ERYTECH Supplies Industry and Monetary Replace
for the Fourth Quarter and Complete 12 months 2021
Convention name and webcast on Tuesday, March 14, 2022
at 8:30am EDT / 1:30pm CET
Growth in opposition to in search of approval of GRASPA® for the remedy of ALL sufferers with allergy to pegylated asparaginase; BLA virtually in a position to put up pending FDA’s acceptance to record utility
Ultimate effects of Segment 3 trial in moment–line pancreatic most cancers introduced as oral presentation at ASCO GI
Treasured strategic choices and partnering choices beneath assessment
Cambridge, MA (U.S.) and Lyon (France), March 11, 2022 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical corporate creating leading edge remedies by way of encapsulating healing drug elements inside of crimson blood cells, lately equipped a industry replace and an replace on its money place on the finish of December 2021.
“However the setback of our Segment 3 trial in pancreatic most cancers no longer assembly its number one endpoint, 2021 has been a yr of necessary success for Erytech,” stated Gil Beyen, CEO of ERYTECH. “We’re very inspired by way of the growth we’re making in opposition to in search of an acclaim for our lead product candidate GRASPA® for the remedy of ALL sufferers who skilled hypersensitivities to pegylated asparaginase. Our BLA is able to be submitted briefly as soon as the FDA will have wholed its assessment of the final data requests and providess us the fairway gentle to put up. The assessment of our strategic choices is advancing smartly and other partnering discussions are in complex levels of negotiation.”
The NOPHO trial evaluated the protection and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) sufferers who had up to now skilled allergy reactions to pegylated asparaginase treatment. In December 2020, certain trial effects have been introduced on the 2020 American Society of Hematology annual assembly.
Eryaspase, additionally known as GRASPA®, its not too long ago accepted invented identify, together with chemotherapy and administered each two weeks, equipped a sustained asparaginase enzyme job degree, and was once most often smartly tolerated with few allergy reactions.
The Corporate pursues its interactions with the U.S. Meals and Drug Management (FDA) referring to a possible regulatory approval on this indication according to the NOPHO-sponsored trial. A pre-BLA assembly to speak about the submission of a Biologics License Utility (BLA) came about in June 2021 and then the Corporate showed its goal to put up a BLA matter to a hit crowning glory of last actions.
In July 2021, the Corporate introduced that the FDA had granted eryaspase Speedy Observe designation for the remedy of ALL sufferers who’ve evolved allergy reactions to E. coli-derived pegylated asparaginase.
The BLA utility is now virtually finished, permitting a quick submission as soon as the FDA has finalized its assessment of the remainder data requests and offers the fairway gentle to record.
As reported in October 2021, the Segment 3 TRYbeCA-1 trial didn’t meet the principle efficacy endpoint of general survival (OS). The median OS for sufferers handled with eryaspase plus chemotherapy was once 7.5 months, in comparison to 6.7 months for chemotherapy on my own, with an OS danger ratio (HR) of 0.92 within the intent-to-treat (ITT) inhabitants (p-value 0.375).
The prespecified subgroup of sufferers handled with eryaspase and FOLFIRI, an irinotecan-based chemotherapy, demonstrated a nominal build up in median OS of two.3 months, from 5.7 to eight months (HR = 0.77; in keeping with protocol inhabitants), which the Corporate believes deserves additional investigation.
Sufferers handled with eryaspase demonstrated stepped forward illness keep watch over in comparison to sufferers handled with chemotherapy handiest. Different secondary endpoints confirmed nominal growth.
The security profile of eryaspase was once in line with previous medical trials effects and protection critiques.
Ultimate information of the trial have been introduced as a late-breaking oral presentation at ASCO-GI in January 2022.
Attainable continuation of building in pancreatic most cancers was once mentioned with Key Opinion Leaders, who showed that additional exploration of the mix of eryaspase with irinotecan- and fluoropyrimidine-based chemotherapy is of hobby, and who advisable to imagine additional building in later strains of remedy.
rESPECT is a Segment 1 trial, subsidized by way of the Georgetown Lombardi Complete Most cancers Middle, comparing the protection of eryaspase together with mFOLFIRINOX as a first-line remedy for in the neighborhood complex and metastatic pancreatic most cancers in roughly 18 sufferers.
Affected person enrollment began in January 2021, and the primary dose cohort (75 U/kg) of 3 sufferers was once enrolled by way of the tip of February. No dose-limiting toxicity (DLT) was once noticed, and the trial was once escalated to the following dosing cohort (100 U/kg).
After assessment of the protection information within the first two dose cohorts, the dose escalation committee concluded that the radical mixture of mFOLFIRINOX plus eryaspase was once smartly tolerated without a dose restricting toxicity. As a result, the utmost tolerated dose (MTD) was once made up our minds at a dose of 100 U/kg eryaspase.
Period in-between information, introduced as ASCO GI in January 2022, showed the appropriate protection profile and confirmed encouraging medical job. Out of the twelve sufferers enrolled, ten sufferers had been evaluated for reaction. All of them completed illness keep watch over; 5 sufferers with function reaction and 5 with solid illness.
The trial will proceed enrolling as much as roughly 18 sufferers. Reporting of ultimate information is predicted within the 3rd quarter of 2022.
The TRYbeCA-2 trial is comparing eryaspase together with gemcitabine and carboplatin chemotherapy, in comparison to chemotherapy on my own, in metastatic TNBC. Goal enrollment is roughly 64 sufferers. The principle finish level of the trial is function reaction charge.
Following the disappointing result of eryaspase together with a gemcitabine-based chemotherapy within the TRYbeCA-1 trial in second-line pancreatic most cancers, the Corporate has, in session with the trial’s Guidance Committee, determined to prevent additional enrollment within the TRYbeCA-2 trial.
The result of the sufferers enrolled within the TRYbeCA-2 trial up to now are anticipated to be reported round mid 2022.
As introduced on October 25th 2021, the Corporate has appointed a specialised consultant to judge its strategic and partnering choices. The method is ongoing and other partnering alternatives are in complex degree of negotiations.
Replace on This fall 2021 Monetary Effects and Money Place
As of December 31, 2021, ERYTECH had money and money equivalents totaling €33.7 million (roughly $38.1 million), in comparison with €44.4 million as of December 31, 2020 and €38.0 million on September 30, 2021. The €10.7 million lower in money place right through the one year of 2021 was once the results of a €57.1 million internet money usage in running actions and making an investment actions and €44.7 million generated in financing actions, together with €34.6 million in mixed internet proceeds from the at-the-market (ATM) fairness financing program, two Registered Direct choices in April ($30M) and December ($7.85M), and €11.4 million from the drawdown of 4 tranches of convertible notes (OCABSA), whilst the adaptation of the U.S. greenback towards the euro resulted in a €1.3 million certain forex alternate affect.
The Corporate believes that its present money place, with out bearing in mind long run proceeds from possible strategic choices, can fund its deliberate running bills and present techniques smartly into the 3rd quarter of 2022.
Given its ongoing discussions, the Corporate will want to provide proforma FY2021 accounts in keeping with marketplace law, to replicate the possible affect of a transaction on its operations. As a result and given the time had to get ready, audit and assessment proforma accounts with marketplace regulators, the Corporate is suspending the reporting of its FY2021 monetary effects to a later date in April.
Key Information Drift and Milestones Anticipated Over the Subsequent 12 Months
Deliberate BLA submission of eryaspase in hypersensitive ALL (Q2 2022)
Knowledge from the randomized Segment 2 TRYbeCA-2 trial of eryaspase in TNBC (Q3 2022)
Effects from the Segment 1 rESPECT Trial of eryaspase together with mFOLFIRINOX in first-line pancreatic most cancers (2H 2022)
Fourth Quarter and Complete 12 months 2021 Convention Name Main points
ERYTECH control will dangle a convention name and webcast on Monday, March 14, 2021 at 8:30am EDT / 1:30 pm CET to speak about the hot industry and fiscal updates. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will ship a temporary presentation, adopted by way of a Q&A consultation.
The audio name is available by way of the underneath registering hyperlink: http://www.directeventreg.com/registration/tournament/1086874 (Convention ID : 1086874)
As soon as registered, members will obtain a singular get right of entry to code and the decision quantity main points to sign up for the teleconference.
The webcast can also be adopted reside on-line by way of the hyperlink: https://edge.media-server.com/mmc/p/fjy26gtk.
An archived replay of the decision shall be to be had for 7 days by way of dialing + 1 855 859 2056, Convention ID: 1086874#.
An archive of the webcast shall be to be had on ERYTECH’s website online, beneath the “Traders” segment at buyers.erytech.com
ERYTECH plans on attending the next upcoming investor meetings:
Investor Get entry to Convention, April 4-5, Paris
Kempen Existence Science Convention 2022, April 20-21, Amsterdam
Jefferies 2022 World Healthcare Convention, June 8-10, New York
About ERYTECH and eryaspase
ERYTECH is a clinical-stage biopharmaceutical corporate creating leading edge crimson blood cell-based therapeutics for critical types of most cancers and orphan sicknesses. Leveraging its proprietary ERYCAPS® platform, which makes use of a singular generation to encapsulate drug elements inside of crimson blood cells, ERYTECH is creating a pipeline of product applicants for sufferers with prime unmet scientific wishes. ERYTECH’s number one focal point is at the building of product applicants that concentrate on the altered metabolism of most cancers cells by way of depriving them of amino acids important for his or her expansion and survival.
The Corporate’s lead product candidate, eryaspase, which is composed of L-asparaginase encapsulated inside of donor-derived crimson blood cells, goals the most cancers cells’ altered asparagine and glutamine metabolism. The evidence of idea of eryaspase as a most cancers metabolism agent was once established in several trials in acute lymphoblastic leukemia (ALL) and pancreatic most cancers. An investigator subsidized Segment 2 trial (IST) comparing the usage of eryaspase in ALL sufferers who evolved allergy reactions to pegylated asparaginase not too long ago reported certain effects, according to which the Corporate intends to request approval in the USA and probably different territories. The Corporate could also be pursuing a Segment 1 investigator-sponsored medical trial in first-line pancreatic most cancers.
Eryaspase gained Speedy Observe designation from the U.S. Meals and Drug Management (FDA) for the remedy of complex pancreatic most cancers and remedy of acute lymphoblastic leukemia (ALL) sufferers who’ve evolved allergy reactions to E. coli-derived pegylated asparaginase. The FDA and the Eu Drugs Company have granted eryaspase orphan drug standing for the remedy of pancreatic most cancers and ALL.
ERYTECH produces its product applicants for remedy of sufferers in Europe at its GMP-approved production web page in Lyon, France, and for sufferers in the USA at its GMP production web page in Princeton, New Jersey, USA. Eryaspase isn’t an accepted drugs.
ERYTECH is indexed at the Nasdaq World Choose Marketplace in the USA (ticker: ERYP) and at the Euronext regulated marketplace in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is a part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Subsequent Biotech indexes.
For more info, please discuss with www.erytech.com
This press free up accommodates forward-looking statements together with, however no longer restricted to, statements with appreciate to the medical building and regulatory plans of eryaspase together with the timing of a possible BLA submission to the FDA for the remedy of acute lymphoblastic leukemia, the Corporate’s skill to acquire regulatory acclaim for the remedy of sufferers with acute lymphoblastic leukemia who evolved allergy reactions to PEG-asparaginase, the Corporate’s skill to increase the indication scope of eryaspase, the Corporate’s skill for extra investment beneath the OCABSA financing settlement or different financing makes an attempt, and the Corporate’s expected money runway. Positive of those statements, forecasts and estimates can also be identified by way of phrases corresponding to, with out limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “might”, “will” and “proceed” and equivalent expressions. Such statements, forecasts and estimates are according to more than a few assumptions and checks of identified and unknown dangers, uncertainties and different components, which have been deemed cheap when made however might or would possibly not end up to be right kind. Precise occasions are tricky to are expecting and might rely on components which might be past ERYTECH’s keep watch over. There can also be no promises with appreciate to pipeline product applicants that the applicants will obtain the important regulatory approvals or that they are going to end up to be commercially a hit. Subsequently, precise effects and timeline might transform materially other from the predicted long run effects, efficiency or achievements expressed or implied by way of such statements, forecasts and estimates. Additional description of those dangers, uncertainties and different dangers can also be discovered within the Corporate’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Corporate’s Securities and Trade Fee (SEC) filings and reviews, together with within the Corporate’s 2020 File d’Enregistrement Universel filed with the AMF on March 8, 2021 and within the Corporate’s Annual File on Shape 20-F filed with the SEC on March 8, 2021 and long run filings and reviews by way of the Corporate. Given those uncertainties, no representations are made as to the accuracy or equity of such forward-looking statements, forecasts and estimates. Moreover, forward-looking statements, forecasts and estimates handiest discuss as of the date of this press free up. Readers are cautioned to not position undue reliance on any of those forward-looking statements. ERYTECH disclaims any legal responsibility to replace this kind of forward-looking observation, forecast or estimates to replicate any trade in ERYTECH’s expectancies in regards thereto, or any trade in occasions, stipulations or cases on which this kind of observation, forecast or estimate is founded, excluding to the level required by way of regulation. As well as, the COVID-19 pandemic and the related containment efforts have had a significant adversarial affect at the financial system, the severity and period of that are unsure. Govt stabilization efforts will handiest in part mitigate the results. The level and period of the affect at the Corporate’s industry and operations is extremely unsure, and that affect comprises results on its medical trial operations and provide chain. Components that may affect the affect at the Corporate’s industry and operations come with the period and extent of the pandemic, the level of imposed or advisable containment and mitigation measures, and the overall financial penalties of the pandemic. The pandemic can have a subject material adversarial affect at the Corporate’s industry, operations and fiscal effects for a longer time frame.