| €K | 2023 | 2022 |
|---|---|---|
| Turnover | - | - |
| Operating income | 319 | 1,246 |
| Other purchases and external charges | 5,076 | 3,967 |
| Wages and social security charges | 2,600 | 3,165 |
| Amortization and depreciation of fixed assets |
256 | 332 |
| Other operating expenses | 31 | 39 |
| Operating expenses | 7,963 | 7,503 |
| Net operating income/(expenses) | (7,644) | (6,257) |
| Net financial income/(expense) | 14 | (158) |
| Non-recurring expenses | - | (771) |
| Income tax | 802 | 619 |
| Net income/(expense) | (6,828) | (6,567) |
2023 annual financial results (French GAAP)
The 2023 full-year results were approved by the company's Board of Directors on 29 April 2024 and were the subject of a report by the company's Statutory Auditors.
As in 2022, opera2ng income for 2023 (€319 K) mainly consisted of opera2ng grants: in par2cular €239 K awarded by BPI France for the balance of the PSPC Neurolead project, and €52 K funded by ANR for the NI2D project co-developed with CERMEP.
Other external charges (€5,076 K in 2023 compared with €3,967 K in 2022) mainly included R&D costs incurred by the company. The increase recorded is due to the study purchases and research services item rela2ng to the con2nua2on of the Phase I/II clinical trial for Ba`en-1. The trial began in the first half of 2022, with progressive recruitment of pa2ents during 2022, which explains the lower 2022 expenses compared to 2023.
Wages and salaries registered a significant decline between 2022 and 2023, falling from €3,165 K to 2,600 K. This substan2al decline is due to the departure of two staff members who are yet to be replaced, the end of appren2ceship and internship contracts, and the absence of variable salary components for the 2023 financial year (unlike in 2022 during which bonuses were paid).
Amor2za2on and deprecia2on costs for 2023 were €256 K compared to €332 K in 2022.
The net financial result for 2023 benefited from interest rates that were higher than during the previous year, and therefore rose as a result of interest on cash investments.
The major part of the €802 K tax income is due to Research Tax Credit (CIR). For 2023, Research Tax Credit stood at €785 K. The calcula2on includes grants and repayable advances received for the NeuroLead project, which are deducted from the expenses eligible under the program. Research Tax Credit was €583 K for 2022.
Cash posi:on as of 31 March 2024
On 31 March 2024, total available funds stood at €3.1 M, which added to the expected payments due (final PSPC Neurolead payment, reimbursement of the 2023 Research Tax Credit), will cover cash requirements un2l early Q2 2025.
The company is considering different solu2ons to fund its ac2vity beyond that date:
- A partnership agreement for its most advanced drug candidate Batten-1; and/or
- A capital raise.
Arrival of Chris:ne Placet as Chief Financial Officer
"Moreover, we are delighted to welcome Chris5ne Placet as our new Chief Financial Officer who takes over from Thierry Lambert. We sincerely thank Thierry, who supported the company since its IPO, for his strong commitment and we wish him all the very best for his future endeavors. Chris5ne joined Theranexus in early April. Her solid experience in the financing and running of biotech companies such as Trophos and Coave Therapeu5cs for some twenty years are undeniable assets for the financial running of Theranexus and the company's development strategy" concluded Theranexus Chairman and CEO, Mathieu Charvériat.
Chris2ne Placet graduated from Kedge Business School. Aher 8 years' experience with Ernst and Young, and 9 years of financial management in SMEs, in 2004 she joined the biotech Trophos as Chief Financial Officer and subsequently Chair of the Board of Directors un2l the company was sold to the Roche group
for €470 M in 2015. In 2016, Chris2ne Placet was appointed CEO of the biotech company Horama (now Coave Therapeu2cs). Aher two funding rounds of €4 M and €22 M, and ini2al product entry into the development phase, she recruited her successor to devote 2me to consul2ng from 2021 onwards. She joined Theranexus as Chief Financial Officer in April 2024.
Highlights of 2023 and Q1 2024
In January 2023 the company and its partner BBDF presented ini2al safety and pharmacokine2c results achieved in the Phase I/II trial to evaluate Baen-1 in Baen disease. Aher a 9-week course with the maximum dose of 600 mg/day in six pa2ents with juvenile Baen disease (CLN3) aged 17 and over, Baen-1 showed good user safety and tolerability, and a pharmacokine2c profile in line with expecta2ons.
In February 2023 the company formed a project team for rare neurological diseases, jointly with INRIA, Claude Bernard University Lyon 1 and Hospices Civils de Lyon.
In May 2023 Theranexus and its partner BBDF won approval from the FDA (American health authori2es) on efficacy endpoints for the future Phase III trial to evaluate Baen-1 in Baen disease (CLN3), then in June won the same approval from the European Medicines Agency (EMA).
In July 2023 the company raised funds of roughly €3.1 million through the issuance of 2,412,511 new shares. The American Beyond Ba`en Disease Founda2on took a 11.6% stake in the company (on a nondiluted post-fundraising basis).
In June and September 2023, the company and BBDF announced highly promising interim results aher 6 and 12 months of treatment in the Phase I/II trial for Ba`en disease (CLN3) with a reduc2on in neurofilaments (a neuronal death biomarker) and stabiliza2on of motor symptoms for treated pa2ents in comparison to the decline expected with the natural disease course.
The posi2ve final 18-month safety and efficacy data announced on 18 April 2024 also showed stabiliza2on of motor symptom progression in young adult pa2ents. These results are highly encouraging for pa2ents and their families, and in collabora2on with BBDF and the clinical trial inves2gators the company has implemented an Expanded Access Program (EAP) to enable the 6 trial pa2ents to con2nue receiving the treatment in view of its highly favorable risk-benefit profile.
The company does not currently have the funds to begin the pivotal Phase III trial in Europe and the United States for pa2ents with juvenile Ba`en disease before the end of 2024. It should secure funding, for example via one or a combina2on of the following routes: an industrial partnership, the issuance of shares or other securi2es giving access to capital, debt or non-dilu2ve funding (grants, repayable advances, etc.). Theranexus is considering all these op2ons to have the resources required for its development.
Lastly, the PickASO project sponsored by Theranexus, and its partners Diverchim and Inserm's ARNA laboratory received government support via the "Innova2ons in biotherapies and biomanufacturing" call for proposals under the France 2030 investment plan. The project will receive a €4.7 M, 3-year funding package broken down into grants and repayable advances. PickASO aims to produce a revolu2onary autophagy ac2va2on therapy with the development of a novel an2sense
oligonucleo2de, an innova2ve drug candidate targe2ng TFEB, the protein iden2fied as an autophagy regulator.
About Theranexus
Theranexus is an innova.ve biopharmaceu.cal company that emerged from the French Alterna.ve Energies and Atomic Energy Commission (CEA). It specializes in the treatment of rare neurological diseases. The company has a unique plaCorm for the iden.fica.on and characteriza.on of advanced therapy drug candidates targe.ng rare neurological disorders and an ini.al drug candidate in clinical development for BaFen disease.
Theranexus is listed on the Euronext Growth market in Paris (FR0013286259 - ALTHX).
For more informa2on:
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Contacts:
THERANEXUS Chris/ne PLACET Chief Financial Officer [email protected]
FP2COM Florence PORTEJOIE Medias Rela:ons + 33 (0)6 07 76 82 83 [email protected]
Disclaimer
This press release contains certain forward-looking statements concerning Theranexus and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Theranexus considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the universal registration document of Theranexus filed with the AMF on 27 April 2023 under number D.23-0345 (a copy of which is available on www.theranexus.com) and to the development of economic conditions, financial markets and the markets in which Theranexus operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Theranexus or not currently considered material by Theranexus. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Theranexus to be materially different from such forward-looking statements. Theranexus expressly declines any obligation to update such forward-looking statements.