ERYTECH provides an update on its regulatory activity – 08/24/2022 at 22:05

ERYTECH

provides an update on its regulatory activity

• Stop
  
  

  of the
  
  

  activities
  
  

  in view of
  
  

  submit a
  
  

  request
  
  

  of approval
  
  

  for
  
  

  grass
  
  

  ® in
  
  

  the treatment of patients with Acute Lymphoblastic Leukemia
  
  

  (
  
  

  ALL
  
  

  )
  

• Evaluation
  
  

  In progress
  
  

  of
  
  

  s options
  
  

  strategic
  
  

  partnership
  

Lyon (France), and Cambridge, MA (US)

the

24

august

2

022

–

ERYTECH

Pharmaceuticals (Euronext

&

Nasdaq: ERYP), a clinical-stage biopharmaceutical company that develops innovative therapies by encapsulating drugs in red blood cells (RBCs),

provides an update on its regulatory activity and announces

her

decision

following

answers

of the F

Food and Drug Administration (FDA)

,

no longer

request

r

of approval

of

grass

®

for

the treatment of

s patients with

ALL

with hypersensitivity to asparaginase

pegylated

.

”

We are

obviously very

disappointed

to stop

the

permission application process for

grass

in the ALL after all the

road traveled

and the

results

clinics

promising

observed in this indication

»

,

declared

Gil Beyen, Managing Director of ERYTECH

.

”

In

numerous

clinical tests,

grass

has shown promising results for patients, and we have been encouraged by

the discussions

with the FDA and the

obtaining, last year, the

has Fast Track designation for this indication.

However, the evolution of the competitive environment,

associated

to

new

queries

of

the FDA of

clinical data

complementary

which would require significant additional resources on our part, has led to the difficult

decision

to stop the development of

grass

in the ALL.

We are now focusing our resources on our most promising preclinical programs, while

continuing discussions of opportunities

partnership

in order to best promote the interests of our shareholders and our employees.

»

Following the positive results of the Phase 2 study sponsored by the Nordic Society of Pediatric Hematology and Oncology (NOPHO), presented at the 2020 Annual Meeting of the American Society of Hematology, ERYTECH has entered into discussions with the FDA in for the approval of Graspa for the treatment of patients with ALL who have developed hypersensitivity to pegylated asparaginase.

A meeting prior to filing an authorization request (Biologics License) took place in June 2021, following which the Company confirmed its intention to submit a BLA request, subject to the submission of the additional information requested. by the FDA and agreement on an initial pediatric study plan (iPSP).

The Company recently received responses from the FDA regarding its iPSP, submitted in July 2022. After careful consideration of these comments, which include a new request for additional data, and given the evolving competitive environment in the treatment of hypersensitive ALL, the Company has determined that it is in the best interests of the Company and its shareholders to no longer seek Graspa’s approval for the treatment of ALL and to focus its resources on its preclinical programs and partnering activities strategic.

After selling its US production site in Princeton (New Jersey) for $44.5 million in April 2022, the Company selected a specialist advisor to assess its strategic alternatives for operating its ERYCAPS® platform with complementary assets and/or or a larger corporate transaction. Several options are being discussed, and the Company expects to communicate on these strategic initiatives during the fourth quarter of this year.

About ERYTECH

www.erytech.com

Founded in Lyon in 2004, ERYTECH is a clinical-stage biopharmaceutical company that develops innovative therapies based on red blood cells to fight against cancers and orphan diseases. Leveraging its proprietary ERYCAPS® platform, an innovative technology for encapsulating drugs in red blood cells, ERYTECH is developing a portfolio of product candidates targeting markets with significant unmet medical needs.

ERYTECH produces its drug candidates for the treatment of patients in Europe at its GMP-compliant production site in Lyon, France, and believes it has the means to produce for patients in the United States thanks to its long-term supply agreement with Catalent, operating from ERYTECH’s former GMP production site in Princeton, New Jersey, USA.

ERYTECH is listed on the Nasdaq Global Select market

market

in the United States (symbol: ERYP) and on the regulated Euronext market in Paris (ISIN code: FR0011471135; symbol: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC

Mid

& Small, CAC All

Tradable

,

EnterNext

PEA-PME 150 and Next Biotech.

CONTACTS

Forward-looking statements

This press release contains forward-looking statements, including with respect to the clinical development and development strategy of eryaspase, the commercial and regulatory strategy, the deployment of production capacities and the expected future performance of ERYTECH and the market on which the Company operates. Some of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “projects”, “plans”, “seeks”, “estimates”, “may”, “wants” and “continues” and other similar expressions. All statements contained in this press release, except statements of past facts, are forward-looking statements, including, without limitation, statements relating to ERYTECH’s business strategy and its assessment of potential strategic transactions; the clinical study data reporting schedule; the achievement of certain regulatory and commercial milestones, ERYTECH’s estimated manufacturing capacity and ability to meet future demands, including the anticipated long-term supply agreement with Catalent; as well as ERYTECH’s projected cash flow and the adequacy of liquidities. 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 not prove to be correct. Actual events are difficult to predict and may depend on factors beyond the Company’s control. Accordingly, actual results and timing may differ materially from any anticipated future results, performance or achievements as expressed or implied by such statements, forecasts and estimates. Important factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, among others, the following: (1) failure to achieve certain regulatory and business milestones; (2) the inability to maintain the listing of ERYTECH shares on the Nasdaq Global Select market and on the regulated market of Euronext; (3) changes in applicable laws or regulations; (4) the possibility that ERYTECH will be adversely affected by other economic, commercial and/or competitive factors; (5) non-fulfilment of the long-term supply agreement with Catalent; and (6) other risks and uncertainties further indicated from time to time in documents filed by ERYTECH with regulatory authorities. The documents filed by ERYTECH with the Autorité des Marchés Financiers (AMF) and the Securities and Exchange Commission (SEC), including the Company’s 2021 Universal Registration Document filed with the AMF on April 27, 2022, Company’s Annual Report (Form 20-F) filed with the SEC on April 28, 2022 and future Company filings and reports, describe such risks and uncertainties. Given these uncertainties, no representation is made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, forward-looking statements, forecasts and estimates speak only as of the date of this release. Readers are therefore cautioned not to place undue reliance on these forward-looking statements. ERYTECH disclaims any obligation to update such forward-looking statements, forecasts or estimates to reflect any change in the company’s expectations with respect thereto, or any change in events, conditions or circumstances on which such statements, forecasts or estimates are based, except as required by law.

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