On March 16, 2021 Merck, a leading science and technology company, reported that topline data from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant of first-line platinum-based chemotherapy (Press release, Merck & Co, MAR 16, 2021, View Source [SID1234576709]).

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In the study of 159 patients, bintrafusp alfa demonstrated single-agent efficacy and durability with a manageable safety profile after more than nine months of follow-up, with an Independent Review Committee (IRC)-adjudicated objective response rate (ORR) of 10.1% (95% CI: 5.9% to 15.8%) per RECIST 1.1. Though single-agent activity was observed, the study did not meet the pre-defined threshold that would have enabled regulatory filing for BTC in the second line setting. The results will be submitted for presentation at an upcoming medical meeting or publication.

"Given the high unmet treatment need in BTC, where single agent immunotherapy in PD-L1 all comers has shown an ORR of 5.8%, we are encouraged by the single agent clinical activity of bintrafusp alfa in this study as a second-line treatment," said Milind Javle, MD, professor of GI medical oncology, MD Anderson Cancer Center, and an investigator for the INTR@PID BTC 047 study. "The bintrafusp alfa 047 study is one of the most important clinical investigations conducted for chemo-refractory biliary cancers, and I would like to thank the patients, families, and study team for their valuable participation."

"This study demonstrates single-agent activity with bintrafusp alfa in locally advanced or metastatic BTC, a disease that has been historically difficult to treat," said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business sector of Merck. "The data will contribute to our understanding of addressing both TGF-β and PD-L1 inhibition in the tumor microenvironment."

A Phase II/III study of bintrafusp alfa in combination with chemotherapy as a first-line treatment for BTC (INTR@PID BTC 055), which is assessing a different hypothesis than the second-line monotherapy study, has completed enrollment in the Phase II portion and is currently ongoing.

*Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About Biliary Tract Cancer (BTC)

BTCs are a group of rare, aggressive gastrointestinal cancers associated with poor outcomes and limited treatment options. There is currently no globally accepted standard of care in the second-line setting and chemotherapy as well as immunotherapies have demonstrated low response rates in BTC. Epithelial-to-mesenchymal transition (EMT), a hallmark of tumor progression and drug resistance, plays an important role in BTC, and has been shown to be triggered by TGF-β signaling.

About Bintrafusp Alfa

Bintrafusp alfa (M7824), discovered in-house at Merck, and currently in clinical development through a strategic alliance with GSK, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-β and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

About the INTR@PID Clinical Trial Program

INTR@PID is a global clinical trial program investigating the potential co-localized, dual inhibition of TGF-β and PD-L1 with bintrafusp alfa (M7824) in multiple tumor types. Current clinical trial information can be found on the INTR@PID website at www.intrapidclinicaltrials.com. To date, globally more than 1,300 patients with various types of solid tumors have received bintrafusp alfa in the INTR@PID clinical development program.

The INTR@PID clinical development strategy is comprehensive and is pursuing non-redundant hypotheses grounded in preclinical and early clinical data findings that continue to be explored and may yield clinically meaningful insights to patients in need, including exploring settings where simultaneous, synchronized targeting of TGF-β and PD-L1 may offer the key to expanding the potential of immunotherapy; focusing on opportunities where PD-1/PD-L1 has suboptimal clinical activities and pathogenesis linked to TGF-β biology; and targeting specific tumors with biomarkers with a strong link to TGF-β signaling pathway.

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On March 16, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported results for the year ended December 31, 2020 and provides a financial and operational outlook for 2021 (Press release, MorphoSys, MAR 16, 2021, View Source [SID1234576733]).

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Financial Highlights for Full Year 2020

The Company achieved revenues of € 327.7 million (2019: € 71.8 million) and EBIT of € 27.4 million (2019: € -107.9 million).
Monjuvi(R) (tafasitamab-cxix) product sales totaling € 18.5 million (US$ 22 million) since launch in the U.S. in August 2020.
Royalties on net sales of Tremfya amounted to € 42.5 million (2019: € 31.8 million).
Liquidity position of € 1,244.0 million[1] at year-end 2020 (2019: € 357.4 million).
Corporate and Program Updates

Monjuvi (tafasitamab-cxix):

Revenues from Monjuvi product sales of € 14.1 million (US$ 17 million) for Q4.
>400 accounts have ordered Monjuvi by end of 2020.
Share of Voice consistently reaching approximately 50%.
Tafasitamab:

Preliminary data from the firstMIND study in previously untreated DLBCL patients were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) in December 2020; data support the start of the pivotal study in the first half of 2021.
Long-term data of the L-MIND study in patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation, after a follow-up of two years confirming previously reported results. Tafasitamab in combination with lenalidomide resulted in long-lasting remissions. At the time of analysis, patients continued to experience long median duration of response (mDoR) of 34.6 months and median overall survival (mOS) of 31.6 months.
Clinical collaboration between MorphoSys, Incyte and Xencor to investigate the combination of tafasitamab, lenalidomide and plamotamab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL) in November 2020.
The European Marketing Authorization Application (MAA), seeking approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with r/r DLBCL was validated in May 2020 and is currently under review.
Felzartamab (MOR202):

M-PLACE study in autoimmune membranous nephropathy ongoing: safety run-in phase completed and the full enrollment phase opened.
Tremfya(R) (guselkumab):

The European Commission approved in December 2020 the use of Tremfya in the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Corporate Developments:

MorphoSys successfully placed unsubordinated, unsecured convertible bonds due 2025 in an aggregate principal amount of € 325 million in October 2020. The bonds will be convertible into new and/or existing no-par value ordinary bearer shares of MorphoSys.
MorphoSys and Cherry Biolabs entered into a licensing agreement in November 2020 granting MorphoSys the rights to apply Cherry Biolabs’ innovative, multispecific Hemibody technology to six exclusive targets.
Signifcant Events After The Reporting Year:

On January 5, 2021, MorphoSys and Incyte announced that the Swiss Agency for Therapeutic Products (Swissmedic) had accepted the marketing authorization application (MAA) for tafasitamab. The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.
On January 6, 2021, MorphoSys announced the appointment of Sung Lee as Chief Financial Officer, effective February 2, 2021. Mr. Lee succeeds Jens Holstein, who stepped down in December 2020, and will lead all corporate finance functions as a member of the Management Board of MorphoSys AG. He will be based in Planegg, Germany.
On January 12, 2021, MorphoSys and Incyte announced that the Health Canada had accepted the New Drug Submission (NDS) for tafasitamab. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, ASCT.
On January 25, 2021, MorphoSys and I-Mab announced that the first patient had been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MOR210/TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States.
In February 2021, the first patient with autoimmune membranous nephropathy was dosed with felzartamab in the New-PLACE study, a phase 2 study evaluating different treatment schedules to identify the regimen for the pivotal study.
On March 2, 2021, we announced that our partner GSK reported preliminary results of the OSCAR study using otilimab for the treatment of severe pulmonary COVID-19 related disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings. The dosing of the first patient in the expanded study triggered milestone payments of € 16 million to MorphoSys.
"2020 was a transformational year for MorphoSys. Despite the challenges brought on by the global pandemic, we delivered one of the most successful years as a company. The accelerated FDA approval of Monjuvi was an important milestone in our transformation into an integrated commercial-stage biopharma company," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We believe tafasitamab has the potential to transform the standard of care and could be a potential backbone in DLBCL, along with being a combination partner of choice in other hematological malignancies. Beyond tafasitamab, we were also able to progress felzartamab, which is being developed in autoimmune membranous nephropathy, an autoimmune disease affecting the kidney. In 2021, the focus will be on executing on our ambitious goals: continuing to drive the launch of Monjuvi and provide access to patients with DLBCL, advance tafasitamab in potential first line setting and other non-Hodgkin’s lymphoma indications, further develop felzartamab, and expand our pipeline. With our strong balance sheet and a liquidity position of more than € 1.2 billion, we are well positioned to execute on our growth strategy."

Financial Review for the Full Year 2020 (IFRS)

In 2020, MorphoSys continued to focus on applying its proprietary technology and expertise to the research and development of innovative drug candidates. Group revenues for 2020 increased to € 327.7 million (2019: € 71.8 million).

Revenues for 2020 include € 255.8 million stemming from the collaboration and license agreement with Incyte, royalties of € 42.5 million (2019: € 31.8 million) on net sales of Tremfya as well as revenues from Monjuvi product sales totaling € 18.5 million (US$ 22 million) since launch in August 2020.

In the Proprietary Development segment, MorphoSys focuses on research and clinical development of its own drug candidates in the fields of cancer and inflammation. In 2020, this segment recorded revenues of € 278.6 million (2019: € 34.3 million). This increase was mainly due to revenues in the amount of € 255.8 million from the collaboration and license agreement with Incyte as well as revenues from Monjuvi product sales of € 18.5 million (US$ 22 million).

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. Revenues in the Partnered Discovery segment increased from € 37.5 million in 2019 to € 49.1 million in 2020. This increase included primarily performance-based payments of € 46.4 million in 2020 and € 33.2 million in the previous year. The performance-based payments were mainly related to royalties from Janssen for net sales with Tremfya of € 42.5 million in 2020 and of € 31.8 million in 2019.

In 2020, cost of sales decreased to € 9.2 million (2019: € 12.1 million).

Total operating expenses in 2020 increased to € 309.7 million from € 179.9 million in 2019, driven by an increase of research and development expenses, selling expenses and general and administrative expenses.

In 2020, research and development expenses amounted to € 141.4 million, as compared to € 108.4 million in 2019. Growth over 2019 reflects primarily the increased investment to support the advancement of proprietary programs and impairment charges taken against legacy deals.

Selling expenses increased to € 107.7 million (2019: € 22.7 million) and general and administrative expenses increased from € 36.7 million in 2019 to € 51.4 million in 2020. Increases for both categories reflect higher expenses for personnel and external services.

Earnings before interest and taxes (EBIT) amounted to € 27.4 million (2019: € -107.9 million). The Proprietary Development segment reported an EBIT of € 22.9 million (2019: € -109.1 million). EBIT in the Partnered Discovery segment was € 37.4 million (2019: € 26.8 million). In 2020, a consolidated net profit was generated of € 97.9 million (2019: € -103.0 million). In 2020 the earnings per share basic was € 3.01 and the earnings per share diluted was € 2.97. In 2019 the earnings per share, basic and diluted was € -3.26.

At year-end 2020, the Company had a liquidity1 position of € 1,244.0 million compared to € 357.4 million at the end of 2019.

The number of shares issued totaled 32,890,046 at year-end 2020 (year-end 2019: 31,957,958).

Financial Guidance and Operational Outlook for 2021

For 2021, MorphoSys expects to generate Group revenues in the range of € 150 to € 200 million. This forecast includes the recently announced € 16 million milestone payments from GSK, but excludes other potential significant milestones from development partners and/or licensing partnerships. The range also captures the potential for variability from the first full year of the Monjuvi product launch and the impact from the COVID-19 pandemic which is anticipated to be greater in the first half 2021.

Operating expenses, inclusive of Incyte’s share of Monjuvi selling expenses, are anticipated to be in the range of € 355 to € 385 million with R&D expenses expected to represent 45-50% of this amount. The R&D expenses represent our continuing investment in the development of tafasitamab, felzartamab, early-stage development programs, and further development of our technologies.

For its proprietary projects, MorphoSys expects the following events and activities in 2021:

Tafasitamab

Continue the phase 1b trial of tafasitamab in previously untreated DLBCL (firstMIND);
Initiate a pivotal phase 3 trial of tafasitamab in previously untreated DLBCL (frontMIND);
Initiate a pivotal phase 3 trial (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL);
Investigate tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL, first-line DLBCL and relapsed or refractory follicular lymphoma (r/r FL) jointly with Incyte and Xencor;
Continue the L-MIND study of tafasitamab and evaluate the long-term efficacy and safety data;
Continue the phase 3 trial (B-MIND) of tafasitamab in combination with bendamustine for r/r DLBCL;
Continue the phase 2 COSMOS study with tafasitamab in CLL/SLL in combination with idelalisib and venetoclax;
Collaborate with Incyte for the initiated regulatory submissions to the EMA, support Incyte for regulatory submissions to Swissmedic and Health Canada for tafasitamab in combination with lenalidomide for r/r DLBCL; and
Support Incyte in submitting marketing authorization applications in other markets.
Felzartamab (MOR202)

Continue the clinical development of felzartamab (MOR202) in autoimmune membranous nephropathy and generate data from the phase 1/2 trial M-PLACE (proof-of-concept);
Continue treatment schedule finding study (New-PLACE) in autoimmune membranous nephropathy; and
Support partner I-Mab in its regulatory filing (BLA) for felzartamab (MOR202/TJ202) for multiple myeloma in China.
For projects that are developed by partners, MorphoSys expects the following events in 2021:

Otilimab: Publication of results of the OSCAR study using otilimab for the treatment of severe pulmonary COVID-19 related disease by partner GSK (preliminary results published in February 2021).

* Percentage point
** Tremfya and Monjuvi are still considered as clinical programs due to ongoing studies in various indications and/or treatment lines
*** Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK

MorphoSys will hold its conference call and webcast tomorrow, March 16, 2021, to present the full year 2020 results and the outlook for 2021.

A live webcast and slides will be made available at View Source

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

Consolidated Financial Statements 2020 (IFRS) are available for download at:
View Source

About Monjuvi(R) (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.
Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

On March 16, 2021 COTA, Inc., an oncology real-world data and analytics company, reported a collaboration with Kite, a Gilead company, through which COTA’s real-world data will be used to accelerate Kite’s drug development pipeline (Press release, COTA, MAR 16, 2021, View Source [SID1234576750]). This approach will help inform decisions about future therapeutic applications for blood cancers while inspiring new ways of thinking about how clinical trials are designed.

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The use of real-world data (RWD) is expanding as it is increasingly used in a complementary role to support, clarify, or accelerate randomized clinical trials. Kite will work closely with oncologists, data scientists, and researchers at COTA to develop and validate real-world endpoints and accelerate the clinical development timeline for patient benefit.

"COTA’s real-world data will be used to accelerate Kite’s drug development pipeline." – COTA CEO Mike Doyle

"At COTA, we pride ourselves not just on the high quality of the data we deliver to our partners, but also on our ability to collaborate with sponsors to inform clinical research and get the best drugs to patients more efficiently," said Mike Doyle, CEO of COTA. "With the support of the FDA, Kite and many others, COTA is helping to pioneer the use of RWD in clinical research with the ultimate goal of accelerating clinical development, reducing healthcare costs, and helping cancer patients live longer, healthier lives."

COTA provides comprehensive and diverse cancer RWD to leading life sciences and healthcare provider organizations that are caring and developing treatments for patients living with a wide range of cancers. COTA uniquely combines its oncology expertise with technology-enabled human data abstraction to curate meaningful, longitudinal, and de-identified patient data. As RWD is increasingly applied in clinical development, COTA’s customized data sets can help increase patient diversity in clinical trials; expand indications of already approved drugs; replace the traditional standard-of-care or placebo group via a RWD-powered synthetic control arm; and empower life sciences companies to make faster decisions on their pipeline.

On March 16, 2021 Acepodia, a biotechnology company developing next generation solid tumor and hematologic cancer cell therapies, reported the closing of its $47 million Series B financing (Press release, Acepodia, MAR 16, 2021, View Source [SID1234579659]). The funding will be used to advance the company’s lead off-the-shelf natural killer (NK) cell therapy candidate, ACE1702, through clinical development in solid tumors, and to advance its preclinical NK and gamma delta T cell therapy pipeline into the clinic. Acepodia anticipates completing IND-enabling studies for two additional pipeline products in 2021.

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The funding round was supported by new U.S. institutional investors, including Ridgeback Capital Investments, 8VC, and DEFTA Partners, and the Taiwan-based institutional investor-CDIB Capital Healthcare. Acepodia’s Series A investors also participated.

"This second capital raise for Acepodia represents a strong vote of confidence by our investors in our highly differentiated approach to cell therapy, particularly with NK cells, and in the Company’s potential to provide superior treatment options for patients with cancer," said Sonny Hsiao, Ph.D., founder and chief executive officer of Acepodia. "Accessible and effective allogeneic, off-the-shelf cell therapies will be an important part of next generation cancer therapy. With our discipline and capital efficiency, we are well-positioned to execute on our corporate objectives, including the continued clinical development of these therapies, including our lead candidate, ACE1702 for the treatment of solid tumors, and execution of future clinical trial initiations for our promising preclinical portfolio of NK and NK-like gamma delta T cell therapy candidates."

Wayne Holman, M.D., Chief Executive Officer and Founder of Ridgeback Capital, added, "We are excited to participate in this financing for Acepodia as we are believers in the foundational evidence suggesting cell therapies should play a significant role in the future of cancer therapy. We believe the prior success of Acepodia’s leadership group in cell therapies, and the unique Antibody-Cell Conjugation (ACC) technology when applied to allogeneic off-the-shelf cryopreserved NK cells could lead to enhanced and differentiated results."

Acepodia’s technology enables development of cell therapies with improved tumor engagement and targeting through optimized cell receptor selection, and seamless conjugation with antibody therapies. Utilizing its proprietary, patent-protected Antibody-Cell Conjugation (ACC) technology, Acepodia is able to directly conjugate and arm NK or gamma delta T cells with validated anti-tumor antibodies for cell therapies, a design which has demonstrated the ability to overcome traditionally resilient tumor defenses in preclinical trials. The company is currently conducting an ongoing Phase 1 clinical trial of ACE1702, the first antibody-conjugated NK cell therapy in clinical development for the treatment of HER2-expressing solid tumors.

On March 16, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company"), reported that the Company will hold a conference call on Thursday, March 18, 2021 at 2 p.m. CET / 9 a.m. ET, following the release of its financial results for the full year ending December 31, 2020 (Press release, Innate Pharma, MAR 16, 2021, View Source [SID1234576710]).

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Presenting during the call will be Innate Pharma’s Chief Executive Officer Mondher Mahjoubi, MD, Chief Financial Officer Laure-Hélène Mercier and Chief Medical Officer Joyson Karakunnel, MD, MSc, FACP.

Details for the Virtual Event

The live webcast will be available at the following link:
View Source

Participants may also join via telephone to ask questions by registering in advance of the event at View Source Upon registration, participants will be provided with dial-in numbers, a direct event passcode and a unique registrant ID that they may use 10 minutes prior to the event start to access the call. Call reminders will also be sent to registered participants via e-mail the day prior to the event.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.