On November 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla (Press release, Seattle Genetics, NOV 7, 2019, View Source [SID1234550654]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 15 data presentations, including updated analyses from ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are encouraged by the ECHELON-1 update supporting a sustained progression-free survival benefit for ADCETRIS in combination with AVD when compared to ABVD in advanced classical Hodgkin lymphoma and additional analyses from trials evaluating ADCETRIS in combination with nivolumab. We continue to invest in our ADCETRIS clinical development program with the goal of improving outcomes for patients."

Details of oral presentations featured at ASH (Free ASH Whitepaper) include:

Safety and Efficacy of Brentuximab Vedotin in Combination with AVD in Stage II-IV HIV-Associated Classical Hodgkin Lymphoma: Results of the Phase 2 Study, AMC 085
Abstract: 130
Presenter: P. Rubinstein, Rush University Medical Center, Chicago, Ill.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:15 a.m. ET
Location: Tangerine 2 (WF2)

Brentuximab Vedotin in First Refractory/Relapsed Classical Hodgkin Lymphoma Patients Treated By Chemotherapy (ICE) before Autologous Transplantation. Final Analysis of Phase II Study
Abstract: 132
Presenter: A. Stamatoullas, Departement d’Hematologie, Centre Henry Becquerel, Rouen, France
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:45 a.m. ET
Location: Tangerine (WF2)

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years
Abstract: 237
Presenter: C. Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Ore.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:30 p.m. ET
Location: W224

Brentuximab Vedotin and Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma: Long-term Follow-up Results from the Single-arm Phase 1/2 Study
Abstract: 238
Presenter: A. Moskowitz, Memorial Sloan Kettering Cancer Center, New York, N.Y.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:45 p.m. ET
Location: W224

A Phase I/II Trial of Brentuximab Vedotin (BV) Plus Rituximab (R) as Frontline Therapy for Patients with Immunosuppression-Associated CD30+ and/or EBV+ Lymphomas
Abstract: 351
Presenter: W. Pearse, Loyola University Medical Center, Maywood, Ill.
Session: Oral presentation Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Optimizing Frontline Chemotherapy
Date and Time: Sunday, December 8, 8:00 a.m. ET
Location: Hall E2

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant
Abstract: 464
Presenter: K. Savage, British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia and the Department of Medical Oncology, Vancouver, B.C., Canada
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Date and Time: Sunday, December 8, 12:15 p.m. ET
Location: Valencia D (W415D)

Details of company-sponsored presentations are as follows:

Patterns of Care and Clinical Outcomes in Peripheral T-Cell Lymphoma Patients Receiving First-Line Treatment in Routine Clinical Practice in France and the United Kingdom
Abstract: 3482
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma (PTCL)
Abstract: 3492
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma (cHL): Four-Year Update of the ECHELON-1 Study
Abstract: 4026
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of select investigator-sponsored presentations are as follows:

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin as Pre-Transplant Salvage for Hodgkin Lymphoma
Abstract: 1555
Session: Poster Presentation
Date and Time: Saturday, December 7, 5:30-7:30 p.m. ET
Location: Hall B

A Pilot Study of Brentuximab Vedotin Combined with AVD Chemotherapy and Radiotherapy in Patients with Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Abstract: 2834
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Preliminary Results from a Phase 2 Trial of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas
Abstract: 4023
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of company-sponsored trials in progress are as follows:

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma
Abstract: 2836
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Adults Age 60 and Above
Abstract: 2852
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

A Phase 2 Study of Retreatment with Brentuximab Vedotin in Patients with cHL, sALCL or other CD30 Expressing PTCL
Abstract: 4054
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

On November 7, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported that it will present at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7 new understandings of the mechanism of action of its T cell engager clinical candidate, AMV564 (Press release, Amphivena Therapeutics, NOV 7, 2019, View Source [SID1234550670]). Specifically, Amphivena said that AMV564, a bivalent CD33/CD3 T cell engager, selectively depletes myeloid-derived suppressor cells (MDSC) in patients, sparing normal neutrophils and monocytes. The company announced in October initiation of a Phase 1 trial to evaluate the effect of AMV564 on these immune suppressive cells and the potential therapeutic benefit of relieving this important source of T cell suppression in patients with solid tumors.

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Vitoria Smith Ph.D., Chief Scientific Officer, who will make the oral presentation, noted, "AMV564 selectively reduces MDSC in the bone marrow and periphery in acute myeloid leukemia and myelodysplastic syndrome patients. In addition, we observed that T cell activation on therapy can lead to rapid increases in MDSC. However, this can be modulated by AMV564 due to avid binding of activated CD33 on MDSC. We believe that with application of a continuous dosing regimen we may control immune-suppressive MDSC and promote anti-tumor immunity."

The oral presentation (071) is scheduled for 2:25 pm ET in Potomac Ballroom CD.

Amphivena will also present a "Trials in Progress" poster summarizing the study design and objectives of its ongoing study AMV564-301 "Phase 1 Dose Escalation with Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AMV564 in Patients with Advanced Solid Tumors" (NCT04128423). The multi-center Phase 1 study is currently open for enrollment at NEXT Oncology (PI: Raghad Karim) in San Antonio, TX, MD Anderson Cancer Center (PI: Sarina Piha-Paul) and Peninsula Cancer Institute (PI: Alexander Starodub) in Newport News, VA. AMV564 is being administered to solid tumor patients by subcutaneous injection.

The poster presentation (P416) is scheduled for 7:00 pm – 8:30 pm ET in Prince George’s Exhibition Hall AB.

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) and at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

On November 7, 2019 Selvita (WSE: SLV) – one of the largest preclinical contract research organizations in Europe – reported third quarter 2019 financial results and provided a corporate update following a recent corporate split of the oncology therapeutics (Ryvu Therapeutics) and contract research (CRO) business units (Selvita) (Press release, Selvita, NOV 7, 2019, View Source [SID1234550703]).

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The services segment of the Company has recorded USD 5.59 million of commercial revenue in Q3 2019, which marks a 45% increase compared to Q3 2018.

In the first three quarters of 2019, Selvita Group recorded USD 18.8 million of revenues, 32% increase comparing to the corresponding period in 2018. Operating profits, (EBITDA excluding IFRS16 impact) result amounted to USD 3.5 million, an increase of 21% compared to Q3 2018, and the backlog **for 2019 currently amounts to USD 25.1 million and is 38% higher than at corresponding time in 2018.

– Our financial results up to date represent more than we wished for. The increase in the commercial revenues was significantly higher than the declared 30%, as it amounted to 36% in the period from January to September, and 45% in Q3 2019 alone. Operating margin for Q1-Q3 2019 amounted to 11.4% – says Boguslaw Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

Revenues of the services segment in the first three quarters amounted to USD 15.1 million, up by 36% comparing to Q1-Q3 2018, and operating profit to USD 2.0 million (11% more y/y). In the third quarter alone, these dynamics reached 45 and 13%, respectively.

– The last quarters of this year were a period of a dynamic development for Selvita. Not only we have increased employment, but also made significant investments in the equipment. This has allowed us to build a solid base for another organic leap of business scale. The first results of our work were already visible in Q3 2019 – says Boguslaw Sieczkowski.

The service segment is comprised of two departments: chemistry and biology. In 2019, the dynamics of the biology department have stood out in particular – its backlog currently amounts to USD 9.9 million and is 75% higher than for a corresponding point of time in 2018.

The total commercial backlog of the service segment currently sums up to USD 20.9 million, a 40% increase compared to 2018.

Revenues of the bioinformatics segment (Ardigen, in which Selvita S.A. holds 52 percent of shares), amounted to USD 2.5 million and were 32% higher than in Q3 2018. Operating profit amounted to USD 0.2 million, compared to USD 0.3 million in the same period last year.

– At the moment, Ardigen’s primary goal is dynamic development of its own technology platforms, as well as marketing and sales activities. This drives the increase in costs, but in the long run it will lead to a significant growth in the scale of business, resulting in the increase in the value of the company – explains Bogusław Sieczkowski.

The backlog of the bioinformatics segment amounts to USD 2.6 million, which is 27% higher than a year ago.

Selvita after the split

At the beginning of October, the National Court Register of Poland ("KRS") has recognized the corporate split of the Selvita parent company into two distinct organizations. The recognition by the court follows the Sept. 19, 2019, shareholder resolution to separate oncology therapeutics and contract research (CRO) business units.

Selvita provides comprehensive research and development services, mainly to clients in the pharmaceutical and biotechnology industries. The company’s medium-term goal is to enter the top ten largest preclinical CROs in the world.

Selvita’s Services Segment has been growing in the last years at a rate of 30-40% per year and has been permanently profitable. The company assumes maintaining this level of growth dynamics. At the same time, the company plans to grow through acquisitions, expecting the first transaction in 2020. Selvita is interested both in domestic and foreign companies which will allow it to achieve its business goals: increasing the scale of operations and expanding the portfolio of services offered. As a leading company on the market, Selvita will be in an excellent position to build lasting value, thanks to selective and systematic takeover strategies, which will be made possible through e.g. debt financing, which was difficult to access before the corporate split.

Boguslaw Sieczkowski, serves currently as the Chief Executive Officer at Selvita. He is also one of the co-founders of the company, and former Executive Vice President and Chief Operating Officer. In addition, the Management Board is comprised of three members from the company’s current top management: dr Milosz Gruca, Director of the Biology Department and Executive Vice President, dr Miroslawa Zydron, Director of the Chemistry Department and Edyta Jaworska responsible for the development of integrated drug discovery projects. New appointments to the Management Board have also been made, which include Dawid Radziszewski, General Counsel and Head of Corporate Development who will be directly responsible for the acquisitions and integration of companies within the Group, and Dariusz Kurdas, who assumed the position of Chief Financial Officer.

**Backlog for 2019 as on 28/10/2019, backlog for 2018 as on 9/11/2018. Backlog defined as the value of the portfolio of contracts signed as of the report publication date, incl. commercial contracts and grant agreements.

On November 7, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the third quarter ended September 30, 2019 and highlighted recent corporate developments (Press release, pSivida, NOV 7, 2019, View Source [SID1234550719]).

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"We are pleased with the strong growth in customer orders during the quarter as our sales team is making significant progress in penetrating targeted accounts for both DEXYCU and YUTIQ," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "At the customer level, DEXYCU is gaining momentum at high volume ambulatory surgery centers with increasing repeat orders by physicians who favor its targeted, efficient ocular administration, and its positive efficacy and safety profile. We also saw continued strong growth of 17% in physician demand for YUTIQ quarter over quarter despite a cumbersome reimbursement process under a miscellaneous J-Code. We expect that the issuance of a permanent and specific J-Code for YUTIQ, which went into effect on October 1, 2019, will enable customers to experience a faster and more straightforward reimbursement process and will support continued growth in demand for this important product. These positive customer and reimbursement trends were masked by our distributor’s strategic decision to substantially reduce carried inventory, limiting their restocking during the quarter and resulting in decreased reported revenue from the prior quarter."

Commercial Performance in Third Quarter 2019

DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery

Customer orders up 207% over Q2 with September representing the highest volume month to date, and with repeat customers representing 74% of Q3 order volume.

The average time for an account to re-order dropped from 4.8 weeks during Q2 to 2.5 weeks during Q3, as customers incorporate DEXYCU as part of their surgical protocol.

Medicare fee for service claims continue to be paid consistently, and Medicare Advantage and Commercial insurance claims increased quarter over quarter.

The average time to payment in all payor sectors continues to improve post launch. We expect the time to payment to decrease as payor systems incorporate DEXYCU’s J-Code.

Since launch, over 5,400 patients have been injected with DEXYCU. In that time, over 500 physicians have been trained to use the product.

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the posterior segment of the eye

Customer orders up 17% over Q2, prior to effective date of a permanent J-Code.

Repeat customers represented 85% of order volume, and importantly, 40% of the target account list has ordered, representing solid adoption with continued growth opportunity.

Medicare fee for service claims paid consistently and Medicare Advantage and Commercial payors beginning to cover YUTIQ.

The permanent and specific J-Code, J7314, was issued by the Centers for Medicare and Medicaid Services (CMS) one quarter earlier than under prior CMS policy and is in effect as of October 1, 2019.

Corporate Developments

In November 2019, EyePoint announced two new agreements to expand the reach of DEXYCU and YUTIQ within large integrated healthcare networks. An interim agreement with the U.S. Department of Veterans Affairs (VA) became effective on November 2, 2019, adding DEXYCU and YUTIQ to the Federal Supply Schedule. The VA serves approximately nine million beneficiaries. A final VA contract is anticipated within several months and is expected to have a five-year term. In addition, a three-year contract was signed with Vizient Inc., effective November 1, 2019, offering DEXYCU to its diverse membership network. Vizient provides solutions and services to over 50% of the nation’s acute care providers, including 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers.

In August 2019, EyePoint received a $1 million milestone payment from Ocumension Therapeutics triggered by the approval of its Investigational New Drug (IND) in China for Eyepoint’s three-year intravitreal micro-insert containing 0.18mg of fluocinolone acetonide using the Durasert technology (known as YUTIQ in the United States). The IND allows the importation of finished product into China for use in its initiated clinical trial to support regulatory approval for the treatment of chronic uveitis affecting the posterior segment of the eye. Ocumension has also received a special approval by the Hainan Province People’s Government to market this product for chronic, non-infectious posterior segment uveitis in the Hainan Bo Ao Lecheng International Medical Tourism Pilot Zone.

R&D Highlights

Two oral presentations highlighting 36-month data supporting YUTIQ for the treatment of non-infectious uveitis affecting the posterior segment of the eye occurred at the annual Retina Society meeting held in London, United Kingdom, on September 11-15, 2019. The first presentation "Minimizing Uveitic Recurrences: Results from a 36M Study of Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment" concluded that treatment with YUTIQ not only resulted in a reduction in the 3-year rate of uveitic recurrences but that YUTIQ also reduced the cumulative number of inflammatory episodes in eyes that did relapse. The second presentation, "The Use of Adjunctive Anti-inflammatory Medications: Results from a 36M Study of a Fluocinolone Acetonide

Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis (NIPU) Affecting the Posterior Segment" highlighted that the treatment with a single intravitreal injection of YUTIQ significantly reduced the need for adjunctive therapies in this group of patients.

YUTIQ was highlighted in separate events at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting held October 12 – 15, 2019 in San Francisco, CA. First, an oral presentation entitled, "Effect of Fluocinolone Acetonide Insert on the Presence of Uveitic Macular Edema: Outcomes at 36 Months" was presented at a well-attended session at the Retina Subspecialty Day and demonstrated the long-term durability of YUTIQ for this difficult to treat ocular disease. Additionally, a poster entitled, "Fluocinolone Acetonide Intravitreal Insert for Noninfectious Posterior Uveitis: Analysis of Significant IOP Elevation" provided further evidence of the favorable safety and tolerability profile of YUTIQ.

Review of Results for Third Quarter Ended September 30, 2019

For the three months ended September 30, 2019, total revenue was $2.5 million. Net product revenue was $1.0 million, primarily generated from sales of DEXYCU.

DEXYCU and YUTIQ are sold through a distributor under a title model and, accordingly, product revenue is recognized as inventory is shipped to the distributor and title transfers. Due to this title model, quarterly reported revenue and underlying customer sales will likely track separately for an extended period of time beyond initial launch, as customer demand patterns may not align with the distributor’s inventory restocking procedures.

Net revenue from licenses, royalties and collaborations for the three months ended September 30, 2019 totaled $1.5 million compared to $486,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended September 30, 2019 increased to $16.6 million from $14.0 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, and cost of sales related to product revenue, partially offset by a decrease in research and development expense. Non-operating expense, net, for the three months ended September 30, 2019 totaled $1.6 million of net interest expense. Net loss for the three months ended September 30, 2019 was $15.6 million, or $0.15 per share, compared to a net loss of $33.1 million, or $0.44 per share, for the prior year quarter.

Review of Nine Months Results Ended September 30, 2019

For the nine months ended September 30, 2019, total net product revenue was $8.9 million. Neither product had net revenue in the corresponding period in 2018. Net revenue from licenses, royalties and collaborations for the nine months ended September 30, 2019 totaled $2.8 million compared to $2.1 million in the corresponding period in 2018.

Operating expenses for the nine months ended September 30, 2019 increased to $50.6 million from $30.1 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation, cost of sales related to product revenue and amortization of the DEXYCU intangible asset, partially offset by a decrease in research and development expense. Non-operating expense, net, for the nine months ended September 30, 2019 totaled $7.5 million and consisted of $3.7 million of net interest expense and $3.8 million from the loss on extinguishment of debt related to the payoff of the SWK term loan. Net loss for the nine months ended September 30, 2019 was $46.4 million, or $0.45 per share, compared to a net loss of $74.5 million, or $1.27 per share, for the prior year period.

Cash and cash equivalents at September 30, 2019 totaled $31.8 million compared to $44.2 million at June 30, 2019.

Financial Outlook

We expect that the Company’s existing cash and cash equivalents at September 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund the Company’s operating plan into 2020.

Conference Call Information

EyePoint will host a conference call today, Thursday, November 7, 2019 at 8:30 AM ET to discuss the results for the third quarter ended September 30 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 3149087. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On November 7, 2019 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the quarter ended September 30, 2019 (Press release, ERYtech Pharma, NOV 7, 2019, View Source [SID1234550750]).

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"Our lead program, TRYbeCA1, the Phase 3 trial in pancreatic cancer, is progressing on plan and recently reached two important milestones," said Gil Beyen, CEO of ERYTECH. "A planned safety review by an independent data monitoring committee of the first 150 patients in the study revealed no safety concerns, and the study was opened for patient enrollment in the United States. Our new production facility in Princeton is ready to produce the batches for the U.S. patients in the trial."

Recent Business Highlights

Patient enrollment is on track in TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer. Clinical trial authorizations have been obtained in all twelve participating countries, eleven countries in Europe plus the United States, and the trial is actively enrolling patients in close to 50 clinical sites in Europe.

TRYbeCA1 was opened for patient enrollment in the United States last week, and the first of a total of approximately 30 planned U.S. sites were activated.

The newly established U.S. manufacturing facility in Princeton, N.J. is ready to produce clinical batches, and will supply eryaspase for the U.S. patients in the TRYbeCA1 trial.

Separately, also last week, the independent data monitoring committee (IDMC) reviewed the safety data of the first 150 patients enrolled and treated in the TRYbeCA1 trials. No safety issues were identified and the IDMC recommended to continue the trial as planned.

Q3 2019 Financial Results

Key financial figures for the first nine months of 2019 compared with the same period of the previous year are summarized below:

Net loss for the first nine months of 2019 was €43.3 million, up €13.6 million (+46%) as compared to the same period in 2018, with a €13.2 million increase (+39%) in operating loss and a €0.4 million decrease in financial income. The €13.2 million increase in operating loss was attributable to the €11.3 million increase in preclinical and clinical development expenses, mostly related to expenses incurred related to the Company’s Phase 3 clinical trial in pancreatic cancer, the €3.2 million increase in G&A expenses, of which €1.9 million related to the launch readiness of the Company’s additional manufacturing capacity, and the €1.2 million increase in operating income, of which €0.9 million upfront payment from the license agreement with SQZ Biotechnologies.

As of September 30, 2019, ERYTECH had cash and cash equivalents totaling €81.9 million (approximately $89.2 million), compared with €134.4 million on December 31, 2018 and €94.5 million at the end of June 2019. The €52.4 million decrease in cash position in the first nine months of 2019 was the result of a €55.6 million net cash utilization, comprised of a €36.7 million net cash utilization in operating activities, €19.3 million used for investing activities and €0.4 million of cash generation in financing activities, while the appreciation in the period of the U.S. dollar against the euro led to a €3.2 million favorable currency exchange impact. After a peak in capital expenditure disbursements in the first quarter of 2019 related to the expansion of the manufacturing facilities in Lyon and in Princeton, cash utilization has slowed in the second and third quarter. The Company’s cash position at the end of September remains in line with the earlier guidance of sufficient cash resources to fund operations until the end of 2020.

Key News Flow and Milestones Expected Over the Next 12 Months

First U.S. patients randomized in TRYbeCA1, the Phase 3 clinical trial in second-line metastatic pancreatic cancer (Q4 2019)

Initiation of investigator sponsored Phase 1 trial in first-line metastatic pancreatic cancer (H1 2020)

Interim results of investigator sponsored Phase 2 trial in second-line acute lymphoblastic leukemia(H1 2020)

Interim (superiority) analysis in TRYbeCA1 (Q3 2020)

Q3 2019 Conference Call Details

ERYTECH management will hold a conference call and webcast on Friday, November 8th, 2019 at 02:30pm CET / 08:30am ET on the business highlights and financial results for the third 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#: 7394954#

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: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 7394954#.

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

Financial Calendar

Next quarterly financial updates:

Business Update and Financial Highlights for the 4th Quarter and Full Year of 2019: March 16, 2020 (after U.S. market close), followed by a conference call and webcast on March 17, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 1st Quarter of 2020: May 6, 2020 (after U.S. market close), followed by a conference call and webcast on May 7, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 2nd Quarter of 2020: September 21, 2020 (after U.S. market close), followed by a conference call and webcast on September 22, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 3rd Quarter of 2020: November 5, 2020 (after U.S. market close), followed by a conference call and webcast on November 6, 2020 (2:30pm CET/8:30am ET)

ERYTECH will Present at the Following Upcoming Investor Conferences:

Jefferies Healthcare Conference, November 20-21, London

◾Salon Actionaria, November 22, Paris

ODDO Investor Conference, January 9, Lyon

LifeSci Advisors Corporate Access Event, January 13-14, San Francisco

About TRYbeCA1

TRYbeCA1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.