ERYTECH Provides Business Update and
Reports Financial Results for First Quarter 2019

On May 6, 2019 ERYTECH Pharma (Euronext: ERYP—Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and reports its financial results for the quarter ended March 31, 2019 (Press release, ERYtech Pharma, MAY 6, 2019, View Source [SID1234536954]).

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"The first quarter of 2019 has been particularly intense in terms of execution of our late stage clinical trials and the extension of our manufacturing capacity, all while making progress on our earlier stage programs. Patient enrollment for TRYbeCA 1, our pivotal Phase 3 trial in second-line metastatic pancreatic cancer, continues ahead of plan in Europe, and we recently filed an IND in the United States in order to begin enrollment there," said Gil Beyen, CEO of ERYTECH. "Construction of the new manufacturing site in Princeton and the expansion of our Lyon manufacturing facility have been completed and validation is now ongoing."

Recent Business Highlights

TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer, is actively enrolling patients in several European countries. In view of opening the trial to patients in the United States, the company recently submitted an IND application to the US FDA. In this trial, ERYTECH is evaluating eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) compared to standard chemotherapy alone. The primary endpoint of the trial is overall survival. An interim efficacy analysis is planned when approximately two-thirds of events have occurred. The trial is expected to enroll approximately 500 patients at more than 120 sites in Europe and the United States.

TRYbeCA2, a Phase 2 proof-of-concept trial in patients with previously untreated metastatic triple-negative breast cancer (TNBC), is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone in approximately 64 patients. The primary endpoint is objective response rate. First sites were initiated in December 2018, and the trial is now open for enrollment in Spain and France.

To ensure supply of the product for the clinical trials and potential initial commercial needs, the Company is establishing a GMP manufacturing facility in Princeton, New Jersey. It is also expanding its European manufacturing capacity in Lyon, France. Construction has now been completed at both sites and validation activities are ongoing, as planned.

ERYTECH is also advancing the preclinical programs to leverage its proprietary ERYCAPS encapsulation platform. The Company’s lead preclinical program and next product candidate is erymethionase, methionine-gamma-lyase encapsulated in red blood cells. Activities in support of initiating a Phase 1 clinical trial of erymethionase in solid tumor indications are ongoing. The company expects to begin this Phase 1 trial in Europe in the first quarter of 2020.

In preparation for the next stage of the company’s development, ERYTECH recently announced that its Board of Directors will propose the appointment of Jean-Paul Kress as a Director at the Annual General Meeting on June 21, 2019, with a view to appointing him as Chairman of the Board of Directors. Dr. Kress has over 25 years’ experience as a senior executive in international biotech and pharma groups. He was President and Chief Executive Officer of Syntimmune (Cambridge, MA, US) until the end of 2018, when the company was acquired by Alexion Pharmaceuticals.

Q1 2019 Financial Results

Net loss for the first quarter of 2019 was €11.7 million, stable from the same period in 2018. The €4.0 million increase in operating loss was offset in the period by the €4.1 million improvement in financial Income. The €4.0 million increase in operating loss was attributable to the €1.5 million increase in preclinical and clinical development expenses, mostly related to the Phase 3 clinical trial in pancreatic cancer, the €2.1 million increase in G&A expenses, primarily driven by professional fees in relation to the launch readiness of the Company’s additional production capacity, and the €0.4 million decrease in research tax-credit income. The €4.1 million improvement in financial Income was mainly related to the translation into Euro of the portion of the Company’s cash position denominated in U.S. Dollar, which had a positive foreign exchange impact and explained most of the €1.6 million financial Income in the first quarter of 2019, compared to a negative foreign exchange impact and a €2.5 million financial expense in the first quarter of 2018.

As of March 31, 2019, ERYTECH had cash and cash equivalents totaling €110.5 million (approximately $124 million), compared with €134.4 million on December 31, 2018. The €23.9 million decrease in cash position in the first quarter of 2019 was the result of a €25.2 million net cash utilization, comprised of a €15.9 million net cash utilization in operating activities, €8.9 million in capital expenditures and €0.4 million in loan and lease reimbursement, while the appreciation in the period of the U.S. Dollar against the Euro lead to a €1.3 million favorable currency exchange impact. Cash utilization in the first quarter of 2019 was, as anticipated, relatively high due to the non-recurring capital expenditure disbursements

for the production facility expansions in Lyon and in Princeton. As both projects are now close to completion, cash utilization is expected to be lower again in the coming quarters and the Company continues to expect its cash resources to be sufficient to fund operations until the end of 2020.
Key News Flow and Milestones Expected over Next 12 Months

First patient enrolled in TRYbeCA-2, Phase 2 proof-of-concept clinical trial in TNBC

Start of GMP production at Princeton facility and Lyon extension

Start of US patient enrollment in TRYbeCA 1, Phase 3 trial in second-line pancreatic cancer

Initiation of Phase 1 clinical trial with erymethionase

Q1 2019 Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, May 7th, 2019 at 02:30pm CEST / 08:30am EDT on business highlights and financial results for the first quarter of 2019. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 2199912#:

USA/Canada: +1 (833) 818-6807

International Dial-In Number: +1 (409) 350-3501


France: +33 1 70 80 71 53

United-Kingdom: +44 2031070289

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 2199912#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

2019 Financial Calendar:

General Assembly Meeting of Shareholders: Friday, June 21, 2019 at 9:30am CET in Paris

Quarterly financial updates:

Business Update and Financial Highlights for the 2nd quarter and first-half of 2019: September 17, 2019 (after U.S. market close), followed by a conference call and webcast on September 18, 2019 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 3rd quarter of 2019: November 7, 2019 (after U.S. market close), followed by a conference call and webcast on November 8, 2019 (2:30pm CET/8:30am ET)

ERYTECH will Present at the Following Upcoming Investor Conferences:

Gilbert Dupont Annual Healthcare Conference, May 23, Paris

Jefferies 2019 Global Healthcare Conference, June 4-7, New-York

European Midcap Event – Spring, June 18-19, Paris

JMP Securities Life Sciences Conference, June 19, New York

France Biotech, Health Tech Investor Day, June 25, Paris

PharmaCyte Biotech Advances Manufacturing Process for Clinical Trial in Pancreatic Cancer

On May 6, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that advances have been completed in the manufacturing process for the clinical trial product that will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, MAY 6, 2019, View Source [SID1234535887]).

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Since PharmaCyte’s last press release describing the manufacturing process for its clinical trial product and the testing of that product, the data from the manufacturing process has been reviewed, analyzed and discussed in great detail among PharmaCyte’s management team, including the leader of its clinical development program in pancreatic cancer and designated Principal Investigator (PI) for the LAPC trial, Prof. Manuel Hidalgo of the Harvard Medical School, Austrianova’s management team (the manufacturer of the clinical trial product), cGMP Validation (PharmaCyte’s cGMP expert consulting firm), Eurofins Lancaster Laboratories (who produced the cells for PharmaCyte’s Master Cell Bank) and several consulting cellular biologists.

The data obtained to date from the encapsulation parameters of the manufacturing process itself indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the FDA.

On the advice of PharmaCyte’s cGMP expert, the company plans to conduct two additional and staggered manufacturing runs in order to maximize the chances for a successful IND submission given the novelty and complexity of the entire process. In the time since the last manufacturing run, which we reported on in January of this year, those involved with the manufacturing process have been concentrating on changes that can be made to improve the process. We believe that these changes will improve the cGMP manufacturing process to the point that the entire process can be shown to be consistently reproducible and robust as required by the FDA, and to ensure that the end-products of these manufacturing runs will convert the cancer prodrug ifosfamide into its cancer-killing form as well as they should.

This intensive effort has involved several independent tests by Austrianova and Eurofins. The results of these tests strongly indicate that, after the suggested changes are implemented, positive results should be obtained. When the changes are made to the cGMP manufacturing process, they should significantly improve the growth of the cells obtained from the Master Cell Bank both before and after encapsulation takes place. PharmaCyte and Austrianova and its team of consultants are in the final stages of optimizing this aspect of the manufacturing process.

Meanwhile, PharmaCyte’s clinical development program in pancreatic cancer is progressing. As explained by Prof. Hidalgo, "PharmaCyte has a strong clinical trial program for pancreatic cancer. The trial design has been thoroughly vetted by a team of the best pancreatic cancer specialists in the country. I continue to lead PharmaCyte’s program in pancreatic cancer, and I am eager to get underway as its PI for the LAPC trial. Members of PharmaCyte’s team are working on various aspects of implementing the program. I remain excited about the potential that PharmaCyte’s technology can offer patients who are suffering from LAPC and am looking forward to what a successful trial may mean for the way some types of solid cancerous tumors are treated in the future."

Omeros Corporation to Announce First Quarter 2019 Financial Results on May 9, 2019

On May 6, 2019 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its first quarter 2019 financial results for the period ended March 31, 2019, on Thursday, May 9, 2019, after the market closes (Press release, Omeros, MAY 6, 2019, View Source [SID1234535840]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4095776. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 4095776.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

FibroGen to Report First Quarter 2019 Financial Results

On May 6, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported that it will report first quarter 2019 financial results on Thursday, May 9, 2019 after market close, and will host a conference call to discuss financial results and provide a business update at 5:00 p.m. ET (2:00 p.m. PT) (Press release, FibroGen, MAY 6, 2019, View Source;p=irol-newsArticle&ID=2397383 [SID1234535839]).

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 48545313#.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 48545313

Gilead Sciences to Present at the Bank of America Merrill Lynch 2019 Health Care Conference on Tuesday, May 14

On May 6, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Robin L. Washington, Gilead’s Executive Vice President and Chief Financial Officer, and John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of Research & Development, will participate in a fireside chat at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas on Tuesday, May 14 at 10:00 a.m. Pacific Time (Press release, Gilead Sciences, MAY 6, 2019, View Source [SID1234535838]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.