On September 7, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2020 (Press release, Innate Pharma, SEP 7, 2020, View Source [SID1234564709]). The consolidated financial statements are attached to this press release.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In the first half of 2020, Innate has made meaningful progress across its portfolio, quickly resuming enrollment in the lacutamab Phase 2 study, TELLOMAK, for patients with Sézary syndrome and mycosis fungoides," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "In the second half of the year, our partner, AstraZeneca, expects to initiate the Phase 3 clinical study for monalizumab in combination with cetuximab in IO-pretreated patients with recurrent or metastatic head and neck squamous cell cancer. This represents a significant clinical and financial milestone, as we progress our first Phase 3 asset and advance a promising, potentially first-in-class treatment for a patient population that needs novel, effective and tolerable therapies. More broadly, we continue to execute on our long-term strategy, transitioning into a global commercial-stage biotech company as we assume full US commercial responsibilities for Lumoxiti by the end of the year."

Webcast and conference call will be held today at 2:00pm CEST (8:00am ET)

Webcast access: View Source
or Dial in numbers:
France: +33 (0)1 70 70 07 81 US only: + 1 877 870 9135
Standard International: +44 (0) 2071 928338
Conference ID: 7368163

The presentation and access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference.
A replay will be available on Innate Pharma’s website after the conference call.

Financial highlights for the first half of 2020:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2020 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €184.6 million (€m) as of June 30, 2020 (€255.9m as of December 31, 2019).
Revenue and other income amounted to €36.7m in the first half of 2020 (€59.2m in the first half of 2019) and mainly comprise of:
Revenue from collaboration and licensing agreements, which mainly resulted from the spreading of the upfront and opt-in payments received from AstraZeneca (LSE/STO/NYSE: AZN):
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €4.7m to €19.6m in the first half of 2020 (€24.3m in the first half of 2019), due to a catch up on the period of a non material decrease in the collaboration budget; and
(ii) Revenue from collaboration and licensing agreements for IPH5201 decreased by €13.8m to €8.7m in the first half of 2020 (€22.5m in the first half of 2019), primarily due to an extension of the recognition period of such revenue after the renewal in November 2019 of the collaboration with AstraZeneca for 12 months.
Revenue from invoicing of research and development (R&D) costs for avdoralimab (IPH5401) and IPH5201 was €1.1m the first half of 2020 (€4.4m in the first half of 2019), after IPH5201 transitioned to Phase 1, which is carried out and paid by AstraZeneca.
Government funding for research expenditures of €6.9m in the first half of 2020 (€7.6m in the first half of 2019).
Operating expenses of €46.0m in the first half of 2020 (€45.9m in the first half of 2019), of which 68.5% (€31.5m) are related to R&D.
R&D expenses decreased by €5.1m to €31.5m in the first half of 2020 (€36.6m in the first half of 2019), following the completion of regulatory work for certain pipeline programs, including the Lumoxiti filing in Europe and the Phase 1 transition of IPH5201 to AstraZeneca.
Selling, general and administrative (SG&A) expenses increased by €5.2m to €14.5m in the first half of 2020 (€9.3m in the first half of 2019) primarily as a result of the structuration of the US subsidiary and commercialization of Lumoxiti.
The Lumoxiti distribution agreement generated a net income of €0.9m in the first half of 2020 (net loss of €3.8m in the first half of 2019) primarily as a result of the transition of commercial costs from AstraZeneca to Innate Pharma.
A net financial loss of €2.0m in the first half of 2020 (net financial income of €3.8m in the first half of 2019), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 outbreak on the financial markets.
A net loss of €10.3m for the first half of 2020 (net income of €13.2m for the first half of 2019).

On September 7, 2020 ACT Genomics reported that the completion of the first closing of the latest round of equity financing from a group of strategic investors including Aflac Ventures LLC and Kyoto University Innovation Capital (Press release, ACT Genomics, SEP 7, 2020, View Source [SID1234564708]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are very pleased to have reputable strategic investors from USA and Japan participating in the first closing of our latest round of equity fund raising which will further strengthen our capital base and will provide strategic value for our business expansion in Asia and globally. New capital from this round of investment will support ACTG’s strategic plan to further expand our technology, product portfolio and global presence. Partnering with our new strategic shareholders will enable ACTG to become a global player in cancer genomic diagnostics," said Dr. Hua Chien Chen, Co-Founder and CEO of ACTG.

ACTG is a leading DNA sequencing-based cancer solution provider and transforms science into actionable solutions empowering clinicians and patients with evidence-based information to fight cancer. Company’s mission is to provide every cancer patient personalized genomic information-based treatment plans. ACTG currently has Next Generation Sequencing ("NGS") labs in Taiwan, Hong Kong and Japan. Leveraging this strategic lab footprint, it also has operations throughout Asia, catering to the unmet precision medicine needs in the local markets.

On September 7, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL) (Press release, Ascentage Pharma, SEP 7, 2020, View Source [SID1234564706]). This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. This ODD from the FDA qualifies APG-2575 for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by the FDA, and most importantly, 7 years of US market exclusivity upon approval for the treatment of CLL.

CLL is a form of leukemia among adults, characterized by progressive accumulation of abnormal lymphocytes cells in the peripheral blood, bone marrow and lymphoid tissues. The American Cancer Society estimates the U.S will have approximately 21,040 new cases of CLL and about 4,060 deaths from the disease in 2020[1]. The most recent SEERs update reiterates that the prevalence of CLL remains below 200,000 in the USA[2]. Development of Bruton tyrosine kinase (BTK) inhibitors and Bcl-2 inhibitors have improved the outcomes of patients with CLL; however, there is still the medical needs for therapies with improved safety profile and shortened ramp-up schedule that achieve deep responses with shorter duration of treatments especially for chemotherapy free regimens in CLL.

APG-2575 is a novel, orally administered Bcl-2 selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is one of the few Bcl-2 selective inhibitors currently in active clinical development worldwide and the first China-developed Bcl-2 selective inhibitor having entered clinical trials in China. APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US in a range of hematologic malignancies, including a global Phase Ib/II clinical study of APG-2575 as a single agent or in combination with other therapeutic agents in patients with relapsed/refractory CLL/ SLL (small lymphocytic lymphoma). The study is currently recruiting in US and Australia.

"At present, CLL still presents considerable unmet medical needs. APG-2575 is a key drug candidate in Ascentage Pharma’s pipeline targeting apoptosis. The APG-2575 received this ODD from the FDA shortly after the first ODD in WM, and this designation will be helpful in enhancing our communication with the FDA and expediting our development of APG-2575 in these rare cancer diseases," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "All the policy support and incentives as a result of this ODD will help us accelerate the global clinical development of APG-2575, which we hope will soon offer additional treatment options for patients with CLL."

References:

1. Cancer Statistics 2020, American Cancer Society

2. 2020 Cancer Incidence Data, Surveillance, Epidemiology, and End Results Program, National Cancer Institute

About APG-2575

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced Phase I studies of AGP-2575 single agent in China, Australia, and the United States. Since March 2020, the company has received approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, and is advancing clinical development of APG-2575 for a variety of hematologic malignancy indications, including relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström macroglobulinemia, relapsed/refractory multiple myeloma, and relapsed/refractory acute myeloid leukemia. APG-2575 was recently granted two orphan drug designations by the US Food and Drug Administration in the treatment of Waldenström Macroglobulinemia and Chronic Lymphocytic Leukemia.

On September 7, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will present four posters with data relevant to its GB001 and GB002 programs at the Virtual European Respiratory Society International Congress 2020, which takes place from September 7th through 9th (Press release, Gossamer Bio, SEP 7, 2020, View Source [SID1234564705]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details for presentations related to GB001, an oral DP2 antagonist for eosinophilic asthma and chronic rhinosinusitis (CRS), are as follows:

Session Type: E-Poster Session
Session Title: Clinical and laboratory pharmacology in asthma (Session 109)
Abstract Number: 2922
Poster Code: 1420
Poster Title: GB001 is a potent, insurmountable DP2 antagonist with long receptor residence time and extended pharmacodynamic effects
Link: View Source

Session Type: E-Poster Session
Session Title: Clinical and laboratory pharmacology in asthma (Session 109)
Abstract Number: 2915
Poster Number: 1421
Poster Title: GB001, a selective prostaglandin D2 receptor 2 antagonist, blocks signaling in the peripheral blood of healthy subjects
Link: View Source

Session Type: E-Poster Session
Session Title: Asthma science: novel targets and mechanisms (Session 193)
Abstract Number: 2885
Poster Number: 2902
Poster Title: GB001 potently inhibits PGD2 metabolite-induced DP2-mediated cell signaling and eosinophil activation
Link: View Source

Details for a presentation related to GB002, an inhaled PDGFR inhibitor for pulmonary arterial hypertension (PAH), are as follows:

Session Type: E-Poster Session
Session Title: Pathophysiology of pulmonary hypertension (Session 231)
Abstract Number: 2551
Poster Number: 3550
Poster Title: Pharmacologic characterization of GB002, a novel inhaled PDGFR kinase inhibitor in development for pulmonary arterial hypertension (PAH)
Link: View Source

On September 7, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe, a therapeutic equivalent generic version of Faslodex (fulvestrant) Injection, 250 mg/5 mL (50 mg/mL), approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, SEP 7, 2020, View Source [SID1234564704]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Faslodex brand and generic market had U.S. sales of approximately $­­­­­407 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes.

Please click here full prescribing information.

Faslodex is a trademark of the AstraZeneca group of companies.

*IQVIA Retail and Non-Retail MAT June 2020

RDY-0820-306