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 November 2020
Commission File Number: 001-38281
ERYTECH Pharma S.A.
(Translation of registrants 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): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Press Release
Presentations at the American Society of Hematology Annual Meeting
On November 5, 2020, ERYTECH Pharma S.A. (the Company) issued a press release announcing that certain abstracts of the Company regarding eryaspase were selected for presentation at the 62nd American Society of Hematology Annual Meeting to be held in December 2020. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.
Business Update
On November 5, 2020, the Company issued a press release announcing its business update and financial results for the third quarter of 2020. A copy of this press release is attached to this Form 6-K as Exhibit 99.2.
EXHIBITS
Exhibit |
Description | |
99.1 | Press Release dated November 5, 2020. | |
99.2 | Press Release dated November 5, 2020. |
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.
ERYTECH Pharma S.A.
| ||||||
Date: November 6, 2020 | By: | /s/ Eric Soyer | ||||
Name | Eric Soyer | |||||
Title: | Chief Financial Officer and Chief Operating Officer |
Exhibit 99.1
PRESS RELEASE |
ERYTECH Announces Abstract with Results from Eryaspase
Phase 2 Trial in Acute Lymphoblastic Leukemia Selected for
Oral Presentation at the American Society of Hematology
2020 Annual Meeting
◾ | Oral presentation to discuss findings from the Nordic Society of Paediatric Haematology and Oncology (NOPHO)-sponsored Phase 2 trial that confirm the potential of eryaspase as a treatment option for ALL |
◾ | Second abstract of new analysis supporting population pharmacokinetics of eryaspase in patients with ALL or pancreatic adenocarcinoma will also be presented |
Lyon (France) and Cambridge, MA (U.S.), November 5th, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announces that an abstract detailing results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients, has been selected for oral presentation at the upcoming 62nd American Society of Hematology (ASH) Annual Meeting being held virtually December 5-8. A second abstract detailing population pharmacokinetics of eryaspase in ALL or pancreatic adenocarcinoma patients has been accepted for a poster presentation at the meeting.
Abstract #467: NOR-GRASPALL 2016 (NCT03267030): Asparaginase encapsulated in Erythrocytes (eryaspase) a promising alternative to PEG-asparaginase in case of hypersensitivity
The NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The study findings will be featured as an oral presentation at ASH by Dr. Line Stensig Lynggaard, representing NOPHO, on 6th December 2020 2.45pm PST/ 5.45pm EST / 11.45pm CET. Final results from this trial will be presented at the meeting.
The abstract can be found on-line at: https://ash.confex.com/ash/2020/webprogram/Paper139373.html
Abstract #2799: Population Pharmacokinetics of Eryaspase in Patients with Acute Lymphoblastic Leukemia or Pancreatic Adenocarcinoma
An analysis of the population pharmacokinetics (Pop PK) of eryaspase in patients with ALL or pancreatic adenocarcinoma (PAC) will be presented as a poster by Dr. Frank Hoke (ERYTECHs Head of Clinical Pharmacology) on Monday 7th December 2020 from 8am PST / 11am EST / 5pm CET. The analysis shows the extended circulation time of eryaspase, provides information on patient factors that influence the exposure of eryaspase, and evaluates patient population (PAC vs ALL) and formulation (native vs recombinant).
The abstract can be found on-line at: https://ash.confex.com/ash/2020/webprogram/Paper134377.html
We are proud to be working with the NOPHO group and look forward to their presentation of new clinical data for the treatment of ALL at ASH this year. Alongside the POP PK analysis, the reporting of the NOPHO study represents significant progress towards our goal of finding a potential path forward with the FDA for eryaspase in ALL, said Dr. Iman El-Hariry, ERYTECHs Chief Medical Officer. We believe that our science-driven approach to the development of eryaspase will provide a new option for people with ALL and, potentially, other haematological malignancies and solid tumours.
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Data included in the abstracts is based on data cut-offs in second quarter 2020. The final oral presentation and poster will include additional data collected between the abstract submission cut-off and the ASH congress.
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.
About ERYTECH and eryaspase
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECHs primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.
The Companys lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of first-line triple-negative breast cancer. An investigator-sponsored Phase 2 study in acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.
ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit www.erytech.com
Forward-looking information
This press release contains forward-looking statements including but not limited to statements with respect to the clinical development plans of eryaspase; the potential indications for and benefits of eryaspase; statements relating to the TRYbeCA-1 clinical trial, including the timeline for patient enrollment as well as expected timing of the availability of results and interim superiority analysis; potential impacts on the Companys clinical trials, including TRYbeCA-1 clinical trial, due to the coronavirus (COVID-19) pandemic such as delays in regulatory review, manufacturing and supply chain interruptions; and the overall impact of the COVID-19 pandemic on the global healthcare system as well as the Companys business, financial condition and results of operations. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, believes, anticipates, expects, intends, plans, seeks, estimates, may, will and continue and similar expressions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECHs control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results and timeline may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorité des Marchés Financiers (AMF), the Companys Securities and Exchange Commission (SEC) filings and reports, including in the Companys 2019 Document dEnregistrement Universel filed with the AMF on March 18, 2020 and in the Companys Annual Report on Form 20-F filed with the SEC on March 18, 2020 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECHs expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on the Companys business and operations is highly uncertain, and that impact includes effects on its clinical trial operations and supply chain. Factors that will influence the impact on the Companys business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on the Companys business, operations and financial results for an extended period of time.
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CONTACTS
ERYTECH Eric Soyer CFO & COO |
LifeSci Advisors, LLC Investor Relations Corey Davis, Ph.D. |
NewCap Mathilde Bohin / Investor relations Nicolas Merigeau Media relations | ||
+33 4 78 74 44 38 investors@ERYTECH.com |
+1 (212) 9152577 cdavis@lifesciadvisors.com |
+33 1 44 71 94 94 ERYTECH@newcap.eu |
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Exhibit 99.2
PRESS RELEASE |
ERYTECH Provides Business Update and
Reports Financial Results for the Third Quarter of 2020
Conference call and webcast on Friday, November 6
at 2:30 pm CET/8:30 am ET
◾ | TRYbeCA-1 Phase 3 trial in second-line metastatic pancreatic cancer: |
✓ | More than 95% of the approximately 500 patients enrolled |
✓ | Number of events required for the interim superiority analysis has been reached |
✓ | Interim superiority analysis expected to report in Q1 2021 |
◾ | NOPHO-sponsored Phase 2 trial in acute lymphoblastic leukemia: |
✓ | Patient enrollment completed: 55 patients enrolled |
✓ | Topline final data selected for oral presentation at ASH in December 2020 |
◾ | Appointment of Dr. Stewart Craig as Chief Technical Officer |
◾ | Cash and cash equivalents of 40.5 million ($47.5 million) at the end of September 2020 |
◾ | 10 million ($11.7 million) in non-dilutive financing secured in the form of state-guaranteed loans |
Lyon (France) and Cambridge, MA (U.S.), November 5, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today provided a business and financial update.
The third quarter was marked by continued momentum and strong execution across our late-stage clinical programs despite the ongoing COVID-19 global pandemic, said Gil Beyen, CEO of ERYTECH Pharma. TRYbeCA-1, our Phase 3 trial in 2L pancreatic cancer, has nearly completed enrollment and the NOPHO-sponsored Phase 2 trial in acute lymphoblastic leukemia (ALL) achieved full enrollment in August. As we look towards the balance of the year and into 2021, we are keenly focused on continued milestone execution in all of our clinical programs, but specifically the interim and final readouts in TRYbeCA-1 and the final data in the NOPHO Phase 2 clinical trial. If both are favorable, we would have the opportunity to prepare and submit applications for marketing approval in two indications of high unmet need. I am also pleased to report that we have secured financing alternatives despite the turbulent market conditions. Collectively, the recently secured state-guaranteed loan, the closing of a convertible debt financing, and the establishment of an ATM equity facility, give us the opportunity to extend our cash horizon until the end of next year.
Business Highlights
◾ | TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECHs lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, is nearing complete enrollment and the required number of events to trigger the interim superiority analysis has been reached. The Independent Data Monitoring Committee (IDMC) is expected to conduct the interim analysis in the first quarter of 2021. Since the interim analysis does not include a test for futility, there will be two possible outcomes: the trial will either (1) continue toward a final analysis, expected in the second half of 2021, or (2) conclude early for superiority if compelling improvement of overall survival is demonstrated. TRYbeCA-1 is being conducted in close to 90 clinical sites in the United States and 11 countries across Europe, and targets to enroll approximately 500 patients. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan based regimen) or |
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chemotherapy alone. The primary endpoint of TRYbeCA-1 is overall survival (OS). The trial is designed to identify an OS hazard ratio (HR) of 0.725 with close to 90% power. |
◾ | The Phase 2 clinical trial of eryaspase in acute lymphoblastic leukemia (ALL) patients who developed hypersensitivity to pegylated asparaginase, sponsored by the Nordic Organization of Pediatric Hematology and Oncology (NOPHO), completed enrollment in August 2020. Fifty-five patients have been enrolled at 22 clinical sites in the Nordic and Baltic countries of Europe. Preliminary findings of the trial suggest that eryaspase achieved the target level and duration of asparaginase activity in these patients. The addition of eryaspase to the combination chemotherapy was associated with an acceptable tolerability profile, enabling the majority of these patients to receive their fully intended courses of asparginase. Hypersensitivity to pegylated asparaginase represents an important unmet medical need, given the limited treatment choices for these patients. The abstract with interim data from the NOPHO trial has been selected for oral presentation at the ASH Annual Meeting in December 2020. Top-line final results will be presented at that occasion. ERYTECH plans to further discuss these data with the FDA to determine the potential next steps and to assess the path forward to potential approval for eryaspase in this indication. |
◾ | ERYTECH strengthened its leadership team with the appointment of Dr. Stewart Craig as its Chief Technical Officer (CTO) and member of the executive team. Dr. Craig brings 35+ years of experience in the development, manufacture, technical operations, quality systems and regulatory affairs for complex biologics and cell & gene therapies worldwide for companies such as Orchard Therapeutics, Sangamo and Stem Cells Inc. |
Financial Results for the first nine months of 2020
◾ | Key financial figures for the first nine months of 2020 compared with the same period of the previous year are summarized below: |
In thousands of euros |
3Q 2020 (9 months) |
3Q 2019 (9 months) |
||||||
Revenues |
| | ||||||
Other income |
2,890 | 3,881 | ||||||
|
|
|
|
|||||
Total operating income |
2,890 | 3,881 | ||||||
|
|
|
|
|||||
Research and development |
(42,940 | ) | (36,977 | ) | ||||
General and administrative |
(11,448 | ) | (13,743 | ) | ||||
Total operating expenses |
(54,389 | ) | (50,720 | ) | ||||
|
|
|
|
|||||
Total operating loss |
(51,499 | ) | (46,839 | ) | ||||
|
|
|
|
|||||
Financial income |
573 | 3,975 | ||||||
Financial expenses |
(2,625 | ) | (392 | ) | ||||
Financial income, net |
(2,052 | ) | 3,582 | |||||
|
|
|
|
|||||
Loss before tax |
(53,551 | ) | (43,257 | ) | ||||
|
|
|
|
|||||
Income tax |
(2 | ) | 1 | |||||
|
|
|
|
|||||
Net loss |
(53,553 | ) | (43,256 | ) | ||||
|
|
|
|
◾ | Net loss for the first nine months of 2020 was 53.6 million, up 10.3 million (+24%) year-over-year, with a 4.7 million increase (+10%) in operating loss and a 5.6 million decrease in financial income. The 4.7 million increase in operating loss was attributable to a 6.0 million increase in preclinical and clinical development expenses, mostly related to expenses for the Companys Phase 3 clinical trial in pancreatic cancer, a 2.3 million decrease in general and administrative expenses, which was related to the end of expenses related to the establishment of the manufacturing capacity, mostly incurred in 2019, and a 1.0 million decrease in income, of which 0.9 million consisted in the upfront payment from the June 2019 license agreement with SQZ Biotechnologies that did not recur in 2020. |
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◾ | As of September 30, 2020, ERYTECH had cash and cash equivalents totaling 40.5 million (approximately $47.5 million), compared with 73.2 million on December 31, 2019 and 45.4 million on June 30, 2020. The 32.7 million decrease in cash position during the first nine months of 2020, consisting of 14.6 million in the first quarter of 2020, 13.1 million in the second quarter and 4.9 million in the third quarter, was the result of a 32.3 million net cash utilization which was mostly comprised of a 38.2 million net cash utilization in operating activities, 1.4 million used for investing activities and 7.4 million generated in financing activities, while the depreciation at the end of the period of the U.S. dollar against the euro led to a 0.4 million negative currency exchange impact. |
◾ | Financing activities included the draw down of two tranches of 3 million each, in July and August 2020, under the convertible bond financing agreement with Alpha Blue Ocean, for net proceeds of 5.6 million. As of the date of this press release, all notes have been converted and have resulted in the issuance of 1,125,873 new shares, representing 5.90% of the Companys outstanding share capital to date. |
◾ | In September, ERYTECH announced the implementation of an at-the-market (ATM) equity financing program. A new shelf registration statement on Form F-3 was filed by the Company with the U.S. Securities and Exchange Commission (the SEC) on September 21, 2020 to roll over the Companys previously filed shelf registration and to cover the ATM program and the registration statement was declared effective by the SEC on October 9, 2020. To date, the Company has not sold any securities pursuant to the ATM program. |
◾ | Earlier this week, ERYTECH announced that it had secured with Bpifrance and Société Générale a 10 million non-dilutive financing in the form of a state-guaranteed loan (PGE loan). Each of Bpifrance and Société Générale will provide ERYTECH with a loan in the amount of 5 million and the French government will guarantee 90% of the total amounts due under the loans. The loans will bear interest at a fixed rate of 1.75% and 0.25% per annum respectively, with an initial term of one year. At the end of this initial term, the Company, at its option, may defer repayment of the principal amount over a five-year period. |
◾ | The Company believes that the 10 million state-guaranteed loan, in combination with its current cash and cash equivalents, will extend its cash horizon into Q3 2021. When taking into account the potential proceeds under the convertible bonds financing and the ATM program, the horizon could be extended until the end of 2021. |
Key News Flow and Milestones Expected Over the Next 12 Months
◾ | Topline final results of the Phase 2 investigator-sponsored NOPHO trial in acute lymphoblastic leukemia at ASH (Dec 2020) |
◾ | Interim (superiority) analysis in the TRYbeCA-1 Phase 3 clinical trial in 2L metastatic pancreatic cancer (Q1 2021) |
◾ | First patient enrolled in the Phase 1 investigator-sponsored trial in 1L metastatic pancreatic cancer (Q4 2020); interim updates and results expected in 2021 |
◾ | Final results of TRYbeCA-1 trial (in case the IDMC recommends to continue the trial as planned at the interim superiority analysis) (Q4 2021) |
Conference Call Details
ERYTECH management will hold a conference call and webcast on Friday November 6, 2020 at 02:30pm CEST / 08:30am ET on the business and financial highlights for the quarter and nine months ended September 30, 2020. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.
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The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 2943988#
USA/Canada: +1 (833) 818-6807 | France: +33 1 70 80 71 53 | |
International Dial-In Number: +1 (409) 350-3501 | United-Kingdom: +44 2031070289 |
The webcast can be followed live online via the link: https://edge.media-server.com/mmc/p/cm8pkxrh
An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 2943988#.
An archive of the webcast will be available on ERYTECHs website, under the Investors section at investors.erytech.com
Financial Calendar 2021
◾ | Business Update and Financial Highlights for the Fourth Quarter and Full Year 2020: March 8, 2021 (after U.S. market close), followed by a conference call & webcast on March 9, 2021 (2:30pm CET/8:30am ET) |
◾ | Business Update and Financial Highlights for the First Quarter of 2021: May 4, 2021 (after U.S. market close), followed by a conference call & webcast on May 5, 2021 (2:30pm CET/8:30am ET) |
◾ | Business Update and Financial Highlights for the Second Quarter of 2021: September 20, 2021 (after U.S. market close), followed by a conference call & webcast on September 21, 2021 (2:30pm CET/8:30am ET) |
◾ | Business Update and Financial Highlights for the Third Quarter of 2021: November 15, 2021 (after U.S. market close), followed by a conference call & webcast on November 16, 2021 (2:30pm CET/8:30am ET) |
ERYTECH will Present at the Following Upcoming Investor Conferences:
◾ | Jefferies Healthcare Conference, November 17-19, 2020, London (virtual) |
◾ | LifeSci Advisors Corporate Access Event, January 6-13, 2021, San Francisco (virtual) |
About ERYTECH and eryaspase
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECHs primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.
The Companys lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of first-line triple-negative breast cancer. An investigator-sponsored Phase 2 study in acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.
ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit www.erytech.com
Forward-looking information
This press release contains forward-looking statements including but not limited to statements with respect to the clinical development plans of the Companys product candidates including the timing and progress of the interim superiority analysis, the impact of the COVID-19 pandemic on the Companys and the extension of the Companys anticipated cash runway to the end of 2021. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, believes, anticipates, expects, intends, plans, seeks, estimates, may, will and continue and similar expressions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECHs control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be
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commercially successful. Therefore, actual results and timeline may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorité des Marchés Financiers (AMF), the Companys Securities and Exchange Commission (SEC) filings and reports, including in the Companys 2019 Document dEnregistrement Universel filed with the AMF on March 18, 2020, in the half-year report for the six-month period ended June 30, 2020 published on September 21, 2020 and in the Companys Annual Report on Form 20-F filed with the SEC on March 18, 2020 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECHs expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on the Companys business and operations is highly uncertain, and that impact includes effects on its clinical trial operations and supply chain. Factors that will influence the impact on the Companys business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on the Companys business, operations and financial results for an extended period of time.
CONTACTS
ERYTECH Eric Soyer CFO & COO |
LifeSci Advisors, LLC Investor Relations Corey Davis, Ph.D. |
NewCap Mathilde Bohin / Investor relations Nicolas Merigeau Media relations | ||
+33 4 78 74 44 38 investors@ERYTECH.com |
+1 (212) 9152577 cdavis@lifesciadvisors.com |
+33 1 44 71 94 94 ERYTECH@newcap.eu |
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