UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of September 2019

Commission File Number: 001-38281

ERYTECH Pharma S.A.

(Translation of registrant’s name into English)

60 Avenue Rockefeller

69008 Lyon France

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:  ☒  Form 20-F  ☐  Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

INCORPORATION BY REFERENCE

This Report on Form 6-K and Exhibit 99.1 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form F-3 (File No. 333-232669) and registration statements on Form S-8 (File Nos. 333-222673 and 333-232670), of ERYTECH Pharma S.A. (the “Company”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Half-Year Financial Report

On September 18, 2019, the Company issued a press release announcing its financial results for the first half of 2019. The Company’s half-year financial report, including its condensed consolidated financial statements as of June 30, 2019, is attached to this Report on Form 6-K as Exhibit 99.1.

Exhibits

Reference is made to the Exhibit Index included hereto.

EXHIBIT INDEX

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Exhibit 99.1

HALF-YEAR FINANCIAL REPORT

30 JUNE 2019

“I hereby certify that, to my knowledge, the condensed financial statements for the six-month period ended June 30, 2019 were prepared in accordance with applicable accounting principles and give a fair view of assets, financial position and results of the Company and all companies included in the scope of consolidation, and the half-year business report attached provides an accurate picture of the significant events during the first six months of the financial year, of their impact on the half-year financial statements, of the major transactions with related parties as well as a description of the main risks and uncertainties for the remaining six months of the financial year.”

Lyon, September 17, 2019

Gil BEYEN

Chief Executive Officer

			1  |  Page

May 2019:

June 2019:

The Company’s lead product candidate, eryaspase, is currently being evaluated in three clinical trials: one in pancreatic cancer, one in triple-negative breast cancer (TNBC) and one in acute lymphoblastic leukemia (ALL).

After obtaining positive results in a Phase 2b clinical trial in second line metastatic pancreatic cancer in 2017, TRYbeCA1, a Phase 3 clinical trial, was designed and launched to evaluate eryaspase in combination with standard chemotherapy compared to chemotherapy alone, in approximately 500 patients with second line metastatic pancreatic cancer in the United States and Europe. The primary endpoint of the trial is overall survival (OS). The TRYbeCA1 trial has received clinical trial approvals in eleven participating countries in Europe and is enrolling patients, first in Spain in September 2018 and in several of other countries. As mentioned as a “Major Event of the Period,” the FDA has accepted ERYTECH’s IND application for eryaspase in May 2019.

			2  |  Page

The acceptance of the IND will enable ERYTECH to initiate enrollment at U.S. clinical sites for the ongoing TRYbeCA1 trial and the Company expects to begin patient enrollment in the United States in the fourth quarter of 2019.

The Company selected triple negative breast cancer (TNBC) as the next target indication for broadening scope of the eryaspase product development in solid tumors. The Company launched a Phase 2/3 clinical trial in first-line metastatic TNBC, referred to as the TRYbeCA2 trial, is evaluating eryaspase in combination with chemotherapy, compared to chemotherapy alone in approximately 64 patients. . The primary endpoint of the trial is objective response rate.

Finally, in acute lymphoblastic leukemia (ALL), a Phase 2 clinical trial initiated in 2017 by investigators of the Nordic Society of Pediatric Haematology and Oncology (NOPHO). The trial is still ongoing in the Nordic countries of Europe, and evaluates eryaspase in ALL patients who experience hypersensitivity reactions or silent inactivation to PEG-asparaginase. This trial is expected to continue into 2020.

Alongside the development of eryaspase (GRASPA®), ERYTECH has conducted extensive research regarding its proprietary ERYCAPS® platform and to identify additional therapeutic enzymes that could induce tumor starvation by targeting tumor metabolism, and whose encapsulation in red blood cells would be relevant. The Company is developing a second drug candidate, erymethionase, which consists of the encapsulation of methionine-g-lyase (MGL) in red blood cells. Subject to ongoing preclinical toxicity studies and other feasibility assessments, the Company may launch the clinical development of erymethionase.

To complement its technology platform, the Company has developed at preclinical stage the ERYMMUNE project, which aims at treating cancers by using the ERYCAPS® platform to induce an immuno-modulation response, and the ERYZYME project that aims at using the ERYCAPS® platform to treat rare and chronic metabolic diseases.

Both ERYZYME and ERYMMUNE projects have been developed and incubated preclinically in view of exploring various value creation options, including partnerships. As part of this strategy, ERYTECH entered into an agreement with SQZ Biotechnologies, which aims to advance novel red blood cell-based therapeutics for immune modulation.

To meet the demand for eryaspase in current and future clinical studies and to ensure the supply of eryaspase for the initial marketing phase in the event of regulatory approval, the Company is in the process of building a new U.S. manufacturing facility in Princeton, New Jersey, United States and increasing its production capacity at its Lyon site in France. ERYTECH expects these two capacity extensions to be operational for the production of clinical batches in 2019.

As of June 30, 2019, the Company owned 15 patent families with more than 250 issued patents globally.

			3  |  Page

Operating income

To date, the Company has not generated any revenue from the sale of its products.

Revenues from licenses or other contracts consisted of:

Operating expenses

The research and development expenses are broken down as follows:

The increase in research and development expenses is mainly due to:

				4  |  Page

The general and administrative expenses are broken down as follows:

The increase in general and administrative expenses is mainly due to a €2,194 thousand increase in services and subcontracting, primarily related to to costs related to the establishment of the Princeton manufacturing facility.

Financial income (loss)

The financial income (loss) is mainly comprised of:

Cash position

The Company’s cash and cash equivalents were €94.4 million as of June 30, 2019 compared to €134.4 million as of December 31, 2018, representing a cash utilization of €40 million during the first half of 2019. The cash was primarily used as part of:

In the second half of 2019, ERYTECH will mainly focus on the execution of its clinical development strategy with:

				5  |  Page

No significant event occurred after the close of the reporting period.

Transactions with related parties are consistent with those set out in Items 6.B “Compensation” and 7.B “Related party transactions” of the Annual Report on Form 20- F filed with the United States Securities and Exchange Commission (“SEC”) on March 29, 2019. Note that:

The remuneration of directors and other members of the executive committee is disclosed in the section 5.16 of the half-year financial report.

The risks and uncertainties likely to have a significant impact on the Company’s financial situation and results are consistent with those set out in Item 3.D “Risk factors” of the Annual Report on Form 20- F filed with the SEC on March 29, 2019.

The Company does not anticipate any changes in these risk factors during the second half of 2019.

			6  |  Page

III. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2019

CONSOLIDATED STATEMENT OF INCOME (LOSS)

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS)

The Company applied IFRS 16 standard for the first time as of January 1, 2019, using the modified retrospective approach. Under this approach, the comparative information is not restated.

				7  |  Page

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

The Company applied IFRS 16 standard for the first time as of January 1, 2019, using the modified retrospective approach. Under this approach, the comparative information is not restated.

				8  |  Page

CONSOLIDATED STATEMENT OF CASH FLOW

The Company applied IFRS 16 standard for the first time as of January 1, 2019, using the modified retrospective approach. Under this approach, the comparative information is not restated.

				9  |  Page

CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY

The Company applied IFRS 16 standard for the first time as of January 1, 2019, using the modified retrospective approach. Under this approach, the comparative information is not restated.

				10  |  Page

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The notes are an integral part of the accompanying condensed consolidated financial statements. The condensed consolidated financial statements were approved and authorized for issuance by the Board of Directors of the Company on September 16, 2019.

1. DESCRIPTION OF THE BUSINESS

ERYTECH Pharma S.A. (“ERYTECH,” and together with its subsidiary the “Company”) is incorporated in Lyon, France, and was founded in 2004 to develop and market innovative red blood cell-based therapeutics for cancer and orphan diseases. The Company’s most advanced product candidates are being developed for the treatment of pancreatic cancer.

The Company completed its initial public offering on Euronext Paris in May 2013, raising €17.7 million and a follow-on offering of €30.0 million (on a gross basis before deducting offering expenses), in October 2014. The initial public offering triggered the conversion of the totality of the convertible bonds previously issued. Two private placements of respectively 940,000 ordinary and 793,877 ordinary shares for €25.4 million and €9.9 million (on a gross basis before deducting offering expenses) were completed in December 2015 and 2016 with institutional investors in the United States and in Europe. In April 2017, the Company completed a follow-on offering of €70.5 million (on a gross basis before deducting offering expenses). The Company completed an initial public offering on the Nasdaq Global Select Market raising €124 million ($144 million on a gross basis before deducting offering expenses).

The Company has incurred losses and negative cash flows from operations since its inception and had shareholders’ equity of €117,025 thousand as of June 30, 2019 as a result of several financing rounds, including an initial public offering. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates.

The Company’s future operations are highly dependent on a combination of factors, including: (i) the success of its research and development; (ii) regulatory approval and market acceptance of the Company’s proposed future products; (iii) the timely and successful completion of additional financing; and (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies. As a result, the Company is and should continue, in the short to mid-term, to be financed through partnership agreements for the development and commercialization of its drug candidates and through the issuance of new debt or equity instruments.

The accompanying condensed consolidated financial statements and related notes (the “Condensed Consolidated Financial Statements”) present the operations of ERYTECH Pharma S.A. and its subsidiary, ERYTECH Pharma, Inc.

				11  |  Page

Major events of the first half of 2019

Business

May 2019:

June 2019:

Management

January 2019:

April 2019:

June 2019:

				12  |  Page

2. STATEMENT OF COMPLIANCE

The Condensed Consolidated Financial Statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standard Board (“IASB”) and were approved and authorized for issuance by the Board of Directors of the Company September 16, 2019.

Due to the listing of ordinary shares of the Company on Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, the Condensed Consolidated Financial Statements of the Company are also prepared in accordance with IFRS, as adopted by the European Union (EU).

As of June 30, 2019, all IFRS that the IASB had published and that are mandatory are the same as those adopted by the EU and mandatory in the EU. As a result, the Condensed Consolidated Financial Statements comply with International Financial Reporting Standards as published by the IASB and as adopted by the EU.

The Condensed Consolidated Financial Statements as of June 30, 2019 have been prepared in accordance with the standard IAS 34, “Interim financial reporting.” As condensed financial statements, they do not include all information that would be required by the full IFRS standards. They must be read in conjunction with the consolidated financial statements for the year ended December 31, 2018.

Except for the standards applicable as of January 1, 2019 described below, the standards applied in the preparation of the Condensed Consolidated Financial Statements are the same as those applied to prepare the financial statements as of December 31, 2018.

The Company adopted the following standards, amendments and interpretations that are mandatory as of January 1, 2019:

These new texts did not have any significant impact on the Company’s results or financial position with the exception of IFRS 16 (refer to note 3.4).The standards and interpretations that are optionally applicable to the Company as of June 30, 2019 were not applied in advance.

Recently issued accounting pronouncements that may be relevant to the Company’s operations but have not yet been adopted are as follows:

				13  |  Page

3. SIGNIFICANT ACCOUNTING POLICIES

3.1 Scope of consolidation

Details of the Company’s subsidiary as of June 30, 2019 are as follows:

3.2 Foreign currencies

Functional Currency and Translation of Financial Statements into Presentation Currency

The Condensed Consolidated Financial Statements are presented in euros, which is also the functional currency of the parent company, ERYTECH Pharma S.A.

The exchange rates used for the preparation for the translation of the financial statements of ERYTECH PHARMA, Inc. are as follows:

3.3 Use of estimates and judgments

Preparation of the Condensed Consolidated Financial Statements in accordance with the rules prescribed by the IFRS requires the use of estimates and the formulation of assumptions having an impact on the financial statements. These estimates can be revised where the circumstances on which they are based change. The actual results may therefore differ from the estimates initially formulated. The main estimates are described in the annual consolidated financial statements, except new significant judgments linked to the accounting treatment of the leases in accordance with IFRS 16, as described in note 3.4.

3.4 Change in accounting policies

The Company applied IFRS 16 – Leases for the first time as of January 1, 2019.

IFRS 16 eliminates the distinction between operating leases and finance leases and requires all leases to be recognized on the lessee’s balance sheet, in the form of an asset (representing the right to use the rented asset during the duration of the contract – see note 5.3) and of a liability (corresponding to the future lease payments – see note 5.12). The standard also impacts the presentation of the income statement (allocation of expense between operating loss and financial charges) and the cash flow statement (allocation of cash outflows between cash flow from operating activities and cash flow from financing activities).

The Company has applied the modified retrospective approach. Under this approach, the cumulative effect of initially applying IFRS 16 is recognized as an adjustment to equity at the transition date, i.e. January 1, 2019. Consequently, the comparative information disclosed for 2018 were not restated. There are disclosed as previously in accordance with IAS 17 standard and its interpretations. The consequence of this change in accounting policies are disclosed in detail below.

Definition of a lease

Until the current period, the Company determined at the signing of the contract whether an agreement constituted or included a lease in accordance with the provisions of IFRIC 4, “Determining Whether an Arrangement Contains a Lease.” As a lessee, the Company previously classified lease agreements as operating or finance leases by assessing whether the contract transferred substantially all the risks and benefits inherent in the ownership in accordance with IAS 17.

				14  |  Page

The Company now assesses whether a contract is or contains a lease in accordance with IFRS 16, i.e. whether it grants the right to control the use of an identified asset for a certain period in exchange for consideration.

At the transition date, the Company chose to apply the simplification measure of keeping past analyses for the identification of leases and applying IFRS 16 only to contracts previously classified as leases.

Significant accounting policies

In accordance with IFRS 16, the right of use and the lease liability are recognized on the lessee’s balance sheet when the asset linked to the lease agreement become available:

The right of use is subsequently measured at cost less depreciation and any accumulated impairment loss. The amount can be adjusted based on certain revaluations of the lease liability.

The lease liability is then increased by the interest expense and decreased by the rents paid.

The lease liability may be remeasured in the following situations:

The duration corresponds to the firm period of the commitment and takes into account the optional periods that are reasonably certain to be exercised.

The Company has used its judgment in determining the term of the lease agreements providing for an extension option. The fact that the Company has determined that it is reasonably certain to exercise such options affects the lease term and has a significant impact on the amount of the right of use and the lease liability.

Transition information

At the transition date, the lease liability linked to contracts classified as operating leases in accordance with IAS 17 (mainly real estate) was measured at the value of the remaining lease payments discounted at the marginal borrowing rate as of January 1, 2019. The right of use is measured at an amount equal to the lease liability, corrected with lease payments prior to the commencement date or remaining due in the statement of financial position.

For contracts previously classified as finance leases, the value of the right of use and the lease liability as of January 1, 2019 were determined as those of the underlying asset and the lease debt that were calculated in accordance with IAS 17.

The Company has applied simplification measures set out in IFRS 16 regarding:

				15  |  Page

As part of the transition to IFRS 16 as of January 1, 2019, the Company recognized in liabilities a lease liability of €7,734 thousand (refer to note 5.12) and in assets a right of use of €7,443 thousand (refer to note 5.3) taking into account a liability of €291 thousand recognized in the statement of financial position as of December 31, 2018.

The discount rates applied for contracts previously classified as operating leases are based on the Company’s marginal borrowing rate, to which is added a spread which takes into account the total duration of the contract. The average marginal borrowing rate selected as of January 1, 2019 is 1.4% in France and 3.8% in the United States.

The gap between the off-balance sheet commitments disclosed in note 8 of the Consolidated financial statements as of December 31, 2018 and the lease liability recognized as of January 1, 2019 in accordance with IFRS 16 (see note 5.12) can be explained as follows:

Impact on the half-year financial statements

In accordance with IFRS 16, the Company recognized as of June 30, 2019:

3.5 Presentation of the statement of income (loss)

The Company presents its statement of income (loss) by function. As of today, the main activity of the Company is research and development. Consequently, only research and development expenses and general administrative expenses functions are considered to be representative. This distinction reflects the analytical assignment of the personnel, external expenses and depreciation and amortization. The detail of the expenses by nature is disclosed in note 4.2.

3.6 Presentation of the statement of cash flow

For the financial year ended December 31, 2018, the line “acquisition of property, plant and equipment “ in the consolidated statement of cash flow included an amount of fixed assets payables not yet paid of €8,587 thousand, which should not have been included in this line.

The net cash flows used in 2018 should have been as follows:

From January 1, 2018 to June 30, 2019, the cumulative amount of cash flows used in the acquisition of property, plant and equipment amounted to €23.3 million and related mainly to the increase of the production capacity of the Company’s manufacturing facilities in Lyon and Princeton.

				16  |  Page

3.7 Segment reporting

In accordance with IFRS 8, “Operating Segments,” reporting by operating segment is derived from the internal organization of the Company’s activities; it reflects management’s viewpoint and is established based on internal reporting used by the chief operating decision maker (the Chief Executive Officer) to allocate resources and to assess performance.

The Company operates in a single operating segment: the conducting of research and development of innovative red blood cell-based therapeutics for cancer and orphan diseases in order to market them in the future.

3.8 Events after the close of the reporting period

No significant event occurred after the close of the reporting period.

				17  |  Page

4. NOTES RELATED TO THE CONSOLIDATED STATEMENT OF INCOME (LOSS)

4.1 Operating income

The Company does not generate any revenue from the sale of its products considering its stage of development.

Revenues from licenses or other contracts

Revenues from licenses or other contracts comprised:

4.2 Operating expenses by nature

4.2.1 Research and development expenses

The increase in research and development expenses is mainly due to:

				18  |  Page

4.2.2 General and administrative expenses

The increase in general and administrative expenses is mainly due to a €2,194 thousand increase in services and subcontracting, primarily related to costs related to the establishment of the Princeton manufacturing facility.

4.3 Personnel expenses

4.3.1 Research and development expenses

The increase in personnel expenses is mainly due to an increase in research and development employee headcount. The weighted average full-time employees (FTE) was 142 during the first half of 2019 and 87 during the first half of 2018.

4.3.2 General and administrative expenses

The increase in personnel expenses is due to an increase in general and administrative employee headcount. The weighted average full-time employees (FTE) was 43 during the first half of 2019 and 34 during the first half of 2018.

				19  |  Page

4.3.3 Share-based payments (IFRS 2)

Share subscription warrants (“BSA”) plan

The main assumptions used to determine the fair value of the plans granted during the first half of 2019 are:

Stock-options (“SO”) plan

The main assumptions used to determine the fair value of the plans granted during the first half of 2019 are:

				20  |  Page

Free shares (“AGA”) plan

The main assumptions used to determine the fair value of the plans granted during the first half of 2019 are:

				21  |  Page

Breakdown of expenses per half-year