On May 20, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2021 (Press release, Tracon Pharmaceuticals, MAY 5, 2021, View Source [SID1234579186]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to be pleased with the pace of enrollment in the pivotal ENVASARC trial and remain on track to deliver interim data in the 2nd half of this year and final data in 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We have now initiated 22 sites and have enrolled more than 20 patients which has triggered the initial Data Monitoring Committee review of safety data from each cohort, which we expect later this quarter."

Recent Corporate Highlights

Envafolimab

In April, we resubmitted our Orphan Drug Designation application to the FDA in response to a request for preclinical or clinical evidence of activity for envafolimab in sarcoma. We expect correspondence from the FDA this quarter based on the amended application.

As of May 5, we have initiated 22 U.S. clinical sites and enrolled more than 20 patients in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy, which has triggered the initial Data Monitoring Committee review of safety data from each cohort.
Expected Key Upcoming Milestones

Orphan Drug Designation for envafolimab in soft tissue sarcoma from FDA in 1H 2021.

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) presentation of ENVASARC pivotal trial design in 1H 2021.

ASCO presentation of TJ004309 Phase 1 data in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Request FDA breakthrough therapy designation or Fast Track designation for envafolimab in 2H 2021.

Decision on the envafolimab New Drug Application (NDA) in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration (NMPA).
First Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $30.4 million at March 31, 2021, compared to $36.1 million at December 31, 2020. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the first quarter of 2021 were $2.3 million, compared to $2.0 million for the first quarter of 2020.

General and administrative expenses for the first quarter of 2021 were $2.7 million, compared to $1.9 million for the first quarter of 2020.

Net loss for the first quarter of 2021 was $5.1 million, compared to $4.0 million for the first quarter of 2020.
Conference Call Details

Wednesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 8852857
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 5, 2021 Race Oncology Limited (ASX: RAC) reported that it has received binding commitments to raise $5.4m (before associated costs) in an oversubscribed equity placement to new and existing institutional and sophisticated investors (Placement), and the commencement of a bonus issue of options to existing eligible shareholders of Race (Bonus Option Issue) (Press release, Race Oncology, MAY 5, 2021, View Source [SID1234580021]).

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"This new funding supports efforts to deliver outsized returns to shareholders via our Three Pillar strategy, where we are investigating Bisantrene as both a potential precision oncology agent, and as a heart-friendlier chemotherapeutic. We appreciate the amount of interest shown in both Race and Bisantrene through this process and thank all those who participated in the Placement."

Race’s CEO and Managing Director, Phil Lynch
"We thank our new and existing shareholders for their continuing support. We believe that this raise will accelerate our plans and rewards our loyal shareholders. Race remains efficient with our capital usage and will always be focused on achieving the best outcome for our shareholders and the patients who may be helped by Bisantrene."

Dr Daniel Tillett, Race’s CSO and Executive Director
About the Placement
Race will raise $5.4m (before associated costs) under the Placement by the issue of approximately 1.8m new fully paid ordinary shares (New Shares) at an issue price of $3.00 per share. The issue price represents a 2.3% discount to the last traded price and an 7.8% discount to the 10-day volume weighted average price of $3.25.

Participants in the Placement will receive 1 free attaching option (exercisable at $4.50 and expiring 16 May 2022) (Placement Option) for every 20 New Shares subscribed for and issued under the Placement. The Placement, including the Placement Options, is not subject to shareholder approval.

The cornerstone investor to the Placement was existing Race shareholder, Merchant Opportunities Fund. Merchant Opportunities Fund is a boutique fund with a number of long-term, strategic investments in the Australian biotechnology industry. Race accepted bids above $5m to cover all costs in managing the Placement leaving approximately $5m for planned activities.

Merchant Capital Partners Pty Ltd and MST Financial Services Pty Ltd acted as Joint Lead Managers and bookrunners to the Placement. IR Department provided investor relations support.

The New Shares and Placement Options are expected to be allotted and issued by 14 May 2021 and New Shares will rank equally with the existing ordinary shares on issue. The New Shares and Placement Options will be issued pursuant to the Company’s existing placement capacity under ASX listing rule 7.1.

Use of Funds
The Placement provides Race with additional capital to be primarily deployed toward its Three Pillar strategy and supporting plans:

Pillar 1: Phase 1 dose escalation trial to determine optimal FTO-targeted Phase II dosage
Pillar 2: Preclinical study to determine the molecular mechanism of action of Bisantrene’s heart safety
Pillar 3: Initiation of studies in Europe and the United States to support extramedullary Acute Myeloid Leukaemia clinical trials
Corporate: scaled manufacturing of Bisantrene to support Phase II/III trials
About the Bonus Option Issue
Race is also pleased to announce a pro-rata non-renounceable Bonus Option Issue (exercisable at $4.50 and expiring 16 May 2022) (Bonus Options) to existing eligible shareholders on the basis of 1 Bonus Option for every 20 shares held on the record date.

The primary purpose of the Bonus Option Issue is to reward loyal shareholders in Race, while efficiently growing the Company.

The Bonus Option Issue is being extended to eligible shareholders who have a registered address in Australia or New Zealand at 7:00 pm AEST on 13 May 2021.

The Bonus Options and the Placement Options will be in the same class and will not be listed. The details of the offer are contained in the Bonus Option Prospectus below.

On May 5, 2021 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended March 31, 2021 (Press release, Allogene, MAY 5, 2021, View Source [SID1234579206]).

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"We’ve had a strong start to the year as evidenced by the significant clinical and regulatory progress made across our growing AlloCAR T portfolio, including the start of our first solid tumors study," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We believe our progress demonstrates our ability to advance the field of allogeneic CAR T cell therapy and we look forward to sharing data from our CD19 program on May 19th during our virtual forum event."

Pipeline Highlights

Anti-CD19 Program

Updated data from the dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 study of ALLO-501A at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The presentation will include longer-term follow-up from the initial cohort of patients reported at ASCO (Free ASCO Whitepaper) 2020, additional data on patients treated subsequent to ASCO (Free ASCO Whitepaper) 2020, dose escalation data from ALPHA2, and initial results from patients treated with consolidation dosing of ALLO-501 and ALLO-501A. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory NHL and multiple myeloma.
Subject to further study progress and data, the Company plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021.
On May 19, 2021, the Company will host a virtual CD19 Forum focused on clinical data being presented at ASCO (Free ASCO Whitepaper), along with the Company’s vision for the future of CAR T therapy. In addition to presentations from Company management, the Forum will include a discussion with clinical investigators.
Anti-BCMA Program
The Company continues to execute on its portfolio of anti-B cell maturation antigen (BCMA) therapies in patients with multiple myeloma (MM).

ALLO-715 UNIVERSAL Trial
The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715, Allogene’s most advanced AlloCAR T candidate for relapsed/refractory MM. The designation follows proof-of-concept data from the Phase 1 UNIVERSAL trial in heavily pretreated, relapsed/refractory MM patients, which demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve clinical responses while eliminating the need for bridging therapy or delays in treatment associated with manufacturing.

Patient dosing has begun in the portion of the UNIVERSAL trial investigating ALLO-715 in combination with nirogacestat in patients with relapsed/refractory MM. Nirogacestat is an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics.

ALLO-605 TurboCAR IGNITE Trial
The FDA cleared the Investigational New Drug (IND) application to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in relapsed/refractory MM. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells to potentially improve efficacy, overcome exhaustion, and reduce cell dose requirements. The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.
Solid Tumor Program

ALLO-316 TRAVERSE Trial
Patient dosing has begun in the Phase 1 TRAVERSE trial examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316, Allogene’s first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma.

Expanded TurboCAR Platform
In April 2021, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company reported on pre-clinical data that expands the TurboCAR technology platform to address the biology of solid tumor oncology. TurboCARs were engineered to confer cytokine signaling that is inducible upon binding to PDL1 in the tumor microenvironment or when stimulated with an anti-PD1 antibody while acting as a dominant negative for PDL1 and PDL2 immunosuppressive signaling. These TurboCARs are designed to overcome the challenges in solid tumors associated with an immuno-suppressive tumor microenvironment (TME) by turning negative signals into positive signals.
First Quarter Financial Results

Research and development expenses were $55.2 million for the first quarter of 2021, which includes $7.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $16.4 million for the first quarter of 2021, which includes $8.9 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2021 was $33.0 million, or $0.25 per share, including non-cash stock-based compensation expense of $16.8 million.
The Company had $964.2 million in cash, cash equivalents, and investments as of March 31, 2021.
2021 Financial Guidance
Allogene continues to expect full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 9435559. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Virtual CD19 Forum
Additional information on the Company’s May 19 Virtual CD19 Forum will be made available in a separate press release and on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event.

On May 5, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the Company’s CEO, Eric Ostertag, MD, PhD, will present at the BofA Securities 2021 Virtual Health Care Conference on Wednesday, May 12, 2021 at 2:45pm ET (Press release, Poseida Therapeutics, MAY 5, 2021, View Source [SID1234579222]).

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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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A webcast of the presentation will be available on the Investors & Media Section of the Poseida website, www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.

On May 5, 2021 MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported its financial results for the first quarter of 2021 (Press release, MorphoSys, MAY 5, 2021, View Source [SID1234579187]).

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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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"For 2021, our focus is on three key areas: executing on the Monjuvi launch; rapidly advancing the tafasitamab backbone strategy through additional clinical studies; and expanding our pipeline," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "While we experienced headwinds from the pandemic in the first quarter, we are cautiously optimistic that the COVID-19 impact in the U.S. will start to diminish in the second half of 2021. We are confident in the potential of Monjuvi given its broad second-line label and overall profile in the r/r DLBCL setting. We are also making important progress initiating key trials for both tafasitamab and felzartamab this year."

Tafasitamab Highlights

Monjuvi(R) (tafasitamab-cxix) U.S. net product sales of € 12.9 million (US$ 15.5 million).
Monjuvi was granted a product-specific HCPCS J-Code, effective April 1, 2021.
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 and on January 12, 2021, MorphoSys and Incyte announced that Health Canada had accepted the New Drug Submission (NDS) for tafasitamab. Both applications seek 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 eligible for, or refuse, autologous stem cell transplantation (ASCT).
Pipeline Highlights

Felzartamab:

M-PLACE study of felzartamab in autoimmune membranous nephropathy ongoing: the safety run-in phase was completed and the full enrollment phase opened.
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.
Otilimab:

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 totaling € 16 million to MorphoSys.
MOR210:

On January 25, 2021, MorphoSys and I-Mab announced that the first patient has 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.
Corporate Updates

On January 6, 2021, MorphoSys announced the appointment of Sung Lee as Chief Financial Officer, effective as of February 2, 2021.
Significant Events After The Reporting Period

On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

First Quarter 2021 Financial Results (IFRS)

Total revenues for the quarter ended March 31, 2021 were € 47.2 million compared to € 251.2 million for the comparable period in 2020. The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the USA.

Cost of Sales: In the first three months of 2021, cost of sales increased to € 5.0 million (3M 2020: € 3.3 million).

Research and Development (R&D) Expenses: In the first three months of 2021, research and development expenses were € 33.3 million (3M 2020: € 21.5 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.

Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first three months of 2021 to € 28.2 million (3M 2020: € 12.8 million) and general and administrative expenses remained almost unchanged at € 10.3 million (3M 2020:€ 10.1 million). The year-over-year increase in selling expenses was primarily driven by the full quarter impact of the expenses for services provided by Incyte as part of the joint U.S. marketing activities for Monjuvi.

Operating Loss: Operating loss amounted to € 29.6 million in the first three months of 2021 (3M 2020: operating profit of € 203.5 million).

Consolidated Net Loss: For the first three months of 2021, consolidated net loss was € 41.6 million (3M 2020: consolidated net profit of € 195.5 million).

Cash and Investments: As of March 31, 2021, the Company had cash and investments of € 1,215.0 million compared to € 1,244.0 million on December 31, 2020.

Number of shares: The number of shares issued remained unchanged since year-end 2020 and totaled 32,890,046.

Financial Guidance and Operational Outlook for 2021

*Group revenues includes the announced € 16 million milestone payments from GSK, but excludes other potential significant milestones from development partners and/or licensing partnerships. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner’s business operations.

**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte’s share of Monjuvi selling costs in the USA.

MorphoSys expects for Tafasitamab the following events and activities in 2021:

Continuation of the phase 1b trial with tafasitamab in previously untreated DLBCL (firstMIND);
Initiation of a pivotal phase 3 trial of tafasitamab in previously untreated DLBCL (frontMIND);
Continuation of the phase 3 inMIND trial of tafasitamab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL);
Investigation of 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;
Continuation of the L-MIND study of tafasitamab and evaluate the long-term efficacy and safety data;
Continuation of the phase 3 B-MIND study of tafasitamab in combination with bendamustine for r/r DLBCL;
Presentation of data from the 3-year follow up of L-MIND as well as other abstracts at several scientific conferences (e.g. ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper));
Decision on 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 which is currently under review;
Support of Incyte in submitting marketing authorization applications in other markets.
MorphoSys will hold its conference call and webcast tomorrow, May 6, 2021, to present the results for the first quarter of 2021 and the further outlook for 2021.

A live webcast and slides will be made available at the Media and Investors section under Conferences on MorphoSys’ website at View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The interim statement for the first quarter of 2021 (IFRS) is available online:
View Source/Reports

About tafasitamab
Tafasitamab 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(R) (tafasitamab-cxix) 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). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being 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.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

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