Lysogene announces its financial results for the first half of 2022


PARIS–(BUSINESS WIRE)–Regulatory news:

Lysogen (FR0013233475 – LYS) (Paris:LYS), a gene therapy platform company in phase 3 targeting diseases of the central nervous system (CNS), today publishes its financial results for the first half of 2022, approved by the Board of Directors on September 23, 2022. Financial statements have been reviewed by the Company’s auditors. The full half-year financial report is available on the Company’s website in the Investors section.

Karen Aiach, Founder, President and CEO of Lysogene, said: “We are finally reaching the most exciting moment in Lysogene’s journey, as results from our lead gene therapy candidate, LYS-SAF302, are expected in the coming weeks. The data set is currently being analyzed by independent data providers and we look forward to having a full view of the efficacy of our drug candidate to hopefully confirm the positive preliminary efficacy signal observed so far. ‘now. Based on these results, we will be able to discuss the next steps with the regulatory authorities. » Karen Aich added: “We also continue to work on strategic options to expand the company’s cash runway to fund the development of our extensive pipeline of preclinical programs targeting high-prevalence diseases.”

Selected financial information as of June 30, 2022 (IFRS accounts)

Statement of comprehensive income

in thousands of euros

06/30/2022

06/30/2021

Operating result

Revenue

8,439

2,922

Other exploitation products

1,603

1,305

Total operating result

10,042

4,227

Operating Expenses

Research and Development expenses

(6,512)

(6,859)

General and administrative expenses

(2,625)

(2,566)

Total operating expenses

(9,137)

(9,425)

Operating result

905

(5,198)

Net financial income (expenses)

(202)

(333)

Net profit (loss)

703

(5,531)

Weighted average number of shares outstanding

17,385,028

16,794,212

Earnings per share (€)

0.04

(0.33)

Number of shares outstanding as of June 30, 2022: 17,811,140

Cash position as of January 1

12,336

18,780

Change in net cash

(4,616)

(3,710)

Cash position as of June 30

7,720

15,070

In the first half of 2022, total operating income reached €10.0 million compared to €4.2 million in 2021 with:

  • Revenue of €8.4 million compared to €2.9 million in 2021. Until December 31, 2021, payments made by Sarepta under the license-collaboration agreement were recognized on a pro rata basis of internal direct costs and related to the development of LYS-SAF302 in accordance with IFRS 15.

Due to the termination of the agreement notified on January 11, 2022, the Company fully recognized in the first half of 2022 all the payments remaining due to Sarepta for an amount of €8.4 million.

  • Other operating income amounts to €1.6 million and is mainly made up of the Research Tax Credit.

Operating Expenses amounted to €9.1 million in the first half of 2022 compared to €9.4 million in 2021 with:

  • Research and Development costs of €6.5m, down €0.3m compared to 2021 mainly due to:

    • a reduction in payroll costs linked to the change in the workforce over the period and a lesser impact of free share plans,

    • external expenses almost stable over the period with an increase in expenses related to the production campaign for the LYS-GM101 clinical batches, offset by a decrease in expenses related to litigation since the Company recorded in 2021 an impact of $2.8 million from the settlement of a commercial dispute with an industrial partner.

  • General and administrative expenses of €2.6 million, up slightly compared to 2021 with:

    • an increase in external costs, particularly related to legal fees related to the structuring of financing,

    • partially offset by a drop in personnel costs due to the change in the workforce over the period and a lesser impact of free share plans.

Net financial result is negative by €0.2 million composed of commissions and accrued interest on loans granted to the Company at the end of 2021 and beginning of 2022.

The net profit for the period was €0.7 million compared to a net loss of €5.5 million in 2021.

As of June 30, 2022, the Company’s cash amounted to €7.7 million. Based on the forecast cash flow, it would allow the Company to finance its operations until the end of January 2023.

To extend its cash trail, the Company has already initiated discussions to explore all possible strategic options. It is currently evaluating the following options: (i) a capital increase (private placement, public offering, capital lines or other capital instruments); (ii) debt financing (bond loan, repayable advance or risk loan); (iii) a license grant on one or more of its products to benefit from the initial and staggered payments linked to this collaboration.

Nevertheless, among all the possible options, the Company currently favors a non-dilutive option in the form of licensing collaboration on one or more of its products. Given the current low market capitalization, potential equity financings would be deemed highly dilutive. Debt financing is the least probable solution at this stage given that the Company has already taken out several debt instruments over the last 18 months for an amount of €11.9 million with the European Investment Bank, Banque Publique d’Investissement and Bred (see Note 10 to the financial statements).

In addition, the Company will continue its cost control initiatives initiated at the beginning of the year. To cover expenses already incurred and general costs until September 30, 2023, the Company estimates that it will need additional financing of €8 million (which could be reduced by €3.2 million from reimbursement of the 2022 Research Tax Credit). This amount assumes that no new R&D expenditure will be incurred from February 2023.

Clinical Update

LYS-SAF302 program

In the first half of 2022, the Company published the first efficacy data from the AAVance Phase 2/3 clinical trial evaluating LYS-SAF302 in patients with MPS IIIA.

The positive effect of LYS-SAF302 on heparan sulfate, a biomarker of MPS IIIA disease, in cerebrospinal fluid was confirmed with statistically significant decreases of approximately 20% in mean levels of total oligosaccharides derived from HS in CSF compared to baseline levels. In addition, the drug candidate seems to have a positive effect on the development of the youngest patients. In the 6 patients treated at less than 31 months, stable or continuously increasing cognitive, language and motor functions were observed, including subjects carrying SGSH mutations associated with the severe disease phenotype.

Full study results are expected in early Q4 2022, along with results from the PROVide study on patient-reported outcomes videos. Based on this comprehensive set of clinical data, the company plans to initiate discussions with regulatory authorities in the United States and Europe to determine next steps.

LYS-GM101 program

In the first half of 2022, the Company completed the recruitment of its phase 1 adaptive clinical trial with its investigational gene therapy LYS-GM101 in GM1 gangliosidosis which is designed to assess the safety of the drug candidate.

The five patients treated in this initial phase will be followed up and, depending on the results, the next phase of the study should be launched early next year with the recruitment of 12 additional patients.

About Lysogen

Lysogene is a gene therapy company focused on treating orphan diseases of the central nervous system (CNS). The Company has developed a unique capability to enable the delivery of gene therapies to the CNS to treat lysosomal storage diseases and other CNS disorders. A phase 2/3 clinical trial in MPS IIIA is underway. An adaptive clinical trial in GM1 gangliosidosis is also underway. Lysogene is also developing an innovative AAV gene therapy approach for the treatment of fragile X syndrome, a genetic disease linked to autism. The Company has also entered into an exclusive worldwide licensing agreement with Yeda, the commercial arm of the Weizmann Institute of Science, for a novel gene therapy candidate for Parkinson’s disease with GBA1 mutations. www.lysogene.com.

Forward-looking statement

This press release may contain certain forward-looking statements, particularly about the Company’s progress in its clinical trials and its cash trail. Although the Company believes that its expectations are based on reasonable assumptions, all statements other than statements of historical facts included in this press release regarding future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, (iii) results of clinical trials, (iv) increased manufacturing costs, (v) potential claims on its products. Such statements may include, but are not limited to, any statement preceded, followed by, or including words such as “target”, “believe”, “expect”, “aim”, “intend”, ” to be able”, “to anticipate”, “to estimate”. ,” “plan”, “aim”, “project”, “will”, “may have”, “probably”, “should”, “should”, “could” and other words and terms of similar meaning or their negative . Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from any expected results, performance or achievements expressed or implied. implied by these forward-looking statements. A more detailed list and description of these risks, uncertainties and other risks can be found in the regulatory documents filed by the Company with the Autorité des marchés financiers, including in the 2021 Universal Registration Document, registered with the Autorité. of the French markets on April 19, 2022, and future filings and reports of the Company. Further, these forward-looking statements speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn that it will or will not make additional updates with respect to such or other forward-looking statements.

This press release was written in French and English. In case of differences between the two texts, the French language version will prevail.

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